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Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol (1998)

Chapter: Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations

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Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
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Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
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Page 80
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 81
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 82
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 83
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 84
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 85
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 86
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 87
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 88
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 89
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 90
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 91
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 92
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 93
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 94
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
×
Page 95
Suggested Citation:"Appendix C: Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations." Institute of Medicine. 1998. Adequacy of the VA Persian Gulf Registry and Uniform Case Assessment Protocol. Washington, DC: The National Academies Press. doi: 10.17226/6084.
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Page 96

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Appendix C Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program: Overall Assessment and Recommendations* 1.) OVERALL ASSESSMENT OF THE CCEP GOALS PROCEDURES: The Comprehensive Clinical Evaluation Program (CCEP) clinical protocol is a thorough, systematic approach to the diagnosis of a wide spectrum of diseases. A specific medical diagnosis or diagnoses can be reached for most patients by using He CCEP protocol. The Department of Defense (DoD) has made conscientious efforts to build consistency and quality assurance into this program at the many medical treatment facilities (MTFs) and regional medical centers (RMCs) across the country. The committee is impressed with the quality of the design and the efficiency of the implementation of the clinical protocol, the considerable devotion of resources to this program, and the remarkable amount of work that has been accomplished in a year. The high professional standards, commitment, and diligence of the physicians involved in the CCEP at He RMCs were readily apparent at the Free committee meetings. The committee commends He DoD for its efforts to provide high-quality medical care in He CCEP and the success that it has achieved to date in developing the inDas~ucture necessary to efficiently contact, schedule, refer, and Pack thousands of patients Trough the system. This appendix is excerpted from the Institute of Medicine report, Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation, Washington, D C.: National Academy Press, 1996. 79

80 ADEQUACYOFTHEVAPERSIANGULFREGISTRYANDUCAP Overall, the systematic, comprehensive set of clinical practice guidelines set forth in the CCEP are appropriate, and they have assisted physicians in the determination of specific diagnoses for thousands of patients across the country. 2.) GENERAL RECOMMENDATIONS FOR THE IMPLEMENTATION OF THE CCEP: 2.1.) Referrals of Patients from Phase I to Phase II of the CCEP: 2.1.1.) Structure and revise the CCEP protocol and logistics to allow the majority of patients to receive a final diagnosis by Phase I: Currently, the majority of patients do not receive a final diagnosis until Phase II, yet some of these patients have straightforward medical problems. The Committee recommends that final diagnoses could be reached in Phase I if more diagnostic resources are made available. This major change would require the availability of substantial numbers of internists or family practitioners at MTFs to perform comprehensive evaluations. It would also require better, more consistent explanations to MTF physicians about the purposes and procedures of the CCEP. It would require regional medical center physicians to provide adequate quality assurance of MTF work-ups and timely feedback to MTF . prove Hers. On January, 17, 1995, the DoD adopted these suggestions by setting goals that about 80% of patients would receive a definitive diagnosis at an MTF level. For some patients, this change has required specialty consultations at the MTF, as well as advice from an RMC physician. These changes necessitated an enhanced quality control role by the RMC physician and prompt, appropriate feedback to the MTF physician. 2.1.2.) Curtail diagnostic work-ups in patients not seriously disabled with minor complaints: Initially, patients who do not accept their initial diagnosis could request a continued evaluation all the way Trough Phase II. The Committee recommends that diagnostic work-ups in patients not seriously disabled but with minor complaints should be curtailed. Alternatively, if a physician has made a definitive diagnosis and appropriate treatment has been given, the evaluation would be concluded. On January 17, 1995, the DoD implemented the suggestions that referral to Phase II be made on the basis of the clinical judgment of the primary care physician, and patients were no longer permitted to self-refer to an RMC.

APPENDIX C 81 2.1.3.) Require additional efforts to provide more care at the primary care level: The Committee encourages efforts to provide more care at the primary care level, because they will enhance the continuity of care and will foster the establishment of an ongoing therapeutic relationship. 2.1.4.) Continue referral of subgroups of patients whose illnesses are difficult to diagnose: Patients whose illnesses are difficult to diagnose should continue to be referred to Phase II at an RMC. The decision to refer to Phase II should be leased on the clinical ~ud~nent of Me primary Are physics=, which, in tum, would be dependent on the Claris of the patient's diagnoses and the feasibility of the proposed treatment program at the MTF level. The DoD should continue its goal of enhanced accessibility of RMC physicians to allow regular consultations with MTF primary care physicians on patients with more complex diagnoses. 2.2.) Systematic Guidelines for Psychiatric Referrals and Adequacy of Psychiatric Resources: 2.2.1.) Develop explicit guidelines for the identification of Phase I patients who would benefit from a psychiatric evaluation: CCEP physicians have noted the need for standardized guidelines for screening, assessing, evaluating, and treating patients. Such Phase I guidelines should be developed to help ensure adequate psychiatric resources for both the initial evaluation and long-term follow-up care. 2.2.2.) Alert primary care physicians about the high prevalence of psychiatric disorders: Two methods Cat have been proposed by RMC physicians to expedite the scheduling of psychiatric evaluations would be (1) the more Dequent use of civilian psychiatrists and (2) consideration of using Ph.D.- level psychologists, as well as psychiatrists, when necessary. 3.) SPECIFIC OBSERVATIONS OF AND RECOMMENDATIONS FOR THE IMPLEMENTATION OF THE CCEP: 3.1.) Analysis and Interpretation of the CCEP Results: 3.1.1.) Symptoms and diagnoses in the CCEP population:

82 ADEQUACYOF THE VA PERSIAN GULFREGISTRYAND UCAP 3.1.1.1.) No evidence has been found that the DoD has been flying to avoid reaching a single unifying diagnosis: The committee found no evidence that the DoD has been trying to avoid reaching a single "unifying" diagnosis when a plausible one was available. A "unifying" diagnosis is defined here as a single diagnosis that could explain most or all of a patient's symptoms. 3.1.1.2.) Signs and symptoms in many patients can be explained by well-recognized conditions: One interpretation of the CCEP results is that the signs and symptoms in many patients can be explained by well-recognized conditions that are readily diagnosable and treatable. The committee concludes that this is a more likely interpretation than the interpretation that a high proportion of the CCEP patients are suffering from a unique, previously unknown "mystery disease." 3.1.1.3.) Provide more detailed information on specific diagnoses in future reports: By providing more detailed information on specific diagnoses in its future reports, the DoD might help correct the impressions among the general public that exist about the high degree of prevalence of a "mystery disease" or a new, unique "Persian Gulf Syndrome." 3.1.1.4.) Investigate the diagnosis in patients with disability processing actions: Disability processing actions in the Services' Physical Disability Processing Systems have been completed for 246 of the 10,020 CCEP patients. The DoD has not provided any data about their diagnoses or their reasons for medical separation from the mili0. The committee recommends that the DoD investigate the diagnoses in this group of patients in future reports, as well as whether or not the disorders could have been caused or exacerbated by service in the Persian Gulf. 3.1.1.5.) Don't view CCEP results as estimates of the prevalence of disability related to Persian Gulf service: Many other individuals who served in the Persian Gulf have left active service and, hence, are not eligible for the DoD's CCEP. Some of these veterans may have disabilities related or unrelated to their service in the Persian Gulf, and those with disabilities might be more likely to have left active service. For these reasons, the CCEP results should not be viewed as estimates of the prevalence of disability related to Persian Gulf service.

APPENDS C 83 3.1.2.) Evidence of a New, Unique Persian Gulf Syndrome: 3.1~2.1.) There is a lack of clinical evidence of a unique Persian Gulf Syndrome: The committee agrees with DoD that there is currently no clinical evidence in the (:CEP of a previously unknown, serious illness among Persian Gulf veterans. If there were a new or unique illness or syndrome among Persian Gulf veterans that could cause serious impairment in a high proportion of veterans at risk, it would probably be detectable ~ the population of 10,Q20 CCEP patients. On the Aver hand, if an unknown illness were mild or affected only a small proportion of veterans at risk, it might not be detectable in a case series, no matter how large. 3.1.2.2.) Share the entire CCEP data set with qualified researchers outside of the DoD: The committee encourages the DoD's plan to share the entire CCEP data set with qualified researchers outside of the DoD who might be able to undertake the kind of research with the methodological sophistication that the identification of a new syndrome would require. 3.1.3.) Potential Relationship of Illnesses in CCEP Patients to Service in the Persian Gulf: 3.1.3.1.) Discuss the issue of causality explicitly and unambiguously in its future reports: Physicians involved with the development and the administration of the CCEP have, in various public presentations, acknowledged that some CCEP patients have developed illnesses that are directly related to their service in the Persian Gulf. The recent DoD report on 10,020 CCEP participants, however, only touches on this issue indirectly. The committee encourages the DoD to discuss the issue of causality explicitly and unambiguously in its fixture reports. Such a discussion might help to alleviate the current climate of confusion and mistrust that exists among some Persian Gulf veterans and the general public. 3.1.3.2.) Determine the timing of the onset of disease: The committee recommends that the DoD attempt to determine the timing of the onset of disease, especially for patients who have significant impairments. Review of military or civilian medical records that predate enrollment in the CCEP may provide

84 ADEQUACYOF THE VAPERSIANGULFREGISTRYAND UCAP contemporaneous documentation of the onset of symptoms in some patients, especially if the symptoms are serious. ~ addition, it is important to determine whether service in the Persian Gulf has contributed to the exacerbation of preexisting diseases in some CCEP patients. 3.1.4.) Comparison of the CCEP Population with Other Populations: 3.1.4.1.) Be cautious about comparison with other populations: In its most recent report, the DoD compares the symptoms and diagnoses in the CCEP population with the symptoms and diagnoses in several community-based and clinically based populations. ~ the committee's view, interpretations based on comparisons with other populations should be made with great caution and only with the explicit recognition of the limitations of the CCEP as a self-selected case series. The CCEP was not designed to answer epidemiological questions, such as how the frequencies of certain diagnoses compare between the CCEP population and a control population. Instead, it was designed as a medical evaluation and treatment program. Indeed, the research aims of the CCEP do not appear to be stated explicitly, nor does there appear to be a concrete epidemiological study plan. Without research hypotheses, it is not possible to judge whether any particular comparison group is appropriate. Each individual population should be described to prevent confusion. 3.1.4.2.) It's difficult to establish causal relationships by relying on CCEP data alone: It would be extremely difficult to establish causal relationships or to identify and characterize a new "Persian Gulf Syndrome" definitively by relying on data from the CCEP alone. The latitude permitted in the clinical examination program conflicts with the rigor necessary to answer an epidemiological question. 3.1.4.3.) Consider the CCEP data to have high clinical utility: The CCEP data do have considerable clinical utility, and they could be used to address many important questions from a descriptive perspective. Many case series could be derived from these data. In addition, the results of the clinical exams could provide guidance in the selection of research questions and in the design of future epidemiological research. The CCEP findings could be used to generate epidemiological questions on other types of diseases that are much more Sequent in the CCEP population, such as musculoskeletal diseases.

APPENDIX C 3.2.) Specific Medical Diagnosis: 3.2.1.) Psychiatric Conditions: 85 3.2.1.1.) Make patients aware of psychiatric conditions and their prevalence and morbidity: Patients need to understand Cat psychiatric conditions and disorders are real diseases that cause real symptoms and that diagnoses are made with objective criteria and are not merely "labels" applied because physical abno~malit~s were not Fields The CCEP patients, as well as their primal care physicians, also need to understand the prevalence of and the concomitant morbidity that result Dom psychiatric disorders in We general population (major depression, for example). Finally, Me CCEP patients need to be aware that effective treatments Cat actually ameliorate symptoms exist for many of these disorders. 3.2.1.2.) Emphasize effects and diagnosis of psychosocial stressors: In its fixture reports, the DoD is encouraged to emphasize Cat psychosocial stressors can produce physical and psychological effects Cat are as real and potentially devastating as physical, chemical, or biological stressors. The DoD should also emphasize Cat Borough efforts to diagnose psychiatric conditions in Me CCEP population may lead to appropriate, successfill ~ea~anents. 3.2.1.3.) Identify people with risk of developing depression or Post-Traumatic Stress Disorder (PTSD): The committee is particularly concerned about the CCEP patients who have developed or who are at risk of developing major depression or PTSD. These people need to be identified and provided with some form of preventive intervention. 3.2.1.4.) Improve standardization of psychiatric evaluations: The committee recommends that the DoD consider methods of improving the standardization of Me psychiatric evaluations in the CCEP. The DoD should consider establishing detailed guidelines for the psychiatric evaluations and should attempt to obtain greater standardization of these evaluations among Me various hospitals across Me country. These guidelines could provide suggested procedures for Me use of selected self-report instruments for the assessment of the most commonly diagnosed disorders, as well as

86 ADEQUACY OF TlIE VA PERSIAN GULFREGISTRYAND UCAP procedures for more in-depth structured clinical interviews when indicated. 3.2.1.5.) Document and investigate the onset and course of symptoms and psychosocial stressors: It would be especially important to document the onset and course of symptoms and to investigate their possible link with psychosocial stressors associated with mobilization and return home, as well as with service-related exposures in the Persian Gulf region. This assessment would require an additional set of questions to supplement the questionnaire currently used in Phase I of the CCEP. The thorough assessment of psychosocial stressors is essential information for treatment planning for patients with complex, chronic symptoms. 3.2.1.6.) Standardize neuropsychological evaluations: Standardization of the neuropsychological evaluations is a related concern. The neuropsychological methods vary from pencil and paper testing at some sites to computer-administered testing at other sites. One method of achieving a better consensus is to convene a meeting attended by one psychiatrist and one neuropsychologist from each center to attempt to standardize their methods. 3.2.1.7.) Standardize classification and coding of diseases: In addition to the standardization of psychiatric evaluations in the CCEP, the classification and coding of these diseases should also be standardized. 3.2.1.8.) Document headache categories differently: The classification of different types of headaches into three separate categories may be consistent win ICD-9 coding rules, but the DoD should also report a special tabulation Mat combines all headaches into one group. 3.2.1.9.) Add explicit written instruction on medical record- keeping and coding: More explicit written instructions could be added to Me CCEP guidelines to help prevent the most frequent problems found in Me medical record-keeping and coding. Committee comments about inconsistencies are mainly aimed at the quality control necessary for accurate reporting of summary data rather than at Me quality of Me medical care itself.

APPENDIX C 87 3.2.1.10.) Expand discussion of psychological stressors: DoD should consider expanding discussion of the psychological stressors that were present during the Persian Gulf War. 3.2.1.11.) Utilize results of on-going studies to revise CCEP: It is possible ~ Me DoD will be able to use We results of on- going epidemiologic studies on psychiatric conditions to revise the CCEP, that is, to revise the standardized questionnaires or to add or delete targeted lab tests or specialty consultations. In addition, the CCEP clinicians may be able to utilize these results in the counseling ~ treatment of Dew priers. These reedits may ~o be Swell for the DoD in its planning to minimize the effects of psychosocial stressors in future deployments through the use of preventive medicine interventions. 3.2.2.) Musculoskeletal Conditions: 3.2.2.1.) Provide more details of diagnostic categorization of musculoskeletal conditions: The draft and final DoD reports on 10,020 CCEP patients do not provide adequate details for the IOM committee to make a thorough evaluation of the diagnostic categorization of musculoskeletal conditions. More explanation about Me diagnostic aspects of these musculoskeletal conditions would be useful, for example, information on singlejoint involvement versus multijoint conditions or articular versus non-articular conditions. In addition, details on disease severity and disease activity would be useful. 3.2.2.2.) Place more emphasis on musculoskeletal conditions: The DoD and We DVA should consider placing more emphasis on research on musculoskeletal conditions, since these are the most prevalent disorders among the CCEP populations. 3.2.3.) Signs, Symptoms, and Ill-Defined Conditions: 3.2.3.1.) Clarify types of disorders included in the ICD-9 category: The committee recommends that in future reports the DoD attempt to clarify the types of disorders that are included in the ICD- 9 category of signs, symptoms, and ill-defined conditions (SSIDC). Individuals with these signs, symptoms, and ill-defined conditions should be evaluated in a rigorous manner, just as individuals with any other symptoms are evaluated.

88 ADEQUACY OF THE VA PERSIAN GULFREGISTRYANDUCAP 3.2.4.) Infectious Diseases: 3.2.4.1.) Infectious disease is not a frequent cause of serious illness: The IOM committee concludes Cat infectious diseases are not a frequent cause of serious illness in the CCEP population. 3.2.4.2.) Veterans are not likely afflicted with some previously unknown pathogen: On the basis of We current evidence, it is unlikely that a significant proportion of Persian Gulf veterans are afflicted with some previously unknown pathogen that is evading the current diagnostic efforts. 3.2.5.) Chronic Fatigue Syndrome, Fibromyalgia, and Multiple Chemical Sensitivity: 3.2.5.1.) Estimating prevalence of chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity is difficult: The IOM committee's review of the CCEP protocol suggests that data on chronic fatigue syndrome (CFS), fibromyalgia (FM), and multiple chemical sensitivity (MCS) may have been collected by various diagnostic methods. For this reason, it is not possible to estimate the prevalence of these conditions from the CCEP data. 3.2.5.2.) Collect data using established diagnostic criteria for CFS and FM: In the clinical evaluations, data should be collected by using established diagnostic criteria for CFS and FM. 3.2.5.3.) Established diagnostic criteria do not exist for MCS: A widely accepted set of diagnostic criteria does not exist for MCS. Consequently, the medical evaluation in CCEP cannot be expected to diagnose the clinical syndrome of MCS. 3.2.5.4.) Include CFS, FM, and MCS in on-going and future epidemiological research studies: If more is to be learned about the relationship between these disorders (CFS, FM, and MCS) and Persian Gulf service, they should be included among the epidemiological research studies that are ongoing or planned for Me future.

APPENDIX C 89 3.2.5.5.) Continue thorough workup to diagnose sleep disturbances and fatigue: Because of the thorough, systematic workup mandated in the CCEP, many disorders that could contribute to sleep disturbance and fatigue have been diagnosed. These diligent efforts to unmask occult medical problems that could substantially contribute to plague have been productive and should continue. 3.3.) Use of the CCEP Results for Education Improvements in the Medical Protocol and Outcome Evaluations: 3.3.1.) Use of the CCEP Results for Education: 3.3.1.1.) Continue public release of analysis results of the CCEP · · · - on an on-going, perloc IC JaSIS: The IOM committee encourages the DoD to continue to release its analysis of the results of the CCEP on an ongoing, periodic basis. Several audiences that would be interested in these results include active-duty members of the service, veterans, members of the U.S. Congress, the lay media, as well as military, DVA, and civilian medical and public health professionals. The CCEP medical findings would also be of interest to physicians in the DVA system and in the general community. 3.3.1.2.) Distribute CCEP findings to all primary care physicians at MTFs and RMCs: The medical findings of the CCEP should be distributed promptly to all primary care physicians at the MTFs and RMCs. This would provide feedback on their diagnostic decision-making. Information on the frequencies of particular symptoms and their specific diagnoses made in the CCEP population could be useful, for instance, in developing a differential diagnosis for individual patients. 3.3.1.3.) Develop a more concise version of the DoD report for active-duty service personnel and veterans: A more concise version of the DoD report on 10,020 patients, written in nontechnical language and with clearly stated conclusions, should be developed for a target audience of active-duty service personnel and veterans. If the DoD developed and distributed a fact sheet or newsletter aimed at Persian Gulf veterans, the information on the CCEP would be more accurate and more comprehensive than most reports in the general news media. This would also provide an

9o ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP additional opportunity to notify the readers about the availability of the medical exam in Me CCEP, the hotline number, and the eligibility criteria. 3.3.1.4.) Develop a more comprehensive document describing potential exposures in more detail: The DoD should also consider developing for clinical use in the CCEP a more comprehensive document that describes the many potential exposures in more detail. Any document that is prepared, however, must make clear what is known and what is unknown about the relationship between these stressors and the physical or psychological consequences. 3.3.2.) Use of the CCEP Results to Improve the Medical Protocol: 3.3.2.1.) Use CCEP examination results to improve standardi- zation practices: The DoD now has results on the examinations of more than 10,000 CCEP patients, which could be used to improve the standardized questionnaires, lab tests, and specialty consultations. 3.3.2.2.) Refine questions related to potential psychological stressors: More refined questions related to potential psychological stressors could be added systematically to the Phase I medical history. The CCEP physicians might find this information useful in diagnosing and counseling their patients. In addition, it may be possible to identify patients who are at increased risk of psychological problems on the basis of their experiences in the war. Perhaps explicit questions on death exposure and other known risk factors could be added to the Phase I questionnaire. 3.3.2.3.) Determine if lab tests or specialty consultations should be added to Phase I: The CCEP results should be analyzed to determine whether there are lab tests or specialty consultations that should be added systematically to Phase I to increase its diagnostic yield. Diseases that are diagnosed relatively frequently in Phase II may often be overlooked in Phase I. If such diseases could be identified, perhaps appropriate screening instruments could be added to Phase I.

APPENDIX C 91 3.3.2.4.) Compare and coordinate methods and clinical results of the CCEP and UCAP: The DVA uses a protocol similar to that used in the CCEP called Me Uniform Case Assessment Protocol (UCAP). The methods and clinical results of the CCEP and UCAP should be compared to coordinate- and improve the two programs. 3.3.3.) Use of the CCEP Results for Patient Outcome: 3~3.1~) Perform targeted patient evaluations. On Me basis of more Man 10,000 patient evaluations to date, RMC physicians could begin to perform a series of targeted patient evaluations. The most common diseases in the CCEP could be identified, and suggested approaches to patient treatment could be developed. Consensus guidelines for the treatment and counseling of CCEP patients who have the most common disorders could be useful for primary care physicians. 3.3.3.2.) Communicate successful treatment methods between RM:Cs: If one RMC has had a lot of experience with a particular disease category and some measure of success in its treatment, the DoD could ensure that a description of their successful methods is communicated to the other MTFs and RMCs across the country. 3.3.3.3.) Review disorders among CCEP patients who have applied for disability payments or for medical discharge from the service: The DoD could perform a review of the types and severities of the disorders among CCEP patients who have applied for disability payments or for medical discharge from the service. In addition, the final disposition of these cases could be evaluated, including the potential relationship between particular diseases and Persian Gulf service. The DoD could use the results of these disability determinations to predict which diseases are likely to be associated with the most impairment among CCEP patients in Me future. The DoD could also use these results to develop rehabilitation and early intervention methods for impaired Persian Gulf veterans, such as the Specialized Care Centers (SCC). Another reason to analyze these disability claims would be to investigate possible preexisting risk factors for the development of the impairment. If such risk factors are identifiable, then targeted preventive medicine interventions

92 ADEQUACY OFTlIEVA PERSIAN GULF REGISTRYANDUCAP could be planned for individuals participating in future overseas deployments. 3.3.4.) Specialized Care Center (SCC): 3.3.4.1.) The DoD has made serious efforts to develop an SCC program that has ambitious goals: The IOM committee concludes that the DoD has made serious efforts to develop an SCC program with ambitious goals for a select group of seriously impaired military personnel. The committee's review should be considered preliminary, however, because it is based on one visit and it is still early in the development of the program. 3.3.4.2.) Provide multidisciplinary treatment modalities: The SCC currently performs a thorough reevaluation of each patient's medical problems. SCC physicians should consider limiting the diagnostic role that they play to focusing on the incoming patients who have been very difficult to diagnose at the RMC level. Instead, the SCC should focus on providing multidisciplinary treatment modalities that are not readily available at the RMC level. 3.3.4.3.) Need for regimens: The need for individualized follow-up is crucial for the types of difficult patients who are likely to be treated at the SCC. Medical staff at the SCC will need to lmow whether a particular therapeutic plan is feasible at the patient's nearest MTF and whether long-term follow-up care can be performed. The primary care physician at the MTF needs to encourage continuous patient compliance with the carefully designed, individualized therapeutic regimens. i] ndividualized follow-up and therapeutic 3.3.4.4.) Develop objective measure of functional status for follow-up evaluation: The SCC physicians should develop a set of relatively objective measures of functional status for the follow-up evaluation. These could include (1) appropriate utilization of medical care, (2) appropriate use of medications or other methods to cope with symptoms, (3) general level of activities of daily living, (4) employment status, and (5) status of interpersonal relationships.

APPENDIX C 93 3.3.4.5.) Evaluate the SCC program itself: The SCC program itself needs an evaluation component after several of its graduates have returned for their 6-month reevaluations. Several issues will need to be evaluated in light of the successes arid barriers that the program has experienced, including ~gib~ty criteria for patienm-, roles of the SCC in a diagnostic reevaluation of patients; successful continuity of care of patients, with shared responsibility by the SCC and MTFs; and the unique need for the SCC, beyond the usual standard of a tertiary care medical center. 3.3.4.6.) DoD has taken a serious approach to the treatment and rehabilitation of these patients in the SCC: The committee believes that the DoD has taken a serious approach to the treatment and rehabilitation of these impaired patients who have treatable, chronic diseases. 3.3.4.7.) Investigate costs and benefits of the SCC program: Because this program is very labor-intensive, it is probably very expensive on a per-patient basis. At the same time, the potential benefits for each patient could be high, if successful rehabilitation of serious, long-term impairment can be achieved. Subsequent evaluations of We SCC program should investigate its costs and benefits, if possible. 3.3.4.8.) Identify the most effective elements of the SCC program: If the SCC program is successful in improving the health and fimctional status of its patients, perhaps the elements that are most effective in enabling the patients to cope with their symptoms could be identified. Perhaps some of these elements could be disseminated and integrated into existing MTF programs that are close to where CCEP patients live and work. 3.4.) Research Relevant to the CCEP: 3.4.1.) Epidemiological Research Relevant to the CCEP: 3.4.1.1.) Utilize on-going epidemiological studies for revising or improving the CCEP: The results of on-going epidemiological studies may be useful for making revisions or improvements in the CCEP medical protocol

94 ADEQUACY OF THE VA PERSIAN GULFREGISTRY AND UCAP itself, for example, to revise the standardized questionnaires or to add or delete targeted lab tests. The study results may also be useful in the counseling and treatment of CCEP patients. 3.4.1.2.) Acknowledge the serious limitations of the CCEP data for epidemiological purposes: Data from individuals in the CCEP are also being used in some of these epidemiological studies. ~ these studies, the serious limitations of the CCEP data for epidemiological purposes that were previously identified must be kept in mind. 3.4.2.) Exposure Assessment Research Relevant to the CCEP: 3.4.2.1.) Investigate experiences of individuals in UICs with higher rates of CCEP participation: The IOM committee encourages DoD to perform fiercer investigations on the war and postwar experiences of individuals in the Unit Identification Codes (UICs) with higher rates of CCEP participation. 3.4.2.2.) Investigate exposures restricted to particular locations or special occupational groups: The committee encourages the DoD to investigate exposures that were restricted to particular locations or special occupational groups, such as troops who had direct combat exposure. The types of symptoms and diseases in CCEP participants in these special groups and UICs could be analyzed and contrasted win the symptoms and diagnoses of CCEP participants in over units. COMMIII~E ON ,1~ DOD PERSIAN GULF SYNDROME COMPREHENSIVE CLINICAL EVALUATION PROGRAM Gerard Burrow, Chair, Dean, Yale University School of Medicine, New Haven, Connecticut Dan Blazer, Dean of Medical Education and Professor of Psychiatry, Duke University Medical Center, Durham, North Carolina Target Bleecker, Director, Center for Occupational and Environmental Neurology, Baltimore, Maryland Member, Institute of Medicine.

APPENDIX C 95 Ralph Horwitz, Chairman, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut Howard Kipen, Associate Professor and Director, Occupational Health Division, Roben Wood Johnson Medical School, Piscataway, New Jersey Adel Mahmoud, Chairman, Department of Medicine, Case Western Reserve University and University Hospitals of Cleveland, Cleveland, Ohio Michael Osterholm, State Epidemiologist, Minnesota Department of Health, Minneapolis, Minnesota Robert Pynoos, Professor of Psychiatry, University of California at Los Angeles, Los Angeles, California Anthony Scialli, Associate Professor, Deparunen:t of Obstetrics and Gynecology, Georgetown University Medical Center, Washington, D.C. Rosemary Sokas, Associate Professor of Medicine, Division of Occupational and Environmental Medicine, George Washington University School of Medicine, Washington, D.C. Guthrie Turner, Chief Medical Consultant, Division of Disability Determination Services, State of Washington, Tummwater, Washington Michael Weisman, Professor, Division of Rheumatology, University of California at San Diego Medical Center, San Diego, California Staff Michael A. Stoto, Director, Division of Health Promotion and Disease Prevention Kelley A. Brix, Study Director Deborah Katz, Research Assistant Amy Noel O'Hara, Project Assistant Donna D. Thompson, Division Assistant Mona Brinegar, Financial Associate

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As mandated in Public Law 103-446, the Department of Veterns Affairs (VA) asked the Institute of Medicine (IOM) to review its Uniform Case Assessment Protocol (UCAP) for Persian Gulf veterans. The purpose of the program is to provide a systematic, comprehensive medical protocol for the diagnosis of health problems of Persian Gulf veterans. This report is the third in a series of studies by IOM reviewing the protocols used by the VA and the Department of Defense to diagnose the health complaints of Gulf veterans. The committee reviews and makes recommendations concerning the adequacy of the medical protocol and its implementation by the VA, as well as the VA's outreach and education efforts aimed at informing Persian Gulf veterans and their care providers of the purpose and availability of this program. In addition, the report contains as appendixes the findings and recommendations of the previous reports, as well as those of two related IOM reports on Health Consequences of Service During the Persian Gulf War.

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