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EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN 15 GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM provided in a later section of this report (see Epidemiological Research Relevant to the CCEP). SPECIFIC MEDICAL DIAGNOSES In addition to the committee's general review of symptoms and diagnoses, it has reviewed five disease categories in more detail. Three of these disease categories are the most prevalent in the CCEP population: psychiatric conditions; musculoskeletal conditions; and signs, symptoms, and ill-def~ned conditions. In addition, infectious diseases have been reviewed because of the possibility that troops deployed to the Persian Gulf may have acquired diseases that are unusual outside that region. Finally, the last category includes three conditions that have been reviewed because of their poorly defined nature: chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity. Psychiatric Conditions Three major issues that are relevant to psychiatric conditions will be discussed: (1) the prevalence and impact of psychiatric conditions among CCEP patients, (2) the standardization of psychiatric evaluations in the CCEP, and (3) the recognition of psychosocial stressors in the CCEP population, including relevant epidemiological research. Prevalence and Impact of Psychiatric Conditions Among CCEP Patients Of the primary diagnoses in the CCEP population, 19% are psychiatric conditions (DoD, l995d). A primary or secondary diagnosis of a psychiatric condition has been made in 37 % of CCEP patients. According to the DoD, the prevalence of psychiatric diagnoses in the CCEP population may be "somewhat higher than that found for other groups of health seeking individuals in which structured psychiatric interviews were used" (DoD, l995d). The most common psychiatric conditions in the CCEP population are major and minor depression (diagnosed in 3% and 8% of all CCEP patients, respectively), PTSD (5%), adjustment disorder (4%), and mild anxiety syndromes (2%) (DoD, l995d). In addition, personality disorders appear to be common in the CCEP populations; however, use of the section of the Structured Clinical Interview for DSM III-R (Diagnostic and Statistical Manual of Mental Disorders, 3rd edition, revised) that is used to diagnose these disorders is not currently mandated by the DoD (Engel, 1995~.

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16 EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM Many aspects of military service in wartime can cause significant physical and psychological stress. Physicians have observed that in many previous wars, including the Vietnam War, wartime stressors can lead to the development of higher rates of psychiatric illnesses than are observed in the general population. PTSD and major depression are prevalent problems in veterans. As might be expected from experiences in previous conflicts, many of the patients who have been evaluated in the CCEP have been diagnosed with psychological problems, as well as with other medical problems. Patients need to understand that these are real diseases that cause real symptoms and that these diagnoses are made with objective criteria and are not merely "labels" that were applied because physical abnormalities were not found. The CCEP patients, as well as their primary care physicians, also need to understand the prevalence of and the concomitant morbidity that result from psychiatric disorders in the general population (major depression, for example). Finally, the CCEP patients need to be aware that effective treatments that actually ameliorate symptoms exist for many of these disorders. In addition to the IOM committee on the CCEP, several other review groups have examined the health concerns of Persian Gulf veterans. Three major reviews have recognized the potential impact of psychological stress in this population, including rapid deployment, primitive living conditions in the desert, the threat of chemical and biological warfare agents, and actual combat exposure (Defense Science Board, 1994; NIH, 1994; IOM, l995b). The committee concludes that many of the psychiatric diseases in the CCEP population have both physical and psychological symptoms and manifestations. In its future reports, the DoD is encouraged to emphasize that psychosocial stressors can produce physical and psychological effects that are as real and potentially devastating as physical, chemical, or biological stressors. The DoD should also emphasize that thorough efforts to diagnose psychiatric conditions in the CCEP population may lead to appropriate, successful treatments. 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. Some people can develop depression or PTSD as long as 5 years after a traumatic event, and they may also develop related delayed-onset problems such as substance abuse. In addition, there may be Persian Gulf veterans who currently have symptoms of depression or PTSD who have not sought medical care, and some form of outreach is needed to identify them and notify them that help is available through the CCEP. Some Persian Gulf veterans who have these conditions may be experiencing physical symptoms that could have psychological underpinnings. Both depression and PTSD could be underlying mechanisms for some sleep disorders, for example. There appears to be an unexpectedly high prevalence of sleep disorders in the CCEP

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EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN 17 GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM populations, which, in turn, could be contributing to other symptoms (Matthews, 1995). Standardization of Psychiatric Evaluations in the CCEP Psychiatric evaluations are mandated for all patients in Phase II of the CCEP. These include the Structured Clinical Interview for DSM III-R and the Clinician Administered PTSD Scale in addition to a clinical evaluation by a psychiatrist. With the use of such validated instruments, the psychiatric evaluations can be performed more systematically across the many hospitals in the country. Nonetheless, there are difficulties in some patients in differentiating psychopathology versus illness behavior versus difficulties in adjustment to activities of daily living; that is, there is variability in the threshold of psychiatric diagnosis. This is complicated in patients who are strongly attached to a sickness role. As a result, there is likely to be variability in the CCEP psychiatric diagnoses despite strong efforts to standardize procedures. For instance, the proportion of patients who receive a primary diagnosis of a psychiatric disease varies considerably from site to site. For example, the rates of serious psychiatric diseases are particularly high at the Walter Reed Army Medical Center. In addition to the mandated tests, Walter Reed staff always include the Minnesota Multiphasic Personality Inventory and a social worker's evaluation in the psychiatric exam (Roy, 1995~. The committee recommends that the DoD consider methods of improving the standardization of the 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 the various hospitals across the country. These guidelines could provide suggested procedures for the use of selected self-report instruments for the assessment of the most commonly diagnosed disorders, as well as procedures for more in- depth structured clinical interviews when indicated. Validated self-report instruments are available to assist primary care physicians in screening patients for common psychiatric conditions (Spitzer et al., 1995~. 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. Standardization of the neuropsychological evaluations is a related concern. The neuropsychological methods vary from pencil and paper testing at some

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18 EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM sites to computer-administered testing at other sites. This could lead to diagnostic variability from site to site. At some sites, it appears that patients receive only a computerized test battery without an individualized clinical evaluation. At these sites, it is unknown how cutoff scores for judging whether the patient's performance is abnormal were determined. It is also unknown how premorbid abilities are assessed. In addition, explicit criteria would be helpful for determining which patients would benefit from a neuropsychological evaluation. One method of achieving a better consensus, suggested by RMC physicians, is to convene a meeting attended by one psychiatrist and one neuropsychologist from each center to attempt to standardize their methods. In addition to the standardization of psychiatric evaluations in the CCEP, the classification and coding of these diseases should also be standardized. In general, the ICD-9 coding of the diagnoses in the CCEP appears to be appropriate, but the categorization of some psychiatric and neurological conditions is confusing. Migraine and other severe headaches are categorized under the nervous system, tension headaches are categorized under psychological conditions, and still a third group of headaches is categorized under the group signs, symptoms and ill-defined conditions (DoD, l995c). The classification of different types of headaches into these three separate categories may be consistent with ICD-9 coding rules, but the DoD should also report a special tabulation that combines all headaches into one group. This is particularly important, since 39% of the CCEP patients complain of headache symptoms (DoD, l995d). If psychiatric and neuropsychological diagnoses are made inconsistently or are not coded uniformly, the DoD will not be able to provide accurate and reliable summary data based on the combination of information from many patients. The DoD now has experience with more than 10,000 patients; therefore, the more frequent types of chart errors, omissions, or inconsistencies should be apparent by now. More explicit written instructions could be added to the CCEP guidelines to help prevent the most frequent problems found in the medical record-keeping and coding. These comments about inconsistencies are mainly aimed at the quality control necessary for accurate reporting of summary data rather than at the quality of the medical care itself. Recognition of Psychosocial Stressors in the CCEP Population A brief overview of the psychological stressors faced by the troops who were deployed to the Persian Gulf appears in two section in the DoD report on 10,020 CCEP patients: Potential Health Risks Associated with Persian Gulf Deployment, and Individual and Group Response to Environmental Hazards as a Factor Contributing to Health Consequences Among CCEP Participants (DoD, l995d). In future reports, the DoD should consider expanding this description

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EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSON 19 GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM to provide a more thorough, in-depth discussion of the psychological stressors that were present during the Persian Gulf War. For example, although there were few American casualties, thousands of Iraqi soldiers were killed. Witnessing large numbers of dead Iraqi soldiers or involvement in their burial has been associated with the development of significant psychological distress (Sutker et al., 1994a,b). The DoD and the DVA have recognized the need for epidemiological research on the psychological stressors of the Gulf War and on the prevalence of psychiatric outcomes among Persian Gulf veterans. This need was summarized in a recent document that outlines their current research strategy (PGVCB, 1995a). The justification by the DoD and the DVA for this type of research is as follows (PGVCB, 1995a): Psychiatric morbidity among U.S. troops deployed to the Persian Gulf area was predicted even though the war was of short duration, resulted in a relatively low number of casualties, and positive support for the war prevailed at home. Persian Gulf veterans were exposed to many psychophysiological stressors besides direct combat, such as sudden mobilization for military service (especially among members of resene and National Guard units), exposure to dramatic oil well fires, the constant threat of chemical and biological warfare agents, and fear of combat in general. A wide range of somatic and psychological responses could be expected from individuals deployed to the Persian Gulf area from stress associated with deployment (Wolfe et al., 19931.... A variety of symptoms have been reported by Persian Gulf veterans. Some symptoms may be related to post-traumatic stress disorder (PTSD). Published findings(Sutker etal., 1993; Sutkeret all, 1994a,b; and Wolfe et al., 1993) suggest an increased prevalence of PTSD and other psychiatric diagnoses, such as depression, in some Persian Gulf War veterans. Although the prevalence of these disorders was found to be lower than that found among Vietnam veterans, it is evident that stressors during the Persian Gulf conflict were sufficient to cause significant psychiatric morbidity. Because of the low level of combat experienced by many troops in the Persian Gulf conflict, the presence of psychiatric problems among some returnees suggests the importance of stress other than actual combat as a precipitating factor. Currently, the DoD and the DVA are funding several research projects relevant to psychiatric conditions in Persian Gulf veterans (PGVCB, 1995a). These include four DoD and six DVA projects, which will acquire self-reported data on exposures to psychophysiological stressors among Persian Gulf veterans. These projects will also collect questionnaire data, which will allow the

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20 EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM development of prevalence estimates of psychological symptoms and diagnoses (PGVCB, 1995a). It is possible that the DoD will be able to use the results of these 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 and treatment of their patients. These results may also be useful for the DoD in its planning to minimize the effects of psychosocial stressors in future deployments through the use of preventive medicine interventions. For instance, a better understanding of the psychological symptoms in the CCEP, coupled with more information on the deployment circumstances associated with patients with these problems, might suggest hypotheses for further research on prospective interventions. Musculoskeletal Conditions Musculoskeletal conditions account for 17% of the primary diagnoses in the CCEP population. A primary or secondary diagnosis of a musculoskeletal condition has been made in 45% of the CCEP patients. Of these conditions, 51 % are included in three categories: joint pain, osteoarthritis, and backache/lumbago (DoD, l995d). These musculoskeletal conditions could be related to the physical demands of military service. Occupational and recreational overuse injuries frequently occur as a consequence of the physical activities associated with military training and operations (DoD, l995d). It is fortunate that most of these musculoskeletal conditions do not appear to cause serious impairment. Of the patients who had a musculoskeletal condition as their primary diagnosis, 82% stated that in the previous 90 days they had not missed even 1 day of work because of illness (DoD, 1995c). 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 (DoD, l995c,d). All three of the categories of musculoskeletal conditions mentioned joint pain, osteoarthritis, and backache/lumbago are broad and vague; therefore, some explicit examples of the actual diseases categorized under musculoskeletal conditions would be helpful. More explanation about the 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.

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EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN 21 GULF COMPREHENSIVE CLINICAL EVALUATIONPROGRAM The DoD and DVA apparently are not currently performing any epidemiological investigations that are focused on musculoskeletal conditions among Persian Gulf veterans (PGVCB, 1995a). The DoD and DVA are performing several general health surveys among Persian Gulf veterans in which musculoskeletal conditions may be a minor consideration. The IOM committee believes that the DoD and the DVA should consider placing more emphasis on research on musculoskeletal conditions, since these are the most prevalent disorders among the CCEP populations. A variety of instruments are available for use in epidemiological research on musculoskeletal conditions. Musculoskeletal conditions represent a significant cause of morbidity among military personnel in general, that could be prevented if risk factors could be identified (DoD, l995d). Signs, Symptoms, and Ill-Defined Conditions The ICD-9 category of signs, symptoms, and ill-defined conditions (SSIDC) Is extremely heterogeneous. It encompasses generalized symptoms such as fatigue and malaise, nonspecific abnormal laboratory results (i.e., an elevated sedimentation rate), and signs and symptoms that prove to be transient (i.e., a history of a skin rash). In general, no significant objective anatomical, pathological, or biochemical abnormalities are detectable in this category. Since many specific conditions that are not otherwise classified in ICD-9 are categorized as SSIDC, coding a diagnosis as SSIDC may reflect limitations in the ICD-9 criteria, as much as a physician's inability to explain the condition. SSIDC is the primary diagnosis for 17% of CCEP patients, and 41% of CCEP patients have a primary diagnosis or a secondary diagnosis of SSIDC (DoD, 1995d). This group does not have homogeneous symptoms, and some of the patients in this group have well-recognized diseases, such as dyslexia or sleep apnea, which are not classified elsewhere in ICD-9. Therefore, it should not be concluded that the 17% of the CCEP patients whose primary diagnosis is SSIDC have a "mystery illness." Rather, the committee recommends that in future reports the DoD attempt to clarify the types of disorders that are included in the category of 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. Infectious Diseases An overview of the infectious diseases that occurred during the Persian Gulf War was recently published (Hyams et al., 1995~. The most frequently reported

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22 EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSL4N GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM infectious causes of acute morbidity were generally mild cases of acute diarrhea and upper respiratory infections, neither of which would be likely to lead to long-term sequelae. There were unexpectedly low rates of arthropod-borne infections, for example, sandily fever. These very low rates were due to low insect populations in the winter months. A total of 226 noncombat deaths, primarily from accidental injuries, were reported during the Persian Gulf War. No deaths due to infectious diseases were reported (Helmkamp, 1994; Hyams et al., 19951. The DoD report on 10,020 CCEP patients summarized the types and prevalence of infectious diseases as follows (DoD, l995d): The threat to deployed military personnel posed by infectious diseases was recognized and preparations were made from the earliest stages of Operation Desert Shield. Specific infectious diseases observed in U.S. troops during Operations Desert Shield/Storm conformed with expected disease threats. Data suggest that overall exposure to recognized pathogens was quite low. Furthermore, it suggests that no route of infection, other than ingestion of locally- produced food, was common. The reported incidence of infectious diseases observed during the Operations is relevant to evaluation of current health complaints of Gulf War veterans.... The low incidence of leishmaniasis during and immediately after Operations Desert Shield/Storm, the absence of other sandfly-borne diseases in our troops, and the low prevalence of objective findings pointing to leishmania disease among 10,000 CCEP patients, all indicate that viscerotropic leishmaniasis plays no significant role in the current complaints of Gulf War veterans. The CCEP itself has identified a wide variety of infectious diagnoses. Of these, by far the largest group has been fungal infections of the skin due to fungi common in the United States. Virtually all of the remaining infections have represented common illnesses, such as sinusitis, diarrheas, and a few cases of viral hepatitis, not specific to the Persian Gulf region. The overwhelming majority of these diagnoses represent incidental diagnoses which would not explain persistent systemic complaints. The IOM committee concludes that infectious diseases are not a frequent cause of serious illness in the CCEP population. Only 3% of the CCEP population has a primary diagnosis of an infectious disease. A primary or secondary diagnosis of an infectious disease has been made in 9% of the CCEP population (DoD, l995d). Of the 278 patients who have a primary diagnosis of

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EVALUATION OF THE U.S. DEPARTMENT OF DEFENSE PERSIAN 23 GULF COMPREHENSIVE CLINICAL EVALUATION PROGRAM an infectious disease, 81% stated that in the previous 90 days they had not missed even one day of work because of illness (DoD, l995c). A variety of organ systems have been affected by infectious diseases in the CCEP population, without any observable patterns. The majority of these diseases have been minor or asymptomatic, or they were diseases that were diagnosed before the patient enrolled in CCEP (Gasser, 19951. To date, very few CCEP patients have demonstrated the classical objective physical and laboratory abnormalities that would indicate a chronic infectious process, such as documented fever, leukocytosis, lymphadenopathy, hepatomegaly, or splenomegaly (Gasser, 1995; Hyams et al., 1995; PGVCB, l995b). The IOM committee concludes that on the basis of the 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. Chronic Fatigue Syndrome, Fibromyalgia, and Multiple Chemical Sensitivity The IOM committee's review of the CCEP protocol suggests that data on chronic fatigue syndrome (CFS), f~bromyalgia (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. In the clinical evaluations, the IOM committee believes that data should be collected by using established diagnostic criteria for CFS and FM. 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. 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 the future. The symptoms of some of the CCEP patients are similar to or overlap the nonspecific symptoms that previous authors (Holmes et al., 1988; Wolfe et al., 1990) have described for CFS or FM, as shown in Table 7 of the DoD report on 10,020 patients (DoD, l995d). These nonspecific symptoms include fatigue, joint and muscle pain, headache, sleep disturbance, and depressed mood. Because of the thorough, systematic workup mandated in the CCEP, many disorders that could contribute to sleep disturbance and fatigue have been diagnosed. These have included obstructive sleep apnea, gastroesophageal reflux, hyperthyroidism, chronic sinusitis, and PTSD. For example, 5 % of the first 10,020 CCEP patients were diagnosed with PTSD (DoD, l995d). These