Challenging issues in randomised controlled trials
Challenging issues in randomised controlled trials
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DOI：
10.1016/j.injury.2010.03.033
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发表时间：
2010-07-01
影响因子：
2.5
通讯作者：
Cooper, D. J.
中科院分区：
文献类型：
--
作者：
Nichol, A. D.;Bailey, M.;Cooper, D. J.
本主题内容：随机对照试验（RCT）是确定治疗与结果之间是否存在因果关系的最严谨方法，是指导当前临床实践的证据等级体系的一个组成部分。无论是确保一项随机对照试验的成功，还是解读医学文献，了解随机对照试验设计的关键要素以评估其质量，进而确定应给予其研究结果的权重都很重要。本文将通过莫纳什大学澳大利亚和新西兰重症监护研究中心正在协调的一些创伤研究来强调其中的一些关键要素。
常见问题与挑战：许多随机对照试验的质量可以通过避免一些常见的陷阱来提高，例如（i）假设不明确和目标过多，（ii）终点选择不当，（iii）受试者选择标准不合适，（iv）治疗/干预方案与临床无关或不可行，（v）随机化、分层、设盲不充分，（vi）小型随机对照试验中缺乏分层，（vii）试验设盲不充分，（viii）样本量/检验效能不足，（ix）未使用意向性治疗分析，以及（x）未能预见到在进行随机对照试验过程中遇到的常见实际问题。
给研究人员的建议：最有可能获得资助和/或高质量的随机对照试验总是会解决这些问题。（C）2010爱思唯尔有限公司。保留所有权利。
What this topic is about: Randomised controlled trials (RCTs) are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and are an integral component in the hierarchy of evidence which guide current clinical practice. Whether ensuring the success of a RCT or interpreting the medical literature, it is important to understand the key components of RCT design to assess their quality and therefore the weight which should be attributed to its findings. This article will highlight some of these key components by using a number of ongoing trauma studies being coordinated by the Australian and New Zealand Intensive Care Research Centre, Monash University.Common problems and challenges: The quality of many RCTs could be improved by avoiding some common pitfalls, such as (i) unclear hypotheses and multiple objectives, (ii) poor selection of endpoints, (iii) inappropriate subject selection criteria, (iv) non-clinically relevant or feasible treatment/intervention regimens, (v) inadequate randomisation, stratification, blinding, (vi) lack of stratification in small RCTs (vii) inadequate blinding of trials, (viii) insufficient sample size/power, (ix) failure to use intention to treat analysis and (x) failure to anticipate common practical problems encountered during the conduct of a RCT.Tips for researchers: The RCTs most likely to be funded and/or be of high quality always address these issues. (C) 2010 Elsevier Ltd. All rights reserved.