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Randomized treatment trial in mild traumatic brain injury |
Ghaffar O, McCullagh S, Ouchterlony D, Feinstein A |
Journal of Psychosomatic Research 2006 Aug;61(2):153-160 |
clinical trial |
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine whether multidisciplinary treatment of mild traumatic brain injury (MTBI) improves neurobehavioral outcome at 6 months postinjury. METHODS: Subjects with MTBI were randomly assigned to treatment (n = 97) or nontreatment (control, n = 94) groups. Treated patients were assessed within 1 week of injury and thereafter managed by a multidisciplinary team according to clinical need for a further 6 months. Control subjects were not offered treatment. Six-month outcome measures included: severity of postconcussive symptoms (Rivermead Post-Concussion Disorder Questionnaire), psychosocial functioning (Rivermead Follow-up Questionnaire), psychological distress (General Health Questionnaire), and cognition (neurocognitive battery). RESULTS: Treatment and control subjects were well-matched for demographic and MTBI severity data. In addition, the two groups did not differ on any outcome measure. However, in individuals with preinjury psychiatric difficulties (22.9% of the entire sample), subjects in the treatment group had significantly fewer depressive symptoms 6 months postinjury compared with untreated controls (p = 0.01). CONCLUSIONS: These findings suggest that routine treatment of all MTBI patients offers little benefit; rather, targeting individuals with preinjury psychiatric problems may prove a more rational and cost-effective approach.
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