Thomas Roger E, Alves Jorge, Vaska Mlis Marcus M, Magalhaes Rosana
Department of Family Medicine, Faculty of Medicine, Health Sciences Centre, University of Calgary, Calgary, AB, Canada.
CEREBRO - Brain Health Center, Braga, Portugal.
Restor Neurol Neurosci. 2017;35(6):643-666. doi: 10.3233/RNN-170761.
Assessment of therapies for the key consequences of mild traumatic brain injury (mTBI)/concussion is required.
Identify all RCTs of mTBI/concussion therapy, risks of bias, and therapies with significant positive results.
17 electronic, 9 grey-literature databases searched without language/date restrictions; independent assessment of 1450 Abstracts/titles, 141 fulltext articles, 14 included RCTs.
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.
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.
需要对轻度创伤性脑损伤（mTBI）/脑震荡的关键后果的治疗方法进行评估。
识别所有mTBI/脑震荡治疗的随机对照试验（RCT）、偏倚风险以及有显著阳性结果的治疗方法。
检索17个电子数据库和9个灰色文献数据库，无语言/日期限制；对1450篇摘要/标题、141篇全文文章进行独立评估，纳入14项RCT。
4项RCT采用美国康复医学会脑损伤定义，其他采用独特定义。偏倚风险：43%随机化低风险；14%分配隐藏；21%参与者/人员设盲；57%评估者设盲；64%失访低风险；100%无选择性报告。11项RCT仅纳入mTBI。10项有显著阳性结果：6项认知行为疗法（CBT）、3项录像带、传呼机或个人数字助理，1项物理治疗。转诊至医疗专业人员的一项无显著阳性结果。3项RCT纳入mTBI和中度TBI。我们希望评估作者证明两组使用相同干预措施是否合适。2项使用CBT，1项使用传呼机。所有3项RCT均有显著阳性结果，但轻度和中度TBI患者的结果未分开。2项RCT评估了重返工作情况，干预措施之间无差异。
在14项RCT中，6项CBT、4项数字助理或录像带反馈以及1项物理治疗均有显著阳性结果。1项将患者转诊至顾问处，无显著阳性结果。2项评估了重返工作情况，干预措施之间无差异。局限性在于：（1）仅4项RCT使用相同的脑震荡定义；（2）平均年龄38岁（除一项青少年研究外）；（3）所有研究使用独特的干预措施；（4）大多数作者使用多种干预措施，效果无法分开；（5）从符合条件到随机分组有大量失访，（4）随机化低风险仅64%，（5）80种不同的结局测量指标，无法进行荟萃分析，（6）仅2项研究评估了重返工作情况。
