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IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS

Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans

Board on Military and Veterans Health

Jonathan M. Samet and Catherine C. Bodurow, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans Board on Military and Veterans Health Jonathan M. Samet and Catherine C. Bodurow, Editors

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee respon- sible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. V101 (93) P-2136 between the National Academy of Sciences and United States Department of Veterans Affairs. Any opin- ions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-10730-3 International Standard Book Number-10: 0-309-10730-X Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2008. Improving the presumptive disability decision-making process for veterans. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general wel- fare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON EVALUATION OF THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS JONATHAN M. SAMET (Chair), Professor and Chair, Department of Epidemiology, Jacob I. and Irene B. Fabrikant Professor in Health, Risk, and Society, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD MARGARET A. BERGER, Suzanne J. and Norman Miles Professor of Law, Brooklyn Law School, NY KIRSTEN BIBBINS-DOMINGO, Assistant Professor of Medicine and of Epidemiology, Biostatistics, University of California, San Francisco ERIC G. BING, Endowed Professor of Global Health and HIV, Charles R. Drew University of Medicine and Science, Los Angeles, CA BERNARD D. GOLDSTEIN, Professor of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh, PA GUY H. McMICHAEL III, President, GHM Consulting, Washington, DC JOHN R. MULHAUSEN, Director, Corporate Safety and Industrial Hygiene, 3M Company, St. Paul, MN RICHARD P. SCHEINES, Professor and Head, Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA KENNETH R. STILL, President and Scientific Director, Occupational Toxicology Associates, Inc., Hillsboro, OR DUNCAN C. THOMAS, Verna Richter Chair in Cancer Research, Professor, and Director, Biostatistics Division, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles SVERRE VEDAL, Professor, Department of Environmental and Occupational Health Sciences, University of Washington School of Public Health and Community Medicine, Seattle ALLEN J. WILCOX, Senior Investigator, Epidemiology Branch, National Institute of Environmental Health Sciences, and Editor-in-Chief of Epidemiology, Durham, NC SCOTT L. ZEGER, Frank Hurley-Catharine Dorrier Professor and Chair, Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD LAUREN ZEISE, Chief, Reproductive and Cancer Hazard Assessment Branch, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, Oakland v

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Volunteer Scientific Consultant MELISSA McDIARMID, Professor of Medicine, Occupational Health Program, University of Maryland School of Medicine, Baltimore Consultant ROBERT J. EPLEY, Independent Consultant, Waxhaw, NC Staff CATHERINE BODUROW, Study Director MORGAN A. FORD, Program Officer (May-August 2007) LESLIE SIM, Program Officer (February-May 2006) ALICE VOROSMARTI, Research Associate (May-August 2007) CARA JAMES, Research Associate (June 2006-May 2007) ANISHA DHARSHI, Research Associate (June 2006-January 2007) KRISTEN BUTLER, Research Assistant (March-July 2007) KRISTEN GILBERTSON, Research Assistant (February-July 2006) JON Q. SANDERS, Program Associate (March 2006-May 2007) REINE Y. HOMAWOO, Senior Program Assistant (May-August 2007) VERA DIAZ, Intern (February-April 2007) vi

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BOARD ON MILITARY AND VETERANS HEALTH ROBERT B. WALLACE (Chair), Professor of Epidemiology and Internal Medicine, and Director, Center on Aging, College of Public Health, University of Iowa, Iowa City GEORGE K. ANDERSON, Executive Director, Association of Military Surgeons in the United States, Bethesda, MD MICHAEL S. ASCHER, Senior Medical Advisor, Defense Biology Biosciences Directorate, Lawrence Livermore National Laboratory, Livermore, CA ARTHUR J. BARSKY, Professor of Psychiatry, Harvard Medical School, and Director of Psychiatric Research, Brigham and Women’s Hospital, Boston, MA DIANA D. CARDENAS, Professor and Chair, Department of Rehabilitation Medicine, University of Miami, FL LINDA D. COWAN, Professor, University of Oklahoma College of Public Health, Oklahoma City TIMOTHY R. GERRITY, Senior Partner, Noventus Medical, Worcester, MA KATHERINE L. HEILPERN, Acting Chair, Department of Emergency Medicine, Emory School of Medicine, Atlanta, GA MYRON M. LEVINE, Head, Division of Geographic Medicine, and Director, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore SUSAN H. MATHER, Department of Veterans Affairs (Retired), Bowie, MD MATTHEW L. PUGLISI, Director, Business Development, Aptima, Inc., Washington, DC PHYLLIS W. SHARPS, Professor and Director, Master’s Program, Johns Hopkins University School of Nursing, Baltimore, MD ERNEST T. TAKAFUJI, Director, Office of Biodefense Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD Board Staff FREDERICK ERDTMANN, Director PAMELA RAMEY-McCRAY, Administrative Assistant ANDREA COHEN, Financial Associate IOM boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the reports rests with the authoring committee and the institution. vii

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Dan G. Blazer, Duke University Medical Center Mark R. Cullen, Yale University School of Medicine Lynn R. Goldman, Johns Hopkins Bloomberg School of Public Health Steven N. Goodman, Johns Hopkins University School of Medicine Robert F. Herrick, Harvard School of Public Health Susan H. Mather, Department of Veterans Affairs (Retired) Francis L. O’Donnell, Department of Defense’s Force Health Protection and Readiness Programs Louise M. Ryan, Harvard School of Public Health Patrick Ryan, PricewaterhouseCoopers David A. Savitz, Mount Sinai School of Medicine Harold C. Sox, American College of Physicians and Internal Medicine Michael A. Stoto, Georgetown University ix

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x REVIEWERS Judith P. Swazey, The Acadia Institute Joseph Thompson, Aequus, Inc. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Gilbert S. Omenn, University of Michigan Medical School, and Willard G. Manning, Univer- sity of Chicago. Appointed by the National Research Council and Institute of Medicine, respectively, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface This committee, the Committee on Evaluation of the Presumptive Dis- ability Decision-Making Process for Veterans (Committee), was charged with describing the current process for how presumptive decisions are made for veterans who have health conditions arising from military service and with proposing a scientific framework for making such presumptive deci- sions in the future. Although an individual veteran can establish a direct service connection for an illness, the needed information on the responsible exposure received during military service may be unavailable or incom- plete. Additionally, there may be scientific uncertainty as to whether the exposure is known to cause the health condition. To ensure that veterans are compensated when information for direct service connection is needed but unavailable, Congress or the Secretary of the Department of Veterans Affairs (VA) can decide to service connect entire groups of veterans for specific health conditions due to exposures received during service. This decision to compensate particular groups of veterans is called a presump- tive disability service-connection decision or, simply, a presumption. A pre- sumption may address unavailable or incomplete information on exposure or gaps in the evidence as to whether the exposure increases risk for the health condition. Each veteran identified as eligible for coverage under a presumptive decision will have a separate, individual disability rating conducted by the VA and will be eligible for disability compensation based on the nature and severity of the health condition. That is, the presumptive disability service- connection decision is separate from the rating evaluation and compensa- tion process. xi

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xxii TABLES, FIGURES, AND BOXES 9-1 Hypothetical Example of Risks from Multiple Causal Exposures, 209 9-2 Hypothetical PAFs Due to Smoking and Military Exposure, 210 9-3 True and False Positive and Negative Rates, 215 9-4 Comparing Sensitivity and Specificity of Two Hypothetical Sets of Compensation Criteria, 216 9-5 Hypothetical Scenario 1: PPV When AF = 50 Percent, 217 9-6 Hypothetical Scenario 2: PPV When AF = 9 Percent, 217 9-7 Hypothetical Scenario 3: PPV When AF = 2 Percent, 218 10-1 Timeline for Medical Surveillance and Exposure Data Collection, 242 10-2 Service-Specific Databases for Exposure, 257 10-3 Summary of VET Registry Projects, 267 10-4 National Academies’ and VA Medical Monographs on Veterans’ Health by Theater or Exposure, 268 10-5 VA Health Registries, 274 FIGURES GS-1 Proposed framework for future presumptive disability decision- making process for veterans, 4 S-1 Roles of the participants involved in the presumptive disability decision-making process for veterans, 11 S-2 Proposed framework for future presumptive disability decision- making process for veterans, 17 3-1 Roles of the participants involved in the presumptive disability decision-making process for veterans, 53 6-1 Information gathering and its use in making general and specific compensation decisions, 139 7-1 Causal and spurious associations, 158 7-2 Scenario for causation without association, 158 7-3 The power of randomization, 161 7-4 Age as a confounder, 163 7-5 Unmeasured confounders, 163 7-6 TV and obesity, 163 7-7 Instrumental variable, 165 7-8 Rothman’s sufficient component causes model, 167

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xxiii TABLES, FIGURES, AND BOXES 8-1 Hypothetical illustrations, 179 8-2 Focusing on unmeasured confounders/covariates, or other sources of spurious association from bias, 180 8-3 IARC evaluation scheme, 184 8-4 Example posterior for Sufficient, 190 8-5 Example posterior for Equipoise and Above, 191 8-6 Example posterior for Below Equipoise, 192 8-7 Example posterior for Against, 193 9-1 Example of ROC curves, 219 9-2 “Economically rational” compensation plan, based on the attributable fraction, 225 9-3 Complete compensation (100 percent) for all exposed persons with disease, regardless of attributable fraction, 225 9-4 Complete compensation for all exposed persons only when attributable fraction is 50 percent or more, 226 9-5 Complete compensation for an AF of 50 percent or more, plus graduated compensation below 50 percent, 227 9-6 A rational process for determining veterans’ compensation, 228 10-1 Timeline for medical surveillance and exposure data collection, 241 10-2 DoD’s deployment health surveillance elements, 256 10-3 National Defense Occupational and Environmental Health Readiness System (DOEHRS), 258 12-1 Proposed framework for future presumptive disability decision- making process for veterans, 311 BOXES 3-1 Representatives at Each Tier of VA’s Internal Review of NAS Reports, 59

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Acronyms and Abbreviations ACB Army Classification Battery ACES-EM Automated Civil Engineering System-Environmental Management ACHRE Advisory Committee on Human Radiation Experiments ADA American Diabetes Association AEC Atomic Energy Commission AF Attributable fraction AF-EMIS Air Force Environmental Management Information System AFCESA Air Force Civil Engineer Support Agency AFHLTA Armed Forces Health Longitudinal Technology Application AFHS Air Force Health Study AFHSC Armed Forces Health Surveillance Center AHA American Heart Association AHLTA Armed Forces Health Longitudinal Technology Application AhR Aryl hydrocarbon receptor AIDS Acquired immunodeficiency syndrome AIS Automated information systems ALS Amyotrophic lateral sclerosis (Lou Gehrig’s disease) AML Acute myelogenous leukemia ANG Air National Guard ANLL Acute non-lymphocytic leukemia xxv

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xxvi ACRONYMS AND ABBREVIATIONS APIMS Air Program Information Management System AS Assigned share ASTM American Society for Testing and Materials ATSDR Agency for Toxic Substances and Disease Registry BEIR Biological Effects of Ionizing Radiation BMI Body mass index C&P Service Compensation and Pension Service CCB Configuration Control Board CCS Command Core System (Air Force) CDC Centers for Disease Control and Prevention CDVA Commonwealth Department of Veterans’ Affairs CERHR Center for the Evaluation of Risks to Human Reproduction CES-D Centers for Epidemiological Studies-Depression Scale CFR Code of Federal Regulations CHD Coronary heart disease CHF Congestive heart failure CHPPM Center for Health Promotion and Preventive Medicine (Army) CI Confidence interval CIA Central Intelligence Agency CIRRPC Committee on Interagency Radiation Research and Policy Coordination CLL Chronic lymphocytic leukemia CNS Central nervous system COPD Chronic obstructive pulmonary disease CRDP Concurrent Retirement and Disability Payments CRS Congressional Research Service CRSC Combat-Related Special Compensation CSM Cerebrospinal malformation CSP Cooperative Studies Program CVD Cardiovascular disease DALY Disability-adjusted life year DCI SCI Director of Central Intelligence Sensitive Compartmented Information Programs DECC-D Defense Enterprise Computing Center-Detachment DHHS Department of Health and Human Services DISA Defense Information Systems Agency DMDC Defense Manpower Data Center

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xxvii ACRONYMS AND ABBREVIATIONS DMSS Defense Medical Surveillance System DNBI Disease and nonbattle injury DoA Department of the Army DoD Department of Defense DoDI Department of Defense Instruction DOE Department of Energy DOEHRS Defense Occupational and Environmental Health Readiness System DoL Department of Labor DSM-III-R Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised DTAS Defense Theater Accountability Software EA Exposure Assessment EAR Excess absolute risk EEOICPA Energy Employees Occupational Illness Compensation Program Act EESOH-MIS Enterprise Environmental Safety and Occupational Health-Management Information System EO Executive Order EPA Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act ERIC Epidemiologic Research and Information Center ERR Excess relative risk FECA Federal Employees’ Compensation Act FERS Federal Employees Retirement System FHIE Federal Health Information Exchange FHP Force Health Protection fMRI Functional magnetic resonance imaging FN False negative FNR False negative rate FOUO For official use only FP False positive FPR False positive rate FR Federal Register FY Fiscal Year GAF Global Assessment of Functioning GAO Government Accountability Office GBD General birth defect GBS Guillain-Barre syndrome

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xxviii ACRONYMS AND ABBREVIATIONS GPS Global Positioning System GT test General Technical test GW Gulf War Gy Gray (measure of dose of irradiation) HART Health Assessment Review Tool HCFA Health Care Financing Administration HEW U.S. Department of Health, Education, and Welfare HHIM Health Hazard Information Module HIV Human immunodeficiency virus HMMS Hazardous Materials Management System HUS Hemolytic-uremic syndrome IARC International Agency for Research on Cancer ICD International Classification of Diseases IH Industrial hygiene IHIMS Industrial Hygiene Information Management System (Navy) IOM Institute of Medicine IQ Intelligence quotient IREP Interactive RadioEpidemiological Program IU Individual unemployability LIMDIS Limited Dissemination LMF Lovelace Medical Foundation MDS Myelodysplastic syndrome MFUA Medical Follow-up Agency MMPI Minnesota Multiphasic Personality Inventory MOA Memorandum of Agreement MOS Military occupational specialty MRI Magnetic resonance imaging MS Multiple sclerosis MTF Military Treatment Facility NAS National Academy of Sciences NCEH National Center for Environmental Health NCHS National Center for Health Statistics NCI National Cancer Institute NEHC Navy Environmental Health Center NESHAP National Emission Standards for Hazardous Air Pollutants NHANES National Health and Nutrition Examination Survey NHL Non-Hodgkin’s lymphoma

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xxix ACRONYMS AND ABBREVIATIONS NHLBI National Heart, Lung, and Blood Institute NHS Nurses Health Study NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health NOCONTRACT Not releasable to contractors NOED Navy Occupational Exposure Database NOFORN Not releasable to foreign nationals NPV Negative predictive value NRC National Research Council NTP National Toxicology Program NTS Nevada Test Site OEF Operation Enduring Freedom OEH Occupational and environmental health OEHHA Office of Environmental Health Hazard Assessment OEHS Occupational environmental health and safety OEL Occupational exposure limit OGC Office of the General Counsel OH Occupational health OHMIS Occupational Health Management Information System OIF Operation Iraqi Freedom OMB Office of Management and Budget OPHEH Office of Public Health and Environmental Hazards OPM Office of Personnel Management OR Odds ratio ORCON Originator controlled dissemination and extraction of information ORD Office of Research and Development OSHA Occupational Safety and Health Administration OSTP Office of Science and Technology Policy PAF Population attributable fraction PAR Population attributable risk PC Probability of causation PCB Polychlorinated biphenyl PDDM Presumptive disability decision making PHA Periodic health assessment PKDL Post-kala-azar dermal leishmaniasis PL Public Law POM Program Objectives Memorandum POW Prisoner of War PPB Parts per billion PPG Pacific Proving Grounds

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xxx ACRONYMS AND ABBREVIATIONS PPM Parts per million PPV Positive predictive value PSA Prostate-specific antigen PSG II Professional Staffing Group II PTF Presidential Task Force PTSD Posttraumatic stress disorder PY Person-year RADS Reactive airways dysfunction syndrome RCT Randomized controlled/clinical trial RD Restricted data ReA Reactive arthritis RECA Radiation Exposure Compensation Act of 1990 RECAC Radiation Exposure Compensation Act Committee REVCA Radiation-Exposed Veterans Compensation Act RO Rey-Osterreith Test ROC Receiver Operator Characteristics curve RR Relative risk/risk ratio RTI Research Triangle Institute SAD Service-attributable disease SAF Service-attributable fraction SANG Saudi Arabian National Guard SAP Special Access Program SCI Sensitive Compartmented Information SCID Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders SCL Symptoms Checklist SEER Surveillance Epidemiology and End Results SEG Similar exposure group SES Socioeconomic status SF Standard Form SFFWG Shared Functions Focus Working Group SHAD Project Shipboard Hazard and Defense SMITREC Serious Mental Illness Treatment Research and Evaluation Center SMR Standardized mortality ratio SSA Social Security Administration SSDI Social Security Disability Insurance SSI Supplemental Security Income TBI Traumatic brain injury TCDD Tetrachlorodibenzo-p-dioxin

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xxxi ACRONYMS AND ABBREVIATIONS TN True negative TNR True negative rate TP True positive TPR True positive rate UNSCEAR United Nations Scientific Committee on the Effects of Atomic Radiation USC United States Code USPSTF U.S. Preventive Health Services Task Force VA Department of Veterans Affairs VAO Veterans and Agent Orange VASRD Veterans Administration Schedule for Rating Disabilities VBA Veterans Benefits Administration VDBC Veterans’ Disability Benefits Commission VDRECSA Veterans’ Dioxin and Radiation Exposure Compensation Standards Act VES Vietnam Experience Study VET (registry) Vietnam Era Twin (registry) VHA Veterans Health Administration VHI Veterans Health Initiative VISTA Veterans Health Information Systems and Technology Architecture VOC Volatile organic compound VSO Veterans Service Organization WAIS-R Wechsler Adult Intelligence Scale-Revised WNINTEL Warning notice, intelligence sources, and methods involved WRIISC War-Related Illness and Injury Study Centers WWI World War I WWII World War II YLD Years of life lived with disability YLL Years of life lost

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