1 15 51 https://www.nal.usda.gov/exhibits/speccoll/files/original/831290c6971ca2ec6a8b06b08dcea0f3.pdf 8e688da38c25fbfbc1ef0deb7f735230 PDF Text Text Item ID Number °1846 Author Goldberg, Jack Corporate Author Roport/Artlde Title Typescript: The Vietnam Era Twin (VET) Registry: Ascertainment Bias Journal/Book Title 0000 Month/Day Color Number of Images DeSGTipton NOtGS D 38 Alvin L Youn 9filed this item under "Vietnam Veterans Twin Study." Wednesday, July 11, 2001 Page 1847 of 1870 �The Vietnam Era Twin (VBT) Registry: Ascertainment Bias Jack Goldberg Ph.D. University of Illinois, School of Public Health and Mines VA Cooperative Studies Coordinating Center, Hines, IL William True, Ph.D. Psychiatry & Research Services St. Louis VA Medical Center, St. Louis, MO and St. Louis University School of Medicine Seth Eisen, M.D. Research Service, St. Louis VA Medical Center, St. Louis, MO and Washington University School of Medicine William Henderson, Ph.D. Hines VA Cooperative Studies Coordinating Center, Hines, IL C. Dennis Robinette, Ph.D. Medical Follow-up Agency, National Academy of SciencesNational Research Council, Washington, D.C. Work Performed at: Cooperative Studies Program Coordinating Center, Hines VA M e d i c a l Center, Hines, IL; Research Service, St. Louis VA Medical Center, St. Louis, MO; Medical Follow-up Agency, National Academy of Sciences-National Research Council, Washington, D.C. Acknowledgment of Funding: Cooperative Studies program, Study #256, Veterans Administration Medical Research Service Correspondence: Jack Goldberg, Ph.D., Study Epidemiologist, Vietnam Era Twin Study, Hines VA CSPCC (151JO, Hines, IL 60141 USA Running Title: VET Registry: Ascertainment Bias 1 �VET Registry: Ascertainment Bias ABSTRACT An examination of ascertainment bias in the identification of twin pairs in the Vietnam Era Twin Registry has been conducted. A complete listing of all male-male Vietnam era veteran twin pairs born in Connecticut between 1939 and 1955 was obtained (n=150). An attempt was made to match these pairs with a listing of Vietnam era veteran twin pairs derived from the United States Department of Defense's Defense Manpower Data Center (DMDC) computer files. The results indicate that the DMDC files identified only 46.7% of the 150 Connecticut born Vietnam era veteran pairs. Statistically significant differences (p<.05) between pairs found on the DMDC files and Connecticut veteran pairs missing from the DMDC files are observed for the following variables: a) year of discharge from military service, b) total length of active military service, c) branch of service, and d) foreign service. No consistent pattern of bias is observed for factors related to the physical and psychosocial health of veteran pairs. The implications of the ascertainment biases in the Vietnam Era Twin Registry are discussed. �VET Registry: Ascertainment Bias Key Words: Twin registers, Vietnam veterans, Bias, Military service �VET Registry: Ascertainment Bias INTRODUCTION Veterans have claimed that service in Vietnam during the Vietnam War is associated with a wide variety of psychological and physiological illnesses (3,5,7,12). For example, exposure to combat in the war theater may cause Post-Traumatic Disorder (PTSD) (2). Stress Other features of the war having potential long-term effects include exposure to chemicals, diseases endemic to Southeast Asia, and certain medications and illicit drugs (8). In spite of considerable effort to define the relationship between the Vietnam experience and adverse health effects, few well-designed studies exist. To a large extent, this reflects the problems involved with defining a group of veterans who can serve as an adequate non-Vietnam experienced control population. The Vietnam Era Twin Study (VETS) has been suggested as a method for minimizing this problem. In brief, the VETS will assess the effects of the Vietnam experience on health by studying twin pairs concordant on military service but discordant on service in Vietnam. Thus, maximum control of non-Vietnam related hereditary and environmental factors is obtained, since monozygotic twins are genetically identical and monozygotic and dizygotic twins share more common environmental experiences than any other pair of individuals. The first step in the project was the development of a registry of Vietnam era twin pairs. In a companion paper, the rationale and method of construction of the Vietnam Era Twin 4 �VET Registry: Ascertainment Bias (VET) Registry are discussed (6); the purpose of this paper is to evaluate the potential for bias in the Registry. �VET Registry: Ascertainment Bias METHODS AND MATERIALS The examination of ascertainment bias in the VET Registry first required an unbiased source of veteran twin pairs. This unbiased source was provided by the State of Connecticut twin register (1). Based on an exhaustive manual search of hard copy military records at the National Personnel Records Center (NPRC) (6) veteran twin pairs born in Connecticut between 1939 and 1955 were identified (10,11). The completeness of the VET Registry is easily accomplished by attempting to link the veteran twin pairs identified using the Defense Manpower Data Center (DMDC) (9) database (the source of the VET Registry) with veteran twin pairs derived from the Connecticut twin register. Linkage is based on an exact match for social security number and date of birth; matched names were confirmed by manual review. The proportion of all Connecticut born veteran twins found on the DMDC database describes the completeness of VET Register ascertainment. The next step in assessing bias in the VET Registry involved comparing Connecticut born veteran twins found on the DMDC database and those not found on the DMDC database. It is thereby possible to determine if the veteran pairs ascertained via the DMDC database are any different than the veteran pairs missing from the DMDC database. The variables used to compare the groups are derived from two sources: a) the military service record and b) a twenty-four page questionnaire which is administered to all veteran twin pairs as part of the VETS. The variables obtained �VET Registry: Ascertainment Bias from the service record are shown in Table 1; those obtained from the questionnaire are shown in Table 2. (Insert Tables 1 and 2 about here) The statistical analysis presents the data in unpaired form for simplicity. Since the paired analysis of these data show no difference from the unpaired analysis only the unpaired analysis is presented. Hypothesis testing is done using the chi-squared statistic for categorical data except where indicated. For continuously distributed data the t-test is used for hypothesis testing. �VET Registry: Ascertainment Bias RESULTS Completeness of the Vietnam Era Twin Registry A microdata tape transcript of the Connecticut twin register was obtained. This register contained 1,544 male-male twin pairs born between 1939 and 1955. Based on a manual search of hard copy military records at NPRC it was determined that 150 Connecticut born pairs both served on active military duty during the Vietnam era; for these 150 pairs social security numbers were ascertained from the military records. A listing of 15,711 potential veteran twin pairs from the DMDC was also obtained; these potential twins were identified using a matching algorithm based on: a) same last name, different first name, b) same date of birth, and c) same first five digits of the social security number (6). Using the social security number and date of birth an attempt was made to link the 150 Connecticut born veteran twins with the DMDC file of 15,711 potential veteran twin pairs. The record linkage identified 70 pairs that appeared on both files. Thus, the DMDC file contains approximately half (46.7%) of the total number of Vietnam era veteran twin pairs born in Connecticut. It was therefore important to evaluate the VET Register for possible ascertainment bias. Demographic Factors Table 3 presents the distribution of the demographic factors: age, race, education at enlistment, and marital status at 8 �VET Registry: Ascertainment Bias enlistment by DMDC status. Of the demographic factors examined, race demonstrated a marginally significant difference between the two DMDC groups. The non-DMDC group contains a smaller percentage of non-whites compared to the DMDC group (though this difference is difficult to evaluate due to the small number of non-whites). (Insert Table 3 about here) Enlistment Examination Factors Table 4 presents the enlistment examination factors by DMDC status. Both systolic and diastolic blood pressure are measured during the enlistment physical examination. The Department of Defense classifies fitness for military duty on six dimensions: physical, upper extremities, lower extremities, hearing, vision, and neuropsychiatric. For each dimension a rating of 1 (no limitations) to 4 (unfit for duty) is assigned. These six variables have been dichotomized into no limitations versus any limitations. An examination of the enlistment examination factors shows that there are no significant differences between individuals on the DMDC compared to individuals not on the DMDC. (Insert Table 4 about here) Military Service Factors Military service factors (Table 5) are strongly related to the presence of an individual on the DMDC. The mean year of discharge for individuals that appear on the DMDC (x^ = 1971) is �VET Registry: Ascertainment Bias significantly later that the mean year of discharge for individuals who do not appear on DMDC Cx"2 » 1969). Likewise, mean year of enlistment is significantly later in the DMDC group CXi = 1968) compared to the non-DMDC group ("x"2 « 1966). Somewhat more surprising is the significant difference in the mean length of military service; the DMDC group served longer (x^ •> 1,175 days) compared to the non-DMDC group (x^ = 1,027 days). of service is strongly associated with DMDC status. Branch Those individuals who appeared on the DMDC, by comparison with those who did not appear on the DMDC, were more likely to be Navy (33.6 vs 23.1) or Air Force (19.3 vs 10.6) personnel. Lastly, the percent of foreign service was significantly greater for men who appeared on the DMDC (87.0) compared to those who did not (66.0). (Insert Table 5 about here) Vietnam Experience Factors Table 6 presents the distribution of Vietnam experience factors by DMDC status. No significant differences were observed for the percent who served in Vietnam or the mean length of service in Vietnam by DMDC group. However, a marginally significant association exists between the mean year of first rotation through Vietnam and DMDC group, with the DMDC group entering Vietnam an average of one year later than the non-DMDC group. The specific combat roles/experiences are worthy of special discussion. Eighteen specific combat roles/experiences were developed with the assistance of expert consultants in the area 10 �VET Registry: Ascertainment Bias of war stress. The respondent was asked to indicate whether he had experienced a particular combat role/experience while serving in Vietnam. The combat index is created by taking the sum of all positive responses to the 18 combat role/experience questions. The results indicate that four combat role/experiences exhibit an association with DMDC status. For the combat role/experiences of firing an artillery on enemy and receiving incoming fire, sharp differences exist between DMDC and non-DMDC veterans. Nearly 20% of the veterans not found on the DMDC fired artillery on the enemy compared to 2.1% of the veterans found on DMDC; and 80% of the non-DMDC veterans received incoming fire compared to 56.3% of DMDC veterans. Veterans not found on the DMDC are also more likely to have served on a river patrol and engaged the enemy in a firefight. While only four of the combat roles/experiences exhibited at least marginally significant differences, a general pattern of increased combat exposure in the non-DMDC group compared to the DMDC group is displayed in 14 of the 18 possible combat roles/experiences. However, the mean combat intensity index was not significantly greater in the non-DMDC group compared to the DMDC group. (Insert Table 6 about here) Physical Health Factors Table 7 presents the distribution of the physical health factors by DMDC status. Each of 15 physical health questions were asked in the form: "Since active military duty 1965 - 1975, have you 11 �VET Registry: Ascertainment Bias had this problem?" Only the prevalence of nerve disorders demonstrated a statistically significant association with DMDC status; a greater proportion of men found on the DMDC database reported nerve disorders compared to men not found on the DMDC database. It is interesting to note that no trend of increased or decreased prevalence of physical health factors is associated with DMDC status. Of the 15 conditions examined, seven had an increased prevalence associated with the DMDC database while eight had decreased (or no difference) in prevalence associated with DMDC database. (Insert Table 7 about here) Health Habit Factors Table 8 presents the relationship between health habits and DMDC status. No significant differences were observed between the two DMDC groups and the following variables: current smoking status, mean number of cigarettes smoked per day, current alcohol drinking status, and mean number of alcoholic drinks per week. (Insert Table 8 about here) Psychosocial Health Factors The relationship between psychosocial health factors and DMDC status is presented in Table 9. Fifteen indicators of the PTSD, derived from the American Psychiatric Association's most recent revision of the Diagnostic and Statistical Manual (DSM-III) are included in the survey. (12), Veterans were asked to rank the frequency of occurrence of each symptom during the preceding six 12 �VET Registry: Ascertainment Bias months on a five-point scale from very often to never. Only one of the fifteen indicators of PTSD symptomatology, trouble concentrating, demonstrated a significant association with DMDC status. Individuals on the DMDC database reported a statistically significant lower frequency of difficulty concentrating by comparison with individuals not found on the DMDC database. The final psychosocial health factor examined was whether servicemen had sought professional help for emotional problems following discharge. No significant association with DMDC status was demonstrated. (Insert Table 9 about here) 13 �VET Registry: Ascertainment Bias DISCUSSION The preceding analysis demonstrates that the VET Registry contains about half of the total cohort of twin pairs who meet the eligibility criteria for inclusion. By comparison with all veteran twin pairs, the Registry is biased in terms of certain aspects of military service but not in terms of the physical and psychosocial variables of importance to the VETS. Pairs found on DMDC are more likely to have served at a later period during the Vietnam era and to have had their first rotation in Vietnam at a later date. These results are expected, based on our knowledge of when the DMDC database was developed (6). Somewhat more difficult to explain are the DMDC biases toward a longer length of active duty service, a greater proportion of Navy and Air Force personnel, a greater proportion of foreign service, and a possibly lower combat exposure. One explanation of these biases might be that individuals in the Navy and Air Force typically serve longer tours of duty (4 years) and are less likely to be combat exposed. For example, an Army draftee who served two years beginning in 1965 would not appear in the DMDC database, since the DMDC began collecting data with men discharged in 1968; conversely, a Navy enlisted man who served aboard a ship off the coast of Vietnam for four years (beginning in 1965) would appear in the DMDC database. A second possible explanation is that the quality of discharge data submitted to DMDC headquarters varied by the branch of service. 14 �VET Registry: Ascertainment Bias If the Marines and Army submitted data that had a greater number of errors in the spelling of last name, dates of birth or social security numbers by comparison with Navy and Air Force data, then fewer potential Army and Marine twins would be identified by the matching algorithm. The observed biases in duration of service, foreign service and combat exposure would result. In contrast to the several biases in the DMDC database related to the military service experience, relatively few biases were observed for the variables that pertained to physical and psychosocial health. It is possible that the rarity of many specific health outcomes made it unlikely to detect differences between the DMDC and non-DMDC groups. However, the great similarity between the DMDC and non-DMDC groups for variables such as alcohol consumption, marital status, cigarette smoking, physical health, and psychosocial health suggest that major biases are not present. In summary, there is no reason to believe that the observed military service biases in the DMDC data tapes will substantially affect the validity of the analyses of the physical and psychosocial variables of twin pairs identified using the DMDC data files. 15 �VET Registry: Ascertainment Bias REFERENCES 1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders III (DSM III). Washington, DC; 1980. 2. Boulanger G, Kadushin C (1986): The Vietnam Veteran Redefined: Fact and Fiction. Hillsdale, NJ: Lawrence Erlbaum Associates. 3. card J (1983): Lives after Vietnam. Lexington, MA D.C. Heath 4. Connecticut Division of Health Statistics: Multiple Birth Tape Layout. 5. Unpublished document, October, 1980. Egendorf A, Kadushin C, Laufer RS, Rothbart G, & Sloan L (1981): Legacies of Vietnam Vol. 1 Summary of findings. Washington, DC: US Government Printing Office. 6. Eisen S, True Wm, Goldberg J, Henderson Wm: The Vietnam Era Twin (VET) Registry: Method of Construction of a New Twin Panel. Acta Genet Med Gemellol (Roma), submitted. 7. Harris L (1980): Myths and realities: A study of attitudes toward Vietnam era veterans. Washington, DC: Veterans Administration, Senate Committee. 8. Sonnenberg SM, Blank AS Jr, Talbott JA (1985): The Trauma of War: Stress and Recovery in Viet Nam Veterans. Washington, DC: American Psychiatric Press, inc. 9. United States Department of Defense, Defense Manpower Data Center: Data Base profile and Overview. October, 1982. 16 Unpublished document, �VET Registry: Ascertainment Bias 10. United States, National Archives and Records Service, National Personnel and Records Center: Directory of Military Personnel and Related Records. Unpublished document, September, 1974. 11. United States, National Archives and Records Service, National Personnel Records Center: Administrative History of the National Personnel Records Center. Unpublished document, December, 1981. 12. Veterans Administration, Reports and Statistics Service, Office of the Controller, 1979 National Survey of Veterans II, Summary Report, 1980. 17 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 1. Variables Obtained From the Military Service Record Demographic Factors Age Race Education at Enlistment Marital Status at Enlistment Enlistment Examination Factors Blood Pressure Fitness for Military Duty Military Service Variables Branch Year of Enlistment Year of Discharge Length of Service Foreign Service 18 �VET Registry: Ascertainment Bias Table 2. Variables Obtained From the Survey Vietnam Experience Factors Service in Vietnam Year First Sent to Vietnam Length of Service in Vietnam Fired Artillery on Enemy Flew in Aircraft Flew in Helicopter Stationed at Forward Observation Post Served as a Tunnel Rat Served on a River Patrol Field Demolitions Expert Retrieved Dead Bodies From Field Served as a Medic in Combat Received Incoming Fire Encountered Mines and Booby Traps Received Sniper or Sapper Fire Unit Patrol Ambushed Aircraft Shot Down Engaged Enemy in Firefight Saw Soldiers Killed Wounded Captured by the Enemy 19 �VET Registry: Ascertainment Bias Table 2. Variables Obtained From the Survey (continued) Combat Exposure Index Physical Health Factors Hypertension Respiratory Condition Cancer Heart Disease Stroke Kidney Problems Skin Disorders Diabetes Stomach Disorders Liver Disorders Blood Disorders Nerve Disorders Joint Disorders Hearing Problems Other Health Problems 20 �VET Registry: Ascertainment Bias Table 2. Variables Obtained From the Survey (continued) Health Habits Factors Current Smoking Status Total Pack Years of Smoking Current Alcohol Drinking Status Number of Alcoholic Drinks Consumed Per Week Psychosocial Health Factors Trouble Sleeping Dreams or Nightmares About Military Service Painful Memories About Military Service Avoided Activities That Brought Back Memories of Military Service Experienced Flashbacks Strong Feelings About Military Memories Felt Guilt About Actions In The Military Had Trouble Concentrating Had Trouble With Memory Irritable and Short-Tempered Angry or Agressive Behavior Lost Interest in Usual Daily Activities Felt Distant From Everyone 21 �VET Registry: Ascertainment Bias Table 2. Variables Obtained From the Survey (continued) Felt Life is Not Meaningful Easily Startled or on Guard All The Time Sought Help For Emotional Problems After Discharge 22 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 3. DMDC Status by the Demographic Factors Found on DMDC Mean Education Grade 97.5 (n=138) White (%) (n=159) 92.8 Race* 20 (n=139) Mean Age at Enlistment on DMDC 20 Demographic Factors Not Found (n-160) 12 (n*139) Single (%) *p<.10 by Fisher's Exact Test 23 94.7 (n=138) Martial Status at Enlistment (n=154) 98.6 at Enlistment 12 (n-151) �VET R e g i s t r y : A s c e r b a i n m e n t Table 4. DMDC Status by the Enlistment Examination Factors Found Enlistment Examination Factors Not Found on DMDC on DMDC Mean Systolic Blood Pressure 124 124 (n=119) 73 75 (n=119) (n-146) 0.8 0.7 (n-128) (n-150) 1.6 .7 (n=128) (n-150) 3.9 2.0 Mean Diastolic Blood Pressure Fitness for Military Duty Physical Limitations (%) Upper Extremities Limitations (%) Lower Extremities Limitations (%) (n-150) 24 Bias �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 4. DMDC Status by the Enlistment Examination Factors .(Continued) Found Not Found on DMDC on DMDC Hearing - Limitations (%) 2.3 2.7 (n=*128) (n»150) » Visual - Limitations (%) 34.4 32.0 (n=150) Neuropsychiatric - Limitations (%) 0.0 25 0.0 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 5. DMDC Status by Military Service Factors Found Not Found Military Service Factors on DMDC on DMDC Mean Year of Discharge* 1971 1969 (n=139) (n-158) Mean Year of Enlistment* 1968 1966 (n-139) (n-159) 1,175 1,027 (n=139) (n-158) Mean Length of Active Duty Service in days* Branch* Army (%) 45.0 56.3 Navy (%) 33.6 23.1 2.1 10.0 19.3 10.6 Marines (%) Air Force (%) (n-140) 26 (n-160) �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 5. DMDC Status by Military Service Factors . (Continued) Found on DMDC Foreign Service ( ) %* Not Found on DMDC 87.0 66.0 (n=138) (n=156) *p<.001 27 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 6. DMDC Status by Vietnam Experience Factors Found Vietnam Experience Factors Vietnam Service (%) Not Found on DMDC on DMDC 40.3 (n="119) 30.8 (n-133) Mean Year of First Service in Vietnam*** 1969 1968 (n=48) (n-41) 327 343 (n-43) (n=36) 2.1 19.5 (n=47) (n-41) 14.6 12.2 (n=48) (n=41) 14.6 22.0 (n=48) (n-41) Mean Length of Vietnam Service in days Fired Artillery on Enemy* (%) Flew in Aircraft (%) Flew in Helicopter (%) 28 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 6. DMDC Status by Vietnam Experience Factors '(Continued) Found on DMDC Vietnam Experience Factors Not Found on DMDC Stationed at a Forward Observation Post (%) 16.7 (n=48) (n-41) 4.2 Served as a Tunnel Rat (%) 19.5 4.9 (n-41) Served as a River Patrol ** (%) 0.0 7.3 (n=48) 8.3 5.0 (n=48) Field Demolitions Expert (%) (n=40) 0.0 4.9 Retrieved Dead Bodies From Field (%) (n=48) Served as a Medic in Combat (%) 2.1 2.4 (n=48) (n-41) 29 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 6. DMDC Status by Vietnam Experience Factors .(Continued) Found Vietnam Experience Factors Not Found on DMDC on DMDC 27.1 29.3 Wounded (%) (n=48) Captured by Enemy (%) 2.1 (n-41) 0.0 (n=48) Mean Combat Exposure Index 3.2 (n=48) *p<.05 by Fisher's Exact Test **p<.10 by Fisher's Exact Test ***p<.10 by Unpaired t-test Test 31 4.3 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 7. DMDC Status by the Physical Health Factors Found on DMDC on DMDC 16.4 Physical Health Factors Not Found 15.5 Hypertension (%) (n-116) Respiratory Condition (%) 6.9 (n-116) Cancer (%) 0.0 (n=116) Heart Disease (%) . 1.7 (n-116) Stroke (%) 0.0 (n-129) 10.9 (n-129) 0.0 (n»128) 3.1 (n-129) 0.0 (n»129) Kidney Problems (%) 8.6 (n-116) Skin Disorder (%) 12.9 (n-116) 32 5.4 (n-129) 11.0 (n-127) �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 7. DMDC Status by the Physical Health Factors .(Continued) Found Physical Health Factors Not Found on DMDC on DMDC Diabetes (%) 0.0 2.3 <n-129) Stomach Disorders ( ) % 15.5 15.5 (n=116) <n-129) Liver Disorders 2.6 (n-116) Blood Disorders 0.9 3.9 (n-129) 2.3 (n-129) Nerve Disorders* (%) 12.9 (n-116) Joint Disorder (%) 12.7 (n=118) 33 3.9 (n-129) 12.4 (n-129) �VET R e g i s t r y : Ascertainment Bias Table 7. DMDC Status by the Physical Health Factors (Continued) Found Physical Health Factors Hearing Problem (%) Not Found on DMDC on DMDC 16.2 (n-117) Other Health Problems ( ) % 28.4 (n-102) *p=.01 by Fisher's Exact Test 34 14.6 (n-130) 24.3 (n=107) �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 8. DMDC Status by the Health Habits Factors Found Not Found Health Habits Factors on DMDC on DMDC Currently Smoking (%) 37.9 45.0 (n=116) (n-132) Mean Number of Cigarettes 26 Per Day Among Smokers (n=80) 27 (n=101) Currently Drinks Alcoholic 89.6 82.7 (n-115) Beverages (%) (n-127) Mean Number of Alcoholic Beverages Consumed Per Week Among Drinkers 17 16 (n=103) 35 �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 9. DMDC Status by The Psychosocial Health Factors Found Psychosocial Health Factors Not Found on DMDC on DMDC Mean Value for Trouble Sleeping 3.5 3.6 (n-117) (n-132) 4.5 4.5 (n-119) (n-132) 4.4 4.5 (n=119) (n-132) Mean Value for Dreams or Nightmares about Military Service Mean Value for Painful Memories about Military Service Mean Value for Avoided Activities that Brought Back Memories of Military Service 4.5 (n-118) 4.5 (n-132) Mean Value for Experienced Flashbacks 4.6 (n-119) 36 4.4 (n-132) �VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 9. DMDC Status by The Psychosocial Health Factors (Continued) Found Psychosocial Health Factors Not Found on DMDC on DMDC Mean Value for Strong Feelings about Military Memories 4.3 (n-119) 4.4 (n-132) Mean Value for Felt Guilt About Actions in the Military 4.3 (n-119) 4.4 (n-132) Mean Value for Trouble* Concentrating 4.1 (n-119) 4.4 (n-132) Mean Value for Trouble With Memory 4.1 (n-119) 4.3 (n-132) Mean Value for Being Irritable or Short-Tempered 3.7 (n-119) 37 3.8 (n-132) �•I k VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 9. DMDC Status by The Psychosoclal Health Factors (Continued) Found Psychosoclal Health Factors Not Found on DMDC on DMDC Mean Value for Angry or Aggressive Behavior 4.1 (n-118) 4.1 (n-132) Mean Value for Lost Interest In Usual Daily Activities A.I (n-119) 4.2 (n-132) Mean Value for Felt Distant From Everyone 4.1 (n-119) 4.2 (n-132) Mean Value for Life is Not Meaningful 4.5 4.4 (n-132) 38 �V < VET R e g i s t r y : A s c e r t a i n m e n t Bias Table 9. DMDC Status by The Psychosocial Health Factors (Continued) Found Psychosocial Health Factors Not Found on DMDC on DMDC Mean Value for Easily Startled or on Guard All The Time 4.2 (n=119) 4.3 (n=132) Sought Help for Emotional Problems After Discharge (%) 17.7 (n-119) *p<.05 39 21.2 (n=132) � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1846 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Goldberg, Jack William True Seth Eisen William Henderson C. Dennis Robinette Title A name given to the resource Typescript: The Vietnam Era Twin (VET) Registry: Ascertainment Bias Subject The topic of the resource Vietnam Experience Twin Study DMDC NPRC ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/1516419f8d411753953829faab4f24e5.pdf 8c8791b180b3fd5c1fda29c7cd2fddba PDF Text Text ItemDNunber °1045 Author Eisen, Seth Corporate Author Roport/Artldo TltlO TyPesci"iPt: The Vietnam Era Twin (VET) Registry: Method of Construction Journal/Book Title Year 000 ° Month/Day n Number of Images DOSCrlDtOn NOtBS 16 Alvin L - Young filed this item under "Vietnam Veterans Twin Study." Wednesday, July 11, 2001 Page 1846 of 1870 �The Vietnam Era Twin (VET) Registry: Method of Construction Seth Eisen, M.D. Research Service, St. Louis VA Medical Center, St. Louis, MO and Washington University School of Medicine William True, Ph.D. Psychiatry & Research Services St. Louis VA Medical Center, St. Louis, MO and St. Louis University School of Medicine Jack Goldberg Ph.D. University of Illinois, School of Public Health and Hines VA Cooperative Studies Coordinating Center, Hines, IL William Henderson, Ph.D. Hines VA Cooperative Studies Coordinating Center,Hines, IL C. Dennis Robinette, Ph.D. Medical Follow-up Agency, National Academy of SciencesNational Research Council, Washington, D.C. Work Performed at: Research Service, St. Louis VA Medical Center, St. Louis, MO; Cooperative Studies Program Coordinating Center, Hines VA Medical Center, Hines, IL; Medical Followup Agency, National Academy of Sciences-National Research Council, Washington, D.C. Acknowledgment of Funding: Cooperative Studies Program, Study #256, Veterans Administration Medical Research Service Correspondence: Seth Eisen, M.D. (151A-JB), St. Louis VA Medical Center, St. Louis, MO 63125, USA Running Title: VET Registry: Construction �VET Registry: Construction ABSTRACT A Vietnam Era (1964 - 1975) Twin Registry of American male-male veterans born between 1939 and 1955 has been developed to provide / a study sample for research evaluating the impact of Vietnam service on the medical and psychosocial aspects of health. In preparation for developing the Registry, several alternative sources of twins and methods for identifying twins were investigated. A computerized database of veterans discharged from the military after 1967 was selected as the source because it contains about fifty percent of the total Vietnam era veteran population, is reasonably unbiased, and provides a feasible method for identifying twins. Twins were identified using an algorithm which involved matching entries on the database for same last name, different first name, same date of birth, and similar social security number. Twin status was confirmed by review of military records. The registry, now complete, is composed of 7,400 twin pairs. It will be an important resource for future research projects. �VET Registry: Construction Key Words: Twins, Registries, Vietnam War, Veterans �VET Registry: Construction INTRODUCTION In the wake of America's reassessment of its attitudes towards the Vietnam War, persistent and increasing concern has developed t about possible long-term psychological and physical effects of the war on its servicemen.^ Consequently, the Veterans Administration (the government agency responsible for providing services to American veterans) has been encouraging research to clarify the relationship between Vietnam military service and current health. The Veterans Administration's Medical Research Service, Cooperative Studies Program has provided funds to perform the Vietnam Era Twin Study (VETS), a research project which will assess the long-term effects of the Vietnam experience on health by studying twin pairs where both siblings served in the military during the Vietnam era. The first step in the project was the development of a registry of Vietnam era twin pairs. paper describes the construction of this registry. The present A companion paper (5) examines the issue of bias in the registry. �VET Registry: Construction METHODS AND RESULTS Eligibility Criteria Eligibility criteria for entry into the, Vietnam Era Twin (VET) Registry are: male-male monozygotic and dizygotic twins born between 1939 and 1955 where both siblings served in the armed forces of the United States between 1964 and 1975. Approaches to the Ascertainment of Veteran Twin Pairs Two general approaches are available for identifying veteran twin pairs. The first starts with state based twin registries and attempts to determine whether the known twins on the state registries served on active duty during the Vietnam era. The second starts with computerized records of individuals with known military duty during the Vietnam era and attempts to identify twin pairs. Both approaches were piloted to determine the best method for constructing the VET Registry. 1. State Based Twin Registries Twin registries are maintained by several states in the United States. For example, the States of California, Virginia, and Connecticut have computerized registries of twins identified at birth using birth certificates (1,3). It is important to note that these registries do not continue to collect data on twins as they age. The process for identifying the subset of twins found on state registries who meet the VET Registry eligibility criteria was pilot tested with 55 twin pairs randomly selected from pairs born in the state of Connecticut during the years of �VET Registry: Construction interest. The selected pairs were matched against a comprehensive computer based list of discharged servicemen. list of discharged servicemen and their military records are located at the National Personnel Records Center (NPRC), St. Louis, Missouri. Because the NPRC contains 70 (including those of approximately nine million veterans), no uncommon names exist. The comprehensive million records Vietnam era The only relevant information coded on the computer file are names, social security or military service numbers, and military record location numbers. The matching of the 55 Connecticut twin names with the NPRC computer file produced thousands of potential twin pairs. Many names could be eliminated though, either because both twins were not listed or because the social security or military record location numbers excluded the particular names from military duty during the Vietnam era. typically matched pairs. Still, many names (sometimes hundreds) It was then necessary to obtain the stored military records and compare places of birth and parents names to determine whether a matched pair were in fact twins. 2. Computerized Records of Military Service The National Personnel Records Center (NPRC) To identify potential twin pairs using the NPRC location registry, a matching algorithm using two variables on the computerized data file (name and social security number) was developed. The social security number is a nine-digit �VET Registry: Construction identification number issued to every American wage earner as part of the national retirement system. The first three digits of the social security number indicate the state in which the application was made. The next two digits are encoded to reflect the year of application. It was assumed that twin siblings made application for their social security numbers in the same state, at the same social security office, and on approximately the same date. Therefore, the first three digits of the social security number would be the same for twins and the subsequent six digits would be very similar. The twin status of matched pairs was confirmed by review of military records located at the NPRC. The Bonus State Files Following the Vietnam War, the following states in the United States offered monetary awards to discharged veterans who served during the Vietnam era: Illinois, Indiana, Iowa, Minnesota, New Hampshire, North Dakota, Ohio, Pennsylvania, South Dakota, Vermont, and Wisconsin. Veterans applied to the state in which they lived for their Vietnam era service "bonus". states Many of the developed computerized application and disbursement records which can be used to identify potential twin pairs. While states varied in the data elements which were entered into the bonus files, and a social required was most contained name, sex, race, date of birth, security number. To identify twins from these files developing a computer matching algorithm. Twin status confirmed by reviewing military records at the NPRC. �VET Registry: Construction The Beneficiary Identification and Record Locator Subsystem (BIRLS) The BIRLS, a computerized listing of veterans who have filed for a benefit with the Veterans Administration, is maintained in a standard format and includes name, date of birth, race, and social security number (15). identified Potential twin pairs were by developing a computer matching algorithm similar to those previously described. Confirmation of twin status required examination of military records at the NPRC. The Defense Manpower Data Center (DMDC) The United States Department of Defense, at the Defense Manpower Data Center (DMDC), maintains a computer file of servicemen who were discharged from active military duty beginning in 1968. DMDC claims to have a complete listing of all discharges after 1972; between 1968 and 1972, the proportion of all discharges contained The in the DMDC computer files is unknown. The DMDC computer files contain between four and five million Vietnam era veterans (about fifty percent of all Vietnam era veterans) (14). Potential twin pairs were identified using a matching routine based on name, date of birth, and social security number. Confirmation of twin status was performed by military record review at the NPRC. Summary of Approaches of the Ascertainment of Veteran Twin Pairs A summary evaluation of possible sources of veteran twin pairs is presented in Table 1. Feasibility and bias are the two criteria 8 �VET Registry: Construction which form the basis for evaluation. Feasibility addresses the issue of whether it is possible to construct a large twin registry from a particular data source given the constraints of time and money. Bias addresses the issue of whether a systematic error in the ascertainment source might substantially compromise the subsequent utility of the VET Registry. (Insert Table 1 About Here) The major advantage of state twin registries is that they contain the universe of twin pairs born in a state during a specified time period and are therefore unlikely to be biased. However, since state registries usually contain a limited amount of information, determining whether both members of a pair served on active military duty during the Vietnam era is time consuming and expensive. Using the NPRC registry as a source of twins is also not feasible; the scant number of variables and the large number of veterans included on the registry precludes the development of a computer matching algorithm that has sufficient sensitivity. Both the Bonus State files and the BIRLS can be used to identify twin pairs at low cost. However, the potential for health related bias is large, since both members of a twin pair must have applied for a bonus or Veterans Administration benefit. The DMDC database permits rapid and low-cost identification of potential twin pairs. A known bias in this database is that it contains records for only those veterans who were discharged beginning in 1968. �VET Registry: Construction After carefully considering the advantages and disadvantages for constructing the twin registry from each of the above sources, the DMDC database was selected because it contains a '• r large proportion of the total Vietnam era population (about 50 percent), is reasonably unbiased, and is a feasible method for identifying twins. Final Method of Identifying Twin Pairs in the DMDC Database Only about 12 percent of pairs of DMDC registry members who had the same last name, different first names, same date of birth, and the same first three digits of the social security were demonstrated to be twins after review of their numbers military records. This twin identification rate was too small to be an economical method for construction of the VET Registry. Narrowing the criteria to include matching on the first five digits of the social security number, however, increased the proportion of possible pairs proven to be actual pairs to 50 percent. Therefore, this was the final matching criteria selected for construction of the Registry. The Registry is now complete. It contains 7,400 twin pairs. The addresses of Registry members are currently being obtained and a zygosity determination (13) and health survey questionnaire is being mailed. 10 �VET Registry: Construction DISCUSSION The present paper describes the construction of a new, large (7,400 pairs) twin registry which is based on military service during the Vietnam War era. The study of twins offers unique opportunities for understanding the role of genetic and environmental factors in a wide variety of normal biologic processes and diseases (6,11). The availability of registries of twins substantially facilitates the use of twins in research. Twin registries have been constructed using many different methods. These include all volunteer registries (for example, the Kaiser-Permanente registry) (4), disease focused registries (for example, the UCLA Registry for Genetic Studies in Autism) (12), registries where all members share a common, significant event (for example, the NAS-NRS Twin Registry of World War II veterans) (7), registries composed of a carefully constructed sample of a total population (for example, the registry developed from the National Health Examination Survey) (10), and national registries (for example, the Norwegian and Swedish registries) (2,9). The registry described in the present article is event focused, since it is based on male-male twins born between 1939 and 1955 where both members of each pair served in the armed forces of the United States during the Vietnam era. It was constructed from a computer data file provided by the Department of Defense, Defense Manpower Data Center, which contains a list 11 �VET Registry: Construction of servicemen discharged from active military duty beginning in 1968. The major advantages of the VET Registry are that it is t large and composed of a relatively young twin cohort who can be followed for many years. A detailed examination of ascertainment bias in the identification of twin pairs in the VET Registry is presented in a companion paper (5). It should be noted that Registry members are likely to be both physically and psychologically healthier then the general male population born between 1939 and 1955 (8). The NAS-NRC Twin Registry of World War II veterans is similar to the VET Registry. Both are composed of veteran twin pairs. The NAS-NRC Twin Registry was assembled by matching the names and dates of Caucasian multiple births between 1917 and 1927 provided by 42 state vital statistics offices with a VA master index which contained 99% of all World War II veterans. Twinship was confirmed by review of military records. About 16 r OOO twin pairs were identified (7). used This registry has been extensively to support diverse and important research projects. broaden the The VET Registry will supplement and substantially usefulness of the NAS-NRC Twin Registry. The VET Registry will be administered in a manner similar to the NAS-NRC Twin Registry. Access to the Registry will be overseen by the Committee on Epidemiology and Veterans Follow-up Studies, Division of Medical Sciences, National Academy of 12 �VET Registry: Construction Sciences-National Research Council. The Committee will review submitted proposals for scientific validity and encourage use of the Registry in a manner which insures long-term participation of the twins in research efforts. The first use of the Registry will be to support the VETS research project. It is expected that outside requests for access to the panel will be considered after 1989. 13 �VET Registry: Construction REFERENCES 1. California Bureau of Vital Statistics and Data Processing: Processing Procedures for Twin Study File. Unpublished document, March, 1984. 2. Cederlof R, Lorich U (1978): The Swedish Twin Registry. Prog Clin Biol Res 246(pt B):189-95. 3. Connecticut Division of Health Statistics: Multiple Birth Tape Layout. 4. Friedman GD, Lewis AM (1978): The Kaiser-Permanente Twin Registry. 5. Unpublished Document, October, 1980. Prog Clin Biol Res 24(pt B):173-7. Goldberg J, True Wm, Eisen S, Henderson Wm, and Robinette CD: The Vietnam Era Twin (VET) Registry: Ascertainment Bias. Acta Genet Med Gemellol (Roma), submitted. 6. Hrubec Z, Robinette CD (1984): The study of human twins in medical research. 7. N Engl J Med 310(7):435-41. Jablon S, Neel JV, Gershowitz H, Atkinson GF (1967): The NAS-NRC Twin Panel: methods of construction of the panel, zygosity, diagnosis, and proposed use. Am J Human Genet 19:133- 161. 8. Kendler KS, Holm NV (1985): Differential enrollment in twin registries: its effect on prevalence and concordance rates and estimates of genetic parameters. 34(3-4) :125-40. 14 Acta Genet Med Gemellol (Roma) �VET Registry: Construction 9. Kringlen E (1978): Norwegian twin registers. Prog Clin Biol Res 24(pt B):185-7. 10. McDowell AJ (1978): Twin Data Available from the National f Health Examination Surveys. 11. Nance WE (1984): The relevance of twin studies to cardiovascular research. 12. Prog Clin Biol Res 24(pt B):197-201. Prog Clin Biol Res 147:325-48. Ritvo ER, Freeman BJ, Mason Brothers A, Mo A, Ritvo AM (1985) : Concordance for the syndrome of autism in 40 pairs of afflicted twins. 13. Am J Psychiatry 142(1):74-7. Sarna S, Kaprio J, Sistonen P f Koskenvuo M (1978): Diagnosis of twin zygosity by mailed questionnaire. Hum Hered 28(4) :241-54. 14. United States Department of Defense, Defense Manpower Data Center: Data Base Profile and Overview. Unpublished document, October, 1982. 15. United States, Veterans Administration: Beneficiary Identification and Records Locator Subsystem. document, April, 1968. 15 Unpublished �VET Registry: Construction Table 1 - Potential Sources of Veteran Twin Pairs ASCERTAINMENT IMPLEMENTATION SOURCE BIASES FEASIBILITY State Twin time consuming and Registries costly National Per- time consuming and sonnel Records none likely costly none likely Center Registry Bonus State rapid and low cost Files biased toward veterans who requested a "bonus" from the state Beneficiary rapid and low cost biased toward VA benefit applicants Identification and Record Locator Subsystem (BIRLS) Defense Man- rapid and low cost biased towards power Data veterans discharged Center (DMDC) after 1968 16 � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1845 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Eisen, Seth William True Jack Goldberg William Henderson C. Dennis Robinette Title A name given to the resource Typescript: The Vietnam Era Twin (VET) Registry: Method of Construction Subject The topic of the resource Vietnam Experience Twin Study NPRC BIRLS DMDC ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/e29611c2eda1a5df1cc27fb81154e8f1.pdf a58622cb376d4bcb69e63f0de6717983 PDF Text Text ItemlDNiinbor °1844 Author Corporate Author Roport/Artldo Tltto Typescript: Data Base for Mother Study Journal/Book Title Year 000 ° Month/Day Color Number of Images DOSGTlpton NOtBS D 27 Alvin L Your| gfiled this item under "Vietnam Veterans Twin Study." Wednesday, July 11, 2001 Page 1845 of 1870 �Data Base For Mother Study Ra c e / E t h n1c C l a s s i f i c a t i o n What do you perceive your ethnic o r i g i n to be? 1 2 3 4 5 6 7 8 9 Gentile white non-hispanic Jewish non-hispanlc North American Black C a r i b b e a n Black (non-hispanic.) Cuban Other Caribbean hispanic Mexican and/or Central American South American (Specify) _ _ _ NADKDA " _ ~ E d_u c a_t i p n What, level of education have you a t t a i n e d ? Primary Secondary 0-4 5 6-7 8 02 05 09 19 1 2 3 4 29 35 40 60 University 1 2 3 5+ 80 84 88 98 NADKA 99 Have you had any o t h e r training or e d u c a t i o n such as vocational school? (Specify) _ (Enter n u m b e r of month's.) W h e n were you born? (Month, day, year) _ _ •* Ma r ijtaj S t aj us 1 2 3 4 5 6 Single Married Widowed I) i v o r c e d Separated Cohabitation " / C o m b i n a t i o n (Specify e.g. s e p a r a t e d but c o h n b t t a t i n g with another partner) __ __ __ 8 Other (specify)_ 9 NADKA How long has your p r e s e n t m a r r i a g e or liaison lasted? (Enter n u m b e r of years up through e i g h t ) 0-7 A c t u a l n u m b e r of years 8 Eight or more (1= One or less) 9 NADKDA �Marr_iage_ History Have you had any other marriages? 0 1-7 8 9 If so, how many? No n e Actual Number of marriages Does riot answer-Does not know Not applicable How long did each marriage last? 1st Marriage back 2nd Marriage back 3rd Marriage back 4th Marriage back 5th Marriage, back 6th Marriage back 00 01~96 97 98 99 One year or less Actual number of yrs Does not know Does not answer Not applicable How did the marriage end? 1 2 3 4 5 8 9 Divorce Voluntary Separation (by mutual consent)? Ego abandoned by spouse " '* Spouse abandoned by ego Death of Spouse Does not answer - Do.es not know Not applicable 1st Marriage back 2nd Marriage back 3rd Marriage back 4th Marriage back 5th Marriage back 6th Marriage back �Res idence How many people live in your household? Who are They? (Specify total number of household residents) al grandparents 0™ 7, 8 or more , 9 NADKDA al grandparents 0- 7, 8 or more , 9 NADKDA ndparents 0 -• 7, 8 or more, 9 NADKDA Ego ' s mo ther. 0~ 7, 8 or more , 9 NADKDA Ego's father 0-7, 8 or more , 9 NADKDA Spouse's parents enta 0~ 7, 8 or more , 9 NADKDA Ego's spouse 0- 7, 8 or more, 9 NADKDA Ego's brother r 0- 7, 8 or tnore , 9 NADKDA Ego's sister 0- 7, 8 or more , 9 NADKDA Ego's and sp o u s e ' s s o n 0~ 7, 8 or more, 9 NADKDA Ego's and sp ouse's daughter 0™ 7, 8 or more , 9 NADKDA Ego's son 0« 7, 8 or more , 9 NADKDA er Ego's daughter 0-7, 8 or more , 9 NADKDA Idren Spouse's chil 0- 7, 8 or more, • n Grandchildren 0- 7, 8 or more , NADKDA •>? 9 NADKDA ves Other Relatives 0- 7, 8 or more , 9 NADKDA s Non-Relatives 0~ 7, 8 or more , 9 NADKDA How many of these are your relatives? How many children have you had? (live births) How many children do ou have living in the home? 0-7 Actual number up to seven 9 NADKDA 8 or more �How often do you make contact with your relatives who do not live with you? 1 Never 2 Less tan once a year 3 Several times a year 4 Several times a month 5 Several times a week 9 NADKDA Do they live in your immediate area? 1 2 3 4 5 6 9 They do not live within 50 miles They live in Broward, Monroe, or Palm Beach County They live in Dade County They live in the same municipality They live within a few blocks They live on the same block or street NADKDA Employment Stajtus_ and^Inegme *What is your present occupation? (Record exact occupation) **What is your usual occupation? (Record exact occupation) What job have you been trained to do? (Record exact occupation) * Code from Nam occupation code 5 ** Code from Nam occupation code 10 How much do you earn per year at your present job? \ -' (Record amount) 1 2 3 4 5 0 to $3999 $ 4,000 to $ 8,000 to $14,000 to $20,000 to " $ 7,999 $13,999 $19,999 $24,999 Does your spouse work? 6 7 8 $25,000 to $34,999 $35,000 to $49,999 $50,000 + 9 NADKDA If so, what does he do? (Record exact occupation) 9 9 "No spouse How much does he earn in a year? (Record amount) �1 2 3 4 5 0 to $3999 $ 4,000 to $ 8,000 to $14,000 to $20,000 to 6 .7 8 $25,000 to $34,999 $35,000 to $49,999 $50,000 + 9 $ 7,999 $13,999 $19,999 $24,999 NADKDA Other Household Income Do other members of your household have an Income? much? _ __ __ (Record Amount) 1 2 3 4 5 0 to $3999 $ 4,000 to $ 8,000 to $14,000 to $20,000 to If so, how 6 7 8 $25,000 to $34,999 $35,000 to $49,999 $50,000 + 9 $ 7,999 $13,999 $19,999 $24,999 NADKDA Do you have any sources of income other than wages, salaries, or business earnings? if so, what are they? (Specify) 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 88 None Welfare Aid to dependent children Unemployment compensation Food Stamps Refugee Center Aid Disability allowance Private sector pension Government pension Social Security Income earning property Dividends and interest Business income Combination of any or all of 01 through 04 Combination of any or all 05 through 09 Combination of 10 and 11 Combination of groups 12 and 13 (specify) Other (specify)JU._ZH™'...,,.I..."Z 99 NA'DKA " "' " " What is the amount of this outside income per year? (Record Amount) 0 $ $ 2,000 4,000 to to to $ $ $ 1999 3,999 7,999 �1 2 3 4 5 0 to $3999 $ 4,000 to $ 8,000 to $14,000 to $20,000 to 6 7 8 $25,000 to $34,999 $35,000 to $49,999 $50,000 + 9 $ 7,999 $13,999 $19,999 $24,999 NADKDA Other Household Income Do other members of your household hav.e an income? much? (liecord Amount) 1 2 3 4 5 0 to $3999 $ 4,000 to $ 8,000 to $14,000 to $20,000 to 6 7 8 $ 7,999 $13,999 $19,999 $24,999 If so, how $25,000 to $34,999 $35,000 to $49,999 $50,000 + NADKDA Do you have any sources of income other than wages, salaries, or business earnings? if so, what are they? (Specify) 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 88 None Welfare Aid to dependent children Unemployment compensation Food Stamps Refugee Center Aid Disability allowance Private sector pension Government pension Social Security Income earning property Dividends and interest Business income Combination of any or all of 01 through 04 Combination of any or all 05 through 09 Combination of 10 and 11 Combination of groups 12 and 13 (specify) __ ._._ Other (s pecif y )_J".'ZT___ HI'I_T_~ 99 ? A D K A " What is the amount of this outside income per year? (Record Amount) 1 2 3 0 2,000 4,000 to to to $ $ $ 1999 3,999 7,999 �4 5 6 7 8 9 $ 8,000 $ 14,000 $ 20,000 $ 35,000 $ 50,000 + NADKDA to to to to $ $ $ $ 13,999 19,999 34,999 49,999 Total household income (adding occupational, other household earners and other sources) < $ 1000 $ 500 $ 1 > 000 2» $ $ 2 t 500 $ 3 > 000 $ 3 j 500 $ 4 > 000 5 $ 6> 000 $ > 000 1 » 000 to to to to to to to to to $ $ $ $ $ $ $ $ $ 1, 499 1, 999 2, 499 2, 999 3, 499 3, 999 4, 999 5, 999 6, 999 001 002 004 006 008 Oil 013 017 023 029 $ 7,000 $ 8,000 $ 9,000 $ 10,000 $ 12,000 $ 15,000 $ 25,000 $ 50,000 NADKDA to to to to to to to + $ $ $ $ $ $ $ 7,999 8,999 9,999 11,999 14,999 24,999 49,999 036 043 051 061 074 089 098 100 999 If you are not employed, how long ago were you last employed? 0 1 2 3 One Two Two Six week or less to seven weeks to five months months to 11 months 4 5 6 9 One to three eyar Four to ten years More than ten years NADKDA 4 5 6 9 One to three eyar Four to ten years More than ten years NADKDA How long did that job last? 0 1 2 3 One Two Two Six week or less to seven weeks to five months months to 11 months What is the longest time you have ever held a job? 0 1 2 3 One Two Two Six week or less to seven weeks to five months months to 11 months 4 5 6 9 One to three eya,r Four to ten years''1 More than ten years NADKDA Birthpla_ce and Lega 1 J>_taJtus U.S. 1 Other country than U.S. 2 Refuses to answer 8 NADK 9 Birthplace: Legal Status: U.S. Citizen Legal permanent or temporary status Illegal alien or lapsed temp, status Citizen & Resident of country other than U.S. Not applicable, or otherwise missing 1 2 3 4 9 �Ego birthplace (If other specify) Ego legal status (Specify) Mother birthplace ' Mother legal status ___ Father birthplace Spouse birthplace _____ Spouse legal status Religious Preference What is your 1 2 3 4 5 6 7 8 9 religion? No religious preference Old line protestant: (Lutheran, Presbyterian, Methodist) Protestant Sects (Free-will Baptist, Primitive Baptist) Catholic Jewish Other (specify) __ _____ Doesn't know Doesn't Answer Not applicable About how often do you attend your Church/Synagogue? 01 Every Week 02 2-3 times a month 07 Never 03 Once a month 97 Doesn't know 04 Several times a year 98 Doesn't answer 05 Only once or twice a year 99 Not applicable ' -* Formal 06 Less than once a year Associations Have you ever been a member of any organization, club, formal group or associaton? 1 No 2 Yes If yes, indicate wat kind: 1 2 3 4 5 6 Social Political Cultural/Intellectual Occupational Hobby/Special Interest Combination �8 Other 9 NADKDA 'Club I _ (specify) Club II Club III_ (specify) __ _ ^(specify) Club IV Club V ___ __ _ Club VI __ ( specify) ( specify) _ _ ( s p e c i fy) -'a !•' °n " -L— °r 3L The i n t e r v i e w e r should begin this line of questioning as follows: We would like to know about the d i f f e r e n t places you have lived. Where were you born? How long was it before you moved away from that place? Who lived with you there? Continue this line of questioning untl you have covered ten moves or the person's complete migration history, whichever comes first. If a radical change in household composition takes place, record that as a separate T, keeping the location c o n s t a n t , but changing dates and household code. From Tl_ T2 T3 T/ *. T5 T6 T7_ T8 Places To Inclusive *Household �T9 T10 * S e e s e p a r a t e coding sheet (after Blllingsley) n i _Inst£H.c ? ^ ori l®: ^8e pl- ace codes for first place (e.g. where born) followed by second place (e.g. where family moved after birthplace) on same line. Then enter d a t e (month/year) when the subject was born, followed on next line by d a t e of first move. Continue, using second place code for first place code on T2. This is an example of coding layout, using 2-and~4-digit codes for data points. Tl Places (From-To) Dates (From) Dates (To) Household Type 10 �Lega 1 His tory Have you ever been arrested or detained by the police? many t i m e s ? 1 2 3 4 Zero One Two Three If so, how 5 Four 6 Five plus 9 NADKDA Have you ever been in jail? If so, where? 1 Never 2 South Florida 3 O t h e r Florida City (Specify) 4 Other U.S. city (Specify) 5 Other foreign city (Spcci'fy) 9 NADKDA Length of time: 1 Less than 24 hours 2 One to three days 3 Four to seven days 4 Eight to thirty days 5 One to six months 6 Seven months to one year 7 More than one year 9 NADKDA What were you hooked for? 1 Crime against property 2 Crime agianst person 3 Crime of conduct 4 Victiraless crime 5 Combination of 0 and 1 6 Other combination 9 NADKDA (specify) (Write d e s c r i p t i o n and code later, place f i r s t , then time, then c r i m e •i Crime 1 Crime 2 Crime 3 Crime 4 11 �How long have you been out since the last time? 1 2 3 4 5 9 Less than one month ago Two to six months ago Seven to eleven months ago One to four years ago Five or more years ago NADKDA U_se Do you use tobacco? If so, what kind? 1 None at all 5 Pipe 2 Snuff (dipping or 6 A combination of the above sniffing) (specify) 3 Cigars 7 Chewing 4 Cigarettes 9 NADKDA How long h a v e you been using tobacco? Indicate years__ _ __ __ __ (99 means NA) How much tobacco do you use per day? a. __ _ Cigarettes per day b. Cigars per day c. __ Tobacco-plugs per day d. _ Snuff-tins per week e. __ Pipe-pouches per week Do you ever drink alcoholic beverages? ONever 1 Once a 2 Two to 3 Once a 4 Two to year or less ten times a year month three times a month If so, how o f t e n ? 50nceaweek 6 Two to four times a 7 Every day 8 More than once a day 9 NADKDA D u r i n g the past m o n t h , on how mnay occasions did yo.u have f i v e or more d r i n k s at one time? * 1 Never 2 One or two time 3 Three or more times 4 Five or more times 9 NADKDA Do you e v e r awaken in the m o r n i n g a f t e r an evening of d r i n k i n g and f i n d you are unable to r e m e m b e r part of the evening? 1 Yes 2 No 9 NADKDA Do your friends or relatives think you are a normal drinker? 1 Yes 2 No 12 9 NADKDA �Have you ever used medicines to help calm your nerves? If so, when was the last time? 1 2 3 4 5 6 9 Never Less than one month ago Two to six months ago Seven to eleven months ago One to four years ago Five or more years ago NADKDA Have you ever used medication to help you sleep? If so, when was the last time? 1 2 3 4 5 6 9 Never Less than one month ago Two to six months ago Seven to eleven months ago -One to four years ago Five or more years ago NADKDA Have you ever taken medication to help you to cope with depression? If so, when was the last time? 1 2 3 4 5 9 Less than one month ago Two to six months ago Seven to eleven months ago One to four years ago Five or more years ago NADKDA Have you ever used medication to help you to lose w e i g h t ? If so, when was the last t i m e ? 1 2 3 4 5 9 Less than one month ago Two to six months ago Seven to eleven months ago One to four years ago Five or more years ago NADKDA • Do you feel you are a normal drinker? 1 Yes 2 No 9 NADKDA 2 No 9 NADKDA Do you drink in the mornings? 1. Yes Do you feel bad about your drinking? 1 Yes 2 No 13 9 NADKDA �Do the people you live with ever worry or complain about your d r i n k i n g ? 1 Yes 2 No 9 NADKDA Do you use marihuana? 1 2 3 4 5 6 7 8 9 Do you use cocaine? If so, how often do you use it? Never Eleven times a year or less Once a month Two to three times a month Once a week Two to four times a week Everyday More than once a day NADKDA If so, how often do you use it? 1 2 3 4 5 6 7 8 9 Never Eleven times a year or less Once a month Two to three times a month Once a week Two to four times a week Everyday M o r e t h a n once a clay NADKDA Have you ever used other drugs? 0 1 2 3 4 5 6 7 8 9 None Opiates or methadone LSD PGP Mescaline Mushrooms Inhalants Combinations (specify) Other " ^~'_J^~~~T _"L-lj_"(8PecifX) NADKDA " "' " " '• ~ ~: " '* Do you use any of these now? 1 2 3 4 5 6 7 8 9 If so, which ones? If so, how o f t e n ? Never Eleven times a year or less Once a month Two to three times a month Once a week Two to four times a week Everyday More than once a day NADKDA 14 �How often do you watch television? 0 1 2 3 4 5 6 7 9 More than five hours a day Two to five hours a day One or two hours a day Less than ten hours a week Two to four hours a week Less than ten hours a month Ten hours a year None NADKDA 15 �Appendix B Here are three examples of scalar measures to be used in theclosed-end part of the home interview. It is not exhaustive, because two of the scales have not. been developed. These two will be derived from Laufer's behavioral and mental health scales. Each scale is to be administered twice, one administration for each twin. �Alcohol and Drug Use Inventory (To be filled out for each twin separately) Yes No DK Did vet ever smoke tobacco cigarettes, regularly? 0 1 9 Did vet ever smoke pipe regularly? 0 1 9 Did vet ever chew tobacco o r d i p snuff regularly? 0 1 9 Did vet drink to the point of intoxication? (If mothers respond "seldom" or "never," score 0; if "sometimes" or " r e g u l a r l y " o r "often", score 1.) 0 1 9 Did vet ever drink to t h e point o f passing out? 0 1 9 Did vet's drinking result i n problems with friends? 0 1 9 Did vet's drinking result in ati accident, injury, arrest, o r some disciplinary action? 0 1 9 Did vet get into trouble at school because o f drinking? 0 1 9 Did vet get into trouble at work because o f drinking? 0 1 Did you ever suspect that vet was dependent o n alcohol? 0 Did vet ever use medicines t o calm h i s nerves? Did vet ever take sleeping pills? 0 0 Did vet ever take diet pills o r p e p pills? Did vet ever take a n anti-depressant? , 1 9 9 1 1 0 0 , 1 1 9 9 9 9 �Did vet ever use marihuana to the point. that you thought his personality w a s changing? Did vet ever use methaqualone to the point of seeming drunk? 0 0 D i d v e t ever use LSD? Did vet ever use mushrooms, peyote, mescaline? 1 1 9 0 0 9 1 1 9 9 D i d v e t ever use cocaine? 0 1 9 Did vet ever inject a drug o f a n y kind? 0 1 9 Did vet ever use heroin? 0 D i d vet ever u s e methadone? 1 0 9 1 9 Did vet's use of marihuana or other drugs ever result in problems with friends? 0 1 9 Did vet's use of marihuana or other drugs ever result in an accident, injury, arrest, o r disciplinary action? 0 1 9 Did vet ever use drugs t o t h e point where h e passed out? 0 1 9 Did you ever suspect that vet w a s d e p e n d e n t o n drugs? 0 ., ' . ^ 1 9 Did vet ever use more than one drug at the same time? 0 1 9 Did vet ever have trouble with family members over drug or alcohol use? 0 1 9 (Repeat the above protocol for the second twin.) �I am going to read you some statements about people; for each one I read to you, please tell If it is true or false for Twin 1. True False _ i __ He never hesitates to go out of his way to help someone i n trouble. 0 He is sometimes irritated by people w h o a s k favors o f him. 1 0 Don't Know 9 1 9 He has never Intensely disliked anyone. 9 He sometimes tries to get even rather than forgive and forget. 9 The have been times when he was quite jealous of the good fortune of others. He is always willing to admit it when he makes a mistake. 1 9 He always tries to practice what he preaches. 1 9 There have been occasions when he took advantage of someone. 1 . 9 He would never think of letting someone else bepunished for his wrongdoing. He never resents being asked to return a favor. Ele sometimes thinks that, when people have a misfortune they only gel: what they deserve. 0 9 He likes to gossip at times. 0 9 He has never been irked when people expressed ideas very different from his own. He has never deliberately said something that hurt someone's feelings. �He sometimes feels resentful when he doesn't get his way. I am goinj> to read you some statements about peopl.e; for each one I read to you, please tell If it is true or false for Twin J2. (Repeat above protocol for twin 2.) �When he gets angry, how o f t e n Is he (INSERT ITEM FROM L 1ST)-~wouId you say (read categories) Very Fairly SomeAlmost O f t e n O f t e n times Never Never Not Sure y e l l or shout 1 2 3 4 5 9 swear or curse 1 2 3 4 5 9 c r i t i c i s e someone 1 e 2 3 4 5 9 get I n t o a n argument 1 2 3 4 5 9 try to calmly exp l a i n his feelings or o p i n i o n s , would yousay 1 2 3 4 5 9 h i t somebody, would y o u s a y j u s t smile 1 1 make a fist and show an angry e x p r e s s i o n on h i s face 2 2 3 3 1 4 4 2 5 3 5 9 " 4 9 5 just stop talking, avoid arguing and s t a r t to do something else 1 2 3 4 5 h i d e his anger, try not to show it 1 2 3 4 5 . take out his a n g e r by k i c.k i ng t h i n g s like a chair, giving a d o o r a good slam, p u n c h the w a 1 1. , or look for somet h i n g I: o throw or smash 1 2 3 4 5 9 (Repeat the above p r o t o c o l for second twin.) 9 •# 9 9 �Interview Guide on Twins' Childhood I. Family of O r i e n t a t i o n A. Composition 1. Presence of biological parents a. Changes in parent presence (1) How many changes (2) What kind of changes? (3) Time span for each new regime and household composition during it b» Who would you say raised the twins? (1) inculcation features (a) roles of each parent ( b ) p u n i s h m e n t s - b o. h a v i o r s (c) rewards-behaviors (d) other relatives' roles (2) special relationships (a) Did twins have favorite parent? (b) Was it the same person for each? (c) Why? (d) Did twins establish close relationships with other relatives? (e) Were they the same person for each twin? (f) Why? 2. Siblings a. b i r t h order b. twins' relations w i t h other siblings (1) P o s i t i v e aspects (2) Negative aspects c. Did the twin get punished more or less than o t h e r siblings? Why? d. Did older siblings help raise twins? (1) role (a ) p u n i s h m e n t (b ) rewa rd (c) caretaking (2) frequency 1 �e. Do the twins keep in contact w i t h other siblings? B. Economics of Family of Orientation 1. Characterize family as lower, Working, Lower M i d d l e , Upper m i d d l e , or upper class? a. Did this change? (1) If so, for how long? (2) characteriEe fluctuations as progression or regression (3) describe standard of living d u r i n g twins' childhood in terms of: (a) (b) (c) (d) provission of basic necessities availability consumer good housing q u a l i t y , u t i l i t i e s money crises (eviction, power cut off, supperless nights) 2. Who p r o v i d e d income? 3. Who made family money decisions? C. A t t e n t i o n in family of Orientation 1. Kissing and hugging? 2. Kind words? . ' '* 3. Was one child recipient of more affection or n e g a t i v e c o n t a c t than the other? Did the twins d i f f e r in t h i s respect? D. P e r f o r m a n c e / E x p e c t a t i o n 1. Was it i m p o r t a n t to you that your sons... a. do well in school? b. do well in sports? c. be artistic or musical? d. be well-liked by others? e. only went around with children you knew or a p p r o v e d of? f. be religious? g. be polite and obedient? How important wasoit to you that your sons p e r f o r m e d �well in this (these) areas? 2, K. Did you bring pressure to bear for sons to perform well? The same for each twin? Family of Orientation: Disagreements 1. Did you and your spouse share or have s e p a r a t e s o c i a l lives? 2. Did you and your spouse enjoy each other's company? 3. Were you affectionate towards each other? 4. Did either of you complain at or argue with the other often? 5. Frequency of apparent anger on your part with household members 6. Disagreement with spouse a. b. Frequency Behaviors (1) avoidance/silence (2) shouting (3) indirect v i o l e n c e . ' -t (throwing, s t a m p i n g , smashing inanimate objects) (4) weeping (5) abandoning the house (a) frequency (b) dura t ion (6) physical violence (a) frequency (b) severity (c) twin(s) p r e s e n t ? (7) Did either of the twins a p p e a r u p s e t because of d i s a g r e e m e n t s b e t w e e n you and your spouse? IIow did you handle it? c. Content of d i s a g r e e m e n t 7. F. Chores Decision making between interviewee and spouse? 3 �Did you assign chores to the twins? 1. Division of labor among children 2. How carr ted out (a) time spent per week (b) d i s a g r e e m n t a , rankling �G. Education A. Grade school a. b. c. d• general performance special honors relations with teachers problems (1) ever fail a year? (2) seem to like school? B. Junior High a. b. c. d. general performance special honors relations with teachers problems (1) ever fail a year? (2) seem to like school? C. Sr. High a. b. c. d. general performance special honors relations with teachers problems (1) ever fail a year? (2) seem to like school? D. College a. b. c. d. general performance special honors relations with teachers problems (1) ever fail a year? (2) seem to like school? E. Vocational-technical a. b. c. d. general p e r f o r m a n c e special honors relations with teachers problems (1) ever fail a year? (2) seem to like school? H. Peers/Friends �1. Any continuous friends through high school? 2. At what stages did friends change? a. migration-related b. change in gradea/schoo1s c. other processes of change (specify clearly) (1) special interests, (athletics, scouts, cars, hobbies) (2) ethnic affiliation I. Dating 1. When s t a r t e d 2. Frequency 3. Seriousness Jobs 1. 2. 3. 4. 5. 6. 7. 8. Full-time Part-time Summer Age of first job Interaction between school and work Interaction between work and recreation Problems on job Volunteer work � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1844 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Typescript: Data Base for Mother Study Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/30638fcad2a5a274b91a83711931f0fe.pdf 26e0c5a3b2b1aca75f38b9db32af3436 PDF Text Text Item ID Hunter °1843 Author Collins, Joseph F. Corporate Author RODQTt/ArtlCla TltlB Guidelines for VA Cooperative Studies, Fifth Edition, April, 1981. Journal/Book Tltto Year 1981 Month/Day A ril Color Nimtaororimagos DOSCNptOn Notes P D 48 Alvin L - Young filed this item under "Vietnam Veterans Twin Study." Wednesday, July 11, 2001 Page 1844 of 1870 �GUIDELINES FOR VA COOPERATIVE STUDIES PREPARED BY: Joseph F. Collins, Sc.D. Assistant Chief Bertha D. Carter Administrative Officer Cooperative Studies Program Coordinating Center, VAMC, Perry Point, MD EDITED BY: Yick-Kwong Chan, Ph.D. William G. Henderson, Ph.D. Ping C. Huang, Ph.D. Kenneth E. James, Ph.D. C. James Klett, Ph.D. Mike R. Sather, R.Ph., M.S. Chief, CSPCC, VAMC, West Haven, CT Chief, CSPCC, VAMC, Hines, IL Staff Assistant, CSP, VACO, Washington, DC Chief, CSPCC, VAMC, Palo Alto, CA Chief, CSPCC, VAMC, Perry Point, MD Chief, CSPCRPCC, VAMC, Albuquerque, NM ENDORSED BY: James A. Hagans, M.D., Ph.D. Chief, Cooperative Studies Program VACO, Washington, DC Fifth Edition April, 1981 �TABLE OF CONTENTS Page IMPORTANT EVENTS IN A VA COOPERATIVE STUDY / I. INTRODUCTION 1 II. DEVELOPING A COOPERATIVE STUDY 2 A. Submission of Ideas 2 B. Planning of Study 2 1. 2. 3. 4. 3 3 3 4 C. Planning Committee Meetings Duties Pilot Studies or Feasibility Trials 4 1. 2. 3. D. CSPCC Human Rights Committee 4 5 5 Composition Responsibilities CSPCRPCC Drug Information Report The Proposal 5 1. 5 5 5 6 6 6 7 2. 3. E. Introductory Material a. Cover Letter b. Letter of Justification c. Study Article Letter d. Table of Contents The Study Protocol Appendices a. Human Rights Committee Report and Informed Consent Forms b. Research Data Forms c. Budgets d. Biostatistical and Research Data Processing Procedure (B.R.D.P.) e. Drug Handling Protocol (D.H.P.) f. Special Laboratories g. Curriculum Vitae 7 9 9 ' 11 11 12 12 12 1. 2. 3. III. Evaluation 12 13 13 Submission and Deadlines Outside Review CSEC and BRG Evaluation INITIATING A COOPERATIVE STUDY 15 A. Study Chairperson 15 B. Selection of Participating VA Medical Centers 15 C. Form Approval and Printing 17 D. Operations Manual 18 E. Hiring and Training 18 F. Acquisition of Additional or Replacement Equipment 18 �Page IV. CONDUCTING A COOPERATIVE STUDY 19 A. Management 19 1. 2. 3. 4. 19 19 20 21 Study Group Executive Committee Operations Committee Human Rights Committee B. C. Data Collection and Editing D. Newsletter 24 E. Site Visits 24 F. Early Termination of a Medical Center 24 G. Replacement of a Participating Investigator or Study Chairperson During the Course of a Study 25 H. Subsequent CSEC Review 25 I. Breaking the Double-Blind Code of Study Medications 26 J. CSPCC Files 26 K. Reports 27 1. 2. 3. V. Arranging Meetings and Travel 22 27 27 27 > Research and Development Information System (RDIS) Annual Report to Congress of Medical Research in the VA Smithsonian Science Information Exchange (SSIE) 23 28 A. Closing Down 28 B. Final Study Group Meeting 28 C. VI. CONCLUDING A COOPERATIVE STUDY Publications 29 RESPONSIBILITIES IN A COOPERATIVE STUDY 30 APPENDIX A-Addresses 33 APPENDIX B-Schedule of Important Events 39 APPENDIX C - Medical Research Service "Core Committee" for Triage Review for Veterans Administration Cooperative Studies 40 APPENDIX D - Cooperative Studies Evaluation Committee and Budget Review Group 41 APPENDIX E — Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Evaluation Committee (CSPCRPCCEC) 42 APPENDIX F-Study Budget Example 43 APPENDIX G - Request for Planning a VA Cooperative Study Precis Submission Checklist 44 �IMPORTANT EVENTS IN A VA COOPERATIVE STUDY Principal Proponent Submits Idea (precis letter) (Page 2) Triage Review and Decision by Director, MRS (and Director, HSR&DS or RER&DS as appropriate) (Page 2) Planning and Protocol Development (Page 2) Human Rights Committee Review of Protocol (Page 4) CSEC and BRG Review and Decision by Director, MRS (and Director, HSR&DS or RER&DS as appropriate) (Page 13) Selecting Medical Centers and Obtaining Local R&D Approval, Selecting Operations and Executive Committee Members (attention to this begins in active planning phase) (Page 15) Initiating Study: Forms and Study Article Preparation, Operations Manual Development (Page 17) Study Funding, Hiring, Training, etc. (Page 15, 18) Patient Intake Started (Page 19) Interval Meetings of Study Group, Executive Committee, Operations Committee and Human Rights Committee (Page 19) Three-Year CSEC and BRG Review (Page 25) Closing Down Study (Page 28) Publication of Results (Page 29) �I. INTRODUCTION The purpose of this manual is to describe policies and procedures for the organization and operation of VA cooperative studies, including the required laboratory and other technical support functions. Cooperative studies are those in which investigators from two or more VA medical centers voluntarily agree to study collectively a selected problem in a uniform manner, under a common protocol with central coordination. Cooperative studies are particularly advantageous for certain problems in the Medical Research Service (MRS) as well as for selected problems in the Health Services Research and Development Service (HSR&DS), and the Rehabilitative Engineering Research and Development Service (RER&DS). For the more common medical conditions, they can deal with the problems of diverse approaches, local bias, work load, duration of study, and differences in clinical setting. For medical conditions which are relatively rare so that one medical center may admit only a few patients a year, knowledge can be accumulated more rapidly by the pooling of observations of several facilities. With few exceptions, however, a cooperative study is not the place for the development and refinement of therapeutic techniques. Instead, clinical trial cooperative studies should be performed to evaluate the safety, efficacy, and cost effectiveness of health care intervention measures that have been developed and refined by preliminary trials in humans. Some epidemiological issues, however, may also be appropriate topics for cooperative studies. When such an approach is considered appropriate and advantageous, cooperative studies are encouraged by the Veterans Administration. Because of the importance attributed to this type of study, the VA has established the Cooperative Studies Program within the Medical Research Service to administer and coordinate them regardless of whether they fall within MRS, HSR&DS, or RER&DS. The Chief, Cooperative Studies Program (CSP), has in turn established four Cooperative Studies Program Coordinating Centers (CSPCCs), located at the VA Medical Centers, Hines, IL, Palo Alto, CA, Perry Point, MD, and West Haven, CT, and a Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), located at the VAMC, Albuquerque, NM. (Appendix A). The primary responsibilities of the CSPCCs are to provide biostatistical and data processing support and administrative coordination for VA cooperative studies and to ensure that they are conducted according to the guidelines set forth in this manual. Although it is expected that the CSPCCs will be responsible for the biostatistical and data processing needs of most cooperative studies, in certain situations these responsibilities may be performed by an outside contractor. In such cases, a CSPCC will monitor the study to ensure that these guidelines are followed and that the outside contractor is performing adequately. The primary responsibilities of the CSPCRPCC, in those studies where they are involved, are to assist in developing the study design and to acquire, assure the quality, distribute, monitor usage and adverse reactions, provide accountability and direct the disposition of all study articles (drugs, medical devices, diagnostic agents, biologicals, electronic devices, etc. for human use) under inventory in VA cooperative studies. The CSPCRPCC acts as a liaison between the pharmaceutical industry or manufacturers and the Study Chairperson and the related study committees, solves study article-related problems, provides guidance on and monitors compliance with FDA regulations governing clinical investigations and provides a comprehensive drug information service to study participants. The drug information service includes information on pharmacological mechanisms, absorption, half-lives, steady-state levels, distribution, metabolism, excretion, adverse and toxic effects, drug-drug, drug-laboratory and drug-food interactions, stability data, and assay methods of drugs in biological fluids. In a cooperative study most responsibilities are shared. However, certain persons and groups will have primary or major responsibilities. It is the purpose of these guidelines to identify the responsibilities and the means of providing for them. �II. DEVELOPING A COOPERATIVE STUDY A. Submission of Ideas An individual or someone representing a group (the Principal Proponent), interested in developing a cooperative study, sends a request for funds to plan a protocol to the Chief of the Cooperative Studies Program in VACO through his/her medical center's ACOS for Research and Development. This individual must either (a) be at least a 5/8 time employee of the VA or (b) if less than a 5/8 time employee, must have applied for and received approval for eligibility to receive Research and Development (R&D) funds from the Eligibility Panel of the VACO, R&D Service. In the latter case, a copy of the letter establishing eligibility to receive funds must be attached to the request The request for planning funds should be a one or two page statement indicating the objectives of the proposed research, the importance of the study topic to the VA and its patients, and why it requires a cooperative study within the VA. A paragraph which provides a firm summary statement indicating that the procedure(s) to be evaluated have had sufficient preliminary trials to be considered refined enough for a cooperative study evaluation should be included. The letter should also contain a statement of the Principal Proponent's eligibility to receive Medical Research Service funds and estimates of the number of medical centers required, the duration of the study in years, and the annual and total budget. A tentative protocol and other relevant background materials, including reprints, references and summaries of the Principal Proponent's experience, may be appended to this request. Appendix G provides a checklist of items that should be included in this request At various times during the year (usually three times; see Appendix 6), requests for planning funds are first reviewed by VA program specialists who provide a written critique of the proposal and then evaluated by a "triage review committee" constituted by the VACO Medical Research Service (see Appendix C), which may either reject them, assign a priority rating, or ask for additional information. The requests assigned a priority are put on a waiting list and those with the highest priority are chosen for planning. The actual number of studies released for active planning will depend primarily on the travel funds available and the current work load capacities of the CSPCCs. All VA cooperative studies (regardless of the source of funding) must have the approval of the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). All protocols, whether funded by the VA or by outside sources such as the Public Health Service, will have to be evaluated by the Cooperative Studies Evaluation Committee (CSEC) before VA approval will be granted. Each protocol will be submitted for evaluation through the assigned CSPCC and the Chief, CSP, VACO. All rules and regulations that govern cooperative studies in the VA must be adhered to in both the development of the protocol and in the conduct of the study when approved. In general, submissions of protocols to outside agencies for funding should occur after evaluation by CSEC and approval of the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). These protocols must identify all participating medical centers and be approved by all local R&D and Human Studies Committees and the respective medical center directors prior to submission to outside agencies. When necessary or highly desirable, an exception to this may be sought by petitioning the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate), through the Chief, CSPCC and the Chief, CSP. B. Planning of Study When funds for planning a study have been authorized, the Chief, CSP will assign the study to one of the four CSPCCs. The Chief of the assigned CSPCC will notify the Principal Proponent, with a copy of this letter to the local ACOS for Research and Development (and the Chief, CSPCRPCC if the study involves study articles), that the study has been approved for planning. The Chief will then assign the project to a biostatistician who will collaborate with the Principal Proponent in setting up the planning meetings. �1. Planning Committee. Once funds for planning have been authorized, a Planning Committee must be established. This committee should include the Principal Proponent, the CSPCC Biostatistician, at least two potential Participating Investigators who are eligible for VA research funding and any additional relevant consultants. If several disciplines are involved (such as medical and surgical), the composition of the Planning Committee should reflect this and may require a consultant for each discipline. The total planning group should usually consist of four to eight persons. Supporting resource personnel from VACO (including the Chief, CSP, or representatives from Nursing Service, Pathology Service, etc.) and the Chief, CSPCC are not usually included in this count. When a study involves drugs or other study articles, the Chief, CSPCRPCC will assign a Clinical Research Pharmacist to the project to collaborate with the committee. This pharmacist or the Chief, CSPCRPCC will ordinarily attend the first planning meeting and any additional planning meetings as determined to be appropriate by the Chief, CSPCRPCC and the Chief, CSPCC. In such studies, a discussion with the Chief, CSPCRPCC concerning attendance at the planning meetings will occur prior to the meetings. 2. Meetings. Planning will ordinarily require two major meetings lasting two or three days each. Under special circumstances, additional minor planning activities may be funded. The Principal Proponent should submit a list of proposed attendees through the appropriate CSPCC to the VACO, CSP office at least five weeks prior to a meeting. It is strongly encouraged, when travel costs allow, that planning meetings be held in the vicinity of the participating CSPCC to permit attendance of other relevant CSPCC staff. This is obligatory for the final planning meeting to facilitate the Human Rights Committee review of the proposal during a portion of that meeting. Meeting dates will be at the joint convenience of the CSPCC Biostatistician and the other attendees, and meetings will not be funded by VACO, CSP unless the biostatistician is able to attend. Under ordinary circumstances, if the first planning meeting is not held within three months of notification that funding for planning is authorized, or if subsequent planning meetings and activities do not occur within six months of the prior meeting, it will be assumed that the planning activity has ceased and no further support for planning will be provided. It is the responsibility of the Chief, CSPCC to notify VACO, CSP at the appropriate time to discontinue support for planning or, if the Chief, CSPCC concurs that the circumstances in a given situation are unusual and justify a deviation from this practice, to petition the Chief, CSP for an extension. 3. Duties. The Planning Committee is responsible for the preparation of a final protocol for ethical review by the CSPCC Human Rights Committee and ethical, professional, and scientific merit review by the Cooperative Studies Evaluation Committee (CSEC). This protocol should reflect a close, collaborative, in-depth effort in its planning and essential agreement on major issues of goals, experimental design, sample size, variables to be measured, methods of monitoring the study, data analysis, etc. The CSPCC Biostatistician has primary responsibility for the general scientific methodology and validity of the experimental design, sample size estimates, plans for monitoring data summaries, final data analysis, and biostatistical interpretation of the results. In studies involving drugs or other study articles, the CSPCRPCC Clinical Research Pharmacist has primary responsibility for assisting the Principal Proponent in designing treatment regimens, obtaining study articles and assuring their quality, assuring compliance with drug accountability and other legal requirements by designing study article handling protocols, adverse drug reaction reporting procedures, and preparing and coordinating the IND and IDE submissions to the FDA when applicable. Before the first planning meeting, the Principal Proponent should distribute to the committee members any material bearing on the subject of the study, such as pertinent journal articles, the request for planning funds, and a rough draft of the proposed protocol or a detailed outline for a draft protocol. This material will allow the committee members to acquaint themselves beforehand with the proposed study. At this first meeting, the committee should define the primary question(s) to be answered by the study, the patient population to be studied, the therapeutic regimens (if any), the response to be measured, the �optimal method of comparisons, what types of outcome will be of interest, the number of patients needed and how they will be assigned to regimen groups (if any), other specifics of the experimental design, the method of analysis to be employed, and any secondary questions that seem important After these issues have been considered, the Planning Committee must decide the feasibility of doing the study and the probability of its providing valid information. If the Planning Committee decides that the study is not feasible, the Chief, CSP should be notified in writing by the Principal Proponent through the appropriate CSPCC Chief giving reasons so that further planning support can be canceled. If it is decided that the study should be conducted, as is usually the case, the committee must make plans for writing a final protocol. This generally means that on the basis of the discussions at the meeting, the best qualified committee members write the individual sections of the protocol. These sections are then sent to the Principal Proponent who is responsible for integrating them into a well-organized draft protocol. The final planning meeting should be spent in refinement of the protocol, final formulation of the budget and other details of the final proposal, and a review by the Human Rights Committee. To ensure that these activities can be completed and particularly that there is a valid human rights review, an essentially complete protocol must be mailed to each member of the Planning Committee prior to the meeting. If the protocol is not received at the CSPCC three weeks before the meeting or if the protocol is substantially incomplete, as determined by the Chief, CSPCC, the final planning meeting will need to be rescheduled. This period of time will also allow other relevant personnel at the CSPCC to review the protocol so that their comments can be considered at this final meeting. Ideally, the CSPCC should be able to prepare the final protocol for submission to CSEC immediately after the final planning meeting. However, there will usually need to be some additional work by the committee before the CSPCC can begin production of the final protocol. This additional work should be completed as quickly as possible. 4. Pilot Studies or Feasibility Trials. It is sometimes necessary to explore the feasibility of a cooperative study. In such cases, a pilot study or feasibility trial will be conducted in two or three medical centers to determine whether the protocol for a study is workable or to answer some preliminary question required by the main protocol. Pilot studies require the approval of the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). They are generally developed by the usual planning process and presented to CSEC for evaluation since they are typically small-scale trials of a completely developed protocol. C. CSPCC Human Rights Committee In studies that involve risks (physical, psychological, sociological, or other) for the participants, the most important single consideration is always the protection of the. individual. To assure that the rights of patients are protected in a cooperative study, a Human Rights Committee has been established at each of the four CSPCCs. 1. Composition. Currently the Human Rights Committee should consist of a minimum of seven persons. A person should represent fulfilling only one requirement even though qualifications indicate the ability to represent two or three categories. This committee should include a lawyer (not selected for expertise in forensic medicine), a person concerned with human ethics (such as a member of the clergy, a sociologist, philosopher, humanist etc.), a veteran who has been hospitalized (or an outpatient) in a VA medical center (not officially representing a veterans' organization), and a member of a recognized minority group. None of these members should be a full- or part-time VA employee when appointed. The fifth member, who will chair the committee, will be a VA employee, but will not be a physician or directly involved in research. In addition to the CSP requirements for Human Rights Committee membership, it is necessary to be in full compliance with current agency requirements for Human Rights Committee membership (at present covered in Interim Issue 10-81-44, Octobers, 1981). �2. Responsibilities. The responsibility of this committee is to assess the cooperative study at the proposal stage with respect to the patient's rights and welfare. This is generally done at the final planning meeting but always prior to submission for CSEC review. The committee must ensure that each patient (or a guardian if the patient is judged incompetent) is made fully aware of exactly what participation in the study involves and what risks it entails. This review should include an in-depth consideration of the protocol and the informed consent procedures and form(s). The Human Rights Committee may, on considerations of human rights issues only, accept the study as proposed, accept it with conditions, or reject it outright If the study is rejected, the Planning Committee must make the necessary changes and resubmit the study to the Human Rights Committee. A recommendation by a Human Rights Committee may not be reversed except by its own action. Therefore, no study will be submitted to CSEC for evaluation unless the Human Rights Committee has approved it If the study is accepted with conditions, it does not necessarily have to be resubmitted to the Human Rights Committee, but the CSPCC Biostatistician is responsible for ensuring that the conditions are met before it is submitted for CSEC evaluation. A letter to this effect, co-signed by the Chief, CSPCC and the Chairman, Human Rights Committee, is required. It should be stressed that the CSPCC Human Rights Committee provides a global assessment of the human rights aspects of the proposal. Neither this review nor the CSEC review, which is a global assessment of the scientific merit, relevance, and professional ethics, is conducted as a substitute for the review by the local participating facility's R&D and Human Studies Committees. 3. CSPCRPCC Drug Information Report When a study involves drugs, the Clinical Research Pharmacist, through the Chief, CSPCRPCC and the Chief, CSPCC will provide the Chairperson of the CSPCC Human Rights Committee with a comprehensive drug information report (prior to the second planning meeting). The report will include known side effects, adverse effects, contraindications, and precautions of the drugs to be used in the study. This information is to be used by the CSPCC to brief their Human Rights Committee on the unwanted effects peculiar to the study drugs. A copy of the report will also be sent to the Principal Proponent and the Study Biostatistician. D. The Proposal Although not all proposals can have exactly the same format, they all must contain certain elements. The following is a list of these common elements. In general, every proposal requires some introductory material, the formal protocol, a complete budget, and a complete set of data forms. Technical details, such as procedures for biostatistical and research data processing, should be described in appendices. (Each proposal must include the following material. The order given below is the suggested sequence.) 1. Introductory Material. a. Cover Letter. This letter, preceding everything else in a submission, is a simple statement that the Principal Proponent, the Study Biostatistician, and the Chief, CSPCC agree that the proposal is ready to be submitted for evaluation. In cases where there is disagreement, this letter would point out where the disagreement lies. It may also relay other relevant information, for instance, in the case of rcsubmission, it may indicate where the recommended changes have been made. Resubmissions must also include, after the cover letter, the summaries of the previous review (letter from the Director, Medical Research Service and the Director, HSR&DS or RER&DS as appropriate, reports of CSEC and the Budget Review Group). b. Letter of Justification. In a separate letter, the Principal Proponent must summarize other relevant work in the field and state why the proposed study is unique. If the study is not unique, the reasons for its being replicated must be given. Whenever possible, this letter should include an estimate of the potential impact of the study on improved patient care and/or reduced medical center costs. �c. Study Article Letter. This letter is required whenever a study involves drugs or other study articles. The Clinical Research Pharmacist and the Chief, CSPCRPCC will provide a Letter of Certification identifying (1) any drug-related problems that may possibly exist in the study, (2) whether or not an IND or IDE is required, and (3) if an IND or IDE is required, that the appropriate forms (completed by the CSPCRPCC and Principal Proponent) have been reviewed by the CSPCRPCC and in its opinion, are ready for submission to the FDA. The IND or IDE submission will follow CSEC's approval of the proposed study. d. Table of Contents. 2. The Study Protocol. The protocol should reflect a cooperative effort of all members of the Planning Committee. Since different types of studies will require different formats, the following is provided as a guide and should not be construed as an all-inclusive list of what should be contained in the main protocol. Each protocol should have background information and references indicating previous and current related research and a statement why the authors feel that the study should be done, specifically, why it should be done as a VA cooperative study. If the study involves the use of drugs, all pertinent pharmacological and toxicological data should be included with appropriate documentation. The purposes of the study, both primary and secondary, should be clearly stated. The protocol should also contain the experimental design of the study, patient selection criteria, methods of treatment, schedule of observations and laboratory tests, measures of success, and appropriate consideration of sample size. Within this framework, details such as double-blindness, controls, methods of follow-up, training procedures, specialized rating scales, central readings, central laboratories, assignment of patients to therapy groups, and methods of assuring uniformity of care and follow-up should be discussed along with certain administrative aspects such as the use of a pilot trial, duration of the study, number of medical centers, and data flow. A section devoted to moral and ethical considerations should include a description of the safeguards to protect the patients, assurance that they may withdraw from the study at any time without prejudicing their medical care or VA benefits and the informed consent procedures and form(s) to be used. It is with these considerations that the Human Rights Committee will be most concerned so they should be clearly spelled out. This section should also give consideration to the duties of the witness of the informed consent. Should the witness merely witness the signature or should the witness be an auditor witness who witnesses the entire informed consent procedure? Although the Planning Committee will initially decide the type of witness to be used, the Human Rights Committee has the option of requiring the study to use an auditor witness if, in its opinion, the risks of participation in the study are of such a magnitude or if the patients will be in such a confused state that the committee feels that someone other than the Study Investigator should be present to determine that the patient is really given a fully informed consent If the Human Rights Committee does require an auditor witness, this decision will be binding on the study and all medical centers in the study. It is suggested that the individuals who participate in a cooperative study be referred to as "patients," "participants," or "volunteers" rather than as "subjects." Also, because of recent legislation, Social Security numbers and VA Claim numbers should not be used to identify patients if at all possible. If they are considered necessary for the conduct of the study, as they might be in studies that require a long follow-up period, the patient must consent to the use of these numbers. This is most easily achieved by including this request in the informed consent the patient signs when agreeing to participate in the study. If nonveterans must be used in the study because not enough veteran patients are available, it is important that they provide a clear consent, that they do not encumber the medical center's operating �budget, and that they are admitted to the study for the sole purpose of participating in the project and not for obtaining treatment from the Veterans Administration. All costs for caring for the nonveterans should be charged against the study's research appropriation. The VA physician should not assume a doctor-patient relationship outside the scope of the study with nonveterans unless it is through the VA medical center's medical school affiliation. All of this must be clearly stated in the protocol and must have the approval of CSEC and the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). If a decision to use nonveteran patients is made during the study, the proposal must be formally resubmitted to CSEC as a protocol modification, and if approved, resubmitted for R&D Committee approval at the participating medical centers (see General Counsel's Opinion VA-Op, GC. 28-58, June 25, 1958). 3. Appendices. In addition to the appendices required of every protocol, it may be appropriate to include other supporting material relevant to the study as appendices rather than in the body of the text, e.g., summaries of reliability or validity studies of proposed research data forms or a report of pilot studies. a. Human Rights Committee Report and Informed Consent Forms. The report of the Human Rights Committee, signed by the chairperson, showing that the committee has approved the study, must be included in the proposal. In case of resubmissions, all reports must be included in chronological sequence. The informed consent forms to be used for the study must be included with the final proposal. VA Form 10-1086, "Agreement to Participate in Research By or Under the Direction of the Veterans Administration," must always be completed. This form requires the signatures of the patient, a witness, and the Participating Investigator or designated professional equivalent. VA Circular 10-81-20 (dated 2/2/81, Subj: Revised Instructions for VA Form 10-1086, Obtaining Informed Consent From Investigational Subjects) further directs that a separate document be used in conjunction with the VA Form 10-1086. This document should describe the study in language that will be easily understood by the patient or his/her representative so that a reasonable decision concerning participation can be made. Each sheet of the document must be headed with "Information About the VA Cooperative Study on..." followed by the title of the study. It must include the following: 1. A statement that the patient is being invited to participate in a clinical research project, the purpose of the investigation and an explanation of its nature including how it relates to other knowledge, the use to be made of the results obtained, expected duration of the patient's participation, and identification of any procedures which are to be experimental. 2. The procedures to be used, including invasive techniques, restrictions on normal activities, and the possibility of receiving inactive material in a double-blind trial. 3. Known risks, inconveniences, such as frequent.clinic visits, or side effects that can be expected and what measures will be taken to minimize any hazard or discomfort or, where applicable, a statement that the risks cannot be predicted. 4. Any benefits that may accrue to the patient as a result of participation in the trial, including therapeutic benefits, payments, and recognition. 5. Any alternate courses of action open to the patient in lieu of participation in the study. 6. When appropriate, a statement of the result to be anticipated if nothing is done, e.g., when neither an experimental nor a control drug (placebo or standard drug) is taken. �7. A statement that the patient may decline to participate or decide to withdraw from participation at any time without prejudicing his/her medical care or other VA benefits. 8. If patient compensation or the medical treatment available is different than that provided for in VA Form 10-1086, then a statement is required informing the patient of the compensation and medical treatment that is available should he/she sustain physical injury as a result of participation in the study. The Food and Drug Administration further requires (Volume 46, Federal Register, 8951) for all projects that fall within its purview that the following elements be included in the informed consent: 1. An explanation of whom to contact for answers to pertinent questions about the study and patients' rights and whom to contact in the event of a study-related injury to the patient 2. A statement that the provisions of the privacy act and freedom of information act will be adhered to and that there is a possibility that the study's research records may be inspected by the FDA. When appropriate, the following elements should also be included. 3. Anticipated circumstances under which the patient's participation may be terminated without regard to the patient's consent. 4. Any additional costs to the patient that may result from participation in the study. 5. The consequences of a patient's decision to withdraw from the study and procedures for orderly termination of participation. 6. A statement that any significant new findings developed during the course of the study which may relate to the patient's willingness to continue participation will be provided to the patient 7. The approximate number of patients involved in the study. This information sheet may also be used to ask the patient for permission to use Social Security or VA Claim numbers. In obtaining informed consent, the investigator must specifically inform the patients of their right to compensation and treatment for physical injury. The required information must be given in conformity with federal laws and the contents of Circular 10-78-300 (dated 12/29/78, Subj: DHEW (DHHSI Required Information About Compensation and Treatment of Injured Clinical Research Participants) and the FDA regulations (Volume 46, Federal Register, 8951). Different information will have to be provided to veterans eligible for medical care on the one hand and to noneligible veterans and nonveterans on the other. Eligible veterans are entitled to medical care and treatment for any injury sustained. Compensation may also be payable under 38 USC 351 or, in some circumstances, under the Federal Tort Claims Act Noneligible veterans and nonveterans are entitled to medical care and treatment only on a humanitarian emergency basis with the medical care appropriation reimbursed from research funds. Any compensation for them, however, would be limited to situations where negligence occurred and would be controlled by the provisions of the Federal Tort Claims Act. Each patient must be allowed to read the informed consent form or have it read and understood before discussing consent with the investigator. Each page of the document must be signed by the patient. In discussing the study with the patient, the investigator may have to go somewhat beyond the �statements in the information sheets, but there must be no substantive addition, deletion, or modification of these statements. For cooperative studies, no local changes of the information sheets will be allowed. The information sheets are the tangible evidence of what the investigator tells the patient. A copy shall be given to the individual signing the form. In addition to the aforementioned circulars and regulations, this document and procedure should also be consistent with the HHS guidelines for informed consent. If anesthesia, surgical operations, or other procedures are to be used, consent for these procedures must also be obtained on SF 522. b. Research Data Forms. They must be designed in a format which will permit the investigator to record usable, complete, and accurate data. They should permit assessment of all planned aspects of the study, and represent a data repository for later retrospective probes into questions related to the study. For these reasons, a complete set of prototype forms is required when the proposal is submitted to CSEC for scientific evaluation. The case report forms should provide a complete patient data record for research purposes. Tailored to the specific aims and objectives of the study, they are not routine hospital or clinic medical records and are not intended to replace them, but to supplement them. They must contain all data and information pertinent to the conduct of the study, be easy to use and understand, in logical sequence for the recorder, meet biostatistical and data processing needs to minimize checking, encoding and automated data processing handling, and be acceptable to the study participants, the Study Biostatistician, the computer specialist, the encoders, and the keypunch operators. If the forms are to be filled out by the patient or used to interview the patient, the privacy act statement must be included on the first page of each form. Whenever possible, the forms should avoid narrative replies, but rather make use of objective questions. In general, the forms should be time-oriented. The initial forms should provide space for screening information, such as specified elements of the patient's history, physical examinations, routine and special laboratory testing, checklists of eligibility and exclusion criteria, and should include rather complete baseline information, such as identification information, age, race, sex, etc. Follow-up forms should be formatted to accommodate planned follow-up visits, records of interval history, physical examinations and laboratory assessments. Final report forms relating to death, early withdrawal, and successful completion of the planned observation period and final evaluation are also needed. c. Budgets. Every protocol must have a study budget, a CSPCC budget and, when appropriate, a CSPCRPCC budget and a special laboratory budget. 1. Study Budgets. To provide CSEC with an overview of the funds required for the conduct of a proposed study, each proposal should contain as complete and detailed an estimate of the costs involved as possible (see Appendix F for format). Although it is sometimes possible to increase the budget later should the need arise, this should not be counted on and all foreseeable expenses should be included. The budget should be computed for the first year and each succeeding year with justification for items such as added personnel and patient travel. The breakdown should show the cost per medical center as well as the total cost of the study. Furthermore, the Study Chairperson's office budget should be separate from that of his/her participating medical center's costs as should expenditures of all special reference laboratories, etc. Any costs incurred by the CSPCC or CSPCRPCC above and beyond the normal or core costs of the center, such as hiring a technician for use only on the study, should also be listed in this budget. The core costs of the CSPCC and CSPCRPCC should not be listed here. Items to be included in the budget are the salaries of supporting personnel, consultation fees, equipment, supplies, investigational or study articles and other medications and chemicals, nonveteran care, and costs of patient travel if required by the study. The budget should allow for a start-up period so that newly hired personnel can familiarize themselves with the protocol and their �medical center. This start-up period will usually be no more than three months, but it is study-oriented so that studies requiring a longer start-up time should budget for it. Supporting personnel are those hired solely for working on the study and not existing personnel who work on it as part of their regular duties. They might include technicians or other assistants at each medical center, a clinical coordinator for the Study Chairperson's office, or additional secretarial help. The Principal Proponent must prepare a generic position description with tentative grade levels for each of these positions as part of the budget request Personnel hired for the study are to be used solely for the study and are not to be used for other work unless they have no study functions to perform. The services of consultants and special research laboratories inside or outside the VA will be funded, if needed by the study, for providing such services as expert advice, central readings and assessments, and quality control. Equipment and supplies include any material that is to be used solely for the study, such as testing materials, laboratory equipment, and office supplies. Patient travel should only be included if the patient is required to travel for the sole purpose of being in the study. If the patient's presence is required for reasons other than those of participation in the study, then travel funds should come from the usual medical center sources. Any other costs that the study requires should also be included. There are procedures for requesting an increase to the budget after a study has been funded, but approval will only be given in exceptional circumstances. Requests for such increases with complete justification should be sent by the Participating Investigator through the Study Chairperson and Chief, CSPCC for concurrence to the Chief, CSP. For costs greater than $5,000, action will not be taken until the concurrence of the study Operations Committee and the Chief, CSPCC has been forwarded to the Chief, CSP. Funds for units and functions in general use by most cooperative studies, such as the CSPCCs and the CSPCRPCC, will be provided and directed by the VACO, CSP. A proportionate share of their costs will be assigned by the respective Chief to each study using those facilities. Funding for extra travel and attendance at various nonroutine meetings before and during the study should be budgeted as a separate item but, if approved, will be provided from centrally directed funds. The proposal budget should only include extra travel needs such as training meetings and site visits, and should not include the routine meetings of the Study Group, Executive Committee or Operations Committee; estimates of the latter will be provided by the CSPCC. Funds provided for a cooperative study will be limited to the needs of the study and must not be used to supplement other clinical or research activities. Unused cooperative study funds are not available locally for other research activities. Furthermore, funds for a cooperative study at a given VA medical center are considered "line item" type allocations, especially in regards to personnel, but also for unusually costly equipment or other operating costs (i.e., greater than $500 annually). Funds may not be arbitrarily transferred from one category (e.g., personnel) to another (e.g., equipment or other operating costs) within a given cooperative study at a VA medical center without submission of written justification by the Participating Investigator through the Study Chairperson and the Chief of the appropriate CSPCC for endorsement to VACO, CSP for approval. Any unused funds will ordinarily be returned to VACO, CSP on at least a quarterly basis, unless a specific exception is granted. 2. Cooperative Studies Program Coordinating Center Budget. This budget contains a cost estimate of the biostatistical and data processing support for the study. It will ordinarily include estimates of personnel and other costs for handling the study at the CSPCC or if the CSPCC performs only a monitoring role, a detailed breakdown of the outside contractor's estimated costs and the CSPCC's costs for monitoring the study. Budget and justification for term appointment staff should be included if the study requires additional manpower support beyond that of the center's core staff. 3. Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Budget. As part of the final study proposal, the CSPCRPCC will submit a projected cost estimate of existing 10 �CSPCRPCC core resources necessary to support the proposed study. An additional projected cost estimate and justification for resources beyond core costs will be submitted (when applicable) for additional pharmacy staff term appointments (centrally and at the field station level) for specific large work load projects and for study articles (drugs, medical devices, diagnostic agents, biologicals, electronic devices, etc., for human use) and related supplies. The estimated beyond core resources budget must also be included in the study budget as a separate line item. 4. Special Laboratory Budget. If a special laboratory is needed for the study, a detailed cost estimate for the laboratory must be included. This should include such things as personnel costs, materials needed, and shipping and packaging. The total cost of the laboratory should be listed separately on the study budget. d. Biostatistical and Research Data Processing Procedure (B.R.D.P.). The protocol must also contain a set of plans for analysis that is as complete as can be envisioned at the time for both periodic (monitoring summaries) and final analysis. It should include a statement of the variables to be analyzed, the intervals at which summaries and analyses will be done, and the specific methods to be used. Details for these procedures should be furnished in the Biostatistical and Research Data Processing Procedure Appendix (Appendix B.R.D.P.). This appendix should include a detailed description of the planned biostatistical data monitoring and management procedures to be used in the study, as well as the planned biostatistical analyses to be performed at the close of the study. It should include prototype tables, charts, data summaries, summaries of analyses, etc., and an outline of the format of the progress reports to be provided to the Study Chairperson, the Executive Committee, the Study Group, and the Operations Committee. It is expected that at least 80% of the preplanned final data summaries and biostatistical analyses will be defined and described in this appendix. This appendix should also include the following two items: 1. Patient Intake Graph. For each proposal, the biostatistician must prepare a graph of the anticipated patient intake and patient follow-up for the proposed duration of the study, including the start-up period. This will usually be based on the sample size estimated by biostatistical rationale. Expected number of patients should constitute the vertical axis and time the horizontal axis. 2. Summary of Quality Assurance. A summary page of planned quality assurance measures to be used to monitor the study and the data must also be a part of the proposal. This is submitted on a standard form completed by the CSPCC Biostatistician. e. Drug Handling Protocol (D.H.PJ. 1. Drug Handling Procedure. A detailed procedure for handling drugs used in the proposed study must be furnished in the Drug Handling Protocol (Appendix D.H.P.). If investigational or study articles and other medications and/or chemicals are to be used, the CSPCRPCC will secure and distribute them and provide drug accounting to the Study Chairperson and Chief, CSPCC. Each drug study proposal submitted for CSEC review must have an Appendix D.H.P. This appendix is written by the CSPCRPCC and includes detailed instructions for distribution, receipt, disposition of unused portions of drugs, and the recording of these activities. The Appendix D.H.P. will be prepared in accordance with Circular 10-80-253, Investigational Drugs and Research. 2. Notice of Claimed Investigational Exemption for a New Drug (IND) and Investigational Device Exemption (IDE). If study articles that are to be used in a study do not have Food and Drug Administration (FDA) approval, and in certain other situations also, an IND or IDE must be filed with the FDA before the study can begin. In the case of studies involving study articles, the CSPCRPCC will provide the necessary guidance as to whether the study will require FDA approval. 11 �Ordinarily, one member of the Study Planning Committee (usually the Principal Proponent) will be designated as the sponsor of the study. He/she is required to complete a "Notice of Claimed Investigational Exemption" (FD Form 1571), and a "Statement of Investigator" (FD Form 1573) known as an IND. The CSPCRPCC will assist the sponsor in completing these forms (see Guidelines for an IND Submission to the FDA in the VA Cooperative Studies Program). The completed forms (IND or IDE) must be sent to the CSPCRPCC by the sponsor 15 days prior to the CSPCC deadline. The CSPCRPCC will send copies of the entire submission to the CSPCC, the Principal Proponent, and the Chief, CSP, VACO. Immediately after the study is approved by CSEC, these forms must be sent in triplicate to the FDA by the sponsor along with three copies of the study protocol. By law, the FDA must either give or refuse approval within 30 days. If word has not been received within 30 days, the investigator is allowed to proceed with the study. Thus, it is advisable to send this material to the FDA by certified mail so that there is a record of when it was received. Every investigator who will be participating in the study must complete a "Statement of Investigator" (FD Form 1573). The investigator must submit this completed form to the CSPCRPCC. Copies of these forms must be sent to the FDA by CSPCRPCC through the sponsor (chairperson), with reference made to the FDA assigned IND number as soon as they are all received. It is not required that the FD Form 1573 be filed concurrently with the initial submission of the Study Chairperson's FD Forms 1571 and 1573 to the FDA. Completed copies of all FD Form 1573's must be on file in the CSPCRPCC and CSPCC before drugs can be distributed to the participating medical centers. When the pharmaceutical company is acting as the sponsor of the study, they accept the responsibility of filing a "Notice of Claimed Investigational Exemption for a New Drug" (FD Form 1571) with the FDA. The "Statement of Investigator" (FD Form 1573) of the Study Chairperson and the "Statement of Investigator" (FD Form 1573) from the Participating Investigators are to be sent to the sponsor by the CSPCRPCC through the Study Chairperson. A letter from the pharmaceutical company, identifying their FDA assigned IND number will be accepted as a substitute for FD Form 1571 as described above. Copies of all completed FD Form 1573's must be forwarded to the CSPCC and the Study Chairperson by the CSPCRPCC as previously described. In the event that clinical pharmacology investigations are to be conducted in the study, FD Form 1572 (Statement of Investigator-Clinical Pharmacology) is to be substituted for the aforementioned FD Form 1573, for those investigators who are responsible for conducting and evaluating this aspect of the study. f. Special Laboratories. If provision has been made for central laboratory determinations, urine testing, centralized readings of EEC's and ECG's, etc., there should be a fairly detailed protocol included as an appendix which describes the procedure for obtaining specimens, evaluating results, and transmittal of data. g. Curriculum Vitae. At a minimum, the curriculum vita of the Principal Proponent and the Study Biostatistician must be included. If consultants or Co-Principal Proponents are to appear before CSEC, their curricula vitae should also be included. In order to limit the length of the curriculum vitae to four pages, the list of publications should, if necessary, be restricted to those relevant to the study. E. Evaluation 1. Submission and Deadlines. As detailed in the preceding section, a proposal that is to be submitted to CSEC for scientific evaluation should be as complete, precise, and scientifically excellent as possible. The Principal Proponent must submit the proposal for evaluation to CSEC through the CSPCC. It is the responsibility of the CSPCC Biostatistician to review the final proposal to assure its completeness and 12 �accuracy. Only after the Principal Proponent, the CSPCC Biostatistician, and the Chief, CSPCC agree that the proposal is ready should it be submitted to CSEC for evaluation. (Appendix B). In the event that the Principal Proponent believes strongly that the proposal should be submitted for evaluation and the biostatistician believes just as strongly that it should not, an outside consultant (biostatistician) will be engaged on contract to review the proposal and arbitrate the matter. The consultant will be selected by the Chief, CSP, and will provide recommendations to the Chief, CSP. On occasion, this outside consultant may be a senior biostatistician at one of the other CSPCCs. Such a disagreement should be rare since the Principal Proponent should be working closely with the CSPCC Biostatistician in developing the proposal. The CSEC meets each year in February, June, and October. The three associated deadlines for submission of completed proposals to the VACO, CSP office for CSEC review are December 1, April 1 and August 1. There will be no extensions of these deadlines. If a proposal is received after these dates, it will not be reviewed at the upcoming CSEC meeting, but will be deferred to the next meeting. Because every proposal must be submitted through and reviewed by a CSPCC Biostatistician, the Principal Proponent must send a complete final draft to the CSPCC at least six weeks before the deadline, i.e., a complete final draft will be due at the CSPCC before October 15 for a December 1 submission, before February 15 for an April 1 submission, and before June 15 for an August 1 submission. There will be no extensions of these deadlines; protocols that are late will automatically be deferred until the next submission. If they are received in time, they will be promptly reviewed by the Chief, CSPCC for completeness and accuracy. If the protocol is complete and accurate, the CSPCC will assume responsibility for the final typing to assure uniformity of the proposal and for making the 25 copies that are necessary for submission of new proposals or the 20 copies necessary for three-year reviews, study extensions or special reviews. However, if the protocol is deficient in any important respect, the deficiencies will be identified and the Principal Proponent will be instructed to resubmit by the next deadline. 2. Outside Review. The CSP office reviews the proposal and makes sure that all required information is attached to each copy. It then distributes copies to selected outside reviewers, the Cooperative Studies Evaluation Committee, and to the Budget Review Group. There are generally two or three outside reviewers selected by the Chief, CSP. One of these reviewers will be a biostatistician, while the other(s) will be expert(s) in the subject matter field. They will be asked to submit written critiques of the proposal which will be made available to the CSEC and BRG members before the CSEC meeting. When practicable and as a courtesy, copies will also be made available to both the Principal Proponent and the Study Biostatistician. These reviewers are permitted to request anonymity for their comments if they wish to do so. The subject matter reviewers will be asked to comment on the importance of the project, its feasibility, the clarity and achievability of its objectives, the adequacy of the plan of investigation, the correctness of the technical details, the adequacy of safeguards for the welfare of the patients, and on any other relevant features of the proposal. The biostatistical reviewer will be asked to comment on the clarity of the proposal and apparent achievability of its objectives; the adequacy and correctness of the plan of investigation and the technical details such as character and adequacy of response variables, definition, measurement, data recording, frequency of observations, adequate patient eligibility and exclusion criteria, sample size, and plans for data handling and analysis; adequacy of safeguards for the welfare of patients; and on any other features considered relevant. 3. CSEC and BRG Evaluation. It is the responsibility of the Cooperative Studies Evaluation Committee to review new study proposals for cooperative studies, to recommend approval for funding or define reasons for disapproval, and to review the progress of each cooperative study every three years or more frequently upon request. For new studies, CSEC advises the Director, Medical Research Service (and 13 �the Director, HSR&DS or RER&DS as appropriate), and the Chief, CSP regarding the scientific merit and VA funding priorities of the studies. Approval by this committee constitutes a recommendation and is not tantamount to funding. The committee is composed of seven to nine regular members including the chairperson. Two to four of the members are biostatisticians, one is an expert on drugs and drug usage (clinical pharmacology) while the other members come from various fields of medicine, usually psychiatry, surgery, and internal medicine. All of these members should have had some experience in clinical research and in the conduct of cooperative studies. The committee will usually be augmented by an ad hoc member knowledgeable in the particular subject matter of the protocol being reviewed. The Chief, CSP and his staff assistant serve as coordinators for the meetings, but have no voting rights. (Appendix D). The Principal Proponent and the Study Biostatistician (as well as the monitoring CSPCC Biostatistician if the Study Biostatistician is from outside the Coordinating Center) appear before the committee to discuss and clarify all matters relevant to the proposal. If a discipline other than that of the Principal Proponent or the Study Biostatistician is significantly involved in the study, the Principal Proponent may request that a member of the Planning Committee, knowledgeable in that discipline, be present at the evaluation meeting. Such a request will usually be granted, but should be asked for when the Principal Proponent submits the proposal to the CSPCC. The CSEC will meet with the Principal Proponent and Study Biostatistician for about one and a half to two hours. The ad hoc committee member opens the discussion by presenting the essentials of the written critiques by the outside reviewers and his/her own opinion. Next, one of the regular committee members (not a biostatistician) discusses additional relevant medical questions and comments. A committee biostatistician then provides an in-depth review of the biostatistical elements. The Budget Review Group (BRG) attends the CSEC meeting and holds its review of the study budget immediately afterwards. This group, composed of three members experienced in assessing research budgets, reviews the proposed budget to see that it is reasonable. It may accept the budget as is or make recommendations for an increase or decrease if the members feel that the Principal Proponent has underestimated or overestimated certain items. These deliberations will generally take. 15 to 30 minutes. After the Study Investigators have met with the CSEC and BRG, CSEC goes into executive session to formulate its recommendations concerning the study. The CSEC will generally make one of four recommendations to the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate) through the Chief, CSP: a. Completely reject the study. In this case, the proposed study in its present form is finished. If the investigators wish to resubmit it in a changed form, they must start from the beginning by submitting a new request for planning to the Chief, CSP, proceed through the Medical Research Service triage review, and go onto the waiting list if the new version is accepted. b. Reject the study with recommendation for resubmission. Here, the committee provides specific recommendations for reworking the study which, if followed, will increase the probability of favorable consideration upon resubmission. In such cases, at least one more planning meeting is normally authorized, and the investigators can resubmit the proposal for CSEC evaluation as soon as they and the CSPCC believe they have met the committee's recommendations. The proposal must be resubmitted within one year or the study activity will no longer be supported. An extension may be granted by the Chief, CSP for extenuating circumstances, but such requests should first have the approval of the Chief, CSPCC. c. Conditional approval. In this event, the committee gives its approval under the condition that certain changes or additions be made that will improve the professional, scientific, ethical, and/or 14 �operational quality of the study. Before the study is approved for funding, these changes have to be made to the satisfaction of the Chief, CSP, the Chief, CSPCC, the Study Biostatistician. and the Study Proponent (s). d. Unconditional approval. For those studies that are approved, CSEC gives two priority ratings; the first is a rating on the basis of scientific merit, while the second expresses the opinion of CSEC on the priority of the study for VA funding. CSEC's approval constitutes only a recommendation to the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate) and is not tantamount to funding. Funding is based upon fiscal budgetary considerations and, in lean times, only those proposals deemed of highest priority can be immediately funded. Approved proposals must sometimes await reconsideration for funding at a later date. When funds are readily available, all approved proposals are usually funded. Written notification by the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate), will constitute the only official statement on the status of the proposed study. III. INITIATING A COOPERATIVE STUDY In the period between approval of the study for funding and the time the first patient is entered into the study, several considerations must be taken into account. A. Study Chairperson The chairperson of a cooperative study (usually the Principal Proponent), is responsible to the Chief, CSP through the Chief, CSPCC, for the general supervision of the professional and scientific conduct and administration of the study. The Chairperson should preferably be a member of the same discipline that is represented by the majority of the Participating Investigators. When two disciplines are involved in a major way, it may be appropriate .to consider appointing a co-chairperson for each of these major disciplines. The Study Chairperson should not be a member of the VA Central Office staff or function as the Study Biostatistician. Furthermore, he/she should not be chairperson of more than one cooperative study simultaneously (regardless of sources of funding), nor ordinarily be a participant in another ongoing cooperative study. The chairperson must be a VA employee (at least 5/8 time), except in unusual circumstances when an exception may be made by the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). In such a case, a VA employee (at least 5/8 time) is appointed as co-chairperson of the study. In general, the Study Chairperson should not be a Participating Investigator at his/her local facility. B. Selection of Participating VA Medical Centers At the initiation of funding for planning, an R&D letter is circulated to all VA medical centers inviting them to express their interest in participation to the Principal Proponent of the study. When a study is approved for funding, another R&D letter will inform the directors of all VA medical centers, domiciliaries, outpatient clinics, and regional offices with outpatient clinics that the study has been approved and that any facility interested in participating in the study should notify the Principal Proponent. It is the responsibility of the Study Chairperson and the Study Biostatistician to review the eligibility of the medical centers and the Participating Investigators making application to join the study. They will first consider whether a facility has the necessary resources, staff (physicians, nursing staff, psychologists, biochemists, social workers, pharmacists, or others), and a high level of interest, including an eligible staff member willing to accept the duties of the Participating Investigator. The potential Participating 15 �Investigator should be advised and be willing to accept CSP publication policies as stated in the protocol and in Section V.C. of these Guidelines. Ordinarily, one person should not be a Participating Investigator in more than one ongoing cooperative study. Past experiences with the facilities in other studies is also useful in determining a facility's capabilities. Another important consideration is whether the facility can enter enough patients to achieve the required sample size. Other things being essentially equal, facilities that can produce more of the needed type of patient should be chosen. For this purpose, each facility should be asked to screen its records for the last year to see how many of its patients would have qualified for the study. Finally, it is, in general, not appropriate that a facility participate in more than one cooperative study involving identical or very similar patients or whose participation in one cooperative study would interfere with its participation in another. After the medical centers that are believed to best serve the needs of the study have been selected, the Study Chairperson invites them to participate in the study and sends the list of nominations to the Chief, CSPCC with a copy to the Chief, CSP. Participation in any cooperative study is voluntary. The Participating Investigator at each invited facility must submit the proposal to the local R&D Committee for approval, which should include the approval of the Committee on Human Studies. The local R&D Committee has the following options: 1. Reject the proposal and elect not to participate. 2. Elect not to participate unless certain clearly specified alterations are made in the proposal (i.e., for the entire cooperative study). 3. Approve the proposal in its current form and elect to participate. For option 2, only major, relevant defects should be identified and not trivial and relatively unimportant ones. If major defects are found, they should be reported to the Study Chairperson through the prospective Participating Investigator, with a statement that the medical center will participate in the project only if the defects are corrected. The chairperson (often with the help of the Study Biostatistician and the CSPCC Human Rights Committee) must then decide if the defect is important enough to require amendment of the study proposal. If the Study Chairperson decides that the defect is too minor to require a change, he/she may so inform the facility and seek a substitute facility. However, if the defect is indeed major, the proposal must be amended and resubmitted to the CSPCC Human Rights Committee for their approval, and to each of the participating centers for another review by their R&D Committees. Since such a procedure is costly in effort and time and will usually delay the start of the study, it should only be used when absolutely necessary. If a center selects option 3, it agrees to conform to all of the protocol requirements including the informed consent procedures and form(s). This approval by the center also implies that the facility is committing adequate support and resources to the study such as administrative support in the office of the ACOS for Research, pharmacy service, personnel, supply and fiscal support, space, etc. Neither the Participating Investigator nor the medical center has the autonomy to alter the protocol or informed consent unilaterally, as uniformity at all participating centers is required. Local alteration of a protocol or informed consent procedures constitutes a breach of the protocol and is grounds for discontinuing support of that facility for further participation in the study. A copy of the minutes of the R&D Committee's meetings on the proposal, including the human studies review, must be submitted to the CSPCC within six weeks, or continued funding will be in jeopardy. In the case of a study involving study agents, a copy of these minutes must be sent to the Chief, CSPCRPCC by the CSPCC before any study agents can be distributed to the participating medical center. The local R&D Committees should also review the course of the local participation in the cooperative study annually and send a copy of the minutes of this review to the Chief, CSPCC. 16 �Upon receipt of local approval, the Participating Investigator, with the assistance of the local research office, prepares for the signature of the Medical Center Director a formal request for funds which is sent through local channels to their Regional Director ( /151-I). This request should agree with the budgetary estimates submitted to and approved by CSEC and BRG. Any substantial deviation from the approved amount should be sent to the Study Chairperson and the Chief, CSPCC for their endorsement and then to the Chief, CSP. If the deviations are large, it may require resubmission to CSEC. For the hiring of Title 38 personnel, the local personnel office should prepare a simultaneous (but separate) request for an exception and forward it in the usual way. If at any time during the conduct of the study a deviation from the approved budget is needed by a local medical center, the request for the additional funding must be initiated by the Participating Investigator at that center with the appropriate justification and delineation of needs including personnel (FTE, GS grade, dollar costs), equipment, and operating costs. This request should be forwarded to the CSPCC through the Study Chairperson. The endorsements for this request by both the Study Chairperson and the Chief, CSPCC, as well as a copy of the Participating Investigator's request, should then be forwarded to VACO, CSP. If the request is approved, the Participating Investigator's research office will be contacted and told that they should now request the additional funds. The Chief, CSPCC will also be notified of the approval. If the request is disapproved, the denial will be communicated back to the Participating Investigator through the CSPCC and the Study Chairperson. If the total cost of the request is more than $5,000, the documented approval by the Study Operations Committee as well as the concurrence of the Chief, CSPCC will be required to secure approval. Once again, it should be stressed that funds provided for a cooperative study will be limited to the needs of the study and will not be used to supplement other clinical or research activities. Unused funds will be returned to VACO, CSP on a quarterly basis. C. Form Approval and Printing In the two months between the submission of the final protocol and its evaluation by CSEC, the study forms (including CSPCRPCC forms) should be prepared for OMB approval. Upon notification of approval of the proposal, the Study Biostatistician is responsible for initiating SF 83, as soon as possible, but no later than 30 days after notification. Although they do not always require OMB approval, all forms for all cooperative studies should be sent to VACO through the CSPCC as if OMB approval were necessary. VACO approval and VA form numbers are always required for study forms. Besides SF 83, a Supporting Statement must accompany the forms when they are submitted for OMB approval. This Supporting Statement must provide detailed information on the following topics: 1) justification and purpose of the form; 2) description of the survey plan; 3) tabulation and publication plans; 4) time schedule for data collection and publication; 5) consultations outside the agency; 6) estimation of respondent reporting burden; 7) sensitive questions; and 8) estimate of cost to Federal Government. A detailed discussion of the Supporting Statement and SF 83 can be found in SF 83A, OMB entitled, "Instructions for Requesting OMB Approval Under the Federal Reports Act." In the case of cooperative studies where the forms are all related to one research project, only one SF 83 and one Supporting Statement are needed but these must include all required information for each form. The Study Biostatistician then sends to Management Support Division, VACO, four copies each of the proposed data forms, the latest protocol, the Supporting Statement, and the Clearance Request (SF 83). Because the forms require fairly high level approval along the way, the approval process can be and usually is time-consuming and should, therefore, be started as early as possible. After securing OMB clearance, or an exemption from doing so, the forms must be printed, which may also take considerable time. The most practical solution is to have the CSPCC arrange for local printing of the forms. The request for assignment of form numbers and OMB clearance should also state a preference for where the forms should be printed. Whether the printing is to be done centrally or locally, the 17 �documentation of approval of the forms requires the signature of at least the Study Biostatistician, the Study Chairperson, the Chief of Data Processing, and the Computer Programmer. D. Operations Manual After the approval of the study and prior to its funding, the Study Chairperson, the Study Biostatistician, the Clinical Research Pharmacist, and any other study members that the chairperson considers appropriate should prepare an Operations Manual. This manual should include details of data collection, data flow, data recording, encoding, reporting of adverse reactions (when appropriate), the Participating Investigators' responsibilities to the Pharmacy Service concerning prescription writing or drug ordering requirements, Pharmacy Service's responsibility to the Participating Investigator, etc. If appropriate, this manual should include instructions for administering the investigational or study articles. It is to be used by the data collectors at each participating medical center and should cover all problems that they are likely to encounter so that they do not have to frequently call the Study Chairperson. This manual is intended to ensure that the study procedures are followed as uniformly as possible at all participating centers. It will usually be typed and assembled by the CSPCC. E. Hiring and Training If the study requires additional personnel at the Study Chairperson's office or at the participating centers, they should be hired as soon after funding as possible. The centers should use the local procedures for hiring, but it is the responsibility of each Participating Investigator to ensure that the persons hired are capable of performing the tasks required by the study protocol. Positions for cooperative studies at participating medical centers and the chairperson's office are generally term appointments. Funding for each fiscal year is subject to the availability of funds and cannot be continued beyond the authorized duration of the study. Newly hired personnel should be given at least a month to study the protocol and to become familiar with the ways of the medical center. When all personnel have been hired and have had sufficient time to familiarize themselves with the situation, the Study Chairperson, when appropriate, should arrange a training session so that they will know exactly what is expected of them and so that any questions they may have about the study can be answered. Training in new techniques to be used, e.g., surgical techniques, should be completed before any patients enter the study. Arrangements for travel to these training sessions will be similar to those for all other travel as discussed in Section IV.B. Although every attempt is made to provide only those personnel that are essential for the conduct of the study, peaks and valleys in work load sometimes do occur. In those situations where personnel hired for a cooperative study discharge all of their duties for the study and still have free time, it is presumed that the R&O office will see that these personnel are productively assigned to other duties during this free time. Priority of assignments should be given in the following order: unmet needs of other cooperative studies at the medical center or of a CSPCC or the CSPCRPCC if located there; other approved local research of the Participating Investigator; and, finally, other approved local research of other investigators. If it is possible to convert a full-time position to a part-time one, it is the responsibility of the Participating Investigator and the ACOS for Research and Development to notify the appropriate Chief, CSPCC, through the Study Chairperson, of this situation so that the appropriate actions can be taken. F. Acquisition of Additional or Replacement Equipment Should requests for equipment for individual medical centers exceed a total of $5,000 or cost $2,000 or more for a single item, a request for equipment as described in VA Circular 10-79-48 must be made. This request should include a detailed description of the instruments, the approximate hours per week the equipment will be used, a list of all presently available equipment at the facility which can perform the same function, and the reasons that the equipment is needed. 18 �IV. CONDUCTING A COOPERATIVE STUDY It should be recognized at the outset that, in the absence of objectively demonstrated satisfactory performance (i.e., number of patients enrolled, quality of data acquisition, etc.), funding beyond six to 12 months for an approved study cannot generally be continued solely on the basis of faith, stature and competence of the investigators and/or importance of the subject matter. Studies acquiring less than 60 percent of their projected intake will ordinarily be considered as performing unsatisfactorily, while those entering 60 to 80 percent of their projected intake will be considered as performing marginally at best The studies with patient acquisition rates greater than 80 percent are those that might reasonably be expected to finish in their originally planned time frame or to need only relatively minimal extensions of their patient intake periods. It is the responsibility of the Chief, CSPCC and the Operations Committee to objectively assess each study's performance in the early stages and to make the appropriate recommendations that will either improve the performance of the investigators or will result in early termination of the study if the problems seem to be unresolvable. A. Management Primarily four groups share responsibilities for the proper conduct of a cooperative study: The Study Group, the Executive Committee, the Operations Committee, and the Human Rights Committee. All but the last one - which has already assessed the protocol before CSEC approval was sought - should meet before patient intake begins to review operational and other details. Once patient intake has begun, they should again meet at regular intervals. It is the responsibility of the Study Chairperson and the Study Biostatistician to provide these committees with appropriate reports three weeks before their meetings so that they can perform their functions. The Study Biostatistician and Study Chairperson must also provide relevant written updates to the four groups between meetings (usually every four and a half months). The composition, meeting schedules, and responsibilities of the four groups are as follows: 1. Study Group. The Study Group is composed of all Participating Investigators and permanent consultants for the study. The Study Chairperson heads this group, which meets at nine month intervals unless travel funding allocations are not adequate to support this frequency. At each meeting, the group will discuss the progress of the study, any problems that the investigators have encountered, and suggestions for improving the study. The Study Chairperson may also use these meetings to get reactions of the investigators to contemplated changes in the protocol. Results of any blinded part of the study will not be presented to this group. Meetings of this group scheduled for the last six months of patient follow-up serve little purpose and will not ordinarily be funded. Instead, this final meeting will be postponed until after the results of the study are known. It is the Study Chairperson's responsibility to write and distribute a report on each Study Group meeting within two to three weeks of the meeting. 2. Executive Committee. The Executive Committee of a cooperative study usually consists of four to eight members and includes the Study Chairperson, the Study Biostatistician, the head(s) of any special central support unit(s) related to the study, two or three Participating Investigators, and selected consultants when necessary. All Participating Investigators may be members of the Executive Committee if there are no more than five participating medical centers. Usually these individuals will have been involved in the planning stage. The Study Chairperson, who is automatically the Chairperson of the Executive Committee, should inform the Chief, CSPCC with a copy to the Chief, CSP (who is an ex officio member), who the members are. This committee will meet at nine-month intervals and acts, in general, as the management group and major decision-making body for the operational aspects of the study. It decides on all changes in the study and on any subprotocols or other use of the study data, on publications of study results, and takes actions on medical centers whose performance is unsatisfactory. As with the Study Group, the results of blinded portions of the study will not be presented to this group. All major alterations in protocol design or operation of the study recommended by the Executive Committee must be endorsed 19 �in writing by the Operations Committee and communicated to the Chief, CSP prior to being instituted. The ACOS for Research and Development at each participating medical center must also be informed because major changes in the protocol may require resubmission to the local R&O Committee. The Study Chairperson is responsible for writing a report on each meeting of the Executive Committee and distributing it to the members within two to three weeks of the meeting. When a cooperative study involves study articles, the CSPCRPCC Clinical Research Pharmacist is routinely a consultant ad hoc member of the Executive Committee. This means he/she will only attend an Executive Committee meeting when a problem regarding medical center pharmacies or CSPCRPCC support cannot be resolved by telephone, letter, or other means. At the meetings attended, the Study Pharmacist will vote only on those issues related to pharmacy support. If during the course of the study a problem concerning pharmacy support should arise, the Chief, CSPCRPCC should be contacted. If the problem cannot be satisfactorily resolved within a reasonable period, it should be referred to a member of the CSPCRPCC Evaluation Committee listed in Appendix E. 3. Operations' Committee. The Operations Committee is usually made up of three or four members and is comprised of experts in the subject matter of the study, an independent biostatistician, and other appropriate technical or scientific specialists. The members must not have been participants or consultants in the planning or executive phases of the study. The Study Chairperson and the Study Biostatistician are the study representatives (nonvoting) to the Operations Committee and the Chief, CSP and the Chief, CSPCC are ex officio (nonvoting) members. It is the responsibility of the Study Chairperson to nominate the members of this committee, including the Committee Chairperson, through the Chief, CSPCC and the Chief, CSP for approval by the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). The Study Biostatistician and/or the CSPCC Chief will usually suggest the Operations Committee statistician to the Study Chairperson. Each nomination must be accompanied by the curriculum vitae of the proposed member. Alternate nominations for any of the members may be suggested by the VACO CSP office. As soon as the nominations are approved, a complete copy of the study protocol and a copy of these guidelines should be provided to the Operations Committee members by the Chief, CSPCC. This committee will usually meet at nine-month intervals for the entire length of the study unless there is less than six months left of patient follow-up. The committee may also be convened at any time of special need or "crisis" during the course of the study. " The Operations Committee provides a continuing critical and unbiased evaluation of the study's progress and formulates operational policy consistent with the best current biomedical research practice. At its first meeting, the committee reviews the plans presented for interval monitoring by the CSPCC and, when they are judged adequate and are approved by the committee, the study is ready to proceed. It should be stressed that the Operations Committee has primarily a monitoring and evaluation function. It does not initially evaluate the scientific merit of the study or subsequently participate in the conduct of the study. These duties have been assigned to other committees. The prime responsibility of the Operations Committee at each of its review meetings is to decide whether or not the study should be continued and to so inform the Chief, CSP through the Chief, CSPCC, who also informs the Study Chairperson. To help it make this decision, the Study Biostatistician and the Study Chairperson must provide the committee with the required monitoring data summaries, or raw data if requested, three weeks before the meeting. Ordinarily, the Operations Committee is the only group privy to the interval summaries of decoded (unblinded) information during the course of the study. Reasons for recommending discontinuation of the study include inadequate quality of performance or lack of progress made by the participants, ethical problems such as poor results in one treatment group or unacceptable side effects, and monitoring functions so poor that it is impossible to assess the current status of the study (and no realistic chance of remedying these within a reasonable time). 20 �The Operations Committee is also responsible for assessing the performance of each of the participating medical centers. When patient intake is low or performance inadequate at a center, they can recommend that the center be put on probation or even terminated from the study. In cases where performance is marginal but the center's presence in the study is considered essential, the committee should recommend reductions in personnel, supplies or other operating costs so that the costs of the center are more in line with the actual work load rather than the projected work load. In those situations where a reduction in funding at a center seems reasonable, a strong statement of justification for not recommending the reduction will be necessary by the committee or the reduction will probably be made administratively by the VACO CSP. The Operations Committee must be kept informed by the Study Chairperson or the Study Biostatistician of all proposed changes in the protocol, data collection forms, or in plans for analyses since it must review and make a decision on all major changes. Documentation of this approval should be forwarded by the Operations Committee Chairperson through the Chief, CSPCC to the Chief, CSP (Coordinator of CSEC), as well as to the Study Chairperson and the CSPCC Biostatistician. The Operations Committee should clearly differentiate between its suggestions and its recommendations. Suggestions should be made with the understanding that they will be given serious consideration by the Executive Committee, but are not binding. Response to suggestions should be documented in the Executive Committee reports. Recommendations are expected to be accepted and followed by the Executive Committee and it is the joint responsibility of the Executive Committee and the CSPCC to see that they are. If a dispute between the Executive and Operations Committees about a recommendation cannot be resolved, arbitration will be provided by a group nominated by the Chief, CSP and the Chief, CSPCC and appointed by the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate). Decisions of this group (usually CSEC) will be binding on both committees. At their first meeting, the members of the Operations Committee should elect a Committee Chairperson if the Study Chairperson has not nominated one. It is the Committee Chairperson's responsibility to prepare and send a report of each meeting within three weeks to the Chief, CSPCC. This report should delineate between suggestions and recommendations. The CSPCC Biostatistician should then review this report and prepare a cover report listing those suggestions and recommendations with which he/she agrees and those with which he/she disagrees. In the latter case, a brief statement explaining the reasons for disagreement should be made along with substitute suggestions or recommendations. Both the ,w^wcoyer,.report and the Operations Committee .report should be submitted to the Chief, CSPCC, who must review both within six weeks of the Operations Committee meeting and indicate concurrence or disagreement for each suggestion or recommendation. Where there is disagreement with both the Operations Committee and the Study Biostatistician, substitute suggestions or recommendations should be formulated. If a recommendation results in a major change of study procedures or direction, the Chief, CSPCC should raise the issue in this cover report to alert* the Chief, CSP of the consequences of the recommendation. The Chief, CSP would then decide if the CSEC should review the proposed change. The Chief, CSPCC should then distribute these two cover reports with the original report appended to the Chief, CSP, the Study Chairperson, and the Operations Committee. The question of liability has been raised and the decision of General Counsel in a memorandum dated July 7, 1975 was that Operations Committee members, when meeting on a study, are considered VA employees and, as such, are entitled to liability coverage under either 38 U.S.C. 4116 or the Doctrine of Official Immunity. The liability of non-VA members of the Executive Committee, the Human Rights Committee, and the Study Group is also covered. 4. Human Rights Committee. At alternate meetings of the Operations Committee, the Human Rights Committee will participate in that part of the meeting that deals with the patients' rights and safety. 21 �Besides reviewing the protocol for human rights issues prior to submission to CSEC, this committee is responsible for ensuring that the patients' rights and safety are protected during the course of the study. It is the responsibility of the Study Biostatistician and the Study Chairperson to provide the committee with the information that they request, including some or all of the data provided to the Operations Committee and a summary of the progress of the study written in layman's language as well as all or samples of signed patient consent forms from each participating facility. The Human Rights Committee Chairperson is responsible for writing a report of the meeting within two to three weeks of the meeting. This report should be distributed to the Human Rights and Operations Committee members, the Study Chairperson, the Chief, CSPCC, the Chief, CSP and, when appropriate, the Chief, CSPCRPCC. After those meetings of the Operations Committee that the Human Rights Committee does not attend, the Study Biostatistician and the Chief, CSPCC (and the Study Chairperson when appropriate) will meet with the Human Rights Committee within two weeks of the meeting and update them on the progress of the study. Each year, members of the Human Rights Committee at each CSPCC, accompanied by a member of that CSPCC, make site visits to three medical centers that are participating in cooperative studies assigned to the CSPCC. The purpose of these visits is to ensure that the human rights aspects of the studies are being observed. If possible, the Human Rights Committee member will observe at least one informed consent being given and will talk with study patients about their participation in that study. Upon return from the site visit, the member will write a report about the visit as discussed later in Section I V.E. Since each CSPCC will usually have more than three ongoing studies during each year, each study will not have one of its facilities visited every year. However, if possible, at least one human rights site visit will be performed during the course of every study. B. Arranging Meetings and Travel If possible, the Study Group and the Executive Committee should meet on the day(s) just before or after an Operations Committee meeting in order to save travel costs for those members who must attend all three meetings. If this is not possible, the meetings should be held within one month of each other. It is preferable that the Operations Committee meet after the Executive Committee to allow it to review any changes proposed by the Executive Committee. At least every 18 months, the Operations Committee must meet in the vicinity of the CSPCC, in order to facilitate the Human Rights Committee review. If the Executive Committee and/or the Study Group meetings also convene there on contiguous days, CSPCC personnel other than the Study Biostatistician will also be able to attend those meetings. To initiate one of the regularly scheduled group meetings, the Study Chairperson, before notifying VACO, CSP, should contact the Study Biostatistician at least two months before the proposed meeting date so that arrangements can be made. Except for the meeting in the vicinity of the CSPCC, the Study Chairperson, the Study Biostatistician and the CSPCC Administrative Assistant must choose a location with reasonable accommodations that minimizes the cost of travel and per diem but is still convenient for travelers. The CSPCC Administrative Assistant will select three sites that fulfill these conditions and calculate travel costs for each of them. If the cost projections for the three sites are within $100 of each other, the Study Chairperson may then choose one of these. However, if the differences are greater than $100, the site with the lowest cost will be selected. If the chairperson wants to schedule a meeting in a place that requires more funds than the minimum cost meeting site, the attendees (excluding those from the CSPCC) must obtain the additional funds from sources other than locally or centrally directed VA medical research travel funds. Exceptions to these rules for selecting meeting sites will only be granted if there are rather unique and valid reasons to do so, such as special laboratory facilities for training purposes. Allowing committee members to attend a national meeting is not considered a unique or valid reason for changing the meeting site. After the Study Biostatistician has concurred and the Chief, CSPCC has given approval for a meeting, the Study Chairperson must inform the Chief, CSPCC by letter of the dates and place of the meeting, the 22 �names of the attendees and the addresses of any non-VA personnel who will be traveling on letters of agreement. A copy of this letter should be sent to the Study Biostatistician and the Chief, CSP. This letter must arrive at VACO at least six weeks prior to the scheduled meeting date or it will not be honored and the meeting will have to be rescheduled. Nonroutine (extra) meetings of any of the groups necessitated by problems arising during the study may be arranged on shorter notice by contact with the Chief, CSPCC or his/her designate, but these requests must be limited to emergency situations and are dependent on funds available. All nonroutine (extra) meetings require prior VACO, CSP approval. Funding for travel to meetings of the Study Group, Executive Committee, Operations Committee, and other authorized cooperative study activities will be provided from VACO, CSP centrally directed travel funds. When the meeting has been approved, the Study Chairperson will so notify all expected attendees and give them the necessary details. Each VA participant should then submit a travel request through the local facility with the director's concurrence to the Regional Director ( /151-1). These individual requests must be received in VACO, CSP office at least three weeks prior to the date of the meeting. Under no circumstances will requests for travel to routine meetings be honored if they are not received in the CSP office at least three weeks in advance of the meeting. When the date and place of a meeting are such that the meetings precede or follow a professional or scientific meeting, the extra support to permit attendance at the professional meeting (per diem, fees, etc.) will not be provided from VACO, CSP centrally directed travel funds, but must be sought elsewhere. The agenda and any materials to be reviewed at the meetings should be in the hands of the participants at least three weeks prior to the scheduled meeting date, with copies sent to the Chief, CSP. The appropriate chairperson or authorized designee should prepare summary minutes of the meetings, including any actions taken, within three weeks of the meeting and send them to all participants and the Chief, VACO, CSP. It should be emphasized that all participants, including the Operations Committee and CSPCC personnel, are dealing with privileged information from a VA cooperative study that is not available for general dissemination. C. Data Collection and Editing In general, data reported on the study forms should be approved by the Participating Investigator at each medical center before being sent to the Study Chairperson for medical (subject matter discipline) review and assessment If judged satisfactory, the data forms should then be forwarded to the responsible CSPCC for biostatistical and data processing review and assessment. Only when the Participating Investigator, the Study Chairperson, and the CSPCC Biostatistician or their local designees have all approved the data should they be entered into the permanent study data file for interval and final summary and analysis. This is to ensure that the data are legible, accurate, and complete as well as sensible and appropriate. In certain special instances, valid medical (subject matter discipline), scientific, methodologic, or administrative reasons may call for exceptions to this general operational policy and such exceptions will be granted if agreed upon by the Study Chairperson and the Chief of the CSPCC, and approved by the Chief, CSP and/or CSEC. Certain data may need review by an additional person or group other than the Participating Investigator, the Study Chairperson, and the Study Biostatistician, e.g., central readings of EEGs, ECGs, coronary arteriograms, etc. The Cooperative Studies Program allows for such instances, but they must be planned and provided for in detail in the protocol of the study. All data from all studies, regardless of funding, must be sent to the appointed CSPCC, whether the CSPCC has primary responsibility for the biostatistical and data processing aspects of the study (where data flow is regular) or is only monitoring. In the latter case, the data may not have to be sent to the CSPCC until after the study is completed. During the study, a copy of each patient's signed informed consent form must also be sent to the responsible CSPCC. This allows the Study Biostatistician and the Human Rights 23 �Committee to check that every patient has given consent and that all facilities are using the same consent form(s). It is an absolute requirement in a VA cooperative study that all facilities use the same consent form(s) and procedures. The original consent forms should be retained in the patient's hospital record (not research data records) at the medical center. D. Newsletter The Study Biostatistician and the Study Chairperson or the Executive Committee should issue a study newsletter regularly. This newsletter may sometimes be only a brief communication of one paragraph or a more extensive report as called for by the development of the study. It should focus on items of general interest to the participants, such as progress, performance, and problems, but must not contain unblinded data or study results. It should be issued at least twice a year during active patient intake and at least annually throughout follow-up. The newsletter should be sent to all Participating Investigators, the Executive Committee, the Operations Committee, the Human Rights Committee, the Chief, CSP, and the Chief of each CSPCC and of the CSPCRPCC. E. Site Visits Site visits by the Study Chairperson, the CSPCC Biostatistician, the CSPCRPCC Pharmacist, or other technical experts are not routinely a part of cooperative studies, but may be required in certain cases. When site visits are an essential part of the study plan, they should be included as a special line item in the study budget. If an unforeseen problem arises that can only be resolved by visiting the medical center, a site visit may be funded if endorsed by the Study Chairperson, the Chief, CSPCC, the Chief, CSPCRPCC (where applicable), and the Chief, CSP, and if travel funds are available. These "emergency" visits are not encouraged, and will only be considered when deemed truly necessary and essential. For all site visits connected with a cooperative study by persons other than the Study Chairperson, a report of the visit should be sent' to the Study Chairperson within ten days. The Study Chairperson should forward these reports (or his/her own) through the Chief, CSPCC, to the Chief, CSP within 21 days. A copy of this report should also be sent to the Participating Investigator through the appropriate regular channels and, for information purposes, to the Chairpersons of the Operations Committee and the Human Rights Committee and, when appropriate, to the Chief, CSPCRPCC. The Study Chairperson may simply endorse the report, add his/her own recommendations or conclusions, or, if necessary, attach a summary of the actions of the Executive Committee or Operations Committee, or both, together with his/her own recommendations and conclusions. This report should include what specific actions must be taken to correct any deficiencies. The Study (or Monitoring) Biostatistician must ensure that these actions are taken. When appropriate, the local Participating Investigator will receive feedback through regular local channels. F. Early Termination of a Medical Center During the course of a study, it is sometimes necessary to drop one or more medical centers from the study before completion. This early termination is usually based on recommendations from the Operations Committee and may be due to poor performance or lack of patient intake at the centers. Once the decision has been made to terminate a center, the Study Chairperson must promptly notify the Participating Investigator that the medical center has been dropped from the study. Copies of this letter must be sent to the local ACOS for Research and Development through the director of the local center and to the Chief, CSPCC, who will be responsible for notifying the Chief, CSP and, when appropriate, the Chief, CSPCRPCC. Funding up to 90 days after notification will be made available for the placement of personnel who are being phased out in this unplanned fashion. Funding will only be continued during the 90-day period until all personnel have been placed in other jobs. 24 �If special equipment (other than the usual office equipment and furniture) was purchased for the study, the Study Chairperson and the Study Biostatistician must determine if such equipment is needed at another medical center, either known or to be selected. If it is needed at a known facility, the Chief, CSPCC will notify the ACOS for Research and Development at the terminated center that the equipment is to be transferred and, if funds are not available for shipment, a request should be made to the Regional Director ( /151-1) for such funds. In the event that a new center is not yet identified, the Study Chairperson might want to have this equipment transferred to his/her center; the same type of letter would need to be prepared by the Chief, CSPCC to the local ACOS for Research and Development. In the event that the equipment is not needed by the study, its deployment will be the same as that given in Section V.A. G. Replacement of a Participating Investigator or Study Chairperson During the Course of a Study. Cooperative studies frequently take several years to complete. During that time, a Participating Investigator or a Study Chairperson may find it impossible to continue with the study. Should this occur, it is important that suitable replacements be found as quickly as possible so as not to interrupt the progress of the study any more than is absolutely necessary. It is essential that the local medical center and its R&D Committee, the Study Chairperson and the Executive Committee, the CSPCC and the Chief, CSP all accept the replacement Participating Investigator or Study Chairperson as being suitable and qualified. If a Participating Investigator finds that it is not possible to stay with the study until its completion, he/she should, if possible, give at least three months advance notice prior to leaving. If the medical center is to continue in the study, a new Participating Investigator must be selected promptly and have the written endorsement of the center's R&D Committee. The local ACOS for R&D (or counterpart) should initiate a letter, attaching a copy of the R&D Committee's endorsement, through the Study Chairperson and the Chief of the appropriate CSPCC to the Chief, CSP requesting the replacement of the original Participating Investigator with the newly nominated one. Upon receipt of this letter, the Study Chairperson should contact the Study Executive Committee and obtain their endorsement of the nominated replacement Participating Investigator. If the Committee is in agreement, the Study Chairperson should write an endorsement (indicating agreement of the Executive Committee) and send it to the Chief of the appropriate CSPCC. If the Chief, CSPCC finds everything in order, the request should be endorsed and the entire packet sent to the Chief, CSP. This process should be completed as quickly as possible in order to avoid complications in continued funding for the medical center. In cases of "emergency," with little or no advance notice, temporary assignment of an investigator by the local center is permissable until the accomplishment of the formal replacement process. If no suitable or available replacement for the departing Participating Investigator exists, the center's participation in the study will be terminated. In the case of the Study Chairperson, it is requested that, except for an unanticipated "emergency," at least six months advance notice be given prior to leaving so that a suitable replacement can be found. Upon notification of the Chairperson leaving the study, the Executive Committee should nominate a new Chairperson. This nominee does not necessarily have to be from the same center as the original Chairperson. If the nominee accepts the nomination, then his/her medical center should be contacted to obtain the approval and support of the center and its R&D Committee. The local ACOS should then initiate a letter endorsing the nominee as described previously for the replacement of the Participating Investigator. In cases of an "emergency," where there is little or no advance notice of the Chairperson's leaving, the Executive Committee may temporarily appoint one of its own members Chairperson until the formal process is accomplished. However, if no suitable or available replacement Chairperson exists, the study may be terminated prematurely. H. Subsequent CSEC Review All cooperative studies will have an in-depth review by CSEC at three-year intervals. The first review will be scheduled for the CSEC meeting nearest to the three-year anniversary of the first station funding 25 �unless there has been an intervening special CSEC review dealing with major changes in the original proposal. In the latter case, CSEC will determine the interval until the next review. Ordinarily, a three-year review will not be scheduled if there is less than 12 months until the close of patient follow-up. The CSPCC Biostatistician and the Study Chairperson are responsible for scheduling these reviews through the VACO, CSP office. The deadlines for submitting these reviews to VACO, CSP are the same as for reviews of new proposals (see Appendix B). It is also the Study Biostatistician's and the Study Chairperson's joint responsibility to prepare a written progress report that is clear, complete, concise, and highlights all important and relevant aspects and problems of the study at that time. This report should include: 1) the latest version of the protocol and data forms; 2) summaries of what changes in the original protocol and data forms were adopted and when; 3) number of patients entered into the study by semiannual periods and medical center, and comparison with the projected number; 4) losses to the study such as dropouts and changes of therapy due to failure or toxicity, when they occurred and why; 5) preliminary findings, including unblinded data summaries, indicating efficacy and safety status, comparison with study objectives, and estimates of the prospects of success; 6) current cost — overall for each study unit; and 7) cumulative cost since the beginning of the study. In addition, detailed projected plans for the future of the study should be presented for review and endorsement, as well as copies of the Operations Committee's reports. Although this report should fully cover the study up to this stage, the relevant features and special problems will be highlighted in a verbal presentation to the committee. Besides the above information provided by the Study Chairperson and the Study Biostatistician, the Chief, CSPCC will prepare a report which should appear at the front of the submission package. This report will be a complete, accurate but brief review of the study from onset to time of submission for review. I. Breaking the Double-Blind Code of Study Medications The majority of cooperative studies involving drugs are double-blind studies, where neither the patient nor the Participating Investigator knows which drug the patient is receiving. Blinded medication code envelopes for breaking study medication codes are generated by the CSPCC with the assistance of the CSPCRPCC Clinical Research Pharmacist These envelopes are sent to the CSPCRPCC and are shipped with the study medications to the study participants. The code envelopes are placed in the custody of the participating Pharmacy Services along with the study medications. When it is absolutely necessary that a study medication code must be revealed, the Pharmacy Service may open the envelope and reveal the medication code for a given patient to the Participating Investigator. However, protocol procedures for breaking the blind must be complied with. The participating Pharmacy Service must then return the opened code envelope to the CSPCRPCC within 72 hours after it has been opened. The CSPCRPCC will immediately inform the Study Biostatistician at the CSPCC via telephone and send him a hard copy of the opened code envelope. When a study has been completed or terminated early at a medical center, the unopened blinded medication code envelopes must be returned to the CSPCRPCC. The CSPCRPCC will verify that the envelopes were or were not intact and promptly notify the biostatistician of their condition. The blinded medication code envelopes should not be confused with the randomization code envelopes used in some studies to assign patients to a given treatment regimen. J. CSPCC Files Together with the data forms and copies of the signed informed consents (study consent forms and VA Form 10-1086), the CSPCC will maintain a file for the study that contains: 1. Record of CSEC review(s) and CSPCC Human Rights Committee review(s) prior to beginning the study. 26 �2. Record of final protocol and informed consent procedures and forms. Copies of these will also be maintained at the CSPCRPCC for studies involving study articles. 3. Record of each participating facility's R&D Committee review(s) and approval(s) of the protocol prior to its entry into the study. The minutes of the meeting of the Committee on Human Studies should also be included. Copies of these will also be maintained at the CSPCRPCC for studies involving study articles. 4. Record of annual review by the R&D Committee and the Committee on Human Studies, where applicable, from each participating center during the active life of the study. 5. Reports and/or minutes of every meeting of the Operations Committee, the Executive Committee, and the Study Group during the active life of the study. Copies of these will also be maintained at the CSPCRPCC for studies involving study articles. 6. Appended to the appropriate Operations Committee Report, the record of each Human Studies Committee review during the active life of the study. 7. A record of all CSEC reevaluations after the study is initiated. 8. Copies of INDs and IDEs, statements of investigators, and other documents sent to FDA. Copies of these will also be maintained at the CSPCRPCC for studies involving study articles. K. Reports 1. Research and Development Information System (RDIS). The Medical Research Service requires annually certain information from every VA medical center that conducts medical research. This information is utilized for effective planning and program analysis. VA Form 10-5386, Research and Development Information System Report, is to be completed by each Participating Investigator in an ongoing cooperative study and forwarded through the local research office. This form asks for the "Cooperative Study Number," which is assigned by the VACO, CSP office of the Medical Research Service. The Reports Control Symbol for this report is RCS 15-5. 2. Annual Report to Congress of Medical Research in the Veterans Administration. The CSPCC will annually obtain from the Study Chairperson a narrative summary of the study's highlights and progress during the preceding fiscal year and prepare a complete list of individuals who have participated in or otherwise contributed to the cooperative study during that period. This report is prepared with the intention that it will be sent to Congress. 3. Smithsonian Science Information Exchange (SSIE). The SSIE provides accurate, up-to-date information on all VA medical research projects. VA Form 10-1436, "Medical Research Information Project Data Sheet," is to be completed for each research project by the responsible investigator. After review by the local R&D Committee, the project data sheets should be submitted, in triplicate, to the Scientific Communication Unit, VACO. Cooperative studies are to be reported only by the Study Chairperson. The above mentioned Reports Control Symbol 15-5 has been assigned to this report. An initial SSIE Report should be submitted 15 working days after work on the research project has begun. The abstract should include the purpose or significance of the project, the design, and the methodology. An annual progress report should be submitted in the anniversary month of the initiation of the project, indicating the current status and progress made during the year. A final report should be submitted 15 working days after a manuscript has been accepted for publication or if for any reason the project is terminated before completion. The abstract should include the results and the conclusions reached. Only one final report should be submitted for a project. 27 �V. CONCLUDING A COOPERATIVE STUDY A. Closing Down Once follow-up has been completed on all patients enrolled in the study, there is ordinarily no need for further assessment by the Operations Committee or Human Rights Committee. The Chief, CSPCC will inform the Chief, CSP when these committees' services are no longer necessary. The CSPCC now has the responsibility for final data summaries and analyses of the study, which it must accomplish in a reasonable time after receipt of the last piece of data. The Executive Committee is responsible for the publication of all data and results from the study. Material for publication should ordinarily be submitted within one year of receipt of all data at the CSPCC or the outside-contract biostatistical coordinating center. Normally, the Executive Committee will be funded for one meeting during this year to prepare the manuscript for final publication. At the close of the study all data must be sent to the assigned CSPCC. This is true whether the CSPCC had the primary biostatistical-data processing responsibility or was only monitoring the study. The CSPCC will maintain readily accessible (i.e., within the CSPCC's medical center) files on the study for five years after its completion, at which time the data will be placed into dead storage and reevaluated at five-year intervals regarding continued storage. When appropriate, the CSPCRPCC, in cooperation with the Study Chairperson, the Study Biostatistician, and the participating VA medical centers, will direct the return and provide a final accounting of surplus investigational or study articles or chemicals/reagents that were centrally distributed. The CSPCRPCC will also provide an accounting of the drugs utilized by participants. The surplus drugs will be disposed of by the CSPCRPCC at a time and date agreed upon by the Study Chairperson and in a manner, determined by the CSPCRPCC, that is in compliance with the Environmental Protection Agency (EPA) guidelines and found to be acceptable to the involved pharmaceutical companies (when applicable). At the completion of the study, any special equipment (other than the usual office equipment and furniture) that was purchased specifically for the study will be disposed of in the following manner: 1) the first choice is give it to another cooperative study at the medical center; 2) the second choice is give it to other research activities at the medical center; and 3) if neither of the needs stated above exist, then the equipment should be excessed to the Central Research Instrumentation Program at the VA Medical Center, Little Rock, AR. ' B. Final Study Group Meeting The Study Group will have a final "feedback" meeting as soon as the major analyses and results of the study are available for distribution and discussion. This meeting should ordinarily take place from three to 12 months after the last patient follow-up and can be prior to, after, or in conjunction with the manuscript writing meeting of the Executive Committee or its designated Writing Subcommittee(s). At this meeting, the Study Chairperson and the Executive Committee should present the major study results and their interpretation of those results to all of the Participating Investigators. General discussion of the results by the Study Group might provide the manuscript writers with other interpretations of the results which they might find useful as well as allowing each investigator to have a chance to discuss the study, its results, and its ramifications with colleagues. It should be noted that any Study Group having a meeting during the final six months of patient follow-up will ordinarily not be funded for the final "feedback" meeting. Therefore, Study Group meetings scheduled for the final six months of patient intake should be postponed until after the data has been analyzed and the results are ready for distribution. 28 �C. Publications The presentation or publication of any or all data collected by Participating Investigators on patients entered into a VA cooperative study is under the direct control of the study's Executive Committee. This is true whether the publication or presentation is concerned with the results of the principal undertaking or is associated with the study in some other way. No individual Participating Investigator has any inherent right to perform analyses or interpretations or to make public presentations or seek publication of any or all of the data other than under the auspices and approval of the Executive Committee. The Executive Committee has the authority to establish one or more publication committees, usually made up of subgroups of Participating Investigators and some members of the Executive Committee, for the purpose of producing manuscripts for presentation and publication. Any presentation or publication, when formulated by the Executive Committee or its authorized representatives, should be circulated to all Participating Investigators for their review, comments, and suggestions at least four weeks prior to submission of the manuscript to the presenting or publication body. All publications must give proper recognition of the VA Medical Research Service and the Cooperative Studies Program support and HSR&DS or RER&DS support as appropriate, and should list all participants in the study. If an investigator's major salary support and/or commitment is from the VA, it is obligatory for the investigator to list the VA as his/her primary institutional affiliation. Submission of manuscripts must follow the usual VA policy. Ideally, a subtitle is used stating, "A VA Cooperative Study," or, in the case of shared funding, e.g., "A VA-NHLBI Cooperative Study." In a footnote or acknowledgement it should be stated, "Funded by the Veterans Administration Cooperative Studies Program of the Medical Research Service" or "Funded by the Veterans Administration Cooperative Studies Program of the Medical Research Service and the NHLBI by interagency agreement No. ," or "Funded by VA HSR&DS (or RER&DS as appropriate) and supported by the VA Cooperative Studies Program of the Medical Research Service." A copy of the letter to the editor and the manuscript submitted for publication should be sent to the Chief, CSP, VACO and, for information purposes, to the members of the study's Operations Committee. It is a requirement of the VA Cooperative Studies Program that a copy of every manuscript submitted for publication from a VA cooperative study, accompanied by a copy of the letter of submission to the anticipated journal or publisher, be on file in the CSPCC within one week of its submission for publication. Furthermore, when a major manuscript has been submitted which reports the final results of the study, the Study Chairperson should write a brief statement estimating the impact of these results on the VA patient population. This Impact Statement should be sent by the Study Chairperson through the Chief, CSPCC. the Chief, CSP, and the Director, Medical Research Service and the Director, HSR&DS or RER&DS as appropriate, to the ACMD for Research and Development. At the time a major manuscript is submitted for publication, the Study Chairperson and the Study Biostatistician should write a "Highlights" of the results. This should be a brief statement, of no longer than two paragraphs, in simple, expressive, and informal language which describes the results of the study and their importance. When the date of publication of the article is known, a copy of the "Highlights" should be sent to the CSP office stating when the article will be published and in which journal. At the time that the article is to be published, the Chief, CSP will then forward these "Highlights" to the Director, Medical Research Service (and the Director, HSR&DS or RER&DS as appropriate) and the ACMD for Research and Development requesting that it be released in the next published "Highlights" format. In order to give these publications a wider dissemination within the VA, the Study Chairperson, with the approval of the Executive Committee, should send an extra copy of the manuscript to the Chief of the assigned CSPCC who will then forward it within one week of receipt to the Chief, CSPCC, Perry Point, who has undertaken the task of publicizing the results of all cooperative studies. One form of publicity, at the option of the Study Chairperson or the Executive Committee, will be the inclusion of the manuscript in the 29 �"VA Cooperative Studies Reports," a semiannual serial, for distribution within the VA only, of cooperative studies prepublication manuscripts. If the Study Chairperson wants his/her manuscript included in this report, he/she should give authorization in the cover letter accompanying the manuscript to the Chief of the assigned CSPCC. If a revision is required for a submitted manuscript, a copy of the revised manuscript should be sent to both the Chief, CSP and the Chief, CSPCC, Perry Point as should the notice of acceptance of a paper for publication. When the manuscript is published, the Chief, CSPCC, Perry Point should be informed of the journal reference so that arrangements for other publicity, such as a news release, can be made. When reprints are available, the Study Chairperson should send 12 copies to the Chief, CSPCC. Six of these will be forwarded to CSP. VACO and a courtesy copy will be sent to the other CSPCCs and the CSPCRPCC. VI. RESPONSIBILITIES IN A COOPERATIVE STUDY To successfully plan, organize, conduct, and bring to conclusion a cooperative study requires the complete and active cooperation of a great many individuals. It is important that everyone involved should have a clear understanding of what their responsibilities are and what commitments they are making when they agree to participate in one way or another. The intent of these guidelines is to contribute to the understanding of the total process. The scientific and administrative problems encountered in cooperative studies are too numerous and complex to rely on simple good faith understandings arrived at by word of mouth. Participation in a VA cooperative study is voluntary. Any individual or medical center that cannot or will not accept these operational guidelines should not elect to participate. Similarly, it is essential from the scientific and ethical point of view that a specific study will be conducted in the same manner at each participating site and agreement to participate implies a willingness to adhere to the research protocol in all respects. Involvement in cooperative studies in any role is likely to be demanding in time and effort. A Principal Proponent, a Study Chairperson, or a Participating Investigator should realize that he/she is making a personal commitment to the study and must be willing and able to devote time and energy to its success. In the event that he/she cannot continue in this role until the end of the study, he/she should make this information known to the Study Chairperson, the Chief, CSPCC, or the Chief, CSP, whichever is most appropriate, so that a substitute can be found. When the R&D Committee at the medical center approves participation in a cooperative study, the implication is that the study is feasible at that site, that the essential personnel are willing to be involved and are prepared to accept both the guidelines and the research protocol, and that the center is prepared to supply the necessary support including space for the duration of the study. It may be necessary in the course of a cooperative study to terminate or replace a participating facility upon the recommendation of the Executive Committee or Operations Committee. Although this action will always be taken in response to what is considered the best interests of the study, it does not necessarily imply poor performance by the Participating Investigator or the facility, e.g., it is not unprecedented for a center to be unable to recruit sufficient patients in spite of their best efforts. Any member of a cooperative study who does not perform satisfactorily within these guidelines or who does not adhere to the study protocol may be expected to be disengaged from his/her role in that cooperative study and/or have VA cooperative study funding discontinued by the Chief, CSP, upon recommendation of the study's Executive Committee and Operations Committee or by the Operations Committee alone. When such action is taken, that investigator would not ordinarily be considered for future activities of the VA Cooperative Studies Program. 30 �Mechanisms for appeal of any dissatisfied investigator who feels he/she has a justifiable grievance during a cooperative study are: appearance in person before the study's Executive Committee; if not satisfied, appearance before the study's Operations Committee; if not satisfied, appeal to the Assistant Chief Medical Director for Research and Development. Initiation of each step in this appeal process must be preceded by submission of written documentation illustrating the nature of the grievance to be addressed. Information copies should be sent to the Chief, CSPCC, the Chief, CSP and, in the event of appeal to the ACMD for R&D, to the Director, Medical Research Service and the Director, HSR&DS or RER&DS as appropriate, as well. 31 �APPENDIX A ADDRESSES Hollis G. Boren, M.D. Assistant Chief Medical Director for Research and Development (15) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington. DC 20420 FTS 389-2616 Peter G. Goldschmidt, M.D. Director, Health Services Research and Development Service (152) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 FTS 389-2666 Richard J. Greene, M.D., Ph.D. Director, Medical Research Service (151) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington. DC 20420 FTS 389-5041 Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Director Rehabilitative Engineering Research and Development Service (153) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 FTS 389-5177 Cooperative Studies Program (151-1) Veterans Administration Medical Center 1201 N.W. 16th Street Miami, FL 33125 James A. Hagans, M.D., Ph.D. Chief VACO: FTS 389-2861, 2862 Miami: FTS 350-3669, 3660 Ping Huang, Ph.D. Staff Assistant FTS 389-3702. 3703 Freda B. Cherry Administrative Aid for Budget Control FTS 350-3669,3660 Helen G. Bickley Technical Assistant for Travel and Budget FTS 389-3702. 2861 Diana Lopez Secretary FTS 350-3669,3660 P. Dennis Gilliland Technical Assistant for Planning and Evaluation FTS 389-3702. 2861 Secretary FTS 389-3702, 2861 Regional Director ( /151-I) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 James 0. Wear, Ph.D. Chief, Central Research Instrumentation Program (151-B) Veterans Administration Medical Center North Little Rock Division North Little Rock, AR 72114 FTS 740-1525 33 �Cooperative Studies Program Coordinating Center (151K) Veterans Administration Edward Mines, Jr. Hospital Mines, IL 60141 William G. Henderson, Ph.D., Chief Comm. No. 312-261-6700, ext. 2652 FTS 387-2653 Telecopier No. 387-2653 387-2653 Shigeru Ochi, Ph.D., Assistant Chief ADMINISTRATIVE SUPPORT SECTION Vacant, Administrative Assistant Carolyn Barnick, Secretary-Stenographer to Chief Shirley Levin, Clerk-Typist Helma Weyrich, Clerk-Stenographer Sharon Urbanski, Clerk-Typist 387-2653 387-2653 387-2653 387-2653 387-2653 BIOSTATISTICS SECTION Thomas J. Tosch, Ph.D., Biostatistician Julianne Souchek, Ph.D., Biostatistician James F. Martin, M.S., Biostatistician/Stat. Programmer Domenic Reda, M.S., Biostatistician/Stat. Programmer 387-2653 387-2653 387-2653 387-2653 Robert Vogt, Ph.D., Statistical Programmer Selina Mo, M.S., Statistical Programmer Thomas Moritz, M.S., Statistical Programmer Roland F. Mais, M.S., Statistical Programmer Steve Meyer, Stat. Programmer/Stat Assistant Mary Ann Centanni, Statistical Assistant Barbara Christine, Statistical Assistant Mary Ellen Vitek, Statistical Assistant Jane Foregger, Statistical Assistant Carol Colby, Statistical Assistant 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 DATA PROCESSING SECTION Thomas J. Linsenmeyer, Chief, Data Processing Section J. Edward Barnes, Computer Specialist Carolyn Harrison, Computer Specialist Roger Soltysik, Computer Specialist Tom Musial, Computer Programmer Willie Armstrong, Lead Data Transcriber Pam Walther, Data Transcriber Diane Zullo, Data Transcriber Lorrie Ulmer, Forms Specialist 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 387-2653 34 �Cooperative Studies Program Coordinating Center (151K) Veterans Administration Medical Center 3801 Miranda Avenue Palo Alto (Menlo Park). CA 94304 Kenneth E. James, Ph.D., Chief Comm. No. 415-493-5000, ext. 2181 FTS 449-2181 Telecopier No. 449-2181 ADMINISTRATIVE SUPPORT SECTION Betty Maxwell, Administrative Officer Louise King, Clerk Gabrial Tanford, Clerk-Typist 449-2181 449-2181 449-2181 BIOSTATISTICS SECTION Maxwell W. Layard, Ph.D., Senior Biostatistician Kelvin K. Lee, Ph.D., Biostatistician Robin L. Rose, Ph.D., Biostatistician Bonnie Sparks, Statistical Assistant Robert Newman, Statistical Assistant 449-2181 449-2181 449-2181 449-2181 449-2181 DATA PROCESSING SECTION Ronald L. Code, Chief, Data Processing Section Bor-Ming Ou, Statistical Programmer Robert S. Chiang, Statistical Programmer Nan Levitsky, Forms Design 449-2181 449-2181 449-2181 449-2181 35 �Cooperative Studies Program Coordinating Center (151E) Veterans Administration Medical Center Perry Point, MD 21902 Comm. No. 301-642-2411. ext. 571 FTS 922-0571 Telecopier No. 922-0318 922-0572 922-0571 C. James Klett. Ph.D., Chief Joseph F. Collins, Sc.D., Assistant Chief Joyce Letterman, Secretary ADMINISTRATIVE SUPPORT SECTION Bertha D. Carter, Administrative Officer, Chief Barbara A. McMullen, Staff Assistant Sandra L Agenes, Forms Design Specialist Rose M. Gillis, Secretary Darlene Porter, Secretary Carol J. Witmer, Clerk Typist W. Bruce Billings, Research Assistant 922-0354 922-0353 922-0572 922-0430 922-0572 922-0572 922-0572 BIOSTATISTICS SECTION William 0. Williford, Ph.D., Biostatistician Stephen F. Bingham, Ph.D., Biostatistician Joseph F. Collins, Sc.D., Biostatistician David G. Weiss, Ph.D., Biostatistician 922-0572 922-0572 922-0572 922-0572 DATA PROCESSING SECTION Roderic D. Gillis, Computer Systems Analyst, Chief Frederick Lane, Computer Specialist M. Anne Weitzel, Senior Encoder Doris Bosworth, Research Assistant/Encoder Debra Davis, Research Assistant/Encoder Janet Diehl, Research Assistant/Encoder Evelyn Jackson, Research Assistant/Encoder Myra Mandl, Research Assistant/Encoder Dorothy Morson, Research Assistant/Encoder Diana Preston, Research Assistant/Encoder Christine Scheffler, Research Assistant/Encoder Linda Halsey. Computer Operator 922-0430 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 STATISTICAL PROGRAMMING SECTION Robert Kuhn, Ph.D., Statistician, Chief Vacant, Statistician/Programmer Chuan-Shue Lee, M.S., Statistician/Programmer Francis G. Ogrinc, M.S., Statistician/Programmer Hong-Jen Yu, M.S., Statistician/Programmer Vacant, Statistician/Programmer Peter Vlasveld, Computer Specialist 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 922-0573 36 �Cooperative Studies Program Coordinating Center (151 A) Veterans Administration Medical Center West Haven, CT 06516 Yick-Kwong Chan, Ph.D., Chief Comm. No. 203-932-5711. ext. 500 FTS 641-7500 Telecopier No. 641-7505 641-7213 Dorothea Collins, M.S., Assistant Chief ADMINISTRATIVE SUPPORT SECTION Ann L Lutters, Administrative Assistant Barbara A. Trocchio, Secretary Margaret R. Antonelli, Clerk-Typist Mary Wilson, Clerk-Typist Mary L Quinn, Clerk-Typist Lynn Durant, Clerk (Forms Design and Typing) 641-7741 641-7446 641-7510 641-7510 641-7510 641-7510 BIOSTATISTICS SECTION Alvan R. Feinstein, M.D., Senior Biostatistician (Yale) Donald G. Archibald, M.A., M.S., M.Ph., Biostatistician Anne Cross, M.S., Biostatistician Katherine M. Detre, M.D., Dr. P.H., Biostatistician Robert H. Deupree, Ph.D., Biostatistician Gary R. Johnson, M.S., Biostatistician Peter N. Peduzzi, Ph.D., Biostatistician Richard J. Bigelow, Jr., B.A., Statistical Assistant Ann Charboneau. Statistical Assistant Mary Ann Cosh a re k, B.S., Statistical Assistant Joan Derrico, M.S., Statistical Assistant Jo-Anne Falcigno, B.S., Statistical Assistant Patricia Ferrucci, Statistical Assistant H. Teresa Hatch, B.A., Statistical Assistant Mary Anne Hope, M.S., Statistical Assistant Raymond Kilstrom, M.B.A., Statistical Assistant Margaret Lee, M.S., Statistical Assistant Clare M. Paradise, B.A., Statistical Assistant Arnold S. Pfenninger, M.S.; Statistical Assistant Joyce Pritchett, B.S., Research Assistant Comm. No. 203-436-8787 641-7552 641-7520 641-7635 641-7572 641-7520 641-7504 641-7575 641-7517 641-7524 641-7517 641-7576 641-7524 641-7635 641-7621 641-7575 641-7517 641-7203 641-7575 641-7524 Bonnie Charron, Statistical Clerk 641-7517 DATA PROCESSING SECTION Victor Latvis, B.A., Systems Analyst, Chief Dorothea Collins, M.S.. Systems Analyst 641-7212 641-7213 Tenya Economou, M.S., Computer Specialist 641-7215 Chinyu Lee, M.S., Programmer Irene Voynick, M.S., Programmer Carolyn Wells, B.A., Programmer Cynthia Ziemba, B.S., Programmer 641-7216 641-7216 641-7576 641-7215 Stella Marcinauskis, EAM Operator Velma Williams, Keypunch Operator Rosann Botte, Keypunch Operator 641-7537 641-7537 641-7537 37 �Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (151-1) Veterans Administration Medical Center 2100 Ridgecrest Drive, S.E. Albuquerque, NM 87108 Mike R. Sather, R.Ph., M.S., Chief . Comm. No. 505-265-1771 FTS 572-9580 Telecopier No. 572-9408 ADMINISTRATIVE SUPPORT SECTION Sandra L. Buchanan, Administrative Officer Loretta A. Malone, Computer Operator Ella Crum, Secretary Sandra E. Poole, Clerk-Typist 572-9584 572-9584 572-9584 572-9584 CLINICAL RESEARCH PHARMACY SECTION Larry M. Young, R.Ph., Clinical Research Pharmacist Clair M. Haakenson, R.Ph., M.S., Clinical Research Pharmacist John P. Van Eeckhout, R.Ph., Clinical Research Pharmacist 572-9581 572-9582 572-9583 TECHNICAL/MANUFACTURING SUPPORT SECTION Roy W. Fetter, Senior Research Pharmacy Technician Louis Montano, Research Pharmacy Technician 572-9584 572-9584 38 �APPENDIX B SCHEDULE OF IMPORTANT EVENTS DEADLINES Request for Planning (Page 2) To Chief, CSP from Principal Proponent through ACOS December 1 for February review April 1 for June review August 1 for October review Submission of Final Draft of Proposal To CSPCC Study Biostatistician from Principal Proponent (Page 13) October 15 for December 1 submission to CSEC February 15 for April 1 submission to CSEC June 15 for August 1 submission to CSEC Submission of Final Proposals for CSEC Review To Chief. CSP from CSPCC (Page 13) December 1 for February review April 1 for June review August 1 for October review REQUEST FOR TRAVEL APPROVAL To Chief, CSPCC from Principal Proponent (Chairperson); copy to Chief, CSP Planning Committee (Page 3) At least five weeks prior to meeting Training Meetings or Organizational Meetings (Page 23) At least two months prior to meeting Study Group, Executive Committee, Operations Committee (Page 23) At least two months prior to meeting Emergency or unplanned meetings (Page 23) If at all possible at least three weeks prior to meeting REPORTS Study Group (Page 19), Executive Committee (Page 20), Operations Committee (Page 21), Human Rights Committee (Page 22) From Committee Chairperson to all members and Chief, CSPCC; copy to Chief, CSP Within three weeks after meeting Site Visit Reports, etc. (Page 24) To Study Chairperson from Site Visitor Within 10 days after visit To Chief, CSPCC from Study Chairperson; copy to Chief, CSP Within 21 days after visit 39 �APPENDIX C MEDICAL RESEARCH SERVICE "CORE COMMITTEE" FOR TRIAGE REVIEW FOR VETERANS ADMINISTRATION COOPERATIVE STUDIES COORDINATOR AND NONVOTING CHAIRPERSON: Arlene Mitchell. Ph.D. Special Assistant, Merit Review Board Staff Division Medical Research Service (151D) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 MEMBERS: John J. Castellot, Sr., M.D. Director, Medical Service (111) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Chester W. DeLong, Ph.D. Coordinator Program and Liasion Academic Affairs (14D) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Matthew A. Kinnard, Ph.D. Special Assistant to the Director Medical Research Service (151G) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Paul C. Le Golvan, M.D. Director, Pathology Service (113) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 John 0. Lipkin, M.D. Associate Director for Psychiatry Mental Health and Behavioral Sciences Service (116A1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 NOTE: Ad hoc members may be added to the "Core Committee" as needed. 40 �APPENDIX D - COOPERATIVE STUDIES EVALUATION COMMITTEE & BUDGET REVIEW GROUP CSEC MEMBERS COORDINATORS Leo E. Hollister. M.D., Chairperson (Oct '81) Chief, Psychopharmacology Research Veterans Administration Medical Center 3801 Miranda Avenue Palo Alto, CA 94304 Genell Lavonne Knatterud, Ph.D. (Oct. '83) Professor and Deputy Director Division of Clinical Investigation University of Maryland School of Medicine Baltimore, MD 21201 James A. Hagans, M.D., Ph.D. Chief, Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Ronald Lee Nichols, M.D., M.S. (Oct. '81) Henderson Professor of Surgery Tulane University School of Medicine New Orleans, LA 70112 Solomon Sobel, M.D. (Oct. '83) Director, Div. of Metabolism & Endocrinology Federal Drug Administration Room 14, Box HFD-130 5600 Fishers Lane Rockville, MD 20857 Ping C. Huang, Ph.D. Staff Assistant Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Edward A. Carr, Jr., M.D. {Oct '82) Professor and Chairman Dept. of Pharmacology and Therapeutics State University of New York 127 Farber Hall Buffalo, NY 14214 Theodore Colton, Sc.D. (Oct. '82) Professor of Biostatistics & Epidemiology School of Public Health Boston University, School of Medicine 80 E. Concord Street Boston, MA 02118 John A. Colwell, M.D., Ph.D. (Oct '83) ACOS for Research and Development Veterans Administration Medical Center 109 Bee Street Charleston, SC 29403 Clarence E. Davis, Ph.D. (Oct. '83) Associate Professor Department of Biostatistics School of Public Health University of North Carolina Chapel Hill, NC 27514 BRG MEMBERS Mr. Gordon D. Williams, Chairperson AO to Director, Medical Research Service Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Mr. Dennis Roth* AO to ACMD for Research and Development Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Lee Weatherbee, M.D. (Oct '81) Chief, Laboratory Service Veterans Administration Medical Center 2215 Fuller Road Ann Arbor, Ml 28105 Ms. Jeannette A. Landis (Oct '83) AO to ACOS for Research and Development Veterans Administration Medical Center Lexington, KY 40507 Mr. P. Dennis Gilliland Technical Asst for Planning & Evaluation Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Freda B. Cherry Administrative Aid for Budget Control Cooperative Studies Program (151-1) Veterans Administration Medical Center 1201 N.W. 16th Street Miami, FL 33125 "When review of a specific proposal occurs, which is not primarily in the area of Medical Research Service, the AO to the ACMD for Research and Development will attend and serve as Chairperson and an additional ad hoc member from that area (such as HSR&DS or RER&DS) may be added for that specific review. �APPENDIX E COOPERATIVE STUDIES PROGRAM CLINICAL RESEARCH PHARMACY COORDINATING CENTER EVALUATION COMMITTEE (CSPCRPCCEC) Paul Magalian, R.Ph., Ph.D.. Chairperson (Fall '81) Chief, Pharmacy Service (119) Veterans Administration Medical Center 1201 N.W. 16th Street Miami, FL 33125 Richard H. Mattson, M.D. (Fall '81) Director, Epilepsy Clinic (127) Veterans Administration Medical Center West Haven, CT 06516 James J. Rahal, Jr., M.D. (Fall '82) Chief, Division of Infectious Diseases (151 A) Veterans Administration Medical Center First Avenue at E. 24th Street New York, NY 10010 Patsy C. Barnett, Pharm.D. (Fall '83) Assistant Chief, Pharmacy Service (119) Veterans Administration Medical Center Lexington, KY 40507 COORDINATORS: James A. Hagans, M.D., Ph.D. Chief, Cooperative Studies Program (151-I) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Ping C. Huang, Ph.D. Staff Assistant Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 Mr. P. Dennis Gilliland Technical Assistant for Planning & Evaluation Cooperative Studies Program (151-1) Veterans Administration Central Office 810 Vermont Avenue, N.W. Washington, DC 20420 42 �APPENDIX F STUDY BUDGET EXAMPLE Special Travel YEAR 1 Personnel Site Visits Chairperson's Office Medical Center TNG FTP* FTE** Cost 2a Other Oper. Costs YEAR 2 Personnel Equip. Total FTP FTE Cost Other Oper. Costs TOTAL Personnel Total Other Oper. Costs 1.5b FTP FTE Cost Equip. 1 10 Special Laboratory CSPCRPCC TOTAL a. Study Coordinator and Clerk Typist. b. 1.0 Study Coordinator; 0.5 Clerk Typist. c. Operating costs include: drug analyses; local consulting; test scoring and supplies, d. Typewriter, filing cabinets, desk. e. Equipment for Behavioral Tests and special equipment needed for study. f. Costs associated with Central Readings, special analysis (blood, urine, tissue), quality control, etc. g. Cost involving drugs, biological products and devices for the study. FTP denotes actual number of people. FTE denotes equivalent ceiling count (FTEE). Total �APPENDIX G REQUEST FOR PLANNING A VA COOPERATIVE STUDY PRECIS SUBMISSION CHECKLIST When a request to plan a cooperative study is submitted to the Chief, Cooperative Studies Program, the precis should include the following information. Although the details included in the precis are not binding, and modifications and changes undoubtedly will be made during the actual planning phase, the initial request should provide sufficient detail to assure that due consideration has been given to all facets of the proposed study. Use the checklist as a guide in preparing the precis. r~] Primary objectives of the proposed study. Be specific regarding the aim of the research, e.g., to test new drug/medical procedure, to identify characteristics or prognostic factors of a disease, etc. [ | Secondary objectives, if any. [ | The importance of the study. [~J Justification for a cooperative study approach. Description of the type of study proposed. Include all items that apply. I ] Prospective data collection. [ I Randomized. I J Nonrandomized. I Retrospective data collection (chart review or review of patient history). I I j Comparison of new treatment/medical procedure to control. | j No control or comparison to historical control. [ Epidemiological or observational. ] Q Other: Population from which patients are to be drawn. Include all that apply. I j VA inpatients. [~] VA outpatients. I Non-VA inpatients (e.g., at affiliated university). I L_j | Non-VA outpatients. I Males and/or females. Other: [_J Brief description of the study procedures proposed. Provide a preliminary estimate for the following items: I J Number of VA medical centers required. [_j Number of non-VA medical centers required. [_J Number of laboratories anticipated. [_| Duration of the study (in years). Total estimated cost of the study. [ ] Summarize background and supply references of work accomplished on which request for the proposed cooperative study is based. [ Principal Proponents eligibility to receive Medical Research Service funds. j 44 � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1843 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Collins, Joseph F. Bertha D. Carter Date A point or period of time associated with an event in the lifecycle of the resource 1981-04-01 Title A name given to the resource Guidelines for VA Cooperative Studies, Fifth Edition Subject The topic of the resource Vietnam Experience Twin Study CSP ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/137411553a8578da06ee7928ab0aface.pdf 41b3ede144713d34d0a4bcf7c82f50e3 PDF Text Text ItenHDNimber Author Corporate Author RODOrt/ArtldO Tltto Typescript: CSP # 256 Budget Summary Journal/Book Title Yoar 000 ° Month/Day Color a Number of Images 1 DOSCrlDton NotOS Alvin L Your| gfileci this item under "Vietnam Veterans Twin Study." CSP = Cooperative Study Protocol. #256 (Twin Study). Budget summary for the VETS. Wednesday, July 11, 2001 Page 1842 of 1870 �CSP #256 Budget Summary FY84 FY85 FY86 FY87 Total Monies Presumably Allocated to CSP #256 From 823 (Hagans Memo of 9/1/83) 4,641,000 3,105,000 500,000 500,000 8,746,000 CSP #256 Budget Projection as of 9/1/83 2,604,000 (P#2) 1,963.000 (NAS) 4,567,000 5,225,000 534,000 534,000 10,860,000 10/38/83 Protocol #2 Budget 2,678,354 (P#2) 1,963,000 (NAS) 4,641,354 5,031,911 640,136 673,487 10,986,888 1/30/84 Supplement to Protocol //2 Budget 3,259,399 (P//2) 1,963.000 (NAS) 5,222,399 6,165,843 904,034 913,713 13,205,989 (Hagans Memo of 9/1/83) � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1841 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Typescript: CSP # 256 Budget Summary Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/ce7d89a340d8bfa0338bf1ca57ff9aea.pdf 63b0f17f8ad82ab953c4d0eafdf68fa9 PDF Text Text Item ID MOT 0184 Author [Young, Alvin L.] ° Corporate Author Report/Article TltlB Manuscript: Notes, For Telephone call from Dr. Bulkley yo Dr. John Gronvall..., November 9. Journal/Book Title Year 000 ° Month/Day Color n Number of Imapjis 1 DeSCTlptOII NOtOS Alv n ' ^- Young filed this item under "Vietnam Veterans Twin Study." Notes regarding Vietnam Veterans Twin Study protocol. Wednesday, July 11, 2001 Page 1841 of 1870 �KloV fee. K«£tcal \JL3C r ^ \ cure OJUDCL^ � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1840 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Young, Alvin L. Title A name given to the resource Manuscript: Notes, For Telephone call from Dr. Bulkley to Dr. John Gronvall..., November 9. Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/1a0bf05df109281eff2c486dcfb15fc4.pdf d669c4eba5fc1f64cf6ddacac31262ea PDF Text Text Item ID Number °1837 Author True, William Ray Corporate Author Roport/Artido TltlO Typescript: Prevalence Odds Ratios for Stress Symptomology Among Vietnam Veterans from a Major Health Survey Journal/Book Title Year 1986 Month/Day Juno Color Number of Images 21 Alvin L Youn filed this item 9 under "Vietnam Veterans Twin Study." Item includes cover letter from William R. True ot Alvin L. Young, June 26, 1986. Wednesday, July 11, 2001 Page 1838 of 1870 �Medical Center St. Louis, MO 63125 Veterans Administration J u n e 26, 1986 Alvin L. Young, LTCOL, USAF, Ph.D. Senior Policy Analyst for the Life Sciences Executive Office of the President Office of Science and Technology Policy Room 5005, New Executive Office Building Washington, D.C. 20506 Dear Alvin: I really enjoyed seeing you in Washington, and thanks again for lunch. I'm gratified that this project is finally coming to show some results for all the time and effort that has gone into it. We also owe you so much for your significant assistance throughout. I wanted to get your schedule for your St. Louis trip. Please have your secretary give us a call as I'd love to take you to one of our fun Italian restaurants on the hill, former home of Yogi Berra and Joe Garagiola. My growing bride will join us, eating for two. I'm enclosing a copy of the paper I gave last week at the Society for Epidemlological Research in Pittsburgh. It got some press which was fun. Best wishes. I'll look forward to seeing you. Sincerely, William R.- True, Ph.D., M.P.H. Research Anthropologist (151A-JB) cc: Reply Refer To: Seth Eisen, M.D. 65 7/151A JB �Prevalence Odds Ratios for Stress Symptomology Among Vietnam Veterans from a Major Health Survey William Ray True, Ph.D., M.P.H. Research Anthropologist Psychiatry Service (151A-JB) VA Medical Center St. Louis MO 63125 Jack Goldberg, Ph.D. Epidemiologist Cooperative Studies Coordinating Center Hines VA Medical center Hines IL 60141 Seth A. Eisen, M.D. Medical and Research Services VA Medical Center St. Louis MO 63125 Presented at the Society for Epidemiological Research June 18-20, 1986 Pittsburgh PA �I. Introduction Many research s t u d i e s (Figley, 1978) have suggested t h a t p a r t i c i p a t i o n in the V i e t n a m War is c o r r e l a t e d w i t h psychological difficulties presently reported by Vietnam U n d e r a c h i e v e m e n t in e d u c a t i o n a l and employment spheres veterans. (Egendorf et a l . , 1981)/ m a r i t a l and p e r s o n a l i t y problems, and d r u g a n d / o r d r i n k i n g problems are j u s t a few e x a m p l e s of symptom c l u s t e r s which have been a t t r i b u t e d to the c o n f l i c t . Although the Vietnam War, like other wars, left with feelings of danger, combatants loss, helplessness, and d i s r u p t i o n (Laufer, 1985; Y a g e r , 1984), many i n v e s t i g a t o r s h a v e c o n c l u d e d t h a t the V i e t n a m e x p e r i e n c e was u n i q u e and t h e r e f o r e w o r t h y of special r e s e a r c h e f f o r t s . I n c o n t r a s t w i t h other w a r s , v e t e r a n s point out t h a t they l e f t the war zone as i n d i v i d u a l s r a t h e r t h a n as members of m i l i t a r y u n i t s , f a c e d b r o a d - b a s e d o p p o s i t i o n at home t o t h e i r p a r t i c i p a t i o n , s u f f e r e d the f r u s t r a t i o n s "limited war m e n t a l i t y , " and had to deal w i t h an a b r u p t t r a n s i t i o n f r o m a w a r t i m e to a c i v i l i a n e n v i r o n m e n t . of a The issue is f u r t h e r complicated by the perception shared by many v e t e r a n s t h a t e x p o s u r e t o H e r b i c i d e Orange a n d other p o t e n t i a l l y toxic substances while in V i e t n a m c a u s e d the physiologic disorders they believe psychological and t h e y a r e n o we x p e r i e n c i n g ( W a d e , 1979; Holden, 1 9 7 9 ) . While c o n s i d e r a b l e research a t t e n t i o n has been directed t o w a r d s u n d e r s t a n d i n g t h e long-term p s y c h o l o g i c a l health effects and physical of the Vietnam W a r , the relationship remains �Vietnam Veterans 3 incompletely defined. Many clinical studies have had no control groups, inadequate definition of outcomes, attention to confounding factors. and insufficient Four relatively large scale epidemiological studies do exist which examine the relationships between Vietnam service and subsequent health status. Slide 1 Although t h e s e s u r v e y s c o n s t i t u t e an i m p r e s s i v e body of knowledge, some l i m i t a t i o n s u p o n t h e i r interpretation Only the H a r r i s (1980) s t u d y is based on n a t i o n a l sampling t e c h n i q u e s . exist. probability Robins (1974) and Card (1983) both selected p r e s u m a b l y u n b i a s e d samples based upon c h r o n o l o g i c a l c r i t e r i a : Robins used Army examinations positive drug screens study. 'Legacies...') servicemen with 1971 a n d w i t h d r u g - f r e e s o l d i e r s f r o m t h e same Card selected veterans follow-up identify leaving V i e t n a m in September, matched these subjects group; to from The Egendorf the 1974 P r o j e c t T a l e n t study (referred to as i s p o t e n t i a l l y biased b e c a u s e p a r t i c i p a n t s w e r e selected u s i n g an u n u s u a l "snowball" sampling t e c h n i q u e in w h i c h a contacted household r e f e r r e d the study personnel to other v e t e r a n s m e e t i n g study c r i t e r i a . Further, objectives, employed. the research projects had different thereby accounting for Thus, the variety of research methods s t u d i e s d e f i n e d c o n t r o l groups a s V i e t n a m o r n o n - V i e t n a m e x p e r i e n c e d s o l d i e r s , a l t h o u g h t h e r e was considerable �Vietnam Veterans 4 non-Vietnam experienced s o l d i e r s / a l t h o u g h t h e r e was c o n s i d e r a b l e v a r i a t i o n i n levels o f w a r t r a u m a e n c o u n t e r e d . c o n t r o l groups were d e f i n e d as n o n - v e t e r a n s . Card study, comparisons were made reasons for not being Alternatively For example, in the with non-veterans, whose i n t h e m i l i t a r y w o u l d t h e m s e l v e s have complicated any analysis of t h i s q u e s t i o n . The analysis research of r e p o r t e d here is a major study, the based on the Survey of commissioned by the V e t e r a n s A d m i n i s t r a t i o n . secondary Veterans II, The s t u d y was Slide 2 conducted in 1979 by the Census Bureau of the Department of Commerce on the Current Population identified themselves serving since 1917. Era sub-sample Survey respondents who had as veterans of the U.S. Armed Forces From this study sample of 11,230, a Vietnam of 2,452 was identified and interviewed. This group was divided between 1,036 Vietnam theater and 1,416 Vietnam Era veterans. II. Epidemiological Analysis of the SOV II This sample is particularly important because it was studied in 1979, a t i m e p r e c e e d i n g the d e v e l o p m e n t of the major controversy about Agent Orange and the considerable surrounding that issue. litigation Therefore the SOV II was an important benchmark sample against which other current surveys may be compared. �Vietnam Veterans 5 The a n a l y s i s of the e f f e c t s was performed of war service in t h i s sample with Mantel-Haenszel p r e v a l e n c e odds ratios c o n t r o l l i n g for age, race, length of s e r v i c e , year of release Slide 3 from service, years of education at discharge, rank, draftedenlisted, and branch of service. Test-based Confidence Intervals are presented in lieu of significance levels. In this analysis, the controlling variables were adjusted for simultaneously. Further analysis of the specific associations of the individual potential confounding variables with the outcome measures is now in progress. The survey did not include questions about preservice risk factors or youthful liability measures which have been shown to be important in other studies. Questions as they were stated on the questionnaire took the following form: "Since your LAST release from active military service, have you...had any problems with your physical health? /alternatively/. . .had frightening dreams or nightmares?" items asked for overall prevalence The during the years since discharge, and there was no probe for timing of the item. The question concerning Vietnam service was phrased as follows: Were you stationed in Vietnam, Laos, or Cambodia; in the waters in or around these countries; or fly in missions over these areas? The prevalence odds ratios for psychiatric symptom outcomes �Vietnam Veterans 6 revealed increased prevalence odds ratios for those exposed to in-country Vietnam Duty. The striking elevation in prevalence Slide 4 odds ratios for nightmares was the strongest outcome in the study, and this nearly four-fold increase did not diminish with adjustment. Although sufficient data are not available to make a presumptive diagnosis of Post-Traumatic Stress Disorder, we looked at the evidence relevent to this diagnosis. Nightmares, for example, along with confusion, are specifically included in the Diagnostic and S t a t i s t i c a l Manual III (APA, 1980) as contributing to the diagnosis of Post-Traumatic Stress Disorder. Depression and guilt both have also been included in clinical descriptions of post-traumatic stress symptomatology 1979). (Helzer, Another feature of the clinical presentation of troubling d r e a m s are n i g h t terrors, which are often accompanied by retrograde amnesia, therefore causing the symptom to be commonly under-reported. Consequently, we suspect that although these findings are quite dramatic, they may still understate this troubling symptomology. Slide 5 These psychological outcomes, including Troubled Memories, Psychological Problems, and Temper Control also contribute to the �Vietnam Veterans 7 Post Traumatic Stress Disorder diagnosis. The diagnosis itself encompasses two different domains of symptoms, intrusive imagery and numbing. intrusive symptoms, such as the psychological outcomes displayed, suggest the re-experiencing of the original trauma. This may occur through hyper-reactivity to environmental stimuli such as startle responses to backfires, i r r a t i o n a l feelings and actions upon seeing an oriental face, or disturbing dreams. Numbing suggests constricted affect, feelings of estrangement, deliberate efforts to avoid feelings and activities which may directly or indirectly resonate with the original trauma. Thus, for example, a veteran may avoid sports in spite of personal interest because the emotional closeness of the team may recall the esprit of the platoon, which may have been d e c i m a t e d in combat. In these data, life goal indecision suggests a reflection of the numbing symptomology. General Problem Outcomes suggest more of the areas Slide 6 included in the numbing aspect of the Post Traumatic Stress Disorder diagnosis, although in this study, they do not appear to be important. Outcomes relating to job, school and family would suggest these difficulties. These findings are increased with measurement of the combat exposure. Combat was measured with an additive scale for all �Vietnam Veterans Slide 7 Vietnam veterans and was grouped for this analysis levels: none, low, medium, and high. into four The psychiatric outcomes and combat show the increased prevalence odds ratios for Slide 8 higher levels of combat. over a nine-fold Again, Nightmares for high combat shows increase. Prevalence odds ratios for all psychiatric symptoms show highly significant combat effects with the Test for Trend. Similar findings are shown for the psychological outcomes. Slide 9 Troubled memories show almost an eight fold increase, and all outcomes save Life Goal indecision demonstrate clear stepped increases with combat. All trends are highly significant. Of the General Problem Outcomes, Physical Health shows Slide 10 increased Prevalence Odds Ratios and highly significant trend with combat. This finding is interesting although we cannot �Vietnam Veterans 9 determine whether the health problems were the result of injuries from the war itself, or related to the indirect stresses of combat as these might be hypothesized or increased risk-taking. to affect physical health The other outcomes show modest but consistent increases and significant trend. Evidence has been presented of the presence of traumatic stress symptomology for a randomly selected sample of veterans studied in 1979, a time preceding recent increases in the political sensitivities surrounding the issue of the effects of the Vietnam War. That these symptoms are magnified by combat exposures follows clinical experience and other research already conducted. �Vietnam Veterans 10 References American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders III (DSM-III). Washington, D.C.; 1980. Card, J.J.: Lives After Vietnam: The personal impact of military service. Lexington, Mass.: D.C. Heath, 1983. Egendorf, A., Kadushin, C., Laufer, R.S., Rothbart, C., and Sloan, L.: Legacies of Vietnam: Comparative adjustment of veterans and their peers, a study conducted for the Veterans Administration, submitted to the Committee on Veterans' Affairs, U.S. House of Representatives, 1981. Figley, C.R., ed.: Stress Disorders Among Vietnam Veterans: Theory, Research and Treatment. New York: Brunner/Mazel, 1978. Harris, L. and Associates, Inc.: Myths and Realities: A Study of A t t i t u d e s Toward Vietnam Era Veterans. Conducted for the Veterans Administration, Washington, D.C., 1980. Helzer, J.E., Robins, L.N., Wish, E., and Hesselbrock, M. : Depression in Vietnam veterans and civilian controls. Am J Psychiatry 1979; 136:526-529. t Holden, C.: Agent Orange furor continues to build. 24:770-772. Science 1979; L a u f e r , R.S.: War Stress and T r a u m a : the Vietnam Veteran Experience. Presented at the American Sociological Association Meetings, San Francisco, CA 1982. J Health Soc Behavior, 1985. Robins, L.N., Davis, D.H., Goodwin, D.W.: Drug use by U.S.Army enlisted men in Vietnam: A Follow-up on their return home. Am J Epidemiology 1974 (April); 99(4):235-249. Veterans Administration, Reports and Statistics Service, Office of the Controller, 1979 National Survey of Veterans II, Summary Report, 1980. Wade, N.: Viets and vets fear herbicide health effects. 1979; 25:817. Science Yager, T., Laufer, R., and Gallops, M.: Some problems associated with war experience in men of the Vietnam generation. Arch Gen Psychiatry 1984; 41:327-333. �Table 1 Vietnam Veteran Surveys Study Question Population N Controls Robins, 1974 Post service drug use Army enlisted leaving VN 9/71 495 drug 470 drug Legacies of Vietnam, 1981 War effects Strat prob sample: 10 sites 350 VN 363 VN Prob sample 1176 VN Harris, 1980 War effects 629 Veterans 1388 VN 4073 Veterans Card, 1979 War effects Project Talent 500 VN 500 VN 500 Veterans SOV II, 1979 War effects CPS 1036 VN 1416 VN �Table 2 Study Sample Survey of Veterans II (1979) Sponsored by Reports and Statistics Service Veterans Administration Central Office Conducted by Bureau of Census Commerce Department February to April 1979 Sample size: 11,230 male veterans (Military Service since 1917) Bureau of Census Current Population Sample (CPS) �Table 3 Potential Confounding Vnrinblon Age at time of Survey Race Length of Service Year of Release Years of Education Rank Drafted - Enlisted Branch of Service �Table 4 Prevalence Odds Ratios for Psychiatric Symptom Outcomes and Service in Vietnam Unadjusted 95% C.I. Adjusted 95% C.I. Nightmares 3.69 2.91-4.68 3.78 2.85-5.02 Confusion 1.53 1.22-2.19 1.82 1.39-2.39 Depression 1.43 1.20-1.70 1.65 1.35-2.01 Guilt 1.37 1.12-1.68 1.42 1.12-1.81 �Table 5 Prevalence Odds Ratios for Psychological Outcomes and Service in Vietnam Unadjusted 95% C.I. Adjusted 95% C.I. Troubled Memories 3.31 2.64-4.14 3.52 2.69-4.61 Psychological Problems 1.66 1.29-2.13 1.75 1.30-2.35 Temper Control 1.72 1.39-2.12 1.78 1.38-2.29 Life Goal Indecision 1.43 1.18-1.73 1.53 1.22-1.90 Sleeping Problems 1.51 1.22-1.87 1.46 1.13-1.87 �Table 6 Prevalence Odds Ratios for General Problem Outcomes and Service in Vietnam Unadjusted 95% C.I. Adjusted 95% C.I. Physical Health 1.42 1.16-1.75 1.30 1.10-1.68 Drug or Drinking 1.58 1.08-2.37 1.81 1.18-2.79 Finding Job 1.29 1.07-1.56 1.36 1.09-1.71 Holding Job 1.43 1.02-2.07 1.57 1.05-2.36 Inadequate Pay 1.19 1.01-1.41 1.18 .97-1.44 Family Trouble 1.26 1.01-1.57 1.27 .97-1.65 Legal Trouble 1.07 .74-1.56 1.27 .81-1.99 School Trouble 1.05 .71-1.55 1.10 .69-1.79 �Table 7 Combat Scale 1 Artillery Unit which fired on the enemy 2 Flew missions over Vietnam/ Laos, and/or Cambodia 3 Stationed at a forward observation post 4 Received incoming fire (artillary, rockets, or mortars) 5 Encountered enemy mines or booby traps 6 Received sniper or sapper fire 7 Ambushed by enemy 8 Engaged the Vietcong, Guerilla, or unidentified troups in a firefight 9 Engaged the North Vietnamese Army or other organized military forces in a firefight Combat Scale equals sum of positive responses to any of the above. There are two groups: Non-Vietnam and Vietnam (Combat Scale 0 to 9) �Table 8 Prevalence Odds Ratios for Psychiatric Symptom Outcomes and Combat Scale Combat Level Non-VN None Low Med High Test for Trend Nightmares 1.00 1.54 2.27 5.47 9.31 203.333*** Confusion 1.00 1.21 1.26 1.85 2.24 22.811*** Expression 1.00 1.13 1.12 1.97 2.05 29.938*** en I II 1,00 .97 1.00 1.77 2 . 2 .1, 22.533*** *** |> < .00 �Table 9 Prevalence Odds Ratios for Psychological Outcomes and Combat Scale Combat Level Test for Trend Non-VN None Low Med Troubled Memories 1 .00 1.68 1.92 7.74 7.94 188.331*** Psychological Problems 1 .00 1. 04 1 .39 1. 93 2 .72 28. 737*** Temper Control 1 .00 1. 05 1 .46 2. 17 2 .75 43. 049*** Life Goal Indecision 1 .00 1. 42 1 .28 1. 70 1 .52 13. 683*** Sleep Problems 1 .00 1. 09 1 .03 1. 90 3 .02 35. 931*** *** p < .001 High �Table 10 Prevalence Odds Ratios for General Problem Outcomes and Combat Scale Combat Level Non-VN None Low Med High Test for Trend Physical Health 1.00 .92 1.04 2.18 2.17 26.821*** Drug or Drinking 1.00 .66 1.58 2.07 1.82 8.836** Finding Job 1.00 1.17 1.13 1.52 1.62 11.165** Holding Job 1.00 1.05 1.32 1.70 1.78 6.459** Inadequate Pay 1.00 .97 1.15 1.46 1.22 6.382** Family Trouble 1.00 .77 1.12 1.69 1.65 11.047** Legal Trouble 1.00 .67 .98 1.96 1.21 .904 School Trouble 1.00 .58 .91 1.59 1.18 .881 ** p < .01 *** p < .001 � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1837 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource True, William Ray Jack Goldberg Seth A. Eisen Date A point or period of time associated with an event in the lifecycle of the resource 1986-06-01 Title A name given to the resource Typescript: Prevalence Odds Ratios for Stress Symptomology Among Vietnam Veterans from a Major Health Survey Subject The topic of the resource Vietnam Experience Twin Study PTSD ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/6c990d636a544a4e4f4160da0d919994.pdf 6f3ba42969deef3d06f65df2958cf48b PDF Text Text Item ID Number °1835 Author Keller, Carl Corporate Author Report/Article Title Memorandum with several attachments: from Chairman, Science Panel, AOWG, to Members of the Science Panel, AOWG, with subject Meeting of the Science Panel, dated February 5, 1985. Journal/Book Tito Year 000 ° Month/Day Color H Number of Images 12 DOSCTipton Notes Avn ' ' L- Young filed this item under "Vietnam Veterans Twin Study." Memo gives notice of a science panel meeting scheduled for February 21, 1985 with the purpose of reviewing the VETS II protocol. Attachments include inquiries about the possiblity of a female Vietnam veterans study, and the minutes of the November 29,1984 meeting of the Science Panel of the Agent Orange Working Group. Wednesday, July 11, 2001 Page 1836 of 1870 �"r DEPARTMENT OF HEALTH & HUMAN SERVICES • Date Memorandum February 5, 1985 From Public Health Service National Institutes of Health Chairman, Science Panel, AOWG Subject Meeting of the Science Panel TO Members of the Science Panel, AOWG This is to announce that there will be a meeting of the Science Panel of the Agent Orange Working Group at 9:30 a.m., February 21, 1985, in room 729G of the Hubert Humphrey Building, Washington, D.C. The purpose of the meeting will be to review the protocol for the Veterans Administration Twin Study (VETS II). You will (or will have) receive(d) a copy of this protocol under seperate cover. I am enclosing some comments made by a special review group last summer for your information. Please bring your written comments to the meeting and we will summarize our review at that time. We have also received additional congressional correspondence concerning female Veterans' needs. It appears that we are now being requested to recommend what, if any, studies of the health of female Vietnam veterans should be done and to examine proposed studies in that light. I am enclosing appropriate materials and we will discuss this at our meeting. In addition, please find enclosed the minutes of our last meeting (November 29, 1984) for your approval. Carl Keller, Ph.D. �OW1AUN X. MmOM. WVOMWO. ITKOM TMumwND. SOUTH CAMX.INA ALAM CRANSTON. CAuraMM ftOeCRT T. STAf FOMO. VERMONT JCNNINCS lUNOOLPH. WIST VMOMIA MANX H. MUMOWMI. ALASKA (MM M. MATSUNAOA. HAWAII AMCN WCrtll. KNNtnVANM MNNW MCONCIM. AMMNA JCMMIAM OCNTON. ALAIAMA MOMI J. MffCHIU. MANN KUOYSOSCHWraMMNUOTA ANTHONY J. HHNCm CHW COUNSH/tTAW OMICTM JONATHAN H STIIMfMO. MIMOMTY CNItf COUNSO/ STAW OMCTOII A\\ ^.t.^_ * ClLj flff * ff JfeVUllVU • t^+-^*~.^. Pftfafpa 0WVf»VlAJ *^ * ~MtPllfif? 0WIUIV%> COMMITTEE ON VETERANS' AFFAIRS WASHINGTON, DC 20510 January 23, 1985 Honorable Charles Baker Chair Cabinet Council Agent Orange Working Group Department of Health and Human Services Humbert Humphrey Building, 614-G 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Mr. Baker, I have long had a strong interest in the issue of how the Federal Government might conduct research to investigate the possible health effects in female Vietnam veterans of their exposure to Agent Orange. Enclosed is a copy of an October 16, 1984, letter to me on this subject from Dr. James 0. Mason, the Director of the Centers for Disease Control. It is my understanding that the draft protocol outline mentioned in Dr. Mason's letter is pending in the Agent Orange Working Group and may be considered during the Group's next meeting, which is scheduled to take place in early February. I believe that it is extremely important that research be undertaken on this issue, and I strongly urge that the Working Group undertake its review of the protocol outline as expeditiously as possible. It is my strong hope that the members of the Working Group will be able to report favorably on the possibility of a study of female Vietnam veterans, either by endorsing the protocol outline as developed by CDC or by suggesting whatever changes to the outline the members believe are needed in order for a study to go forward. Thank you for your attention to my views on this issue. I would appreciate hearing from you on this matter as soon as possible after the Working Group's February meeting. With best wishes, Sin Alah Cranston Ranking Minority Member Enclosure �CTER JUDICIARY APPROPRIATIONS VETERANS' AFFAIRS WASHINGTON. D.C. 20SIO January 4, 1985 The Honorable Margaret M. Heckler Secretary Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Heckler: I write regarding the government's epidemiological study on Agent Orange being conducted by the Centers for Disease Control (CDC). As a member of the Senate Veterans' Affairs Committee, I am very concerned that CDC's study fails to include women who served in Vietnam. Approximately 20,000 women served there as members of the military or as civilians employed by service organizations. Many of these women are now suffering from health problems that may be associated with Agent Orange. It is my sense that research is needed to assess the problems among women who were in Vietnam to avoid excluding them from Agent Orange compensation programs. I urge that this omission be rectified by the Health and Human Services Administration. Your consideration of this request is greatly appreciated. Sincerely, Arlen Specter AS:gfs _ *s •- TRACER �'DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Memorandum Date 'December 20, 1984 From Director, Center for Environmental Health Subject Possible Study of Female Vietnam Veterans To Dr. Carl Keller Chair, AOWG Science Panel At the Agent Orange Working Group (AOWG) Meeting of December 4, 1984, Dr. Brandt requested that the Centers for Disease Control (CDC) and the AOWG Science Panel discuss what additional information the Science Panel would need to assess the scientific utility of a study of female Vietnam veterans. As you know, CDC assessed the feasibility of a study of women veterans and described the possible study approach in a protocol outline dated June 25, 1984, copy attached. In that document and in the attached memorandum to Dr. Brandt from Dr. James Mason, CDC Director, responding to the Science Panel's initial critique, of the protocol outline, CDC stated its belief that a comprehensive health assessment of female Vietnam veterans motivates the study, rather than any specific hypothesis. In addition, there are gender-specific issues that would not permit generalization of male data to the female veteran. CDC has also clearly stated that the proposed study is a "Vietnam Experience" study rather than an "Agent Orange" study, per se. By that, I mean we believe it will not be possible to estimate individual female veterans' opportunity for exposure by relating their unit's location to herbicide spraying missions. Like the "Vietnam Experience" study being conducted in males, the study of female veterans would compare the health of Vietnam veterans to comparable veterans who served elsewhere. Any of the exposures women veterans experienced in Vietnam, (e.g. stress of caring for a high volume of combat casualties, parasitic diseases, whatever Agent Orange may have been ubiquitous in the Vietnamese environment, etc.) might influence the health of Vietnam veterans compared to other female veterans. �Page 2 - Dr. Keller Given these two assumptions, that any health assessment of women Vietnam veterans should be as comprehensive as that in male Vietnam veterans, and that the study should look at all exposures in Vietnam, not exclusively at the opportunity for Agent Orange exposure, I believe that the study described in the protocol outline is appropriate. If the Science Panel can provide CDC with a list of specific hypotheses that will address the health concerns of female Vietnam veterans, I will request the resources to develop a protocol to study these hypotheses. I look forward to hearing from you in the near future. Please do not hesitate to contact me if you have any further questions. r, ~\": I Vernon N. Houk, M.D. Attachments �MOV T!) 19M Director Centers for Disease Control Possible Study of Female Vietnam Veterans Edward N. Brandt» Jr.» M.D. Chair Pro Tempore Cabinet Council Agent Orange Working Group Thank you for the opportunity to review and respond to the Agent Orange Working Croup Science Panel*• critique of th« protocol outline for a study of female Vietnam veterans. The Science Panel mentioned two Issues which they felt must be carefully considered before proceeding further with development of the study: 1) "the great potential for confounding exposures both during and after Vietnam to teratogenlc agents other than herbicides and their contaminants," and 2) "what a study of female veterans will contribute In the way of scientific Information which Is not already being obtained from the ongoing male studies." Cf»C shares the Science Panel's Interest In having a research plnn which addresses potentially confounding exposures* In this regard, it is important to consider the purpose of the study. As stated in the protocol outline, the proposed study is similar to the Vietnam Experience Study of men currently being conducted. All the exposures unique to the Vietnam environment, from parasitic diseases* to psychological stress, to waste anesthetic gases nay influence the health of the Vietnam veteran cohort. Agent Orange Is only one of many exposures Included In this experience. For analyses of the effects of Vietnam service in general, exposure to t-xcese waste anesthetic gases in field hospitals in Vietnam would not be a confounder of the association of Vietnam service with health outcomes. Rather, the anesthetic gases are but one of the many exposures that are part of the Vietnam Experience* On the other hand, for analyses focusing on specific exposures experienced in Vietnam, such as Agent Orange, waste anesthetic cfls exposure might be • confounder* Such analyses would be expected to control for operating room experience In Vietnam. Occupational exposures, Including waste anesthetic gases, experienced after military service might also be potential confounding factors since they could differ between the Vietnam and non-Vietnam female veterans. Again, these exposures would be considered in the analysis. To respond to the general concern about confounding, CDC would deal with potentially confounding factors in this study with the same approach used in the recent Birth Defects Study and the ongoing study of male veterans. �2 - Fdward K. Brandt, Jr., M.D. retailed Information would be gathered from personal Interviews and record revjf»we about potential conf minders, e.g., dorofirapltic, occupational, or other risk factor* for disease that might occur with differing frequencies among Vietnam and non-Vietnam veterans. In the analysis such factors would be controlled for, eliminating any actual confounding effect of th<:&e variables. The second concern of th« Science Panel related to the research questions urique to women thut would beflr'dreftsedin the proposed study. As fitatf^ above, the study is primarily designed to look at military service in Vietnam, in p.enrral, as the, «r.ain exposure of Interest, rather than estltiatee of /,pent Orcn^e exposure. Two caveats should be mentioned regarding the study of Apcnt Or/jT>£e exposure, per so, in relation to the health of feraale Vietnam veterans. First, because of the duties of t»oet women w^o served in Viet nan, thfir livelihood of erposure to Agent Orange may bo less than that of c-.ale Vletnan veterans. *o«t women who served In Vletnso ver*» stationed «t military horprtals cr headquarter units that were at some distance frora the heaviest <\f>fcnt Orange sprayings. Second, if, ns speculated by BOP.C scientists, A^cnt Ornpfle residues became ubiquitous throughout Vletnan, female Vietn*a- veteror.s way hav« been exposed throi^gh food supplies, drinking water, etc. 1'ofcovor, these types of expoBurcs could not be quantified by relating the prrotii.ity c.f the women'* units to the Ranch llnnd sprayinfc missions or other applications of A.r.«?nr. Throe ^road protipR of hoalth ontcoyfs would be studied In relattor to VJetvan norvicei reproductive outcone«, psychologic outcotaen, and gercral outconts for which T?otwsn may experience different risks than tnpn. ^productive outcomes would include fertility, spontaneous abortion*, con^enltol irnlforciarlono as well as dlRRawcc of fetr^lo reproductive Presnaney outcomes of the women are of pwrtJcular interest since maternal are more c.onnonly aesocfnted with adverfle effects than p«r«rn3l flseasps of reproductive organs nny be related to the Intiurnce of various stresses *nJ insults to the delJcate hypothalarjic-pitultrry-ovarlan ai:lp. Also of note in this repard, certain subclinical paraoitlc diseases, ns iralrria nnd acicbiasie, rsy becowc nanifewt during the f;trrt;n of outcoreo such as nnxlfty, dt-prrsslor, and font lYaur.atlc P rirord«r and hehrtvloral outcomes nuch no substance abuse and crininal activity r;ny crhihit different potternw In r.ole and frwnJc VlettJfln1 veterans. ^'Ith « .l»r^e proportion of acute care nnrses onon^ female Vietnam vetor.^nH, special c.o»>6 iteration would he given to possible ntr«sr.ft*l effects of curing frr a lorfc* volune of combat casualties. The psychosocial component of the fennle study is also crucial to the cowplete evaluation and interpretation of t heother clitics! data to he collected, specifically in the determination of outcwrs as a cause v«rnun on effect of plynlcal and Mochcrical (e.R. hepatitis, cirrhosis, memory c!lsorder&). f'enrrsl health outcooca would Include n vnrlety of conditions of concern to fenole vi«tnair. veterans* These outcomes are similar to those helnr. *ddr«BFct' IP tie ongoing study of trale veterans. An was the case 1n the study of p-alc v*»tcr«ns, there are few specific hypotheses based on previous scientific studies. CPC believer* that a comprehensive health Interview and physical exsii-« nation would he n?edcd f.o addrees the veterans' concerns thoroughly. �Page 3 - Edward N. Brandt, Jr., M.D» The Rtatifttlcal power of the propoeed atudy for Important health outconon would be good. Tha Interview phase of the study la designed to detect Increases of about twofold in the relative rieka for health outcomes occurrinr with the frequency of 0.3Z» while the examination phaae is designed to detect twofold incraaaea in conditions that occur with a frequency of 1*52 or greater (power * 0.95, Alpha * 0*05, J-tail). With that level of statistical power, moat conditions that ara of concern to women vho eerved in Vietnam will be adequately addressed. Only relatively email incraaaea in uncoeaon conditions would escape detection* The Intent of the atudy which CDC was aaked to propoaa la to address the health concama of female Vietnam veterans comprehensively and with sufficient atatiatlcal precision* That haa determined the study design and sample oize, rather than any single research hypothesis. The coat of doing this atudy la significant. A decision to do this resenrch, in a world of finite raeourc«a, aay aean that money for other activities may not be available. We ara neutrsl on doing the atudy* However, if a decision is made to proceed, wa ara confident that we can do a valid atudy, acceptable to the yetarana groups, if we are provided the necaaaary resources. We will he plen*«d to provide any further information you need. >**** Jamas ^rMaflon;"'V,f!#8fcP«H. Assistant Surgeon General cc: OD CEH CDC/W ES/PHS Tracer 85084; CDC ID D19247; CEH #B-59 10/19/84 CDC:CEH!CDD:AOP:PLayde:dd/doc �Minutes of the November 29, 1984 Meeting of the Science Panel of the Agent Orange Working Group The Science Panel of the AOWG met at 9:30 AM on November 29, 1984, in the offices of the United States Army and Joint Services Environmental Support Group (ESG) in room 210, Riddell Building, 1730 K Street, NW, Washington, D.C. Attendees were as indicated on the attached attendance sheet. The purpose of the meeting was to review in depth the procedures to be used by the ESG to assign an Exposure Opportunity Index to individual Vietnam veterans identified from other sources. Since the procedures had been developed during the CDC Birth Defects Study, individual records of Vietnam veteran participants in that study were available for review. Several individual records were selected to illustrate the information available and the method and steps used to assign an estimate of the likelihood of exposure to Agent Orange while in Vietnam. The method used in the CDC Birth Defects Study assigned a value from one to five to each veteran depending on the recorded proximity of his unit to an Agent Orange application while he was assigned to the unit. The value of the assigned index also took into account the particular job classification that the veteran had at the time. For example, a veteran whose job was either clerical, administrative or logistical would not be expected to be with his unit while on patrol away from the base, although he might be expected to serve guard duty on the base perimeter. If exposure consisted of a patrol approaching a Ranch Hand spray track, he would not be included, but if exposure consisted of base perimeter spraying, he could have been exposed. A score of five (highly likely to have been exposed) was assigned to all individuals in a unit which was known to have been within two kilometers within 72 hours of an Agent Orange application and who held military occupational specialties (job classifications) implying that they should have been with their assigned unit on such a mission. A score of five was also assigned to all veterans known to have handled Agent Orange, such as Ranch Handers or chemical personnel. A score of one (very unlikely to have been exposed) indicated that the veteran was assigned to a unit which was neither known nor expected to have been near an application site. Scores of two to four indicated a range of possibility from probably not exposed to probably exposed. Although the methods used to develop these procedures involved considerable subjective judgement on the part of the investigators, a description of the Vietnam experience contained in the records of veterans classified as "very unlikely to have been exposed" seems quite adequate to consider them as much less likely to have been exposed to Agent Orange than those classified as "highly likely to have been exposed". Members of the Science Panel unanimously agreed that the data and methods under consideration are adequate to classify many of the veterans into groups which were highly likely or very unlikely to have been exposed to Agent Orange while in Vietnam. Other methods for assigning intermediate values need to be completed and may best be adopted for specific studies where necessary. �Some of the implications of using the Exposure Opportunity Index as defined above were discussed as follows: 1) Some veterans cannot be classified because their records are not available or are incomplete. It is thought that this will be a small group if adequate search is undertaken. 2) Many veterans, such as would fall in groups two to four of the CDC Birth Defects classification system, cannot be unambiguously assigned to highly likely or very unlikely exposed catagories. Several suggestions as to how to handle these were: a) Classify them as unknown and drop them from further analysis. This would have rendered approximately one half of the Vietnam veterans in the CDC Birth Defects Study as unclassifiable. b) Use five classes (as in the CDC Birth Defects Study) or one or more intermediate classes. This system, would retain larger numbers of classifiable study subjects, but may reduce the statistical power of a study due to missel ass ifications. c) Attempt to classify all veterans with available records into likely or unlikely exposed groups. This is also almost certainly going to increase missclassification and therefor reduce statistical power. 3) The index as currently developed is intended to be a measure of the likelyhood that any exposure took place and presents some problems during analysis since it is not a dose response statistic. Using the computer methods now available, there is the possibility for counting the number of encounters a given unit may have had and trying to estimate the intensity of exposure. There is some support for this since almost all of the encounters which a given unit has had may be recorded in the quarterly reports (at least in those units which have been specifically examined). 4) There is clearly an association between combat and Agent Orange exposure since combat operations are a major factor in determining opportunities for exposure at the individual as well as the unit level. This must be considered in the light of specific study needs e.g., it may not have been relevant for a Birth Defects Study, but may be important in a Mortality Study. 5) While the methods which have been developed do provide for an estimation of the number of opportunities for exposure, there has been no attempt to quantify the possible exposure amount. The index only assigns a value to the likelihood that a given veteran was within two kilometers within three days of an application of Agent Orange. Whether this constitutes an effective toxic dose cannot be determined from the records and is the subject of ongoing health effects research. In order to assist in the usefulness of these methods for future research, a subpanel was assigned the task of developing guidelines for the application of these alternative methods to specific studies. The meeting adjourned at 1:30 PM, November 29, 1984. �, A - 357/ or 4 CASH / st.* 6. A 0 e? -rr U.S. �Department of Medicine and Surgery Washington D.C. 20420 Veterans Administration JAN 3 0 1985 In Reply Refer To: 10A7 Dear Colleague: Enclosed is a copy of the latest version of the Vietnam Experience Twin Study Protocol. These are being distributed at the request of Dr. Carl Keller—he will be in touch with you in the near future to arrange a meeting to discuss his plans for reviewing the protocol. Sincerely, BARCLAY M. (BHEPARD ,* M. D. Director Agent Orange Projects Office Enclosure � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1835 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Keller, Carl Title A name given to the resource Memorandum with several attachments: from Chairman, Science Panel, AOWG, to Members of the Science Panel, AOWG, with subject Meeting of the Science Panel, dated February 5, 1985. Subject The topic of the resource Vietnam Experience Twin Study AOWG ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1834 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Walter, Harry N. Description An account of the resource <strong>Corporate Author: </strong>Veterans Administration Title A name given to the resource Letter: to G.V. (Sonny) Montgomery from Harry N. Walters, January 22, 1985. Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 068 Folder The folder containing the original item. 1833 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Holden, Constance Source A related resource from which the described resource is derived Science Date A point or period of time associated with an event in the lifecycle of the resource November 2 1984 Title A name given to the resource VA Study of Twins May Be Cancelled Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 067 Folder The folder containing the original item. 1832 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Freivogel, William Source A related resource from which the described resource is derived St. Louis Post-Dispatch Date A point or period of time associated with an event in the lifecycle of the resource October 14 1984 Title A name given to the resource Clipping: VA Expected to End Study of Veterans Subject The topic of the resource Vietnam Experience Twin Study popular press ao_seriesIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 067 Folder The folder containing the original item. 1831 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource MacRae, James B., Jr. Description An account of the resource <strong>Corporate Author: </strong>Reports Management Branch, Office of Information and Regulatory Affairs Title A name given to the resource Letter: to Dominick Onorato from James B. MacRae, Jr., September 21, 1984 Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/6531c09f5e4df50a9a41bd385f4c0f1b.pdf 2ef699e7acbfd6f93018f65591ec65f3 PDF Text Text Item D Number 0183 Author O'Brien, Mary Utne Corporate Author NORC RBpOPt/APtlClB TltlB ° Re P°rt °f a Pretest of the Survey Instrument for the Vietnam Era Twin Study Survey of Health. Journal/Book Title Year 1984 Month/Day August Color n Number of Images us DeSCrlDtOD NotGS Alvin L- Young filed this item under "Vietnam Veterans Twin Study." Wednesday, July 11, 2001 Page 1831 of 1870 �UNIVERSITY OF CHICAGO �s t i O 1 eat & �Report of a Pretest of the Survey Instrument for the Vietnam Era Twin Study Survey of Health Mary Utne O'Brien, Ph.D. NORC August 1984 �Table of Contents Overview of the Report. I. The Vietnam Era Twin Study and the Vietnam Era Twin Registry Survey of Health A. Components of the VETS 2 B. Major Sections of the Survey of Health 3 II. Design of the Pretest 4 A. The Sample B. Procedures of the Pretest 5 C. The Analyses III. 4 8 Findings A. Overview 9 9 B. Who Responded: Rates of Response and Characteristics of Respondents 10 C. Findings: Focus Group Reactions to the Introductory Cover Letter 12 D. Findings: Responses to the Items in the Survey of Health 13 IV. Summary and Recommendations 48 �Appendices Appendix 1: Pretest Materials Sent to Respondents 1. Cover letter of introduction to Survey of Health 2. Pretest version. Survey of Health 3. Follow-up letter sent to non-respondents Appendix 2: Focus Group Materials 1. Focus group participants 2. Focus group agenda Appendix 3: Recommended Materials for the Main Study 1. Revised cover letter 2. Revised Survey of Health Appendix 4: Coding and Editing Specifications for Data Entry of Survey of Health �Report of a Pretest of the Survey Instrument for the Vietnam Era Twin Study Survey of Health Overview of the Report This is the report of 8 pretest of the survey instrument and accompanying respondent materials proposed for use in the Vietnam Era Twin Study (VETS) Surveu of Health. The pretest was conducted by NORC, a social science research center at the University of Chicago, under contract to the National Academy of Sciences. The purpose of the pretest was to obtain information about the performance of the items comprising the survey instrument--their clarity and face validity, the suitability of their particular organization within the instrument, and the appropriateness of their interconnecting instructions. Also under study was whether the cover letter accompanying and introducing the study to respondents was as informative and persuasive a document as possible. A convenience sample of veteran twin pairs from the Chicago area was mailed the cover letter and survey instrument in late May, 1984. Returns from this sample were manually reviewed for respondent problems with i nstructions and apparent misunderstandi ngs of the i ntent of items. All such item problems were recorded by case number and are described in this report. Responses to the open-ended items in the survey were recorded verbatim, and questionnaires were then edited for machine entry of responses for computer analysis. Responses to items are also summarized in this report. A subgroup of the respondents to the mail survey, selected to represent diversity with respect to several of the key variables in the questionnaire, was invited to NORC for discussion of the survey instrument and cover letter. Two focus groups, involving fraternal and identical twin pairs (i.e., both brothers present), were conducted. The examination of response problems, the statistical analyses of items, the discussions with the twin veterans themselves, and experience with many other mail survey instruments, lead NORC to conclude that the VETS Surveu of Health is an exceptionally clear and effective document. Responses were remarkably error-free, item non-response was extremely low, and veterans reported enjoying the experience of completing the survey. NORC recommends a number of changes in the survey instrument and in the cover letter, however, and these are described, and the reasons for them documented, in this report. A complete draft of the recommended form of the survey instrument and the cover letter is attached to this report. �The remainder of this report consists of four sections. Section I briefly reviews the purposes of the tvi n registry and the survey of health. Section II descri bes the design of the pretest. Section III presents the study's findings. In the fourth and final section, NORC describes its recommendations for changes in the survey instrument and the cover letter, for use in the main survey. I. The Vietnam Era Twin Study and the Vietnam Era Twin Registry Survey of Health A. Components Of the VETS The Vietnam Era Twin Studu Survey of Health is one component of the overall research program known as the Vietnam Era Twin Study (VETS). The VETS is composed of three distinct activities: 1) identification of a set of approximately 12,000 Vietnam era veteran twin pairs; 2) the mailed Surveu of Health, sent to all 12,000 twin pairs; and 3) a comprehensive medical, psychiatric, psychological and psycho-social examination of 600 pairs of identical twins randomly selected from the Vietnam Era Twin Registry. The identification of 12,000 veteran twin pairs is being carried out by the National Academy of Sciences Medical Follow-Up Agency (NAS-MFUA) under contract with the Veterans Administration. Veteran twin pairs will be identified using the military records maintained at the National Personnel Records Center in St. Louis. The NAS-MFUA is abstracting a large number of socio-demographic and military service variables from the military records. All of the items collected are being entered into a computer file which will form the Vietnam Era Twin Registry. The second component of the VETS, the Surveu of Health, is designed to serve two purposes. First, it will gather information about a wide range of health parameters that can be used as "screener" information by future researchers. For example, all those who report having diabetes might form one group for future study; those with chronic skin conditions, such as severe acne, another group; those who report severe emotional problems, another; and so on. A second purpose of the Surveu of Health will be to provide information for analyses that require no further data collection. That is, it will yield a data set with sufficient information to support original analyses about specific health conditions. By combining the information abstracted from the military records with the Surveu of Health it will be possible to examine the relationship between military service and a wide variety of medical and psychological conditions. The thi rd component of the VETS is the comprehensive medical, psychiatric, psychological, and psycho-social assessment of health. The comprehensive health assessment (which is presently in the planning phase) will involve selecting a random sample of 600 twin pairs from the Vietnam Era -2- �Twin Registry. These 600 twin pairs would then be invited to St. Louis for examination and testing. The purpose of the comprehensive health assessment is to provide a precise understanding of the association between service in Southeast Asia and long-term health status. B. Major Sections of the Survey of Health The VETS Surveu of Health asks questions in seven major topical areas: zygosity, demographic, alcohol and cigarette consumption, physical health, combat experience, emotional health, marriage and reproductive history, and locati ng 1 nformation. Each of these major areas is brief! y discussed below: 1. Zygosity. The purpose of the zygosity questions is to discriminate between monozygotic and dlzygotic twins. The ability to distinguish between mono and dizygotic twins is important for all future studies that examine the impact of genetics and environment on health and disease. 2. Demographics. Basic demographic questions are included so that the Vietnam Era Twin Registry can be compared and contrasted to the population of all Vietnam Era veterans. In addition, many demographic characteristics are strongly associated with health and disease. 3. Alcohol and Cigarette Consumption. These items are known to be associated with many diseases. In studying the health effects of military service it essential to adjust for the potential confounding effects of alcohol and smoking. 4. Physical Health. The twi n pai rs are asked about a broad spectrum of specific illnesses and diseases (such as cancer, stroke, liver disease, etc.). Each veteran is asked whether he currently has a specific disease, whether he has visited a physician for the condition, and whether he has been hospitalized for this condition. 5. Combat Experience. A list of 18 different combat roles or experiences that men could have had while in Southeast Asia is included. These items are potentially important contributors to the long-term physical and emotional health of the veterans. 6. Emotional Health. A considerable number of questions are asked regarding the respondent's emotional health. A special effort has been made to ascertain whether any veterans display symptoms of Post-Traumatic Stress Disorder. 7. Marriage and Fertility History. A complete marital and fertility history is obtained from each veteran. Included in this history are dates of all marriages, divorces and childbirths. 8. Locating Information. The respondent's most recent address and telephone number are requested; also the most recent address and telephone number of his twin are obtained. This information will be very important for future studies involving the Vietnam Era Twin Registry. -3- �II. Design of t&e Pretest The pretest consisted of a mail survey of 119 individuals, all Vietnam-era veteran twins, and focus group discussions of the survey instrument and study procedures with selected mail survey respondents. The entire pretest was conducted over a five-week period from late-May through June, 1984. A. Tile Sample The pretest used two convenience samples of veteran twins. The first sample, which yielded the majority of the cases, was from Defense Manpower Data Center (DMDC) data tapes. The second sample consisted of a group of self-selected veteran twins. 1. The DMDC sample. The DMDC data tapes contain information reported at the time of separation from service for all individuals who were discharged from the U.S. military after 1968. Following an initial sort on year of separation from service (to encompass veterans from the period of service of interest to the study (1968-1975)), and Chicago-area zip code, veteran twin pairs were selected using the following criteria: 1. Same last name 2. Same date of birth 3. Different first name 4. Social security number the same to the first five digits. Selection on these criteria yielded 91 veteran twin pairs. Inspection of the DMDC information available for each case revealed that due to coding and data entry errors, there were actually only 81 likely twin pairs. In addition to the non-twins that were eliminated, two more pairs were excluded because inspection of first names suggested they were female, as later confirmed by parents, bringing the total number of pairs in the DMDC sample to 79. DMDC data on these i ndividuals i ncl ude "home address" at the ti me of separation from service. For most of these young men, this was their parents' home address. The age of this information ranged from 9 to 16 years old--a fairly cold trail for locating. Fortunately, the parents of fully 46% of the veteran twins could still be reached at the address reported at the time of leaving the service. Using the no n-extraordinary locating techniques of directory assitance, telephone directories and criss-cross directories (which, given an address, supply any associated telephone number), 47 twin pairs, or 59 per cent of the DMDC sample of 79 pairs, were located and mailed the questionnai re. [ Note: I n the course of the locati ng effort it was learned from one of the veteran twi ns that his veteran twin brother had died since leaving the military. The deceased brother was not, of -A- �course, sent a questionnaire. Therefore, although 47 pairs were located, only 93 individuals from the DMDC sample group were sent the pretest survey, and the sample number reported is an uneven number.] 2. The self-selected sample. The DMDC sample was augmented by 13 pairs of veteran twins who had contacted NORC, the National Academy, or the Veterans Administration to ask to be included in the study. All had read newspaper accounts of the registry, and wanted to be sure that they were not missed by those seeking to study all Vietnam-era veteran twins. In some cases it was not the twin, but a non-twin sibling or a spouse who contacted one of the three organizations to "volunteer" a veteran twin. Thus, a total of 119 veteran twins--93 from DMDC sources and 26 self-selected-- were sent the pretest questionnaire. Characteristics of respondents from each of the two sources are reported separately, but for the most part responses to the major analytic variables in the questionnaires are combined in this report, because they are assumed to be unrelated to differences in the samples. 0. Procedures of the Pretest Data on the performance of the survey instrument and the individual items were gathered by two methods: a mail survey; and small-group discussions (also called focus group discussions) with the veteran twin mail survey respondents. 1. The mail survey pretest. Locating. The mail survey began with efforts to locate the individuals whose names and 9 to 16 year-old addresses were produced by the DMDC selection procedure, confirm the twin veteran status of these i ndi viduals, and obtai n a current maili ng address for each one. (No locati ng was needed for the self-selected sample, because these individuals reported their current addresses when they approached the study.) Using directory assistance, telephone directories, and criss-cross or reverse directories (which supply phone numbers, given addresses), people at the home addresses listed by the veterans at the time of separation from service were contacted in pursuit of information about current addresses. These approaches yielded information on 58 per cent of the DMDC sample. In not all of these cases was direct access to the veteran obtained. Often a parent would agree to forward any materials sent to their sons at their (the parents') address, rather than give out their sons' addresses to NORC. In some instances one brother, directly contacted, would agree to the same (i.e., he would forward the -5- �material to his brother, rather than give out an address). Other families were very forthcoming, not only with twins' addresses but with their telephone numbers as well. The remaining 42 per cent of the DMDC sample was not pursued with any more extraordinary locating effort. The pretest was designed to use a convenience sample. It was not intended to function as a test of the adequacy of and difficulties associated with use of the DMDC tapes as a sample source (although indications of such were, of course, obtained). The self-selected sample was added to the pretest sample at this point in order to insure enough responses to support the planned item analyses--approximately 75-100 cases. Mailout and follov-up. Each veteran twin in the pretest sample was sent: a cover letter explaining the study and asking the veteran's cooperation in completing the survey; a questionnaire; and a postage-paid envelope addressed to NORC in which to return the questionnaire. These materials were mailed out on May 20,1984. The first returns were received three days later, on May 23. Follow-up telephone calls to the nonrespondents and/or their families began ten days after that, in early June. Several respondents reported that they had not received the original mailing, so a second packet of materials was i mmediatel y sent to them. Three and one- half weeks after the i nitial mailing a second mailing, along with an additional cover letter strongly urging participation, and $5.00 cash payment "as a token of appreciation for [their] assistance" was sent to 29 respondents who at some point had indicated a willingness to participate, but whose questionnaires had not yet been received. Materials contained in the mailouts are reproduced in Appendix 1. Editing and processing survey returns. Surveys were logged in upon receipt at NORC, and batched for data entry. Prior to editing for machine entry, all cases comprising a batch were reviewed, one-by-one, and problems in responses noted (by respondent ID number) and described on a blank questionnaire labelled "Summary of Item Problems." Summari2ed across all batches (i.e., summarized for all cases), these problems are presented in the Findings section below. After item problems were recorded, responses to the two open-ended questions in the questionnaire were recorded verbatim on a separate tally sheet. These responses are also reported in the Findings section below, along with the responses to all other items. -6- �2. Focus group discussions. The purpose of the focus groups was to learn as much as possible from respondents about the cover letter, the items, and the questionnaire as a whole. The focus groups solicited feedback on all aspects of language choice, as well as the adequacy (completeness, mutual exclusivity) of the reponse categories provided, given the varieties of experiences of the respondents. They sought i nformation on any errors of omission, as well. Thus, participants were asked if there were any important health conditions that they felt had been overlooked by the survey, and whether there were any personal experiences--military or otherwise--that they felt were related to their current health that the questionnaire had failed to ask about. The first 50 or so individuals to return their questionnaires to NORC formed the group for consideration for participation in the focus group discussions (because of the short time available for the pretest, the focus groups were to be conducted simultaneously with the field period for the mail surveys). I n exami ni ng the responses of these i ndividuals, NORC sought to represent: twi n pairs in the same group (i.e., both brothers present); identical and fraternal twins; Vietnam and non-Vietnam-experienced veterans; a range of combat experiences; those who reported some post-service distress; the more loquacious (or at least those who wrote a great deal in response to open-ended questions and in the margins of the questionnaire); those who responded selectively (to explore reasons why some items elicit more non- response than others); and those who seemed especially slow (it is essential that the questionnaire be clearly understood by the least educated and least bright, yet not be tedious for others, so it was necessary that ranges of ability be represented). Two focus group discussions were scheduled for two successive weekday evenings, the time NORC has found to be most convenient for participants in such groups. NORC sought to schedule 7-8 individuals for each group. There were to be other individuals present--HORC project staff and three different "outsiders" each evening (VA representatives and the Principal Investigators)-bringing the group totals to approximately 13-14 people (see Appendix 2 for list of participants). NORC's experience is that in focus groups larger than this, the conversational dynamic usually changes such that people become less open, conversation less free-wheeling, and the discussions less productive. Respondents were asked to select one of the two evenings convenient for them, were sent instructions for how to find NORC, and were given $10.00 to offset their expenses. The agenda for the focus groups is included in Appendix 2. -7- �C. The Analyses 1. Q ual i tati vc a nal gses. As noted a bove, al 1 q uesti o n nai res we re ca ref ul 1 y revi ewed, item-by-item, and any apparent difficulties in following instructions for responding and in understanding the intended meaning of items were separately recorded. For example, Question 4. lists people who may have been a part of the repondent's life as a child--parents, siblings, grandparents, classmates, teachers, and strangers--and asks the respondent whether and to what extent each "...had difficulty in telling you and your twin brother apart." Identical twins typically respond that while parents and siblings had difficulty at least "some of the time", the others had difficulty telling them apart "all of the time." Fraternal twins, on the other hand, usually report that the people listed "never" had trouble telling them apart. A close reading of individual questionnaires, however, revealed that two respondents misunderstood the item, responding as if it were asking how often the people listed could tell "you and your twin brother apart" ("all of the time...some of the time... never"). These two respondents, who had already reported being an identical twin, and as like their brother "as two peas in a pod," also said their parents had difficulty telling them apart "all of the time" while strangers "never" had difficulty. Every instance of this type of misunderstanding was recorded, and is described in the the reports on individual items in the next section. The qualitative analyses, then, informed recommendations for changes in item wording and layout or visual presentation (e.g., to be sure words essential to the meaning of an item were prominent). Finally, issues raised in the focus group discussions, while reported in full in the Findings section, were subject to a "qualitative analysis" that informed NORC's final recommendations. That is, not all veterans' recommendations became NORC recommendations. The participants'views were reviewed in light of NORC's experience with usual advice from those who infrequently encounter surveys, and in light of the specific needs, purposes, and limitations (space, time, self-administered format, etc.) of this survey. 2. Quantitative analyses. After responses were data-entered for machine analysis, a number of si rnple i ndicators of data quality were calculated: the percentage of correct and i ncorrect responses to each item; the percentage of non- responses to each item for which there should have been responses (i.e., not including valid skips); and the percentage of questionnaires with no errors at all. Finally, the substance of responses was tabulated; that is, frequencies for each category of response for each item, and descriptive statistics, such as means, where these are meaningful, were calculated and reported. -8- �The information from all the analyses is presented in the following section. III. Findings A. Overvi ew The pretest revealed the VETS Survey of Health to be a survey i nstrument that was clear and easy to understand. Respondents committed relative! y few errors i n completi rig the questionnaire, and the vast majority of these errors was easily corrected using conventional coding rules. For example, a respondent may have circled an entire response category, rather than the code number representing the category. Others circled both category and code. Or, some respondents failed to zero-fill blank columns when reporting numbers, although they otherwise correctly reported the numbers, beginning each sequence from the right. Despite the inclusion of items that dealt with sensitive and potentially threatening topics--mental distress, infant death and abnormality, and income, for example--the instrument enjoyed an exceptionall y low level of item non- response. I n fact, onl y 66 out of a possi ble over-15,600 responses (73 net respondents, approximately 200 variables), or .4%, were left blank. No respondent refused to report income, traditionally among the most sensitive of questionnaire items. In fact, the few cases of item non-response seemed to be due more to misunderstandings of skip patterns and instructions than to a refusal to disclose information deemed "too personal" to report in a survey. Finally, the respondents to the Surveu of Health were highly motivated to respond fully and accurately to a degree that is unusual in NORC experience. For example, it is notable, although impossible to document, that the veteran twins' responses were among the most painstakingly neat that the experienced NORC coders and data processing staff working on this project have ever encountered. When a NORC staff member remarked upon this to focus-group participants, many reported that they had read through the entire questionnaire before responding, so that they could answer as accurately and with as full an understanding of the questionnaire as possible. This kind of care is not typical of general- public samples for mail surveys. In addition, as described in Section 4, not a single veteran failed to provide his current telephone number for the survey, requested explicitly for the purpose of facilitating future contacts for other studies. Although 28 per cent of the responding pretest sample was self-selected, and thus should be expected to be highly motivated to respond, the other 72 per cent, approached "cold," was equally responsive to this item. We believe that the high quality of the survey instrument, as well as the special nature of the study population (twins, Vietnam-era veterans), accounts for the accuracy and completeness of responses. �B. Who Responded: Rates of Response and Characteristics of Respondents 1. Response rates by sample subgroup. The sample for the pretest comprises two subsamples; those whose names were obtained from DMDC records, and a self-selected group of veteran twins. In the course of attempting to locate the DMDC sample twins direct contact was made with some veterans and /or their spouses, while in other cases no direct contact was made (e.g., DMDC address information was simply confirmed by Directory Assistance, and no further contacts were made with the household prior to mailing the survey materials). We further divide the DMDC subsample, then, into those personally contacted, and those with no personal contact prior to receipt of survey materials. The initial composition of the resulting three sample subgroups is described in Table 1. Table 1 shows the importance of the initial personal contact with veteran twins who otherwise have no knowledge of the study. While almost 85 per cent of the self-selected veteran twins responded, and 80 per cent of the DMDC veteran twins who were personally informed of the survey by NQRC locating-callers, the response rate for the DMDC group that received no prior contact was about 56 per cent. Overall response rate for the survey was 68.1 per cent. Table 2 describes the net sample of respondents. Of the 81 questionnaires that were returned, two were from triplets, and one was from an individual who never actually served in the military. None of these i ndividuals are i n the theoretical population of i nterest, so are subtracted from the gross sample to yield a net sample of 78 responses out of an i nitial net sample of 116. Table 1: Survey of Health Response Rates, by Sample Subgroup Subgroup Number Number Sent Received 1. DMDC: Personal contact during 30 locating effort Response Rate 24 80.0% 55.6% 2. DMDC: No personal contact during locating effort 63 35 3. Self- Selected 26 22 84.6% . TOTAL 119 81 68.1% -10- �Table 2: Composition of Final Sample Original sample Out-of-sample (triplet, not in military) Net sample 119 3 116 Returned questionnaires Out-of-sample returns Net responses 81 3 78 Gross response rate (Returned questionnaires/Original sample) Net response rate (Net responses/ Net sample) 68.1% 67.295 2. Characteristics of respondents. The self-selected sample (N = 21) differed from the DMDC sample (N » 57) in a number of respects. The self-selected veteran twins were on average about five years older, had slightly less education, were more likely to have served in Southeast Asia, and thus to have had combat experience, and were much more likely to report that they were identical twins. Information on the two samples is presented in Table 3. Information on the combined total sample is presented, Item-by-item, in the folowing section. Table 3: Characteristics of DMDC and Self-Selected Samples Characteristic 1. Age DMDC Sample Mean = 34.5 2. Level of education (High school degree » 12, College degree = 16, etc.) Mean = 15.3 Mean = 14.2 3. Ever married Yes- 82.5% Yes - 90.5% 4. Any children Yes = 63.295 Yes = 81.0% 5. Zygosltg Identical = 47.495 Fraternal - 50.995 Don't know = 1.3% Identical = 76.2% Fraternal - 23.8% 6. Southeast Asia duty Yes = 38.6% Yes = 57.1% 7. Combat experience Yes = 24.6% Yes = 57.1% -11- Self-Selected Sample Mean = 39.4 �C. Findings: Focus Group Reactions to the Introductory Letter NORC solicited the opinions of focus group participants about the clarity and persuasive effectiveness of the letter accompanyi ng and i ntroduci no; the survey materials. Partici pants provided very useful feedback about the letter, resulting in the changes presented in the proposed modified cover letter in Appendix 3. For the most part the focus group participants found the letter to be very effective. The letterhead stationary of the National Academy of Sciences vas seen as impressive and authoritative, yet removed enough from any association with official government (e.g., military) bodies to not be off-putting. They were of the strong opinion that the letter's description of the study as conducted "...with the cooperation of ...the Department of Defense" would result in a refusal to participate by veterans with very hard feelings toward the military, of whom they felt there would be enough to possibly cause a problem with bias in the sample. The recommended new form of the letter omits the reference to theDepartment of Defense. The major change in the letter is the dropping of the fourth paragraph, which sights the Federal Code of Regulations under which authority the study is being conducted. This paragraph was viewed as jarringly technical and out of place by respondents. NORC recommends that the paragraph be moved to the cover of the questionnaire itself, rather than embedded in the cover letter. No other changes in the introductory letter are recommended. -12- �D. Findings: Responses to the Items in the Survey of Health in this, the longest single section of the report, the responses to each item in the questionnaire are reported. In addition to the substance of the responses (i.e., the frequency of responses in each response category), this section reports all anomalous or non-standard responses to items. If a non-standard response can be rendered accurately interpretable by standard coding and editing procedures, it is described below as an "Item Event." If the response cannot be so corrected, e.g., it would require a call-back to the respondent to clarify the response, it is described as an "Item Error." Item events were edited prior to tabulation of frequencies, and so are not reflected in the Numbers and Percentages reported next to each response category. The findings are reported in the order in which they appear in the questionnaire, and are grouped i nto the seven major topical areas they represent. 1. Zuaosltu Questions (Qs. 1 - 7) 0.1. Do you have a twin brother? (CIRCLE OWE) Yes, living (GO TO Q.2) Yes, deceased (GO TO Q.2) 1 2 No 3 Triplet or higher 4 IF "NO1 OR TRIPLET1, PLEASE STOP HERE AND RETURN FORM IN THE ENVELOPE PROVIDED. Non-standard responses Item Events: Ci rcles "Yes" rather than " 1" Circles both "Yes" and "1" * of 1 nstances: 2 * of instances: 2 % accurate (with conventional codi no/editi no procedures): 100% Item non-response: 0% Discussion and recommendation Neither the focus group nor the item analysis uncovered any difficulties with this question. It is recommended that it be retai ned as is. -13- �Q.2. As children, were you and your twin "as alike as Wo peas in a pod/' or of only ordinary family resemblance? (CIRCLE ONE) Number Percent As alike as two peas in a pod Of only ordinary family resemblance 1 2 49 27 62.8 34.6 DON'T KNOV 8 2 2.6 78 Non-standard responses Item Error: Circles "1"and "2" 100S? * of instances: 1 % accurate (with conventional coding/editing procedures): 99% Item non-response: 0% Discussion and recommendations Focus group discussion indicated that this item was clearly understood and meaningful. Item response analysis confirms this. It is recommended that the item be retained as is. Q.3. Do you yourself believe that you and your twin are identical (monozygotic) twins, or do you believe that you are fraternal (dizygotic) twins? (CIRCLE ONE) Identical (monozygotic) Fraternal (dizygotic) DON'T KNOV Number 1 43 2 34 8 _± 78 Non-standard responses Item Events: Self-corrected error Answer to Q.3. contradict answer to Q.2 Circles"!" and writes in "FACT" * of instances: 1 * of i nstances: 1 * of instances: 1 % Accurate (with conventional codi nq/editi nq procedures): 100% Item non-response: 0% Discussion and recommendations Two veterans said that the terms "monozygotic" and "dizygotic" should be dropped, because these terms are redundant with "identical" and "fraternal." The latter terms cover the topic adequately. Despite the focus group comments, we recommend that the item be retained in its current form. No one reported any problems with the terms, and to insure clarity of meaning, the apparent redundancy should be kept. -14- �Q. 4. Vhen you were children, how often did the following persons have difficulty in telling you and your twin brother apart? (CIRCLE ONE FOR EACH LINE) a. Parents All of Some of DON'T DOES NOT the time the time Never KNOV APPLY 1.. (0.095)...2..(32.5)....3..(62.3) 8...(5.2) 6. Number 77 b. Other Brothers and Sisters 1 ....(1.3) 2..(20.8) 3..(62.3) 8..(10.4) 6 77 c. Grandparents 1 ..(14.5) 2..(38.2) 3..(34.2) 8..(2.6) 6...(10.5) 76 d. Classmates 1 ...(27.3)....2...(40.2)....3..(27.3) 8...(5.2) 6 77 e. Teachers 1 ....(26.9) 2..(38.5) 3..(30.8) 8..(3.8) 6 78 f. Stranger 1 ...(55.1) 2..(15.4) 3..(23.1) 8..(6.4) 6 78 Non-standard responses Item Events: Self-corrected mistake one Self-corrected mistake on c, d Reverses answers For "c11 writes "Never met them" i nstead of "6" Item Errors: Does not answer a-d Does not answer c * of instances: 1 * of instances: 1 * of i nstances: 2 * of i nstances: 1 * of instances: ! * of instances: 1 % accurate (with conventional coding/editing procedures): 99% Item non-response: <1% Discussion and recommendations The editing process revealed that the question may elicit reversed responses, that is, the respondent may read the question as saying "How often could (LIST)...tell you and your twin apart?" It is recommended that the question be reformatted so that the question and its instruction form a clear and unbroken block of type (see layout in Appendix 3). -15- �Q. 5. The following list describes characteristics that you and your twin brother may or may not have shared when you were children. For each characteristic listed, please consider your childhood years (before you were teenagers) and describe whether you and your twin brother were very similar, somewhat similar or very different. (CIRCLE ONE FOR EACH LINE) When we were children our: a. Eye color was b. Hair color was c. Hair type was d. Heights were e. Weights were f Teeth were g. Voices were h. Muscular strength was i. Temperaments were j. Musical abilities were k. Language abilities were 1. Manual skills (dexterity) were Very Similar Somewhat Similar (84.4*) (78.2) (77.9) (63.6) (56.2) (59.0) (55.1) (59.0) (41.0) (51.3) (64.9) 1 (44 7.) Non-standard responses Item Event: self-corrects error at f Item Error: illegiti mate ski p of a, c, d, k 2 2 2 2 2 2 2 2 2 2 2 Very Different (2.6) (14.1) (14.3) (28.6) (34.6) (33.3) (33.3) (32.1) (33.3) (21 .8) (28.6) 2 (21.8) 3 3 3 3 3 3 3 3 3 3 3 (10.4) (6.4) (5.2) (5.2) (6.4) (3.8) (9.0) (7.7) (24.4) (7.7) (0.0) 3 (.) 26 DON'T KNOW 8 (.) 26 8 (.) 13 8 (.) 26 8 (.) 26 8 (.) 26 8 (.) 38 8 (.) 26 8 (1.3) 8(.) 13 8 (.) 65 77 78 77 77 78 78 78 78 78 78 77 8 (.) 13 78 8 (19.2) * of Instances: 1 * of i nstancea: 1 % accurate (with conventional coding/editing procedures): 100% for b. e - i. 1 : 99% fora.c.d. k Item non-response: <1% Discussion and recommendations The item appears to have worked well and it is recommended that it be retained as is. -16- NUMBER �Q. 6. About how tall are you without shoes? (WRITE IN NUMBER OF FEET AND INCHES. IF ZERO INCHES, VRITE IN "00") U FEET l UI_J INCHES Hon-standard responses Item events: Self-corrected error Failure to left justify Use of fractions of an i nch Fail ure to zero fill (Response Range: 5' 3"- 613"; Mean: 5'10" N = 78) * of instances: 1 * of instances: 1 * of i nstances: 2 * of i nstances: 1 % accurate (with conventional codi nq/editi nq procedures): 100% Item non-response: Qg Discussion and recommendations The main observation which can be drawn from item edit and the focus groups is that some respondents like to put in fractions. Recommendation: retain as is. (Fractional and decimal heights can be dealt with in the process of questionnaire coding and editing.) 7. About hov much do you veigh without clothes or shoes? (WRITE IN NUMBER OF POUNDS) I—J—Ul POUNDS (Response Range: 130-243; Mean: 171.98pounds N = 78) Hon-standard Responses There were no non-standard responses. % accurate (with conventional codi no/editing procedures): 100% Item non-response: 0% Discussion and recommendation Neither focus group discussions nor item edit revealed any difficulties with this question. It is recommended that the item be retained as is. -17- �2. Demographq Questions. (Qs.8. and 9.) O.8.A. Are you presently employed part-time or full-time? (CIRCLE ONE) Yes,full-time (GOTO B) Yes, part-time (GOTOB) Not employed (GOTOQ.9) 1 2 3 Number 70 2 J&. 78 Percent 89.7 2.6 77 10095 IF PRESENTLY EMPLOYED: B. What kind of business or industry is this? (Example: TV and radio manufacture, retail shoe store, State Labor Department, farm, etc.) C. What kind of work are you doing? (Example: Electrical engineer, stock clerk, typist, farmer, etc.) D. What are your most important activities or duties? (Example: Typing, filing, selling new cars, finishing concrete, etc.) (A wide range of occupations was reported, from self-employed truck driver to computer analyst, floor layer to clinical psychologist.) Non-standard responses Item Events: Misses ski p at 8 A, gives unneeded ansvers Circles "Yes" not "1" Item Errors: Employer ambiguity, B. (self-employed?) Occupation ambiguity * of i nstances: 2 * of instances: 1 * of instances: 1 •* of i nstances: 1 % Accurate (vith conventional coding/editing procedures): 97.4% Item non-response: 0% Discussion and recommendations One somewhat embarrassed veteran told the focus group that he was gainfully occupied ("Im not on welfare or anything"), but had no outlet to describe his full-time student status. It is recommended that the item be retained but that a new item, asking about student status, be added. Q.9. What is the highest grade or year of school you have completed and gotten credit for? (CIRCLE THE ONE HIGHEST GRADE OR YEAR) a. b. c. d. e. None Elementary High School College Some Graduate 00 01 09 13 School 17 f. Graduate or Professional Degree 02 10 14 03 11 15 04 12 16 05 06 07 08 (Range: 11-13; Mean: 13.8 N = 78) 18 -18- �Q.9. continued Non-standard responses Item Events: Self-corrected errors Circles letter instead of number Item Errors: Ci rcles both 08 and 12 Circles 08,12and 13 Circles 12 and writes in"GED" * of instances: 4 * of instances: 2 * of instances: 2 * of instances: 1 * of instances: 1 % accurate (vith conventional coding/editing practices): 100% Item non-response: 0% Discussion and recommendations: The item needs an option covering post-secondary tertiary institutions other than colleges--for example, vocational schools. -19- �5. Alcohol and Cigarette Consumption Questions (Qs. 10-16) In order to get an accurate picture of each veteran's general health, everyone is asked the next few questions about alcoholic beverages and smoking. Q.I 0. Have you had more than 20 alcoholic drinks in your entire life? (CIRCLE ONE) Yes (GO TO 0.11) 1 No (GO TO 0.16) 2 Hon-standard responses Item Events: Circles "Yes" instead of "1" Ci rcles "Yes" and " 1" Number Percent 75 96.2 _3 5.8 78 100* * of instances: 2 * of i nstances: 1 % accurate (with conventional coding/editing procedures): 100% item non-response: 0% Discussion and recommendations This item emerged from the response analysis and the focus groups as straightforward and clear, it is recommended that it be retained in present form. 0.11. How old were you when you first started drinking alcoholic beverages regularly? (WRITE IN AGE) U__l YEARS OLD Never drink alcoholic beverages regularly (Response range: 15-30 y ears ; Mean: 19.7 years N = 78) 00 (N = 8,10.395) Hon-standard responses There were no non-standard responses. % accurate (with conventional coding/editing procedures)-. 10056 Item non-response: 0% Discussion and recommendations Focus group participants reported some confusion with the word "first" in the question. They suggested that "first" clouds the question's meaning by suggesting "when did you take your first drink." We recommend retaining the question but deleting the word "first." -20- �Q.I2.A. During the entire time that you have been drinking alcoholic beverages, how many days per week or month do you drink alcoholic beverages, on the average? (VRITE IN EITHER DAYS PER VEEK OR DAYS PER MONTH) |_J DAYS PER VEEK (Response range: 1-7; Mean: 3.6 N = 46) or UJ__j DAYS PER MONTH (Response range: 1-25; Mean: 6.7 N = 34) 0.12.B. If a DRINK is considered one can or bottle of beer or one glass of wine, or one mixed drink or shot of hard liquor, how many DRINKS would you have on the average, on those days when you drink? (VRITE IN NUMBER OF DRINKS. PUT A "O" IN ANY EXTRA BOX ON THE LEFT) |_LJ DRINKS Non-standard responses 12. A. Item Events: Fills both halves of disjunct Fails to zero fill (left justify) Self-corrected errors Item Error: Writes "unknown" and leaves blank (Responserange: 1-20;Mean: 4.2) * of instances: * of instances: * of i nstances: * of i nstances: 13 6 2 1 12. B Item Events: Fails to zero fill Writes in answer, leaves 12 B blank 12 .8. filled in by respondent who should have skipped (from "2" at 10.) * of instances: 8 * of instances: 2 * of instances: 2 % accurate (with conventional coding/editing procedures: 12A: 99%: 12B: 100% item non- response: < 1 % Discussion and recommendations: Some respondents utilized both the days-per-week and the days-per-month format. While there was no conflicting information reported--that is, the duplicate days per month figures were always 4 times the reported days per week--It Is likely that with over 12,000 pairs in the main survey some contradictory information will be reported. To prevent the need for arbitrary coding decisions in such instances, we recommend dropping the days per month response option in all the drinking questions. This will result in less sensitivity to those who report infrequent drinking (less than once a week), but infrequent drinkers are of less analytic interest, as well. Focus group participants reported that the question is confusing if you have quit drinking. The particular difficulty with this item is that it would not appear to give the clearest path to the critical data. It is recommended that Q. 12 be dropped. The preferable sequence would be from Q. 11 to Q.I 4 followed by Q.I 3 (see Appendix 3 for all recommended changes.) -21- �0.13. A. Vas there a period in your life (of at least 6 months) when your consumption was more than this? Number Percent Yes (GOTOB) No (GO TO Q. 14) 1 2 53 _2_L 74 72 28 100% IF YES: B. When was this (WRITE IN YEARS) UJ-9-J I I to |_1J_9J 1 | Highest concentration of responses: 1969-72 (start of period of heavier drinking) 1974-76 (end of period of heavier drinking) C. On about how many days per week or month would you drink more alcoholic beverages, on the average? (WRITE IN EITHER DAYS PER WEEK OR DAYS PER MONTH) U DAYS PER WEEK l (Response range: 1 -7; Mean: 4.3 N = 43) or U—I DAYS PER MONTH (Response range: 1 -31; Mean: 16.3 N=17) D. How many drinks would you have, on average, on those days when you were drinking more? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) |_i_J DRINKS Hon-standard responses 13. A. Item Events: Circles "Yes" instead of "1" Circles "No" instead of "2" Circles both "Yes" and "1" Writes "Yes" but circles neither Circles "2" but misses skip (Responserange: 2-30; Mean: 8.7) * of instances: 3 * of instances: 1 * of instances: 1 * of instances: 1 * of instances: 1 13. B. Item Events or Error: None. 13. C. Item Events: Fills in both dags/veek and days/month...* of instances: Qualifies days/week with "in port" * of instances: Left-justifies answer * of instances: 13.D. Item Error: Illegitimate skip * of instances: Item Event: Zero fill problem (fails to left justify) * of instances 9 2 2 1 3 % accurate (with conventional coding/editing procedures): A.B.C= 100%. Item non-response: <1% Discussion and recommendations Item edit and focus group discussion confirmed that the question is accurately understood. However, the order of questions 13 and 14 should be reversed (see discussion at Q. 12). -22- �0.14. A. Do you still drink alcoholic beverages? Yes (GOTOB) No (GOTOQ.15) Number 67 _8 75 1 2 Percent 39.3 10.7 100% IF YES: B. On about how many days per week or month do you currently drink alcoholic beverages, on the average? (WRITE IN EITHER DAYS PER WEEK OR. DAYS PER MONTH) |_J DAYS PER WEEK (Response range: Mean: 1.8) 1-7; or |_1-J DAYS PER MONTH (Response range: 1-20; Mean: 2.6) C. How many drinks do you have, on the average, on those days when you drink? (WRITE IN NUMBER OF DRINKS: PUT A "0" IN ANY EXTRA BOX ON THE LEFT) |_|_1 DRINKS (Response range: 1-10; Mean: 3.3 N = 67) 1 GO TO Q. Ho n - sta nda rd res DO nses 14 A Item Event: Circles "Yes "instead of "1" * of instances: 3 14B Item Events: Fills in both (week + month) Self-corrects error Fails to zero-fill 14C Item Events: Leaves boxes blank but writes i n answer Fails to zero-fill Misses skip (14.A .= "No") * of instances: 7 * of instances: 1 * of instances: 1 * of i nstances: 1 * of instances: 9 * of instances: 1 % accurate (with conventional coding/editing procedures): 100% Item non-response: 0% Discussion and recommendations Non-standard responses to this item were of the readil y editable ki nd. Just as with Q. 12 , Q. 14 sometimes elicited both the days per week and days per month response from the same respondent. As with Q.I 2, it is recommended that the item drop the days-per-month response option, and that its sequence in the questionnaire should be altered (see Appendix 3). -23- �Q.I 5. How old were you when you stopped drinking? (VRITE IN AGE) |_]_| YEARS OLD Non-standard responses Item Event: Fails to skip when should have (writes in "00") (Range: 24-38; Mean age: 29.8 years) * of instances: 18 % accurate (with conventional coding/editing procedures): 100% Item iron- response: 0% Discussion and recommendations The question should be retained. However, given the skip, or failure-to skip, problem, it is recommended that an introductory direction repeat that the item is to be answered only by those who did drink regularly but no longer drink at all. Q.I 6.A. Have you smoked at least 100 cigarettes in your life? (CIRCLE ONE) Yes (CO TO B) 1 No (GO TOO. 17) 2 Number 54 24 78 Percent 69.2 30.8 100* Number Percent IF YES B. Do you smoke cigarettes now? (CIRCLE ONE) Yes 1 30 55 No 2 24 .45 54 100% • C. On the average, about how many cigarettes a day (do/did) you smoke? (VRITE IN NUMBER SMOKED PUT A "O" IN ANY EXTRA BOXES ON THE LEFT) l_j-_L_J CIGARETTES (Response range: Mean: 26.8) 1-60; D. About how long has it been since you last smoked cigarettes fairly regularly? (CIRCLE ONE) Number 29 0 Percent 54 0 Currently smoke Days 1 2 Weeks 3 0 0 Months Years Never smoked regularly 4 5 6 2 21 2 54 4 38 4 10QSS -24- �Q.I6 continued Non-standard responses 16A Item Event: Circles "yes" instead of "1" * of instances: 4 16B Item Events: Circles "yes" instead of "1" Circles "no" instead of "2" 16C Item Events: Fails to zero-fill Item Error: Fails to answer * of instances: 2 * of instances: 2 * of instances: 9 * of instances: 1 16D No errors or item events % accurate (with conventional coding/editing procedures): 99% Item non-response: <1% Discussion and recommendations The Principal Investigators have informed NORC that two substitute questions are needed here to provide more specific information on the number of years the respondent has smoked (i.e., the number of "pack years"), even if the respondent is no longer smoki ng. Part D. was i ntended to provide an indication of pack years, but it is too indirect. For all respondents who have smpoked at least 100 cigarettes, the sequence will now ask how old they were when they first started smoking regularly. For those who have stopped smoking, the sequence will ask how long it has been since they smoked regularly. (See Qs. 17.-19., Appendix 3.) -25- �4. Physical Health Conditions (Qs.17-21) 0.17. Do you currentlu have any of the following health problems? (CIRCLE YES OR NO FOR EACH LINE, 1-16) Yes .No. 1. Accidental injury 1 2 12.8 2. High blood pressure/hypertension 1 2. 9.0 2 5.1 2 2 2 0.0 1.3 0.0 2 2 0.0 16.7 1 1 2 2 1.3 0.0 1 1 1 1 1 1 2 2 2 2 2 2 7.7 1.3 1.3 1.3 21.8 14.1 3. Respiratory conditions, such as lung trouble, persistent coughing, etc 4. 5. 6. 7. Cancer Heart trouble Stroke Kidney, bladder, or urinary problems, such as stones, infections, etc 8. Skin problems, such as acne or skin rash 9. Mental or emotional problems 10. Diabetes 11. Stomach or digestive disorders, such as ulcers, inflammations, etc 12. Liver problems, such as hepatitis, cirrhosis, etc 13. Blood disorders, such as anemia, blood clots, etc 14. Nerve disorders, such as epilepsy, migraines, etc 15. Visual problems 16. Hearing problems N = 78 to all subparts Non-standard responses Accurate (edited) 17. 1. Self-corrected error (1 instance) 2. Circles "2" with note "under control" (1) 3. -4. -5. -6. -7. -8. Self-corrected error (1) 9. 10. 11. 12. 13. 14. Circles "migraines" (0 15. Self-corrected error (1); writes in "glasses" (1) 16. Item non-response: 0% -26- 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% �Q.I7 continued Discussion and recommendations Focus group participants pointed to several significant omissions in the list of health conditions. Skeletal and joint disorders, for example, should be included. Some of the categories of health problems were thought vague: especiall y "accidental i nj ury," "skin problems, such as acne or skin rash," "mental or emotional problems," and "visual problems." The category "mental or emotional problems" seemed to many of the focus group participants as out of place, buried as it is in a list of physical disorders. Finally, a category for describing "Other" health problems was recommended by the veterans in the focus groups. Our recommendations follow closely upon the observations raised in the focus groups: * Omit "accidental injuries." The category is overly broad, and while intended as an indirect measure of risk-taking behavior, there was no evidence from the focus groups that the item is a valid operationalization of this concept. * Omit "mental or emotional problems." This category is best dealt with separately from the list of physical conditions. * Omit "visual problems," which introduces the problem of interpretation as between corrected and uncorrected visual defects. * Sharpen the focus of "Skin problems, such as acne or skin rash" by specifying "persistent" skin problems. * Add a category for joint and skeletal problems. * Add a category for "Other/1 and ask respondent to specify the condition. 18. Please indicate which statement below best describes your military duty status: (CIRCLE ONE) Number Percent Released from active military 1 69 91 Released from duty after 1975 duty during the years 1965-75 2 7 9 Still on active military duty 3 Q 76 Q 10035 ten-standard responses Item Error: no response given Item Event: supplemental information written in * of instances: 2 * of instances: 1 % accurate (with conventional coding/editing procedures): 97.5% Item non-response: 2.5% Discussion and recommendations Other than the fact that two individuals failed to respond to this item, it appears to have worked well and should be retained in its present form. It is noteworthy, however, that in response to Q.23.A. two respondents reported that they were still in the military. These are apparently the two non-respondents to this item, because no one responded in the equivalent category here. The Principal Investigators recommended that a question be added, later in the sequence, to ascertain whether the respondent requested a military duty assignment in Vietnam, to assess the extent of volunteering. (See Q.25, Appendix 3.) -27- �19. The questions below concern your health over the entire period since your active duty during the Vietnam Era, 1965-1973. If you were released from active military duty during the years 1965-1975, pI ease descr i be your heaIth since your date of release. I f you are still on active duty, or released after 1975, describe your health since 1975. In responding, please include any current health problems you described in Q. 17. (ALWAYS ANSWER A AND THEN ANSWER 3 AND C AS APPROPRIATE FOR E_ACH LINE, 1-ld) ~~ " A. Since active' mi I itary duty .1965-75, have you had this problem? B. Have you con- C. Have you ever suited a been hospiphysician taIi zed overabout this night for this problem? problem? IF YES TO THIS, ANSWER 3 * • > •• a. A. 1. Accidental Injury 2. High Blood Pres- sure/Hypertension 3. Respiratory Conditions such as Lung Trouble, Persistent Coughing, etc. 4. Cancer 5. Heart Trouble 6. Stroke 7. Kidney, Bladder, or Urinary Problems such as Stones, Infections, etc. IF YES TO THIS, ANSWER C »»»-> G. Yes... 9 Yes... 29 ( 8 ) 3 % N . . 48 (62%) o.. Yes. ..29 N.. . o.. Yes... 7 ( 9 ) 0% NO.. . 7 (91%) .0 Yes... 5 Yes... 2 No. . . . NO* e e * Yes... 6 NO* • • • NO* • e e Yes... o ( % 0) No.. . 7 (100%) .7 Yes... Yes . . . N.. o.. NO * • • • Yes... 3 ( 4 ) 0% No.. . 7 ( 6 ) .4 9 % Yes .. 3 . Yes... 2 NO * • • • Yes... 8 ( 0 ) 1% No. . . 9 ( 0 ) .6 9% NO. .. . N.. O.. Yes... 2 Yes... o ( % 0) N . . 77 (100%) o.. Yes... Yes . . . N.. O.. N.. o.. Yes... 4 ( 5 ) 0% NO.... 73 (95%) Yes... 4 NO. .. . Yes... 3 No.... Total Number of. Respondents: 77 -28- �19. (continued) A. Sine* active mi litary duty • 1965-75, nave you nad tnis problem? IF YES TO THIS, ANSWER 3 — -> 9. Mental or Emotional Problem IF Y6S TO THIS, ANSWER C »— > a. A. a. Skin Problems such as Acne or Skin Rasn a. Have you con- C. Have you aver suited a been noaplphysician Ta 1 i zed overnight tor This about this problem? problem? Yes. . 1 (25X) .9 No.. ,.58 (75Z) Ys. 3 e.. Y«S,.. 1 No». . . NO* * • • Yes... 4 (052) Mo... .73 (95t) Yes... 3 NO* • • • Yes... i NO* * * • 10. Diabetes Y s . 0 (QZ) e.. Mo.. . 7 ( 0 Z .7 10) Yes... NO* • • * Yes... N.. O.. 11. Y s . 8 (102) e.. N . . 69 ( 0 ) o.. 92 YM... 3 NO* ** * Yes... 5 NO* •• • NO" "76 ( 9 ) 92 Yes... 1 NO. .. . Yes... I NO* • • • 13. Blood Disorders, sucn as Anemia, 3 food Clots, etc. Y s . 2 (32) e.. N . . 75 ( 7 ) o.. 92 Yes... 2 NO* • • • Yes... 2 14. Nerve Disorders, sucft as Ep i 1 epsy Migraines, etc. Yes... 4 ( 5 ) 02 Yes... 4 Yas... i NO.. .-.73 (952) NO« • « • No. .. . IS. Visual Problems Yes... 16 ( 1 ) 22 No.. . 6 (792) .1 Yes... 15 No* •* • Yes... I NO • • • • Yes... 9 (127) Yes... 9 No* • • • Yes... 0 NO* • « • Stomach or Digestive Disorders, sucn as Ulcers, Inflammations, etc 12. Liver Problems, such as Hepatitis, Cirrhosis, etc. 16. Hearing Problems Yes,.. 1 ( 7 ) 1. Mo.. . 6 ( 8 ) .8 8 2 Total Mumber of Re9pondent3: 77 -29- NO* « • e �CM 9 continued Non-standard responses General: Answers B and C even though A is "no" Answers C even though B is "no" Fails to include health problems descri bed i n Q. 17 * of i nstances: 11 * of i nstances: 1 * of i nstances: 4 % Accurate (edited) 19.1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Self-corrects error (2) No problems Yes for Bout ski psC(1) ----Answers C even though B is "no" (1) Answers B and C though A is "no" (1) Answers C even though B is "no" (1) No problems No problems No problems Self-corrects error (1) Self-corrects error (1) "Yes" to A but illegiti mate ski p of B and C (1) Negative answer to 19.15. contradicts response to Q. 17 (1) Self corrects error (1) 100% 100% 99% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%' 100% 100% 97% 100% Item non-response: <1% Discussion and recommendations For a visually very complex item, the error rate is extremely low for Q.I 9. Errors are for the most part in the direction of providing more information than is actually required. Categories must be amended as per recommendations for Q.I 7: omit "Accidental Injury;" qualify "Skin problems" with "persistent;" omit "Mental or emotional problem;" add "Joint or skeletal disorders...;" omit "Visual problems;" and add a category for "Other." The Principal Investigators recommend that a fourth category or question, D., be added to the sequence of 19.A, B, and C. It will ask all those who reported hospitalizatlon for a health problem to also report the date of the first hospitalization. This will allow easy identification of health problems that existed prior to service. (See Q.22., Appendix 3.) -30- �0.20. Vould you say that your health in general is excellent, very good, good, fair, or poor? (CIRCLE ONE) Number Percent 5 Excellent 35 449 4 Very good , 30 385 3 11 Good 14 1 2 2 Fair 26 1 Poor 0 78 00 100SS Non-standard responses Item Error: Circles both "5" and "4" vith line connecting. * of instances: 1 % accurate (vith conventional coding/editing procedures): 99% item non-response: 0% Discussion and recommendations Both focus group discussion and item edit confirmed that the item was straightforward and easily understood. It is recommended that it be retained as is. -31- �0. 21 .A. Compared to your twin brother's healtht how would you rate your health? Would you say your health is...(CIRCLE ONE) Number Percent Better than your brother's (GQTOB) About the same as your brother's (GO TO 0.22) Worse than your brother's (GOTOB) Doesn't apply, because brother is not living 1 2 3 16 52 9 20.5 66.7 11.5 6 1 78 1.3 100% IF HEALTH IS BETTER OR VORSE: B. In what way is your health different from your brother's health? Verbatim Responses to Question 2IB. 1. (R's health worse than brother's) Had surgery (twice) in the last ten years: once for colon re-section, other for polyp on duodenum. 2. (R's health better than brother's) My brother had liver damage from too much alcoholic intake. He has had two operations (about 10 years apart) for polyps in the large intestine. 3. (R's health better than brother's) My brother has back problems and trouble vith his hips. 4. (R's health better than brother's) I don't have an ulcer. 5. (R's health better than brother's) He must take medication for migraines, plus he was wounded in Vietnam, which resulted in a leg injury, keeping him from obtaining total mobility. 6. (R's health better than brother's) My brother suffers from ulcers, migraine (cluster) headaches, and takes blood thinners and other prescribed medication. I take no prescribed medicine nor do I suffer the above problems. However, I suspect that my chloracne condition is possibly the result of exposure to Agent Orange. Two of my partners aborted pregnancy because of this fear. 7. (R's health worse than brother's) Never had malaria or hepatitis or in any severe accident or exposed to Agent Orange. 8. (R's health better than brother's) My brother gets more colds and has had some stomach and nerve problems. 9. (R's health worse than brother's) Worse because although I am very fit and exercise hard regularly, I have arthritis in my left hand which makes it difficult to perform many simple tasks. 10. (R's health better than brother's) My brother is overweight and haa had some stomach problems. -32- �11. (R's health better than brother's) My brother seems to get more colds or flu whereas I rarely get sick at all (once or twice in ten years). 12. (R's health better than brother's) I do not have high blood pressure which requires treatment/or medication. 13. (R's health worse than brother's) I have stomach problems, he does not. 14. (R's health worse than brother's) I catch colds more often and seem to be sick longer. 15. (R's health worse than brother's) --My brother weighs less in relation to his height (6' 2") - - He eats better foods (i .e., mai ntai ns a better diet) --He drinks less alcohol less often (does not smoke either) - - He exercises strenuousl y dail y, while I do so onl y 3 ti mes a week. 16. (R's health worse than brother's) He doesn't smoke cigarettes and I do. 17. (R's health worse than brother's) He is slim and very active whereas I get tired easily (I'm on medication for high blood pressure) and I get in the dumps lately. 18. (R's health better than brother's) I can tell and I know without a doubt my health is better. 19. (R's health better than brother's) Brother's accidental injuries, and problems he had when discharged--which was supposedly malaria he picked up in Nam. 20. (R's health better than brother's) I am more physically active, therefore in better shape. 21. (R's health better than brother's) I'm more physically active and I don't drink as much as my brother and I don't smoke at all. 22. (R's health worse than brother's) He does not smoke. He is in better fitness than I 'm in. 23. (R's health better than brother's) Not as many colds. 24. (R's health better than brother's) He smokes and dri nks more than I. 25. (R's health better than brother's) He is 100?S disabled due to injuries incurred in combat in RYN/I am not, I stay in good physical health by regular excercise. -33- �Q.21. continued Non-standard responses No non-standard responses. All who should have gone on to explain differences, did so. % accurate (with conventional coding/editing procedures): 100% item iron- response: 0% Discussion and recommendations The kinds and quality of data elicited by the question seem impressive. It is recommended the the question be retained. Because it is so productive of rich data, it is also recommended that the better/worse "compared to your brother" format be utilized in an additional context, so that a new item could ask each respondent to compare his adjustment to civilian life to that of his tvin (pretest Q.23., Appendix 3 Qs. 29, 30). -34- �5. SEA and combat experience: Q.22 . 22.A. Vhen you were in the military, were you stationed in Vietnam, Laos, or Cambodia; in the waters in or around these countries; or fly in missions over these areas? (CIRCLE ONE) Yes (GOTOB) No (GGTOQ.23A) B. 1 2 Number 34 44 78 Percent 43.6 56.4 100S8 Below is a list of 18 different combat roles and experiences that men had during the Vietnam war. For each statement. please indicate whether youjiad that combat experience. (CIRCLE YES OR NO FOR EMU LINE, 1-18) N- 34 I2i js. 1. In an artillery unit which fired on the enemy...1 ..2 ^ 14.7 2. Flew In an aircraft (reconnaissance, or fixed wing F-14, 8-52. etc.) I .. 2 23.5 3. Flew helicopter attack gunsnips or medvacs 1 .. 2 11.S 4. Stationed at a forward observation post 1 ..2 26,5 5. Tunnel rat checking enemy base camps..... 1 ..2 -2.9 6. Served on river patrol or gunboat 1 .. 2 5.9 7. Demolitions expert in the field 1 .. 2 11.3 8. Assigned to Graves and Registration to retrieve dead bodies from the field 1 .. 2 0.0 9. Served as a medic in combat 1 .. 2 2.9 to. Received incoming fire I .. 2 61 8 11. Encountered mines and booby traps 1 ..2 38.2 12. Received sniper or sapper fire 1 .. 2 61.8 13. Unit patrol ambushed 1 .. 2 26.5 14. Flew in aircraft (fixed wing or helicopters) and was shot down 1 .. 2 2.9 15. Engaged VC and/or NVA in flrefight 1 .. 2 38.2 16. Saw Americans Killed, and/or saw Vietnamese kl I led 1 ..2 55.9 17. Wounded 1 .. 2 14.7 18. Captured by the enemy 1 .. 2 0.0 -35- - �0. 22. continued Non-standard responses 22A Item Event: Circles neither "1" nor "2" but writes "Classified in Special Forces for a tour" Item Event: Circles "yes" or "no" instead of "1" or "2" 22B Item Event: Misses skip at 22B (that is, answers "no," then gives negative answers for all elements of 22B) * of i nstances: 1 * of instances: 5 * of instances: 6 22A: % accurate (with conventional coding/editing procedures): 100% 22B: % accurate (with conventional coding/editing procedures): 100% Item non-response: 0% Discussion and recommendations Several focus group participants wondered if the geographic range described in 22.A. was sufficiently inclusive. What if one had been stationed in Thailand? What about the Korean DM2? In connection with 22.B., one veteran, a non-combat zone medic, reported that he had felt very stressed in the role although the question gave him no outlet for describing this form of co m bat - r el ated st r ess. Another instanced the role of supplying (for example, with chemicals) front-line forces as a task attended by tensions i n many ways aki n to those of combat. However, given that the intent of the question is geographically restrictive, and that focus is on combat or combat related roles rather than on an exhaustive list of stressful situations, it is recommended that the question be retained as is. 6. Psychological Health conditions, including PTSD (Qs.23-24) 23.A. Overall, how would you describe your readjustment to civilian life after your release from active duty? Would you say that returning to civilian life caused you...(CIRCLE ONE) Number Percent 5 6.4 Considerable difficulty (GO TO B) 1 Some difficulty (GO TO 0 24) 2 20 25.6 Very little difficulty (GO TO 0. 24) 3 11 14.1 None or practically no difficulty (GO TO 0. 24) 4 40 51.3 Does not apply • 1 am still in the military (GO TO Q 24) 5 2 73 100* IF CONSIDERABLE DIFFICULTY B. Pl«« 4ttcwifM th*rttffta|W*«'J™' M -36- 2.6 �Verbatim Responses to Question 23B. 1. I don't believe I had the emotional maturity to deal with the Vietnam experience in the first place. Readjustment was so difficult that it is nearly indescribable. It took about 2-3 years to gain a semblance of normality. I stayed alone quite a bit. Problems with nightmares and flashbacks. 2. Life style of training for Olympics all day long to civilian life of getting an education in college and a job. 3. Adjusting from single life to married life due to the service. 4. I had to adjust to losing one leg and some use of the other leg. 5. (should have skipped: listed "some difficulty") A small problem being accepted by people younger and older than me. The younger and their peace movement activity & the older (World War II vets) with being in a war that had a no win situation. 6. The civilians had no idea what the war was about and still don't know. Only someone who was there will ever know. 7. (should have skipped: listed "some difficulty") The idea drilled in to kill the enemy. Non-standard responses tern Events: Self-corrects on 23A * of instances: 1 Respondent circles "2" for "mental adjustment" and notes that he is circling "4" for health * of instances: 1 Respondent ansvers B when not required * of instances: 2 % accurate (with conventional codi no/editi no procedures): 100% Item non-response: 0% Discussion and recommendations The process of questionnaire edit revealed that some respondents had needed more space for writing answers to 23B. In the focus groups, a number of participants expressed their feelings that the instruction indicating that only those vho had experienced "considerable difficulty" should answer 23B was far too restrictive. Those who had experienced "some difficulty" felt frustrated in not being given the opportunity to relate their problems. Generally, focus group participants felt that the question scratched only the surface of homecoming/readjustment issues, although it was the intention of the investigators that Q.23. be the main outlet for the telling of homecoming problems. As such, the item did not adequately elicit the nature and depth of response which the investigators had hoped for. It is therefore recommended that this item be supplemented by a number of questions, dealing with opportunities to share feelings about the military experience with selected categories of people, with abilties to become rei nvolved i n civilian life, and explicitl y compari ng degree of adj ustment to civilian life with tvin's adjustment (see Appendix 3,Qs.2?-30). -37- �-ee- J.BU4 4.1*4 JO A1in* put Aflnmr 4.1*4 5 u-& "I'zib* "'Cizif '(29t> : "(zoo')1 ""uib" 1 •"*VJ™Y * *o intDUIUMB AOU »|OO»<3 MOIU U*** '*UO "•* s "ttft)* "'(nc)c 'mj)z '1«6»' ""TMO) U-N « ««svv "fm>^ -»w«1296) • -rsarfij ""H 5 //•H £ ••"••• f, •»••••• f S.-T.:;.^.:*- "(ziV)* "(%V£)C T%6z) z Tz'oi)' ""(%V6) (zss) •• (Z8i) ^ZZTfZZJZ T j .... j ... (zoz) (zvo) (zeo) ii-N s *"f£oV)* "Vie'd)1 7zl"z5z *tV*6)' ""(x'fo)"*1 ii-K ! "f",a'o-<* "tv'ontf "t'/'cn\ Z *"/"A'l ' ""TWA"*"* *•**! "• >lu " ! f6u|iu 40 Du|>t *i u| ttuu 40 no* p*p 4-BIU «UO|18ni|S Ul »J»« no/, u*u« j*£ucua.f *M9 -M «UO|A3» JO «DU|I**4 J*IUO U*ll> (Ml | a P*H 8 6u "ZBO" z T%oo) ' ""ubo;U|t6e J**° "*iu tl| d<"u •" "" p*9U*|J*d AJB4.IHIII -» no/ 4.u*M BUIOJOICIP c M&IIOIU W 49B put |**4 Oi P»jjB4.i no/ »j*u« no 1 4 c u| 4i*tjno< punoj • M MX noA 04 p*u*dd«M 4»m tDU|l|4. 40 HO/ PUIMJ 4.UDIIU »p T/f63 ' ""fzYo'J ....... Aj8illM" ••** u| not. 04. D*u*dOBH J*M4 111411 1 no* 04 p»u*dd*u wiu cBuim j.nogt t*JHu.it£|u jo 6U|(*»|t JO dMICB _ J*A*M _ J*A*N ___ .nuu _ u*4-40 ____ 'd»*l«B 6u|||B4 *|qiK>J4 PBH •• «»4.40 (0-P «3Nn Tovf MOd '3NO mDMIO) noA »ABM Auu»nb«j4 «ou SMJ.UOUI J i»u»IQOjcl �Q.24. continued Non-standard responses Item Errors: 24J. and k.: Respondent circles two answers, "3" and "4." 24.0.: Respondent circles two answers, "4" and "5." 24.: One respondent skipped the entire item. Item Events: Self-correction at item f Circles and puts in check marks too Self corrects at item m * of i nstances: 1 * of instances: 1 * of i nstances: 1 % accurate (withconventional coding/editing procedures): 98% Item non-response: 1% Discussion and recommendations Generally, focus group discussants thought the items were easy to understand, and did not cover content that they would feel reluctant to report. One participant, however, found item a. (sleep problems) vague. Given the performance levels revealed by the item analysis, it is recommended that the question be retained in its present form. -39- �7. Fertility and marital hlstoru (Qs 25-50) 25. Since your discharge from active military duty, have you and your partner(s) ever had problems having children? (CIRCLE ONE) Number Percent Yes 1 10 12.8 No 2 * .68 78 Non-standard responses Item events: Self-corrects error Ci rcles "no" 1 nstead of "2" Ci rcles "yes" i nstead of" 1" 87.2 100S5 * of instances: 1 * of i nstances: 2 * of i nstances: 1 % accurate (with conventional codl ng/editi nq procedures): 100% Item non-response: 0% Discussion and recommendations While item analysis indicated that the question yields readily codeable responses, focus group discussions suggested some ways in which the question could be sharpened. Thus, the phrase "Since your discharge from active military duty" would seem inappropriate insofar as some respondents may still be in the military. Also, the vagueness of "any problems" and the lack of a time frame might be rectified by focusing the question on any period of a year or more in which attempts to conceive a child were unsuccessful. Finally, in its pretest form the item does not distinguish between individuals who respond "No" because they have tried to have children without problems, and those who say "No" because they have never tried to have children at all. In order that the item not yield findings biased in the direction of no problems with conceptions, we recommend the new format depicted in Qs. 35 and 36 in Appendix 3. The two alternative items are adapted from the CDC questionnaire. 26. How many children have you ever fathered? (ENTER NUMBER. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) |_J_J CHILDREN (Responserange: 0-6; mean: 1.46) 25 respondents (32S?) reported having no children. Of the remaining 68% with children, the mean number was 2.15. N = 78. Hon-standard responses Item events: Writes in "maybe 3" (2 described in Q 27) Fails to zero-fill (but result unambiguous) Writes "1 1 /2" to mark current pregnancy * of instances: 1 * of instances: 2 * of i nstances: 2 % accurate (with conventional coding/editing procedures): 100% Item non-response: 0% Discussion and recommendations Item edit and focus group discussions uncovered a number of potential ambiguities in this question. In particular, how are current pregnancies, miscarriages, abortions, still births, and neonatal deaths to be counted? I n order to be certai n that such ambiguities not affect the i ntegrity of the data collected, it is recommended that the number of natural children fathered be taken from the live birth question which follows, and supplemented by an additional question relating to current pregnancy (see Appendix 3, Qs. 35 and 36). -40- �27. In the table below we would like you to enter information about your natural (not adopted) children. Please Include a I I live births, even if a c h i l d is no longer Iiving. Please indicate: (A) The date of birth of each child; (B) the child's mother's age at the time of the birth; and (C) whether each child had any abnormal ify7~bTFTh~ defects, or handicaps. Briefly describe any birth defect In the space provided (0). If a child Is no longer l i v i n g , please enter date of death in (E). A. Month IST Chi Id 1 1 1 1 C. Oat* of Birth Natura 1 Ch i I dren a. Mother's Age At Child's Slrth (ENTER Any Birth Defects? (CIRCLE) YEARS) r»» - NO Day Year 1 | 1 1 1 1 n~~i LU S6-57/ 50-35/ 1 1 1 1 1 1 1 1 rn • u_i 67-72X 2no Chi Id Y Deter Ipt Ion of Birth Defects, Abnormality, or Handicap Y If Deceased, Date of Death Month Day Year 1 1 N 1 1 1 | 59-60/ 587 73- 74/ 1 1 E. 0. 1 1 1 1 1 1 (BEGIN DECK 4) 10-I3/ 76-77/ 7V 1 1 61-66/ n i i N 1 1 _ 3rd C h i l d 1 1 1 1 1 | 1 1 1 I 1 1 1 1 1 1 I 1 1 1 1 1 1 1 1 1 1 | 1 | 1 1 1 1 1 1 ' 1 | Y 1 1 1 1 1 ! 1 LU 73-74/ ! 1 1 1 | 59-60/ J8/ 76-77/ 75/ 1 | 1 | 1 1 1 1 | 1 6I-66/ 1 1 N 1 | 44-49X 1 1 N Y 1 1 42-43/ 41/ J6-57/ i 27-32X 1 1 N Y 1 1 2S-26/ 1 U_l 67-72/ 1 1 N 24/ 39-40/ 50-3V 6th Chi Id Y 1 ULJ 33- J8/ 5fh Child 1 1 1 1 22-23X 16-21/ 4th Child 1 U_J 1 1 ! 1 1 1 1 (BEGIN DECK 5) IO-I5/ Other Children 16/ -41- �Q.27. findings continued A total of 114 children were reported. A. Range of dates of first child: second child: third child: birth for: 1955-1982 1958-1984 1960-1984 B. Mean age of mother at child's birth: 23.9 25.9 25.4 fourth child: 1969-1983 27.6 fifth child: sixth child: 29 33 1976,1981 1983 C. Nine respondents reported a total of 13 children born with birth abnormalities or defects. 0. Verbatim description of birth abnormalities 1. (R reports three children. Two born post- VN reported to have birth defects.) Child 2: Tumor. Hole in heart. Child 3: Webbed foot. Extra thumb. 2. (R reports four children. "No" to birth defect for youngest, although "birth abnormality" reported, so coded as "Yes" to birth defect.) Child 1: Jundice in color. 3. (R reports two births, both with abnormalities, as well as a miscarriage.) Child 1: Skin rash comes and goes. Has dizzy spells. Child 2: Born 6 fingers on left hand. Has constant skin rash. 4. (R reports two children, firstborn with birth abnormality.) Child 1: Abnormal. [Verbatim description] 5. (R reports two children, firstborn with birth abnormality) Child 1: Mentally retarded. 6. (R reports three children. Latter two said to have birth abnormality.) Child 2: Positional deformity of right foot. Child 3: Developmental^) delayed and speech delayed. Unknown origin. 7. (R reports two children. Second has abnormality.) Child 2: Skin rashes and growth on shoulder called Nevus (Sp?)[R's question] 8. (R reports two children. Both reported to have abnormalities.) Child 1: Leg's crooked. Child 2: Strolismuss in eyes. 9. (R reports four children. Birth abnormality reported for third birth.) Child 3: Discolored skin on leg. E. No deaths of children were reported. -42- �Q.27. continued Non-standard responses Item Error: Illegitimate skip of entire section * of instances: 1 (x 1 child) Column A Item Error: Birthdate month and day left blank Item event: Fails to zero-fill month and day of birth * of instances: 2 * of instances: 1 Column B Item Error: "Tventy something" put for "Mother's age" Item event: Self-corrects response to B Column C Item Error: Fails to circle "yes" or "no" * of instances: 1 * of instances: 2 * of instances: 3 Column 0 Item Error: writes i n onl y "abnormal." Item event: writes in "none" but should have skipped Column E No errors or item events. * of i nstances: 1 * of instances: 1 Total Number of Items: Scolumnsx 114children= 570 items % accurate (with conventional coding/editing procedures): 99% Item non-response:__\% Discussion and recommendations Focus group discussions and item edit confirmed that this question was effective in eliciting the desired information. It is recommended that it be retained in its present form. 28.A. Have you ever been the father of a stillborn child? (CIRCLE ONE) Yes (GOTOB) No (GOTOQ.29) 1 2 Number 1 Percent 1.3 12 98.7 78 1008 IF YES: B. In what year(s) did this happen? (WRITE IN YEAR OR YEARS) 1.IU2M-I (One respondent had had one stillborn child only) 2. HI9U-J 3. Non-standard responses Item events: Circles "no" but not "2" * of instances: 3 Circles "no" and "2" * of instances: 2 % accurate (with conventional coding/editing procedures): 100% Item non-response: 095 Discussion and recommendations Neither item analysis nor the focus group discussions revealed any difficulty with this question. It is recommended that it be retained as is. -43- �29.A. To your knowledge, did any partner of yours ever have a miscarriage? (CIRCLE ONE) " " Yes (GOTOB) No (GO TO Q. 30) Not applicable (GO TO Q. 30) DON'T KNOV (GO TO Q. 30) IF YES: 1 2 3 8 11 57 8 2 78 B. How many are you aware of? (WRITE IN NUMBER, PUT A "0" IN ANY EXTRA BOX ON THE LEFT) |_1_1 MISCARRIAGES (One respondent reported 3 miscarriages; one reported 2; and nine reported 1) C. In what year(s) did they occur? (VRITE IN YEAR OR YEARS) 1.IH2U-J 21 I U I . 19 3.11191. Non-standard responses 29.1k. Item events: Circles "yes" instead of "1" Circles "no" instead of "2" 29.B. Itemevents: Misses skip and fills in "00" 29.C. Error: Fails to fill in year (one miscarriage) * of instances: 1 * of instances: 2 *of instances: 4 * of instances: 1 % accurate (with conventional coding/editing procedures): A=100%. B=1QO%. C=99% , Item non-response: 1% Discussion and recommendations One focus group discussant raised the issue of whether abortions counted as miscarriages. However, given the general understanding of miscarriage as an unplanned spontaneous event as opposed to a deliberate human intervention, the question as phrased appeared to pose no threat of rnisunderstandi ng. It is recommended that the item be retai ned as is. -44- �Number Percent 30. A. Have you ever been married? Yes (GOTOB) 1 No (GO TO Q. 31) 66 84.6 2 12 78 15.4 £_ B. In the table below, please list the month and year in which you were married. If your first marriage ended because of death or divorce, indicate the date you were widowed or divorced. If you were married and/or divorced more than once, please complete the remainder of the table. Married Month I Year Divorced Month I Year Yldoved Month | Year 1st Marriage U_J_J-J U—I-LJ |_UU_I 2nd Marriage U_I_I-J U_U_I I_U_J_I 3rd Marriage |_|_U_J |_J_U_J U-J-J-J 4th Marriage |_|_J-J—\ LJ—l—l-J I—1—UU (Response frequencies: 66 married, 15 divorced, 0 widowed, 8 second marriages, 0 second divorces) Non-standard responses 30.A. Item event: Circles "Yes" instead of "1" 30.B. Item event: Fails to zero-fill month Item error: "Yes" to A but leaves B blank * of instances: 3 * of instances: 1 * of instances: 3 % accurate (vith conventional coding/editing procedures): A = 100%. 8 = 96% item non- response: 2% Discussion and recommendations Focus group discussion confirmed that the item was well understood. It is recommended that the question be retained in its current form. -45- �8. Income (Q. 51) The next question concerns your total family income. Income is important for analyzing and interpreting the health information ve receive from veterans. For example, income information helps us to learn whether persons in one income group have certain conditions more or less frequently than people in another income group. 31. What was your total combined familu income (that is, for both yourself and your partner, if any) during the past 12 months? Include money from jobs, social security, unemployment payments, retirement income, public assistance and so forth. (CIRCLE ONE) 01 02 03 04 05 06 07 08 09 10 Less than $ 5,000 $ 5,000 - $9,999 $ 10 000 -$14, 999 $ 15,000 -$19,999 $20 ,000 -$24 ,999 $ 25,000 - $29,999 $ 30,000 - $34,999 $ 35,000 - $39,999 $ 40,000 - $49,999 $ 50,000 or more Non-standard responses Item error: circles both 04and 05 !Number 2 0 1 8 13 15 12 11 6 10 78 Percent 2.6 0.0 13 10.3 16.7 19.2 15.4 14.1 7.7 12.8 100% * of instances: 1 % Accurate (vith conventional coding/editing procedures): 99% Item non-response: 0% Discussion and recommendations It vas particularly gratifying that 100% item response was obtained for the income question, since income Hems are notoriously sensitive. Both item analysis and focus group discussion showed the item performing well. It is recommended that it be retained in its present form. -46- �9. Locating information (Qs.32-37) Findings and Non-standard responses 32. Respondent name, address, phone number. All Information provided In full. No errors or item events. 33. Social Security Number. Errors: Fails to provide social security number * of instances: 2 34. Respondent's birthdate. Item event: Fails to zero-fill month of birth * of instances: 1 35. Tvin brother's name, address, phone number. Errors: Omits all information on brother Omits street, number and city from address Omits brother's telephone number * of instances: 2 * of instances: 1 * of instances: 2 36. Whether tvln brother is living. All information provided in full. One brother deceased. No errors or item events. 37. Name, address, phone number of contact person for future locating. Errors: Illegitimate skip of Q. 37 *of instances: 2 Incomplete telephone number * of instances: 1 % Accurate (with conventional coding /editing procedures): Hen-response: 32: 100% 0% 33: 97.5* 2.5* 34: 100* 0* 35: 93.6* complete information; 3.8* partial information. 4* 36: 100* 0* 37: 96* complete information; 1.3* partial information. 1* Discussion and recommendations On the basis of item analysis and focus group discussion, it is recommended that the locating (address updating) section (Q 32 - 37) be retained unchanged. -47- �IV. Summary and Recommendations The performance of the items in the Survey of Health is summarized belov. Item Number 1. 2. 3. 4. 5. 6. 7. 8 9. 10. 11. 12. 1314. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 2526. 27. 28. 29. 30. 31. 32. 3334. 35. 36. 37. % Accurate 100% 99 100 99 >99 100 100 97.4 100 100 100 >99 >99 100 100 99 100 97.5 >99 99 100 100 100 98 100 100 99 100 >99 98 99 100 97.5 100 96 100 98 -48- % Hon-resoonse 0% 0 0 <1 <1 0 0 0 0 0 0 <1 <1 0 0 <1 0 2.5 <1 0 0 0 0 1 0 0 1 0 1 2 0 0 2.5 0 4 0 1 �As the summary makes apparent, the Survey of Health enjoyed an unusually high level of respondent accuracy in completing the questions, and a similarly high level of item reponse. (The figures for Item Accuracy include any illigitimate skips or non-responses to items.) Out of almost 15,600 response possibilities (78 respondents x 200 variables) there were only 66 non-responses (.4%). In the item-by-item review of findings, it was recommended that three items be dropped from the questionnaire for the main survey. The recommended deletions are: Q. 12., a question on average alcohol consumption over one's entire drinking history, which a number of respondents found confusing; Q.I 6.D., an indirect measure of a smoker's "pack years;" and Q. 26., a too-vague question about the number of children ever fathered. MORC also recommended that some items be moved within the questionning sequence. In particular, it was recommended that the items about mental or emotional problems, embedded in lists of physical health problems in pretest questions 17. and 19., be removed from the physical health context and placed later in the questionnaire near other items that deal with psychological health issues, becoming items 32., 33., and 34 (see Appendix 3). A slight modification of the question was also recommended. Rather than ask whether the respondent has consulted a phusician about any emotional problem, the respondent is asked whether he has consulted "...a health care professional (such as a physician, psychologist, or social worker)...." Broadening the reference to "health care professional" rather that just "physician" is less likely to result in underreporting of emotional problems. Several items that did not appear in the pretest questionnaire were recommended for addition to the main survey instrument. They are, by question number in the proposed survey instrument reproduced in Appendix 3: Additions to the occupation sequence: 9.E. How many years have you worked at this job? 10. After your discharge from active military duty, hov lony did it take you to find a full-time job? The above two items are adapted from the Legacies of Vietnam (Eoendorf. et al., 1981) occupation questionnaire, *C-40. Additional category in the educational attainment item: 11 .E. Vocational or technical school after high school. -49- �Substitute in cigarette consumption sequence: 17.C. About hov long has it been since you last smoked cigarettes regularu? 19. About hov old vere you vhen you first started smoking cigarettes regularly ? Addition to list of physical health problems: 20.13. Joint or skeletal disorders, such as arthritis, swollen joints, etc. Addition to sequence of information on hospitalization for health problems: 22.D. Vhen v«re you first hospitalized for this problem? 25. Vhile in the military, did you request a Vietnam duty assignment? The above item is adapted from the June, 1984 draft of the CDC questionnaire for the study of the Vietnam experience and Herbicide Orange. As part of an expanded sequence on the homecoming experience: 27.B. After your discharge from active military duty, hov often did you talk to the following individuals about your experiences in the military ? List: parents, vife or girlfriend, twin brother, friends, other Vietnam veterans. 28. After your discharge from active military duty, vere you eager to get involved in everything, or did you not want to participate in things with other people? The above two items are adapted from the Homecomi ng Questionnai re (items C2- 6 and C2- 9) from the Legacies iof Vietnam research. As part of the revised section on fertility history : 35. Is your vife (or partner) nov pregnant? 36.A. Have you and your partner(s) ever tried for a period of a year or more to conceive a child? [IF YES]: B. Vere you able to conceive a child after a year of trying? These items are adapted from the June, 1984 draft of the CDC questionnaire. These changes result in a questionnaire of substantially similar burden to respondents, but vithout the opportunities for frustration presented to respondents in the pre-test survey due to a small number of vague and inadequate questions and response options. NORC is confident that the recommended changes in the questionnaire will result in an even more successful fielding of the Survey of Health, with the main study sample. -50- �Appendix 1 1. Cover letter of introduction to Survey of Health 2. Pretest version, Survey of Health 3. Follow-up letter to non-respondents �NATIONAL RESEARCH COUNCIL ASSEMBLY OF LIFE SCIENCES 2101 Constitution Avenue Washington, D. C. 20418 TWIN REGISTRY June 1984 Address of Veteran Dear [Name of Veteran]: We need your help in a new study, of great interest and importance to medicine, on the health of twins. This study provides a very unusual opportunity to learn more about the health effects of military service, and the inheritance of many important illnesses. The plan is to create a registry of twins who are veterans of the Vietnam era. We are writing to ask that you participate in this effort by completing the enclosed questionnaire and returning it in the prepaid envelope. The study is a purely scientific one which is being conducted by the National Academy of Sciences-National Research Council, with the cooperation of the Veterans Administration and the Department of Defense. NORC, a research center at the University of Chicago, is responsible for collecting the survey information. The study can be carried out only with the help of the twins themselves, and we want you to take part in the study by supplying the information asked for on the attached form. All information you supply will be held in strict confidence and will be available only to the medical investigators working on this study. The study has nothing to do with any compensation, claims, or other . contacts you may have with the Veterans Administration. No individual will be identified in the published results of the study. The data are being collected under authority of Title 38, Sec 4101 of the Code of Federal Regulations, which authorizes the VA to conduct medical research. Twin pairs who participate in the registry may be asked, from time-to-time, to participate in research studies. Your involvement in any study is entirely voluntary. The purpose of each study will be explained fully so that you can make an informed decision about your participation. The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering to serve government and other organizations �-2- It is hoped that a great deal can be learned about genetic effects upon health and length of life from the registry. We sincerly hope that you will be able to help us by completing and returning the enclosed material. If you have any questions about the registry or studies of twins, please write to Dr. Mary O'Brien, or call her, collect, at 312/962-8967. Sincerely, C. Dennis Robinette, Ph.D. Director National Research Council Twin Registry Ph.D. Director \4 NORC Twin Registry Data Collection �OMB #2900-0411 NORC#4393 VIETNAM ESA TWIN STUDY SURVEY OF HEALTH NOTICE: All information you supply will be held in strict confidence and will be available only to the medical investigators working on this study. The study has nothing to do with any compensation, claims, or other contacts you may have with the Veterans Administration. No individual will be identified in the published results of the study. BEGIN DECK 1 CASE ID: 0 1-7/ �BEFORE YOU BEGIN... PLEASE READ THESE INSTRUCTIONS For some questions in this survey you will simply write answers in your own words. Other questions, however, ask you to follow instructions and use the answer categories provided. You will find instructions for responding included with each question, in CAPITAL LETTERS within parantheses. Below are examples of all the different instructions you will see, and the correct way to answer each type of question. INSTRUCTION 1; (CIRCLE ONE) 1. What is the color of your eyes? (CIRCLE ONE) Blue...................1 Brown ................. <g) Green..................3 IF THE COLOR OF YOUR EYES IS BROWN, YOU WOULD CIRCLE THE NUMBER TO THE Another color..........4 RIGHT OF "BROWN." INSTRUCTION 2; (CIRCLE ALL THAT APPLY) 2. Last week, did you do any of the following? a. Work for pay ...... £D b. c. d. e. Attend classes ..... 1 Watch TV..........® Visit friends......1 Exercise .......... ( $ INSTRUCTION 3; (CIRCLE ALL THAT APPLY) IF YOU WORKED FOR PAY, EXERCISED, AND WATCHED TV LAST WEEK, YOU WOULD CIRCLE THE NUMBERS TO THE RIGHT OF THE ITEMS, AS SHOWN. (CIRCLE ONE FOR EACH LINE) 3. Do you plan to do any of the following next week? a. b. c. d. Visit Go to Go to Watch (CIRCLE ONE FOR EACH LINE) Not Yes Sure No IF YOU DON ' PLAN TO VISIT A T a relative.....1. . . . 2. . . ($ RELATIVE NEXT WEEK, MAY GO TO A a museum.......1 . ( . . ..^.3 MUSEUM, AND DEFINITELY ARE GOING a library ..... ( t . 2----3 f.. TO GO TO A LIBRARY AND WATCH sports on TV. . Q ... 2----3 SPORTS ON TV, YOU WOULD CIRCLE THE NUMBERS AS SHOWN INSTRUCTION 4t (WRITE IN NUMBER. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) 4. How many cups of coffee do you drink each day, on average? NUMBER. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) Cups of Coffee INSTRUCTION 5; IF YOU DRINK 5 CUPS OF COFFEE DAILY, YOU WOULD WRITE IN THE NUMBERS AS SHOWN. (WRITE IN NUMBER) 5. What is your date of birth? Month (WRITE IN Day Year (WRITE IN NUMBER) IF YOU WERE BORN ON THE SIXTH OF JULY,,1952, YOU WOULD WRITE IN THE NUMBERS AS SHOWN, INCLUDING THE "0" IN THE UNUSED BOXES. �-2- 1. Do you have a twin brother? DECK 1 (CIRCLE ONE) Yes, l i v i n g (GO TO Q. 2) .......... 1 Yes, deceased (GO TO Q.2)........2 3 10/ (Triplet or higher................4 IF "NO" OR "TRIPLET", PLEASE STOP HERE AND RETURN FORM IN THE ENVELOPE PROVIDED 2. As children, were you and your twin "as a l i k e as two peas in a pod," or of only ordinary family resemblance? (CIRCLE ONE) As a I i ke as two peas i n a pod ....... . . 1 Of only ordinary family resemblance... 2 1 1/ DON'T KNOW............................8 3. Do you yourself believe that you and your twin are identical (monozygotic) twins, or do you believe that you are fraternal (dizygotic) twins? (CIRCLE ONE) I dent i ca I (monozygot i c ) .......... 1 Fraternal (dizygotic)............2 12/ DON ' T KNOW.......................8 4. When you were children, how often did the following persons have difficulty in t e l l i n g you and your twin brother apart? (CIRCLE ONE FOR EACH LINE) A l l of Some of DON'T the time the time Never KNOW a. Parents .......... 1 ......... 2 ........ 3 ....... 8 DOES NOT APPLY 13/ b. Other Brothers and Sisters ...... 1 ......... 2 ....... .. 3 ....... 8 ....... 6 14/ c. Grandparents ..... 1 ......... 2 ........ 3 ....... 8 ....... 6 15/ d. Classmates....... 1 . . . . 2 . . . . 3 . . . 8 ..... .... .... 16/ e. Teachers ......... 1 ......... 2 ........ 3 ....... 8 17/ * • STPSPQOPS •••••*•• 1 « * « « « « * * * £•*••*••• 3 * « « » * « * o io/ �-3- DECK 1 5. The following list describes characteristics that you and your twin brother may or may not have shared when you were children. For each characteristic listed, please consider your childhood years (before you were teenagers), and describe whether you and your twin brother were very similar, somewhat s i m i l a r or very different. (CIRCLE ONE FOK EACH LINE) When we were children our: a. Eye color was Very Similar Somewhat Similar 1 2 b. Ha i r co I or was 1 Very DON'T Different KNOW 3 2 3 3 197 8 20/ c. Hair type was 1 2 3 8 21/ d. Heights were 1 2 3 8 22/ e. Weights were 1 .... 2 ... 3 8 23/ f. Teeth were 1 2 3 8 24/ g. Voices were 1 2 3 8 257 h. Muscular strength was 1 2 3 8 267 i. Temperaments were 1 2 3 8 277 j. Musical a b i l i t i e s were 1 2 3 8 287 k. Language a b i l i t i e s were.... 1 2 3 3 297 I. Manual s k i l l s (dexterity) were 2 3 8 307 1 6. About how tall are you without shoes? (WRITE IN NUMbER OF FEET AND INCHES. IF ZERO INCHES, WRITE IN "00") FEET 317 7. About how much do you weigh without clothes or shoes? OF POUNDS) INCHES 32-337 (WRITE IN NUMBER POUNDS 34-367 �-4- DECK 8. A. Are you presently employed part-time or full-time? (CIRCLE ONE) Yes, f u l l - t i m e (GO TO B) 1 Yes, part-time (GO TO B) 2 Not employed (GO TO 0.9) 3 37/ IF PRESENTLY EMPLOYED: B. What kind of business or industry is this? (Example: TV and radio manufacture, retail shoe store, State Labor Department, farm, etc.) 38-40/ C. What kind of work are you doing? (Example: Electrical engineer, stock clerk, typist, farmer, etc.) 41-43/ D. What are your most important activities or duties? (Example: Typing, f i l i n g , s e l l i n g new cars, f i n i s h i n g concrete, etc.) 44-45X 9. What is the highest grade or year of school you have completed and gotten credit for? (CIRCLE THE ONE HIGHEST GRADE OR YEAR) a. None 00 b. Elementary 01 02 03 04 c. High School 09 10 11 12 d. College J3_ 14 15 16 05 06 07 08 46-47/ e. Some Graduate Schoo 1 17 f. Graduate or Professional Degree 18 �-5- DECK In order to get an accurate picture of each veteran's general health, everyone is asked the next few questions about alcoholic beverages and smoking. 10. Have you had more than 20 alcoholic drinks in your entire l i f e ? (CIRCLE ONE) Yes (GO TO Q. 11) 1 No (GO TO Q.16) 2 48/ 11. How old were you when you first started drinking alcoholic beverages regularly? (WRITE IN AGE) YEARS OLD .00 Never drink alcoholic beverages regularly, 12. A. 49-50/ During the entire time that you have been drinking alcoholic beverages, how many days per week or month do you drink alcoholic beverages, on the average? (WRITE IN EITHER DAYS PER WEEK OR DAYS PER MONTH) DAYS PER WEEK 517 DAYS PER MONTH 52-53/ or B. If a DRINK is considered one can or bottle of beer or one glass of wine, or one mixed drink or shot of hard liquor, how many DRINKS would you have on the average, on those days when you drink? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) DRINKS 54-55X �-6- OECK 1 13. Was there a period in your l i f e (of at least 6 months) when your consumption was more than this? Yes (GO TO B) 1 No (GO TO Q.14) 2 567 IF YES; B. When was this (WRITE IN YEARS) to 1 1 1 9 I 57-587 C. 59-60/ On about how many days per week or month would you drink more alcoholic beverages, on the average? (WRITE IN EITHER DAYS PER WEEK OR DAYS PER MONTH) DAYS PER WEEK 617 DAYS PER MONTH 62-637 or D. How many, drinks would you have, on the average, on those days when you were drinking more? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) DRINKS 14. A. 64-65/ Do you s t i l l drink alcoholic beverages? Yes (GO TO 8) 1 No (GO TO Q.15) 2 66/ IF YES; B. On about how many days per week or month do you currently drink alcoholic beverages, on the average? (WRITE IN EITHER DAYS PER WEEK OR DAYS PER MONTH) DAYS PER WEEK 677 DAYS PER MONTH 68-697 or �DECK -7- 14. (continued) C. How many drinks do you have, on the average, on those days when you drink? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) DRINKS 70-71/ GO TO Q.16 15. How old were you when you stopped drinking? (WRITE IN AGE) YEARS OLD 16. A. Have you smoked at least 100 cigarettes in your life? 72-73/ (CIRCLE ONE) Yes (GO TO 8) 1 No (GO TO Q.17) 2 74/ IF YES: B. Do you smoke cigarettes now? (CIRCLE ONE) Yes 1 No 2 75/ C. On the average, about how many cigarettes a day (do/did) you smoke? (WRITE IN NUMBER SMOKED. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) I | CIGARETTES D. 76-78X About how long has it been since you last smoked cigarettes fairly regularly? (CIRCLE ONE) Current I y smoke 1 Days 2 Weeks 3 Months 4 Years 5 Never smoked regularly 6 79/ �-8- BEGIN DECK 2 17. Do you currently have any of the following health problems? (CIRCLE YES OR NO FOR EACH LINE, 1-16) Yes _No_ 1. Accidental injury.... 1 .. 2 .. 10/ 2. 1 .. 2 .. 11/ 3. Respiratory conditions, such as lung trouble, persistent coughing, etc 1 .. 2 .. 127 4. Cancer 1 .. 2 .. 13/ 5. Heart trouble 1 ... ..2 14/ 6. Stroke 1 .. 2 .. 157 7. Kidney, bladder, or urinary problems, such as stones, infections, e c . . t... 1 .. 2 .. 16/ ? .. 2 .. M/ 1 .. 2 .. 187 1 .. 2 .. 19/ 1 .. 2 .. 20/ 12. Liver problems, such as hepatitis, cirrhosis, etc 1 .. 2 .. 21/ 13. Blood disorders, such as anemia, blood clots, etc 1 .. 2 .. 22/ 14. Nerve disorders, such as epi lepsy, migraines, etc... 1 .. 2 .. 237 15. Visual problems 1 .. 2 .. 247 16. Hearing problems.... 1 .. 2 .. 257 8. High blood pressure/hypertension..... Skin problems, such as acne or skin rash 9. Mental or emotional problems 10. Diabetes 11. Stomach or digestive disorders, such as ulcers, inflammations, etc 18. Please indicate which statement below best describes your military duty status: (CIRCLE ONE) Released from active military duty during the years 1965-75 1 Released from duty after 1975 2 S t i l l on active military duty 3 267 �UECK 2 -9- 19. The questions below concern your health over the entire period since your active duty during the Vietnam Era, 1965-1975. If you were released from active m i l i t a r y duty during the years 1965-1975, please describe your health since your date of release. If you are s t i l l on active duty, or released after 1975, describe your health since 1975. In responding, please include any current health problems you described in Q.I7. (ALWAYS ANSWER A AND THEN ANSWER B AND C AS APPROPRIATE FOR EACH LINE, 1-16) A. Since active B. Have you con - C. Have you ever mi Iitary duty suited a been hospi1965-75, have physician taI ized ove about this you had this night for th : .. problem? problem? problem? IF YES TO THIS, ANSWER B ==«> A. 1v Accidental Injury IF YES TO THIS, ANSWER C ====> B. Yes...1 ===> No.... 2 Yes...1 ==*> No.... 2 C. Yes...1 No... .2 27/ 3. Respiratory Conditions such as Lung Trouble, Persistent Coughing, etc. 4. Cancer Yes . . 1 ===> . No.... 2 317 No.... 2 307 2. High Blood Pressure/Hypertens i on 28/ Yes...1 Yes . . 1 . Yes...1 ===> No.... 2 Yes...1 ===> ===> No.... 2 No.... 2 ===> 37/ 42/ 7. Kidney, Bladder, or Urinary Problems such as Stones, Infections, etc. Yes...1 Yes . . 1 . No.... 2 Yes...1 ===> No.... 2 Yes . . 1 ===> . No.... 2 387 417 40/ 39/ 6. Stroke 357 Yes . . 1 . No. . . .2 Yes...1 ===> No.... 2 Yes . . 1 ===> . No. . . .2 327 No.... 2 Yes...1 ===> No.... 2 36/ 5. Heart Trouble Yes . . 1 . 34/ 33/ Yes...1 No. . . .2 297 Yes . . 1 . No.... 2 447 43/ Yes . . 1 ===> . No.... 2 45/ Yes . . 1 . No.... 2 =*=> No.... 2 46/ 477 �-10- 19. DECK 2 (continued) A. Since active mi 1 itary duty 1965-75, have you had th i s problem? B. Have you consulted a phys ician about this problem? IF YES TO THIS, ANSWER B ====> 8. Skin Problems such as Acne or Skin Rash B. Yes...1 ===> Yes...1 No.... 2 C. ===> No. . . .2 497 Yes . . 1 ===> . Yes...1 No.... 2 No . . 2 .. ===> Yes...1 ===> No.... 2 12. Yes . . 1 ===> . No.... 2 Stomach or Digestive Disorders, such as Ulcers, Inflammations, ,etc Yes . . 1 ===> . Yes...1 No.... 2 Yes . . 1 . No. . . .2 No.... 2 Liver Problems, such as Hepatitis, Cirrhosis, etc. Yes...1 No. . . .2 587 Yes...1 13. Blood Disorders, such as Anemia, Blood Clots, etc. Yes...1 No.... 2 617 Yes . . 1 . No.... 2 No.... 2 Yes...1 No. . . .2 64/ Yes...1 ===> No.... 2 ===> No. . . .2 677 697 16. Hearing Problems 707 Yes...1 Yes...1 ===> No.... 2 717 Yes . . 1 . No.... 2 ===> No.... 2 727 687 Yes . . 1 . No.... 2 Yes...1 ===> No. . . .2 Yes...1 ===> No.... 2 657 Yes . . 1 . No.... 2 667 Visual Problems 627 Yes . . 1 ===> . ===> 637 14. Nerve Disorders, such as Epi lepsy Migraines, etc. 597 Yes . . 1 . ===> No.... 2 No.. . .2 567 Yes . . 1 . ===> 57/ ===> 537 557 607 15. Yes . . 1 . 527 54/ 11. 507 No.... 2 517 10. Diabetes Yes...1 No.... 2 487 9. Menta 1 or Emot i ona 1 Problem Have you ever been hosp i tal i zed overnight for this problem? IF YES TO THIS, ANSWER C ==«> A. C. 737 747 �DECK 2 20. Would you say that your health in general is excellent, very good, good, fair, or poor? (CIRCLE ONE) Exce I I ent 5 Very Good 4 Good 3 Fair 2 Poor 1 75/ 21. A. Compared to your twin brother's health, how would you rate your health? Would you say your health is . . . (CIRCLE ONE) Better than your brother's (GO TO B) 1 About the same as your brother's (GO TO Q 2 ) . . .2..2 767 Worse than your brother's (GO TO 8 . . ).' 3 Doesn't apply, because brother is not l i v i n g (GO TO 0.22) 6 (IF HEALTH IS BETTER OR WORSE): B. In what way is your health different from your brother's health? 77-78X �-12- 22. A. BEGIN DECK 3 When you were in the military, were you stationed in Vietnam, Laos, or Cambodia; in the waters in or around these countries; or fly in missions over these areas? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO Q.23A) 2 10/ IF YES: B. Below is a list of 18 different combat roles and experiences that men had during the Vietnam war. For each statement, please indicate whether you had that combat experience. (CIRCLE YES OR NO FOR EACH LINE, 1-18) Yes Jjo_ In an artillery unit which fired on the enemy...1 ..2 11/ Flew in an aircraft (reconnaissance, or fixed wing F-14, B-52, etc.) 1 ..2 127 3. Flew helicopter attack gunships or medvacs...... 1 .. 2 13/ 4. Stationed at a forward observation post 1 .. 2 14/ 5. Tunnel rat checking enemy base camps 1 ..2 15/ 6. 1 ..2 16/ 7. Demolitions expert in the field 1 .. 2 177 8. Assigned to Graves and Registration to retrieve dead bodies from the f i e l d 1 .. 2 18/ 9. 1 .. 2 197 1 .. 2 207 Encountered mines and booby t a s . . . . . . . 1 ..2 rp........ 21/ 1. 2. Served on river patrol or gunboat. Served as a medic in combat 10. Received incoming fire 11. • 12. Received sniper or sapper fire 1 .. 2 22/ 13. Unit patrol ambushed 1 ..2 23/ 14. Flew in aircraft (fixed wing or helicopters) and was shot down 1 .. 2 24/ 15. Engaged VC and/or NVA in firefight 1 ..2 25/ 16. Saw Americans k i l l e d , and/or saw Vietnamese k i l l e d 1 .. 2 26/ 17. Wounded 1 .. 2 277 18. Captured by the enemy.. 1 .. 2 287 �-13- DECK 3 23 A. Overall, how would you describe your readjustment to c i v i l i a n life after your release from active duty? Would you say that returning to c i v i l i a n l i f e caused you ... (CIRCLE ONE) Considerable difficulty (GO TO B) 1 Some difficulty (GO TO Q.24) 2 Very I itt le di f f icu Ity (GO TO Q.24) .3 None, or practically no difficulty (GO TO Q.24) 4 DOES NOT APPLY; I AM STILL IN THE MILITARY (GO TO Q.24) 6 29/ IF CONSIDERABLE DIFFICULTY: B. Please describe the difficulties you had. 30-317 24. In the past 12 months how frequently have you experienced the following problems? (CIRCLE ONE FOR EACH LINE, a-o) Very Often a. Often Sometimes 1 2 3 4 5 32/ 1 2 3 4 5 337 1 2 3 4 5 34/ 1 2 3 4 5 35/ Found yourself in a situation where you started to feel and act as though a disturbing event you experienced in the m i l i t a r y was happening all over again.......... 1 .... 2 .... 3 .... 4 .... 5 ... ... ... ... 36/ Had trouble f a l l i n g asleep, stay Ing as Ieep or sIeepIng too much b. Had repeated dreams or nightmares about things that happened to you w h i l e In the military..... c. Had p a i n f u l memories of things that happened to you w h i l e in the m i l i t a r y d. Avoided activities that might remind you of things that happened to you w h i l e in the m i l i t a r y e. Almost Never Never �-14- DECK 3 24. (continued) Very Often f. Had times when other feelings or actions became stronger when you wero in situations that reminded you of times in the military Often Sometimes Almost Never Never 1 .. 37/ g. Felt ashamed or guilty about the kind of things you did to survive w h i l e 1 2 . . .. 3 . . . . .. .. 1 2 .. .. 3 .. .... .. j. Have been irritable and short-tempered..... 1 2 4I/ k. Had explosions of angry or aggressive behavior 1 2 42/ 1 .'. 2 h, J9/ i. Had trouble with your I. Lost interest in your usual daily activities m. Felt distant from everyone, even those people you care about n. o. 25. .. 5 .. 3 40/ 43/ 1 44/ Felt that Iife is not m a i g u . . . . . . . . . . . . 1 .... 2 .... 3 ennfl............ ... ... 45/ Felt jumpy and easily startled or felt that you had to stay on guard all the time 46/ 1 Since your discharge from active military duty, have you and your partner(s) ever had problems having children? (CIRCLE ONE) Yes. .1 No.. .2 47/ 26. How many children have you ever fathered? ANY EXTRA BOX ON THE LEFT) (ENTER NUMBER. PUT A "0" IN CHILDREN 48-49X �-15- 27. DECK 3 In the table below we would like you to enter information about your natural (not adopted) children. Please include a I I l i v e births, even if a c h i l d is no longer I i ving. Please indicate: (A) The date of birth of each c h i l d ; (B) the chiId's mother's age at the time of the birth; and (C) whether each c h i l d had any abnormality, birth defects, or handicaps. Briefly describe any birth defect in the space provided (D). If a c h i l d is no longer l i v i n g , please enter date of death in (E). A. B. D. C. E. Mother's Age At Date of Birth Natura 1 Chi Idren Month 1st Chi Id 1 1 Day Year 1 | 1 1 Chi Id's Birth (ENTER YEARS) Any Birth Defects? (CIRCLE) Yes - No Description of Birth Defects, Abnormal Ity, or Handicap If Deceased, Date of Death Month Day Year I 1 1 1 1 1 1 1 1 1 | 1 1 1 1 1 1 1 1 1 ! 1 1 1 1 1 1 1 Y N 58/ Y 73-747 nn U_J 16-21/ 1 1 24/ 1 I 1 1 1 'I N 4th Chi Id I I 1 I I 1 1 1 1 1 1 1 1 1 1 ! 1 1 1 1 1 1 1 1 1 1 ! 1 1 1 1 U_J 67-727 1 1 56- 57/ 73-74/ 1 1- r i i i N N 75/ l 44-497 i 1 76-777 i r 1 1 61-667 1 1 1 1 1 1 1 1n 1> 1' 1 59-607 58/ Y 1 1 42-437 41/ Y 1 1 27-327 1 1 N 1 1 U 50-55/ 6th Chi Id Y 39-40/ 33-387 5th Chi Id 1 1 1 ~ 1 1 1 1 25-267 t I I [i (BEGIN DECK 4) 10-157 76-77/ 75/ 22-237 1 l iI l i & 1-667 1 1 N Y 1 1 59-60/ 1 U_l 67-72/ 3rd Ch i 1 d 1 1 56-577 50-55/ 2nd Chi Id 1 1 1 1 1 1 1 1 1 1 (BEGIN DECK 5) 10-157 Other Children 167 �-16- DECK 5 28. A. Have you ever been the father of a stillborn c h i l d ? (CIRCLE ONE) Yes (GO TO 8) 1 No (GO TO 0.29) 2 177 IF YES; B. In what year(s) did this happen? (WRITE IN YEAR OR YEARS) 1. 2. 18-197 1 9 I 20-21/ 3. | 1 | 9 22-237 29. A. To your knowledge, did any partner of yours ever have a miscarriage? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO 0.30) 2 Not Applicable (GO TO 0.30) 6 DON'T KNOW (GO TO .Q.30) 8 247 IF YES: B. How many are you aware of? BOX ON THE LEFT) (WRITE IN NUMBER, PUT A "0" IN ANY EXTRA MISCARRIAGES C. In what year(s) did they occur? 25-267 (WRITE IN YEAR OR YEARS) 1. 1 9 I I 27-287 2. 29-307 3. 31-327 �-17- OECK 5 30. A. Have you ever been married? Yes (GO TO B) 1 No (GO TO 0.31) 2 33/ IF YES: B. In the table below, please list the month and year in which you were married. If your first marriage ended because of death or divorce, indicate the date you were widowed or divorced. If you were married and/or divorced more than once, please complete the remainder of the table. Married Month | Year Divorced Month | Year 1st Marriage 34-377 1 | 2nd Marriage 46-49/ 1 | 3rd Marriage 58-6 1/ 1 | Widowed Month | Year r~ 38-4 1/ | 50-53/ | | 62-657 42-457 | 1 : r~ 54-577 r~ 66-697 (BEG N DECK 6) 4th Marriage 70-73/ 1 74-777 1 10-137 The next question concerns your total family income. Income is important for analyzing and interpreting the health information we receive from veterans. ' For example, income information helps us to learn whether persons in one income group have certain conditions more or less frequently than people in another income group. 31. What was your total combined family income (that is, for both yourself and your partner, if any) during the past 12 months? Include money from jobs, social security, unemployment payments, retirement income, p u b l i c assistance and so forth. (CIRCLE ONE) Less than $ 5,000 01 $ 5,000 - $ 9,999 02 $10,000 - $14,999 03 $15,000 - $19,999 04 $20,000 - $24,999 05 $25,000 - $29,999 06 $30,000 - $34,999 07 $35,000 - $39,999 08 $40,000 - $49,999 09 $50,000 or more 10 14-15/ �-18CASE ID 0 AODRESS UPDATING INFORMATION The last set of questions w i l l help us to make sure that we have the correct address for both you and your twin brother in case we need to contact you in future years for additional health surveys. 32. Please print your name, address, and telephone number (where you can be reached in the coming year). Your Ful I Name Number and Street Address Apt. City State Zip Code is/ i i i i -r n r n | | | || Telephone Number Area Code -I I I-I LJ_J I I8-26/ 33. Your Social Security Number 1 34. Your Date of Birth 35. 1 1 1 ! ' i 1 i 1 27-327 If your twin brother Is alive, pleas* print his name, current address and telephone number. Your Twin Brother's Name Apt. Number and Street Address City State Zip Code 33/ I 36. A. B. If your twin brother Is dead, In what year did he die? ( | | I ' I 9 I In what city, state, and country did he die? City | I State f I 35-36X Country 37/ 37. Since we may need to contact you again at some time, please give us the name, address and telephone number of a person other than your twin who w i l l always know where you can be reached. Fu11 Na Apt. Number and Street Address City Zip Code State 38/ I I I i Telephone Number | | | | | Area Code 39/ THANK YOU FOR YOUR ASSISTANCE Your responses w i 1 1 be kept strictly confidential. Please return this questionnaire to NORC in the envelope provided. �June 20,1984 Dear Veteran Twin: 1 am the Project Director for the Vietnam Bra Twins Study (VETS) Survey of Health, and I'm writing to you because we need your help. Several weeks ago we sent to you a letter, a questionnaire, and a stamped return envelope for sending the questionnaire back to us. A copy of the same materials is enclosed with this letter. Since that time a member of the project staff called and spoke with you or someone in your household. He was calling to make sure that the questionnaire had reached you, and to answer any questions you might have about the study. You, or the household member we spoke with, assured us that the questionnaire had indeed arrived at your home, and that you would likely be sending it back to us shortly. Unfortunately, we have not yet received your questionnaire. It is possible that it is in the mail to us right now. If so, please accept our sincere thanks, and just discard the enclosed materials. If you have not had a chance to fill out your questionnaire, or have misplaced it, we ask that you take 15-20 minutes right now to complete the copy enclosed with this letter and send it off to us. As the letter explaining the study states, this study of the health of twins will provide extremely valuable information to medical researchers about many important illnesses. The findings of the study can not be considered accurate, however, if only a limited number of the twins we contact reply. Already close to 100 Chicago-area veteran twins have responded to the survey. Please join them, and contribute to medical knowledge by responding today. If it is more convenient for you, we will be happy to collect your answers over the phone. Please call me, Mary O'Brien, at (312) 962-8967, or Matt Deshler, (312) 962-10-45. We will be happy to arrange a time to call you back and interview you. Whether mailed to us or given over the phone, your responses will be kept strictly confidential. Receiving your answers as soon as possible is very important for the success of the study. To be included in the preliminary report, which will be presented to the federal Office of Management and Budget in early July, we must have your responses within a week of your receipt of this letter. As a token of our appreciation, enclosed you will find $5.00 for your help. Very sincerely, Mary O'Brien, PhJ). �Appendix 2 1. Focus group participants 2. Focus group agenda �List of People Attending Veteran Twins Focus Group at NORC, June 13 and 14, 7-9 pan. Wednesday. June 13 Thursday. June 14 Veterans [Names removed to preserve confidentiality] Other Guests Jack Goldberg Bill Henderson Dennis Robinette William True John Leavitt Seth Eisen Mary O'Brien Matt Deshler Martha Van Haitsma Mary O'Brien Matt Deshler Stephen Ingels HORC Staff �AGENDA FOR VETERAN TWINS FOCUS GROUP June 13 & 14, 1984 I. Introduction by Mary O'Brien of NORC Description of the evening's agenda II. Introduction of those present: Names, where we're from Veterans please include: —your branch of service —your period of service —whether you served in SouthEast Asia —whether you are a fraternal or identical twin, if you know this III. Review of the cover letter sent with the survey Strengths? Weaknesses? Recommendations to strengthen its appeal? IV. Review of the questionnaire Length: How long did it take to fill out? Too long? About right? Could even be added to without discouraging cooperation? Item-by-item review of the questions. Review of question sequences or sections, as well (e.g., alcohol questions) V. Additions to the questionnaire Veterans' views: Health issues not covered? Military experiences that might be related to current health not asked about? etc. Guests' ideas on additional questions, and veterans' reactions VI. Anything else: Questions about this study, about twin research, about the military experience, about being twins, etc. �Appendix 3 1. Revised cover letter, recommended for main survey 2. Revised Survey of Health, recommended for main survey �(as on NRC letterhead) July 9, 1984 Address of Veteran Dear [Name of Veteran]: We need your help in a new study, of great interest and importance to medicine, on the health of twins. This study provides a very unusual opportunity to learn more about the health effects of military service, and the inheritance of many important illnesses. The plan is to create a registry of twins who are veterans of the Vietnam era. We are writing to ask that you participate in this effort by completing the enclosed questionnaire and returning it in the prepaid envelope. The study is a purely scientific one which is being conducted by the National Academy of Sciences-National Research Council, with the cooperation of the.Veterans Administration. NORC, a research center at the University of Chicago, is responsible for collecting the survey information. The study can be carried out only with the help of the twins themselves, and we want you to take part in the study by supplying the information asked for on the attached form. All information you supply will be held in strict be available only to the medical investigators working on study has nothing to do with any compensation, claims, or may have with the Veteran's Administration. No individual in the published results of the study. confidence and will this study. The other contacts you will be identified Twin pairs who participate in the registry may be asked, from time-totime, to participate in research studies. Your involvement in any study is entirely voluntary. The purpose of each study will be explained fully so that you can make an informed decision about your participation. �-2- It is hoped that a great deal can be learned about genetic effects upon health and length of life from the registry. We sincerely hope that you will be able to help us by completing and returning the enclosed material. If you have any questions about the registry or studies of twins, please write to Dr. Mary O'Brien, or call her, collect, at 312/962-8967. Sincerely, C. Dennis Robinette, Ph.D. Director National Research Council Twin Registry Mary O'Brien, Ph.D. Director NORC Twin Registry Data Collection �OMB#2900-0411 NORC#4393 VIETNAM ERA TWIN STUDY SURVEY OF HEALTH NOTICE: The information asked for in this survey is being collected under authority of Title 38, Section 41 of the Code of Federal Regulations, which authorizes the VA to conduct medical research. A l l information you supply w i l l be held in strict confidence and w i l l be available only to the medical investigators working on this study. The study has nothing to do with any compensation, claims, or other contacts you may have with the Veterans Administration. No individual w i l l be identified in the published results of the study. BEGIN DECK 1 CASE ID: 1-7/ �BEFORE YOU BEGIN...PLEASE READ THESE INSTRUCTIONS For some questions in this survey you will simply write answers in your own words. Other questions, however, ask you to follow instructions and use the answer categories provided. You will find instructions for responding included with each question, in CAPITAL LETTERS within parantheses. Below are examples of all the different instructions you will see, and the correct way to answer each type of question. INSTRUCTION 1; (CIRCLE ONE) 1. What is the color of your eyes? Blue Brown Green Another color INSTRUCTION 2: 2. (CIRCLE ONE) IF THE COLOR OF YOUR EYES IS BROWN, YOU WOULD CIRCLE THE NUMBER TO THE RIGHT OF "BROWN." 3 4 (CIRCLE ALL THAT APPLY) Last week, did you do any of the following? (CIRCLE ALL THAT APPLY) a. Work for b. c. d. e. Attend classes.....1 Watch TV .......... <P Visit friends......1 Exercise .......... { ) J INSTRUCTION 3; IF YOU WORKED FOR PAY, EXERCISED, AND WATCHED TV LAST WEEK, YOU WOULD CIRCLE THE NUMBERS TO THE RIGHT OF THE ITEMS, AS SHOWN. (CIRCLE ONE FOR EACH LINE) 3. Do you plan to do any of the following next week? Yes Not Sure No a. Visit a relative.....1....2... jQ) b. Go to a. museum 1.(.. ..^.3 c. Go to a library ().2.. I....3 d. Watch sports on TV.. £Q . . 2 . INSTRUCTION 4; 4. (WRITE IN NUMBER. 3 (CIRCLE ONE FOR EACH LINE) IF YOU DON'T PLAN TO VISIT A RELATIVE NEXT WEEK, MAY GO TO A MUSEUM, AND DEFINITELY ARE GOING TO GO TO A LIBRARY AND WATCH SPORTS ON TV, YOU WOULD CIRCLE THE NUMBERS AS SHOWN PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) How many cups of coffee do you drink each day, on average? NUMBER. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) Cups of Coffee INSTRUCTION 5: (WRITE IN IF YOU DRINK 5 CUPS OF COFFEE DAILY, YOU WOULD WRITE IN THE NUMBERS AS SHOWN. (WRITE IN NUMBER) 5. What is your date of birth? O 7 O & S" 3L Month Day Year (WRITE IN NUMBER) IF YOU WERE BORN ON THE SIXTH OF JULY, 1952, YOU WOULD WRITE IN THE NUMBERS AS SHOWN, INCLUDING THE "0" IN THE UNUSED BOXES. �Vietnam Era Twin Study Survey of Health This survey concerns the health of twins who served in the U.S. m i l i t a r y . W h i l e some of the questions may not appear to be directly related to health issues, they all ask for information that has been shown in other studies to be associated with the physical or psychological health of veterans, twins, or both. 1. Do you have a twin brother? (CIRCLE ONE) Yes, l i v i n g (GO TO Q.2) 1 Yes, deceased (GO TO 0.2) 2 No 3 Triplet or higher.. .4 . IF "NO" OR "TRIPLET", PLEASE STOP HERE AND RETURN FORM IN THE ENVELOPE PROVIDED 2. As children, were you and your twin "as a l i k e as two peas in a pod," or of only ordinary-family resemblance? (CIRCLE ONE) As a l i k e as two peas in a pod 1 Of only ordinary family resemblance...2 DON'T KNOW 3. 8 Do you yourself believe that you and your twin are identical (monozygotic) twins, or do you believe that you are fraternal (dizygotic) twins? (CIRCLE ONE) I dent i ca I (monozygot ic) 1 Fraterna I (d i zygot i c) 2 DON'T KNOW 8 4. When you were children, how often did the following persons have difficulty in t e l l i n g you and your twin brother apart? (CIRCLE ONE FOR EACH LINE) A l l of the time a. Parents Some of the time Never DON'T KNOW 1 2 3 DOES NOT APPLY 8 b. Other Brothers and bisters...... i . . . . ^ . . . . .3. *•«••«• o . . . o . . . . . ..... .... c. Grandparents 1 2 3 8 d. 1 2 3 8 Classmates 6 �-2- 5. The f o l l o w i n g l i s t describes characteristics that you and your twin brother may or may not have shared when you were children. For each characteristic listed., pi ease consider your childhood years (before you were teenagers), and describe whether you and your twin brother were very s i m i l a r , somewhat s i m i l a r or very different. (CIRCLE ONE FOR EACH LINE) When we were children our: Very Similar Somewhat Simi lar Very Different 3 DON'T KNOW a. .. 2 .. .. .. b. .... 2 . . . . 3 ...,. . . 8 . . .. . c. .... 2 .... 3 .. .... .. d. .... 2 . . , .. 3 . .. . 8 .. . . .. . e. .... 2 .. .. 3 .. 8 .. f. .. .. 2 .. .. 3 .... 8 g. .... 2 .. .. 3 .. 8 .. h. ,... 2 ..... . 3 ..... . 8 .. .. i. .. 2 .. .... ... 3 . . ....8 .. J- .. 2 .. .... ... 3 . . . . 8 .. . . k. . . 2 ..... . 3 . . . . 8 .. .. .... 1. Manual s k i l l s (dexterity) .. 2 .. 6. .... ... 3 ...., . . 8 . About how t a l l are you without shoes? (WRITE IN NUMBER OF FEET AND INCHES. IF ZERO INCHES, WRITE IN "00") FEET 7. .. . . 8 31/ About how much do you weigh without clothes or shoes? OF POUNDS) INCHES (WRITE IN NUMBER POUNDS �-3- 8. Are you a part-time or full-time student? (CIRCLE ONE) Yes, ful I-time Yes, part-time A. 2 No, not a student 9. 1 3 Are you presently employed part-time or full-time? (CIRCLE ONE) Yes, f u l l - t i m e (GO TO 8) ! Yes, part-time (GO TO B) 2 Not employed (GO TO Q.10) 3 IF PRESENTLY EMPLOYED: B. What kind of business or industry is this? (Example: TV and radio manufacture, retail shoe store, State Labor Department, farm, etc.) C. What kind of work are you doing? (Example: stock clerk, typist, farmer, etc.) Electrical engineer, D. 'What are your-most important activities or duties? (Example: Typing, f i l i n g , s e l l i n g new cars, f i n i s h i n g concrete, etc.) E. How many years have you worked at this job? (WRITE IN NUMBER OF YEARS. IF LESS THAN ONE YEAR, WRITE IN "00") YEARS 10. After your discharge from active military duty, how long d i d it take you to find a full-time job? (CIRCLE ONLY ONE) a. Less than one month....... ...1 b. Less than six months c. Less than one year d. Greater than one year e. Does not apply; became a student after discharge f. Does not apply; s t i l l on active m i l i t a r y duty ..2 3 .. .4 5 6 �-4- 11. What 'is the highest grade or year of school you have completed and gotten credit for? (CIRCLE THE ONE HIGHEST GRADE OR YEAR) a. None 00 b. Elementary _OJ_ 02 03 . 04 c. 09 10 11 12 J3. 14 15 J6 High School d. College e. Vocational or technical school after high school 05 06 07 08 17 f. Some Graduate Schoo I _18_ g. Graduate or Professional Degree 19 In order to get an accurate picture of each veteran's general health, everyone is asked the next few questions about alcoholic beverages and smoking. 12. Have you had more than 20 alcoholic drinks in your entire life? ONE) Yes (GO TO Q.I3) 13. How old were you when you regularly? (WRITE IN AGE) 1 No (GO TO Q.17) (CIRCLE 2 ' started drinking alcoholic beverages YEARS OLD Never drink alcoholic beverages regularly (WRITE "00" IN BOXES ABOVE)....00 �-5- 14. A. Do you s t i l l drink alcoholic beverages? Yes (GO TO B) 1 No (GO TO Q.16) 2 IF YES: B. On about how many days per week do you currently drink alcoholic beverages, on the average? (WRITE IN DAYS PER WEEK) DAYS PER WEEK C. How many drinks do you have, on the average, on those days when you drink? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) DRINKS 15. Was there a period in your l i f e (of at least 6 months) when your consumption was more than this? Yes (GO TO B) 1 No (GO TO Q.17) 2 IF YES; B. When was this (WRITE IN YEARS) nim C. to 57-58X On about how many days per week would you drink more alcoholic beverages, on the average? (WRITE IN DAYS PER WEEK) DAYS PER WEEK D. How many drinks would you have, on the average, on those days when you were d r i n k i n g more? (WRITE IN NUMBER OF DRINKS. PUT A "0" IN ANY EXTRA BOX ON THE LEFT) DRINKS PER DAY GO TO Q.17 �-6- IF YOU NO LONGER DRINK: 16. How old were you when you stopped drinking? (WRITE IN AGE) YEARS OLD 17. A. Have you smoked at least 100 cigarettes in your l i f e ? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO Q.20) 2 IF YES; B. Do you smoke cigarettes now? (CIRCLE ONE) Yes (GO TO 0.18) No (GO TO C) C. 1 2 About how long has it been since you last smoked cigarettes regularly? (WRITE IN YEARS. IF LESS THAN ONE YEAR, WRITE IN "00") YEARS Never smoked cigarettes regularly (WRITE "00" IN BOXES ABOVE) 18. On the average, about how many cigarettes a day (do/did) you smoke? (WRITE IN NUMBER SMOKED. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) CIGARETTES 19. About how old were you when you first started smoking cigarettes regularly? (WRITE IN AGE. PUT A "0" IN ANY EXTRA BOXES ON THE LEFT) YEARS OLD Never smoked cigarettes regularly (WRITE "00" IN BOXES ABOVE) �-7- 20. Do you currently have any of the f o l l o w i n g health problems? (CIRCLE YES OR NO FOR EACH LINE, 1-16) Yes _No_ 1 2 2. Respiratory conditions, such as lung trouble, persistent coughing, etc 1 .... 2 3. Cancer 1 .. .. 2 1 .. .. 2 1 .. .. 2 Kidney, bladder, or urinary problems, such as stones, infections, kidney failure, etc 1 .. .. 2 Persistent skin conditions, such as severe acne, rashes, etc 1 .. .. 2 1 .. .. 2 1 .. .. 2 1 .. .. 2 1. High blood pressure/hypertension (INCLUDE EVEN IF CONTROLLED BY MEDICATION) •t 4. Heart trouble i 5. Stroke 6. 7. 8. Diabetes 9. Stomach or digestive disorders, such as ulcers, inflammations, e.tc 10. Liver problems, such as hepatitis, cirrhosis, etc 11. Blood disorders, such as anemia, blood clots, etc 1 .. 2 .. 12. Nerve disorders, such as epilepsy, migraines, etc 2 13. Joint o r skeletal disorders, such as arthritis, swollen joints, etc 1 .... 2 14. Hearing problems. 1 .. 2 .. 15. 21. 1 .. .. 1 .. 2 .. Other (PLEASE SPECIFY) Please indicate Which statement below best describes your military duty status: (CIRCLE ONE) Released from active military duty during the years 1965-75 1 Released from duty after 1975 2 S t i l l on active military duty 3 �-8- \2. The questions below concern your health over the entire period since your active duty during th Vietnam Era, 1965-1975. If you were released from active m i l i t a r y duty during the years 1965-1975, please describe your health since your date of release. If you are s t i l l on active duty, or released after 1975, describe your health since 1975. In responding, please include any current health problems you described in Q.20. (ALWAYS ANSwE A AND THEN ANSWER B.CMOb&fcAPPROPRIAT E FOR EACH LINE, 1-1 5) A. Since active B. Have you con- C. Have you ever D. In what year mi I itary duty sulted a been hosp i were you physician 1965-75, have ta 1 i zed ovei— f i rst hosp i you had th i s about this night for this tal zed for problem? problem? problem? this problerr IF YES TO THIS, ANSWER B =»=»> High Blood Pressure/Hypertens i on (INCLUDE EVEN IF CONTROLLED BY - MEDICATION) IF YES TO THIS, ANSWER D ===> A. 1.. IF YES TO THIS, ANSWER C =•«> B. C. Yes...1 =»> No 2 Yes...l ===> No 2 Yes...1 3. Yes...1 Cancer Mo 4. Heart Trouble 5. Stroke Yes...1 9 MA =»> No Yes...1 . , 1 9 Yes...1 No - ' 9 Yes...V N. , ===> ===> ===> INO . . 9 . £. . MA . 1 Yes...1 No - 1 Yes . . 1 . No. . . .2 Yes...l ===> No. . . .2 Yes...1 =«> No.... 2 1 / MA . . . . / O NO Yes...1 »»> . / Yes...1 No ===> 7 Yes...1 ]f9 ^ / 9 Yes...1 Yes . . 1 ===> . MA . . ./ NO. 9 Mo / 7 MA . . 9 NO. 6. Kidney, Bladder, or Urinary Problems, such as Stones, Infections, Kidney Fai lure, etc. =«> / No Yes . . 1 . / / 2. Respiratory Conditions such as Lung Trouble, Persistent Coughing, etc. D. ' 1 / 9 9 9 �-9?2. (continued) A. Since active mi 1 itary duty 1965-75, have you had this problem? IF YES TO THIS, ANSWER B ==«> IF YES TO THIS, ANSWER C ====> A. 7. Persistent Skin Conditions, such as Severe Acne, Rashes, etc. B. Have you consuited a physician about this problem? B. Yes...1 «=> No.... 2 C. Yes...l *«> No.... 2 Have you ever D. In what year been hospiwere you t a l i zed overfirst hospi night for this ta 1 i zed for problem? this problem IF YES TO THIS, ANSWER D «=> C. D. Yes...1 No.... 2 / 1 1 9 ' Yes...1 »»*> No.... 2 Yes . . 1 «=> . No.... 2 Yes . . 1 . No.... 2 9. Stomach or Digestive Disorders, such as Ulcers, Inflammations, etc Yes...1 *«> No. . . .2 Yes...1 ===> No. . . .2 Yes...1 No.... 2 1 9 0. Liver Problems, such as Hepatitis, Cirrhosis, etc. Yes...1 =«> No.... 2 Yes...1 »•*> No. . . .2 Yes...1 No.... 2 1 9 3. Diabetes 1 / 1. Blood Disorders, such as Anemia, Blood Clots, etc. Yes...1 =»=> No. . . .2 Yes...1 ===> No. . . .2 Yes...1 No. . . .2 1 9 2. Nerve Disorders, such as Epi lepsy, Migraines, etc. Yes.,.1 »»> No.... 2 Yes . . 1 «=> . No.... 2 Yes...1 No.... 2 1 9 3. Yes...! =«> No. . . .2 Yes...1 ===> No. . . .2 Yes . . 1 . No.... 2 1 9 Yes...1 =«> No.... 2 Yes...l ==»> No.... 2 Yes . . 1 . No. . . .2 / 1 9 Joint or Skeletal Disorders, such as Arthritis, Swol len Joints, etc. 4. Hearing Problems / 5. Other (PLEASE SPECIFY) Yes...1 »»»> No.... 2 Yes...1 No.... 2 Yes . . 1 =«> . No.... 2 1 1 I �-10- 23. Would you say that your health in general is excellent, very good, good., fair, or poor? (CIRCLE ONE) Exce I I ent 5 Very Good 4 Good 3 Fair 2 Poor 1 24. A. Compared to your twin brother's health, how would you rate your health? Would you say your health is ... (CIRCLE ONE) Better than your brother's (GO TO B) 1 About the same as your brother's (GO TO 0.25)....2 Worse than your brother's (GO TO B) 3 Doesn't apply, because brother is not l i v i n g (GO TO 0.25) 6 (IF HEALTH IS BETTER OR WORSE): B. In what way is your health different from your brother's health? 25. W h i l e in the military, did you request a Vietnam duty assignment? (CIRCLE ONE) Yes 1 No 2 �-1126. A. When you were in the m i l i t a r y , were you stationed in Vietnam, Laos, or Cambodia; i n the waters in or around these countries; or f l y in missions over these areas? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO Q.27A) 2 IF YES: B. Below is a list of 18 different combat roles and experiences that men had during the Vietnam War. For each statement, please Indicate whether you had that combat experience during the Vietnam War. (CIRCLE YES OR NO FOR EACH LINE, 1-18) 1. 2. Yes _No In an artillery unit which fired on the enemy...1 .. 2 Flew in an aircraft (reconnaissance, or fixed wjng F-14, B-52, etc.) 1 .. 2 3. Flew helicopter attack gunships.pr medvacs 1 ..2 4. Stationed at a forward observation post 1 . 2 . 5. Tunnel rat checking enemy base camps............ 1 .. 2 6. Served on river patrol or gunboat 1 .. 2 7. Demolitions expert in the f i e l d 1 .. 2 8. Assigned to Graves and Registration to retrieve dead bodies from the field..... 1 .. 2 9. 1 . 2 . Served as a medic in combat 10. Received incoming fire 11. Encountered mines and booby traps ....1 . 2 . 1 .. 2 12. Received sniper or sapper fire 1 .. 2 13. 1 •• 2 Unit patrol ambushed 14. Flew in aircraft (fixed wing or helicopters) and was shot down 1 . 2 . 15. Engaged VC and/or NVA in firefight 1 .. 2 16. 17. Saw Americans ki I led, and/or saw Vietnamese k i l l e d 1 . 2 . Wounded 1 .. 2 18. Captured by the enemy 1 •• 2 �-1227. A. Are you s t i l l on active m i l i t a r y duty? (CIRCLE ONE) Yes (GO TO 0.31) ................. 1 No (GO TO B) ..................... 2 IF NO: B. After your discharge from active m i l i t a r y duty, how often did you talk to the f o l l o w i n g i n d i v i d u a l s about your experiences in the m i l i t a r y ? (CIRCLE ONE FOR EACH LINE) Very OccaDOES NOT Often Often sional ly Rarely APPLY a. Parents ....... 1 ....... 2 ........ 3 ........ 4 ....... 6 b. Wi fe or ««* '••••••• ^•••••••« 3» • * • • • * * 4"« • • * • • • O c. Twin Brother.. 1 ....... 2 ........ 3 ........ 4 ....... 6 0• ri e. Other VietnamV0 T ©f~9nS • * !•*•*••• £. m • • • • • * • 28. After your discharge from active m i l i t a r y duty were you eager to get involved in everything, or did you not want to participate in things with other people? Were you ... (CIRCLE ONE) Very reluctant to get involved ........ 1 Somewhat reluctant to get invol ved. . .2 . Somewhat eager to get involved........3 Very eager to get involved............4 �-1329 A. Overall, how would you describe your adjustment to c i v i l i a n l i f e after your release from active duty? Would you say that returning to c i v i l i a n l i f e caused you . . . (CIRCLE ONE) Considerable d i f f i c u l t y Some difficulty 3 None, or practically no difficulty 4 Does not apply; I am s t i l l in the m i l i t a r y A. 2 Very Iittle d i f f i c u I t y 30. 1 6 Compared to your twin brother's adjustment to c i v i l i a n l i f e , how would you rate your adjustment to c i v i l i a n life? Would you say your adjustment was . . . (CIRCLE ONE) Easier than your brother's (GO TO B) 1 About the same as your brother's (GO TO" 0.31)....2 More d i f f i c u l t than your brother's (GO TO 8) 3 Does not apply because brother is either not l i v i n g or s t i l l on active duty (GO TO Q.31) 4 IF ADJUSTMENT WAS EASIER OR MORE DIFFICULTY: B. 31. In what way was your adjustment to c i v i l i a n l i f e different from your brother's adjustment to c i v i l i a n life? In the past 6 months how frequently have you experienced the f o l l o w i n g problems? (CIRCLE ONE FOR EACH LINE, a-o) Very Often Often Sometimes Almost Never a. Had trouble f a l l i n g asleep, staying asleep or sleeping too much t 2 3 4 5 b. Had repeated dreams or nightmares about things that happened to you w h i l e rn the m i l i t a r y t 2 3 4 5 Never �-14- 31. (continued) Very Often Often c. Had painful memories of things that happened to you w h i l e In the military.. 1 2 d. Avoided activities that might remind you of things that happened to you wh11e In the military Sometimes Almost Never Never 3 .... 4 ... 5 1 .... 2 ... 3 4 5 e. Found yourself In a situation where you started to feel and act as though a disturbing event you experienced In the military was happening all over again 1 2 3 4 5 f. Had times when other feelings or actions became stronger when you were In situations that reminded you of times In the military 1 2 3 4 5 g. Felt ashamed or guilty about the kind of things you did to survive while In the military 1 2 3 4 5 h. Had trouble concentrating 1 2 .... 3 ... 4 5 I. Had trouble with your mmr..... eoy..... 1 .... 2 .... 3 .... 4 .... 5 ... ... ... ... J. Have been irritable and short-tempered. 1 k. Had explosions of angry or aggressive behavior 1 .... 2 ... 3 4 .... 5 ... I. Lost Interest In your usual daily activities 1 3 4 2 2 3 .... 4 ... 5 5 m. Felt distant from everyone, even those people you care a o t . . . . . . . . . . . . 1 .... 2 .... 3 .... 4 .... 5 bu............ ... ... ... ... n. Felt that life Is not meaningful.... 1 .... 2 ... 3 4 5 o. Felt jumpy and easily startled or felt that you had to stay on guard all the time 1 3 4 5 2 �-1532. A. Have you ever consulted a health care professional (such as a physician, psychologist, or social worker) about a mental or emotional problem? (CIRCLE ONE) Yes (GO TO B) | YES. F B. 1 No (GO TO 0.33) 2 In what year did you first consult a health care professional about this problem? (WRITE IN YEAR) Tirm 33. A. ,F B. Have you ever been hospitalized for a mental or emotional problem? (CIRCLE ONE) Yes (GO TO B) 1 YES. 2 No (GO TO 0.34) In what year were you first hospitalized for this problem? (WRITE IN YEAR) "1 9~ 34. Do you currently have a mental or emotional problem? (CIRCLE ONE) Yes 1 No 2 The final set of questions concerns health issues regarding your family life. 35. Is your wife (or partner) now pregnant? (CIRCLE ONE) Yes No 2 DOES NOT APPLY 36. A. 1 6 Have you and your partner(s) ever tried for a period of a year or • more to conceive a c h i l d ? Yes, we tried for a year or more (GO TO B).. 1 No, it took us less than one year to conceive a child.....2 No, I have not tried to have a c h i l d 3 IF YES: B. Were you able to conceive a c h i l d after a year of trying? Yes 1 No 2 �-1637. In the table below we would l i k e you to enter information about your natural (not adopted) children. Please include a l l Iive births, even if a c h i l d is no longer I i vi ng. Please indicate: (A) The date of birth of each c h i l d ; (B) the chi Id's mother's age at the time of the birth; and (C) whether each c h i l d had any abnormal-ity, birth defects, or handicaps. Briefly describe any birth defect in the space provided (0). If a c h i l d is no longer l i v i n g , please enter date of death in (E). 1 • A. | | 1 Date of Natural Birth Children , Month Day Year 1st Child | ) '1 1 1 1 1 i 3rd Chlld 1 | 1 6th Chlld I Any Birth Defects? (CIRCLE) Yes - No | I ' / i / ' " 1 '1 \ / , ' \ E. | Description of Birth Defects, Abnormality, or Handicap . 'I If Deceased, Date of Death Month Day Year LTrrrr/ rrrrn 1 /i / 1 '1 / /, LELTLU/ N ' , , / Y '1 | ' . • I 1 | | 1 Other Children '1 1 1 | | D. | Y 1 | n , . '1 | 7 ) ) 1 5th Chlld 1 I '1 | 4th C h l l d 1 C. | Mother's | Age At Child's Birth (ENTER YEARS) i . ) 1 2nd Chi Id i B. i 1! N ' "n Y N /, / , \ '\ /, / unm �-1738. A. Have you ever been' the father of a stillborn c h i l d ? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO 0.39) 2 IF YES; B. In what year(s) did this happen? (WRITE IN YEAR OR YEARS) 1 - 1 | 9 - 32JJ 3. 39. A.. _1 9_ To your knowledge, did any partner of yours ever have a miscarriage? (CIRCLE ONE) Yes (GO TO B) 1 No (GO TO 0.40) 2 Not A p p l i c a b l e (GO TO 0.40) 6 DON'T KNOW (GO TO 0.40) 8 IF YES: B. How many are you aware of? BOX ON THE LEFT) (WRITE IN NUMBER, PUT A-"0" IN ANY EXTRA MISCARRIAGES C. In what year(s) did they occur? (WRITE IN YEAR OR YEARS) 1. 2. 3. �-1840. A. Have you ever been married? Yes (GO TO B), No (GO TO 0.41) 2 IF YES: B. In the table below, please list the month and year in which you were married. If your first marriage ended because of death or divorce, indicate the date you were widowed or divorced. If you were married and/or divorced more than once, please complete the remainder of the table. Married Month I Year Divorced Month I Year Widowed Month I Year 1st Marriage 2nd Marriage 3rd Marriage 4th Marriage The next question concerns your total f a m i l y income. Income is important for analyzing and interpreting the health information we receive from veterans. For example, income information helps us to learn whether persons in one income group have certain conditions more or less frequently than people in another income group. 41. What was your total combined fami ly income (that is, for both yourself and your partner, if any) during the past 12 months? Include money from jobs, social security, unemployment payments, retirement income, p u b l i c assistance and so forth. (CIRCLE ONE) Less than $ 5,000 01 $ 5,000 - $ 9,999 02 $10,000 - $14,999 03 $15,000 - $19,999 04 $20,000 - $24,999 05 $25,000 - $29,999 06 $30,000 - $34,999 07 $35,000 - $39,999 08 $40,000 - $49,999 09 $50,000 or more 10 �CASE ID ADDRESS UPDATING INFORMATION The last set of questions w i l l help us to make sure that we have the correct address for both you and your twin brother. In case we need to contact you In future years for additional health surveys. 1. Please print your name, address, and telephone number (where you can be reached In the coming year). Your FulI Name Number and Street Address Apt. City State Zip Code Telephone Number Area Code 2. Your Social Security Number 3. Your Date of Birth Month 4. Day Year If your twin brother Is alive, please print his name, current address and telephone number. Your Twin Brother's Name Number and Street Address Apt. City State Zip Code Telephone Number Area Code 5. A. If your twin brother Is dead. In what year did he die? B. In what city, state, and country did he die? City 6. State Country Since we may need to contact you again at some time, please give us the name, address and telephone number of a person other than your twin who w i l l always know where you can be reached. PulI Name Apt. Number and Street Address State City Zip Code Telephone Number Area Code THANK YOU FOR YOUR ASSISTANCE Your response* will be kept strictly confidential. Please return this questionnaire to NORC In the envelope provided. �Appendix 4 1. Coding and editing specifications for data entry of Survey of Health responses �DATA ENTRY SPECIFICATIONS I. FOR "VIETNAM ERA TWIN REGISTRY" 4393 GENERAL INSTRUCTIONS A. Leading zeros should appear in output file. B. All survey caselD's are prefixed with a preprinted "0" which should be punched. Thus, the caselD is seven (7) digits long. C. Each questionnaire represents six decks of data on the output file. The first seven characters of each deck are the caselD with a five digit sequential number, a one digit twin number (always 1 or 2) and a one digit check digit. The eighth and ninth columns of each deck will be the deck number (ranging from 01 - 06). (NOTE: Deck Number is not columned on the quex, but is printed at the top of each page on the sample quex with the deck number to be punched/columns to punch them in indicated in red pencil. For example, on page 2 is marked "01/8-9" to indicate that deck number 01 is punched in columns 8-9 of that deck). The following columns are filled for each deck: DECK FILLED COLUMNS ALWAYS BLANK 1 1-37, 46-79 38-45, 80 2 1-76 3 1-29, 32-58 61-75 30-31,59-60,76-80 4 1-24,27-41,44-58, 61-75 25-26,42-43,59-60, 76-80 5 1-77 78-80 6 1-39 40-80 77-80 The decks should all be eighty (80) columns long with the unfilled columns left blank. D. There are skip patterns in the questionnnaire such that every respondent will not answer every question. If Ql (Question 1) is answered with the value of "3" or "4", that is the only information that need be punched for that case, and is the only information which should appear on the survey form. If the answer is "1" or "2", however, the respondent should complete the questionnaire. For those who answer "1" or "2" to Ql, the following questions must be answered: �Questions that ALL respondents (who respond "1" or "2" to Ql) MUST answer: (SHOULD NOT BE BLANK ON QUEX) QUESTION CASEID - 8A Q9 - Q10 Q16A Q17 - Q19.1A Q19.2A Q19.3A Q19.4A Q19.5A Q19.6A Q19.7A Q19.8A Q19.9A Q19.10A Q19.11A COLS QUESTION 1-37 46-48 74 10-27 30 33 36 39 42 45 48 51 54 57 Q19.12A Q19.13A Q19.14A Q19.15A Q19.16A Q20 - Q21A Q22A Q23A Q24 - Q26 Q28A Q29A Q30A Q31 - Q37 DECK 1 1 1 2 2 2 2 2 2 2 2 2 2 2 DECK 2 2 2 2 2 2 3 3 3 5 5 5 6 COLS 60 63 66 69 72 75 - 76 10 29 32 - 49 17 24 33 14 - 39 NOTE: These items have a "*" beside them on the attached sample quex and in the field specific instructions below. E. If an item with an asterisk beside it (indicating it may not be skipped) IS left blank by the respondent, enter asterisks (***) in those columns. Asterisks should be written in by coders to indicate that the special character "*" should be 'entered in those columns. F. On the last page, the respondent's caselD will appear in the upper left hand corner of the page. This should NOT be punched. The caselD appears always and only in the first seven columns of every eighty column deck. G. On the last page, only the respondent's social security number and date of birth, and his twin's date of death (if applicable) will-be punched as such. The other locating information will be punched as 1 (present) or left blank (absent). If the column number is circled in red by NORC coders, then a "1" should be punched. If the column has an R (reject) beside it, then it should be left blank. H. All questionnaires should be 100% verified in the following fields: QUESTION DECK COLUMNS CASEID: SEQUENTIAL # TWIN NUMBER CHECK DIGIT 1-6 1-6 1-6 1-5 6 7 DECK NUMBER Ql Q2 Q18 Q22A Q31 Q33 Q34 1-6 1 1 2 3 6 6 6 8-9 10 11 26 10 14-15 18-26 27-32 �I. CaselD appears on the cover page. Ignore page 1— these are simply instructions to the respondent. J. NORC coders will mark the questionnaires in red pencil. Columns to be left blank will be marked with "R" (reject). Whole sections or entire pages to be left blank will have an "R—>" (R,arrow) to mark the span of columns to be left blank. All corrections will be in red pencil, including the asterisk convention (marking missing data where the respondent should have answered) and corrected respondent error such as failure to right justify, zero-fill, or follow a skip pattern. The red pencil edit markings take precedence over the respondent's own marks. II. FIELD SPECIFIC INSTRUCTIONS POSITION IN OUTPUT FILE QUESTION *CASEID DECK SEQUENTIAL 1 TWIN # 1 CHECK DIGIT 1 COLUMN 1-5 6 7 VALID VALUES COMMENTS 00001 - 00215 1,2 0-9 100% VERIFIED 100% VERIFIED 100% VERIFIED NEVER BLANK NEVER BLANK NEVER BLANK 01 100% VERIFIED NEVER BLANK 100% VERIFIED IF Ql - "3" OR "4", END KEYPUNCH. IF Ql "1" OR "2", Q2 - Q8A NEVER BLANK * DECK NUMBER 1 8-9 * Ql 1 10 1-4 * Q2 11 1,2,8 * Q3 12 1,2,8 13 14 15 16 17 18 1-3,8 1-3,6,8 1-3,6,8 1-3,8 1-3,8 1-3,8 19 20 21 22 23 24 25 26 27 28 29 30 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 1-3,8 * Q4 * Q5 Q4A Q4B Q4C Q4D Q4E Q4F Q5A Q5B Q5C Q5D Q5E Q5F Q5G Q5H Q5I Q5J Q5K Q5L 1 1 1 1 1 1 1 1 1 1 1 1 100% VERIFIED �QUESTION DECK COLUMNS VALID VALUES 1 1 31 32-33 4-7 00-12 * Q7 1 34-36 050-400 * Q8A 1 37 1-3 Q8B Q8C Q8D 1 1 1 38-40 41-43 44-45 ALWAYS BLANK ALWAYS BLANK ALWAYS BLANK * Q9 1 46-47 00-18 * Q10 1 48 1-2 Qll 1 49-50 COMMENTS ) Q6 Q6.1 Q6.2 05-41,96,97,99, BLANK Q12A1 Q12A2 1 1 51 52-53 0-7, BLANK 00-31, BLANK Q12B 1 54-55 00-99, BLANK Q13A 1 56 1-2, BLANK Q13B1 Q13B2 1 1 57-58 59-60 55-84, BLANK 55-84, BLANK Q13C1 Q13C2 1 1 61 62-63 0-7, BLANK 00-31, BLANK Q13D 1 64-65 00-99, BLANK Q14A 1 66 1-2, BLANK Q14B1 Q14B2 1 1 67 68-69 0-7, BLANK 00-31, BLANK Q14C 1 70-71 00-99, BLANK Q15 1 72-73 12-41, BLANK 1 74 * Q16A 1-2 100% VERIFIE1 100% VERIFIE1 ALWAYS BLANK ALWAYS BLANK ALWAYS BLANK �DECK COLUMNS VALID VALUES Q16B 1 75 1-2, BLANK Q16C 1 76-78 000-150, BLANK Q16D 1 79 1-6, BLANK 1 80 ALWAYS BLANK DECK NUMBER 2 8-9 02 Q17.1 Q17.2 Q17.3 Q17.4 Q17.5 Q17.6 Q17.7 Q17.8 Q17.9 Q17.10 Q17.11 Q17.12 Q17.13 Q17.14 Q17.15 Q17.16 2 2 2 2 2 2 2 2 2 -2 2 2 2 2 2 2 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 1-2 26 1-3 QUESTION COMMENTS BEGIN DECK 2 *Q17 Q18 Q19A1 Q19B1 Q19C1 Q19A2 Q19B2 Q19C2 Q19A3 Q19B3 Q19C3 Q19A4 Q19B4 Q19C4 Q19A5 Q19B5 Q19C5 Q19A6 Q19B6 Q19C6 Q19A7 Q19B7 Q19C7 Q19A8 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 100% VERIFIED 100% VERIFIED �QUESTION DECK COLUMNS VALIp_yALUES COMMENTS 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 * Q20 2 75 1-5 * Q21A 2 76 1-3,6 Q21B 2 77-78 ALWAYS BLANK ALWAYS BLANK 2 79-80 ALWAYS BLANK ALWAYS BLANK DECK NUMBER 3 8-9 Q22A 3 10 Q22B1 Q22B2 Q22B3 Q22B4 Q22B5 Q22B6 Q22B7 Q22B8 Q22B9 Q22B10 Q22B11 Q22B12 Q22B13 3 3 3 3 3 3 3 3 3 3 3 3 3 11 12 13 14 15 16 17 18 19 20 21 22 23 Q19B8 Q19C8 Q19A9 Q19B9 Q19C9 Q19A10 Q19B10 Q19C10 Q19A11 Q19B11 Q19C11 Q19A12 Q19B12 Q19C12 Q19A13 Q19B13 Q19C13 Q19A14 Q19B14 Q19C14 Q19A15 Q19B15 Q19C15 Q19A16 Q19B16 Q19C16 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK 1-2 1-2, BLANK 1-2, BLANK NOTE THAT CODES ARE IN DESCENDING ORDER IN THE QUEX BEGIN DECK 3 03 1007. VERIFIED 1-2 100% VERIFIED 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, 1-2, BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK �QUESTION DECK COLUMNS VAIJD_VALUES Q22B14 Q22B15 Q22B16 Q22B17 Q22B18 3 3 3 3 3 24 25 26 27 28 Q23A 3 29 Q23B 3 30-31 ALWAYS BLANK Q24A Q24B *Q24C Q24C Q24D Q24E Q2AF Q24G Q24H Q24I Q24J Q24K Q24L Q24M Q24N Q240 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 1-5 * Q25 3 47 1-2 * Q26 3 48-49 00-50 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 50-51 52-53 54-55 56-57 58 59-60 61-62 63-64 65-66 67-68 69-70 71-72 73-74 75 76-77 78-80 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK 1-2, BLANK ALWAYS BLANK 01-12, BLANK 01-31, BLANK 56-84, BLANK 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK 1-2, BLANK ALWAYS BLANK ALWAYS BLANK COMME|[T.S * Q27A1MO Q27A1DAY Q27A1YR Q27B1 Q27C1 Q27D1 Q27E1MO Q27E1DAY Q27E1YR Q27A2MO Q27A2DAY Q27A2YR Q27B2 Q27C2 Q27D2 1-2, 1-2, 1-2, 1-2, 1-2, BLANK BLANK BLANK BLANK BLANK 1-4,6 ALWAYS BLANK NOTE: Y-l N-2 ALWAYS BLANK NOTE: Y-l N-2 ALWAYS BLANK ALWAYS BLANK BEGIN DECK 4 8-9 DECK NUMBER Q27E2MO Q27E2DAY Q27E2YR 4 4 4 10-11 12-13 14-15 04 01-12, BLANK 01-31, BLANK 56-84, BLANK 100% VERIFIED �QUESTION Q27A3MO Q27A3DAY Q27A3YR Q27B3 Q27C3 Q27D3 Q27E3MO Q27E3DAY Q27E3YR Q27A4MO Q27A4DAY Q27A4YR Q27B4 Q27C4 Q27D4 Q27E4MO Q27E4DAY Q27E4YR Q27A5MO Q27A5DAY Q27A5YR Q27B5 Q27C5 Q27D5 Q27E5MO Q27E5DAY Q27E5YR Q27A6MO Q27A6DAY Q27A6YR Q27B6 Q27C6 Q27D6 DECK COLUMNS VALID VALUES COMMENTS 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 16-17 18-19 20-21 22-23 24 25-26 27-28 29-30 31-32 33-34 35-36 37-38 39-40 41 42-43 44-45 46-47 48-49 50-51 52-53 54-55 56-57 58 59-60 61-62 63-64 65-66 67-68 69-70 71-72 73-74 75 76-77 78-80 1-2, BLANK ALWAYS BLANK ALWAYS BLANK NOTE: Y-l N-2 ALWAYS BLANK ALWAYS BLANK 5 5 5 5 5 8-9 10-11 12-13 14-15 16 05 01-12, BLANK 01-31, BLANK 56-84, BLANK 1-2, BLANK 1007. VERIFIED 17 1-2 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK 1-2, BLANK ALWAYS BLANK 01-12, BLANK 01-31, BLANK NOTE: Y-l N-2 ALWAYS BLANK 56-84, BLANK 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK 1-2, BLANK ALWAYS BLANK 01-12, BLANK 01-31, BLANK NOTE: Y-l N-2 ALWAYS BLANK 56-84, BLANK 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK 1-2, BLANK ALWAYS BLANK 01-12, BLANK NOTE: Y-l N-2 ALWAYS BLANK 01-31, BLANK 56-84, BLANK 01-12, BLANK 01-31, BLANK 56-84, BLANK 13-50, BLANK BEGIN DECK 5 DECK NUMBER Q27E6MO Q27E6DAY Q27E6YR Q27F * Q28A Q28B1 Q28B2 Q28B3 * 5 5 5 Q29A 5 Q29B 5 18-19 20-21 22-23 24 25-26 56-84, BLANK 56-84, BLANK 56-84, BLANK 1,2,6,8 00-10, BLANK 1- +6 CHILDREN BLANK- 1-6 CHILDREN OR NO CHILDREN �QUESTION Q29C.1 Q29C.2 Q29C.3 * Q30A Q30B1.AMO Q30BI.AYR Q30B1.AMO Q30BI.AYR Q30B1.AMO Q30BI.AYR Q30B2.AMO Q30B2.AYR Q30B2.AMO Q30B2.AYR Q30B2.AMO Q30B2.AYR Q30B3.AMO Q30B3.AYR Q30B3.AMO Q30B3.AYR Q30B3.AMO Q30B3.AYR Q30B4.AMO Q30B4.AYR Q30B4.AMO Q30B4.AYR VALID VALUES 56-84, BLANK 56-84, BLANK 56-84, BLANK 33 5 5 5 COLUMNS 27-28 29-30 31-32 DECK 1-2 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 34-35 36-37 38-39 40-41 42-43 44-45 46-47 48-49 50-51 52-53 54-55 56-57 58-59 60-61 62-63 64-65 66-67 68-69 70-71 72-73 74-75 76-77 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 01-12, 56-84, 6 6 6 8-9 10-11 12-13 06 01-12, BLANK 56-84, BLANK COMMENTS BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BLANK BEGIN DECK 6 DECK NUMBER Q30B4.AMO Q30B4.AYR * Q32A Q32B 6 6 16 17 01-10,99 1, BLANK 1, BLANK 6 18-26 000000000-999999999 Q34MONTH Q34DAY Q34YEAR 6 27-28 29-30 31-32 01-12 01-31 43-56 Q35A Q35B 6 6 33 34 1, BLANK 1, BLANK * Q33 *Q34 14-15 Q31 100% VERIFIED 100% VERIFIED 1- COLUMNS CIRCLED IN RED 100% VERIFIED 100% VERIFIED 100% VERIFIED 100% VERIFIED 1- COLUMNS CIRCLED IN RED �QUESTION DECK COLUMNS VALID VALUES COMMENTS Q36A 6 35-36 Q36B 6 37 1, BLANK 1- COLUMN CIRCLED IN RED Q37A Q37B 6 6 38 39 1, BLANK 1, BLANK 1- COLUMN CIRCLED IN RED 43-83, BLANK � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 067 Folder The folder containing the original item. 1830 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource O'Brien, Mary Utne Description An account of the resource <strong>Corporate Author: </strong>NORC Date A point or period of time associated with an event in the lifecycle of the resource 1984-08-01 Title A name given to the resource Report of a Pretest of the Survey Instrument for the Vietnam Era Twin Study Survey of Health. Subject The topic of the resource Vietnam Experience Twin Study NAS ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/35c777d716742ce9f3614ec6762cd87b.pdf 3bed5479e628b180f4e47d63e20b991e PDF Text Text Item ID Number °1829 Author Corporate Author Report/Article Title Materia|s from the VETS II Review, including agenda, participant list, and summary, August 30,1984. Journal/Book Title Year 000 ° Month/Day Color n Number of hnaues 25 UOSCrtatOn NotBS ^'v'n ^- Young filed this item under "Vietnam Veterans Twin Study." Duplicate is of summary only. Wednesday, July 11, 2001 Page 1830 of 1870 �AGENDA TO REVIEW VETS II August 30, 1984 TIME SUBJECT SPEAKER OR PARTICIPANTS 8:00 a.m. - 8:30 a.m. Welcome and Charge to Committee Dr. Greene 8:30 a.m. - 9:15 a.m. Ranch Hand Study (U.S. Air Force) Dr. Wolfe a) Epidemiological Study of the Health of Vietnam Veterans Dr. Erickson 9:15 a.m. - 10:00 a.m. b) Agent Orange Birth Defects Study (Centers for Disease Control) 10:00 a.m. - 10:15 a.m. Questions Concerning Studies of Exposure to Agent Orange 10:15 a.m. - 10:45 a.m. Vietnam Twin Register Study, Protocol I (Medical Follow-up Agency National Academy of Sciences) Dr. Robinette 10:45 a.m. - 11:00 a.m. National Needs Assessment of Vietnam Era Veterans Dr. Greene (Veterans Administration's RFP 101-9-84) 11:00 a.m. - 3:00 p.m. Review of VETS II and Working Lunch Review Committee 3:00 p.m. - 5:00 p.m. Meeting with Principal Investigator and Staff of VETS II Review Committee Discussion, Recommendations, and Preparation of Summary Statement Review Committee 5:00 p.m. - 8:00 p.m. Attachment A �Participants "Vietnam Experience Twin Study" August 30, 1984 Review Committee Theodore Colton, Sc.D. (Chairman) Professor of Public Health Boston University School of Public Health 80 East Concord Street Boston, MA ^02118 Arthur B. Bloom, M.D. ^ Professor Department of Pediatrics Columbia Medical School Babies Hospital - Room 115 3959 Broadway .New York, NY 10032 Patricia A. luffler, Ph.D. Associate Dean for Research Professor of Epidemiology University of Texas P. 0. Box 20186 Houston, TX 7702] s^~~ W. Day, M.D., Ph.D. Robert Director Fred Hutchinson Cancer Research Center, 1124 Columbia Street Seattle, WA 98104 Thomas Associate Senior Vice Chancellor, Health/Sciences "University of Pittsburgh 3811 O'Hara Street Pittsburgh, PA 15213 Larry Ewing, Ph.D. Director of Reproductive Biology Department of Population Dynamics Johns Hopkins School of Hygiene and Public Health 615 North Wolfe Street Baltimore, MD 21205 Dhodanand Kowlessar,- M.D. Professor of Medicine Director of Gastroenterology Thomas Jefferson University 1025 Walnut Street Philadelphia, PA 19107 Lewis Kuller, M.D., D.P.H. Chairman, Department of Epidemiology University of Pittsburgh Pittsburgh, PA 15261 or MAIL TO: House Aging Committee 715 House Annex 1 Washington, D. C. 20515 Robert W. Miller, M.D. Chief, Clinical Epidemiology Branch National Cancer Institute - NIH Landow Bldg. Room 8C41 Bethesda, MD 20205 Walter E. Nance, M.D., Ph.D. Professor and Chairman Department of Human Genetics Box 33 MCV Station Virginia Commonwealth Univ. College of Medicine Richmond, VA 23298 Andre Ognibene, M.D. Hospital Director San Antonio State Chest Hospital P. 0. Box 23340 San Antonio, TX 78223 Morris Parloff, Ph.D. Consultant 5010 Wickett Terrace Bethesda, MD 20814 �Review Committee, (Cont.) Ming Tso Tsuang, M.D., Ph.D. > Professor and Vice Chairman ' Department of Psychiatry and Human Behavior Brown University MAIL TO: Director, Psychiatric Epidemiology Research Unit Butler Hospital 345 Blackstone Blvd. Providence, Rhode Island 02906 John Wilson, Ph.D. Professor Department of Psychology Cleveland State University Cleveland, Ohio 44115 Alastair J.J. Wood, M.D. Associate Professor of Medicine and Pharmacology Department of Clinical Pharmacology Vanderbilt University Medical School Medical Center North Nashville, TN 37232 �Related Studies Personnel J. David Erickson, D.D.S., Ph.D. Birth Defects Branch Centers for Disease Control 1600 Clifton Rd., Chamblee Bldg. 5 Atlanta, GA 30333 William H. Wolfe, M.D. Colonel, USAF, MC, FS Chief. Epidemiology Services Branch USAF, SAM/EKE Brooks AFB, TX 78235 C. Dennis Robinette, Ph.D. Director of Twin Registries National Research Council National Academy of Sciences 2101 Constitution Avenue Washington, D.C. 20418 St. Louis Investigators and Hines VAMC Cooperative Studies Center Personnel Seth Eisen, M.D. - Principal Investigator VA Medical Center (151A-JB) Research and Development Service St Louis, MO 63125 Dan Blazer, M.D., Ph.D. Associate Professor Department of Psychiatry Head Division of Social and Community Psychiatry Duke Medical Center Box 3173 Durham, NC 27710 Jack Goldberg, Ph.D. Staff Epidemiologist (151K) Cooperative Studies Program Coordinating Center VA Medical Center Hines, IL 60141 William G. Henderson, Ph.D. Chief, Cooperative Studies Program Coordinating Center (15IK) VA Medical Center Hines, IL 60141 John Leavitt, Jr., Ph.D. (151A-JB) Psychology Service VA Medical Center St Louis, MO 63125 William True, Ph.D., M.P.H. (151A-JB) Staff Anthropologist Psychiatry Service VA Medical Center St Louis, MO 63125 �William H. Wolfe, M.D. Colonel, USAF, MC, FS Chief, Epidemiology Services Branch USAF, SAM/EKE Brooks AFB, TX 78235 is VAMC Cooperative Studies Center Personnel /estigator munity Psychiatry xrdinating Center gram Coordinating Center (15IK) i-JB) 151A-JB) �VA Central Office Richard J. Greene, M.D. Director Medical Research Service VA Central Office 810 Vermont Avenue N.W. Washington, D. C. 20420 Ralph E. Peterson, M.D. Deputy Director Medical Research Service VA Central Office 810 Vermont Avenue, N.W. Washington, D. C. 20420 Robert E. Allen, Ph.D. Special Assistant Medical Research Service VA Central Office 810 Vermont Avenue N.W. Washington, D. C. 20420 James A, Hagans, M.Di, Ph.D. Chief, Cooperative Studies Program VA Central Office 810 Vermont Avenue N.W. Washington, D. C. 20420 Ping C. Huang, Ph.D. Staff Assistant, Cooperative Studies Progr, VA Central Office 810 Vermont Avenue N.W. Washington, D. C. 20420 �PARTICIPANTS "Vietnam Experience Twin Study' August 30, 1984 Review Committee Theodore Col ton, Sc.D. (Chairman) Lewis Roller, M.D., D.P.H. Professor of Public Health • Chairman, Department of Epidemiology Boston University School of Public Health University of Pittsburgh 80 East Concord Street Pittsburgh, PA 15261 Boston, MA 02118 Arthur B. Bloon, M.D. Professor Department of Pediatrics Columbia Medical School Babies Hospital - "Room 115 3959 Broadway New York, NY 10032 Robert W. Day, M.D., Ph.D. Director Fred Hutch inson Cancer Research Center 1124 Columbia Street Seattle, WA 98104 Detre, M.D. Associate Senior Vice Chancellor, Health Sciences University of Pittsburgh 3811 O'Hara Street Pittsburgh, PA 15213 Larry Ewing, Ph.D. Director of Reproductive Biology Department of Population Dynamics Johns Hopkins School of Hygiene and Public Health 615 North Wolfe Street Baltimore, MD 21205 MAIL TO: House Aging Committee 715 House Annex 1 Washington, DC 20515 Robert W. Miller, M.D. Chief, Clinical Epidemiology Branch National Cancer Institute - NTH Landow Bldg. Room 8C41 Bethesda, MD 20205 Walter B. Nance, M.D., Ph.D. Professor and Chairman Department of Human Genetics Box 33 MCV Station Virginia Commonwealth Univ. College of Medicine Richmond, VA 23298 Andre Ognibene, M.D. Hospital Director San Antonio State Chest Hospital P.O. Box 23340 San Antonio, TX 78223 Moris Parloff, Ph.D. Consultant 5010 Wickett Terrace Bethesda, MD 20814 ; Dhodanand Kowlessar, M.D. Professor of Medicine Director of Gastroenterology Thomas Jefferson University 1025 Walnut Street Philadelphia, PA 19107 Attachment A �eviewCommittee/ (Cont.) Ming Tso Tsuang, M.D., Ph.D. Professor and Vice Chairman Departnvant of Psychiatry and Hunan Behavior Brown University * : MAIL TO: Director, Psychiatric Epidemiology Research Unit Butler Hospital, 345 Blacks tone Blvdi" ' ' Providence, *hode Island 02906 John Wilson, Ph.D. Professor Department of Psychology Cleveland State University Cleveland, Ohio 44115 Alastair J.J. Wood, M.D. Associate Professor of Medicine and Pharmacology Department of Clinical Pharmacology Vanderbilt University Medical School Medical•Center >torth Nashville, TO 37232 �Related Studies Personnel J. David Erickson, D.D.S., Ph.D. Birth Defects Branch Centers for Disease Control 1600 Clifton Rd., Chamblee Bldg. 5 Atlanta, GA 30333 ^ William H. Wolfe, M.D. Colonel, USAF, MC, FS Chief, Epidemiology Services Branch OSAF, SAM/FXE Brooks, AFB, TX 78235 C. Dennis Robinette, Ph.D. Director of Twin Registries Kat-ional Research Council National Academy of Sciences • 2101 Constitution Avenue Washington, DC 20418 St. Louis Investigators and Hines VAMC Cooperative Studies Center Personnel Seth "Eisen, M.D. - Principal Investigator VA Medical Center (151A-JB) Research and'Development Service St. Louis, MO 63125 Dan Blazer, M.D., Ph.D. Associate Professor Department of Psychiatry Head Division of School and Community Psychiatry Duke Medical Center Box 3173 Durham, KC 27710 Jack Goldberg, Ph.D. Staff Epidemiologist (151K) Cooperative Studies Program Coordinating Center VA Medical Center Hines, IL 60141 William G. Henderson, Ph.D. Chief, Cooperative Studies Program Coordinating Center (151K) VA Medical Center Hines, IL 60141 John Leavitt, Jr., Ph.D. (151A-JB) Psychology Service VA Medical Center St. Louis, MD 63125 William True, Ph.D., M.P.H. (15lA-xTB) Staff Anthropologist Psychiatry Service VA Medical Center St. Louis, MO 63125 �VA Centred Office Richard J. Greene, M.D. Director Medical Research Service VA Central Office 810 Vermont Avenue N.W. Washington, DC 20420 ' Ralph T=\ Peterson, M.D. Deputy Director • Medical Research Service VA Central Office 810 Vermont Avenue N.W. Washington, DC 20420 Robert E. Allen, Ph.D. Special Assistant Medical Research Service VA Central Office 810 Vermont Avenue N.W. Washington, DC 20420 James A. Hagans, M.D., Ph.D. Chief, Cooperative Studies Program VA Central Office 810 Vermont Avenue N.W. Washington, DC 20420 Ping C. Huang, Ph.D. Staff Assistant, Cooperative Studies Program VA Central Office 810 Vermont Avenue N.W. Washington, DC 20420 �AGENDA TO REVIEW VETS II August 30, 1984 TIME . jt . ,- SUBJECT SPEAKER - -OR PARTICIPANT! -- ._ ! •*• l 8:00 a.m. - 8:30 a.m. Welcome and Charge to Committee Dr. Greene 8:30 a.m. - 9:15 a.m. Ranch Hand Study (U.S. Air Force) Dr. Wolfe a) Epidemiological Study of the Health of Vietnam Veterans Dr. Erickson 9:15 a.m. -'10:00 a.m. b) Agent Orange Birth Defects Study (Centers for Disease Control) 10:00 a.m. - 10:15 a.m. Questions Concerning Studies of Exposure to Agent Orange 10:15 a.m. - 10:45 a.m. Vietnam Twin Register Study, Protocol I (Medical Follow-up Agency National Academy of Sciences) Dr. Robinette 10:45 National Needs Assessment of Vietnam Era Veterans i a.m. - 11:00 a.m. (Veterans Administration's RFP 101-9-84) 11:00 a.m. - 3:00 p.m. Dr. Blank Dr. Denny - Review of VETS II and Working Lunch Review Committe j 3:00 p.m. - 5:00 p.m. Meeting with Principal Investigator Review Committe and Staff of VETS II 5:00 p.m. - 8:00 p.m. Discussion, Recommendations, and Preparation of Summary Statement Review Committe Attachment �VIETNAM EXPERIENCE TWIN STUDY PROTOCOL NO. 2 CSP #256 RESUME The Cooperative Study Protocol (CSP) under review is designed to investigate the impact of military service on the Vietnam veterans' medical, psychological and overall social adjustment. This study has one primary purpose/and two ancillary purposes: the primary purpose is to further examine the nature and degree of relationship between characteristics of Vietnam service and a range of medical, psychiatric, psychological, and psychosocial aspects of the veteran's health. Secondary purposes include the investigation of possible relationships between exposure to Agent Orange and the health of the veteran and his offspring, and efforts to define and measure Post Traumatic Stress Disorder. One of the unique features of this approximately 10 million dollar investigation is the inclusion of monozygotic co-twin pairs. It is proposed to locate and intensively study 600 male monozygotic twin pairs born during 1939-1953 who served in the military between 1965-1971. It is anticipated that of this sample about 360 will be discordant for service in Vietnam and 240 will be concordant, i.e., 120 co-twin pairs in which neither member had any Vietnam service and 120 co-twin pairs in which each member had some period of Vietnam service. The investigation will test whether there is reliable evidence of differential post-service medical, psychological or social well-being changes associated with different service experiences. The plan is to bring subjects to St. Louis for a week of extensive examinations. The feasibility of the proposed study is, of course, contingent on the prior successful completion of the Vietnam era Twin Registry. The preparation of such a registry was approved (Protocol fl) and is being undertaken by the National Research Council Commission on Life Sciences—Medical Follow-up Agency of the National Academy of Sciences. The application for review (Protocol 12) does not, however, include a report indicating the successful completion of this Registry or its readiness for use in Protocol 12. Also to be completed prior to initiating the study are such instruments as the DIS III, Current Behavioral Indices, the Life History and Medical History Questionnaires. CRITIQUE - General criticisms of project design and concepts. The overall impression of the proposed study is that it is fundamentally overambitious, with not enough serious, scientific rationale provided for the work described. The hypotheses for performing »the numerous laboratory procedures outlined in the proposal are not based on solid scientific data. This is basically ATTACHMEMT C �2. a "fishing expedition" among cohorts of twins, in which the focus will be on clinical, laboratory, and behavioral parameters of disease, or of disease indicators. The General Medical Assessment, as outlined in this protocol, represents a cosmic approach to clinical assessment, which may also be said for the extensive battery of laboratory tests proposed. Instead of a proposal consisting of a series 6f well-defined questions for which research studies are to be done, the veterans will be subjected to all manner of tests, clinical and other, on basically flimsy scientific evidence, to see what emerges. Even the more specialized tests have insufficient justification and weak scientific rationale. The only independent variable in this proposed study is service in Vietnam. A reasonable hypothesis might be generated that links Vietnam service to psychiatric sequelae, however, other studies directed to this goal are already being undertaken. Because the nn" (sample size) is small the study has only a low statistical power to detect modestly increased risks for medical or psychiatric illnesses. The small "n" may also invalidate the meaning of a negative result. While it may be true, as the investigators argue, that the "n" is large enough to detect subclinical differences in continuous variables such as laboratory values, such differences would have no clinical significance and are of insufficient importance to argue for implementing such a massive study. What are the implications of finding small deviations from normality in the co-twin pairs? Two problems with the data analysis presentation deserve some comment. First, information on data analysis is scattered throughout the proposal. Although each of these subsections is clearly presented, the relationships between the various types of analyses is not fully discussed. The second problem is relevant to the issue of multiple comparisons and spurious effects. This would be less of a problem if the data anaylses were divided into confirmatory and exploratory analyses. The confirmatory analyses should test a prior hypotheses which are explicitly specified by the investigators. These hypotheses could be based on either past empirical findings or theoretical developments. Since this group of tests will be less than the number pf tests discussed in the proposal, it would be reasonable to apply a higher alpha level to them than to the exploratory analyses. The medical illnesses of Vietnam servicemen, were for the self-limiting and will likely have long ago disappeared. acute and/or chronic exposure to drugs or chemicals might some abnormal test results initially, 14 or 20 years have elapsed since active Vietnam service and any -relationship and effect will be compromised. most part Although yield now of cause �3. A basic problem is that health differences between twins may be unrelated to Vietnam service, and may have developed in the 14 to 20 years post-Vietnam. Since it will not be possible to obtain accurate data on which servicemen were exposed to Agent Orange this study has essentially no relevance to the problem of Agent Orange effects on health. Thus, the hypothesis that the numerous psychological and biochemical tests are for purposes of evaluation of Agent Orange effects are invalid because, 1) of uncertainty of Agent Orange exposure, 2) the long period of time that has elapsed after a possible exposure to this herbicide and 3) the small number (65) of twins to be studied, who might have been exposed to Agent Orange. i A basic concern is possible sample bias. The twins to be studied appear to be coming from only 4 or 5 states, however, this is a problem that is disregarded by the investigators. The individuals picked at random, who are invited to participate in the study cannot be assumed to be neutral with regard to the outcome of this study. Some may be recipients of medical care for service connected or service aggravated disabilities or may be receiving pensions. As a consequence there may be a problem in gaining full and objective cooperation from those veterans who fear that they may be jeopardizing their future or present VA claims. Some subjects may be selected out because of illness or their job commitment, and are unable to travel to St. Louis. Others, because of an affluent life-style or professional commitments may not wish to volunteer for the extensive studies and trip to St. Louis. This may then result in the study assembling a group of volunteers who are unrepresentative of the population of Vietnam veterans. Another general problem of concern to the reviewers was the feasibility of assuring quality of medical, psychological and laboratory examinations via competitively bid contracts. What input will the investigators have on the letting of the contract and sub- contracts, and how will they monitor the competence of these contractors. SPECIFIC CRI'TICIMS OF EXAMINATION ELEMENTS Mental Health Examinations: (1 Psychiatric assessment is to be made using the Diagnostic Interview Schedule (DIS), medical records, and interview with spouse or equivalent. The preferred diagnostic instrument is to be the. DIS III. This may strike the psychiatric community as an odd choice. The major value of the DIS, to date, is as an epidemiological- survey instrument �4. that can be administered by non-clinicians; however,in the contemplated study expert clinicians could more appropriately be used. The poteatial contribution of this instrument for clarifying PTSD is not self-evident. It is ironic that the protocol involves transporting 1,200 person to St. Louis, but ignores the opportunity for expert clinical examination in favor of a survey instrument.' ^ ^. •r A more serious and certainly more pragmatic concern is that at the time this protocol was prepared the DIS III had not yet become available for inclusion in this study. The Psychological assessment is to use a wide array of psychological instruments: 1) four self report measures of psychological distress, 2) three measures of cognitive deficit, 3) one measure of psychological constriction, 4) three coping measures, 5) two measures of cognitive measures, 6) life events, and 7) a measure yet to be developed (Current Behavioral Indices). In general, the theoretical and conceptual specification of the diagnostic outcomes of primary interest is adequate; however, there are several points of concern. First, regarding diagnostic outcome of primary interest, there is no DIS algorithm for the schizotypal ' borderline or narcissistic personality disorders which current research suggests overlaps with PTSD. Secondly, the specification of four distinct groups of veterans is not well conceputalized, either theoretically or operationally. The delineation of construct areas is a useful procedure, however, the proposed scales to measure the construct area do not always represent the best possible measures, i.e., CPT to assess psychological constriction, or the resurrection of the out-moded California P scale as an index of cognition. A more detailed operational definition of hypotheses is necessary. What is it about war stress that contributes differentially to PTSD, primary diagnostic outcomes and psychosocial measures? What independent validations are being employed to cross-check preservice risk factor variables? There is a need to interview significant others and obtain documentation for the occurrence of a self-reported risk factor. ., Of great concern is the need to establish the feasibility of subjecting individuals to the onerous chore of completing the timeconsuming battery of tests. Could there be a serious sample biasing effect toward compliance and perhaps "health" for those subjects who fully cooperate in this heavy assessment program? What will b,e the rate of subject attrition? Consider the likelihood of a movie-version PTSD patient holding still for these evaluations. �5. Overall, th,e measures will generate a plethora of data which ultimately may have to be factored into empirically derived rather than rationally predetermined dimensions suggested. The limits of the study, include 'such factors as: 1) inability to match within twin pairs for post military experience, 2) possible relevant aspects of military service, e.g., duration of service, rank, time of service, branch, etc,,, and 3) the limits of the cross-sectional design involving measurement of "effects" taken 15-20 years after the putatively critical service experiences. It is difficult to be reassured by the argument that a "longitudinal" view will be constructed. Medical and Laboratory Examinations. < It is proposed to perform a multitude of liver function tests. This combination of tests, if abnormal, may indicate that the subject has hepatic dysfunction, however, it will not define the type liver disease. The primary usefulness of assays of gammaglutamyl transpeptidase (GGT) as a diagnostic test is limited to confirmation of elevated alkaline phosphatase of bony origin, since GGT is not found in bone and should be low in isolated disease of the bone. ^ finding of elevated GGT has limited usefulness, because the enzyme is ubiquitous and elevation of GGT in no way specifies hepatic disease. Of concern in this study is the fact that this is an inducible enzyme. Numerous enzyme-inducing drugs, most notably alcohol, elevate the serum level of the enzyme in the absence of other evidence of hepatic disorder. In reading their protocol it would appear that the Pi's will depend solely on the subject's concepts of his drinking habits. On the other hand if all of the other liver associated tests are within normal limits, an elevated GGT may be an indication of recent and/or continous alcohol intake. In summary, results will be obtained from the performance of a battery of liver associated tests. The interpretation of these results will be difficult unless those with abnormalities undergo liver biopsy to determine the morphologic changes associated with liver diseases. It will be difficult to interpret whether Agent Orange is responsible for any of the biochemical changes that may be found. The section on porphyria is weak. The'authors have failed to delineate the modern day concepts of hepatic porphyrias. The latent and manifest forms of acute intermittent porphyria and porphyria cutanea tarda (PCT) differ in the excretion of porphobilinogen, delta-aminolevulinic acid, uroporphyrin and coproporphynn. They do not specify which of these intermediates of heme synthesis they will measure. Most cases of PCT are sporadic, although there is a inherited enzymatic defect (deficient �6. activity o'f uroporphyrinogen decarboxylase) that predisposes to development of PCT4 The "andrology" studies, as proposed, have little intellectual basis, with the literature briefly summarized instead of critically reviewed. The studies of spontaneous abortion are seriously undersold in their complexity;" The cytogenetic testing for sister chromatid exchanges and chromosomal aberrations has several specific flaws, but the allusion that somatic cell chromosome alterations may reflect alterations in haploid cells which, in turn, bear on sterility, fetal wastage, teratogenesis, etc., is especially troublesome in its conceptualization, even more so than in its implementation. The mechanism of communication of cytogenetic test results is left, pretty much as it was at the Love Canel, unexplained. The semen analysis is unfortunately open to serious question for several reasons. It is stated that only a single semen sample will be collected. This is inadequate because of the variability in ejaculate volume, sperm numbers and sperm motility in human semen samples. A minimum of two and optimally three semen samples collected at 1-2 month intervals should be obtained. The qualitative assessment of sperm motility is inaccurate and unacceptable. A quantitative estimate of sperm motility is essential. There is a question about the wisdom of freezing semen for assessment of sperm numbers and morphology since there is no description of the method of freezing semen and no assurance that it will be done properly. Recent large, independent investigations of Australian Vietnam veterans (NEJM 308:719, 1983) and American Vietnam veterans (JAMA 252s903, 1984) concluded that there was no evidence that service in Vietnam was related to the risk of fathering a child with a birth defect, and thus there is little reason for further evaluation of this topic with such a small number of subjects. A wide range of immunological assays, particularly of T cell function are proposed, again with little evidence of a rationale for the studies. No review of Agent Orange effects on this immune system is provided, in humans or in experimental systems, and there is no specific reason to believe that being in Vietnam per se alters immune function. Tmmunotoxicolpgy is a developing science,, and is not yet applicable for definitive studies of humans exposed to toxins. What are normative Values in the population? What would small alterations of suppressor T cells mean for these subjects? In summary, it is felt that the many specific laboratory tests proposed would be of little value. More troublesome is the weak or absent rationale for including many of the laboratory procedures. �7. BUDGET Since the prospects^ of generating objective, scientifically sound data from this project are slim, the total costs of approximately 10 million dollars is highly cost ineffective. The request for 100 percent support for so many principal investigators is surprising. The budget justificatiop .indicates that the staff members are to work on other projects and conduct clinical duties in addition to work, on this proposal. INVESTIGATORS The reviewers expressed considerable concern about the competence of most of the investigators, who have never before directed a project of this magnitude. The physician PI, Dr. Eisen has no significant research experience and no scientific publication for the past 8 years, except for a case report in 1982. He has one active VA supported research project through HSR&D, but has demonstrated no expertise in any of the areas of this proposal. Dr. Levitt, Ph.D., psychologist has no publication as a primary author and no research support. Dr. True, Ph.D., anthrophology and MPH in epidemiology has no publications in refereed journals and no research support. Dr. Goldberg, Ph.D. in epidemiology has 12 refereed publications in health service research and is senior author of five of these. He lists no research funding. Susan Fisher has a BS in Nursing and an MS in Biostatistics. She is the primary or coauthor of eight publications in the field of nursing. Dr. Henderson, Ph.D. in biostatistics is Associate Professor, Department of Pharmacology, Loyola University and Chief, Hines VA Cooperative Prograrm, Hines, Illinois. He has an impressive list of publications, mostly in field of Clinical Trials and is considered to be a global authority in this area. RECOMMENDATIONS Disapproval of Twin Protocol #2, CSP #256 (by a vote of 13 to 1). Protocol #1 should continue to develop the registry of Vietnam, twins and increase the scope of the mortality and morbidity questionnaire for all of the approximately 10,000 male twin pairs born between 1939-1953 with military service from 1965-1975. If necessary additional funds should be provided to expand the questionnaire and/or sample size in order to provide an improved data base for a possible future implementation of a clinical study on a subset of twins. The questionnaire for the morbidity study might be expanded to include selected behavioral questions, family and social history and other confounding variables such as drug and alcohol abuse. �VIETNAM EXPERIENCE TWIN STUDY PROTOCOL NO. 2 CSP 1256 RESUME The Cooperative Study Protocol (CSP) under review is designed to investigate the impact of military service on the Vietnam veterans' medical, psychological and overall social adjustment. This study has one primary purpose/and two ancillary purposes: the primary purpose is to further examine the nature and degree of relationship between characteristics of Vietnam service and a range of medical, psychiatric, psychological, and psychosocial aspects of the veteran's health. Secondary purposes include the investigation of possible relationships between exposure to Agent Orange and the health of the veteran and his offspring, and efforts to define and measure Post Traumatic Stress Disorder. One of the unique features of this approximately 10 million dollar investigation is the inclusion of monozygotic co-twin pairs. It is proposed to locate and intensively study 600 male monozygotic twin pairs born during 1939-1953 who served in the military between 1965-1971. It is anticipated that of this sample about 360 will be discordant for service in Vietnam and 240 will be concordant, i.e., 120 co-twin pairs in which neither member had any Vietnam service and 120 co-twin pairs in which each member had some period of Vietnam service. The investigation will test whether there is reliable evidence of differential post-service medical, psychological or social well-being changes associated with different service experiences. The plan is to bring subjects to St. Louis for a week of extensive examinations. The feasibility of the proposed study is, of course, contingent on the prior successful completion of the Vietnam era Twin Registry. The preparation of such a registry was approved (Protocol 11) and is being undertaken by the National Research Council Commission on Life Sciences—Medical Follow-up Agency of the National Academy of Sciences. The application for review (Protocol 12) does not, however, include a report indicating the successful completion of this Registry or its readiness for use in Protocol 12. Also to be completed prior to initiating the ;study are such instruments as the DIS III, Current Behavioral Indices, the Life History and Medical History Questionnaires. CRITIQUE - General criticisms of project design and concepts. The overall impression of the proposed study is that it is fundamentally overambitious, with not enough serious, scientific rationale provided for the work described. The hypotheses for performing -the numerous laboratory procedures outlined in the proposal are not based on solid scientific data. This is basically ATTACHMENT C �2. t a "fishing expedition" among cohorts of twins, in which the focus will be on clinical, laboratory, and behavioral parameters of disease, or of disease indicators. The General Medical Assessment, as outlined in this protocol, represents a cosmic approach to clinical assessment, which may also be said for the extensive battery of laboratory tests proposed. Instead of a proposal consisting of a series of well-defined questions for which research studies are to be done, the veterans will be subjected to all manner of tests, clinical and other, on basically flimsy scientific evidence, to see what emerges. Even the more specialized tests have insufficient justification and weak scientific rationale. The only independent variable in this proposed study is service in Vietnam. A reasonable hypothesis might be generated that links Vietnam service to psychiatric sequelae, however, other studies directed to this goal are already being undertaken. Because the "n" (sample size) is small the study has only a low statistical power to detect modestly increased risks for medical or psychiatric illnesses. The small "n" may also invalidate the meaning of a negative result. While it may b« true, as the investigators argue, that the "n" is large enough to detect subclinical differences in continuous variables such as laboratory values, such differences would have no clinical significance and are of insufficient importance to argue for implementing such a massive study. What are the implications of finding small deviations from normality in the co-twin pairs? Two problems with the data analysis presentation deserve some comment. First, information on data analysis is scattered throughout the proposal. Although each of these subsections is clearly presented, the relationships between the various types of analyses is not fully discussed. The second problem is relevant to the issue of multiple comparisons and spurious effects. This would be less of a problem if the data anaylses were divided into confirmatory and exploratory analyses. The confirmatory analyses should test a prior hypotheses which are explicitly specified by the investigators. These hypotheses could be based on either past empirical findings or theoretical developments. Since this group of tests will be less than the number pf tests discussed in the proposal, it would be reasonable to apply a higher alpha level to them than to the exploratory analyses. The medical illnesses of Vietnam servicemen, were for the self-limiting and will likely have long ago disappeared. acute and/or chronic exposure to drugs or chemicals might some abnormal test results initially, 14 or 20 years have elapsed since active Vietnam service and any -relationship and effect will be compromised. most part Although yield now of cause �3. A basic problem is that health differences between twins may be unrelated to Vietnam service, and may have developed in the 14 to 20 years post-Vietnam. Since it will not be possible to obtain accurate data on which servicemen were exposed to Age'nt Orange this study has essentially no relevance to the problem of Agent Orange effects on health. Thus, the hypothesis that the numerous psychological and biochemical tests are for purposes of evaluation of Agent Orange effects are invalid because, 1) of uncertainty of Agent Orange exposure, 2) the long period of time that has elapsed after a possible exposure to this herbicide and 3) the small number (65) of twins to be studied, who might have been exposed to Agent Orange. A basic concern is possible sample bias. The twins to be studied appear to be coming from only 4 or 5 states, however, this is a problem that is disregarded by the investigators. The individuals picked at random, who are invited to participate in the study cannot be assumed to be neutral with regard to the outcome of this study. Some may be recipients of medical care for service connected or service aggravated disabilities or may be receiving pensions. As a consequence there may be a problem in gaining full and objective cooperation from those veterans who fear that they may be jeopardizing their future or present VA claims. Some subjects may be selected out because of illness or their job commitment, and are unable to travel to St. Louis. Others, because of an affluent life-style or professional commitments may not wish to volunteer for the extensive studies and trip to St. Louis. This may then result in the study assembling a group of volunteers who are unrepresentative of the population of Vietnam veterans. Another general problem of concern to the reviewers was the feasibility of assuring quality of medical, psychological and laboratory examinations via competitively bid contracts. What input will the investigators have on the letting of the contract and sub- contracts, and how will they monitor the competence of these contractors. SPECIFIC CRI'TICIMS OF EXAMINATION ELEMENTS -- Mental Health Examinations: . T ^ Psychiatric assessment is to be made using the Diagnostic Interview Schedule (DIS), medical records, and interview with spouse or equivalent. The preferred diagnostic instrument is to be the DIS III. This may strike the psychiatric community as an odd choice. The major value of the DIS, to date, is as an epidemiological- survey instrument �4. that can be administered by non-clinicians; however,in the contemplated study expert clinicians could more appropriately be used. The potential contribution of this instrument for clarifying PTSD is not self-evident. Tt is ironic that the protocol involves transporting 1,200 person to St. Louis, but ignores the opportunity for expert clinical examination in favor of a survey instrument.' ^ ,. •v A more serious and certainly more pragmatic concern is that at the time this protocol was prepared the DIS III had not yet become available for inclusion in this study. The Psychological assessment is to use a wide array of psychological instruments: 1) four self report measures of psychological distress, 2) three measures of cognitive deficit, 3) one measure of psychological constriction, 4) three coping measures, 5) two measures of cognitive measures, 6) life events, and 7) a measure yet to be developed (Current Behavioral Indices). In general, the theoretical and conceptual specification of the diagnostic outcomes of primary interest is adequate; however, there are several points of concern. First, regarding diagnostic outcome of primary interest, there is no DIS algorithm for the schizotypal borderline or narcissistic personality disorders which current research suggests overlaps with PTSD. Secondly, the specification of four distinct groups of veterans is not well conceputalized, either theoretically or operationally. The delineation of construct areas is a useful procedure, however, the proposed scales to measure the construct area do not always represent the best possible measures, i.e., CPT to assess psychological constriction, or the resurrection of the out-moded California F scale as an index of cognition. A more detailed operational definition of hypotheses is necessary. What is it about war stress that contributes differentially to PTSD, primary diagnostic outcomes and psychosocial measures? What independent validations are being employed to cross-check preservice risk factor variables? There is a need to interview significant others and obtain documentation "for the occurrence of a self-reported risk factor. ^ Of great concern is the need to establish the feasibility of subjecting individuals to the onerous chore of completing the timeconsuming battery of tests. Could there be a serious sample biasing effect toward compliance and perhaps "health" for those subjects who fully cooperate in this heavy assessment program? What will be the rate of subject attrition? Consider the likelihood of a movie-version PTSD patient holding still for these evaluations. �5. i Overall, the measures will generate a plethora of data which ultimately may have to be factored into empirically derived rather than rationally predetermined dimensions suggested. The limits of the study, include 'such factors as: 1) inability to match within twin pairs for post military experience, 2) possible relevant aspects of military service, e.g., duration of service, rank, time of service, branch, etc,,.and 3) the limits of the cross-sectional design involving measurement of "effects" taken 15-20 years after the putatively critical service experiences. It is difficult to be reassured by the argument that a "longitudinal" view will be constructed. Medical and Laboratory Examinations. It is proposed to perform a multitude of liver function tests. This combination of tests, if abnormal, may indicate that the subject has hepatic dysfunction, however, it will not define the type liver disease. The primary usefulness of assays of gammaglutamyl transpeptidase (GGT) as a diagnostic test is limited to confirmation of elevated alkaline phosphatase of bony origin, since GGT is not found in bone and should be low in isolated disease of the bone. * finding of elevated GGT has limited usefulness, because the enzyme is ubiquitous and elevation of GGT in no way specifies hepatic disease. Of concern in this study is the fact that this is an inducible enzyme. Numerous enzyme-inducing drugs, most notably alcohol, elevate the serum level of the enzyme in the absence of other evidence of hepatic disorder. In reading their protocol it would appear that the Pi's will depend solely on the subject's concepts of his drinking habits. On the other hand if all of the other liver associated tests are within normal limits, an elevated GGT may be an indication of recent and/or continous alcohol intake. In summary, results will be obtained from the performance of a battery of liver associated tests. The interpretation of these results will be difficult unless those with abnormalities undergo liver biopsy to determine the morphologic changes associated with liver diseases. It will be difficult to interpret whether Agent Orange is responsible for any of the biochemical changes that may be found. * f • The section on porphyria is weak. The authors have failed to delineate the modern day concepts of hepatic porphyrias.. The latent and manifest forms of acute intermittent porphyria and porphyria cutanea tarda (PCT) differ in the excretion of porphobilinogen, delta-aminolevulinic acid, uroporphyrin and coproporphyrin. They do not specify which of these intermediates of heme synthesis they will measure. Most cases of PCT are sporadic, although there is a inherited enzymatic defect (deficient �• *•. 6. activity of uroporphyrinogen decarboxylase) that predisposes to development of PCTt The "andrology" stu'dies, as proposed, have little intellectual basis, with the literature briefly summarized instead of critically reviewed. The studies of spontaneous abortion are seriously undersold in their complexity.' The cytogenetic testing for sister chromatid exchanges and chromosomal aberrations has several specific flaws, but the allusion that somatic cell chromosome alterations may reflect alterations in haploid cells which, in turn, bear on sterility, fetal wastage, teratogenesis, etc., is especially troublesome in its conceptualization, even more so than in its implementation. The mechanism of communication of cytogenetic test results is left, pretty much as it was at the Love Canel, unexplained. The semen analysis is unfortunately open to serious question for several reasons. It is stated that only a single semen sample will be collected. This is inadequate because of the variability in ejaculate volume, sperm numbers and sperm motility in human semen samples. A minimum of two and optimally three semen samples collected at 1-2 month intervals should be obtained. The qualitative assessment of sperjii motility is inaccurate and unacceptable. A quantitative estimate of sperm motility is essential. There is a question about the wisdom of freezing semen for assessment of sperm numbers and morphology since there is no description of the method of freezing semen and no assurance that it will be done properly. Recent large, independent investigations of Australian Vietnam veterans (NEJM 308:719, 1983) and American Vietnam veterans (JAMA 252:903, 1984) concluded that there was no evidence that service in Vietnam was related to the risk of fathering a child with a birth defect, and thus there is little reason for further evaluation of this topic with such a small number of subjects. A wide range of immunological assays, particularly of T cell function are proposed, again with little evidence of a rationale for the studies. No review of Agent Orange effects on this immvane system is provided, in humans or in experimental systems, and there is no specific reason to believe that being In Vietnam per se alters immune function. Tmmunotoxicology is a developing science,, and is not yet applicable for definitive studies of humans exposed to toxins. What are normative values in the population? What would small alterations of suppressor T cells mean for these subjects? In summary, it is felt that the many specific laboratory tests proposed would be of little value. More troublesome is the weak or absent rationale for including many of the laboratory procedures. �7. •, BUDGET Since the prospects, of generating objective, scientifically sound data from this project are slim, the total costs of approximately 10 million dollars is highly cost ineffective. The request for 100 percent support for so many principal investigators is surprising. The budget justification indicates that the staff members are to work on other projects and conduct clinical duties in addition to work on this proposal. INVESTIGATORS The reviewers expressed considerable concern about the competence of most of the investigators, who have never before directed a project of this magnitude. The physician PI, Dr. Eisen has no significant research experience and no scientific publication for the past 8 years, except for a case report in 1982. He has one active VA supported research project through HSR&D, but has demonstrated no expertise in any of the areas of this proposal. Dr. Levitt, Ph.D., psychologist has no publication as a primary author and no research support. Dr. True, Ph.D., anthrophology and MPH in epidemiology has no publications in reiereed journals and no research support. Dr. Goldberg, Ph.D. in epidemiology has 12 refereed publications in health service research and is senior author of five of these. He lists no research funding. Susan Fisher has a BS in Nursing and an MS in Biostatistics. She is the primary or coauthor of eight publications in the field of nursing. Dr. Henderson, Ph.D. in biostatistics is Associate Professor, Department of Pharmacology, Loyola University and Chief, Hines VA Cooperative Prograrm, Hines, Illinois. Re has an impressive list of publications, mostly in field of Clinical Trials and is considered to be a global authority in this area. RECOMMENDATIONS Disapproval of Twin Protocol 12, CSP 1256 (by a vote of 13 to 1). Protocol II should continue to develop the registry of Vietnam, twins and increase the scope of the mortality and morbidity questionnaire for all of the approximately 10,000 male twin pairs born between 1939-1953 with military service'from 1965-1975. If necessary additional funds should be provided to expand the questionnaire and/or sample size in order to provide an improved data base for a possible future implementation of a clinical study on a subset of twins. The questionnaire for the morbidity study might be expanded to include selected behavioral questions, family and social history and other confounding variables such as drug and alcohol abuse. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 067 Folder The folder containing the original item. 1829 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Materials from the VETS II Review, including agenda, participant list, and summary, August 30, 1984. Subject The topic of the resource Vietnam Experience Twin Study study criticism ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/015a9d2af529b19dc1ca774ff0cc436b.pdf 614f77815d7c8f7d43941840a90f9950 PDF Text Text Item ID Number °1028 Author Eisen, Seth Corporate Author Report/Article TltlB Typescript: Brief Chronological Summary of the VETS, Journal/Book Title Year 000 ° Month/Day Color D Number of hiauas 5 DeSCTlpton NOt8S Alvin L Your| gfiled this item under "Vietnam Veterans Twin Study." Summary is the enclosure in a letter to Alvin Young from Seth Eisen, August 26,1984. Wednesday, July 11, 2001 Page 1829 of 1870 �Medical Center St. Louis MO 63125 Veterans Administration AugUSt 26, 1984 In Reply Refer To: 151A-JB • Dr. Alvin Young Executive Office of the President Office of Science and Technology Room 5005, New Executive Office Building Washington, D. C. 20506 Dear Alvin, A "Brief C h r o n o l o g i c a l S u m m a r y of the VETS", w h i c h I recently assembled, is enclosed. To me, it r e i n f o r c e s how hard some people w i t h i n the VA are w o r k i n g to see our proposal fail. I spoke to H o b s o n a c o u p l e of d a y s a g o . He s a i d t h a t G r e e n e has successfully f r o z e n him out of all VETS related i n f o r m a t i o n and a c t i v i t i e s . He s a i d he w o u l d l i k e to a t t e n d the A u g u s t 30 m e e t i n g but w a s n ' t sure he will be permitted to. Y e s t e r d a y , Bill True had lunch w i t h Art Blank and Bob L a u f e r in Toronto, Canada (they are all a t t e n d i n g a s c i e n t i f i c m e e t i n g ) . Blank heard for the f i r s t time that Greene will be presenting the N a t i o n a l Needs Assessment Study before the VETS Protocol II m e r i t review group on August 30. Blank was a p p a r e n t l y f u r i o u s and said that he will make sure that he, Blank, makes the presentation. B l a n k also s a i d t h a t G r e e n e h a s b e e n a c t i n g " b i z z a r e " l a t e l y , p a r t i c u l a r l y i n r e l a t i o n t o t h e VETS p r o t o c o l , a n d c o n t i n u e s t o t a l k i n v e r y n e g a t i v e t e r m s a b o u t t h e VETS t o a n y o n e w h o w i l l l i s t e n . O n e r u m o r c i r c u l a t i n g i n VACO i s t h a t o u r p r o t o c o l w i l l be r e j e c t e d , but no a n n o u n c e m e n t will be made u n t i l a f t e r the presidential elections. This will m i n i m i z e the negative impact of the decision and the a b i l i t y of interest groups to i n f l u e n c e it. Surely the review c o m m i t t e e will make a recommendation about P r o t o c o l I I b e f o r e they a d j o u r n o n A u g u s t 3 0 . S o m e h o w , w e m u s t f o r c e the VA to a n n o u n c e that decision p r o m p t l y . The longer an a n n o u n c e m e n t is d e f e r r e d , regardless of w h a t the decision is, the less likely the project will ever be c a r r i e d out. John, Bill, and I will r e m a i n in Washington on F r i d a y , August 31. I hope that we w i l l be able to meet w i t h you. Sincerely, �COMBAT 1. Kadushin, C.G.; Boulanger, G.; Martin, J.; 1981. Long Term Stress Reactions: Causes Consequences and Naturally Occurring Ego Systems. ? In Egendorf, A.; Kaushin, C.G.; Laufer, R.S.; Rothbart, C.; Sloan, L. Legacies of Vietnam Combat Adjustments of Veterans and Pals, VA Study 1981. 2. Laufer, R.S.; Yager, T.; Frey-Wouters, E.; Dollen, J. 1981. Post War Psychological Problems on Veitnam Veterans in the aftermath of the Vietnam War. In same as above. 3. Wilson, J.; Kraus, G.; The Vietnam ERA Stress Inventory, 1980. 4. Wilson, J.; Kraus, G.; Predicting Post Dramatic Stress Syndrom Among Vietnam Veterans Presented to the 25th Neropsychological Inventory VA Medical Center, Coatesville, PA. October 1982. STRESS 1. See number 1 above. 2. Laufer, R.S.; Brett, E.; Gallops, M.; 1983. Demostration of Post Dramatic Stress Among Vietnam Veterans May 1983. �BRIEF CHRONOLOGICAL SUMMARY OF THE VETS 1981 Mid 1981 - RFP from VACO soliciting research proposals in the area of Health Effects of Agent Orange exposure December - Larry Hobson visits St Louis VAMC. Twin concept presented 1982 June - Submission to VACO by St. Louis investigators of "A Proposal for a Herbicide Orange Protocol Development" August - Proposal reviewed. The review committee stated that the "notion of studying twins had considerable merit and posed some i n t r i g u i n g possibilities for i n n o v a t i v e research and had potential for generating useful information." 1983 January - VACO meeting. VETS co-principal investigators agree to become part of the Cooperative Studies Program. August - Protocol I approved September - Contract signed between NAS and the VA to begin identifying twin pairs October 28 - First CSEC Merit Review of Protocol II. Twenty recommendations made. December 13 - Meeting of Custis, Shepard, Hobson, Greene (and perhaps others) to discuss Protocol II. Greene is critical of the protocol, particularly the specialized "Agent Orange" tests. He suggests that a "super oversight committee" be formed which will have final decision making responsibility for all aspects of the protocol. Custis is noncommittal 1984 Early J a n u a r y - Response to the 20 CSEC recommendations submitted J a n u a r y 30 - COG II Merit Review of the revised Protocol II. The m i n u t e s of the m e e t i n g s t a t e t h a t "COG a p p r o v e d the s t u d y to go f o r w a r d w i t h t h e m o d i f i c a t i o n s a s noted." O n l y t h e f o l l o w i n g issues remained unresolved: 1) COG II recommended that DZs should be i n c l u d e d in the St. Louis sample, 2) some f u r t h e r c l a r i f i c a t i o n of the key p s y c h i a t r i c outcome v a r i a b l e s is n e c e s s a r y , 3) f u r t h e r c o n s i d e r a t i o n of tests selected for the Agent Orange assessment is necessary, taking into account the herbicide exposure data which should soon be available from the CDC B i r t h D e f e c t s S t u d y , a n d 4 ) f u r t h e r c l a r i f i c a t i o n o f t h e a n a l y s i s o f t h e r e c o m m e n d e d i m m u n o l o g i c tests i s n e c e s s a r y . �(Note: the VETS co-principal investigators were told at the conclusion of the January 30 meeting that the VETS had been approved. The investigators were informed that $2.6 million is available to be spent on the VETS in FY '84.) February 7 - VETS St. Louis staff give an interview to Constance Holden of Science Magazine on the condition that nothing be published until approval is received from VACO. VACO notified of interview February 8 (approx) - Nora Kinzer joins Greene in becoming a very outspoken critic of the VETS. February 15 (approx) - Walters directs Custis to place the VETS on hold and to carefully re-examine the value of the study. Mid February - Putnam (Staff Asst to the CMD) prepares, at the request of Gronval (Asst CMD) and Christian (Executive Asst to the CMD), an "impact statement" about the probable reaction of the media and service organizations to an announcement by the VA that the VETS will no longer be supported. February 27 (approx) - Constance Holden notifies VACO that Science Magazine will publish information obtained from VETS coinvestigators unless she is given a good reason not to. Cable News Network, about this time, also notifies VA that they are planning to do a story on the VETS March 1 - Meeting of Custis, Boren, Greene, Shepard, Hobson, and others to discuss the VA's policy towards to VETS. Hobson presents an "Option and Decision Paper" which details the pros and cons of the VETS. Custis confidentially tells Shepard that he supports the VETS and will recommend to Walters that the VETS be submitted to the Science Panel of the AOWG and OTA for review. VETS investigators informally informed that it has now been decided that the January 30 COG II review was not sufficient. Further review by the AOWG and OTA is required before Protocol II can proceed. March 7 - Lathrop briefs Custis and Walters about the Ranch Hand Study results. Tells both Custis and Walters that he thinks the VETS is excellent and should proceed. March 12 - Custis sends memo to Walters supporting concept of VETS and recommends that additional scientific reviews be obtained from OTA & AOWG. Subsequently, Walters rejects AOWG review (reportedly because he dislikes Brandt, the chairman). April 4 (approx) - At a routine staff meeting, Custis asks Shepard about the status of the VETS. Custis requests a briefing in his office on April 18 to resolve the following issues: should the VETS be performed, and which division within the VA should administratively be responsible for the VETS? April 18 - Custis announces he will retire in early May. Meeting �among Gronval (Deputy CMD), Shepard, Boren and others to discuss VETS. Conclusions were: Research Service will be entirely responsible for the VETS, VETS will remain a VA study (i.e. will not be referred to CDC or some non-VA group), and psychological assessment portion of VETS will be performed as part of the overall contract. Announced that OTA has (unoffically) agreed to review the VETS. However, a formal request must come from the VA via the Senate Veterans Affairs Committee. April 24 - Revised VETS Protocol II, which includes responses to each of the four issues still unresolved after the January 30 COG II meeting, submitted to VACO April 30 - OMB directs VA to submit VETS to AOWG. VA refuses. May 4 - Memo to Deputy CMD from Boren and Shepard which confirms that responsibility for the management and conduct of the VETS remains with the ACMD for Research and Development. The Agent Orange Projects Office will provide support and assistance only as required. May 11 - COG II review of VETS scheduled for June 22 May 17, 1984 - Eisen briefs Senate Veterans Affairs Committee about the VETS. Committee staffers tell Greene that Simpson is likely to respond favorably to a request by the VA that the VETS be reviewed by OTA. Greene says that the VA will therefore make a formal request. May 31 - Greene notifies VETS to suspend all Protocol II activity. The previously scheduled meeting of COG II has been "postponed". VACO states the OTA will review Protocol II instead. VETS investigators attendence at a previously planned June 6 meeting with Ranch Hand and CDC researchers is cancelled. June 6 - Notified that OTA refuses to review VETS June - VACO trying to decide who will review VETS (since Walters refuses to permit the AOWG to review it and OTA refuses to review it) July 19 - Officially notified that VETS Protocol II will be reviewed on August 30 by a newly formed committee, composed entirely of non-VA scientists, selected by Greene � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 067 Folder The folder containing the original item. 1828 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Eisen, Seth Title A name given to the resource Typescript: Brief Chronological Summary of the VETS, 1984. Subject The topic of the resource Vietnam Experience Twin Study ao_seriesIII