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Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol Committee on the Evaluation of the Department of Veterans Affairs Unifonn Case Assessment Protocol Division of Heady Promotion and Disease Prevention INSTITUTE OF MEDICINE IOM NATIONAL ACADEMY PRESS Washington, D.C. 1998

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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 competences and with regard for appropriate balance. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of 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 the president of the Institute of Medicine. This study was supported by the Department of Veterans Affairs under Contract Number V101~93)P-1580. The views presented are those of the Institute of Medicine Committee on the Evalution of the Department of Veterans Affairs Uniform Case Assessment Protocol and are not necessarily those of the funding organization. International Standard Book No. 0-309-06046-X Additional copies of this report are available for sale 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 on-line bookstore at http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at http :I/www2.n as.ed u/io m. Copyright 1998 by the National Academy of Sciences. All rights reserved. Printed in the United States. 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.

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COMMITTEE ON THE EVALUATION OF THE DEPARTMENT OF VETERANS AFFAIRS UNIFORM CASE ASSESSMENT PROTOCOL Arthur K Asbury, M.D. (ChairJ, Van Meter Professor of Neurology, Hospital of the University of Pennsylvania, Philadelphia Dan G. Blazer, II, M.D., Ph.D., M.P.H., Dean of Medical Education and J.P. Gibbons Professor of Psychiatry and Community and Family Medicine, Office of the Dean, Duke University Medical Center, Durham, North Carolina Dedra Stefanie Buchwald, M.D., Associate Professor, Department of Medicine, University of Washington, Harborview Medical Center, Seattle, Washington Jerrold J. Ellner, M.D., Executive Vice Chair, Department of Medicine, Case Western Reserve University, Cleveland, Ohio William E. Golden, M.D., Director, Division of General Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas Bonnie Lepper Green, Ph.D., Professor of Psychiatry, Department of Psychiatry, Georgetown University Medical School, Washington, D.C. Isabel V. Hoverman, M.D., Austin Internal Medicine Associates, L.L.P., Austin, Texas and Clinical Assistant Professor of Medicine, University of Texas Medical Branch, Galveston, Texas Karl T. Kelsey, M.D., M.O.H., Associate Professor of Occupational Medicine, Harvard School of Public Health, Boston, Massachusetts David L. Olive, M.D., Department of Obstetrics and Gynecology, Yale University School of Medicine, New Haven, Connecticut Bernard M. Rosof, M.D., F.A.C.P., Senior Vice President, Medical Affairs, Huntington Hospital, Huntington, New York Board on Health Promotion and Disease Prevention Liaison Elena O. Nightingale,* Scholar-in-Residence, Institute of Medicine and Board on Children, Youth and Families, Washington, D.C. Board on Neuroscience and Behavioral Health Liaison William E. Bunney, Jr.,* Distinguished Professor and Della Martin Chair of Psychiatry, University of California, Irvine, California Staff Lyla M. Hernandez, Study Director Donna D. Thompson, Division Assistant Sanjay S. Baliga, Research Associate Donna M. Livingston, Project Assistant Kathleen R. Stratton, Director, Division of Health Promotion and Disease Prevention Constance M. Pechura, Director, Division of Neuroscience and Behavioral Health * Member Institute of Medicine. . . .

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Preface This report is the third in a series of efforts by the Institute of Medicine to review the protocols used by the DeparOnent of Veterans Affairs (VA) and the Department of Defense (DoD) to diagnose the health complaints of Persian Gulf veterans. The first IOM review began in September 1994 and focused on the DoD implementation of the protocol which is referred to as the Comprehensive Clinical Evaluation Program (CCEP). This diagnostic protocol had been jointly developed and simultaneously implemented in mid-1994 by the VA and the DoD. The early initiation of this review provided the opportunity to analyze information on health complaints and programs collected from the very beginning of the implementation process. In January 1996, the committee issued a final report assessing the adequacy of the clinical procedures described in Me protocol, and providing detailed recommendations to DoD for refining the original clinical approach. The second IOM review initiated in July 1996 again focused on the DoD protocol, this time regarding the diagnosis of difficult-to-diagnose and ill- defined conditions, stress and psychiatric disorders, and health complaints that might be related to low-level exposure to nerve agents. Detailed information available from the existing data system was essential for conducting this evaluation on specific diagnoses in these areas. The final report was published in January 1998. This third review differs from previous efforts in two key respects. First, this committee was charged with a much broader task. In conducting this v

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V1 PREFACE review of the diagnosis of health problems of Persian Gulf veterans, we were asked to examine the VA health care delivery system, a system which differs markedly from that of DoD in both size and patient population. This analysis of the system included evaluating (1) the adequacy of the protocol as a diagnostic toolfor the broad range of medical assessment needs of Persian Gulf veterans, not for specific clinical diagnoses, (2) how well the program was implemented including the process for patients referrals, (3) VA outreach activities, and (4) VA provider education. The timing of this review is a second critical difference. Because the committee began deliberations in February 1997, almost two and a half years after the initial review of the DoD protocol, we had the opportunity to draw upon and benefit from both the IOM evaluations and additional information not heretofore available. For example, information was available reflecting nearly three years of VA experience in implementing the protocol, we could solicit new information from VA facilities regarding the strengths and challenges of the protocol, and we could draw upon recent research literature on health problems of Persian Gulf veterans and on advances made in developing clinical practice guidelines and pathways aimed at improving efforts to diagnose health complaints. The committee was, therefore, in an excellent position to evaluate the adequacy of the system used by the VA to identify and diagnose the health complaints of Persian Gulf veterans. Thus, the recommendations of this report are different from those of previous reports, not only because of the much broader scope of He committee's charge, but also because of recent advances in clinical practice guidelines and quality evaluation approaches, and because of new information available to the committee about the strengths and challenges of the ongoing system. The earlier IOM studies provided important recommendations for implementing and improving the DoD and VA protocol. But any serious evaluation of an ongoing diagnostic screening program will lead, ultimately, to new and improved generations of protocols and systems. The timing and resources available to this committee allowed us to develop recommendations toward that end. Arthur K. Asbury, M.D. Chair, Committee on the Evaluation of the Department of Veterans Affairs Uniform Case Assessment Protocol

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Acknowledgments The committee wishes to express its appreciation to the many individuals who contributed in various ways to the completion of this project. Those who made time in busy schedules to meet with us during our VA facility site visits include Mack Anderson, Kimberly Arlinghaus, Donald Barnes, William Binkley, Tom Bird, Carol Bodenheimer, Thomas Bowen, Andrea Cohen, Tesfai Gabre-Kidan, Arnold Gorin, Larry Hawkins, Steve Hunt, Raye Hurwitz, Susan Killin, Shirley Laday-Smith, Sum Lee, Linda Lewis, Jeff Lindeman, Leonard Marcella, Miles McFall, Patricia Ordorica, Jaime Ortiz-Toto, Warrenson Payne, Tammy Porter, Ron Ratliff, Alfredo Rohaidy, Arthur Rosenblatt, Richard Schrot, B.J. Searles, Phillip Shenefelt, Richard Silver, Charles Smith, Glenn Smith, Philip While, John Wicher, Ruel Wiley, and Timothy Williams. We are also grateful to the following individuals with whom the committee met or from whom information was received: Mark A. Brown, Joseph S. Cassells, Timothy Finnegan, Patricia Jones, Stuart Fleishman, Frances M. Murphy, George Poindexter, Joan P. Porter, Matthew Puglisi, and Joseph Violante. The committee also wishes to extend its thanks to the VA health care facilities and the veterans service organizations who responded to our request for information. We hope we have included all those who contributed to this project. Any omission is inadvertent. This report has been reviewed by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review . . V11

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. . . V111 ACKNOWLEDGMENTS is to provide candid and critical comments that wiI1 assist the authors and the IOM in making the 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 content of 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 participation in the review of this report: Mark R. Cullen, M.D., Yale University School of Medicine; Bernard D. Goldstein, M.D., UMDNJ-Robert Wood Johnson Medical School; John E. Helzer, M.D., University of Vermont College of Medicine; Richard T. Johnson, M.D., Johns Hopkins University School of Medicine; Joseph P. Newhouse, Ph.D., Harvard University; Herbert S. Rigberg, M.D., Health Services Advisory Group, Inc.; and M. Donald Whorton, M.D., M.P.H., M. Donald Whorton, M.D., Inc. While the individuals listed above have provided many constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the IOM.

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Contents EXECUTIVE SUGARY 1 INTRODUCTION 2 THE INSTITUTE OF MEDICINE'S PERSIAN GULF ACTIVITIES 3 THE DEPARTMENT OF VETERANS AFFAIRS PERSIAN GULF REGISTRY AND UNIFORM CASE ASSESSMENT PROTOCOL Persian Gulf Registry, 21 Phase II: Unifonn Case Assessment Protocol, 22 Referral, 22 Data Collection and Reporting, 23 Personnel, 23 Performance Monitoring, 24 Descriptive Statistics, 24 Outreach, 26 Provider Education, 27 4 COMMITTEE ON THE EVALUATION OF THE DEPARTMENT OF VETERANS AFFAIRS UNIFORM CASE ASSESSMENT PROTOCOL Site Visits, 29 Written Testimony, 31 1X 15 19 21 29

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x FINDINGS AND RECOMMENDATIONS Discussion, 33 Diagnostic Process, 34 Implementation and Administration, 42 Outreach, 48 Provider Education, 48 6 CONCLUSION REFERENCES AND SELECTED BIBLIOGRAPHY APPENDIXES A Health Consequences of Service During the Persian Gulf War: Initial Findings and Recommendations for Immediate Action B Health Consequences of Service During the Persian Gulf War: Recommendations for Research and Information Systems Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations D Adequacy of the Comprehensive Clinical Evaluation Program: Nerve Agents Adequacy of the Comprehensive Clinical Evaluation Program: A Focused Assessment VA Phase I Protocol VA Phase II Protocol Persian Gulf Registry Code Sheet VA Persian Gulf Bi-Monthly Report Examples of Persian Gulf Registry Follow-Up Letters VA Monitoring Instrument for Appropriate Medical Care Annual Persian Gulf Conference Agenda M Site Visit Questions N Summary of Responses to Requests for Information O Questions Related to Traumatic Exposure P Patient Satisfaction CONTENTS 33 51 53 67 79 97 105 113 117 123 135 141 145 155 163 167 185 187

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Adequacy of Abe ~ Persian Calf Registry gad firm Case Assessment Protocol

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