Developing core outcome sets for clinical trials: issues to consider.
Developing core outcome sets for clinical trials: issues to consider.
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DOI：
10.1186/1745-6215-13-132
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发表时间：
2012-08-06
期刊：
影响因子：
2.5
通讯作者：
Tugwell P
中科院分区：
文献类型：
--
作者：
Williamson PR;Altman DG;Blazeby JM;Clarke M;Devane D;Gargon E;Tugwell P
在设计临床试验时，选择适当的结果或领域至关重要，以便以最小化偏倚的方式直接比较不同干预措施的效果。如果研究结果要影响政策和实践，那么所选择的结果需要对关键利益相关者（包括患者和公众、医疗保健专业人员和其他医疗保健决策者）具有相关性和重要性。越来越多的人认识到，临床试验中测量的结果没有得到足够的重视。这些问题可以通过开发和使用商定的标准化结局集合来解决，称为核心结局集，在特定临床领域的所有试验中，至少应测量和报告核心结局集。这一领域的工作不断积累，已确定有必要为核心成果集的制定提供一般性指导。在制定一套核心成果时要考虑的关键问题包括其范围、参与的利益攸关方群体、协商一致方法的选择和达成共识。
The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.
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