Mortality of Veteran Participants in the CROSSROADS Nuclear Test

Medical Follow-up Agency

INSTITUTE OF MEDICINE by

J. Christopher Johnson

Susan Thaul

William F. Page

Harriet Crawford with oversight from the

Institute of Medicine

Committee on the CROSSROADS Nuclear Test

NATIONAL ACADEMY PRESS
Washington, D.C.
1996



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--> Mortality of Veteran Participants in the CROSSROADS Nuclear Test Medical Follow-up Agency INSTITUTE OF MEDICINE by J. Christopher Johnson Susan Thaul William F. Page Harriet Crawford with oversight from the Institute of Medicine Committee on the CROSSROADS Nuclear Test NATIONAL ACADEMY PRESS Washington, D.C. 1996

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--> National Academy Press 2101 Constitution Avenue, N.W. Washington, DC 20418 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 responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the U.S. Department of Veterans Affairs contract nos.V101(93)P1431 and V101(93)P1165), cofunded by the Defense Special Weapons Agency (formerly, Defense Nuclear Agency). This support does not constitute an endorsement of the views expressed in this report. Library of Congress Catalog Card No. 96-71162 International Standard Book No. 0-309-05596-2 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, N.W. Box 285 Washington, DC 20055 Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's online bookstore at http://www.nap.edu. Copyright 1996 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 Staatlichemuseen in Berlin.

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--> COMMITTEE ON THE CROSSROADS NUCLEAR TEST RICHARD B. SETLOW, Chair, Associate Director for Life Sciences and Senior Biophysicist, Biology Department, Brookhaven National Laboratory, Upton, New York GILBERT W. BEEBE, Statistician, Radiation Epidemiology Branch, National Cancer Institute, Bethesda, Maryland RICHARD L. BOYLAN, Senior Military Reference Archivist, National Archives and Records Administration, College Park, Maryland DANIEL H. FREEMAN, JR., Professor, Office of Biostatistics, University of Texas Medical Branch, Galveston, Texas ETHEL S. GILBERT, Senior Staff Scientist and Statistician, Pacific Northwest Division, Battelle Memorial Institute, Richland, Washington DENNIS F. HOEFFLER, Medical Director, General Electric Lighting, Cleveland, Ohio BARBARA S. HULKA, Professor, Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina KEITH J. SCHIAGER, Director Emeritus, Radiological Health Department, University of Utah, Salt Lake City, Utah SEYMOUR JABLON, Radiation Epidemiology Branch, National Cancer Institute, Bethesda, Maryland (through 1/93) Study Staff J. CHRISTOPHER JOHNSON, Study Director HARRIET CRAWFORD, Operations Team Leader WILLIAM F. PAGE, Biostatistician PAMELA C. RAMEY-McCRAY, Project Assistant SUSAN THAUL, Epidemiologist DENNIS ROBINETTE (through 12/91) YOUN SHIM (6/94–1/95)

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--> BOARD OF THE MEDICAL FOLLOW-UP AGENCY NORMAN BRESLOW, Chair, Professor of Biostatistics, University of Washington, Seattle JOHN C. BAILAR, III, Professor, Department of Epidemiology and Biostatistics, McGill University, Montreal, Canada DAN G. BLAZER, J.P. Gibbons Professor of Psychiatry, Dean of Medical Education, Duke University Medical Center, Durham, North Carolina DONALD L. CUSTIS, Senior Medical Advisor, Paralyzed Veterans of America DAVID G. HOEL, Chairman, Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston MICHEL M. IBRAHIM, Dean, School of Public Health, Department of Epidemiology, University of North Carolina, Chapel Hill BERNARD T. MITTEMEYER, Executive Vice President and Provost, Texas Tech University Health Sciences Center, Lubbock H. ELDON SUTTON, Professor of Zoology, Director, The Genetics Institute, The University of Texas at Austin MARIE G. SWANSON, Professor, Cancer Center at Michigan State University, East Lansing MYRNA M. WEISSMAN, Professor of Psychiatry and Epidemiology, Columbia University, College of Physicians and Surgeons, New York Staff RICHARD N. MILLER, Director, Medical Follow-up Agency CARLISS PARKER-SMITH, Administrative Assistant NANCY DIENER, Financial Associate Operations Team HARRIET CRAWFORD, Operations Team Leader and Senior Programmer/Analyst CHIQUITA BENSON, Programmer/Analyst JIHAD DAGHMASH, Programmer/Analyst NOAH DROPKIN, Coder/Abstractor MARY JUMAN, Senior Program Assistant SYLVIA MCKINNIS, Manager, St. Louis Office NICK FINDLAY, Records Assistant (7/95–6/96) ALEXANDER SAENGER, Programmer/Analyst (9/93–7/95)

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--> Preface In November of 1983 the Congress of the United States passed Public Law 98–160 that directed the Veterans Administration (VA) to provide for the conduct of epidemiological studies of the long-term adverse health effects of exposure to ionizing radiation from detonation of nuclear devices. In response, the Medical Follow-up Agency (MFUA), then in the Commission on Life Sciences, National Academy of Sciences (NAS), proposed to compare the mortality experience of veteran participants in the CROSSROADS nuclear test to a similar group of nonparticipants. Operation CROSSROADS involved approximately 40,000 military personnel, mostly Navy, and occurred in July of 1946 at the Bikini Atoll in the Marshall Islands. The VA convened an ad hoc scientific committee to review the NAS proposal which they recommended should be funded to "enlarge the growing body of information relating to the effects of low levels of radiation on human populations." The study was begun in September of 1986 and in 1988, a committee of the Institute of Medicine was organized to provide guidance and advice to the MFUA staff on the conduct of the study. The study was interrupted by the untimely death of the principal investigator, Dr. Dennis Robinette, in 1992. Both the Committee and MFUA staff wish to acknowledge their debt of gratitude to Dr. Robinette who laid the ground work for this study and assembled the comparison cohort. We regret he was not able to see the fruits of his labors in the publication of this report. The Committee to Study the Crossroads Nuclear Test has met periodically since 1988 to review and guide the work of the MFUA staff as they have conducted the study. As with all research, resources are not boundless, and decisions must be made to apply them where the potential for gain is the

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--> greatest. This study is no exception. While servicemen from all services participated in Operation CROSSROADS about 91 percent were from the Navy and the rest were distributed among the Marine Corps and the Army, which then included the Air Force. We chose to concentrate on the Navy cohort, and the reader will find that the conclusions are based on that group alone. Detailed investigation of the remaining branches of service are left to other ongoing and future studies in which the populations of Army, Air Force and Marines are much larger. Since this is a congressionally mandated study, we expect that these results will be of interest to a wide range of readers from epidemiologists and scientists, to policy makers, veterans, and interested but possibly nontechnical readers. To make the report useful to such a wide audience has been a challenge. Hopefully, the scientists will find the detail and rigor they are accustomed to seeing in a technical report, while the interested readers with training outside the sciences will find sufficient background material to enable them to follow the technical discussion and understand the findings in the context of standard epidemiologic methods. RICHARD B. SETLOW, CHAIR

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--> Acknowledgments The Committee and the authors wish to express their appreciation to the veterans, too numerous to thank individually, who have provided us with information on their participation in CROSSROADS and to the veterans' groups that represent them. We are particularly indebted to Mr. Boley Caldwell of the National Association of Atomic Veterans (NAAV), who gave us the list of CROSSROADS veterans that we used as one source in verifying our participant list; Dr. Oscar Rosen for his perspective on Operation CROSSROADS as a participant and Director of NAAV; Mr. Robert Campbell, for the relevant information and documents he has provided over the course of the study; and Mrs. Pat Broudy, for her insights on the legislative aspects of atomic veteran compensation programs. We have performed this study under Department of Veterans Affairs (VA) contracts (V101(93)P1431 and V101(93)P1165) which were cofunded by the Defense Special Weapons Agency (DSWA). We are appreciative of their support. The DSWA also provided indispensable information about the participants in Operation CROSSROADS study from their Nuclear Test Personnel Review (NTPR) database. In addition to funding, the VA has provided support in ascertaining the mortality of the cohort. We are also in the debt of the National Archives and particularly the National Personnel Records Center, St. Louis MO, and their staffs, who provided us with necessary individual, mortality and unit data. Dr. Eric Gunderson and Dr. Frank Garland of the Naval Health Research Center, San Diego, gave us much useful information on the classification of both ships and personnel within the Navy.

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--> We particularly acknowledge the contributions of the Operations Team of the MFUA, for their untiring, behind-the-scenes work to compile, edit, endlessly query and maintain the files of nearly 80,000 veterans whose records make up the database for this study. Without their expertise and experience in building military study cohorts of this type, the CROSSROADS investigation would not have been possible. Finally, we thank Dr. Richard Miller, director MFUA for his assistance and encouragement, Mrs. Pamela Ramey-McCray for her administrative support, Ms. Nancy Diener for budgetary guidance, and Mr. Peter Slavin for his editorial review.

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--> Glossary and Acronyms A ABLE. Military code name of 1 July 1946 nuclear detonation in Operation CROSSROADS. AMFIT. A statistical modeling program (in the Epicure software package) used to compute standardized mortality ratios (SMRs). B background radiation. Detected disintegration events not emanating from the sample. Natural background is that radiation that is a natural part of a person's environment, primarily terrestrial radioactivity and cosmic rays. BAKER. Military code name of 25 July 1946 nuclear detonation in Operation CROSSROADS. BEIR. Biological Effects of Ionizing Radiation: A series of reports by committees of the National Academy of Sciences. BEIR IV. Biological Effects of Ionizing Radiation, 1988 Report IV (see References). BEIR V. Biological Effects of Ionizing Radiation, 1990 Report V (see References). BIRLS. Beneficiary Identification and Records Locator Subsystem, Department of Veterans Affairs. BRER. Board on Radiation Effects Research, National Research Council. C CDC. Centers for Disease Control and Prevention, DHHS. CFR. Code of Federal Regulations. CI. Confidence interval (epidemiology/statistics). CJTF-1. Commander, Joint Task Force One.

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--> CLL. Chronic lymphocytic leukemia, a form of leukemia that has not been found in studies to be radiogenic. CNS. Central nervous system. cohort study. An epidemiologic investigation or follow-up of a group of individuals who are known to have had an exposure or a disease and whose health status is followed over time. Can usually provide a basis for calculating risk or disease outcome. confounder. A variable that is causally related to the disease under study and is associated with exposure in the study population, but is not a consequence of this exposure. CROSSROADS. Military code name of atmospheric test of nuclear weapons, July 1946, Bikini Atoll, Marshall Islands. D DD-214. Military service discharge form. DHHS. Department of Health and Human Services, USA. DNA. Defense Nuclear Agency. The name was changed to Defense Special Weapons Agency (DSWA) in June 1996. DoD. Department of Defense, USA. dose. The amount of absorbed radiation energy. DSWA. Defense Special Weapons Agency (new name for DNA as of June 1996). E E1-E7. Enlisted personnel paygrades. exposure (radiation). A term describing the amount of ionizing radiation that is incident upon living or inanimate material. F FARC. Federal Archives Records Center. film badge. Photographic film shielded from light; worn by an individual to measure radiation exposure. G gamma ray. Radiation emitted from the nucleus having a wavelength range of 10-9–10-12 centimeters. GAO. General Accounting Office, USA. H HCFA. Health Care Financing Administration, DHHS. I ICD9. International Classification of Diseases, 9th revision. (See References, World Health Organization, 1995) ICRP. International Commission on Radiological Protection. incidence. The number of persons who have developed a disease in a given period of time divided by the total population at risk. IOM. Institute of Medicine.

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--> ionizing radiation. Radiation that produces ion pairs along its path through a substance. irradiation. Exposure to radiation. J JTF. Joint task force. L LTFU. Lost to follow-up. M MFUA. Medical Follow-up Agency, Institute of Medicine. mrem. Millirem, one-thousandth of a rem. MSN. Military service number. mSv. Millisievert, one-thousandth of a Sv. N NAAV. National Association of Atomic Veterans. NARA. National Archives and Records Administration. NAS. National Academy of Sciences. NCRP. National Council on Radiation Protection and Measurements. NDI. National Death Index, maintained by the National Center for Health Statistics, CDC, DHHS. NPRC. National Personnel Records Center. NRC. National Research Council. NRC Nuclear Regulatory Commission. United States government agency regulating by-product material. NRPB. National Radiological Protection Board, U.K. NTPR. Nuclear Test Personnel Review, DNA. O O1–O10. Commissioned officer paygrades. odds ratio (OR). Used as an estimation of relative risk. Primarily used for case-control studies and is calculated from the odds of exposure among the cases to that among controls. OTA. Office of Technology Assessment, U.S. Congress. P p. Probability (epidemiology/statistics, e.g., p = .05). PHREG. Proportional hazards regression program, SAS. R radiation. Energy propagated through space or matter as waves (gamma rays, ultraviolet light) or as particles (alpha or beta rays). External radiation is from a source outside the body, whereas internal radiation is from a source inside the body (e.g., radionuclides deposited in tissues). RADSAFE. Radiation safety monitor units, or personnel. relative risk—RR. The ratio of the incidence of a condition in the exposed population divided by the incidence in the nonexposed population. If there is no difference as a result of exposure, the RR is 1.0.

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--> rem. A unit of radiation dose equivalent; replaced by the sievert. Roentgen (R). Quantity of x-or gamma radiation that produces one electrostatic unit of charge per cubic centimeter of air; a unit of exposure. S SAS. Originally ''Statistical Analysis System,'' proprietary software package. shield (shielding). A body of material used to reduce the intensity of radiation. SI. International System of Units (as instituted in 1960). sievert (Sv). A unit of effective or equivalent dose. Equivalent dose incorporates an adjustment for the fact that different types of radiation (alpha, beta, gamma, neutron) differ in their ability to do biologic damage. Effective dose also incorporates adjustments for the relative sensitivity of different organ systems. The sievert is the SI unit that replaced the rem. SMR. Standardized mortality ratio. SSN. Social Security Number. Sv. sievert. U UNSCEAR. United Nations Scientific Committee on the Effects of Atomic Radiation. A committee of the U.N. General Assembly. US. United States. USS. United States Ship, Navy. V VA. Department of Veterans Affairs. VAMI. Veterans Affairs (was Veterans Administration) Master Index. VARO. Veterans Affairs Regional Office. W W1-W4. Warrant officer paygrades.

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--> Contents     Summary   1 1   Study Rationale and Overview   4     Rationale,   4     Overview,   6 2   Other Studies of the Human Health Effects of Radiation Exposure   8 3   Epidemiology Primer   11     Choice of Comparison Group,   12     Fine Tuning of Exposed Group,   14     Confounders,   14     Data Collection,   15     Interpreting Data Findings,   17     Epidemiology Summary Related to this Study,   19 4   Description of Operation Crossroads   21 5   Data Sources for the Crossroads Study   24 6   The Participant Cohort   27     Independent Verification of Participant Cohort,   29

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-->     Exclusion of "Post-Crossroads" Participants,   29     Crossroads Participants Who Participated in Other Nuclear Tests,   29     Primary Analysis—Navy Personnel Only,   30     Exclusivity of Participant and Comparison Cohorts,   30 7   The Comparison Cohort   31     Comparison Cohort Selection,   31     Navy and Shipboard Marines,   31     Army and Army Air Corps,   33     Military Personnel Records,   33     Additional Controls,   34 8   Exposure Definition, Measurement, and Verification   35     Introduction,   35     Dosimetry Background,   36     Definition of Potential Surrogate Dose Groups,   36     DNA-Provided Dose Estimates,   37     Participant versus Nonparticipant Cohorts as an Exposure Surrogate,   38     Boarders versus Nonboarding Participants versus Nonparticipants as Exposure Surrogates,   39     Engineering & Hull versus Other Specialty Status as an Exposure Surrogate,   39     Relationships of Surrogates with DNA Dose Data,   42     Decisions for the Analyses in this Report,   43 9   Mortality Ascertainment   44     Procedure,   45     Vital Status Ascertainment,   45     Cause and Date-of-Death Ascertainment,   46     Summary of Mortality Ascertainment Quality and Its Potential Effects on Valid Interpretation of the Findings,   46 10   Characterization of the Cohorts and Analysis Plan   49     Data Decisions Taken Before Analysis,   49     Restricting Data Elements or Sample Definition,   49     Data Cleaning and Variable Development,   50     Univariate Descriptions of Study Population,   51     Missing Data,   53     Imputation of Fact and Date of Death,   53     Imputation of Date of Birth,   54     Summary,   54

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-->   Mortality Comparisons, 55   Multivariate Analyses, 56   Cox Proportional Hazards Model, 56   Standardized Mortality Ratios, 59   Analysis of Army (including Army Air Corps) and Marine Data, 60   Not the Subject of Analysis in this Report, 60 11  Findings and Discussion 62   Organization, 62   Findings: Displayed in Tables, 64   Narrative Summary of Findings, 72   Participant Status, 72   Boarder Status/Hypothesized Exposure Gradient, 73   Engineering & Hull Status/Hypothesized Exposure Surrogate, 74   Findings for Marines and Army (including Army Air Corps) Personnel, 74   Discussion, 76   Boarders, 76   Engineering & Hull, 77   Discussion of Other Findings, 78   Other Models and Parameters Considered During Analysis, 79   Standardized Mortality Ratios, 81   Discussion Relating These Findings to Those of Similar Studies, 81   Findings in Other Studies of Atomic Veterans, 81   Selection Bias as an Explanation for Increased Participant All-Cause Mortality, 82   Avenues of Further Exploration, 84 12  Conclusions 86   Summary of Findings, 86  References 89  Appendixes A  National Association of Atomic Veterans (NAAV) Medical Survey, 93 B  Participant Description (DNA memorandum dated July 11, 1994), 99 C  Standardized Mortality Ratios, 105 D  Radiation Doses for CROSSROADS Participants and Exposure Surrogate Groups, 110 E  Verification of Completeness and Accuracy of the Participant Roster, 114 F  Verification of Completeness and Accuracy of Mortality Ascertainment, 128

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--> List of Tables TABLE 6-1.   Distribution of Participation in Nuclear Test Series   30 TABLE 8-1.   Broad Occupational Specialty Groupings of Navy Enlisted Ratings Developed from "Navy Career Paths" (1949)   40 TABLE 8-2.   General Rank/Rating and Occupational Specialty Categories for Navy Personnel   41 TABLE 10-1.   Age-at-Shot Distribution of Navy Participants and Controls   51 TABLE 10-2.   Distribution of Ranks and Ratings Among Navy Participants and Controls   52 TABLE 10-3.   Distribution of Occupational Specialties Among Navy Participants and Controls   53 TABLE 10-4.   Distribution of Boarders in the Study Cohort   53 TABLE 10-5.   Number and Percent of Records with Missing Needed Data Item   54 TABLE 10-6.   Vital Status on Follow-Up   55 TABLE 10-7.   Information Available on Deaths   55 TABLE 10-8.   Definitions of Analysis Variables   57 TABLE 10-9.   ICD9 Mortality Codes Used as Case Definitions for Analyses   58 TABLE 11-1.   Rate Ratios of Major Mortality Endpoints for Exposed to Not Exposed Personnel   65 TABLE 11-2.   Mortality Rate Ratios from Six Selected Major Cause-of-Death Categories (subset of Table 11-1)   66

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--> TABLE 11-3.   Mortality Rate Ratios from Remaining Major Cause-of-Death Categories (subset of Table 11-1)   67 TABLE 11-4.   Mortality Rate Ratios from Selected Cancer Sites within All Malignancies (Table 11-2)   68 TABLE 11-5.   Mortality Rate Ratios for Selected Cancer Sites within Digestive, Respiratory, and Lymphopoietic Cancers (subset of Table 11-4)   69 TABLE 11-6.   Mortality Rate Ratio for Selected Subset of Other Lymphatic Tissue (subset of Table 11-5)   69 TABLE 11-7.   Mortality Rate Ratios for Subset of External Causes (subset of Table 11-2)   70 TABLE 11-8.   Mortality Rate Ratio for Subset of All Accidents (subset of Table 11-7)   71 TABLE 11-9.   Rate Ratios for All-Cause Mortality of Engineering & Hull to Non-Engineering & Hull Groups by Status as Participants or Controls   71 TABLE 11-10.   Mortality Rate Ratios of Participants Relative to Controls (Marines, n = 1,137)   75 TABLE 11-11.   Mortality Rate Ratios of Participants Relative to Controls (Army, including Army Air Corps, n = 6,482)   75 TABLE 11-12.   Nonsignificant Risk Estimates from Tables 11-4 and 11-5 that Indicate at Least a 40 Percent Excess or Deficit in Mortality   80 TABLE 11-13.   All-Cause Mortality Rate Ratios, Including and Excluding Records with Imputed Dates of Birth   80 TABLE C-1.   Standardized Mortality Ratios for All Causes of Death in Navy Participants and Controls   107 TABLE C-2.   Standardized Mortality Ratios for All-Malignancy Deaths in Navy Participants and Controls   108 TABLE C-3.   Standardized Mortality Ratios (SMR) for Leukemia (including CLL) for Navy Enlisted Personnel (n = 66,831)   109 TABLE C-4.   Standardized Mortality Ratios (SMR) for Army (including Army Air Corps, n = 6,482)   109 TABLE C-5.   Standardized Mortality Ratios (SMR) for Marines (n = 1,137)   109 TABLE D-1.   Tabulation of DNA Assigned Total Doses (rem [cSv]) by Study Grouping and Status as a Boarder or Nonboarder   113 TABLE E-1.   Resolution of 617 Apparent Participant Deletions Between 1986 and 1994   119 TABLE E-2.   Summary of Completeness of the NTPR Participant List as Indicated by Veteran Responses to MFUA Solicitations Published in Veterans' Publications   121 TABLE E-3.   Disposition of 103 Records of Putative Participants in CROSS-ROADS Whose Status Was Uncertain   122

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--> TABLE E-4.   Disposition of 89 Discrepant Records from the NAAV Medical Survey List,   123 TABLE E-5.   Summary of Completeness of the NTPR Participant List According to Write-in Data (includes verification of 17 discrepancies by personnel record searches at DNA),   123 TABLE F-1.   Procedural Steps and Success Rates for Determination of Vital Status Information,   129 TABLE F-2.   Vital Status for Navy Personnel,   130 TABLE F-3.   Completeness of Mortality Information,   130 TABLE F-4.   Summary of Vital Status for Study Records Submitted to HCFA,   131 TABLE F-5.   Comparison of VA and HCFA Vital Status for Operation CROSS-ROADS Participants and Controls,   133 TABLE F-6.   Number of Potential Matches for Each Record Submitted to NDI,   135 TABLE F-7.   Comparison of NDI and MFUA Mortality Information,   136 TABLE F-8.   NDI and HCFA Comparisons,   137 TABLE F-9.   Distribution of Causes of Death for 641 Death Certificates Sent for Recoding,   138

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