Findings On Brain Injury Rehabilitation
Conclusions and Summary of Findings
The purpose of this document is to provide an exhaustive, evidence-based approach to rehabilitation for traumatic brain injury. In order to make this a feasible undertaking, five specific topics were selected from among the many aspects of TBI rehabilitation. These aspects were closely defined and then subjected to rigorous and explicit evidence-based literature review and analysis.
In producing a "conclusions" section to this work, two issues need to be addressed. First, the results of the literature investigations into the five topics should be summarized. Second, their implications should be discussed. Because of the nature of the evidence-based medicine process and the overall weakness of the literature, however, these processes must be undertaken with care.
Although formulated around specific questions, evidence-based medicine is driven by the literature. For instance, the questions that are developed at the outset are almost never directly reflected in any one individual study much less in a body of literature. Therefore, the results of evidence-based medicine efforts will be strongly influenced by the approaches to individual topics taken in the body of relevant literature and by the strength of those studies. Because of these constraints, it is hazardous to separate a synopsis of the conclusions of an evidence-based medicine analysis from the studies that specifically drive those conclusions. Unless there is a large body of Class I literature, separating summary statements from the strength of their supporting evidence vastly increases the risk of their misinterpretation. For that reason, the summary statements contained in this section with respect to the five questions are strictly limited to reflections of the statements made in their individual sections. Readers are strongly encouraged to study those sections prior to interpreting these summary statements.
In addition, because of the overall weakness of the literature as reflected in this work, clinical interpretation is hazardous. It must be remembered that the absence of evidence is not evidence of absence. Although none of the issues involved in TBI rehabilitation that are addressed in this work are supported by Class I evidence, it must be recognized that there also is not a similarly strong body of evidence standing in disproof. Therefore, because something has not been definitively proven as effective must not be interpreted to mean that it does not have clinical utility, should not be continued, or should not be funded. The proper interpretation would be that, in the presence of a need for treatment and the absence of clearly superior alternatives, choices must be made between therapies without proven superiority over others based on clinical pragmatism.
From a funding viewpoint, it must also be recognized that there is a vast difference between making a choice between alternate therapies based on less than optimal evidence and denying an entire category of therapeutic management based on the absence of strong scientific proof of efficacy. The application of evidence-based medicine techniques to the current body of clinical literature over the past several years has effectively raised the scientific bar much higher than ever before. Although it is expected that the new height of the bar will be recognized by clinical researchers and result in significantly better design and more powerful studies in the future, the application of this new degree of rigor to studies done in even the recent past must be seen as an attempt to improve medicine, not paralyze it.
Summary of Findings
Question 1: Should interdisciplinary rehabilitation begin during the acute hospitalization for traumatic brain injury?
One small, retrospective, observational study from a single rehabilitation facility supports an association between the acute institution of formalized, multidisciplinary, physiatrist-driven TBI rehabilitation and decreased LOS (acute hospital and acute rehabilitation) and some measures of short-term physiologic (non-cognitive) patient outcome. The level of evidence is Class III. This study concerned patients with severe brain injury (GCS 3-8). There is no evidence from comparative studies for or against early rehabilitation in patients with mild and moderate injury.
Deriving clinical implications from the single Class III study that directly addresses this question must be done with trepidation. It is generally felt that the application of modalities such as physical therapy as early as possible following TBI is beneficial. In addition, the transition from acute stay at the trauma hospital to a rehabilitation facility for severe TBI patients is almost always driven by issues that are peripheral to the proper timing of rehabilitation efforts (e.g., systemic complications, bed availability, etc.). Since the one study did suggest that the institution of formalized, multidisciplinary, physiatrist-driven TBI rehabilitation efforts early in the posttraumatic period was favorably associated with short-term outcome and logistics, it would seem reasonable, based on the present body of literature, to include a physiatrist in the acute care team in as expedient a fashion as possible.
Question 2: Does the intensity of inpatient interdisciplinary rehabilitation affect long-term outcomes?
When measured as the hours of application of individual or group therapies, there is no indication that the intensity of acute-inpatient TBI rehabilitation is related to outcome. Because of methodological weaknesses, however, previous studies are likely to have missed a significant relationship if one exists (a Type II error). These studies contained insufficient information about severity of injury and baseline function to ensure the comparability of the compared groups. These studies also did not consider the quality of individual treatments, their lack of autonomy in the cognitive realm, and the delivery milieu. One or more of these factors might affect the outcome of care more than the time spent in each modality. Therefore, future research into efficacy of acute inpatient TBI rehabilitation must more adequately measure such factors and include them in their predictive models. Future studies also must employ a wider spectrum of outcome measures including measurement of outcomes for a longer period after discharge. Such an analysis would be an ideal application of a universal uniform data set.
With regard to the clinical aspect, the evidence does not support equating different systems of TBI rehabilitation delivery based on equivalent times of patient exposure to various therapeutic modalities. For example, this analysis would not support the assumption that patient benefit would be equal if an equal time spectrum of rehabilitation therapies were delivered at a rehabilitation center as compared with a skilled nursing facility. More detailed analysis of factors involved in predicting response to rehabilitation modalities must be considered in approaching such questions.
Additionally, mandating a minimum number of hours of applied therapy for all TBI patients is not supported by the present state of scientific knowledge. The issues of how much intervention optimizes recovery in a given type of patient remains inadequately studied. It is certainly reasonable to avoid situations in which patients do not receive potentially beneficial treatment. Based on the above studies, however, defining a minimum rehabilitation program in terms of time of applied therapy is not likely to optimize either therapist time or patient recovery. It is probable that a specific basic program will have to be related to individual patient groups. Developing such algorithms requires future research.
Many people who suffer TBI do not enter acute inpatient rehabilitation. Only one study of the effectiveness of inpatient rehabilitation included a comparison group of patients who did not undergo inpatient rehabilitation. Future studies should compare acute, inpatient rehabilitation with commonly used alternatives to inpatient rehabilitation, such as care in a well-staffed, skilled nursing facility or in less intense variations of acute rehabilitation. Very little is known about the outcomes of TBI in these settings.
Question 3: Does the application of compensatory cognitive rehabilitation enhance outcomes for people who sustain TBI?
One small randomized controlled trial (Class I) and one observational study (Class III) provide evidence of the direct effects of compensatory cognitive devices (notebooks, wristwatch alarms, programmed reminder devices) on the reduction of everyday memory failures for people with TBI. A second randomized controlled trial provides evidence that compensatory cognitive rehabilitation reduces anxiety and improves self-concept and interpersonal relationships for people with TBI. The level of evidence is Class II[a].
Two small randomized controlled trials (Class I) provide limited evidence that practice and computer-aided cognitive rehabilitation improve performance on laboratory-based measures of immediate recall. No studies evaluated the link between such cognitive tests and health outcomes, and the associations between performance on cognitive tests and employment in the literature were inconsistent.
Current practice in cognitive rehabilitation lacks a firm basis in experimental clinical studies. It is unlikely that the studies we reviewed, designed to address effectiveness, accurately describe the totality of techniques, stimulation, and human effort and ingenuity that constitute cognitive rehabilitation programs, particularly if the programs are multi- or transdisciplinary. Therapists observe that their patients improve; what is causing the improvements is not understood. In making decisions about the course of treatment, clinicians are compelled to follow their experiences and observations until strong research designs provide evidence from which guidelines and standards can be derived.
Question 4: Does the application of supported employment enhance outcomes for people with TBI?
There is some Class II evidence that supported employment can improve the vocational outcomes of survivors of TBI. Most of the evidence on the effects of supported employment comes from two programs of research, each of which used different experimental designs and different models of supported employment. Both designs used prospective data collection, but one compared the treatment group with an independent control, while the other was a case control study comparing preinjury employment with postinjury employment without and then with supported employment. The findings have not been replicated at other centers, so the results cannot be generalized to the general population of survivors of TBI. Most studies of supported employment in TBI research are of the individual placement model, but some evidence also supports the use of the apprenticeship model.
The evidence for improvement of vocational outcomes with supported employment is sufficient to warrant its use in practice while further research continues. However, much remains unknown about the amount of improvement that is actually gained by these programs and which components of the programs contribute most to the improved outcomes. It also may be important to explore other models of supported employment, like the apprenticeship model or some variations of the work enclave model.
Question 5: Does the provision of long-term care coordination enhance the general functional status of people with TBI?
Very few studies of the effectiveness of case management have been done, and results have been mixed. The clearest demonstration of improvement due to case management is in vocational status, where at least two studies, using different models of case management, showed similar improvements. One of these two programs showed superior results when a single case manager administered all the insurance benefits of each patient; the other showed results in the same direction using a combination of nurse and vocational case manager to select and time the interventions. There were conflicting results on other effects of case management, including disability or functional status, living status, and effects on the family, and some outcomes were mentioned in only one study. The clinical trial, using separate hospital systems randomly assigned to a case management condition, showed that there were no functional status changes among case management participants, despite an extended period of rehabilitation and followup. But, when two forms of case management were compared, both the single and multiple case manager/insurance models showed significant functional improvements.
Although the present evidence is mixed, it seems warranted to continue the use of several case management models to select and time interventions in cases of TBI, and it also may be of benefit to survivors to have the advocacy by the case manager in finding and obtaining treatments. There is a certain face validity to the basic idea of case management, which is simply a matter of careful planning of the choice, sequence, and timing of interventions, and some variation of it is really a standard component of most clinical practice. Also, there probably is some value to the person with TBI of an advocate able to obtain benefits that otherwise would be missed by an unaided survivor. The extent of the benefit of case management, however, remains undemonstrated, and more studies using control groups would be very beneficial in clarifying the actual improvement in outcomes due to case management. It also is unclear whether some models of case management are better than others and for what kinds of clients they might be best suited. These questions contribute to the agenda for future research.
Due to the methods through which the above five topics have been approached in the literature and the relative absence of powerful studies in these areas, the conclusions reached by this evidence-based approach and the clinical implications drawn therefrom are extremely limited. As a direct result, the utility of this document in driving profound alterations in TBI rehabilitation based on the scientific literature is very restricted. Because this report is the product of an exhaustive review of the literature in these five areas, however, we are in an ideal position to be able to summarize the shortcomings of the studies in these fields and to make generalizable recommendations regarding how future efforts could be improved. Since the five topics addressed in this work run the temporal gamut from acute care through long-term survival, this document also serves as an ideal conduit for suggesting the means for optimizing continuity and consistency of research efforts across the spectrum of recovery from TBI. Because the ability to suggest improvements in research efforts in a knowledgeable fashion is probably the most valuable result of this work, special attention was directed to this area. For further information, readers are directed to the analyses of research shortcomings and sets of recommendations presented in the Aspen Consensus Conference proceedings (Chesnut, Alexander, Antoinette, et al., forthcoming).