Brain Injury Newsroom

Critical Appraisal of Key Articles

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

All of the critical articles for the five questions were individually read by the principal investigator. Summaries were presented and discussed with national xperts at the Aspen Neurobehavioral Conference in April 1998.

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 length of stay (acute hospital and acute rehabilitation) and some measures of short-term physiologic (noncognitive) patient outcomes. The level of evidence is Class III. This study concerned adult patients with severe brain injury (Glasgow Coma Scale 3-8); there is no evidence from comparative studies for or against early rehabilitation in patients with mild and moderate injury.

When measured as the hours of application of individual or grouped 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 2 error). These studies contained insufficient information about severity 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 the cognitive realm, and the delivery milieu. One or more of these factors may 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 the factors in their 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 rehabilitation delivery 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 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. How much of which intervention(s) optimizes recovery in a given type of patient has been 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 minimal rehabilitation program in terms of time of applied therapy is not likely to optimize either the therapists' time or patients' recovery. It is probable 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 the effectiveness of inpatient rehabilitation included a comparison group of patients who did not undergo inpatient rehabilitation. Future studies should compare acute, inpatient rehabilitation to 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.

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

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

There have been very few studies on the effectiveness of case management, and the results of these studies are mixed. The only outcome for which there were results in the same direction from two or more studies pertained to changes in vocational status. This was associated with the single case-manager and insurance approach, as well as with the combined nurse and vocational case-manager model. There were conflicting results about the effects of case management on disability or functional status, living status, family impact, and other aspects, and some findings were mentioned in only one study. The clinical trial resulted in no functional status changes among case-managed subjects, despite an extended period of rehabilitation. However, when two forms of case management were compared, both the single and multiple case-manager/insurance approaches showed significant functional improvements.
The evidence report identifies the following areas for future research.

Randomized trials of the timing and intensity of early and acute rehabilitation would be useful. Because the patient characteristics that affect outcomes also affect the type and level of rehabilitation services delivered, it may be unlikely that any observational study can provide definitive evidence about effectiveness. Moreover, assigning patients to different levels of intensity or to early versus conventional initiation of rehabilitation in a prospective trial may be ethically acceptable, since these different levels represent a range of current practice rather than a deviation from it.
Population-based studies of all patients with TBI, including those who do not enter inpatient rehabilitation facilities, are imperative. Important questions about the effectiveness of rehabilitation and its component disciplines require the development of regional or national registries, with standardized data collection and identification and followup of all patients with head injury.
Research designs for future studies should incorporate health outcomes of importance to people with TBI and their families. Commonly used measures should be more strongly linked to health outcomes. Future studies should address the effect of spontaneous recovery, systematize criteria for entering cognitive rehabilitation, and differentiate between the effects of general stimulation and specific techniques.
The greatest overall need for the evaluation of supported employment programs is a series of 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 the results of case management in TBI rehabilitation. In addition to outcomes of changed patient functionality, there should be outcomes of changed family functionality. Since much of case management communication is directed toward helping family members learn what to expect and where to obtain services, relevant outcomes would include family use of community and rehabilitation services and indicators of family assertiveness about care expectations. While case management may exert only an indirect effect on a patient's functional outcomes such as level of disability, vocational status, and living status, it is possible that case management can directly affect family knowledge of TBI rehabilitation needs and services, level of psychosocial anxiety, and family competency in coping with TBI.