### Evidence Report/Technology Assessment: Number 2

# Rehabilitation for Traumatic Brain Injury

## Summary

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Under its Evidence-based Practice Program, the Agency for Health Care Policy and Research (AHCPR) is developing scientific information for other agencies and organizations on which to base clinical guidelines, performance measures, and other quality improvement tools. Contractor institutions review all relevant scientific literature on assigned clinical care topics and produce evidence reports and technology assessments, conduct research on methodologies and the effectiveness of their implementation, and participate in technical assistance activities. 

Overview / Impact of TBI / Key Questions / Reporting the Evidence / Methodology / Findings / Future Research / Availability of Full Report

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## Overview

Advances in medical technology and improvements in regional trauma services have increasedthe number of survivors of traumatic brain injury (TBI), producing the social consequences andmedical challenges of a growing pool of people with disabilities. Wider awareness of the scopeof the problem and its consequences for society has led to rapid growth in the rehabilitationindustry. Because of this growth and particularly because clinical rehabilitation strategies varywidely, many groups are interested in the effectiveness of rehabilitation for TBI.

To address this need to identify and assess evidence on TBI rehabilitation, the Agency for HealthCare Policy and Research (AHCPR) awarded a contract to Oregon Health Sciences University for a reviewof published reports and compilation of an evidence report. This summary highlights informationpresented in the full report.

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## Impact of Traumatic Brain Injury

Injury is the leading cause of mortality among Americans under 45 years of age; TBI isresponsible for the majority of these deaths. An estimated 56,000 lives are lost in the UnitedStates each year to TBI. Motor vehicle accidents, followed by gunshot injuries and falls, are theleading causes of injuries resulting in death from TBI. Males are 3.4 times as likely as females todie of TBI. About 50 percent of people who sustain TBI are intoxicated at the time of injury.

In a recent analysis based on hospital discharge data and vital statistics, the annual incidence ofTBI in the United States was estimated to be 102.8 per 100,000. In males, the incidence peaksbetween the ages of 15 and 24 (248.3 per 100,000) and again above 75 years of age (243.4 per100,000). The incidence in females peaks in the same age groups, but the absolute rates are lower(101.6 and 154.9, respectively). These rates underestimate the true incidence of head traumabecause patients with milder symptoms at the time of injury are usually not hospitalized.

About three-quarters of traumatic brain injuries that require hospitalization are nonfatal. Eachyear, about 80,000 survivors of TBI will incur some disability or require increased medical care.Direct medical costs for TBI treatment have been estimated at $48.3 billion per year, includingthe costs of hospitalization for acute care and various rehabilitation services. 

In the years 1988 to1992, reports of average length of stay (LOS) for the initial admission for inpatient rehabilitationrange from 40 to 165 days. In one multicenter study (the Model Systems study), the averagerehabilitation LOS was 61 days, and the average charge was $64,648 exclusive of physician fees.Total charges averaged $154,256. In more recent studies performed in the early 1990s,rehabilitation LOS and charges were lower, ranging from 19 days and $24,000 for patients withmilder injuries to 27 days and $38,000 for those with severe injuries. In the Medicare populationin 1994, mean charges for patients admitted for brain injury (excluding stroke) were $42,056.

To focus attention on important questions, the life of an adult survivor of TBI was characterizedby the developers of the report in terms of five phases. The first phase is pre-injury. Medicaltreatment is divided into two phases: the acute (or immediate) treatment phase and the intensivetreatment phase, lasting days to weeks. The rehabilitation phase may last months to years. Thesurvivor phase implies the remaining life of the person with TBI and involves continualdevelopment and adjustment. This division into phases clarifies the three challenges to assessingthe efficacy of rehabilitation discussed above. For each phase, patient populations, interventions,and outcome measures were identified, and the literature was reviewed to answer key questionsidentified by technical experts.

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## Key Questions About Traumatic Brain Injury

The following three questions about the status of brain injury research underlie uncertainty aboutthe effectiveness of rehabilitation services.

-  How should fundamental concepts such as recovery, functional status, and disability bedefined? Because brain function is highly complex, TBI has an extremely wide range of potentialoutcomes, including cognitive deficits, motor disabilities, emotional and social dysfunction,personality changes, and changes in appearance. As a result, therapeutic aims and perspectivesvary widely among studies, as do definitions of outcomes, making valid comparisons acrossstudies difficult.
- How should the type and severity of the injury itself be measured? Variations in methodsto assess the severity of injury in patients entering rehabilitation make it difficult to estimate theeffectiveness of different rehabilitation methods.
-  Which therapies are effective, and what is the best way to match patients with treatmentapproaches likely to be effective for them?

Today, a person's path to rehabilitation after sustaining brain injury may be determined by themechanism of injury, the resources of the community, the person's employment or financialstatus, the consent of the family, and/or the accuracy of the emergency department diagnosis.While a few metropolitan areas have organized referral systems that connect patients withresources and rehabilitation programs, systematic methods for evaluating the needs of peoplewho have sustained brain injury and referring them to appropriate programs are unusual. Withoutknowing the efficacy of rehabilitation methods in their specific applications, systematic referral that produces the desired result is not possible.

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## Reporting the Evidence

Two panels of experts worked with the research team to identify key questions in therehabilitation and survivor phases for adults with TBI. The first panel was composed of twophysiatrists, a survivor of TBI, the wife of a survivor of TBI, a State vocational rehabilitationcounselor, a neuropsychologist, a psychologist, a clinical coordinator of an outpatient TBIrehabilitation program, and a rehabilitation clinical nurse specialist, all from the Portland, OR,area. The second panel was composed of nationally recognized experts in rehabilitation.

The panels formulated five questions pertaining to the phases of recovery described above. Thesequestions addressed the effectiveness of (1) early rehabilitation in the acute care setting (timing),(2) intensity of rehabilitation, (3) cognitive rehabilitation, (4) supported employment, and (5)care coordination (case management). For each of these questions, members of the research teamworked with panelists to write a brief rationale for the question, define key terms, and specify therelevant patient populations, interventions, and outcome measures to be examined in theliterature review. The questions were:

-  Should interdisciplinary rehabilitation begin during the acute hospitalization for traumaticbrain injury?
-  Does the intensity of inpatient interdisciplinary rehabilitation affect long-term outcomes?
-  Does the application of cognitive rehabilitation enhance outcomes for people who sustainTBI?
-  Does the application of supported employment enhance outcomes for people with TBI?
-  Does the provision of long-term care coordination enhance the general functional statusof people with TBI?

Select for Findings.

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## Methodology

A MEDLINE® search (1976 to 1997), supplemented by searches of HealthSTAR (1995 to 1997),CINAHL (1982 to 1997), and PsycINFO (1984 to 1997), produced a total of 3,098 references tobe considered for inclusion; of these, 569 applied to questions 1 and 2, 600 applied to question 3,392 applied to question 4, and 975 applied to question 5.

Abstracts of each article retrieved by these searches were reviewed independently by twomembers of the research team, who applied predefined, broad eligibility criteria. When the tworeviewers disagreed, a third reviewer read the abstract and cast the deciding vote on whether itshould be included. In the event a reference did not have an abstract, and the title for thereference was not sufficient for determination of status, the article was retrieved and reviewed todetermine its eligibility. The two reviewers examined each abstract and indicated whether it metthe inclusion criteria and, if not, the reason for exclusion. If the abstract was eligible, or if it didnot contain sufficient information to determine eligibility, the full text of the article was retrievedfor review in the next phase of the selection process.

Eighty-seven articles pertaining to questions 1 and 2, 114 articles for question 3, 93 articles forquestion 4, and 69 articles for question 5 passed the eligibility screen. Sixty-seven additionalarticles were recommended for inclusion by experts or by review of reference lists of reviewarticles. In all, 363 articles were retrieved for review and abstraction.

Additional criteria for inclusion were defined separately for each of the five questions. Thecriteria varied because the necessary types of studies varied from question to question. Articlesthat applied to more than one question were maintained as duplicates (or triplicates, etc.) in eachquestion-specific file, so they could be considered for inclusion based on their relevance to eachquestion. 

### Data Abstraction

An instrument was designed to record data abstracted from each eligible article. The instrumentincludes items for patient characteristics, interventions, cointerventions, outcomes, studymethods, relevance to the specific research questions, and results of the study. The instrumenthas two components: the first four pages of the instrument apply to all articles specified forinclusion in the study; the remaining pages are individual instruments that apply to one of thefive questions. To abstract an article, a reader used the initial abstraction instrument plus one ormore of the five question instruments.

The first few questions of the initial abstraction instrument allowed the reviewer to determine ifthe article actually met the eligibility criteria for inclusion in the report. If an article wasdetermined to be ineligible, it was passed to a second reader for confirmation. The remainingarticles were subjected to the full abstraction protocol.

### Specification of Level of Evidence

A three-level system was used to rate individual studies. Well-designed randomized controlledtrials (RCTs) were rated as Class I. Studies rated as Class II were RCTs with design flaws;well-done, prospective, quasiexperimental or longitudinal studies; and case-control studies. Casereports, uncontrolled case series, and expert or consensus opinion were generally rated Class III.A well-done, prospective, multicenter or population-based case series can provide valuableinformation that, in some ways, is more reliable than data from a randomized trial done in ahighly selected sample of patients. However, when used to make inferences about effectiveness,an uncontrolled case series is generally classified as Class III, indicating the lowest level ofconfidence. 

A "gray zone" exists between Class II and definite Class III articles. Much of the research inrehabilitation uses quasi-experimental designs. In these observational study designs, controlsubjects are sometimes identified from a separate patient population. For instance, one group ofresearchers compared patients undergoing inpatient rehabilitation to a sample of people with TBIwho had been treated in a region of the country where formal inpatient TBI rehabilitation was notavailable. This was an entirely separate patient group, and all the data except outcome measurescame from an independent database.

The main difficulty with the quasiexperimental design is lack of control over the constitution ofthe compared groups. Because there is no randomization and generally no control over the detailsof the selection process through which the patients received their separate therapies, the groupsare likely to differ in the frequency of characteristics that are associated with the outcomes ofinterest. Even when significant efforts are made to match the experimental and the quasi-controlgroups, it is likely that significant differences between the groups will remain.

Much of the literature relevant to the five questions addressed in this effort falls into the "grayzone" between Class II and Class III. For this reason, critical appraisal of key studies played aparticularly important role in this review. A number of characteristics of these studies wereconsidered relevant to all rehabilitation questions and were recorded in the data abstraction form.Evaluation of the following factors played a major role in critically appraising these articles:

-  Prospective collection of data.
-  Complete description of parent study population.
-  Large study population driven by hypothesis, power, type I error threshold).
-  Study setting—a single center, many centers, or population based.
-  Description of reasons for referral to service being studied.
-  Description of methods sufficiently complete to permit study replication.
-  Complete description of rehabilitation technique in question (independent variable).
-  Complete description of differences between "control" and "experimental" groups.
-  Conditions determining whether patients did or did not receive the rehabilitationtechnique in question.
-  Information about potential confounders, including types and severity of injury, age, andothers (including in some cases, economic status, educational level, lack of family support).
-  Measurement of confounding variables using instruments validated as accurate, sensitive,and reliable.
-  Payer group.
-  Choice of outcome variables that are meaningful to patients and caregivers.
-  Use of functional status and other health outcomes rather than surrogate (intermediate)outcomes.
-  Measurement of outcome variables using instruments validated as accurate, sensitive, andreliable.
-  Timing of outcome measurements.
-  Assessment of patient characteristics and outcomes by blinded observer.
-  Use of multivariate statistical analysis: Were interactions sought and controlled for? Wererisk estimates calibrated? Were all relevant confounders included as candidate variables?

The criteria used to classify articles and the features to be considered in critically appraising themwere discussed at the subcommittee, committee, national expert panel, and AspenNeurobehavioral Conference levels with the goal of maintaining consensus at least on the relativestratification of individual articles.

### Construction of Evidence Tables

Evidence tables were constructed to summarize the best evidence about effectiveness pertainingto each question. No randomized trials and only a few quasiexperimental studies were availablefor questions 1 and 2. There were a large number of relevant observational studies of importantrelationships (for example, the relation of patient characteristics to outcome); studies thatconcerned individual causal links or relationships in evidence tables were not summarized. Forquestion 3, addressing cognitive rehabilitation, 15 randomized controlled trials and comparativestudies that met specified inclusion criteria were placed into evidence tables. All comparativestudies located for the last two questions, which addressed supported employment and carecoordination, were included in evidence tables.

### Critical Appraisal of Key Articles

For each of the five questions, subcommittees were formed consisting of one or two members ofthe research team and one or two members of the local technical panel. Each subcommittee waschaired by a member of the research team. Key articles relevant to the assigned question werereviewed in depth by all members of the subcommittees. These reviews were discussed amongthe various members of the subcommittees, and the results were summarized by the chair. Thiswas an effort to ensure that the summary statements on the research questions reflected theexpertise and experience of a variety of technical experts with relevant skills and training. Theseinterpretive efforts addressed the methods and results of individual studies, their rating, and theirscientific importance.

All of the critical articles for the five questions were individually read by the principalinvestigator. Summaries were presented and discussed with national experts at the AspenNeurobehavioral Conference in April 1998.

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## Findings

### Question 1

One small, retrospective, observational study from a single rehabilitation facility supports anassociation between the acute institution of formalized, multidisciplinary, physiatrist-driven TBIrehabilitation and decreased length of stay (acute hospital and acute rehabilitation) and somemeasures of short-term physiologic (noncognitive) patient outcomes. The level of evidence isClass III. This study concerned adult patients with severe brain injury (Glasgow Coma Scale3-8); there is no evidence from comparative studies for or against early rehabilitation in patientswith mild and moderate injury.

### Question 2

When measured as the hours of application of individual or grouped therapies, there is noindication that the intensity of acute, inpatient TBI rehabilitation is related to outcome. Becauseof methodological weaknesses, however, previous studies are likely to have missed a significantrelationship if one exists (a type 2 error). These studies contained insufficient information aboutseverity of injury and baseline function to ensure the comparability of compared groups. Also,these studies did not consider the quality of individual treatments, their lack of autonomy in thecognitive realm, and the delivery milieu. One or more of these factors may affect the outcome ofcare more than the time spent in each modality. Therefore, future research into efficacy of acuteinpatient TBI rehabilitation must more adequately measure such factors and include the factors intheir predictive models. Future studies also must employ a wider spectrum of outcome measures,including measurement of outcomes across longer periods of time after discharge.

From a clinical aspect, the evidence does not support equating different TBI rehabilitationdelivery systems based on equivalent times of patient exposure to various therapeutic modalities.For example, this analysis would not support predicting that patient benefit would be equal if anequal time spectrum of rehabilitation therapies were delivered at a rehabilitation center ascompared with a skilled nursing facility. More detailed analysis of factors involved in predictingresponse to rehabilitation modalities must be considered in approaching such questions.

Additionally, mandating a minimum number of hours of applied therapy for all TBI patients isnot supported by the present state of scientific knowledge. How much of which intervention(s)optimizes recovery in a given type of patient has been inadequately studied. It is certainlyreasonable to avoid situations in which patients do not receive potentially beneficial treatment.Based on the above studies, however, defining a minimal rehabilitation program in terms of timeof applied therapy is not likely to optimize either the therapists' time or patients' recovery. It isprobable that specific basic programs will have to be related to individual patient groups.Developing such algorithms requires further research.

Many patients who suffer TBI do not enter acute inpatient rehabilitation. Only one study of theeffectiveness of inpatient rehabilitation included a comparison group of patients who did notundergo inpatient rehabilitation. Future studies should compare acute, inpatient rehabilitation tocommonly used alternatives to inpatient rehabilitation, such as care in a well-staffed skillednursing facility or in less intense variations of acute rehabilitation. Very little is known about theoutcomes of TBI in these settings.

### Question 3

There is evidence from two small studies (Class I and Class III) that a personally adaptedelectronic device, a notebook, and an alarm wristwatch reduce everyday memory failures forpeople with TBI. There is evidence from one study (Class II[a]) that compensatory cognitiverehabilitation (CCR) reduces anxiety and improves self-concept and relationships for people withTBI. Evidence from two studies (Class I and Class II[b]) supports the use of computer-aidedcognitive rehabilitation (CACR) to improve immediate recall on neuropsychological testing, butthe clinical importance of this finding has not been validated.

### Question 4

Class II evidence indicates that supported employment can improve the vocational outcomes ofTBI survivors. Nearly all information about supported employment comes from two bodies ofwork, each of which used different experimental designs and different models of supportedemployment. The findings have not been replicated in other settings or by other centers, so thegeneralizability of these programs remains untested.

### Question 5

There have been very few studies on the effectiveness of case management, and the results ofthese studies are mixed. The only outcome for which there were results in the same directionfrom two or more studies pertained to changes in vocational status. This was associated with thesingle case-manager and insurance approach, as well as with the combined nurse and vocationalcase-manager model. There were conflicting results about the effects of case management ondisability or functional status, living status, family impact, and other aspects, and some findingswere mentioned in only one study. The clinical trial resulted in no functional status changesamong case-managed subjects, despite an extended period of rehabilitation. However, when twoforms of case management were compared, both the single and multiple case-manager/insuranceapproaches showed significant functional improvements.

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## Future Research

The evidence report identifies the following areas for future research.

-  Randomized trials of the timing and intensity of early and acute rehabilitation would beuseful. Because the patient characteristics that affect outcomes also affect the type and level ofrehabilitation services delivered, it may be unlikely that any observational study can providedefinitive evidence about effectiveness. Moreover, assigning patients to different levels ofintensity or to early versus conventional initiation of rehabilitation in a prospective trial may beethically acceptable, since these different levels represent a range of current practice rather than adeviation from it.
-  Population-based studies of all patients with TBI, including those who do not enterinpatient rehabilitation facilities, are imperative. Important questions about the effectiveness ofrehabilitation and its component disciplines require the development of regional or nationalregistries, with standardized data collection and identification and followup of all patients withhead injury.
-  Research designs for future studies should incorporate health outcomes of importance topeople with TBI and their families. Commonly used measures should be more strongly linked tohealth outcomes. Future studies should address the effect of spontaneous recovery, systematizecriteria for entering cognitive rehabilitation, and differentiate between the effects of generalstimulation and specific techniques.
-  The greatest overall need for the evaluation of supported employment programs is a seriesof trials with adequate controls and unbiased allocation of clients to the conditions compared. 
-  Future research should focus on improving the outcome measures used to examine theresults of case management in TBI rehabilitation. In addition to outcomes of changed patientfunctionality, there should be outcomes of changed family functionality. Since much of casemanagement communication is directed toward helping family members learn what to expect andwhere to obtain services, relevant outcomes would include family use of community andrehabilitation services and indicators of family assertiveness about care expectations. While casemanagement may exert only an indirect effect on a patient's functional outcomes such as level ofdisability, vocational status, and living status, it is possible that case management can directlyaffect family knowledge of TBI rehabilitation needs and services, level of psychosocial anxiety,and family competency in coping with TBI.

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## Availability of the Full Report

The full evidence report from which this summary was taken was prepared for AHCPR by the Oregon Health Sciences University, Portland, OR, undercontract  No. 290-97-0018. Printedcopies may be obtained free of charge from the Publications Clearinghouse by calling1-800-358-9295. Requesters should ask for Evidence Report/Technology Assessment Number 2,*Rehabilitation for Traumatic Brain Injury* (AHCPR Publication  No. 99-E006). The Evidence Report is available online at the National Library of Medicine Bookshelf.

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*AHCPR Publication  No. 99-E005Current as of October 1999*

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**Internet Citation:**

*Rehabilitation for Traumatic Brain Injury*. Summary, Evidence Report/Technology Assessment: Number 2, December 1998. Agency for Health Care Policy and Research, Rockville, MD. http://www.ahrq.gov/clinic/epcsums/tbisumm.htm

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