Appendix A

Recommendations of the IOM Report Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence

Considering the dearth of conclusive evidence identified to date, the committee recommends an investment in research to further develop cognitive rehabilitation therapy (CRT). [. . .] The evidence provides limited, and in some cases modest, support for the efficacy of CRT interventions. However, the limitations of the evidence do not rule out meaningful benefit. The committee defined limited evidence as “Interpretable results from a single study or mixed results from two or more studies” and modest evidence as “Two or more studies reporting interpretable, informative, and largely similar results” [. . .]. The committee emphasizes that conclusions based on the limited evidence regarding the effectiveness of CRT does not indicate that the effectiveness of CRT treatments are “limited;” the limitations of the evidence do not rule out meaningful benefit. In fact, the committee supports the ongoing clinical application of CRT interventions for individuals with cognitive and behavioral deficits due to traumatic brain injury (TBI). One way policy could reflect the provision of CRT is to facilitate the application of best-supported techniques in TBI patients in the chronic phase (where natural recovery is less of a confound), with the proviso that objectively measurable functional goals are articulated and tracked and that treatment continues only so long as gains are noted.

To acquire more specific, meaningful results from future research the committee has laid out a comprehensive research agenda to overcome challenges in determining efficacy and effectiveness. These recommendations are therefore possible because the evidence review signals some promise. However, to improve future evaluations of efficacy and effectiveness of CRT for TBI, larger sample sizes and volume of data are required, particularly



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Appendix A Recommendations of the IOM Report Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence Considering the dearth of conclusive evidence identified to date, the committee recommends an investment in research to further develop cogni- tive rehabilitation therapy (CRT). [. . .] The evidence provides limited, and in some cases modest, support for the efficacy of CRT interventions. How- ever, the limitations of the evidence do not rule out meaningful benefit. The committee defined limited evidence as “Interpretable results from a single study or mixed results from two or more studies” and modest evidence as “Two or more studies reporting interpretable, informative, and largely simi- lar results” [. . .]. The committee emphasizes that conclusions based on the limited evidence regarding the effectiveness of CRT does not indicate that the effectiveness of CRT treatments are “limited;” the limitations of the evidence do not rule out meaningful benefit. In fact, the committee supports the ongoing clinical application of CRT interventions for individuals with cognitive and behavioral deficits due to traumatic brain injury (TBI). One way policy could reflect the provision of CRT is to facilitate the application of best-supported techniques in TBI patients in the chronic phase (where natural recovery is less of a confound), with the proviso that objectively measurable functional goals are articulated and tracked and that treatment continues only so long as gains are noted. To acquire more specific, meaningful results from future research the committee has laid out a comprehensive research agenda to overcome chal- lenges in determining efficacy and effectiveness. These recommendations are therefore possible because the evidence review signals some promise. However, to improve future evaluations of efficacy and effectiveness of CRT for TBI, larger sample sizes and volume of data are required, particu- 47

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48 COGNITIVE REHABILITATION THERAPY FOR TBI larly to answer questions about which patients benefit most from which treatment(s). This requires more extensive funding of experimental trials and a commitment to mining clinical practice data in the most rigorous way possible. For such approaches to be most informative, the variables that characterize patient heterogeneity, the outcomes that are used to mea- sure impact of treatment, and the treatments themselves need to be defined and standardized. In addition, more rigorous review of potential harm or adverse events related to specific CRT treatments is necessary. Nascent efforts at standardization are under way across multiple ci- vilian and military funding agencies. These efforts should take place in collaboration. The National Institutes of Health (NIH) common data ele- ment (CDE) initiative, a National Institute on Disability and Rehabilitation Research (NIDRR)-supported center on treatment definition, and several practice-based evidence studies are helping to better characterize TBI pa- tients, treatments, and relevant outcomes. Practice-based evidence studies include the Congressionally Mandated Longitudinal Study on TBI, DVBIC Study on Cognitive Rehabilitation Effectiveness for Mild TBI (SCORE!), Millennium, and TBI Model Systems. These cohorts involve collaborative efforts between the Department of Defense (DoD) and the Veterans Admin- istration (VA) via the Defense and Veterans Brain Injury Center (DVBIC). The committee recognizes the ongoing emphasis from both government agencies to enhance collaboration for TBI and psychological health of ser- vice members and veterans through the VA/DoD Joint Executive Council Strategic Plan to integrate health care services. [. . .] This collaboration is especially important in evaluating and maintaining transitions in care and long-term treatment for injured soldiers as they move out of the Military Health System (MHS) and into the VA’s health care system, the Veterans Health System. Because CRT is not a single therapy, questions of efficacy and effec- tiveness need to be answered for each cognitive domain and by treatment approach. Nevertheless, within a specific cognitive domain, there must be sufficient research and replication for conclusions to be drawn. Standard definitions for intervention type, content, and key ingredients will be criti- cal to developing evidence-based practice standards. The documentation of interventions in practice and more frequent use of manual-based inter- ventions in research will help validate measures of treatment fidelity. For example, while there is evidence from controlled trials that internal memory strategies are useful for improving recall on decontextualized, standard tests of memory, there is limited evidence that these benefits translate into meaningful changes in patients’ everyday memory either for specific tasks/ activities or for avoiding memory failures. Therefore, an increased emphasis on functional patient-centered outcomes would allow for a more meaning- ful translation from cognitive domain to patient functioning.

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APPENDIX A 49 The committee recommends the DoD undertake the following: Recommendation 14-1: The DoD should work with other rehabilita- tion research and funding organizations to: 1.  Identify and select uniform data elements characterizing TBI patients including cognitive impairments (to supplement mea- sures of injury severity) and key premorbid conditions, comor- bidities, and environmental factors that may influence recovery and treatment response; 2.  Identify and select uniform TBI outcome measures, includ- ing standard measures of cognitive and global/functional out- comes; and 3. Create a plan of action to: a. Identify currently feasible methods of measuring the deliv- ery of CRT interventions; b.  Advance the development of a taxonomy for CRT inter- ventions that can be used for this purpose in the future; and c.  Advance the operationalization of promising CRT ap- proaches in the form of treatment manuals and associated adherence measures. Recommendation 14-2: The DoD should convene a conference to achieve consensus among a multiagency (e.g., VA, NIH, and NIDRR), multidisciplinary team of clinicians and researchers to finalize the selec- tion of patient characteristic and outcome variables to be included in experimental and observational CRT research, and to plan a strategy to advance the common definition and operationalization of CRT interventions. Recommendation 14-3: The DoD should incorporate the selected mea- sures of patient characteristics, outcomes, and defined CRT interven- tions into ongoing studies (e.g., DVBIC: SCORE!, Millennium, TBI Model System) and develop a comprehensive registry encompassing the existing cohorts and deidentified MHS medical records to allow ongoing evaluation of CRT interventions. Recommendation 14-4: Using these data sources, the DoD should plan to prospectively evaluate the impact of any policy changes related to CRT delivery and payment within the MHS with respect to outcomes and cost-effectiveness.

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50 COGNITIVE REHABILITATION THERAPY FOR TBI Recommendation 14-5: The DoD should collaborate with other re- search and funding organizations to foster all phases of research and development of CRT treatments for TBI, from pilot phase, to early ef- ficacy research (safety, dose, duration and frequency of exposure, and durability), to large-scale randomized clinical trials, and ultimately, effectiveness and comparative effectiveness studies.