Gulf War Clinical Evaluation Programs
VA Gulf War Registry Health Examination Program
Before the end of the Gulf War, VA officials became concerned about the long-term health of combat troops because of the large clouds of smoke from oil well fires. Consequently, a proposal was developed in early 1991 to create a clinical registry of war veterans to determine whether health problems were caused by wartime exposures and to provide optimal health care for returning troops through focused education and outreach. This proposal led to the establishment of the VA Gulf War Registry Health Examination Program, which was authorized on November 4, 1992, by PL 102-585 (Title VII), the "Persian Gulf War Veterans Health Status Act."148 This clinical evaluation program was patterned after the VAs Agent Orange registry, which has aided VA in caring for Vietnam veterans.
The VA Gulf War Registry Health Examination Program offers to every Gulf War veteran a complete physical examination with basic laboratory studies. Additionally, a thorough medical history is obtained and documented in the veteran's medical record. Registry examinations are available at VA treatment facilities nationwide. All veterans who are eligible for VA health care (Reserve, National Guard, and former active duty military personnel) are encouraged to participate in the health examination program, if they have any health concerns related to serving in the Gulf War theater of operations, even if they are feeling well.
The VA clinical evaluation program has been widely publicized and an extensive outreach effort has been implemented to ensure that Gulf War veterans with health concerns are informed about the registry. Varied means have been utilized to contact Gulf War veterans, including:
As of September 30, 1999, 70,385 Gulf War veterans had responded to VA's outreach program and completed a free examination (Figure 1); 2,583 veterans who served in the Gulf region after the war (from July 31, 1991 until 1999) also have been evaluated. In addition to standardized registry examinations, by October 2000 the VA had seen 263,782 unique Gulf War veterans on an outpatient basis and 28,738 unique Gulf War veterans as inpatients.
A centralized mailing lists of registry participants is maintained by VA to inform veterans about new clinical and research findings. This clinical database allows VA to communicate with Gulf War veterans and provides a mechanism to catalogue prominent symptoms, reported exposures, and diagnoses. Each VA medical center has an assigned Registry Coordinator and a Registry Physician for this comprehensive health program.
The standard VA registry clinical examination protocol consists of the laboratory tests and consultations that physicians use to evaluate the symptoms reported by Gulf War veterans during their initial clinical examination.26,148 This baseline examination protocol elicits information about symptoms and exposures, and directs initial laboratory studies, including a blood count, urinalysis and a set of blood chemistry tests. In addition to core laboratory screening, physicians order additional tests and specialty consultations as clinically indicated to arrive at a diagnosis for every participating veteran.
In 1995, the VA expanded this standard protocol as more experience was gained about the health problems of Gulf War veterans. A greater number of symptoms and diagnoses are captured in the revised registry database. Additionally, if a Gulf War veteran's symptoms remain unexplained after initial examination, the revised VA registry provides an expanded assessment protocol, which is a set of clinical guidelines for use in evaluating ill-defined or unexplained illnesses. For this purpose, an "unexplained illness" is characterized as one or more symptoms that do not conform to a characteristic clinical presentation, allowing for a specific diagnosis, but which appear to be causing a decline in the veteran's functional status or quality of life.
This set of extended clinical guidelines -- the Uniform Case Assessment Protocol -- suggests 22 additional tests and auxiliary specialty consultations, and outlines supplementary diagnostic procedures based on the specific symptoms of the veteran and the clinical judgment of the registry physician. The Uniform Case Assessment Protocol was first developed in 1993 by the VA and is now used in both VA and the DoD Gulf War clinical evaluation programs.
In the VA registry, veterans receive a diagnosis based on the International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM).149 However, ICD-9-CM does not provide specific codes to track all symptoms and diagnoses. To address this limitation, three additional coding designations were created for the revised VA registry:
Prior analysis of VA registry data indicated that many participants are healthy when evaluated.26,148 Thirty-two percent of evaluated veterans reported very good health, 41% report good health, and 26% report poor/very poor health. In decreasing frequency, the most common symptoms reported were:
The most common primary diagnoses were diverse and usually were related to the following: 1) musculoskeletal and connective tissue conditions, 2) mental disorders, 3) respiratory illnesses, 4) skin and subcutaneous conditions, and 5) digestive disorders.26
The health problems of a majority of veterans evaluated in the VA clinical evaluation program have been diagnosed. For Gulf War veterans with debilitating symptoms that remain unexplained after completing the Uniform Case Assessment Protocol, the local VA physician initially could refer them to one of VA's four regional Gulf War Referral Centers in: 1) Washington, DC; 2) Houston, Texas; 3) West Los Angeles, California; and 4) Birmingham, Alabama. The decision to send a veteran to a referral center was made by the local medical center physician in consultation with a referral center physician. More than seven hundred veterans were evaluated at the referral centers. With more extensive assessment permitted by hospitalization, most of these veterans were diagnosed as having well-recognized illnesses.
The referral centers recently have been superseded by new VA clinical programs. Gulf War veterans requiring more extensive clinical evaluation are now seen in one of two new War Related Illness and Injury Study Centers, located in East Orange, NJ, and Washington, DC. In May 2001, VA announced the selection and funding of these deployment health research centers, which specialize in studying the treatment of war-related illnesses among active duty troops and veterans. A competitive, scientific peer-review process was used to select the two sites. VA recognized the need for these new centers based on experience treating Gulf War and Vietnam veterans. VA concluded that combat casualties do not always result in visible wounds, and inevitably some veterans return with health problems that while difficult to diagnose are no less disabling. DoD also has established three deployment health research centers.
On April 1, 1996, VA initiated a special program to support health examinations for some spouses and children of participants in the VA Gulf War Registry Health Examination Program (authorized by PL 103-446). The results of these examinations, which are conducted under contract by non-VA physicians in non-VA medical facilities, are included in the VA registry database. Examinations can be provided to individuals who are a spouse or child of a veteran listed in the VA Gulf War registry, who may be suffering from an illness that cannot be disassociated from the veteran's service in Southwest Asia, or who have been granted permission by the VA to be evaluated. The clinical evaluation protocol includes a detailed medical history, physical examination, and laboratory testing as clinically required. Up to October 2001, more than 1100 spouses and children of Gulf War veterans have been evaluated.
In July 1998, VA significantly expanded the Registry Examination to include a new 7-page depleted uranium (DU) questionnaire. Furthermore, a 24-hour urine collection was offered to measure uranium levels of any Gulf War veteran who is concerned about possible DU exposure.
Department of Defense Comprehensive Clinical Evaluation Program (CCEP)
In response to the health concerns of Gulf War veterans, DoD's Office of the Assistant Secretary of Defense for Health Affairs, instituted the Comprehensive Clinical Evaluation Program (CCEP) on June 7, 1994.150 The CCEP was a continuation of prior DoD medical care of active duty Gulf War veterans and screening for unusual illnesses but provided a more systematic evaluation strategy modeled after the VA Gulf War Registry Health Examination Program. As of September 30, 1999, there were 32,876 military personnel evaluated in the CCEP (Figure 1). In addition, some active duty personnel have been evaluated in the CCEP following deployments to the Gulf region after the war with Iraq, and following hazardous deployments to Somalia, Haiti, and Bosnia.
The CCEP was developed to provide a systematic and uniform medical evaluation at 184 military health care facilities located in 39 states, eight foreign countries, and two territories. To institute the CCEP, organizational meetings were held with senior medical officials from all military services; health care officials of the VA were consulted to ensure that the CCEP and the VA Gulf War Registry collected comparable data; and, four instructional meetings were held with military health care personnel on CCEP procedures and to provide clinical and research information related to Gulf War health questions. A special committee of the Institute of Medicine (IOM) reviewed and monitored the CCEP process, including the design and implementation of the program and interpretation of initial findings.135,151-153
Through concerted outreach efforts, the 285,000 Gulf War veterans still on active duty in 1994 when the CCEP was begun were encouraged to enroll if they had any health questions or concerns; a current health problem was not necessary for participation. Also eligible were veterans of the Gulf deployment who were military retirees, Reserve/National Guard personnel on full-time active duty or on special orders, and civilian DoD employees. Family members of qualified Gulf War veterans also could receive a CCEP evaluation. Finally, active duty troops who had participated in more recent deployments outside of the USA could be evaluated in the CCEP.
Military personnel enrolled in the CCEP either by calling a toll- free telephone number or by contacting their nearest military medical treatment facility (MTF). Veterans not eligible for a CCEP examination were referred to the VAs Gulf War Registry Health Examination Program. For the less than 100,000 Gulf War veterans who currently remain on active duty, CCEP examinations are still offered. Veterans of service in the Gulf from August 1990 to the present, who are eligible for care in DoD (active duty, retirees, Reserves/National Guard on active duty) and who wish a CCEP examination, can call 1-800-796-9699 to schedule an evaluation in the CCEP. Their family members are also eligible for evaluation.
The CCEP consists of an initial two-phase clinical evaluation supervised by a board-certified physician in either family practice or internal medicine. All CCEP participants are provided a Phase I examination, which is conducted at the local MTF and consisted of a thorough clinical examination and a standardized provider-administered questionnaire.154 All participants are asked about: 1) medical and family histories; 2) symptoms; 3) number of days of work lost due to illness during the 90 days prior to examination; and, 4) self-perceived exposures in the Arabian Gulf to among the following: petroleum products, pyridostigmine bromide pills, oil well fire smoke, insect repellents, anthrax and botulinum vaccinations, combat casualties, and actual combat. In addition, the following laboratory tests are performed: a complete blood count, urinalysis, and blood chemistries for electrolytes, glucose, creatinine, blood urea nitrogen, and transaminase levels.
For CCEP participants without current medical problems or who had health problems that could be satisfactorily dealt with after the Phase I evaluation, no additional evaluation was conducted. Other CCEP participants proceed to Phase II examination at one of 14 DoD Regional Medical Centers.154 The Phase II CCEP examination is comparable to the VA's Uniform Case Assessment Protocol. Phase II participants are administered the Structured Clinical Interview for DSMIII-R (SCID)155 and the Clinician Administered PTSD Scale (CAPS).156 Additionally, Phase II participants have a PPD skin test and chest x-ray, and a blood sample is analyzed for the following: sedimentation rate, C-reactive protein, rheumatoid factor, fluorescent ANA, thyroid function, B12 and folate levels, creatine phosphokinase level, HIV-I antibody, and hepatitis B surface antigen.135
At the conclusion of the CCEP evaluation process, examining physicians provide a primary diagnosis and additional secondary diagnoses based on clinical importance. After review by accredited medical record coders, up to seven diagnoses were coded using ICD-9-CM and entered into the database.149 A quality control process was instituted when the CCEP was established to ensure uniform evaluation, accurate data collection, and database validity.135
There have been a series of reports and publications dealing with the data collected from the CCEP.157-160 Analysis of the first 20,000 Gulf War veterans showed that the types of primary and secondary diagnoses varied widely.160 A total of 1,263 separate ICD-9-CM codes were needed to categorize primary diagnoses. Of the 1,263 separate codes used, 41% were applicable to only a single CCEP participant. Relatively frequent primary diagnoses found among 25 or more veterans were distributed among 114 different ICD-9-CM codes. For broad ICD-9-CM classifications, the three most common primary diagnoses were: 1) "Diseases of the Musculoskeletal System and Connective Tissue" (19% of diagnoses), 2) "Mental Disorders" (18%), and 3) "Symptoms, Signs, and Ill-Defined Conditions" (18%). Nine percent of participants were found not to have a clinically significant new illness.
Among the first 20,000 CCEP participants, there were: 74 (0.4%) veterans with connective tissue disease; 52 (0.3%) with non-cutaneous malignancies; 42 (0.2%) with peripheral neuropathy; 14 (0.07%) with interstitial pulmonary fibrosis; 12 (0.06%) with renal insufficiency; and, no new case of viscerotropic leishmaniasis.160 For the 3558 veterans with a primary ICD-9- CM diagnosis of "Symptoms, Signs, and Ill- Defined Conditions," no single subcategory of illness predominated, and no characteristic physical sign or laboratory abnormality was identified. Fifty-one percent of veterans in this diagnostic category reported that symptoms began more than six months after returning from the Gulf region.
In summary, no clinical indication of a new or unique illness was found, and the types of physiologic disease that could result from postulated hazardous exposures were uncommon in this self-referred population of 20,000 Gulf War veterans.160 Additionally, severe disability -- measured in terms of reported lost work days -- was not a major characteristic of evaluated military veterans who remained on active duty: 80% of active duty personnel had not missed work because of illness or injury during the 90 days prior to their initial registry evaluation.159 Lastly, there was no association between broad ICD-9-CM diagnostic categories and self-reported exposures to potential health hazards.159,160
In a more recent study of 21,579 CCEP participants, the diagnosis of "Symptoms, Signs, and Ill- Defined Conditions" was not found to be associated with particular self-reported exposures or demographic characteristics.161 Also, more definitive and often psychological diagnoses could be found among veterans of the Gulf deployment by increasing the intensity of the evaluation and by multidisciplinary clinical assessment.
In addition to Phase I and Phase II examinations in the CCEP, a Specialized Care Center (SCC) was opened at Walter Reed Army Medical Center (WRAMC) in March 1995 for intensive evaluation and treatment of symptomatic Gulf War veterans.162,163 Referrals are considered from all DoD clinicians who have evaluated veterans in the CCEP. Clinicians can refer motivated individuals who are suffering from persistent symptoms that interfere with their ability to perform routine military duties or to meet physical fitness and retention standards. Patients come to the SCC for three-week treatment periods in groups of four to six, and reside on the grounds of the medical center as outpatients. They receive treatment from a multidisciplinary team that includes fitness trainers, nutritionists, occupational and physical therapists, art and recreation therapists, internists, social workers, psychiatrists, and psychologists.
By January 2002, about 350 Veterans have been intensely evaluated and treated in the SCC. Initial analysis and follow-up indicate that most veterans have benefited from the program, with improved functional ability following a treatment regimen that utilizes a multidisciplinary team approach.
On September 30, 1999, the Assistant Secretary of Defense for Health Affairs (NHRC) established a DoD Center for Deployment Health Research at the Naval Health Research Center in San Diego, CA. The Centers mission includes conducting epidemiological studies to investigate the longitudinal health experience of previously deployed military personnel, and the development and evaluation of appropriate health surveillance strategies. A key study in fulfilling this mission is the Millennium Cohort Study.164 The Millennium Cohort study is a probability-based, cross-sectional sample of 100,000 U.S. military personnel who will be followed prospectively by postal surveys every 3 years over a 21- year period. The 100,000 subjects will be comprised of 50,000 veterans who have been deployed to Southwest Asia, Bosnia, or Kosovo since August 1997, and 50,000 veterans who have not been deployed to these conflicts. There are further plans to add 20,000 new military personnel to this cohort in 2004 and in 2007. A total of 140,000 veterans will be followed until the year 2022.
The primary objective for the Millennium Cohort Study is to determine how the health of US military service members and veterans change over time, and to determine the health impact of military deployments upon the adjusted incidence of chronic disease. Secondary objectives include comparing the adjusted change in health status between the cohorts as reflected by standardized questionnaires. This study will serve as a foundation upon which other routinely captured medical and deployment data may be added to answer future questions regarding the health risks of deployment, military occupations, and general military service.
British Medical Assessment Programme (MAP)
In 1993, the British Ministry of Defense established a clinical registry -- the Medical Assessment Programme (MAP) -- to assess the health of Gulf War veterans from the United Kingdom. Systematic clinical examinations of an initial 1000 Gulf veterans found a wide range of medical and psychiatric conditions, similar to the VA and DoD clinical registries.18 At least 19% of veterans had a diagnosis of a psychiatric condition, which in over one- half was due to PTSD. Musculoskeletal and respiratory disorders also were common. Like American veterans, British Gulf War troops reported numerous somatic symptoms. The authors of the report on these 1000 British registry participants noted that "there is no evidence of a single illness, psychological or physical, to explain the pattern of symptoms seen in veterans in the assessment programme."18
Over 3000 self- selected veterans have now attended the MAP. A report on the second series of 1000 British Gulf War veterans found similar symptom reporting as in the first series.165,166 An analysis of all 3000 British MAP participants has just been completed. Eighty percent of veterans who attended the MAP were found to be well and 20 percent were unwell. Among the unwell, a psychiatric condition constituted a major or significant part of their ill- health. Of the psychiatric disorders, PTSD (with or without co- morbidity) was the most frequent diagnosis, even though the trauma of warfare had occurred 10 years previously. The emergence of an unusual pattern of disease or unusual diseases or malignancies was not seen. Like civilians in primary health care, veterans frequently present to the MAP with medically unexplained physical symptoms (MUPS). These symptoms did not necessarily indicate disability. Finally, no evidence to support the existence of a unique "Gulf War syndrome" was found among British veterans attending the MAP.
A study comparing MAP registry participants with a randomized sample of the overall population of British Gulf War veterans found that veterans who underwent a registry evaluation reported more symptoms and health problems than the general population of Gulf veterans.167 These data suggest that the clinical registries are unlikely to miss a serious cause of health problems among Gulf War veterans.
Canadian Gulf War Registry
In 1995, the Canadian Department of National Defense also established a Gulf War clinical evaluation program.16 It was not necessary to have a medical problem in order to enroll in this registry, although most participants did have symptoms that concerned them. Veterans were initially evaluated at the local base level. If a diagnosis was reached and the member and examining physician were satisfied, no further workup or referral was done. If however the service member or examining physician requested further assistance, a referral could be made to a single Gulf War Clinic in Ottawa, Canada. The Gulf War Registry ceased recording new entries as of January 1998 after 226 veterans had been enrolled.
The Ottawa Gulf War Clinic saw 104 referred veterans between April 1995 and December 1997 (COL Ken Scott, MD FRCPC, Deputy Chief of Staff Medical Policy, Canadian Forces Medical Group Headquarters, Ottawa, Ontario, Canada). The initial history and physical examination averaged three hours, with a subsequent two-week hospital admission to facilitate other specialist consultations and diagnostic tests. There were, on average, 10 symptoms reported per patient, and 6 ½ specialist consultations were obtained on each veteran. Multiple diagnoses were made, but there was no evidence for a unique or previously undescribed medical condition. Approximately two-thirds of patients seen had either a primary or secondary psychiatric diagnosis. The most common psychiatric diagnoses were major depressive disorders, anxiety disorders, and PTSD.
Approximately 20% of veterans presented with multiple idiopathic physical symptoms that resulted in diagnoses of chronic fatigue syndrome, fibromyalgia, myofascial pain syndrome or soft tissue pain syndrome. These diagnoses were not unique to Gulf War veterans. In January of 1998, multiple "Post-Deployment Clinics" were opened on bases across Canada to which veterans of any Canadian deployment, whether currently serving or not, could be referred. This initiative was undertaken when examining physicians concluded that illnesses among Gulf War veterans were similar to illnesses being seen in Canadian veterans from Somalia, Croatia, Bosnia, Rwanda and Haiti.
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