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Appendix B Health Consequences of Service During the Persian Gulf War: Recommendations for Research and Information Systems* CHARGE TO THE COMMITTEE: ITS FINDINGS AND RECOMMENDATIONS Overview In this chapter we summarize the findings and principal recommendations of the Committee to Review the Health Consequences of Service During the Persian Gulf War (POW). Most of the findings are discussed at greater length in the chapters that follow. Our task was to respond to Free specific charges. Each finding is linked to at least one of the charges, and for each we note the principal connection. Recommendations follow each of the findings. The committee was charged as follows. These findings and recommendations were taken from the Institute of Medicine report, Health Consequences of Service During the Persian Gulf War: Recommendations for Research and Information Systems, Washington, D.C.: National Academy Press, 1996. 67

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68 ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP THE COMMITTEE'S CHARGE Charge 1 Assess the effectiveness of actions taken by the Secretary of Veterans Affairs and the Secretary of Defense to collect and maintain information that is potentially useful for assessing the health consequences of military service referred to subsection (a) [of PL 102-585, Persian Gulf (PG) theater of operations during the POW]. The committee makes four recommendations (recommendations 13-16) in this report regarding the collection and maintenance of information that is potentially useful for assessing the health consequences of military service in the POW. These recommendations support completion of certain data sets, prompt reporting of research findings and submission for publication in peer- reviewed journals, strengthened medical and epidemiologic research capabilities of the aimed forces, and strengthening the decision-making processes for study selection. Charge 2 Make recommendations on means of improving the collection and maintenance of such information. The committee males five recommendations (recommendations 1, 4, and 8-10) on the collection and maintenance of information on He health consequences of service in the PG. We also give considerable attention to information systems that would be usefi~1 in fixture conflicts. These recom- mendations are based largely on experience with systems in place for the POW that have shown some gaps and defects that can be remedied. Charge 3 Make recommendations as to whether there is [a] sound scientific basis for an epidemiologic study or studies of the health consequences of such service, and if the recommendation is that there is [a] sound scientific basis for such a study or studies, the nature of the study or studies.

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APPENDIX B 69 The committee believes that there is indeed a sound basis for epidemiologic studies, and eight recommendations follow (recommendations 2, 3, 5-7, and 11-13~.~ However, the committee does not recommend an additional nationwide epidemiologic study of PG veterans, because such a study is likely to be of limited scientific value at this time. Those large studies that are contently under way should be completed as quickly as possible, while meeting high scientific standards, including a high response rate and a thorough investigation of potential biases, as recommended below. FINDINGS AND RECOMMENDATIONS Finding Recent military deployments, especially in Vietnam and in the Persian Gulf, have demonstrated that concerns about the health consequences of participation in military action may arise long after deployment has ended and that the evaluation of those concerns and the provision of health care to affected personnel may present formidable challenges both to epidemiologists and to medical caregivers. Although some of these challenges can be attributed to the intrinsic difficulty of evaluating poorly understood clusters of events that were not among the expected consequences of combat or of environmental conditions, they also may be attributed in part to limitations of the systems used to collect and manage data regarding the health and service-related exposures of military personnel. No system of record keeping can be expected to provide the information needed to address every unanticipated research issue, including those regarding the health consequences of military service. Nevertheless, the committee has identified several possible improvements in the systems and practices for collecting information on the health and service-related exposures of military personnel. Such changes would increase the ability of the military services to pursue appropriate investigations in the fixture. Such changes also would increase the capacity of the services to evaluate the efficacy of mobilization-supporting health services (including approaches and methodologies for disease prevention employed before, during, and abler mobilization) and would aid in providing the best possible medical care to military service personnel and veterans (Charge 29. Recommendation 1. The Department of Defense (DoD), the branches of the aimed services, and the Department of Veterans Affairs (DVA) Recommendation 13 has been counted as applicable to both Charge 1 and Charge 3, and therefore appears with both.

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70 ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP should continue to work together to develop, fund, and staff medical information systems that include a single, uniform, continuous, and retrievable electronic medical record for each service person. The uniform record should include each relevant health item (including baseline personal risk factors, every inpatient and outpatient medical contact, and all health-related interventions), allow linkage to exposure and other data sets, and have He capability to incorporate relevant medical data from beyond DoD and DVA institutions (e.g., U.S. Public Health Service facilities, civilian medical providers, and other health care institutions). Appropriate consent and protection of individual privacy must be considered for information obtained and included. Finding The number and variety of studies regarding consequences of the POW are already considerable. To date, most health-related studies specifically involving POW veterans have focused on short-term mental health consequences of deployment, the role of combat exposure, and other stressors experienced in the theater of operations and, to a lesser extent, on problems relating to demobilization and readjustment to civilian life among reservist and National Guard personnel. A few reports have included limited longitudinal follow-up data concerning men and women who served in the PG. Important information may be gained through longer follow-up of some of these groups, particularly since at least one of these groups was first to arrive in the theater, and precombat data are available. Also needed are studies of risk factors in modern deployments predictive of combat stress reactions, posttraumatic stress disorder (PTSD), and other psychiatric disorders of military personnel and veterans. Studies relevant to the trauma of war and the ensuing mental health consequences should concentrate special attention on improving efforts in prevention, intervention, and follow-up (Charge 3~. Recommendation 2. The DoD and DVA should conduct furler studies, with appropriate statistical and epidemiological support, to identify risk factors for stress-related psychiatric disorders among military personnel (active and reserve) and to develop better methods to buffer and ameliorate the psychiatric consequences of modern training, deployment, combat, demobilization, and return to daily . . lVmg. Recommendation 3. Studies being conducted by DoD and DVA that have included longitudinal follow-up of the mental health of veterans

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APPENDIXB who served in the PG should be supported with continued follow-up after appropriate peer review of study methods. Follow-up in these studies should be sufficient to provide at least a decade of information comparing the mental health status of those deployed with those not deployed. Finding 71 The milieus dominance of U.S. forces in the POW increased the relative si=~fic=~e of physical and natural environmental exposures as important sources of potential morbidity and mortality, compared with combat injuries. This is likely to recur in future deployments (Charge 2~. Recommendation 4. The DoD should ensure that military medical preparedness for deployments includes detailed attempts to monitor natural and man-made environmental exposures and to prepare for rapid response, early investigation, and accurate data collection, when possible, on physical and natural environmental exposures that are known or possible in the specific theater of operations. Enwinding National Guard and reserve component personnel may differ substantially from active duty personnel in average age, level of training, occupational specialties, family status, and readiness for deployment. Further, it is unclear whether either policies and procedures or the manner in which they are implemented differs between activated reserve or National Guard units and active duty troops for mobilization, deployment, demobilization, and return. All of these factors may affect the health consequences of deployment (Charge 3~. Recommendation 5. Research is needed to determine whether differences in personal characteristics or differences in policies and procedures for mobilization, deployment, demobilization, and return of reserves, National Guard, and regular troops are associated with different or adverse health consequences. If there are associations, strategies necessary to prevent or reduce these adverse health effects should be developed.

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72 ADEQUACY OF THE VA PERSIAN GULFREGISTRY AND UCAP Finding Completed studies have described the mortality experience of troops deployed to the PG during the period of deployment and in the 2-year period after deployment. These studies have documented a consistent pattern of increased risk of death from unintentional injury for the cohort of deployed troops compared with those not deployed to the PG. However, death rates from disease were not significantly increased. Continued monitoring and further study of mortality rates among veterans of the POW will be of value in assessing the long-term health consequences of deployment (Charge 3~. Recommendation 6. The mortality experience of PG veterans should continue to be monitored for as long as 30 years, on a regular basis, including comparisons with that of PG-era veterans. (PG-era veterans have been defined as those in military service at the time of the POW, but assigned or deployed elsewhere.) Research investigators should focus on the reported excess mortality from unintentional injury, on mortality from specific illnesses, and on evidence of elevation (or reduction) in the risk of death from other causes. Recommendation 7. The DVA should exert greater effort to improve understanding of the reasons for excess mortality from unintentional injury. Detailed evaluation is needed beyond death certificate data concerning the circumstances surrounding fatal injury through more focused case-control studies to identify both individual risk factors and remediable causes. Finding The anned services and the DVA together are developing a shared basic epidemiological data system, the Defense Medical Epidemiological Database (DMED) (Charge 2~. Recommendation 8. The DMED system should be continued, expanded as planned, expedited to develop the proposed integrated information management system, linked to other key systems, and evaluated regularly.

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APPENDIX 73 Finding Considerable effort has been devoted by DoD to the development of a Troop Exposure Assessment Model (TEAM) for describing the POW experience of veterans. This has included the completion of an information s3tstem~des~gned to establish the geographic location of each unit from January 15, 1991, until the unit departed from the Gulf theater. This system has the potential to be linked to data on regional environmental conditions but will necessarily be devoid of most individual data (such as pesticide exposure or individual health risk factors) (Charge 2~. Recommendation 9. The DoD should complete development of information systems to expeditiously and directly pinpoint unit locations at a high level of disaggregation in space and time (that is, fine detail) and to document local environmental conditions, including appropriate data quality checks, with direct data entry into the system. There is likely to be a need for a similar information system during and after any future conflict, and DoD should prepare and continually update plans for such a nonpaper system. A manual for use of the information systems by research investigators should be compiled, with the strengths and limitations identified. Finding The power and complexity of analyses based on space-time geographical information system (GIS) data require careful attention to data quality and the limits imposed by various data items. Quality improvement and assessment of limits are continuous processes and depend on detailed evaluation of data needs for specific analytic questions (Charge 2~. Recommendation 10. For every specific question posed to the current TEAM, DoD should assess the strengths and limitations of the TEAM as a resource for evaluating the health significance of geographically defined exposures of troops, including those in the POW and those in conflicts that may develop in the future. Evaluations and recom- mendations for possible modification of the TEAM should be reported to the PG Coordinating Board, Research Working Group.

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74 ADEQ US CY OF THE VA PERSL4N G ULF REGISTR Y AND UCAP Finding Given the unprecedented numbers of women serving in the PG, especially those in largely new roles, including combat support, it is important to specially evaluate the health consequences and needs for health services of women who served in the PG. Preliminary findings from studies being conducted at the Boston VA Medical Center (VAMC) indicate that additional research in this area is needed. Additional research is also needed on the health effects of having male and female personnel serve together in combat or under threat of combat (Charge 3~. Recommendation 11. The DoD and DVA should ensure that studies of the health effects of deployment, including effects on PGW veterans, include evaluation of exposures, experiences, and situations of both women and men, with attention to their age, prior military service, marital and parental status, and other gender-specif~c parameters. Recommendation 12. The DoD and DVA should conduct studies of the health consequences of assigning men and women to serve together in combat or under the threat of enemy action. Such work should be undertaken with a focus on prevention and amelioration of any added stresses. Finding Several important studies are currently under way. Worthwhile data are being collected and prepared, and the studies should be completed promptly, with the necessary personnel and funding to collect the additional data needed, to conduct appropriate analyses, and to evaluate potential biases. Findings from these studies are likely to provide leads as to whether or not additional research along these lines is required to produce more specific findings (Charges 1 and 3~. The Naval Health Research Center at San Diego has undertaken a series of studies under the general title of "Epidemiologic Studies of Morbidity Among Gulf War Veterans: A Search for Etiologic Agents and Risk Factors." These studies hold promise for answering some important questions about the health of PGW veterans after demobilization and about the possibility that veterans and their spouses may experience an excess risk of adverse pregnancy outcomes as a result of service in the PGW. The studies are being carried out with care, excellent planning, and proper pilot efforts to determine feasibility.

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APPENDIX B 75 Upon completion, these studies should provide important guidance concerning whether veterans have experienced hospitalization at rates in excess of their nondeployed peers, have developed specific symptoms or illnesses related to their POW experience, or have experienced risks that have resulted in adverse reproductive outcomes related to their service in the Gulf. Recommendation 13a. The Naval Health Research studies in San Diego should be completed and results published as designed and scheduled. Although there are significant problems with the DVA National Health Survey, the investigators have designed additional phases of the study that will be important to complete. The physical examinations and follow-up of nonres- pondents to the mail survey will be an important step toward describing potential biases and evaluating signs and symptoms of both PG and PG-era study participants. Recommendation 13b. The DVA National Health Survey should be completed and results published as designed and scheduled. The DVA-DoD study that was designed to examine predictors of enrollment in the DVA PG Health Registry (PGHR) may provide useful information as to what objectively measurable factors contribute to self- selection into the registry. In addition to the proposed analysis of associations among demographics, past health experiences, and health behaviors as possible predictors of enrollment, information on the eligibility of individuals for health care, as well as the type of health care, could generate additional hypotheses to be investigated. Recommendation 13c. Evaluation of predictors of enrollment in the DVA PGHR should be promptly completed and results published. Included, if possible, should be information on type of care requested, required, and received. Finding The armed forces have had small but high-quality and effective capabilities in epidemiology. Recent cutbacks have reduced these capabilities, with potentially serious effects on both military preparedness and the health care of veterans. The Theater Area Medical Laboratory (TAML) is an example of how specialists can respond rapidly to potential heals problems of troops deployed in various areas of

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76 ADEQUACY OF THE VA PERSIAN GULFREGISTRYAND UCAP the world and provide immediate and useful information necessary to maintain the military readiness of the armed forces. In addition, well-trained epidemiologists and preventive medicine specialists are necessary for conducting the relevant population-based epidemiologic studies, with comprehensive exposure assessment, that have the greatest likelihood of being informative about the health consequences of any future deployment. Such capability should permit studies that extend beyond the time of an individual's active duty service and that are capable of responding to questions of delayed effects that may emerge only years, or even decades, after a military operation (Charge 1~. Recommendation 14. The epidemiologic capabilities of the armed forces should be strengthened rather than reduced. The command structure should be kept informed about the reasons for and the results of this recommendation and its relevance to military preparedness and effectiveness, and should be encouraged to support appropriate epidemiologic work in the theater of operations and in the postdeployment period. Finding Much good work on symptom complexes and other matters discussed in this report has been done by DoD, DVA, and their contractors. However, it is evident from the references cited in this report that many are in the "gray literature"-available to those who know they exist and how to ask for them, but not published in the open, peer-reviewed scientific literature where they will be fully indexed and readily available, with some assurance that they meet at least minimal scientific standards. Even this committee, with the contacts and expertise it developed over time, had difficulty in identifying and obtaining some of these reports. The committee also is concemed about the high cost of much recent research and the necessity for maximizing the nation's overall return on that investment. In summary, the committee believes that health- related research is not finalized until it is published and readily accessible in peer-reviewed journals (Charge 1~. Recommendation 15. The DoD and DVA should adopt a policy that internal and contract-supported reports on health research will be submitted for publication in the peer-reviewed scientific literature in a timely manner.

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APPENDIX B 77 Finding Some research directed toward reports of unexplained illnesses after the POW was flawed in the questions posed' populations studied' or research design. We believe that these defects could have been identified before research projects ware fielded if requests for proposals had been announced ger~erally and had been open to the scientific community at large and if fully developed research proposals had been reviewed by panels of qualified expert peers. Some research was announced and reviewed in this manner, but much more could be so treated, to the benefit of both veterans and the public (Charge 1~. Recommendation 16. The Congress, DVA, and DoD should adopt a policy that unless there are well-specified, openly stated reasons to the contrary, requests for proposals for research related to unexplained illnesses or other needed health-related research will be publicly announced and open to the scientific community at large, that proposals will be reviewed by panels of appropriately qualified experts, and that funding will follow the recommendations of those experts.

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