Developing Core Outcome (Measurement) Sets for Critical Care Research Using the Modified Delphi Method

Sarah L. Gorst PhD , Diana C. Bouhassira MD , Alison E. Turnbull DVM, MPH, PhD
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Abstract

Topic Importance

High-quality core outcome sets (COSs) and core outcome measurement sets (COMSs) can help to optimize research by allowing the results of clinical trials to be compared and combined in systematic reviews. The number of registered COSs and COMSs for critical care research is increasing, and most are developed using the Delphi method. However, the quality of these tools varies substantially.

Review Findings

At least 39 COSs and 10 associated COMSs have been designed for clinical research in critical care and at least 21 ongoing development projects. The Delphi method is the most common method used to foster agreement on the content of a COS or COMS. It is flexible and permits the development process to be tailored to the medical condition and population of interest. However, designing an effective Delphi study requires time and careful deliberation. Clearly defining scope, piloting survey materials, and crafting a consensus process that uses the strengths of each stakeholder group and minimizes loss to follow-up are encouraged. Reporting on COS and COMS development should be sufficiently detailed for readers to understand and critique both the process and the resulting research tool. Established checklists and guidelines are available to assist with both protocol development and peer review of manuscripts reporting on newly generated COSs and COMSs.

Summary

Thorough preliminary work, planning, and reporting increase the likelihood that COSs or COMSs related to critical care will reflect the opinions of knowledgeable stakeholders and will improve the usefulness of clinical trial data.
使用改进的德尔菲法为危重病研究开发核心结果(测量)集
高质量的核心结局集(COSs)和核心结局测量集(COMSs)可以通过在系统评价中比较和合并临床试验结果来帮助优化研究。注册的COSs和重症监护研究COMSs的数量正在增加,大多数是使用德尔菲法开发的。然而,这些工具的质量差别很大。至少有39个COSs和10个相关的COMSs被设计用于危重症护理的临床研究,至少有21个正在进行的开发项目。德尔菲法是促进对COS或COMS内容达成一致的最常用方法。它是灵活的,允许开发过程根据医疗条件和感兴趣的人群进行调整。然而,设计一个有效的德尔菲研究需要时间和仔细的考虑。鼓励明确界定范围,试点调查材料,制定共识过程,利用每个利益相关者群体的优势,并将后续损失最小化。关于COS和COMS开发的报告应该足够详细,以便读者理解和批评过程和最终的研究工具。已建立的核对表和指南可用于协助制定方案和同行审查报告新生成的COSs和COMSs的手稿。全面的前期工作、计划和报告增加了与重症监护相关的COSs或COMSs反映知识渊博的利益相关者意见的可能性,并将提高临床试验数据的有用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CHEST critical care
CHEST critical care Critical Care and Intensive Care Medicine, Pulmonary and Respiratory Medicine
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