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在核心结局集开发中运用定性方法为德尔菲调查提供信息。

The use of qualitative methods to inform Delphi surveys in core outcome set development.

作者信息

Keeley T, Williamson P, Callery P, Jones L L, Mathers J, Jones J, Young B, Calvert M

机构信息

Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England.

Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, England.

出版信息

Trials. 2016 May 4;17(1):230. doi: 10.1186/s13063-016-1356-7.

DOI:10.1186/s13063-016-1356-7
PMID:27142835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4855446/
Abstract

BACKGROUND: Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required. RESULTS: Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified. CONCLUSIONS: Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article.

摘要

背景：核心结局集（COS）有助于减少试验中的偏倚并促进证据综合。德尔菲调查越来越多地被用作达成关于COS应纳入哪些结局的共识的更广泛过程的一部分。定性研究可用于为德尔菲调查的开发提供信息。这是COS开发领域的一项进步，并且具有潜在价值；然而，对于COS开发者而言，关于如何最好地使用定性方法以及存在哪些挑战，几乎没有指导意见。本文旨在就定性研究在该领域的潜在作用和贡献提供早期指导。我们希望我们提出的观点将受到其他探索定性研究在COS开发中的作用的人的挑战、批评和完善。本文借鉴了在三个不同COS开发的德尔菲前阶段使用定性方法的经验。以这些研究为例，我们确定了定性研究可能有助于COS开发的一些方式、使用此类方法的挑战以及未来需要研究的领域。 结果：定性研究有助于确定哪些结局对利益相关者很重要；促进理解为什么某些结局可能比其他结局更重要，确定结局的范围；确定德尔菲调查中使用的适当语言，并为利益相关者数据与其他来源（如系统评价）之间的比较提供信息。开发者在使用定性研究时需要考虑一些方法学要点：具体而言，涉及哪些利益相关者、如何对参与者进行抽样、哪种数据收集方法最合适、如何与利益相关者一起考虑结局以及如何分析这些数据。确定了一些未来研究的领域。 结论：定性研究有可能增强研究界对COS的信心，尽管这将取决于使用严谨和适当的方法。在本文中，我们已经开始确定一些问题供COS开发者在使用定性方法为德尔菲调查的开发提供信息时考虑。

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