The Comprehensive Clinical Evaluation Program*
In June 1994 the DoD instituted the CCEP to provide a thorough systematic clinical evaluation program for the diagnosis and treatment of Persian Gulf veterans at military facilities in the US and overseas. Since then, more than 37,800 veterans (of whom about 13% are women) have enrolled in the CCEP registry. Of those, about 28,580 (about 12% of whom are women) have requested clinical examinations. By December 31, 1996, 24,400 veterans (or about 12% of those eligible) had received completed evaluations, while an additional 4,180 are currently involved in some phase of the examination process.
The CCEP was designed to: (1) strengthen the coordination between the DoD and the VA; (2) streamline patient access to medical care; (3) make clinical diagnoses in order to treat patients; (4) provide a standardized, staged evaluation and treatment program; and (5) assess possible Gulf War-related conditions. (Veterans who have left military service entirely are eligible for evaluations from the VA; personnel still on active duty, in the Reserves, or in the National Guard may request medical evaluations from DoD.) Phase I of the CCEP consists of a medical history, physical examinations, and laboratory tests. These are comparable in scope and thoroughness to an evaluation conducted during an in-patient internal medicine hospital admission (see Appendix B). All CCEP participants are evaluated by a primary care physician at their local medical treatment facility and receive specialty consultations if they are deemed
appropriate by their primary care physician. Evaluation at this phase includes a survey for nonspecific patient symptoms, including fatigue, joint pain, diarrhea, difficulty concentrating, memory and sleep disturbances, and rashes.
The primary care physician may refer patients to Phase II for further specialty consultations if he or she determines it is clinically indicated. These Phase II evaluations are conducted at a regional medical center and consist of targeted, symptom-specific examinations, lab tests, and consultations. During this phase potential causes of unexplained illnesses are assessed, including infectious agents, environmental exposures, social and psychological factors, and vaccines and other protective agents. Both Phase I and Phase II are intended to be thorough for each individual patient and to be consistent among patients.
Every medical treatment facility has a designated CCEP physician coordinator who is a board-certified family practitioner or internal medicine specialist. The coordinator is responsible for overseeing both the comprehensiveness and quality of Phase I exams. At regional medical centers CCEP activities are coordinated by board-certified internal medicine specialists who also oversee the program operations of the medical treatment facilities in their region.
In March 1995, the DoD established the Specialized Care Center at Walter Reed Army Medical Center to provide additional evaluation, treatment, and rehabilitation for patients who are suffering from chronic debilitating symptoms. A small select group of patients have been referred from regional medical centers to the Specialized Care Center for an intensive 3-week evaluation and treatment program designed to improve their health status.
The DoD has summarized the information obtained through the CCEP in reports released to the public. In the most recent published report, which covered 18,598 participants seen through December 6, 1995, the most frequent primary diagnoses were psychological conditions (18.4%); musculoskeletal conditions and connective tissue diseases (18.3%); symptoms, signs, and ill-defined conditions (17.9%); respiratory diseases (6.8%); and digestive system diseases (6.3%). An additional 9.7% were found to be healthy.
When both primary and secondary diagnoses were considered, the most common diagnostic categories were musculoskeletal diseases (47.2%); symptoms, signs, and ill-defined conditions (43.1%); psychological conditions (36.0%); digestive diseases (17.5%); and nervous system diseases (17.8%) (CCEP report on 18,598 participants, April 2, 1996).
The most frequently recorded psychological diagnoses were tension headache, depression, anxiety disorders, adjustment reactions, and somatoform disorders. For participants with a primary diagnosis of symptoms, signs, and ill-
defined conditions, the most common conditions were malaise and fatigue (26.6%), sleep disturbance (17.7%), and/or headache (15.3%). More than 50% of the patients with a primary diagnosis of musculoskeletal and connective tissue conditions had pain in joints, osteoarthrosis, and backache.
Five percent of the participants in the CCEP had a primary diagnosis of a neurological disorder. In addition, 11.8% of all participants were diagnosed with at least one neurological condition. The most common primary neurological diagnosis was migraine headache (56%) followed by carpal tunnel syndrome (9.5%), other peripheral mononeuropathies (0.25%), and benign essential tremors (2.3%) (DoD, 1996:68).
Major neuromuscular complaints recorded during Phase I included myalgias, fatigue and weakness. Patients who complained of severe muscle weakness, fatigue, or myalgias that lasted at least 6 months and interfered with normal functioning were referred to neuromuscular specialists for evaluation. At a minimum, these patients had median and sural sensory nerve action potentials recorded. Additional tests were ordered as deemed necessary by the neurologist. After extensive clinical, electrophysiological, and histological testing, no significant, objective neuromuscular pathology was identified that would suggest a possibly distinct neuromuscular disorder in these patients.
CCEP: The Initial IOM Report
In July 1994, Dr. Stephen Joseph, Assistant Secretary of Defense for Health Affairs, asked the IOM to convene a committee to evaluate the clinical assessments of the CCEP and to comment on the interpretation of its results to date. That committee was also asked to make recommendations regarding how the clinical assessments should be conducted in the future and on DoD's broader program of Persian Gulf health studies. Committee members included experts in general medicine, occupational and environmental medicine, rheumatology, infectious disease, psychiatry, psychology, and clinical neurotoxicology. The committee reached the following conclusions (for a complete set of recommendations of the first CCEP committee, as well as a list of committee members, see Appendix A):
- The CCEP is a comprehensive effort to address the clinical needs of thousands of active-duty personnel who served in the Gulf War. The CCEP leads to a specific medical diagnosis or diagnoses for most patients. The DoD has made conscientious efforts to build consistency and quality assurance into this program at the many medical treatment facilities and regional medical centers across the country.
- DoD efforts to compare the symptoms and diagnoses in the CCEP with those in several community-based and clinically based 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 results do have considerable clinical utility, and they could be used to address many important questions from a descriptive perspective.''
- "The results of the CCEP can and should be used for several purposes, including (1) educating Persian Gulf veterans and the physicians caring for them, (2) improving the medical protocol itself, and (3) evaluating patient outcomes. The medical findings of the CCEP should be distributed promptly to all CCEP primary care physicians." These findings would also be of "considerable value and interest to physicians in the VA system and in the community."
- "DoD should consider developing a comprehensive document for use in the CCEP that describes the potential physical, chemical, biological, and psychological stressors that were present in the Persian Gulf theater. If the CCEP physicians could obtain a clearer picture of the possible range of exposures, they might be able to counsel their patients more effectively."
- DoD has taken a serious approach to the treatment and rehabilitation of patients who have treatable, chronic diseases. If the Specialized Care Center "program is successful in improving the health and functional status of its patients, perhaps the elements that are most effective in enabling the patients to cope with their symptoms could be identified. It might then be possible to disseminate some of these elements to the DoD medical treatment facilities, which are close to where the CCEP patients live and work."
CCEP: IOM Review Continued
Late in 1995, the DoD asked the IOM to continue its evaluation of the CCEP with special attention to two issues: (1) difficult-to-diagnose individuals and those with ill-defined conditions; and (2) the diagnosis and treatment of patients with stress and psychiatric conditions. A new committee was convened to address these issues. Most members of the newly formed committee were also members of the first IOM CCEP committee.
With the disclosure in June of 1996 that some US ground troops may have been exposed to low levels of nerve agents following the destruction of the munitions dump at Khamisiyah, the DoD asked the IOM to add to its assessment whether the present CCEP protocol is adequate for evaluating the health of individuals who may have been exposed to low levels of nerve agents.
In defining the tasks included in Phase II, it is important to note what is not included in the committee's charge. It is not this committee's charge to determine whether or not there is such an entity (or entities) as "Persian Gulf Illness." It is not this committee's charge to determine whether or not there are
long-term health effects from low-level exposure to nerve agents. These questions are more properly the subject for extensive scientific research.
The committee charge, then, is threefold. It is to evaluate the adequacy of the Dolls Comprehensive Clinical Evaluation Program regarding:
- approaches to dealing with difficult-to-diagnose individuals and those with no diagnosis, as well as poorly defined conditions such as chronic fatigue syndrome, fibromyalgia, and multiple-chemical sensitivity;
- the diagnosis and treatment of stress and psychiatric conditions, the relationship between stress and psychiatric conditions and physical symptoms, and predeployment screening and mitigation of stressors in future deployments; and
- assessment of the health problems of those who may have been exposed to low levels of nerve agents.
The committee also will consider whether there are medical tests or consultations that should be systematically added to the CCEP to increase its diagnostic yield.
A series of workshops was planned to obtain information on these topics. Given the urgency surrounding the question of health problems of those who may have been exposed to low levels of nerve agents, DoD asked the Committee to address this topic first. A 1-day workshop was held on December 3, 1996, during which information was gathered from leading researchers and clinicians about effects of exposure to nerve agents and chemically related compounds, as well as about tests available to measure potential health effects of such exposures. (See Appendix C for the workshop agenda and list of speakers.) The committee spent the day following the workshop examining and analyzing this information in detail in order to develop its recommendations.