Gargon Elizabeth, Williamson Paula R, Young Bridget
Department of Biostatistics, MRC NWHTMR, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL.
Department of Psychology, Health and Society, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool L69 3GB.
J Clin Epidemiol. 2017 Jun;86:140-152. doi: 10.1016/j.jclinepi.2017.04.024. Epub 2017 May 8.
The objective of the study was to explore core outcome set (COS) developers' experiences of their work to inform methodological guidance on COS development and identify areas for future methodological research.
Semistructured, audio-recorded interviews with a purposive sample of 32 COS developers. Analysis of transcribed interviews was informed by the constant comparative method and framework analysis.
Developers found COS development to be challenging, particularly in relation to patient participation and accessing funding. Their accounts raised fundamental questions about the status of COS development and whether it is consultation or research. Developers emphasized how the absence of guidance had affected their work and identified areas where guidance or evidence about COS development would be useful including, patient participation, ethics, international development, and implementation. They particularly wanted guidance on systematic reviews, Delphi, and consensus meetings.
The findings raise important questions about the funding, status, and process of COS development and indicate ways that it could be strengthened. Guidance could help developers to strengthen their work, but over specification could threaten quality in COS development. Guidance should therefore highlight common issues to consider and encourage tailoring of COS development to the context and circumstances of particular COS.
本研究的目的是探讨核心结局集（COS）开发者的工作经历，以为COS开发的方法学指导提供信息，并确定未来方法学研究的领域。
对32名COS开发者进行了有目的抽样的半结构化录音访谈。采用持续比较法和框架分析法对访谈转录本进行分析。
开发者发现COS开发具有挑战性，尤其是在患者参与和获取资金方面。他们的描述引发了关于COS开发地位以及它是咨询还是研究的基本问题。开发者强调了缺乏指导对他们工作的影响，并确定了关于COS开发的指导或证据会有用的领域，包括患者参与、伦理、国际开发和实施。他们特别希望得到关于系统评价、德尔菲法和共识会议的指导。
研究结果提出了关于COS开发的资金、地位和过程的重要问题，并指出了可以加强它的方法。指导可以帮助开发者加强他们的工作，但过度规范可能会威胁到COS开发的质量。因此，指导应突出需要考虑的常见问题，并鼓励根据特定COS的背景和情况对COS开发进行调整。
