8

Recommendations

The committee, drawing on evidence presented in Chapters 27, offers recommendations in five categories:

1. Treatments for chronic multisymptom illness (CMI).

2. The Department of Veterans Affairs (VA) health care system as it is related to improving systems of care and the management of care for veterans who have CMI.

3. Dissemination through the VA health care system of information on caring for veterans who have CMI.

4. Improving the collection and quality of data on outcomes and satisfaction of care of veterans who have CMI and are treated in VA health care facilities.

5. Research on diagnosing and treating CMI and on program evaluation.

TREATMENTS FOR CHRONIC MULTISYMPTOM ILLNESS

In Chapter 4, the committee assessed the evidence on treatments for symptoms associated with CMI. The types of treatments included in the assessment were not predetermined by the committee. Rather, all treatments on which there was evidence were evaluated. Both pharmacologic and nonpharmacologic treatments were assessed.

CMI is a complex condition, and it has multiple co-occurring symptoms that vary from person to person. The committee believed that it was necessary to evaluate both integrative treatment approaches and individual interventions. Therefore, the scientific literature was searched broadly and



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8 Recommendations The committee, drawing on evidence presented in Chapters 2–7, offers recommendations in five categories: 1. Treatments for chronic multisymptom illness (CMI). 2. The Department of Veterans Affairs (VA) health care system as it is related to improving systems of care and the management of care for veterans who have CMI. 3. Dissemination through the VA health care system of information on caring for veterans who have CMI. 4. Improving the collection and quality of data on outcomes and satisfaction of care of veterans who have CMI and are treated in VA health care facilities. 5. Research on diagnosing and treating CMI and on program evaluation. TREATMENTS FOR CHRONIC MULTISYMPTOM ILLNESS In Chapter 4, the committee assessed the evidence on treatments for symptoms associated with CMI. The types of treatments included in the assessment were not predetermined by the committee. Rather, all treat- ments on which there was evidence were evaluated. Both pharmacologic and nonpharmacologic treatments were assessed. CMI is a complex condition, and it has multiple co-occurring symp- toms that vary from person to person. The committee believed that it was necessary to evaluate both integrative treatment approaches and individual interventions. Therefore, the scientific literature was searched broadly and 183

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184 GULF WAR AND HEALTH included nontraditional interventions (for example, complementary medi- cine and alternative medicine) in addition to traditional interventions (for example, pharmaceuticals). A summary of the search strategy can be found in Chapter 3. Three studies of interventions for the symptoms associated with CMI were conducted in the 1991 Gulf War veteran population. Those studies were included in the assessment with studies conducted in different popula- tions that had a similar constellation of symptoms. The generalizability of studies on nonveterans to veterans is not known. As described in Chapter 4, the strength of the evidence on each type of intervention was graded as insufficient, low, moderate, or high. Strength of evidence is not equivalent to efficacy or effectiveness of a treatment. Strength of evidence is a measure of confidence in the body of evidence. Efficacy or effectiveness of treatment takes into account the strength of evidence and the net benefit of the treatment to the patients. Several studies showing high and moderate strength of evidence were conducted in the 1991 Gulf War veteran population (Donta et al., 2003, 2004; Guarino et al., 2001; Mori et al., 2006). Although the study of d ­ oxycycline was found to have high strength of evidence and was conducted in a group of 1991 Gulf War veterans who had CMI, it did not demonstrate efficacy; that is, doxycycline did not reduce or eliminate the symptoms of CMI in the study population (Donta et al., 2004). Of the studies found ­ to have moderate strength of evidence were studies of exercise and group cognitive behavioral therapy (CBT) that were conducted in 1991 Gulf War veterans who had CMI and demonstrated a net benefit in reducing the symptoms associated with CMI (Donta et al., 2003; Guarino et al., 2001; Mori et al., 2006). Those studies evaluated the effects of exercise and CBT in combination and individually. The therapeutic benefit of exercise was unclear in those studies. Group CBT rather than exercise may confer the main therapeutic benefit with respect to physical symptoms. Additional studies, not conducted in 1991 Gulf War veterans, also reported a net ben- efit of exercise or group CBT in reducing symptoms associated with CMI (Bleichhardt et al., 2004; Lidbeck, 2003; Martin et al., 2007; Peters et al., 2002; Rief et al., 2002; Zaby et al., 2008). Studies of individual CBT (high strength of evidence) and St. John’s wort (SJW; moderate strength of evidence) did not include 1991 Gulf War veter- ans who had CMI. Studies of individual CBT showed a consistent pattern of symptom improvement in people who had unexplained symptoms (Allen et al., 2006; Escobar et al., 2007; Sharpe et al., 2011; Sumathipala et al., 2000, 2008). Studies of SJW in people who had somatoform disorders also demonstrated symptom improvement (Muller et al., 2004; Volz et al., 2002).

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RECOMMENDATIONS 185 Many symptoms that define CMI are shared with symptoms associ- ated with other conditions: fibromyaliga, chronic pain, chronic fatigue syndrome, somatic symptom disorders, sleep disorders, IBS, functional d ­ yspepsia, depression, anxiety, posttraumatic stress disorder, traumatic brain injury, substance-use and addictive disorders, and self-harm. There- fore, the committee identified guidelines and systematic reviews of treat- ments for the related and comorbid conditions to determine whether any treatments found to be effective for one of the conditions may be beneficial for CMI. Three pharmaceuticals—selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs), and tri- cyclic medications—and CBT were found to be effective in managing the majority of the related and comorbid conditions assessed. Many other treat- ments, both pharmacologic and nonpharmacologic, have also been shown to be effective in managing at least some of the symptoms associated with conditions related to and comorbid with CMI (see Table 5-3). The best available evidence from studies of treatment for symptoms of CMI and related and comorbid conditions demonstrates that many veterans who have CMI may show some benefit from such medications as SSRIs and SNRIs and from CBT. On the basis of the evidence reviewed, the committee cannot recommend any specific therapy as a set treatment for veterans who have CMI. The committee believes that a “one-size-fits-all” approach is not effective for managing veterans who have CMI and that individualized health care management plans are necessary. The condition is complex and not well understood, and it will require more than simply treating veterans according to a set protocol. Recommendation 8-1. The Department of Veterans Affairs should implement a systemwide, integrated, multimodal, long-term manage- ment approach to manage veterans who have chronic multisymptom illness. VA already has several programs that could be used to manage vet- erans who have CMI, such as postdeployment patient-aligned care teams (­D-PACTs), specialty care access networks-extension for community P health care outcomes (SCAN-ECHO), and war-related illness and injury study centers (WRIISCs). However, the programs have not been consistently implemented throughout the VA health care system, and they have not been adequately evaluated to learn about their strengths and weaknesses so that changes can be made to improve the quality of care. The committee offers additional recommendations to VA related to making better use of existing programs to manage the care of veterans who have CMI.

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186 GULF WAR AND HEALTH IMPROVING CARE OF VETERANS WHO HAVE CHRONIC MULTISYMPTOM ILLNESS The first step in providing care of veterans who have CMI is to identify them and bring them into the VA health care system. Prior to separation from the military, VA, in conjunction with the Department of Defense, offers soldiers a disability examination. However, the disability examination is independent of clinical care and treatment. A comprehensive health evalu- ation, ideally conducted shortly after separation, is important to identify veterans who have CMI, as defined by the committee in Chapter 2, so that they can receive proper care for their CMI and any common comorbidities. Recommendation 8-2. The Department of Veterans Affairs (VA) should commit the necessary resources to ensure that veterans complete a comprehensive health examination immediately upon separation from active duty. The results should become part of a veteran’s health record and should be made available to every clinician caring for the veteran, whether in or outside the VA health care system. Coordination of care, focused on transition in care, is essential for all veterans to ensure qual- ity, patient safety, and the best health outcomes. Any veteran who has chronic multisymptom illness should be able to complete a comprehen- sive health examination. Recommendation 8-3. The Department of Veterans Affairs should include in its electronic health record a “pop-up” screen to prompt clinicians to ask questions about whether a patient has symptoms con- sistent with the committee’s definition of chronic multi­ ymptom illness. s Once a veteran has been identified as having CMI and has entered the VA health care system, the next step is to provide comprehensive care for the veteran, not only for CMI but also for any comorbid conditions. VA has developed multiple clinical practice guidelines (CPGs) for medically unexplained symptoms (VA and DOD, 2001b), common comorbidities and conditions with shared symptoms, such as major depressive disorder, post- traumatic stress disorder, traumatic brain injury, and chronic pain (Chou et al., 2007; VA and DOD, 2009a,b,c, 2010a,b), and post-deployment health (VA and DoD, 2001a). However, there is anecdotal evidence that simply adhering to multiple CPGs often is not effective for managing chronic con- ditions with multiple morbidities such as CMI and can result in incomplete care and decrease patient satisfaction, and increase the likelihood of over- treatment and adverse side effects. As described in Chapter 7, management of the health of veterans who have CMI requires a unique personal care plan for each veteran.

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RECOMMENDATIONS 187 Coordination of care for veterans who have CMI among clinicians and others involved in providing care is essential. VA’s PD-PACTs should be able to provide care for veterans who have CMI if properly implemented. The goal of the PD-PACT model is to provide comprehensive, integrated care, including follow-up health care and education (Reisinger et al., 2012). The PD-PACT serves as a veteran’s medical home within the VA and uses a team approach to providing care. Team members can include a project manager, primary care clinicians, nurse care managers, mental health clini- cians, social workers, and other specialists as needed. The move to a medi- cal home model of care is relatively recent in VA’s health care system, and implementation is ongoing (Reisinger et al., 2012). Recommendation 8-4. The Department of Veterans Affairs (VA) should develop patient-aligned care teams (PACTs) specifically for veterans who have chronic multisymptom illness (CMI; that is, CMI-PACTs) or CMI clinic days in existing PACTs at larger facilities, such as VA medical centers. A needs assessment should be conducted to determine what expertise is necessary to include in a CMI-PACT. Recommendation 8-5. The Department of Veterans Affairs should c ­ ommit the resources needed to ensure that patient-aligned care teams have the time and skills required to meet the needs of veterans who have chronic multisymptom illness as specified in the veterans’ integrated personal care plans, that the adequacy of time for clinical encoun- ters is measured routinely, and that clinical caseloads are adjusted in response to the data generated by measurements. Data from patient experience-of-care surveys are essential to assist in determining needed adjustments. Recommendation 8-6. The Department of Veterans Affairs should use patient-aligned care teams (PACTs) that have been demonstrated to be centers of excellence as examples so that other PACTs can build on their experiences. To address the challenges of bringing care to veterans who lack easy access to VA medical centers, VA adopted the SCAN-ECHO model in 2010. SCAN-ECHO programs are being developed to bring specialty care to veterans who live in rural and other underserved areas. The SCAN-ECHO programs work by connecting clinicians who have expertise in particular specialties through video technology to provide case-based consultation and didactics to isolated primary care clinicians, who would otherwise not have access to care for their patients (Arora et al., 2011). After an initial

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188 GULF WAR AND HEALTH in-person orientation, the team meets weekly via videoconference to present and discuss patients, and together formulate care plans. Another VA program is the WRIISC program, which was established in 2001 to serve combat veterans with unexplained illnesses. Veterans are gen- erally referred to a WRIISC (there are three nationwide) by their clinicians when they are not improving and further local expertise is not available (Reinhard, 2012). Veterans in WRIISCs are evaluated by a multidisciplinary team that conducts a comprehensive health assessment and formulates a comprehensive personal care plan aimed at managing symptoms and improving functional health, which is implemented at the WRIISC and given to the referring clinicians (Lincoln et al., 2006). Although WRIISCs have been in place for more than a decade, the committee does not have informa- tion on awareness of the program among the teams of professionals caring for veterans who have CMI or among the veterans themselves. Information also is lacking on the effectiveness of the program. Recommendation 8-7. The Department of Veterans Affairs (VA) should develop a process for evaluating awareness among teams of profes- sionals and veterans of its programs for managing veterans who have chronic multisymptom illness, including patient-aligned care teams (PACTs), specialty care access networks (SCANs), and war-related illness and injury study centers (WRIISCs); for providing education where necessary; and for measuring outcomes to determine whether the programs have been successfully implemented and are improving care. Furthermore, VA should take steps to improve coordination of care among PACTs, SCANs, and WRIISCs so that veterans can transition smoothly across these programs. DISSEMINATION OF INFORMATION Many opportunities exist for VA to disseminate information about CMI to clinicians. A major determinant of VA’s ability to manage veterans who have CMI is the training of clinicians and teams of professionals in providing care for these patients. Although clinicians are appreciative of the challenges faced by veterans who have CMI and of their suffering, they also are wary of the difficulties in treating these patients (Aiarzaguena et al., 2009). Training clinicians to effectively communicate with and provide care for veterans who have CMI is essential. As noted in Chapter 7, VA can be viewed as the largest health education and health professional training insti- tution in the nation. It has active interprofessional team training programs in palliative care and geriatrics and has recently extended interprofessional team-based training into a small number of primary care settings (VA, 2011). Future training programs for clinicians and other team members

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RECOMMENDATIONS 189 caring for veterans who have CMI can be built upon the infrastructure already in place at VA. Recommendation 8-8. The Department of Veterans Affairs (VA) should provide resources for and designate “chronic multisymptom illness champions” at each VA medical center. The champions should be inte- grated into the care system (for example, the patient-aligned care teams) to ensure clear communication and coordination among clinicians. The champions should be incentivized (for example, by professional advancement and recognition and value-based payment), be given adequate time for office visits with patients who have CMI, have knowledge about the array of therapeutic options that might be useful for treating symptoms associated with CMI, have ready access to a team of other clinicians for consultation, and have training in communication skills. Smaller VA facili- ties, such as community-based outreach clinics (CBOCs), can benefit from CMI champions. For example, the SCAN-ECHO model can be used so that clinicians in CBOCs or even civilian community-based clinics can contact a CMI champion for expert consultation. In addition to using CMI champions to train clinicians about CMI, learning networks have been found to be effective tools for disseminat- ing information. Continuous exchange of information among learning networks can lead to improved quality of care. The networks offer a supportive environment for learning skills informally, role models, and a benchmark for an appropriate environment for adopting new guidelines. Recommendation 8-9. The Department of Veterans Affairs (VA) should develop learning, or peer, networks to introduce new information, norms, and skills related to managing veterans who have chronic multi­ symptom illness. Because many veterans receive care outside the VA health care system, clinicians in private practice should be offered the opportunity to be included in the learning networks and VA should have a specific focus on community outreach. Effective patient–clinician communication and coordination of care are crucial for managing veterans who have CMI and are the foundation of patient-centered care and decision making. They are essential for manag- ing such patients successfully. Chapter 6 outlines factors relating to good patient–clinician interactions and provides recommendations to clinicians to improve their relationships with patients with CMI. Recommendation 8-10. The Department of Veterans Affairs should provide required education and training for its clinicians in communi-

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190 GULF WAR AND HEALTH cating effectively with and coordinating the care of veterans who have unexplained conditions, such as chronic multisymptom illness. IMPROVING DATA COLLECTION AND QUALITY As the committee conducted its assessment of treatments for CMI and of how this condition is managed in the VA health care system, it identified gaps in data on performance. For example, although the WRIISC program has been in place since 2001, the committee did not find a comprehensive evaluation of how well veterans who have been treated through the program are doing or how satisfied they are with their care. What are the measures of success? To assist VA in improving outcomes and ultimately to improve the quality of care that the VA health care system provides, the committee offers the following recommendation. Recommendation 8-11. The Department of Veterans Affairs (VA) should provide the resources needed to expand its data collection efforts to include a national system for the robust capture, aggregation, and analysis of data on the structures, processes, and outcomes of care delivery and on the satisfaction with care among patients who have chronic multisymptom illness so that gaps in clinical care can be evalu- ated, strategies for improvement can be planned, long-term outcomes of treatment can be assessed, and this information can be disseminated to VA health care facilities. Data collection should be derived from structure, process, and outcome measurements. An example of a structure measure is the nurse-to-patient ratio in a health facility. Examples of process measures are the number of veterans were screened for CMI, the total number discharged from the military, and what interventions veterans who have CMI receive. Another process and, also, outcome measure is patient experience-of-care informa- tion, which should be collected for both inpatients and outpatients. Patient experience-of-care information should be easily accessible on the Internet and be facility specific. Another example of an outcome measure is the per- centage of patients’ improvement on a pain scale following an intervention. RESEARCH RECOMMENDATIONS This section contains the committee’s research recommendations. These recommendations are in two categories, treatments for CMI and research needs related to program evaluation.

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RECOMMENDATIONS 191 Treatments for Chronic Multisymptom Illness Many of the studies of treatments for CMI reviewed by the committee had methodologic flaws that limited their usefulness for the committee’s evaluation. Recommendation 8-12. Future studies funded and conducted by the Department of Veterans Affairs to assess treatments for chronic multi­ symptom illness should adhere to the methodologic and reporting guidelines for clinical trials, including appropriate elements (problem– patient–population, intervention, comparison, and outcome of interest) to frame the research question, extended follow-up, active comparators (such as standard-of-care therapies), and consistent, standardized, vali- dated instruments for measuring outcomes. Examples of methodologic and reporting guidelines include those set forth by such organizations as the Agency for Healthcare Research and Quality and the Institute of Medicine and in such other efforts as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Consolidated Standards of Reporting Trials statement. On the basis of its assessment of the evidence on treatments for CMI, the committee found that several treatments and treatment approaches may be potentially useful for CMI. However, evidence sufficient to support a conclusion on their effectiveness is lacking. Recommendation 8-13. The Department of Veterans Affairs should fund and conduct studies of interventions that evidence suggests may hold promise for treatment of chronic multisymptom illness. Specific interventions could include biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies. Several of the above-mentioned interventions are in the area of comple- mentary and alternative medicine and the VA should consider coordinating future research efforts with the National Institutes of Health’s National Center for Complementary and Alternative Medicine. Program Evaluation As noted above, the committee did not find comprehensive evalu- ations of VA programs, such as the PACTs, SCAN-ECHOs programs, and WRIISCs. Program evaluation—including assessments of structures, processes, and outcomes—is essential if VA is to continually improve its services and research.

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192 GULF WAR AND HEALTH Recommendation 8-14. The Department of Veterans Affairs (VA) should apply principles of quality and performance improvement to internally evaluate VA programs and research related to treatments for chronic multisymptom illness (CMI) and overall management of veterans who have CMI. This task can be accomplished using such methods as comparative effectiveness research, translational research, implementation science methods, and health systems research. REFERENCES Aiarzaguena, J. M., I. Gaminde, G. Grandes, A. Salazar, I. Alonso, and A. Sanchez. 2009. S ­ omatisation in primary care: Experiences of primary care physicians involved in a train- ing program and in a randomised controlled trial. BMC Family Practice 10:73. Allen, L. A., R. L. Woolfolk, J. I. Escobar, M. A. Gara, and R. M. Hamer. 2006. Cognitive- behavioral therapy for somatization disorder: A randomized controlled trial. Archives of Internal Medicine 166(14):1512-1518. Arora, S., S. Kalishman, D. Dion, D. Som, K. Thornton, A. Bankhurst, J. Boyle, M. Harkins, K. Moseley, G. Murata, M. Komaramy, J. Katzman, K. Colleran, P. Deming, and S. Yutzy. 2011. Partnering urban academic medical centers and rural primary care clinicians to provide complex chronic disease care. Health Affairs 30(6):1176-1184. Bleichhardt, G., B. Timmer, and W. Rief. 2004. Cognitive-behavioural therapy for patients with multiple somatoform symptoms: A randomised controlled trial in tertiary care. Journal of Psychosomatic Research 56:449-454. Chou, R., A. Qaseem, V. Snow, D. Casey, J. T. Cross Jr., P. Shekelle, and D. K. Owens. 2007. Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medi- cine 147:478-491. Donta, S. T., D. J. Clauw, C. C. Engel, Jr., P. Guarino, P. Peduzzi, D. A. Williams, J. S. Skinner, ­ A. Barkhuizen, T. Taylor, L. E. Kazis, S. Sogg, S. C. Hunt, C. M. Dougherty, R. D. Richardson, C. Kunkel, W. Rodriguez, E. Alicea, P. Chiliade, M. Ryan, G. C. Gray, L. Lutwick, D. Norwood, S. Smith, M. Everson, W. Blackburn, W. Martin, J. M. Griffiss, R. Cooper, E. Renner, J. Schmitt, C. McMurtry, M. Thakore, D. Mori, R. Kerns, M. Park, S. Pullman-Mooar, J. Bernstein, P. Hershberger, D. C. Salisbury, J. R. Feussner, and V. A. C. S. S. Group. 2003. Cognitive behavioral therapy and aerobic exercise for Gulf War veterans’ illnesses: A randomized controlled trial. Journal of the American Medical Association 289(11):1396-1404. Donta, S. T., C. C. Engel, Jr., J. F. Collins, J. B. Baseman, L. L. Dever, T. Taylor, K. D. B ­ oardman, L. E. Kazis, S. E. Martin, R. A. Horney, A. L. Wiseman, D. S. Kernodle, R. P. Smith, A. L. Baltch, C. Handanos, B. Catto, L. Montalvo, M. Everson, W. Blackburn, M. Thakore, S. T. Brown, L. Lutwick, D. Norwood, J. Bernstein, C. Bacheller, B. Ribner, L. W. P. Church, K. H. Wilson, P. Guduru, R. Cooper, J. Lentino, R. J. Hamill, A. B. G ­ orin, V. Gordan, D. Wagner, C. Robinson, P. DeJace, R. Greenfield, L. Beck, M. Bittner, H. R. Schumacher, F. Silverblatt, J. Schmitt, E. Wong, M. A. K. Ryan, J. Figueroa, C. Nice, J. R. Feussner, and V. A. C. Group. 2004. Benefits and harms of doxycycline treat- ment for Gulf War veterans’ illnesses: A randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine 141(2):85-94.

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194 GULF WAR AND HEALTH VA and DOD. 2001b. Clinical Practice Guideline for the Management of Medically ­ nexplained Symptoms: Chronic Pain and Fatigue. http://www.healthquality.va.gov/ U mus/mus_fulltext.pdf (accessed September 19, 2012). VA and DOD. 2009a. Clinical Practice Guideline for the Management of Substance Use Disorders (SUD). http://www.healthquality.va.gov/sud/sud_full_601f.pdf (accessed Sep- tember 19, 2012). VA and DOD. 2009b. Clinical Practice Guideline: Management of Concussion/Mild Trau- matic Brain Injury. http://www.healthquality.va.gov/mtbi/concussion_mtbi_full_1_0.pdf (­ ccessed September 19, 2012). a VA and DOD. 2009c. Clinical Practice Guideline: Management of Major Depressive Disorder (MDD). http://www.healthquality.va.gov/MDD_FULL_3c.pdf (accessed September 19, 2012). VA and DOD. 2010a. Clinical Practice Guideline for Management of Post-Traumatic Stress. http://www.healthquality.va.gov/ptsd/PTSD-FULL-2010a.pdf (accessed September 19, 2012). VA and DOD. 2010b. Clinical Practice Guideline: Management of Opioid Therapy for Chronic Pain. http://www.healthquality.va.gov/COT_312_Full-er.pdf (accessed Septem- ber 19, 2012). Volz, H. P., H. Murck, S. Kasper, and H. J. Moller. 2002. St. John’s wort extract (Li 160) in somatoform disorders: Results of a placebo-controlled trial. Psychopharmacology 164(3):294-300. Zaby, A., J. Heider, and A. Schroder. 2008. Waiting, relaxation, or cognitive-hehavioral ther- apy: How effective is outpatient group therapy for somatoform symptoms? Zeitschrift für Klinische Psychologie und Psychotherapie 37(1):15-23.