LONG-TERM HEALTH EFFECTS OF PARTICIPATION IN PROJECT SHAD (SHIPBOARD HAZARD AND DEFENSE)
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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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 advisory panel that oversaw the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by Contract No. V101(93)P-1637, T/0#26 between the National Academy of Sciences and the Department of Veterans Affairs. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
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Suggested citation: IOM (Institute of Medicine). 2007. Long-term health effects of participation in Project SHAD (Shipboard Hazard and Defense). Washington, DC: The National Academies Press.
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AUTHORS
WILLIAM F. PAGE (Study Director), Epidemiologist
HEATHER A. YOUNG, Statistician
HARRIET M. CRAWFORD, IT Project Manager
ADVISORY PANEL FOR THE STUDY OF LONG-TERM HEALTH EFFECTS OF PARTICIPATION IN PROJECT SHAD
DANIEL H. FREEMAN, Jr. (Chair), Professor,
University of Texas Medical Branch at Galveston, University of Texas
DAN G. BLAZER, J.P. Gibbons Professor of Psychiatry,
Duke University Medical Center
DONALD S. BURKE, Dean,
University of Pittsburgh Graduate School of Public Health
LINDA D. COWAN, George Lynn Cross Research Professor,
University of Oklahoma College of Public Health
GREGORY C. GRAY, Professor,
College of Public Health, University of Iowa
PETER S. SPENCER, Professor of Neurology and Director,
Center for Research on Occupational and Environmental Toxicology, Oregon Health and Science University
Project Staff
WILLIAM F. PAGE, Study Director
HEATHER A. YOUNG, Statistician
HARRIET M. CRAWFORD, IT Project Manager
NOREEN STEVENSON, Research Assistant
DWAYNE BELL, Programmer Analyst
JIHAD DAGHMASH, Programmer Analyst
JOHN LARSON, St. Louis Records Manager
ROBERT MATHES, Research Associate
ALVAR MATTEI, Senior Program Assistant
RICK ERDTMANN, Director,
Board on Military and Veterans Health/Medical Follow-Up Agency
PAMELA RAMEY-MCCRAY, Administrative Assistant
ANDREA COHEN, Financial Associate
JAMES QUINN, Consultant
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:
Norman Breslow, School of Public Health and Community Medicine, University of Washington
Carlos A. Camargo, Jr., Emergency Medicine Network Coordinating Center, Massachusetts General Hospital
Robert Hoover, Epidemiology and Biostatistics Program, National Cancer Institute
Matthew L. Puglisi, Business Development, Aptima, Inc.
Kenneth R. Still, Occupational Toxicology Associates, Hillsboro, Oregon
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 Dr. Melvin Worth, Scholar-in-Residence, Institute of Medicine. Appointed by the Institute of Medicine, he was 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 authors and the Institute of Medicine.
Preface
Our study of the long-term health effects of participation in Project SHAD (Shipboard Hazard and Defense) posed a number of challenges, including difficulties in identifying all the Project SHAD participants, assembling an appropriate control group, devising and administering a suitable survey instrument, and producing a sound analysis and accompanying report. We could not have achieved the results we did without a great deal of help.
Throughout this study, Institute of Medicine (IOM) staff have relied especially on the good guidance of our expert advisory panel. Its members included experts in biostatistics, epidemiology, survey research, infectious disease epidemiology, toxicology, and military veteran epidemiology. We could not have persevered through all of the difficult challenges we faced without their help and support. Nonetheless, although the expert panel provided sound guidance for which the study and this report are better, the authoring staff take full responsibility for the final product.
We are also grateful especially to the military veterans who provided us with information, support, and encouragement. Without their willingness to donate their time and effort in support of this project, this study would not have been possible.
William F. Page, Ph.D.
Heather A. Young, Ph.D.
Harriet M. Crawford, B.S.
Acknowledgments
The study of the health effects of participation in Project SHAD was a large enterprise, and the list of people who deserve recognition for their contribution is enormous. Members of the Medical Follow-Up Agency (MFUA) data operations staff who worked on this study include Dwayne Bell, Jihad Daghmash, John Larson, Robert Mathes, Al Mattei, and Noreen Stephenson. Richard Miller, former Director of MFUA, provided valuable guidance for this study.
The data collection efforts for the Project SHAD study involved many people outside of MFUA. We appreciate the efforts of Robert Bilgrad and staff at the National Death Index; Barbara Bauman and staff at the National Personnel Records Center in St. Louis, Missouri; the staff at the National Archives in College Park, MD (Archives II); and staff at many federal archives centers and Department of Veterans Affairs (VA) regional offices across the country, especially the VA regional office in the District of Columbia. We relied on a few consultants external to the staff for some technical work critical to the conduct of the study, including Victor Miller, James Quinn, and Ada Youk. We are particularly grateful to SRBI, Inc., who conducted the telephone interviews for our health survey, especially John Boyle, Stephen Dienstfrey, and Paul Schroeder.
The MFUA staff has benefited from the vigilance and enthusiasm of many interested veterans, including Jack Alderson, Robert Bates, Jim Druckemiller, Norman LaChapelle, and John Olsen. The latter two also served on the Project SHAD Task Force, chaired by Jack Devine, of the Vietnam Veterans of America (VVA), whom we also thank for their assistance. We are especially grateful to Rick Weidman and Bernard Edelman, VVA staff, for their help and support throughout the study.
The current members of the Advisory Panel for the Study of Long-Term Health Effects of Participation in Project SHAD (Shipboard Hazard and Defense)—chair Daniel H. Freeman, Jr., Dan G. Blazer, Donald S. Burke, Linda D. Cowan, Gregory C. Gray, and Peter S. Spencer—have helped to ensure the quality of the logic followed in the conduct of this study. We thank them and assume responsibility for whatever items of advice they offered that we did not take.
Mark Brown and Han Kang of the VA have provided us valuable help, and Michael Kilpatrick and his staff at the Department of Defense’s Force Health Protection and Readiness Program (formerly Deployment Health) have been particularly helpful to us. We wish to single out Dee Morris and Roy Finno for their special assistance on this project.
Lara Andersen, Sue Barron, Andrea Cohen, James Jensen, Linda Kilroy, Bronwyn Schrecker, Christine Stencel and the many other staff at the Institute of Medicine and the National Academies all helped along the way. Special thanks to Medical Follow-up Agency Director, Frederick (Rick) Erdtmann, and administrative assistant, Pamela Ramey-McCray, who provided much appreciated support to the project.
We—William Page, Harriet Crawford, and Heather Young Durick—thank everyone on this list (and perhaps a few whose names we have unintentionally omitted) for producing with us this report.
Tables and Figures
TABLES
3-1 |
List of Project SHAD Tests, Ships, or Military Units Involved, and Agents, |
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6-1 |
The Process of Selecting Control Ships, |
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6-2 |
List of Participant and Control Units Showing Selected Characteristics, |
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7-1 |
Number and Percent of FedEx-Delivered Mailings by Source of Address, |
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7-2 |
Number and Percent of FedEx-Delivered Mailings by Mailing Group, |
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7-3 |
Percent Distribution of Various Demographic Characteristics by Participation Status, for All Study Subjects and for Survey Respondents, |
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7-4 |
Percent of Study Subjects with Social Security Number, by Analysis Group, |
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7-5 |
Response Proportions by Analysis Group, Participation Status, and Presence of Social Security Number, |
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7-6 |
Comparison of Mail Questionnaire Versus Telephone Interview Respondents for Selected Characteristics by Percentage Distribution, |
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7-7 |
Percent Distribution of Subjects with a VA Outpatient Visit, by Participation and Response Status, for Various Characteristics, |
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8-1 |
Variables Considered for Analysis and Their Sources, |
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8-2 |
Primary, Secondary, and Tertiary Outcome Variables, |
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8-3 |
SHAD Exposure Groups, |
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9-1 |
Vital Status and Availability of Death Data by Project SHAD Participant Status and Exposure Group, |
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9-2 |
Percentage of Study Subjects with SSN and BIRLS Record, by Exposure Group and Project SHAD Participation Status, |
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9-3 |
Proportional Hazards Analysis of Total Mortality, by Exposure Group, Including All Subjects, Regardless of Completeness of Mortality Follow-Up, |
9-4 |
Proportional Hazards Analysis of Total Mortality, by Exposure Group, Including Only Subjects with SSNs, Presumably with Virtually Complete Mortality Follow-Up, |
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9-5 |
Survival Analysis Using Proportional Hazards Regression: Cause-Specific Mortality Comparing Participants to Controls (Adjusted for Age, Race, Pay Grade, and Branch in Group B Only), Including Only Subjects with SSNs, Presumably with Virtually Complete Mortality Follow-Up, |
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9-6 |
Mortality Analysis Using Standardized Mortality Ratios (SMRs): Observed Number of Deaths and SMRs for Participants and Controls with SSNs for Selected Causes of Death, 1979–2004, by Analysis Group, |
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10-1 |
Availability of Mail Questionnaire and Telephone Interview Data by Analysis Group and Participation Status, |
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10-2 |
Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores, by Analysis Group and Participation Status (Sample Sizes in Parentheses), with Results of t-Test Comparisons, |
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10-3 |
Mean SF-36 Subscale Scores, by Analysis Group and Participation Status, with Results of t-Test Comparisons, |
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10-4 |
Mean SF-36 Summary Scores, by Analysis Group and Various Other Factors, with Results of F-Test Comparisons, |
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10-5 |
Adjusted Mean SF-36 Summary Scores, by Analysis Group, with Results of F-Test Comparisons, |
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10-6 |
Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores for Subjects in Group A (Standard Errors in Parentheses), by Agent, with Adjustment for Age, Race, Branch, Pay Grade, Smoking, Drinking, and Body Mass Index (Model 1) or These Factors Plus Number of Tests (Model 2), |
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10-7 |
Mean SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores (Standard Errors in Parentheses) for Subjects in Group A, by “Dose” of Agent, with Adjustment for Age, Race, Pay Grade, and Branch, |
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10-8 |
Mean Somatization Scores, Unadjusted and Adjusted, for Participants and Controls, by Analysis Group, |
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10-9 |
Mean Memory and Attention Scores, Unadjusted and Adjusted, for Participants and Controls, by Analysis Group, |
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10-10 |
Number of Medical Conditions for Participants and Controls, with Adjusted Odds Ratios (ORs) and 95% Confidence Intervals (CIs), by Analysis Group, |
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10-11 |
Summary of Cancer Types by Group and Participant Status, |
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10-12 |
Ungrouped Medical Conditions by Analysis Group, Comparing Participants to Controls (Navy and Marine Only), |
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10-13 |
Reports of Other Neurodegenerative Diseases by Participant and Group Status, |
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10-14 |
Numbers of Symptoms by Group Comparing Participants to Controls, with Adjusted Odds Ratios (ORs), |
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10-15 |
Proportion of Subjects Hospitalized Since Discharge from Active Duty Comparing Participants to Controls, with Adjusted Odds Ratios (ORs), |
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10-16 |
Birth Defects Among Those Who Fathered a Child Comparing Participants to Controls, with Adjusted Odds Ratios (ORs), |
FIGURES
Abbreviations and Acronyms
BIRLS Beneficiary Identification and Records Locator Subsystem
BUPERS Bureau of Personnel (Navy)
DoD Department of Defense
DTC Deseret Test Center
ICD International Classification of Diseases
IOM Institute of Medicine
IRB institutional review board
IRS Internal Revenue Service
MCS mental component summary score of the SF-36
MFUA Medical Follow-Up Agency
MSN military service number
NCHS National Center for Health Statistics
NDI National Death Index
NHIS National Health Interview Survey
NIOSH National Institute for Occupational Safety and Health
NIS Neuropsychological Impairment Score
OPT outpatient treatment file
PCS physical component summary score of the SF-36
PTF patient treatment file
SHAD Shipboard Hazard and Defense
SMR standardized mortality ratio