Appendix E

Recommendations Made by Previous External Review Bodies

NIH Technology Assessment Workshop (April 1994)**

Recommendations and Comments*
• An evolving case definition might be more appropriately used in developing a research strategy. Comment
• Other cohorts of veterans should be evaluated. Comment
• Establish a more accurate estimate of symptom prevalence. Comment
• A coordinated VA and DOD hospital-based case assessment protocol should be developed to provide uniformly thorough assessment, diagnosis, and treatment. Comment
• Symptom rates should be compared among population groups (e.g., deployed vs. nondeployed, case-controls). Comment
• DOD should develop plans for prompt collection of high-quality relevant data (including baseline data) at any time U.S. forces are deployed in the future. Comment 1, Comment 2

Defense Science Board Task Force on Persian Gulf War Health Effects (June 1994)***

Recommendations and Comments*
• DOD needs substantial improvements in pre- and postdeployment medical assessments and data handling. These must be coordinated with VA. Comment 1, Comment 2
• Clinical treatment, absent a proven etiology, must be managed on a case-by-case basis, directed at the symptoms presented. Carefully controlled treatment protocols might assist in carving out specific syndromes from the broad range of symptoms noted. Comment

Institute of Medicine Committee on the DOD Persian Gulf Syndrome Comprehensive Clinical Evaluation Program****

Recommendations in First Report (December 2, 1994) and Comments*
• The current design of the CCEP represents a serious attempt on the part of DOD to evaluate and treat the health problems of military personnel who served in the Persian Gulf region. However, the research aims of CCEP are not stated explicitly, nor does there appear to be a concrete epidemiologic study plan. Comment
• Need for balance and clear delineation of the clinical care and research functions of the CCEP, especially in light of the apparent use of the CCEP by patients to obtain timely high quality medical care, which would otherwise not be as readily accessible. Comment
• Incorporate consideration of the prominence of stress and psychiatric disorders as diagnoses and/or contributing factors in the CCEP findings. Comment
• Recognition of the division of labor and other resources between local medical treatment facilities and regional medical centers, and between phase I and phase II/III of the CCEP, in light of the large numbers of CCEP patients. Comment

  Recommendations in Second Report (August 7, 1995) and Comments*

• The fact that many CCEP patients receive several diagnoses should be emphasized more in the conclusions of the DOD report. It should be clarified that there are many different combinations of diagnoses among the 10,020 patients. DOD should provide greater detail on additional specific diagnoses, including the categories of infectious diseases, and respiratory, digestive, and nervous system disorders. Comment
• The DOD report includes comparisons between symptoms and diagnoses in the CCEP population and in several other populations but provides no explicit reason for making these comparisons. The draft report implies that a research hypothesis is being tested, but does not state what the hypothesis is. Comment
• The DOD report does not explicitly state that it is likely that at least a few CCEP patients have developed illnesses that are directly related to their Persian Gulf service. This is a serious omission. Comment
• The DOD report concludes that "Based on the CCEP experience to date, there exists no clinical evidence for a new or unique illness or syndrome among Persian Gulf veterans." The reasoning for this statement is not well explained, and DOD states it as though it were self-evident. Comment
• DOD should continue to release its analysis of the CCEP results on a periodic basis. Comment

Institute of Medicine Committee on Health Consequences of Service During the Persian Gulf War (1995)*****

Recommendations: Data and Databases and Comments*
• The VA Persian Gulf Health Registry is not a population database and is not administered uniformly, therefore it cannot serve the purposes of research into the etiology or treatment of possible health problems. It should be limited and specific to gathering information to determine the types of conditions reported; there should be quality control and standardization; and the registry should not be promoted as a means to determine prevalence estimates. In addition, VA should improve publicity about the registry, standardize protocol in the referral centers, and improve the timeliness of data entry. Comment
• The Army Geographical Information System model is the proper approach to understand the characteristics of the population at risk. However, the DOD registry needs to be completed as quickly and accurately as possible. The Secretaries of DOD and VA should develop a single service-connected health record for each present active duty and former service member. Comment1, Comment2
• DOD should maintain its lists of those receiving anthrax and botulinum toxoid vaccines for the purpose of conducting studies on these cohorts. Comment

  Recommendation: Coordination/Process

• Presently, the total number of undiagnosed conditions is unknown because the data either are insufficiently understood or available. The Persian Gulf Veterans Coordinating Board should actively coordinate all studies developed from new initiatives that receive federal funding. Comment1, Comment2

  Recommendation: Considerations of Study Design Needs

• To date, most studies of Gulf War veterans have been piecemeal. They are necessarily incomplete, they usually lack proper controls, they are hard to generalize, and they are subject to grave statistical problems, including low statistical power. VA and DOD should determine the specific research questions that need to be answered and should design epidemiologic studies accordingly. They should collaborate to obtain population-based and controlled data on symptom prevalence, health status, and diagnosed disease. Comment1, Comment2

**National Institutes of Health Technology Assessment Workshop Statement, April 1994.

***Report of the Defense Science Board Task Force on Persian Gulf War Health Effects, June 1994.

****Institute of Medicine, Committee on the DOD Persian Gulf Syndrome Comprehensive Clinical Evaluation Program, 1994, 1995.

*****Institute of Medicine, Committee to Review the Health Consequences of Service During the Persian Gulf War, 1995.