14

Directions

Since cognitive rehabilitation therapy (CRT) was first described in published literature, its clinical application and efforts to document efficacy of CRT treatments through research have been ongoing. Innovative interventions aimed to address specific cognitive impairments and whole-person functioning have been characteristic of this field. However, limited empirical research and inadequate standardization currently restrict the ability to formulate evidence-based practices. This current state of knowledge will therefore, benefit from increased organization and funding of both interventional studies and observational analyses. Both approaches, to be optimally productive, must address the challenges in obtaining more useful and interpretable data on the patients treated or enrolled in studies, on the CRT treatments they receive, and on the outcomes they experience.

SYNTHESIS OF EVIDENCE REVIEW

The committee found published data signaling the benefit of some forms of CRT for traumatic brain injury (TBI). However, the evidence for the therapeutic value of CRT is variable across cognitive domains and is currently insufficient overall to provide definitive guidance for translation into clinical practice guidelines, particularly with respect to selecting the most effective treatment(s) for a particular patient. This limitation results from the heterogeneity of TBI as well as a lack of operational definitions of different forms of CRT, small samples typical of most CRT studies, and the variety of premorbid conditions, comorbidities, and environmental factors that may moderate the value of a given form of CRT. Table 14-1



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14 Directions Since cognitive rehabilitation therapy (CRT) was first described in published literature, its clinical application and efforts to document ef- ficacy of CRT treatments through research have been ongoing. Innovative interventions aimed to address specific cognitive impairments and whole- person functioning have been characteristic of this field. However, limited empirical research and inadequate standardization currently restrict the ability to formulate evidence-based practices. This current state of knowl- edge will therefore, benefit from increased organization and funding of both interventional studies and observational analyses. Both approaches, to be optimally productive, must address the challenges in obtaining more useful and interpretable data on the patients treated or enrolled in studies, on the CRT treatments they receive, and on the outcomes they experience. SYNTHESIS OF EVIDENCE REVIEW The committee found published data signaling the benefit of some forms of CRT for traumatic brain injury (TBI). However, the evidence for the therapeutic value of CRT is variable across cognitive domains and is currently insufficient overall to provide definitive guidance for translation into clinical practice guidelines, particularly with respect to selecting the most effective treatment(s) for a particular patient. This limitation results from the heterogeneity of TBI as well as a lack of operational definitions of different forms of CRT, small samples typical of most CRT studies, and the variety of premorbid conditions, comorbidities, and environmental factors that may moderate the value of a given form of CRT. Table 14-1 255

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256 TABLE 14-1 Overall Conclusions by Cognitive Domain and Multi-Modal/Comprehensive CRT Language and Social Multi-Modal/ Domain Attention Executive Function Communication Memory Comprehensive CRT Non- Subdomain Awareness Awareness TBI Moderate- Moderate- Severity Moderate-Severe Moderate-Severe Moderate-Severe Mild Moderate-Severe Severe Mild Severe Recovery Phase Subacute Chronic Chronic Chronic Chronic Subacute Chronic Approach R R R R/IC/EC R IC EC R IC EC M M M Patient- Centered 0 + 0 + 0 0 N/A 0 + ++ 0 + 0 Outcomes Long-Term Treatment + 0 0 0 + + N/A 0 + N/A 0 + 0 Effect Immediate Treatment + + + + ++ + N/A 0 ++ ++ 0 + 0 Benefit NOTES: EC = external compensatory strategy; IC = internal compensatory strategy; M = mixture of treatment approaches; R = restorative strategy; Evidence Grades: 0 no or not informative, + limited, ++ modest, +++ strong. Multiple treatments intended to target cognitive (non-awareness) aspects of executive function were examined in single studies. The treatments varied in their approach from more restorative (e.g., categorization training) to internal compensatory (e.g., Goal Management Training) to external compensatory (e.g., neutral alerting tones). The evidence grading reflects the lack of replication of any single approach.

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257 DIRECTIONS provides an overview of the committee’s conclusions based on the review of literature of modular, domain-specific treatments as well as multimodal/ comprehensive CRT programs. In most cases the evidence provides limited, and in some cases modest, support for the efficacy of CRT interventions. The committee defined lim- ited 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” (see Box 6-2 for all evidence grades and definitions). 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 “lim- ited”; the limitations of the evidence do not rule out meaningful benefit. In fact, the committee supports the ongoing clinical application of CRT in- terventions for individuals with cognitive and behavioral deficits due to TBI. To acquire more specific and meaningful results from future research the committee has laid out a comprehensive research agenda to overcome challenges in determining efficacy and effectiveness. 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. In reviewing the evidence regarding the efficacy and effectiveness of CRT, the committee found no studies addressing cognitive deficits in the acute phase of recovery following TBI, few studies addressing cognitive treatment for individuals with mild injuries—those that did were only in the chronic phase; and few studies addressing treatment of those with moderate to severe injuries in the subacute phase. Table 14-2 provides the committee’s definitions for acute, subacute, and chronic recovery phases. The dearth of evidence in these areas is multi-factorial, but the committee recognized specific practical and methodological limitations. One limitation is that objective measures sensitive to the cognitive complaints of patients with mild TBI are lacking in many instances and the use of subjective self- report measures as an alternative is problematic when studying treatments that cannot be blinded. Also, studies of subacute treatments require rela- TABLE 14-2 Definitions of Acute, Subacute, and Chronic TBI Recovery Mild TBI Moderate-Severe TBI Acute < 3 months Acute hospital care Subacute > 3 months < 6 months Inpatient rehabilitation Chronic > 6 months < 12 months Outpatient rehabilitation

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258 COGNITIVE REHABILITATION THERAPY FOR TBI tively large samples because the ability to gauge the impact of a treatment regimen in individual patients is diminished in the context of rapid and variable natural recovery. Thus, in practice clinicians may defer substantial resource investment in CRT to later stages of TBI when it becomes clear which problems and impairments will persist long term. Evidence supporting the efficacy of CRT in the chronic phase of TBI for patients with moderate-severe injuries varies by cognitive domain and specific CRT treatment modality. Of note, patients with moderate to severe injuries in the chronic phase typically have deficits that can be objectively measured and have a slower rate of natural recovery. These patients are unlikely to improve substantially without intervention; thus, observations of clinical outcomes in the chronic phase of TBI are a more useful source of evidence than in more variable, earlier phases of recovery. However, cur- rently even the most promising treatments lack sufficiently powered trials to answer important practical questions, including (1) which patient charac- teristics are associated with best response from a given treatment, (2) what are the lasting benefits of treatments that have initially positive results, and (3) to what degree does generalization occur of trained tasks to real-world tasks (for modular treatments) or to global impact on community integra- tion and quality of life (for comprehensive treatment programs). RECOMMENDATIONS Considering the dearth of conclusive evidence identified to date, the committee recommends an investment in research to further develop CRT. The committee interpreted its charge as assessing the current state of the evidence. The committee was not asked to develop policy guidelines or make clinical practice recommendations, but to reach evidence-based con- clusions that would inform policy decisions. In most cases 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. In fact, the committee supports the ongoing clini- cal application of CRT interventions for individuals with cognitive and behavioral deficits due to TBI. 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. However, these recommendations are possible because the evidence review signals some promise. Compared to pharmacological studies, which are more conducive to controlled environments, the committee acknowledges the difficulties associated with research for all forms of rehabilitation. Complexity of patient, injury or disease, and environmental characteristics, among other factors, require variability in possible treatment approaches; these complexities create inherent challenges with rehabilitation research in

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259 DIRECTIONS general. Therefore, the committee did not identify methodological issues in this report to hold CRT research to a higher standard than rehabilitation research at large; it serves merely as a overt discussion of the issues that cloud determination of efficacy and effectiveness. To improve future evalu- ations of efficacy and effectiveness of CRT for TBI, larger sample sizes and volume of data are required, particularly to answer questions about which patients benefit most from which treatment(s). This requires more exten- sive 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 measure impact of treatment, and the treat- ments 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 underway 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 (e.g., 15 Year Longitudinal Study of TBI Incurred by Members of the Armed Forces in OIF/OEF), DVBIC Study on Cognitive Rehabilitation Effectiveness for Mild TBI (SCORE!), Millennium, and TBI Model Systems. These cohorts involve collaborative efforts between the U.S. Department of Defense (DoD) and U.S. Department of Veterans Affairs (VA) via the Defense and Veterans Brain Injury Center (DVBIC). Furthermore, the recently funded Federal Interagency Traumatic Brain Injury Research (FITBIR) database will be collecting uniform and high-quality data on traumatic brain injury, including brain imaging scans and neurological test results. The commit- tee recognizes the ongoing emphasis from both government agencies to enhance collaboration on TBI and improve psychological health of service members and veterans through the VA/DoD Joint Executive Council Strate- gic Plan to integrate health care services (VA/DoD 2009). This collaboration is especially important in evaluating transitions in care and long-term treat- ment for injured soldiers as they move out of the Military Health System (MHS) and into the Veterans Health System, run by the VA. For example, it will be important to study how CRT may benefit aging veterans who experience long-term outcomes of TBI, such as cognitive decline associated with dementia. Because CRT is not a single therapy, questions of efficacy and effec- tiveness need to be answered for each cognitive domain and by treatment

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260 COGNITIVE REHABILITATION THERAPY FOR TBI 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 decontextulized, standard tests of memory, there is limited evidence that these benefits translate into mean- ingful changes in patients’ everyday memory either for specific tasks/activi- ties or for avoiding memory failures. Therefore, an increased emphasis on functional patient-centered outcomes would allow for a more meaningful translation from cognitive domain to patient functioning. The committee acknowledges that efforts are underway to facilitate manualization of treat- ments, including the “Cognitive Rehabilitation Treatment Manual” by the Brain Injury Special Interest Group of the American Congress of Rehabili- tation Medicine, and the “Executive Plus” treatment manual developed by the Mount Sinai Brain Injury Research Center. These are promising efforts to build upon, an effort this report supports. The committee recommends the Department of Defense (DoD) under- take the following: • nclude measures in experimental and observational data sets that I characterize important dimensions of patient heterogeneity and factors affecting recovery and response to CRT; • mprove standardization of CRT treatments as well as TBI patient I characteristics and relevant outcome measures in clinical practice and research; • evelop a common registry or linked registries encompassing de- D identified data of large numbers of consenting patients to facilitate data mining and the rationale for testing new interventions; and • rospectively follow any policy changes in coverage for CRT in the P Military Health System. Due to the pressing nature of the problem—TBI affects many thousands of individuals, particularly U.S. service members, every year—these efforts should take advantage of current momentum in TBI research to improve the field of CRT research via existing cohorts. The committee developed and designed the layout of these recommendations systematically, to sequen- tially address fundamental flaws in CRT research. For example, developing a common registry to prospectively facilitate data mining should not be un- dertaken before there are agreed-upon definitions of patient characteristics, outcome measures, and CRT interventions, which cannot be accomplished

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261 DIRECTIONS without accounting for and recognizing TBI-related heterogeneity, factors affecting recovery, and response to CRT. Recognize Heterogeneity, Factors Affecting Recovery, and Response to CRT An individual’s response to CRT may be affected by preinjury status, comorbid conditions, environmental factors, injury severity, impairment severity, and mechanism of injury. For example, it may be that certain types of memory remediation work best for individuals with moderate-severe injury, focal memory impairments, and a supportive home environment. Or, treatment impact may vary with the presence of a sleep disturbance or the extent of family support to enhance participation in or reinforcement of the intervention. Researchers and clinical providers should collaborate to identify the many variables that influence response to therapy interventions. Relatively large samples are therefore necessary to ascertain the interven- tions that are most effective for specific patients and their special needs and circumstances. To enhance the understanding of the optimal treatment candidates for various forms of CRT, and their relative value in affecting different outcome targets, DoD should collaborate with other rehabilita- tion research organizations to capture relevant patient characteristics and outcome measures, which can facilitate comparison of results across studies and treatments and support formal meta-analyses. Categorizing participants by injury severity and recovery phase may be important to create useful categories, group studies, and draw related conclusions. However, in research or treatment of cognitive deficits follow- ing TBI, clinicians and researchers are generally more attentive to severity of the deficit rather than severity of injury. Likewise, in application and research, clinicians and researchers focus more on clinical indicators of treatment need and readiness for treatment than the absolute time since injury. Therefore, in some cases, the severity of injury classification does not correspond with the severity of deficit requiring rehabilitation. For ex- ample, a moderate or severe TBI can result in chronic but mild, moderate or severe cognitive impairments. Likewise, a mild TBI can result in mild but very disabling cognitive impairments that interfere with one’s ability to participate in society. Environmental and social factors, particularly family support, are es- pecially influential in recovery from TBI. Engaging and mobilizing the patient’s family may be accomplished by a range of efforts. Caregivers are directly affected by their family members’ disability and play key roles in motivation, treatment participation, compliance, and follow-up. Thus, education and support for family members and other caregivers are essen- tial in CRT treatment. However, the roles of family and caregivers in CRT

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262 COGNITIVE REHABILITATION THERAPY FOR TBI treatments for TBI are rarely defined systematically and vary by interven- tion, study, and rehabilitation program. DoD should encourage family or caregiver involvement, especially where interventions or rehabilitation pro- grams may require significant support for the treated individual within or beyond the treatment facility. Investigators should consider the important role of caregivers as interventions or rehabilitation programs are tested in controlled environments. DoD should consider the incurred costs of CRT to family members, in part related to the burdens of taking time away from work and traveling to rehabilitation facilities, and thus may want to increase support for families/caretakers as part of the recovery process. Promote Standardization and Operationalization of Patient Characteristics, Outcome Measures, and CRT Interventions Research to document efficacy of CRT will benefit from greater opera- tional definition of the CRT interventions being evaluated. Given that no current treatment taxonomy is sufficiently mature to allow feasible coding of treatment A versus B versus C in practice, the most realistic short-term approach to defining and standardizing specific CRT interventions is to de- velop treatment manuals and adherence measures to verify that the defined treatment is being administered to patients. Developers of CRT treatments and others experienced in their use, along with civilian and military funding agencies, should collaborate to codify and make widely available these op- erationally defined treatments (e.g., specific manual-based forms of CRT), which can be tested in clinical trials. Likewise, collaboration should achieve consensus for recommendations on variables that describe patient char- acteristics and clinical outcomes. To enforce newly established standards, funders can promote these standardized practices by requiring research uniformity in research proposals. Likewise, professional organizations may consider providing continuing education only to those practitioners and providers meeting standard criteria. Recommendation 14-1: DoD should work with other rehabilitation 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

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263 DIRECTIONS 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. Advancing the evidence about CRT requires enlarging the sample size of patients studied in similar ways, by investing in larger studies or ensuring the collection of comparable data across multiple smaller studies and obser- vational data sets. The necessary data include variables that capture charac- teristics of patients that are relevant to predicting their outcomes and their response to treatment, variables that capture a range of outcomes that shed light on the impact of CRT, and variables that capture the type and dose of CRT interventions that patients receive. Measures of many of the relevant patient characteristics are already available, but comparable measures are not being collected across studies. Measures of the relevant outcomes are also available, and the NIH’s CDE effort has already made some progress in suggesting specific consensus outcome measures for patients with TBI. Out- come measures incorporated into CRT research remain variable. Therefore, in the areas of patient characteristics and outcomes, progress can be made by striving for consensus on the available measures that are most useful to incorporate into CRT data collection efforts over time. In the case of variables that define CRT interventions received, how- ever, the field is not nearly as well developed. There is no current taxonomy that defines or names in standardized fashion different forms of CRT in ways that are likely to map onto their efficacy and effectiveness, and thus no straightforward process for recommending treatment-related variables for incorporation into studies and registries. Thus, advancing the process of standardized treatment data collection will evolve over time and may involve (1) considering what measures are currently available that are likely to be useful in this effort, (2) developing a consensus agenda of the work needed to advance CRT treatment definition, and (3) distilling promising forms of CRT into treatment manuals with associated adherence measures, so that the delivery of these well-defined packages can be documented. As a way to make these improvements, the committee recommends that DoD convene a conference to achieve consensus among multiple agencies and professional organizations providing or endorsing CRT. The conference participants should be given specific goals to finalize the selection of patient

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264 COGNITIVE REHABILITATION THERAPY FOR TBI characteristics 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 14-2: DoD should convene a conference to achieve consensus among a multiagency (e.g., VA, NIH, and NIDRR), multi- disciplinary team of clinicians and researchers to finalize the selection of patient characteristics and outcome variables to be included in ex- perimental and observational CRT research, and to plan a strategy to advance the common definition and operationalization of CRT interventions. In addition, researchers and clinicians should reach consensus on the appropriate timing of CRT in the course of recovery following TBI. Current data examine the application of CRT in subacute and chronic phases of mild or moderate/severe TBI, with no parallel identified evidence base for review of CRT delivered during the acute stage. This may in part be due to spontaneous resolution of short-term impairments without rehabilitation. Formal analyses to identify early predictors of spontaneous recovery should be undertaken to best identify patients who are at risk for long-term impair- ments and who are good candidates for CRT. Data are needed to enforce or dispel the current idea that rehabilitation programs should ideally begin treatment only in subacute and chronic phases of TBI. Develop a Registry Among Existing Cohorts The treatment and time course of TBI among military personnel, in- cluding its sequelae and recovery, prompt the cooperative engagement of government agencies and other research organizations to advance evidence- based decision making pertaining to the value of specific interventions for TBI, particularly within the military setting. Ongoing research provides an opportunity to bridge substantial knowledge gaps that require continual compilation and analyses of the results as well as publication of interim findings and data sharing. Throughout its deliberations, the committee had the opportunity to hear from researchers actively engaged in studies of CRT for the treatment of individuals with TBI. Ongoing and new studies provide an opportunity to increase standardization, identify factors that characterize the course of TBI and factors that may affect recovery, and evaluate individual CRT ap- proaches compared to comprehensive or multi-modal treatments. Further- more, such studies provide an opportunity for DoD and allied agencies (e.g., NIDRR, NIH, VA) to better understand the evolving field of CRT and make judgments regarding efficacy of both modular and comprehensive treatments.

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265 DIRECTIONS Longitudinal patient registries represent an evolving resource that will make observational studies of comparative effectiveness more feasible and informative. Such deidentified but coded registries go beyond administrative claims data, which typically lack sufficient clinical data about disease se- verity. Larger integrated health care delivery systems are creating registries with the aid of electronic medical records that link administrative claims data with clinical, pharmacy, and laboratory data, and, increasingly, with patient-reported data that are collected in a systematic fashion. Clinical trials are typically of relatively short duration but contain a wealth of well- characterized data and should be included in the proposed longitudinal registries. Recommendation 14-3: DoD should incorporate the selected measures of patient characteristics, outcomes, and defined CRT interventions into ongoing studies (e.g., DVBIC: SCORE trial, Millennium, TBI Model Systems) and develop a comprehensive registry encompassing the existing cohorts and deidentified MHS medical records to allow ongoing evaluation of CRT interventions. There are many strategies for establishing a registry, but existing stud- ies or cohorts that might be adapted for this purpose include the Con- gressionally Mandated Longitudinal Study on TBI, DVBIC SCORE trial, Millennium, and TBI Model Systems. CRT for TBI ideally would take into account subgroup-level results, given the heterogeneity of populations and forthcoming advances in disease mechanisms/markers (Kent et al. 2010). Randomized trials large enough to conduct such analyses will be expensive and take years; a prospectively designed registry could potentially yield results on subgroups more rapidly to help the inform research community about who would most benefit from CRT. A registry could be used to ana- lyze current implementation of CRT as well as the associated outcomes. This information should prospectively capture additional data elements. The registry should include data from (1) operationally defined categories or taxonomy of CRT treatments (as described in Recommendations 14-1 and 14-2), and (2) providers of CRT-consistent care, such as physical thera- pists, occupational therapists, speech therapists, or others. The different labels and billing codes currently used by various provid- ers (e.g., occupational therapists, physical therapists, and speech-language pathologists) makes it difficult or impossible to identify and track current CRT usage patterns. Operationally defined CRT treatments (i.e., manual- based interventions) will not clear up the ambiguity of services provided via occupational therapy (such as “dressing training”) versus CRT. How- ever, operationally defined CRT treatments will improve identification and tracking of (1) restorative programs (these treatments usually involve “ar-

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266 COGNITIVE REHABILITATION THERAPY FOR TBI tificial” tasks so they cannot be labeled as “dressing training”), and (2) large, organized programs of compensatory CRT treatments. Once a more comprehensive taxonomy of rehabilitation treatments is available, embed- ded CRT activities provided via occupational therapy, physical therapy, or speech-language pathology will be easier to identify due to the services provided (e.g., training, learning, adapting, and compensating). Recommendation 14-4: Using these data sources, 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. Prospectively planned analyses of clinically rich data sets are increas- ingly used to monitor and evaluate the implementation and impact of clinical and policy interventions in health care. These registries provide the opportunity to reassess effectiveness—including both benefits and harms— of interventions as they move into routine care from settings and popula- tions in which they have been tested for efficacy. Because little research exists on dissemination of evidence-based CRT therapies, DoD should evaluate the impact of policy changes about evidence-based CRT interven- tions delivered in the MHS. DoD can shape and monitor implementation rollout, and plan a prospective evaluation of the utilization, health, and financial impacts of any coverage policy change. Advance Current Research To continue efforts to document efficacy and effectiveness of CRT, research should be designed to address the effects of CRT across various levels of TBI severity and recovery among individuals capable of participat- ing in this therapy, especially service members and veterans. Current efforts should provide valuable information about CRT efficacy and effectiveness. For example, the ongoing SCORE! trial includes four arms. The treatment group (with CRT) will be compared to a no-treatment group (to determine efficacy) and other forms of CRT group (to determine effectiveness). As dis- cussed previously, the potential moderating effects of premorbid conditions (e.g., attention deficit hyperactivity disorder [ADHD], learning disabilities), comorbidities (e.g., posttraumatic stress disorder [PTSD], depression), and social environmental context (e.g., family support) on response to CRT should be studied. Investigative attention should be devoted to evaluating the generalization of the effects of CRT across various settings, as well as the persistence of any improvements over time. There are several promising efforts under way or planned, as indicated by the table of ongoing or re-

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267 DIRECTIONS cently completed clinical trials found in Appendix C of this report. Ideally, study designs will include • an emphasis on functional patient-centered outcomes; • d efined control groups of ideally wait-list or usual care compari- sons; and • s ample sizes sufficiently large to inform analyses of the impact of heterogeneities (covariates) within the TBI population on treatment outcome; or • novel, adaptive designs (to surmount sample size issues). DoD should continue to facilitate development of existing, early stage research. Early research may be most efficiently compared to no treatment or a wait-list control, since this does not require design of plausible but inert comparison treatments, and avoids the risk of comparing two effec- tive treatments. Once a treatment is shown to be superior to no treatment, research designs may include increasingly precise comparisons to define the ingredients that account for impact. Such treatments should be distilled into treatment protocols or manuals in consultation with their original develop- ers and/or researchers and clinicians experienced in these approaches, and accompanied by adherence measures that ensure these treatments’ faithful delivery. Once a set of effective modular treatments is assembled, a compre- hensive program could then be built from the set. The protocol would ideally incorporate assessment and treatment selection criteria to determine which patients should receive which modules, as well as assessment of the impact of the program on important aspects of activity and participation. A research program of this magnitude requires substantial and sustained investment, and most likely a multicenter research system to recruit suf- ficient patients for study. Recommendation 14-5: DoD should collaborate with other research and funding organizations to foster all phases of research and develop- ment of CRT treatments for TBI, from pilot phase, to early efficacy research (safety, dose, duration and frequency of exposure, and durabil- ity), to large-scale randomized clinical trials, and ultimately, effective- ness and comparative effectiveness studies. Modeling, observational studies, randomized controlled trials (RCTs), and systematic reviews are the types of research approaches used for com- parative effectiveness and implementation research. Well-controlled trials of CRT will help provide more definitive evaluations of CRT efficacy in

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268 COGNITIVE REHABILITATION THERAPY FOR TBI ameliorating cognitive deficits due to TBI, as will large observational stud- ies that capitalize on existing registries and cohorts, including long-term follow-up of clinical trial populations. Observational studies are potentially less expensive to perform than RCTs; however, observational studies re- quire sufficient sample size and duration to account for variability of injury severity and other factors that influence treatment choice and outcomes. The Patient Centered Outcomes Research Institute, established in 2011, includes a Methodology Committee charged with identifying areas of meth- odological research to improve the quality of findings from comparative effectiveness studies, particularly observational study designs. Meaningful analysis requires accounting for these factors and comparing outcomes of different treatment approaches. Periodic evaluation of accrued evidence should accompany efforts to improve the size and quality of studies, since the value of a systematic review of evidence depends on the quality of stud- ies being assessed. CONCLUSION Members of the military and civilians commonly experience TBI, which often results in significant cognitive, physical, or psychosocial deficits re- quiring rehabilitation. These recommendations aim to assist DoD and al- lied agencies in addressing this increasing and significant problem for U.S. society. Conclusive evidence of efficacy, and particularly effectiveness, is lacking for all forms of CRT even though some forms have modest amounts of evidence. In reviewing the evidence, the committee found no studies addressing cognitive deficits in the acute phase of recovery following TBI, few studies addressing treatment of those with moderate-severe injuries in the subacute phase, and few studies addressing cognitive treatment for individuals with mild injuries overall. Evidence supporting the efficacy of CRT in the chronic phase of TBI for patients with moderate-severe injuries varies by cognitive domain and specific CRT treatment modality. Because the noted limitations of the evidence often were secondary to the methodological shortcomings of the studies reviewed, and do not rule out meaningful benefit of CRT for TBI, the committee supports the ongoing clinical application of CRT inter- ventions for individuals with cognitive and behavioral deficits due to TBI. With thoughtful consideration of the challenges it faced throughout the study process, and in light of the lack of conclusive evidence, the commit- tee has identified these recommendations as a way forward for the Military Health System.

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269 DIRECTIONS REFERENCES Kent, D. M., P. M. Rothwell, J. P. Ioannidis, D. G. Altman, and R. A. Hayward. 2010. As- sessing and reporting heterogeneity in treatment effects in clinical trials: A proposal. Trials 11:85. VA/DoD (U.S. Department of Veterans Affairs/U.S. Department of Defense). 2009. VA/DoD Joint Executive Council Strategic Plan: Fiscal years 2009–2011. Washington, DC; Alex- andria, VA: VA/DoD Joint Executive Council.

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