Epidemiologic Investigation of Health Effects in Air Force Personnel ...

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UNCLASSIFIED SECURITY CLASSIFICATION OF THIS PAGE (When Data Entered) 1. REPORT NUMBER SAM-TR-82-44 4. TITLE (and Subtitle) REPORT DOCUMENTATION PAGE 2. GOVT ACCESSION NO EPIDEMIOLOGIC INVESTIGATION OF HEALTH EFFECTS IN AIR FORCE PERSONNEL FOLLOWING EXPOSURE TO HERBICIDES: STUDY PROTOCOL READ INSTRUCTIONS BEFORE COMPLETING FORM 3. RECIPIENT'S CATALOG NUMBER Initial Report October 1978 - December 1982 5. TYPE. OE REPORT 4 PERIOD COVERED 6. PERFORMING O^G. REPORT NUMBER 7. AUTHOR(s) George D. Lathrop, Colonel, USAF, MC William H. Wolfe, Lieutenant Colonel, USAF, MC Richard A. Albanese, M.D. Pat.Hrla M., Mnynahan, Colonel, USAF. NC 9. PERFORMING ORGANIZATION NAME AND ADDRESS USAF School of Aerospace Medicine (EK) Aerospace Medical Division (AFSC) Brooks...Air Force Base, Texas 78235 11. CONTROLLING OFFICE NAME AND ADDRESS USAF School of Aerospace Medicine (EK) Aerospace Medical Division (AFSC) 8. CONTRACT OR GRANT NUMBERfs; 10. PROGRAM ELEMENT. PROJECT, TASK AREA a WORK UNIT NUMBERS 65306F 2767-00-01 12. REPORT DATE December 1982
UNCLASSIFIED SECURITY CLASSIFICATION OF THIS PAGE(HT>en Data Entered; 20. ABSTRACT (Continued) health effects exist and can be attributed to occupational exposure to herbicides. This study uses a matched cohort design in a nonconcurrent prospective setting incorporating mortality, morbidity, and followup studies. Detailed computer searches of Air Force personnel records, with several crossreferencing techniques, have ensured total ascertainment of the RANCH HAND population. The unique circumstances of exposure in this population of 1264 individuals will permit a semiquantitative estimate of exposure. A comparison group will be formed from a population of 23,978 flight crew members and support personnel who were assigned to duty in Southeast Asia (SEA), but were not occupationally exposed to herbicides. These individuals will be matched to RANCH HAND personnel for the variables of age, type of job, and race. Since both the exposed subjects and their selected controls performed similar combat or combat-related jobs, many of the physical and psychophysiologic effects of combat stress and the SEA environment will also be equivalent in the two groups. In the analysis of mortality, each exposed subject and five randomly selected controls will be followed yearly for at least 20 years, constituting a 1:5 mortality design. The first of the mortality controls will be selected and entered into the questionnaire and physical examination phases of the study, producing a 1:1 morbidity design. The initial questionnaire will look backwards in time and will reconstruct occupational, social, and medical data to quantitate morbidity endpoints and confounding factors. All RANCH HAND personnel and their primary controls will be asked to participate in a comprehensive physical examination, with special emphasis being placed on dermatologic, neuropsychiatn'c, hepatic, immunologic, reproductive, and neoplastic conditions. The questionnaire will be developed and administered by a civilian opinion research organization of national stature under contract to the U.S. Air Force. In-home, face-to-face interviews will be conducted to maximize data quality. Medical and occupational data will be obtained from the study subjects. Fertility data will be obtained from the subject's spouse and/or former spouses whenever possible, preferably by face-to-face interview. In addition, next-of-kin interviews will be obtained for all study subjects who have died of noncombat-related causes between the time of their assignment to SEA and the initiation of this study. The physical examination will be conducted under Air Force contract at a single center by a civilian medical organization of national stature. Blind assessment protocols and strict quality control measures will be used to avoid bias and limit data variability,. Adaptive physical examinations and questionnaires will be developed for use in years 3, 5, 10, 15, and 20 of the followup study. Expected biases arid study difficulties include risk-taking behavior bias in the predominantly volunteer RANCH HAND group, response bias, interviewer bias, loss to study bias, and variability of procedures performed. UNCLASSIFIED SECURITY CLASSIFICATION OF THIS PAGE (Wien Dalit Entnrfd)
Page 1 and 2: Item ID Number 01570 Aether Lathrop
Page 3: NOTICES This initial report was sub
Page 7 and 8: Studies Relating to the Possible Lo
Page 9 and 10: 9 15 June 1981 - Discussion of matc
Page 11 and 12: EXECUTIVE PROJECT RANCH HAND II SUM
Page 13 and 14: physical examination data will util
Page 15 and 16: CONTENTS (Continued) Page VII. Data
Page 17 and 18: List of Tables Table No. Page 1 Est
Page 19 and 20: PROJECT RANCH HAND II EPIDEMIOLOGIC
Page 21 and 22: the peer group recommendations were
Page 23 and 24: caused an increase in the rate of c
Page 25 and 26: IV• Synopsis and Discussion of J-
Page 27 and 28: techniques). Initially, adipose tis
Page 29 and 30: in dogs), excretion (2,4,5-T plasma
Page 31 and 32: If the condition is shown to have o
Page 33 and 34: 1979) indicated that most cases of
Page 35 and 36: V. Epidemiologic Study Desi gn: Mat
Page 37 and 38: ase of operations to a new location
Page 39 and 40: as the spraying. The "exposed" grou
Page 41 and 42: Table 5 COMPARISON OF THE STUDY GRO
Page 43 and 44: Figure 1. MORTALITY ANALYSIS COHORT
Page 45 and 46: the historical morbidity study will
Page 47 and 48: FIGURE 4 EXPOSED DESIGN SCHEMATIC R
Page 49 and 50: and 7. These replacements will be c
Page 51 and 52: SMR * M x 100 k I m i M » "Classic
Page 53 and 54: Table 8 FORMAT OF McNEMAR'S TEST CO
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[3Xi(t)] The proportional hazards m
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history, and review of symptoms wil
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(4) Analysi s of Questi onnai re an
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for if need be, either by analyzing
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FIGURE 5 EFFECT OF NON-RANDOM LOSS
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FIGURE 7 CONTROL REPLACEMENT FOR TH
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FIGURE INTERPRETATION OF HORIZONTAL
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group must have varied widely. Expo
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TCDD contamination then did those h
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V I . Specijl ratns The previous di
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Figure 11 APPARENT RELATIVE RISK VE
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(3) Power in the Pichotomous yajijb
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Using pairing to achieve a power of
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FABLE 14 MORTALITY ANALYSIS POWER C
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.E 16 MORTALITY ANALYSIS POWER COMP
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FIGURE 12 CD POWER VERSUS RELATIVE
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IGURE 14 POWER CURVES OF THE MARINE
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Table 18 CONTROL DISTRIBUTIONS BY E
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(a) larger values of D correspond t
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espect to the replacement strategy.
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VII. Data Repository Throughout the
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VIII. Recogni zed Study Pi f f i cu
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aviation trainees (Waters). This st
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G- Loss to Study/Statistica land Bi
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his own state of health, the altera
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concerning exposures to other herbi
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(f) Laboratory J[)ua1Jt,y Control T
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Figure 16 MANAGEMENT STRUCTURE Prog
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X. Repprti ng Procedures Interim sy
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this time, he will be encouraged to
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SECTION B. Conduct of the Examinati
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CLINICAL RECORD NEUROLOGICAL EXAMIN
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XI Ptosis R£7 L £7 • V Motor R
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C. Spec i a1 P rocedu res (1) Nerve
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(5) Cornell Index (CD Self-administ
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(22) Serum Protein Electrophonesis
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(c) Based upon the reports of toxic
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(k) The following tests should be p
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James A. Wright, MD, MPH Major, USA
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xlv • SELECTED BIBLIOGRAPHY (Key
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Rose, J. Q., J. C. Ramsey, T. H. Wi
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H. ANIMAL STUDIES Allen, J. R., D.
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Hardell, L., M. Eriksson, and P. Le
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Gehan, E. 1965b. A generalized two-
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XV. APPENDIX TABLE A-l TABLE A-2 TA
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TABLE A-2 "SYMPTOM COMPLEX" DERIVED
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TABLE A-3 (CONTINUED) DETAILED LIST
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TABLE A-5 STATISTICAL DESCRIPTION O
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STUDY PHASE Morbidity Study Morbidi
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Figure A-l 2, 3, 7, 8-TETRACHLORODI
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S-ijure A-3 STUDY DESIGN FORMAT MOR
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discovers evidence of acute serious
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56CTIOM PHYSICAL EXAMINATION PULSSS
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Deep Biceps Triceps Remarks Reflexe
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DIAGNOSTIC SUMMARY SYNOPSIS OF POSI
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PERONEAL NERVE (_!) Active electrod
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MOTOR CONDUCTION ULNAR NERVE (3) Ac
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(e) Disposition Forward the recorde
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(2) If a subject's measured word re
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diurnal variations and some are aff
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(e) Rat i ona 1 e .for. 1 a borat f
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(7_) (hi) (jj (jj (kj HDL Triglycer
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;AL RECORD ANATOMICAL FIGURE 161
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NERVE CONDUCTION VELOCITIES SOCIAL
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Ranch Hand II: Psychometric De-Brie
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Symbolic representations of these i
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Following the removal of the inelig
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Glossary of Abbreviations ABBREVIAT
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trr Special i rjjjCw iiia.f (1020
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