Williamson Paula R, Barrington Heather, Blazeby Jane M, Clarke Mike, Gargon Elizabeth, Gorst Sarah, Saldanha Ian J, Tunis Sean
Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.
Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.
J Clin Epidemiol. 2022 Oct;150:154-164. doi: 10.1016/j.jclinepi.2022.06.016. Epub 2022 Jun 30.
To review evidence about the uptake of core outcome sets (COS). A COS is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in a specific area of health or healthcare.
This article provides an analysis of what is known about the uptake of COS in research. Similarities between COS and outcomes recommended by stakeholders in the evidence ecosystem is reviewed and actions taken by them to facilitate COS uptake described.
COS uptake is low in most research areas. Common facilitators relate to trialist awareness and understanding. Common barriers were not including in the development process all specialties that might use the COS and the lack of recommendations for how to measure the outcomes. Increasingly, COS developers are considering strategies for promoting uptake earlier in the process, including actions beyond traditional dissemination approaches. An overlap between COS and outcomes in regulatory documents and health technology assessments is good. An increasing number and variety of organizations are recommending COS be considered.
We suggest actions for various stakeholders for improving COS uptake. Research is needed to assess the impact of these actions to identify effective evidence-based strategies.
回顾关于核心结局集(COS)采用情况的证据。核心结局集是一组商定的标准化结局,在特定健康或医疗领域的所有临床试验中,至少都应予以测量和报告。
本文分析了研究中关于核心结局集采用情况的已知信息。回顾了核心结局集与证据生态系统中利益相关者推荐的结局之间的相似性,并描述了他们为促进核心结局集的采用而采取的行动。
在大多数研究领域,核心结局集的采用率较低。常见的促进因素与试验者的意识和理解有关。常见的障碍包括在开发过程中未纳入可能使用该核心结局集的所有专业,以及缺乏关于如何测量结局的建议。越来越多,核心结局集开发者正在考虑在过程早期促进采用的策略,包括超越传统传播方法的行动。核心结局集与监管文件及卫生技术评估中的结局存在重叠是有益的。越来越多不同类型的组织建议考虑使用核心结局集。
我们为不同利益相关者提出了提高核心结局集采用率的行动建议。需要开展研究以评估这些行动的影响,从而确定有效的循证策略。