Affiliations: [a] Department of Family Medicine, Faculty of Medicine, Health Sciences Centre, University of Calgary, Calgary, AB, Canada | [b] CEREBRO – Brain Health Center, Braga, Portugal | [c] Tom Baker Cancer Centre, Alberta Health Services, Calgary, AB, Canada | [d] Instituto de Psicologia e Ciências da Educação, Universidade Lusíada – Norte (Porto), Porto, Portugal
Correspondence:
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Corresponding author: Roger E. Thomas, Department of Family Medicine, Faculty of Medicine, Health Sciences Centre, 3330 Hospital Drive NW, University of Calgary, Calgary, AB T2N 4N1, Canada. Tel.: +1 403 210 9208; E-mail: rthomas@ucalgary.ca.
Abstract: Background:Assessment of therapies for the key consequences of mild traumatic brain injury (mTBI)/concussion is required. Objective:Identify all RCTs of mTBI/concussion therapy, risks of bias, and therapies with significant positive results. Methods:17 electronic, 9 grey-literature databases searched without language/date restrictions; independent assessment of 1450 Abstracts/titles, 141 fulltext articles, 14 included RCTs. Results:Four RCTs used American Congress of Rehabilitation TBI definition, others used unique definitions. Risk of bias: 43% low risk randomization; 14% concealed assignments; 21% blinded participants/personnel; 57% blinded assessors; 64% low risk attrition; 100% no selective reporting. Eleven RCTs included only mTBI. Ten significant positive results: six cognitive behavioral therapy (CBT), three videotape, pagers or personal digital assistants, and one physical therapy. One of referrals to health professionals no significant positive results. Three RCTs included both mTBI and moderate TBI. We wished to assess if authors proved using same interventions with both groups is appropriate. Two used CBT, one used pagers. All three RCTs significant positive results but results for their mild and moderate TBI patients were not separated. Two RCTs assessed return to work and no differences between intervention. Conclusion:Of 14 RCTs, six CBT, four digital assistants or videotape feedback and one physical therapy all had significant positive results. One referred patients to consultants and no significant positive results. Two assessed return to employment and no differences between interventions. Limitations are: (1) only four RCTs used the same concussion definition; (2) average age 38 (except for one study of adolescents, (3) all studies used unique interventions; (4) most authors used multiple interventions and effects could not be separated; (5) substantial attrition from eligibles to randomization, (4) only 64% at low risk from randomization, (5) 80 different outcome measures and meta-analysis was not possible, (6) only two studies assessed return to work.
