Size and quality of randomised controlled trials in head injury: review of published studies
Size and quality of randomised controlled trials in head injury: review of published studies
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DOI：
10.1136/bmj.320.7245.1308
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发表时间：
2000-05-13
影响因子：
105.7
通讯作者：
Roberts, I
中科院分区：
文献类型：
--
作者：
Dickinson, K;Bunn, F;Roberts, I
目的评估是否在头部损伤的试验是足够大，以避免中度随机误差和设计，以避免中度bias.Design所有随机对照试验的治疗和康复的头部损伤患者在1998年12月之前发表的调查。通过手工检索期刊和会议记录以及联系研究人员，从电子数据库中识别试验。数据被提取的参与者的数量，质量的隐藏分配，使用盲法，后续损失，和类型的参与者，干预措施和结果measures.Results 279报告被确定，包含208个单独的试验的信息。每次试验的平均参与人数为82人，没有证据表明随着时间的推移，参与人数会增加。在203项报告了样本量的试验中，随机化受试者总数为16613人。没有一项试验的规模大到足以可靠地检测到死亡或残疾风险的绝对I降低5%，只有4%的试验的规模大到足以检测到绝对降低10%。在报告的47例患者中，22例的分配隐蔽性充分，25例（23%）不充分或不清楚。在126项评估残疾的试验中，111项报告了随访的患者数量，平均失访率为19%。测量残疾的试验，26（21%）报告说，结果评估是blinding.Conclusions随机试验在头部损伤太小，设计不良，检测或反驳可靠的中度，但临床上重要的好处或危险的治疗有限的资金损伤的研究和不熟悉的问题的同意可能是重要的障碍。
Objective To assess whether trials in head injury are large enough to avoid moderate random errors and designed to avoid moderate biases.Design All randomised controlled trials on the treatment and rehabilitation of patients with head injury published before December 1998 were surveyed. Trials were identified from electronic databases, by hand searching journals and conference proceedings, and by contacting researchers. Data were extracted on the number of participants, quality of concealment of allocation, use of blinding, loss to follow up, and types of participants, interventions, and outcome measures.Results 279 reports were identified, containing information on 208 separate trials. The average number of participants per trial was 82, with no evidence of increasing size over time. The total number of randomised participants in the 203 trials in which size was reported was 16 613. No trials were large enough to detect reliably a 5% absolute I-eduction in the risk of death or disability and only 4% were large enough to detect an absolute reduction of 10%. Concealment of allocation was adequate in 22 and inadequate or unclear in 25 of the 47 (23%) in which it was reported. Of 126 trials assessing disability, 111 reported the number of patients followed up, and average loss to follow up was 19%. Of trials measuring disability, 26 (21%) reported that outcome assessors were blinded.Conclusions Randomised trials in head injury are too small and poorly designed to detect or refute reliably moderate but clinically important benefits or hazards of treatment Limited funding for injury research and unfamiliarity with issues of consent may have been important obstacles.