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Appendix E Adequacy of the Comprehensive Clinical Evaluation Program: A Focused Assessment CONCLUSIONS AND RECOMMENDATIONS * A great deal of time and effort has been expended evaluating DoD's Comprehensive Clinical Evaluation Program. It has been reviewed by the President's Advisory Committee, the General Accounting Office, the Office of Technology Assessment, the Institute of Medicine, and many other organizations. As more is learned, it becomes easier to focus on the kinds of questions He CCEP should be asking. As Dr. Penelope Keyl said in her work- shop presentation on the development of good screening instruments, progress made over time will necessitate new generations of screening instruments. This does not imply that the first instrument developed is bad, but rather that time leads to new knowledge, which leads to the ability to improve Me instrument. Such is the case with the CCEP. Over tune, the CCEP and other programs have generated information that has led us to focus on areas of importance for those concerned about the health consequences of Persian Gulf deployment. This information has enabled us to take a closer look, to make a more thorough examination of the system, and to identify areas in which change will be of benefit. The committee believes that such change is healthy, that it reflects growth, and that it should be a natural part of any system having as one of its goals the delivery of high-quality heals care services. This appendix is excerpted from the Institute of Medicine report, Adequacy of the Comprehensive Clinical Evaluation Program: A Focused Assessment, Washington, D.C.: National Academy Press, 1997. 105

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106 ADEQUACY OF THE VA PERSIAN GULF REGISTRY AND UCAP Change also occurs with individuals. It may be that as time passes or new information is released, some of those who have already participated in the CCEP will develop new concerns or problems. The committee hopes that DoD will encourage these individuals to return to the CCEP for further evaluation and diagnosis. The committee wishes to emphasize that it is impressed with the dedication and concern exhibited by DoD personnel with whom committee members met. These individuals are knowledgeable regarding Persian Gulf issues and willing to learn more about identifying and resolving areas of concern for improving the health of active-duty personnel deployed to the Gulf. MEDICALLY UNEXPLAINED SYMPTOM SYNDROMES The committee spent some time deliberating on the precise meaning of "difficult to diagnose" or "ill deemed" as a description of a category of conditions. When labeling something as difficult to diagnose, one usually means that special expertise is required to arrive at a diagnosis, but many of these conditions do not require such expertise. Chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity are symptom complexes that have a great deal of overlap in the symptoms present In each condition but are well defined clinically, even if they are medically unexplained. Despite the fact that they are medically unexplained, they may cause significant impairment and they are illnesses that are only understood through time, that is, it requires the passage of time and the evaluation of responses to treatment to arrive at these diagnoses. The committee decided, therefore, to refer to this spectrum of illnesses as medically unexplained symptom syndromes. This spectrum of illnesses may include those which are etiologically unexplained, lack currently detectable pathophysiological changes, and/or cannot currently be diagnostically labeled. These medically unexplained symptom syndromes are often associated with depression and anxiety. There remains a debate about how to distinguish these syndromes from psychiatric diagnoses, but it is clear that they are not simply psychiatric diagnoses. However, since most of the recommended treatments for medically unexplained symptom syndromes overlap with the pharmacological and behavioral treatments for psychological conditions or psychiatric diagnoses, the committee believes that it is important to identify and evaluate the symptoms associated with these conditions and then treat those symptoms. The committee recommends that when patients presenting with medically unexplained symptom syndromes are evaluated, the provider must have access to the full and complete medical record, including previous use of services. The presence of such information is important

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APPENDIXE 107 because adequate evaluation of these disorders involves a longitudinal perspective that includes response to treatment. In the area of medically unexplained symptom syndromes, it is sometimes not possible to arrive at a definitive diagnosis. It may be possible, however, to treat the presenting complaints or symptoms. The committee recommends that in cases where a diagnosis cannot be identified, treatment should be targeted to specific symptoms or syndromes (e.g., fatigue, pain, depression). If these symptoms and conditions are left untreated, they can become chronic and potentially disabling. The committee recommends that the CCEP be encouraged to identify patients in this spectrum of illnesses early in the process of their disease. In addition, primary care providers should identify the patients' functional impairments so as to be able to suggest treatments that will help improve these disabilities. STRESS In this group of medically unexplained symptom syndromes it is important to recognize and acknowledge that the problems and stress facing the patient will continue to be difficult. Stress is a major issue in the lives of patients within this spectrum of illness. Stress need not be looked at so much as a causative agent, but rather as a part of the condition of the patient that cannot be ignored. With these medically unexplained symptom syndromes, the potential for stress proliferation is great among both the person deployed to the Persian Gulf and the family members. Media attention and reports by the military to Gulf War veterans that toxic exposure could have occurred are very stressful events, regardless of anyone's efforts to explain what happened. Such announcements carry with them stressful burdens for the veteran. The stress associated with these reports of and worry over toxic exposures needs to be recognized and addressed. Research has shown that stressors have been associated with major depression, substance abuse, and various physical health problems. Those de- ployed to the Gulf were exposed to a vast array of different stressors that carry with them their own potential health consequences. Current collection of exposure information does not adequately address an investigation of traumatic events to which the deployed soldier may have been exposed. The committee recommends that the CCEP contain questions on traumatic event exposures in addition to the exposure information currently being collected. This would include the addition of open-ended questions that ask the patient to list the events that were most upsetting to him or her while deployed. Positive responses to questions regarding such events, as well as to other exposure questions, should be pursued with a narrative inquiry, which would address such items as the specific nature of the exposure; the

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108 ADEQUACYOFTHEVAPERSIANGULFREGISTRYANDUCAP duration; the frequency of repetition; the dose or intensity (if appropriate); whether the patient was taking protective measures and, if so, what these measures were; and the symptoms manifested. Other suggestions for questions that could be added to the CCEP include the following: When did you first have questions or worries about being exposed? When did you first hear other information on possible exposures? What were your responses to that information? Providers in the CCEP need to take a history that includes some narrative to allow the veteran to express how he or she feels. It is always important to understand and acknowledge that the patients' complaints are real. It is certainly important for providers in the CCEP to do so when attempting to identify and address the health concerns of Persian Gulf veterans. Furthermore, no matter what additional information may be forth- coming about potential exposures to toxins and their effects, the committee recommends that DoD providers acknowledge stressors as a legitimate but not necessarily sole cause of physical symptoms and conditions. The committee believes that there are certain jobs undertaken in the midst of war that, by their very nature, result in high stress (e.g., grave registration duty). The effect of stress associated with these jobs can be mitigated if approached properly. The committee recommends that the DoD provide special training and debriefing for those who are engaged in high-risk jobs such as those associated with the Persian Gulf experience. Every soldier who goes to war will be subjected to major disturbing events since war by its very nature involves death and destruction. The committee recommends that DoD provide to each about-to-be deployed soldier risk or hazard communication which is well developed and designed to provide information regarding what the individual can expect and the potentially traumatic events to which he or she might be exposed. The committee wishes to emphasize that the accurate diagnosis of patients with medically unexplained symptom syndromes and/or conditions induced or exacerbated by upsetting events requires the expenditure of time, time in which the provider and the patient interact. It is not possible to hand the patient a questionnaire and expect that all necessary information will be revealed. In a world of time constraints and tightly scheduled appointments, the committee recommends that adequate time must be provided during initial interactions with patients in the CCEP in order to ensure that all pertinent information is forthcoming. The committee believes that the patient-physician interaction should be fostered, and the perception that evaluation is directed by the clock should be avoided.

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APPENDIX E 109 SCREENING Depression is a condition that is common in primary care. Most individuals who experience depression continue to function, but if they are left untreated, their conditio deteriorates. Unlike many of the medically unexplained symptom sy: Ames, there are effective treatments for depression. The data presented indicate rising rates of depression among those examined in the CCEP but no evidence that individuals are being properly diagnosed or treated according to currently accepted clinical practice guidelines. there are many self-rated screening tests (e.g., the Beck Depression Inventory [BDI], the Zung Scale, the Center for Epidemiological Studies-Depression Scale [CES-D], the Inventory to Diagnose Depression [IDD]) that could be used as a first-level screen at the primary care level. The committee recommends that there be increased screening at the primary care level for depression. Every primary care physician should have a simple standardized screen for depression. If a patient scores in the significant range, this person should be referred to a qualified mental health professional for further evaluation and treatment. If depression is identified, there has to be more questioning on exposure to traumatic problems. There has been a great deal of concern evinced about the possibility of widespread PSTD in those deployed to the Persian Gulf. Most of the individuals identified as having PTSD are diagnosed following a structured interview at Phase II. However, the committee believes that there are those who have some of the symptoms of PTSD or of depression but are not true PTSD cases yet might be helped with treatment oftheir symptoms. The committee recommends that any individual who reports any significant PTSD symptoms and/or a significant traumatic stressor should be referred to a qualified mental health professional for further evaluation and treatment. Substance abuse or misuse problems are prevalent in primary care. In addition, individuals with untreated depression or with medically unexplained symptom syndromes may have an enhanced risk of substance abuse. (See Appendix I for examples of screening instruments.) The committee recom- mends, therefore, that every primary care physician should have a simple, standardized screen for substance abuse. Every individual who screens positive should be referred for further treatment and evaluation. There are certain areas in which baseline assessments are of immense value in the clinical evaluation of an individual patient's status (e.g., pulmonary function and neurobehavioral testing). Changes in neurocognitive and peri- pheral nerve function are measured by comparing the individual's current status to a baseline measure. This is also true for measuring complaints of memory

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110 ADEQUACY OF THE VA PERSIAN GULF^GISTRYAND UCAP impairment. Individual baseline information is necessary because the variability across individuals is too great to identify a generalized "normal" screening level. The committee recommends that DoD explore the possibility of using neurobehavioral testing at entry into the military to determine whether it is feasible to use such tests to predict change in functioning or track change in function during a soldier's military career. PROGRAM EVALUATION Most patients in the CCEP receive a diagnosis after completing a Phase I examination; some are referred to Phase II for evaluation; and a few have gone on to participate in the program at the Specialized Care Center. Information presented to the committee indicates that there is great variation across regions in the percentage of patients who are diagnosed as having primary psychiatric diagnoses. A determination of the reasons for this variation should be made. Although there may be many reasons, one explanation could relate to the consistency with which procedures for diagnosis and referral are implemented from facility to facility. The committee recommends that an evaluation be conducted to examine (1) the consistency with which Phase I examinations are conducted across facilities; (2) the patterns of referral from Phase I to Phase II; and (3) the adequacy of treatment provided to certain categories of patients where there is the potential for great impact on patient outcomes when effective treatment is rendered (e.g., depression). This effort could be facilitated by the development and use of clinical practice guidelines such as those currently being developed by the Department of Veterans Affairs and many medical specialties. Clinical practice guidelines are systematically developed statements that assist practitioners and patients in decision making about appropriate health care for specific clinical circumstances (IOM, 19921. The process of developing these guidelines could also serve as an opportunity for increased learning for providers since their participation is crucial to successful implementation. The Specialized Care Center at Waltei Reed Army Medical Center has provided evaluation and treatment to 78 patients. A great deal of effort and thought has gone into the development of a program designed to help the patient understand his or her conditions and engage in behaviors most likely to result in improvement. The committee was asked to assess the effectiveness of this center within the context of medically unexplained symptom syndromes, stress, and psychiatric disorders. As the committee began its discussion of the effectiveness of the Specialized Care Center it became apparent that such an assessment was dependent on a number of factors that have not been well defined. What is the goal of the center is it treatment, research, or education? Should a major consideration in the center's evaluation be the cost of services?

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APPENDLsf E 111 Should the numbers of those receiving care be taken into consideration, and if so, what are the barriers to patients accessing this level of care? The committee concluded that at this time, it is not possible to conduct a fair or adequate evaluation of the Specialized Care Center. The committee recommends that a short-term plan (perhaps 5 years) be developed for the Specialized Care Center that would specify goals and expected outcomes. Based on such a plan, an evaluation could then be undertaken to assess the effectiveness of the center. COORDINATION WITH THE VA Given that many now receiving services in the DoD health care system will eventually move to the VA health care system, it is important to have good communication between DoD and the VA. This may be particularly true in the areas of medically unexplained symptom syndromes and psychiatric disorders, where accurate diagnosis and assessment of response to treatment are important for positive patient outcomes. The committee recommends that DoD explore ways to increase communication with the VA, particularly as it relates to the ongoing treatment of patients. Both patients and providers would benefit from increased educational activity regarding Persian Gulf health issues. Provider turnover within DoD is a factor that must be taken into consideration when examining the special health needs and concerns of active-duty personnel who were deployed to the Persian Gulf. Although efforts at provider education were extensive at the time the CCEP was implemented, three years have passed and many new providers have entered the system. These individuals should be oriented to the special needs, concerns, and procedures involved, and all providers should be updated regularly. The VA has developed a number of approaches to provider education. Interactive satellite teleconferences are available periodically for medical center staff to discuss particular issues of concern. The VA conducts quarterly national telephone conference calls, directs periodic educational mailings to Persian Gulf Registry providers in each health facility, and conducts an annual conference on the health consequences of Persian Gulf service. The committee recommends that DoD examine the activities and materials for provider education developed by the VA to determine if some of the items might be used as educational approaches for DoD providers. Although the topics of ongoing educational efforts are best determined by DoD on a periodic basis, the committee recommends that DoD mount an effort designed to educate providers to the fact that conditions related to stress are not necessarily psychiatric conditions. The committee recom- mends that depression be a topic of education for all primary care

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112 ADEQUACY OF THE VA PERSIAN GULF~GISTRYANDUCAP providers, with emphasis on the facts that depression is common, it is treatable, and individuals who experience depression can continue to function. The committee wishes to reemphasize the fact that the CCEP is not a research protocol but rather a program designed to diagnose the health problems of those who served in the Persian Gulf. As such, information obtained through the CCEP should not be used to answer research questions. It is appropriate, however, to use the data and narrative information obtained Dom the CCEP to inform the clinical treatment process. In doing so, the committee believes that it is important to unbundle diagnostic categories. For example, tension headache is classified as a somatoform disorder within the category of psychiatric . . c .lagnosls. In addition, a tremendous amount of qualitative infonnation could be used in developing case studies to help providers better understand diagnostic and treatment approaches that appear effective at improving individual patients' conditions. The committee recommends that CCEP information be used to develop case studies that will help educate providers about Persian Gulf health problems. There are a number of ways in which these case studies could be shared including presentation during professional meetings. There is also a need for education and communication with individuals who were deployed to the Gulf and with their families. These individuals are concerned about the potential impact of Persian Gulf deployment on their health, whether or not their health concerns will affect their military careers, their ability to obtain health insurance once they leave the service, and a number of other issues that need to be addressed. A variety of mechanisms are available for providing such information including individual post newsletters, the Internet, mailings to those in the Registry, and public forums. It is especially important to provide a forum for discussion each time new infonnation is released on possible exposures. The committee recommends that DoD develop approaches to communication and education that address the concerns of individuals deployed to the Persian Gulf and their families.