Cognitive rehabilitation for traumatic brain injury: A randomized trial (Salazar et al. 2000)
Salazar, A., Warden, D., Schwab, K., Spector, J., Braverman, S., Walter, J., . . . Ellenbogen, R. (2000). Cognitive rehabilitation for traumatic brain injury: A randomized trial. Journal of American Medical Association, 283(23), 3075-3081.
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- The study’s objective was to examine the impact of in-hospital and home rehabilitation programs on the employment and health status of active duty military members with severe traumatic brain injuries (TBIs).
- The study was a randomized controlled trial conducted at the Walter Reed Army Medical Center, where 120 active duty military members with TBI were randomly assigned to receive either in-hospital rehabilitation or home rehabilitation. Researchers collected outcome data 8 weeks and 6, 12, and 24 months after randomization.
- Although the study authors originally hypothesized that in-hospital rehabilitation would increase the rates of patients who were able to return to work or able to return to active duty, the study found no statistically significant difference between the two groups on these outcomes.
- The quality of the causal evidence presented in this report is high because it was based on a well-implemented randomized controlled trial. This means we are confident that any differences in outcomes would be attributable to the more effective program; however, there were no statistically significant differences between the programs.
The in-hospital rehabilitation group combined group and individual therapies that were conducted by board-certified psychiatrists, neuropsychologists experienced in TBI rehabilitation, an occupational therapist, a speech pathologist, and rehabilitation assistants. All therapies were delivered in a hospital setting and included a protocol-driven routine of physical fitness training and group and individual cognitive, speech, and occupational therapies.
In the home rehabilitation group, patients and their families received TBI education and individual counseling from a psychiatric nurse. Patients and their families received educational materials and strategies for improving cognitive and organizational skills, were trained in number and card-game exercises, and were encouraged to watch the news and read books and magazines. They received weekly 30-minute telephone calls from the nurse, who advised on issues and inquired about the week’s events.
Features of the Study
The study was conducted at the Walter Reed Army Medical Center in Washington, D.C. from January 1992 through February 1997. The evaluation consisted of a randomized controlled trial in which 120 patients were deemed eligible to participate in the study and consented to participate. To be included in the study, participants had to meet the following inclusion criteria: (1) diagnosed as having moderate to severe TBI; (2) sustained head injury in the three months before random assignment; (3) cognitive level of 7, as determined by the Rancho Los Amigos cognitive level scale; (4) active duty military member; (5) stable home setting with at least one responsible adult available; (6) ability to walk/move about independently; and (7) no previous severe TBI or other disability that would prohibit return to active duty after treatment.
Eligible patients were randomly assigned to one of two treatment groups. Sixty-seven received in-hospital rehabilitation and 53 received home rehabilitation. Data for the evaluation were collected from multidisciplinary evaluations (including interviews, military records, and medical records) that occurred 8 weeks after randomization as well as re-evaluations at 6, 12, and 24 months. Outcomes of interest included patients’ return to gainful civilian or military employment and fitness for military duty. The study also assessed measures of quality of life, which included belligerence, social irresponsibility, antisocial behavior, social withdrawal, and apathy. The authors estimated the relative effect of the programs by comparing the means of the groups on each of these measures.
- Although it was originally hypothesized that in-hospital rehabilitation would increase the rates of patients who were able to return to work or active duty, there was no significant difference on these outcomes between the two groups. In addition, no significant differences were found in any of the quality-of-life outcomes.
Considerations for Interpreting the Findings
The study was a well-implemented randomized controlled trial. However, the study sample was small, making it difficult to detect statistically significant differences in outcomes. In addition, because the study contrasted two types of treatment, we cannot infer how effective either treatment would be when compared to receiving no treatment. Finally, because this study focuses on active military members, the study’s results might not hold for civilians.
Causal Evidence Rating
The quality of the causal evidence presented in this report is high because it was based on a well-implemented randomized controlled trial. This means we are confident that any differences in outcomes would be attributable to the more effective program; however, there were no statistically significant differences between the programs.