Summary

Traumatic brain injury (TBI) affects an estimated 10 million people worldwide and causes significant physical, emotional, and cognitive disabilities among those affected (CDC 2010; WHO 2011). Conflicts in Iraq (Operation Iraqi Freedom [OIF]) and Afghanistan (Operation Enduring Freedom [OEF]) have put members of the U.S. military at high risk for TBI, largely due to repeated and prolonged deployments, increasing injuries to the head and neck, and attacks with improvised explosive devices (IEDs), which may cause blast-induced neurotrauma (BINT) (Terrio et al. 2009; Warden 2006). More individuals live with the consequences of these injuries due to advances in life-saving measures such protective equipment, emergency care and medical evacuation systems, and treatment and care of TBI (Martin et al. 2008). Individuals with TBI often require some form of treatment for their condition. One form of treatment for the cognitive and behavioral deficits associated with TBI is cognitive rehabilitation therapy (CRT), a systematic, goal-oriented approach to overcoming cognitive impairments. Recognizing that TBI is the signature war wound of OIF/OEF conflicts, the U.S. Department of Defense (DoD) saw the importance of ensuring adequate treatment for personnel who have sustained service-related TBI. Therefore, DoD asked the Institute of Medicine (IOM) to evaluate CRT for TBI to guide its use and coverage in the Military Health System (MHS).

SCOPE AND STRUCTURE OF THE REPORT

To complete its task (see Box S-1 for the Statement of Task), the IOM formed an ad hoc committee of experts from a range of disciplines



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Summary Traumatic brain injury (TBI) affects an estimated 10 million people worldwide and causes significant physical, emotional, and cognitive dis- abilities among those affected (CDC 2010; WHO 2011). Conflicts in Iraq (Operation Iraqi Freedom [OIF]) and Afghanistan (Operation Enduring Freedom [OEF]) have put members of the U.S. military at high risk for TBI, largely due to repeated and prolonged deployments, increasing inju- ries to the head and neck, and attacks with improvised explosive devices (IEDs), which may cause blast-induced neurotrauma (BINT) (Terrio et al. 2009; Warden 2006). More individuals live with the consequences of these injuries due to advances in life-saving measures such protective equipment, emergency care and medical evacuation systems, and treatment and care of TBI (Martin et al. 2008). Individuals with TBI often require some form of treatment for their condition. One form of treatment for the cognitive and behavioral deficits associated with TBI is cognitive rehabilitation therapy (CRT), a systematic, goal-oriented approach to overcoming cognitive im- pairments. Recognizing that TBI is the signature war wound of OIF/OEF conflicts, the U.S. Department of Defense (DoD) saw the importance of ensuring adequate treatment for personnel who have sustained service- related TBI. Therefore, DoD asked the Institute of Medicine (IOM) to evaluate CRT for TBI to guide its use and coverage in the Military Health System (MHS). SCOPE AND STRUCTURE OF THE REPORT To complete its task (see Box S-1 for the Statement of Task), the IOM formed an ad hoc committee of experts from a range of disciplines 1

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2 COGNITIVE REHABILITATION THERAPY FOR TBI BOX S-1 Statement of Task A consensus committee shall design and perform a methodology to review, synthesize, and assess the salient literature and determine if there exists suffi- cient evidence for effective treatment using cognitive rehabilitation therapy (CRT) for three categories of traumatic brain injury (TBI) severity—mild, moderate, and severe—and will also consider the evidence across three phases of recovery— acute, subacute, and chronic. In assessing CRT treatment efficacy, the commit- tee will consider comparison groups such as no treatment, sham treatment, or other non-pharmacological treatment. The committee will determine the effects of specific CRT treatment on improving (1) attention, (2) language and com- munication, (3) memory, (4) visuospatial perception, and (5) executive function (e.g., problem solving and awareness). The committee will also evaluate the use of multi-modal CRT in improving cognitive function as well as the available sci- entific evidence on the safety and efficacy of CRT when applied using telehealth technology devices. The committee will further evaluate evidence relating CRT’s effectiveness on the family and family training. The goal of this evaluation is to identify specific CRT interventions with sufficient evidence base to support their widespread use in the MHS, including coverage through the TRICARE benefit. The committee shall gather and analyze data and information that addresses 1. A comprehensive literature review of studies conducted, including but not limited to studies conducted on MHS or VA wounded warriors; 2. An assessment of current evidence supporting the effectiveness of specific CRT interventions in specific deficits associated with moderate and severe TBI; 3. An assessment of current evidence supporting the effectiveness of specific CRT interventions in specific deficits associated with mild TBI; 4. An assessment of (1) the state of practice of CRT and (2) whether require- ments for training, education and experience for providers outside the MHS direct-care system to deliver the identified evidence-based interventions are sufficient to ensure reasonable, consistent quality of care across the United States; and 5. An independent assessment of the treatment of traumatic brain injury by cognitive rehabilitation therapy within the MHS if time or resources permit. including neurology, psychology, psychiatry, rehabilitation medicine, neu- ropsychology, neuropharmacology, nursing, speech-language pathology, epidemiology and neurocognitive study design, and disability and long- term care. The committee developed a strategy for reviewing the evidence, including a comprehensive review of the literature on CRT for TBI. After reviewing the statement of task and meeting with a representative from the Department of Defense to clarify intent, the committee interpreted its charge as assessing the state of the evidence. The committee acknowledges the goal of evidence assessments is to inform policy, upon which clinical

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3 SUMMARY practice guidelines are developed. Those at the Department of Defense are the only ones in position to make policy judgments for the Military Health System. After extensive deliberation, the committee determined it was be- yond its charge to interpret its assessment of the evidence with respect to policy recommendations or clinical practice guidelines. In addition to reviewing the literature, the committee heard from ex- perts in the fields of cognitive rehabilitation research and practice, investi- gators of major research studies of traumatic brain injury in military and civilian settings, and advocates for the role of families and communities in providing ongoing support to injured members of the military and veterans. The committee also received statements from stakeholders from various organizations and members of the public. Over the course of the study, the committee met six times, engaged the public through two workshops, and participated in a number of ongoing activities organized by working groups. The committee did not complete an independent assessment of the treatment of TBI by cognitive rehabilitation within the MHS (Subtask 5). This exclusion was due to constrained resources, including a lack of access to available data and time limitations. TRAUMATIC BRAIN INJURY In broad terms, a TBI is an injury to the head or brain caused by externally inflicted trauma. DoD defines TBI as a “traumatically induced structural injury and/or physiological disruption of brain functions as a result of an external force.” TBI may be caused by a bump, blow, or jolt to the head, by acceleration or deceleration forces without impact, or by penetration to the head that disrupts the normal function of the brain (CDC 2011b; Katz 1997; VA/DoD 2009a). The events that lead to TBI vary by population. Among civilians, motor vehicle accidents are the leading cause of TBI-related deaths; among young children and older adults, falls are a major cause of TBI (CDC 2010); and among soldiers and veterans, the most common source of TBI is a blast (i.e., BINT), followed by falls, mo- tor vehicle accidents, and lastly, assault (DVBIC 2009). Chapter 2 provides a more complete description of TBI, including mechanisms of injury and classification schemes, which may aid in short- and long-term prognosis. Across time, incidence of TBI has risen among the military population as an all-volunteer force has been engaged in the longest war (OEF) in U.S. history, and service members are exposed to longer and more frequent de- ployments. While in-theater, service members are increasingly attacked by more explosive weaponry. Approximately 22 percent of wounded soldiers from OEF/OIF theaters experienced wounds to the head, face, or neck (Okie 2005). From 2000 to 2010, the number of military service members diagnosed with TBI has nearly tripled (DVBIC 2011). Mild TBI, also called

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4 COGNITIVE REHABILITATION THERAPY FOR TBI concussion, often goes underreported since period of unconsciousness may be negligible and medical attention may not be sought. Therefore the actual annual incidence of TBI is thought to be higher than currently estimated. TBI is a major public health concern for civilians as well as members of the military. Each year, an estimated 1.7 million individuals in the United States sustain a TBI (CDC 2010). Of those, approximately 52,000 indi- viduals die each year from their injuries. According to the U.S. Centers for Disease Control and Prevention (CDC), each year an estimated 124,626 people with TBI experience long-term impairment or disability from their injury (CDC 2011a). TBI Classification Schemes Head injuries have historically been classified using various clinical in- dexes that include pathoanatomical features, severity of injury, or the physi- cal mechanisms of the injury (i.e., causative forces). Different classification systems may be used for clinical research, clinical care and management, or prevention. The classification systems most relevant to rehabilitation deal with severity as it relates to pace of recovery or expected degree of impairment. These include the Glasgow Coma Scale (GCS), posttraumatic amnesia (PTA), and others. Chapter 2 includes descriptions of these scales. One classification system is severity of the injury. TBI severity is generally graded in degree, from mild to moderate or severe. Severity can be graded in multiple ways, and each measure has different predictive utility, includ- ing determining mortality, morbidity, or long-term or functional outcomes. Determining severity is often based on the acute effects of the injury such as the individual’s level of arousal or duration of amnesia; these are measured by GCS, duration of unconsciousness, and PTA. It is important to note that severity of injury does not always correspond with severity of one or more impairments. The majority of TBIs are mild, consisting of a brief change in men- tal status or unconsciousness. Mild TBI is also referred to as a concus- sion. While most people fully recover from mild TBI, individuals may experience both short- and long-term effects. Moderate to severe TBIs are characterized by extended periods of unconsciousness or amnesia, among other effects. The distinction between moderate and severe injuries is not always clear; as such, individuals with moderate and severe injuries are often grouped for research purposes. Throughout the remainder of this report, the committee refers to more severe injuries as moderate-severe TBI. The more severe the injury, the more severe and persistent the cogni- tive deficits—though clinical measurements do not always concur. Severity measures graded during the acute phase sometimes reflect variance due to medications used during resuscitation, substance use, and communication

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5 SUMMARY issues. However, the relationship between clinical severity measures (e.g., GCS, LOC, and PTA) and various types of outcome measures (e.g., neu- ropsychological or functional disability) has been well established (Cifu et al. 1997; Dikmen et al. 2003; Sherer et al. 2002; Temkin et al. 2003). The utility of these measures depends on how long after the injury a patient is evaluated. Measures obtained later in time are generally better predictors of long-term outcomes; specifically, duration of PTA is more predictive than duration of LOC, which is more predictive than GCS at the time of injury (Katz and Alexander 1994). Consequences of TBI The consequences of TBI include short- and long-term effects which likely impact the individual’s family or primary caregiver. These may in- clude disruptions to everyday life and work, changes in family and social functioning, and potentially burdensome financial costs. Recovering from TBI, therefore, may be a slow, long, and painful process for individuals and their families, requiring unique and specific medical, vocational, and rehabilitative therapy (Sayer et al. 2008). The biological and structural impairments caused by TBI are far reach- ing and include physical, emotional, and cognitive impairments (Cernak and Noble-Haeusslein 2010). Cognitive impairments resulting from TBI can affect multiple domains, including attention, language and communica- tion, memory, visuospatial, and executive function.1 Cognitive impairments may limit daily activities (Temkin et al. 2009; Wise et al. 2010) and restrict participation in their community (Hoffman et al. 2007), employment, recre- ation, and social relationships (Temkin et al. 2009). The extent of disability from cognitive impairment is shaped by personal factors, such as age and cognitive reserve (Green et al. 2008), and environmental factors, such as family support (Sady et al. 2010). Chapter 3 provides a more in-depth de- scription of the factors that may affect recovery and outcome. TREATMENT Determining the appropriate method and timing of treatment for an individual with TBI depends on a number of factors, including severity of injury, stage in recovery, and premorbid, comorbid, and environmental conditions, unique to every individual. The focus of treatment changes as a patient progresses from the acute, immediate phase after injury to more 1 The term “executive function” represents a set of integrated cognitive processes necessary to perform or accomplish everyday life activities. Chapter 8 provides a detailed description of these cognitive processes.

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6 COGNITIVE REHABILITATION THERAPY FOR TBI chronic, long-term stages of recovery. In the acute phase, treatment may primarily focus on increasing the patient’s chances of survival while reduc- ing the long-term impact of the sustained injury or injuries (Meyer et al. 2010). Though effects of TBI often coincide shortly after injury, long-lasting effects of TBI do not always appear immediately after injury; likewise, the acute-stage impairments may recover with or without treatment and reha- bilitation (Lovell et al. 2003). (Also known as spontaneous recovery, this type of recovery can occur at any time and is difficult to predict or control for in research.) In the chronic stage of recovery, the goals of rehabilitation are functional recovery of long-lasting physical, cognitive, and emotional impairments. Cognitive Rehabilitation Therapy CRT is a collection of treatments, generally tailored to an individual de- pending on the pattern of the impairments and activity limitations, related disorders (e.g., preexisting conditions or comorbidities), and the presence of a family or social support system. The modern practice of CRT began in the late 1970s, and evolved as a means to treat patients with acquired brain injuries, including those due to stroke, infection, multiple sclerosis or traumatic injury. A more complete description and the state of practice and providers of CRT are discussed in Chapters 4 and 5, respectively. Some forms of CRT are directed toward impairments in specific cog- nitive processes such as attention or memory. Within these focused treat- ments, there are two roughly distinguished approaches: (1) restorative approaches that seek to enhance the overall operation of a cognitive system with the goal of improving performance of a wide range of activities that depend on that system, and (2) compensatory approaches that seek to provide internal mental strategies (e.g., mnemonics) or external devices or aides (e.g., memory notebooks) to support activity performance despite the presence of a cognitive impairment. In addition, a number of different treatment components may be combined into a comprehensive CRT treat- ment program, often referred to as comprehensive, holistic, or multi-modal CRT. Such approaches are more likely to be used for patients with multiple cognitive or behavioral impairments and may include a combination of fo- cused approaches as above, coupled with psychotherapy, pharmacotherapy, behavior modification, occupational therapy, vocational rehabilitation, and other therapies (e.g., nutrition, art or music therapy, acupuncture). CRT is offered in a wide range of settings, including rehabilitation hospitals, community-care centers, and individuals’ homes and workplaces. Due to the range of services offered, CRT providers also vary widely. They represent a number of fields and professions including rehabilitation medi- cine, nursing, physical therapy, speech-language pathology, occupational

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7 SUMMARY therapy, psychology, psychiatry, neuropharmacology, neuropsychology, and vocational rehabilitation. Moreover, members of these disciplines may de- liver services indistinguishable from CRT under the disciplinary headings of “physical therapy,” “occupational therapy,” or “counseling,” such that the correspondence between treatment label and contents is imprecise. While there has been some movement to standardize CRT, wide variations between the expectations of practitioners within different professions still exist, reflecting the fact that the respective accreditation organizations for these professions separately determine the educational and licensing re- quirements for these practitioners. EVALUATION OF THE EVIDENCE The IOM committee iteratively developed a protocol to address the following questions: • o cognitive rehabilitation interventions improve function and D reduce cognitive deficits in adults with mild, or moderate to severe TBI? • re any cognitive rehabilitation interventions associated with risk A for adverse events or harm? • re cognitive rehabilitation interventions delivered through tele- A health technology proven safe and efficacious? Methods The committee reviewed published systematic reviews (Cicerone et al. 2000, 2005, 2011; ECRI 2009; Kennedy et al. 2008) and worked with a research librarian to develop search strategies to identify pertinent evidence. The strategies included searches in the following electronic bibliographic da- tabases: Medline, EMBase, PsycInfo, ERIC, and Cochrane (e.g., Cochrane DB of Systematic Reviews, Database of Reviews of Effects [DARE] and Cochrane Central Register of Controlled Trials). Strategy parameters in- cluded limiting the search to human subjects, the English language, and re- sults published between January 1991 and April 2011. The time period was chosen to include articles prior to Operation Desert Storm, which began in 1991. Setting time parameters allowed for the evaluation of the most recent research of relevance, acknowledging that more recent studies build on the evidence base created by older literature. The committee also culled refer- ences from previously published systematic reviews (Cicerone et al. 2000, 2005, 2011; ECRI 2009; Kennedy et al. 2008) to identify studies meeting selection criteria including any such studies published prior to 1991. Per its charge, the committee considered CRT for TBI across all severities (mild

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8 COGNITIVE REHABILITATION THERAPY FOR TBI and moderate-severe) and across all stages of recovery (acute, subacute, and chronic). The searches limited the scope of terms to traumatic brain injury, and did not consider other forms of acquired brain injury, such as those due to stroke, ischemia, infection, or malignancy. Similarly, the committee did not review literature on the effects of CRT for non-TBI cognitive dis- orders or injuries, such as schizophrenia, dementia, or learning disabilities. Chapter 6 provides a complete description of the committee’s methods for selecting relevant evidence. The committee categorized CRT interventions as either (1) modular strategies aimed at attention, language and communication, memory, visuo- spatial deficits, or executive function, or (2) multi-modal/comprehensive strategies. The intent of the therapy was categorized as restorative or compensatory and the goals and setting of therapy as decontextualized or contextualized. Compensatory strategies that targeted brain function but either did or did not involve changes to the environment were categorized as external or internal, respectively. These categorizations provided useful ways to dissect the literature and analyze findings across studies. FINDINGS The committee identified 90 studies that met selection criteria. These studies signal there is benefit from some forms of CRT for TBI. However, the evidence for the therapeutic value of CRT is variable across domains and is currently insufficient overall to provide definitive guidance for the development of clinical best practice, particularly with respect to selecting the most effective treatment(s) for a particular patient. The committee found the insufficiency of the evidence was due to a number of identified limitations in the research designs, commonly seen among studies evaluating rehabilitation strategies, including the heteroge- neity and lack of operational definitions of different forms of CRT; small sample sizes; the variety of premorbid conditions, comorbidities, and en- vironmental factors that may moderate the value of a given form of CRT across patients; and the range of outcomes that may be targeted. Some of the studies did not identify injury severity or recovery phase for included participants, or there was a lack of uniformity across studies in defining these criteria. Another 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 relatively 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

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9 SUMMARY later stages of TBI when it becomes clear which problems and impairments will persist long term. The committee focused on studies that used one or several forms of CRT to ameliorate the effects of TBI, and evaluated the outcomes of these studies to determine the short-term, long-term, or patient-centered (i.e., real-world functioning) outcomes, when reported, of the therapies. To determine efficacy, the committee relied on studies that compared the pri- mary CRT treatment to either no treatment or a non-CRT treatment. To determine effectiveness, the committee evaluated studies comparing CRT treatment to another form of CRT. In other words, varying comparators were not considered more or less useful, only that they answer different questions about the value of CRT for TBI. In an interactive and collaborative process, the committee graded the overall body of evidence for each CRT category (by domain, TBI severity, and recovery phase [for example, CRT interventions for attention deficits in moderate-severe TBI patients in the chronic phase of recovery]). To draw conclusions about treatment efficacy or effectiveness, the commit- tee qualitatively assessed the strength of individual studies, as well as the consistency of treatment effect among studies. The strength of each study was based on an iterative quality assessment, considering study design, size of the sample, reported characteristics of the sample (e.g., injury severity) and treatment (e.g., dosage, frequency, and timing), control for potentially confounding factors, magnitude of the treatment effect, statistical signifi- cance of the findings, and the length of follow-up. The committee gave more weight to controlled designs than uncontrolled (e.g., results of RCTs were given more weight than results from pre-post single group designs). Conclusions were not based solely on findings from uncontrolled studies, however the committee included pre-post single group designs and single subject, multiple baseline experiments in the review because uncontrolled studies may include useful information about nascent interventions or lend support to a controlled design with similar results. Where evidence was informative, the committee specifically identifies the treatment mode and cites the one or more studies that led to its conclusion. Box S-2 provides the description of evidence grades used to judge the sufficiency of the evi- dence. It is important to note that evidence ruled “limited” does not mean the intervention was inadequate; it may simply mean a better-designed or -executed study is necessary to show meaningful short- or long-term treat- ment effect. In reviewing the evidence regarding the efficacy and effective- ness 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—of those, only in the chronic phase—and few studies addressing treatment of those with moderate to severe injuries in the subacute phase. The committee did not identify any

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10 COGNITIVE REHABILITATION THERAPY FOR TBI BOX S-2 Evidence Grades None or not informative (0): No evidence because the intervention has not • been studied or uninformative evidence because of null results from flawed or otherwise limited studies. • imited (+): Interpretable result from a single study or mixed results from two L or more studies. • odest (++): Two or more studies reporting interpretable, informative, and M largely similar result(s). • trong (+++): Reproducible, consistent, and decisive findings from two or S more independent studies characterized by the following: (1) replication, re- flected by the number of studies in the same direction (at least two studies); (2) statistical power and scope of studies (N size of the study and single or multi- site); and (3) quality of the study design to measure appropriate endpoints (to evaluate efficacy and safety) and minimize bias and confounding. relevant literature for treatment of visuospatial perception deficits, which are more common after stroke than TBI. Table S-1 summarizes the commit- tee’s conclusions for CRT, reflected in Chapters 7 through 11 in narrative form following detailed descriptions of individual studies. In its conclusions, the committee separated evidence grades by cogni- tive domain and multi-modal/comprehensive CRT, further subdividing by reported injury severity, recovery phase, and the treatment approach (i.e., restorative or compensatory). Evidence grades were based on the breadth of literature assessed for each cognitive domain and multimodal/ comprehensive CRT; the table does not reflect the grades for individual studies. Telehealth Technology The committee found that a small evidence base demonstrates that telehealth technologies, including the telephone and two-way messaging, are feasible means of providing at least part of CRT for some patients. No studies evaluated the use of telemedicine, defined by the Centers for Medicare & Medicaid Services as two-way audio and video interactive communication. Overall evidence is insufficient to clearly establish whether telehealth technology delivery modes are more or less effective or more or less safe than other means of delivering cognitive rehabilitation. However, when combined as part of a broader CRT program, telehealth technologies, including telephone calls, can contribute to outpatient treatment programs

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TABLE S-1 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. 11

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12 COGNITIVE REHABILITATION THERAPY FOR TBI with comparable results to inpatient programs for selected individuals. Chapter 12 provides details on relevant studies and the committee’s assess- ments leading to these conclusions. Adverse Events or Harm The committee found that evidence indicating any potential adverse event and risk for harm associated with CRT is scant. Although the limited available evidence suggests no great concern regarding risk for harm, future studies that evaluate cognitive rehabilitation should include and report measures that assess such risks. Chapter 13 provides details on relevant studies and the committee’s assessments leading to these conclusions. RECOMMENDATIONS Considering the dearth of conclusive evidence identified to date, the committee recommends an investment in research to further develop CRT. As reflected in Table S-1, the evidence provides limited, and in some cases modest, support for the efficacy of CRT interventions. However, the limi- tations 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” (see Box 6-2 for all evidence grades and definitions). The commit- tee emphasizes that conclusions based on the limited evidence regarding the effectiveness of CRT does not indicate that the effectiveness of CRT treatments are “limited”; these 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. One way policy could reflect the provi- sion 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-

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13 SUMMARY 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 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, DVBIC Study on Cognitive Rehabilitation Effectiveness for Mild TBI (SCORE!), Millennium, and TBI Model Systems. These cohorts involve collaborative efforts between DoD and the 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 psycho- logical health of service members and veterans through the VA/DoD Joint Executive Council Strategic Plan to integrate health care services (VA/ DoD 2009b). 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 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 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.

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14 COGNITIVE REHABILITATION THERAPY FOR TBI The committee recommends 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 measures of injury severity) and key premorbid conditions, comorbidities, and environmental factors that may influence recovery and treatment response; 2. Identify and select uniform TBI outcome measures, including 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 delivery 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 associ- ated adherence measures. Recommendation 14-2: The DoD should convene a conference to achieve consensus among a multi-agency (e.g., VA, NIH, and NIDRR), multi-disciplinary team of clinicians and researchers to finalize the se- lection of patient characteristic and outcome variables to be included in experimental and observational CRT research, and to plan a strat- egy 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 de-identified 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. Recommendation 14-5: The DoD should collaborate with other re- search and funding organizations to foster all phases of research and

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15 SUMMARY 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. CONCLUSION The current evidence for CRT does not point a clear path to conclu- sive findings regarding CRT efficacy or effectiveness in the treatment of TBI-related deficits. The committee thoughtfully considered the challenges it faced throughout the study process. The committee’s recommendations aim to aid the Department of Defense in addressing a significant problem: Members of the military (and civilians) experience high rates of TBI, and TBI often causes significant cognitive, physical, or psychosocial deficits re- quiring rehabilitation. In light of the lack of conclusive evidence, either be- cause interventions or approaches are new and still being studied, or study designs were flawed, the committee has identified these recommendations as a way forward for the Military Health System. REFERENCES CDC (Centers for Disease Control and Prevention). 2010. What are the leading causes of TBI? http://www.cdc.gov/traumaticbraininjury/causes.html (accessed June 17, 2011). ———. 2011a. How many people have TBI? http://www.cdc.gov/TraumaticBrainInjury/ statistics.html#1 (accessed June 17, 2011). ———. 2011b. Traumatic brain injury. http://www.cdc.gov/traumaticbraininjury/ (accessed June 17, 2011). Cernak, I., and L. J. Noble-Haeusslein. 2010. Traumatic brain injury: An overview of patho- biology with emphasis on military populations. Journal of Cerebral Blood Flow & Metabolism 30(2):255–266. Cicerone, K. D., C. Dahlberg, K. Kalmar, D. M. Langenbahn, J. F. Malec, T. F. Bergquist, T. Felicetti, J. T. Giacino, J. P. Harley, D. E. Harrington, J. Herzog, S. Kneipp, L. Laatsch, and P. A. Morse. 2000. Evidence-based cognitive rehabilitation: Recommendations for clinical practice. Archives of Physical Medicine and Rehabilitation 81(12):1596–1615. Cicerone, K. D., C. Dahlberg, J. F. Malec, D. M. Langenbahn, T. Felicetti, S. Kneipp, W. Ellmo, K. Kalmar, J. T. Giacino, J. P. Harley, L. Laatsch, P. A. Morse, and J. Catanese. 2005. Evidence-based cognitive rehabilitation: Updated review of the literature from 1998 through 2002. Archives of Physical Medicine and Rehabilitation 86(8):1681–1692. Cicerone, K. D., D. M. Langenbahn, C. Braden, J. F. Malec, K. Kalmar, M. Fraas, T. Felicetti, L. Laatsch, J. P. Harley, T. Bergquist, J. Azulay, J. Cantor, and T. Ashman. 2011. Evidence-based cognitive rehabilitation: Updated review of the literature from 2003 through 2008. Archives of Physical Medicine and Rehabilitation 92(4):519–530. Cifu, D. X., L. Keyser-Marcus, and E. Lopez. 1997. Acute predictors of successful return towork 1 year after traumatic brain injury: A multicenter analysis. Archives of Physical Medicine and Rehabilitation 78(2):125–131. Dikmen, S. S., J. E. Machamer, J. M. Powell, and N. R. Temkin. 2003. Outcome 3 to 5 years after moderate to severe traumatic brain injury. Archives of Physical Medicine and Re- habilitation 84(10):1449–1457.

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