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Cognitive rehabilitation for traumatic brain injury: a randomized trial. Defense and Veterans Head Injury Program (DVHIP) Study Group |
Salazar AM, Warden DL, Schwab K, Spector J, Braverman S, Walter J, Cole R, Rosner MM, Martin EM, Ecklund J, Ellenbogen RG |
JAMA 2000 Jun 21;283(23):3075-3081 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
CONTEXT: Traumatic brain injury (TBI) is a principal cause of death and disability in young adults. Rehabilitation for TBI has not received the same level of scientific scrutiny for efficacy and cost-efficiency that is expected in other medical fields. OBJECTIVE: To evaluate the efficacy of inpatient cognitive rehabilitation for patients with TBI. DESIGN AND SETTING: Single-center, parallel-group, randomized trial conducted from January 1992 through February 1997 at a US military medical referral center. PATIENTS: One hundred twenty active-duty military personnel who had sustained a moderate-to-severe closed head injury, manifested by a Glasgow Coma Scale score of 13 or less, or posttraumatic amnesia lasting at least 24 hours, or focal cerebral contusion or hemorrhage on computed tomography or magnetic resonance imaging. INTERVENTIONS: Patients were randomly assigned to an intensive, standardized, 8-week, in-hospital cognitive rehabilitation program (n = 67) or a limited home rehabilitation program with weekly telephone support from a psychiatric nurse (n = 53). MAIN OUTCOME MEASURES: Return to gainful employment and fitness for military duty at 1-year follow-up, compared by intervention group. RESULTS: At 1-year follow-up, there was no significant difference between patients who had received the intensive in-hospital cognitive rehabilitation program versus the limited home rehabilitation program in return to employment (90% versus 94%, respectively; p = 0.51; difference, 4% (95% confidence interval CI -5% to 14%)) or fitness for duty (73% versus 66%, respectively; p = 0.43; difference, 7% (95% CI -10% to 24%)). There also were no significant differences in cognitive, behavioral, or quality-of-life measures. In a post-hoc subset analysis of patients who were unconscious for more than 1 hour (n = 75) following TBI, the in-hospital group had a greater return-to-duty rate (80% versus 58%; p = 0.05). CONCLUSIONS: In this study, the overall benefit of in-hospital cognitive rehabilitation for patients with moderate-to-severe TBI was similar to that of home rehabilitation. These findings emphasize the importance of conducting randomized trials to evaluate TBI rehabilitation interventions.
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