Clinical Evaluation Program for Gulf War Veterans

Preliminary Status Report on the First 1000 Patients

Department of Defense Report

December 1994

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EXECUTIVE SUMMARY

CLINICAL EVALUATION FOR GULF WAR VETERANS:

PRELIMINARY STATUS REPORT OF THE FIRST 1000 PARTICIPANTS

The Comprehensive Clinical Evaluation Program (CCEP) provides an in-depth medical evaluation of Department of Defense beneficiaries who are experiencing illnesses which may be related to their service in the Persian Gulf. Of the 697,000 individuals who deployed to the Persian Gulf, the CCEP has enrolled approximately 11,000 participants currently eligible for DoD health care. A profile of illness in this small sample cannot, of course, be generalized to the larger Gulf War veteran population as a whole. Preliminary findings based on the evaluation of over 1000 CCEP participants include the following:

The preliminary results of the CCEP are consistent with the conclusions of a National Institutes of Health Technology Assessment Workshop Panel that illnesses reported by Persian Gulf veterans are not a single disease or apparent syndrome, but rather multiple illnesses with overlapping symptoms and causes. DoD has asked the Institute of Medicine, National Academy of Sciences to review some of the results contained in this preliminary report.

In addition to the CCEP, DoD is engaged in a variety of joint research studies with the Departments of Veterans Affairs and Health and Human Services. These studies will evaluate the health consequences of the Persian Gulf War, and contribute to the development of programs to protect the health of military personnel during future deployments.

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CLINICAL EVALUATION PROGRAM FOR GULF WAR VETERANS:

PRELIMINARY STATUS REPORT ON THE FIRST 1000 PARTICIPANTS

I. Purpose:

 The Comprehensive Clinical Evaluation Program (CCEP) provides an in-depth medical evaluation of Department of Defense (DoD) beneficiaries who are experiencing illnesses which may be related to their service in the Persian Gulf. It should be noted that the CCEP was designed primarily as a clinical program (rather than a research study) to diagnose and treat veterans of the Persian Gulf War. The Department expects, however, that the results of this large scale evaluation program will increase our overall understanding of the nature of the illnesses experienced by Persian Gulf War veterans. This preliminary report summarizes program activity through November 30, 1994, and includes results from the first 1,019 participants in the program who have completed their evaluations.

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II. Background:

Approximately 697,000 service members deployed to the Persian Gulf. To date, the Department of Veterans Affairs (VA) has enrolled more than 34,000 veterans within the VA Persian Gulf Registry Health Examination Program, while the CCEP has enrolled about 11,000 participants eligible for DoD health care. Taken together, the number of veterans who have sought care through these special programs account for approximately 6% of all military personnel who deployed to the Persian Gulf. Of those who have sought medical care, most have been treated for diagnosable conditions. Some individuals have reported diverse symptoms which do not fit readily into a common, recognizable diagnosis.

Because of concern for the medical problems of Persian Gulf Veterans, the Assistant Secretary of Defense for Health Affairs announced a three point program, on May 11, 1994. The plan included:

1) the development of an aggressive, comprehensive, clinical diagnostic program to offer intensive examinations to veterans who do not have clearly defined diagnoses,

2) an initial independent review of DoD clinical and research efforts concerning the Persian Gulf War by Dr. Harrison C. Spencer, Dean of The Tulane School of Public Health and Tropical Medicine, New Orleans, LA, and,

3) the creation of a forum of national medical and public health experts to review, comment, and advise DoD concerning the results of the clinical evaluation program.

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III. Status of Initiatives:

The Comprehensive Clinical Evaluation Program (CCEP) began on June 7, 1994, and provides a systematic, in-depth, medical evaluation to all military health care beneficiaries who are experiencing illnesses which may be related to the Persian Gulf War. An executive level DoD/VA Planning Group (Flag Officer Work Group), chaired by the Principal Deputy Assistant Secretary for Health Affairs and with representatives from each of the Services and the VA, meets weekly to monitor and ensure the coordinated interagency, tri-service operation of the program.

As the second part of the three point plan, Dr. Spencer reviewed DoD activities on behalf of the Persian Gulf veterans and concurred in his May 31, 1994, report with the need for DoD and the VA to develop standardized, comparable protocols to evaluate the symptoms reported by Persian Gulf veterans.

As the final point of the DoD plan, the Department has asked the Institute of Medicine (IOM), National Academy of Sciences to review the findings of the CCEP. The IOM assembles distinguished members of appropriate professions to examine policy matters of national public health significance. DoD has requested the formation of an IOM panel consisting of experts in Epidemiology, Occupational Medicine, Internal Medicine, Infectious Diseases, Psychiatry/Psychology, Community Mental Health, and Allergy/Immunology. The panel will review clinical findings from the CCEP, and make recommendations. DoD held its first meeting with the IOM on October 24, 1994, and presented some of the preliminary results contained in this report.

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IV. CCEP Process:

U.S. military personnel who served in the Persian Gulf Theater during Operations DESERT SHIELD/STORM and their eligible beneficiaries may enroll in the CCEP. Participants may go to a nearby Medical Treatment Facility (MTF) to begin the evaluation process, or call a specially created national "Hotline" number to provide initial information to arrange for a medical examination. The initial clinical evaluation phase occurs at the local MTF. Patients are referred to TRICARE Regional Military Medical Centers (TRMCs) for advanced phases. Appendix A lists the CCEP regional referral centers.

The Persian Gulf Veterans' Hotline began operation on June 23, 1994, and accepts calls from 8 A.M to 11 P.M. Eastern Standard Time, Monday through Friday (1-800-796-9699; in Europe, 06371-86-8888 or DSN 486-8888). Developed to provide Persian Gulf veterans easy access to the CCEP, the "Hotline" has received wide publicity throughout the services, reserve units and military publications. Callers to the Hotline number are referred to a VA or DoD medical treatment facility depending on their eligibility for DoD health care. Approximately 20% of callers do not desire an examination, but merely wish to register their names in the CCEP data base. Appendix B summarizes the disposition of referrals through the CCEP Hotline.

The CCEP protocol involves a phased, comprehensive medical evaluation reviewed by internal medicine specialists, and developed in coordination with the VA. Each phase represents a progressively more intensive and specialized diagnostic evaluation. The initial phase consists of a general physical examination, exposure questionnaire, and basic laboratory tests conducted at a local MTF. TRMCs conduct the advanced phases of the protocol which include more sophisticated diagnostic procedures and specialty consultations. An expert panel will review special cases involving patients who have undiagnosed conditions and/or who require further evaluation to establish clearer diagnoses. Additionally, DoD will refer these cases to Specialized Care Centers (SCCs) which are being established to provide innovative diagnostic and therapeutic approaches.

TRMCs are responsible for transmitting patient information on a weekly basis to the Navy Medical Information Management Center (NMIMC), Bethesda, MD, where the data is collected and analyzed. The CCEP process is summarized in Figure 1.

Figure 1: CCEP Process

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V. CCEP Status:

Since the start of the CCEP through November 30, 1994, the program has enrolled approximately four to five hundred registrants weekly resulting in a total of 11,006 individuals desiring a medical examination. Of these 11,006 participants, 1,019 have completed their medical evaluations and their reports have been analyzed at NMIMC. Of the remaining 9,987 participants, 8,743 are in the process of being evaluated, 453 have declined medical evaluation after initially requesting an examination, and 791 are being contacted to schedule an appointment. Appendix C summarizes the status of patients in the CCEP.

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VI. Preliminary Results:

NMIMC has collected and analyzed 1,019 reports of patients who have completely finished their CCEP medical evaluations. These reports have undergone quality review to ensure adequacy of clinical evaluation and consistency of diagnostic coding. Figure 2 summarizes the disposition of patients and completed evaluations.

Figure 2: Disposition of CCEP Patients and Completed Evaluations

Demographics

The demographic characteristics of the first 1,019 CCEP registrants who have completed their clinical evaluations are summarized at Appendix D.

Symptoms

Figure 3 presents commonly reported symptoms (either alone or in combination with other symptoms) based on analysis of 1,019 reports of completed evaluations. Most patients reported multiple common, non-specific symptoms, of which fatigue, joint pain, and headache were the most frequent.

Figure 3: Frequency Distribution of Commonly Reported Symptoms Among 1,019 Completed Evaluations

Diagnoses

Final, completed diagnoses have been tabulated for the 1,019 patients currently in the CCEP data base who have completely finished their diagnostic workup. Specific medical diagnoses for these individuals have been grouped into related categories.

Table 1 presents the frequency of diagnostic categories from completed CCEP evaluations.

Table 1: Frequency Distribution of Primary Diagnoses Among 1,019 Completed CCEP Evaluations

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VII. Preliminary Findings:

Preliminary impressions based upon the review of 1,019 CCEP patients who have completely finished their evaluations include the following:
  1. The majority of the first 1000 CCEP patients (85%) who have completed their CCEP evaluations have a clear diagnosis/diagnoses. These diagnoses represent a broad range of known clinical entities for which these patients are receiving treatment and responding favorably.
  2. Infectious diseases account for relatively few diagnoses (4%) and do not represent a major cause of illness among CCEP patients.
  3. Some patients (24%) have psychologically related medical conditions. Most of these conditions are relatively common in the general population and include such diagnoses as depression, anxiety, tension headache, and stress related disorders. These patients have been provided appropriate treatment and many have responded well.
  4. A small number of patients (14%) who completed their CCEP evaluations have symptoms and diagnoses which are commonly seen in civilian medical practice such as fatigue, headache and sleep disturbances. Some of these patients will require further evaluation to establish clearer diagnoses. These individuals will receive follow-up care by DoD in consultation with the Institute of Medicine.
  5. Based on the CCEP experience to date, there is no clinical evidence for a single or unique agent causing a "Gulf War Syndrome". The preliminary results of the CCEP are consistent with conclusions of a National Institutes of Health Technology Assessment Workshop that unexplained illnesses reported by Persian Gulf veterans are not a single disease or apparent syndrome, but rather multiple illnesses with overlapping symptoms and causes.
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VIII. Further Efforts:

Future Directions of the CCEP

Given the large number of individuals wishing to participate in the CCEP since its inception four months ago, data collection and analysis are still at an early stage. Preliminary clinical results of the CCEP indicate that most patients have relatively common, diagnosable and treatable illnesses. In the future, the CCEP will concentrate on accomplishing a greater proportion of evaluations at local medical treatment facilities in order to allow patients to receive follow up from their primary care physicians. DoD is establishing Specialized Care Centers for those individuals who may require further evaluation and treatment for conditions possibly related to environmental and/or psychosocial stressors associated with deployments. In the interim, DoD is continuing to work closely with the VA in a coordinated and intensive effort to determine as well as is possible, the nature of illnesses being experienced by Gulf War veterans.

Research Efforts

DoD is engaged in a variety of collaborative research projects with the VA and Department of Health and Human Services to assess the health consequences of military service during the Gulf War. These research activities span a broad range of areas. Several large epidemiologic studies will compare morbidity and mortality statistics between those who were deployed to the Persian Gulf with those military members who were not deployed. Other projects underway include studies to assess reproductive health, Leishmaniasis research, the health effects of exposure to depleted uranium, and research to determine possible interactive effects of certain chemical compounds used during the Gulf War. These studies will evaluate the health consequences of the Persian Gulf War, and contribute to the development of programs to protect the health of military personnel during future deployments.

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APPENDICES

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