Consensus on the definition and assessment of external validity of randomized controlled trials: A Delphi study

IF 5 2区 生物学 Q1 MATHEMATICAL & COMPUTATIONAL BIOLOGY Research Synthesis Methods Pub Date : 2023-12-25 DOI:10.1002/jrsm.1688
Andres Jung, Tobias Braun, Susan Armijo-Olivo, Dimitris Challoumas, Kerstin Luedtke
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Abstract

External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack of consensus in this field. The objective of this study was to reach consensus on a definition of external validity and on criteria to assess the external validity of RCTs included in systematic reviews. A three-round online Delphi study was conducted. The development of the Delphi survey was based on findings from a previous systematic review. Potential panelists were identified through a comprehensive web search. Consensus was reached when at least 67% of the panelists agreed to a proposal. Eighty-four panelists from different countries and various disciplines participated in at least one round of this study. Consensus was reached on the definition of external validity (“External validity is the extent to which results of trials provide an acceptable basis for generalization to other circumstances such as variations in populations, settings, interventions, outcomes, or other relevant contextual factors”), and on 14 criteria to assess the external validity of RCTs in systematic reviews. The results of this Delphi study provide a consensus-based reference standard for future tool development. Future research should focus on adapting, pilot testing, and validating these criteria to develop measurement tools for the assessment of external validity.

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关于随机对照试验外部有效性的定义和评估的共识:德尔菲研究。
外部效度是健康研究决策中需要考虑的一个重要参数,但目前还没有被广泛接受的随机对照试验(RCT)外部效度评估工具。创建此类工具的最大限制因素之一可能是该领域存在大量异质性且缺乏共识。本研究的目的是就外部有效性的定义以及评估系统综述中随机对照试验外部有效性的标准达成共识。我们进行了三轮在线德尔菲研究。德尔菲调查是根据之前的系统综述结果制定的。通过全面的网络搜索确定了潜在的专家组成员。当至少 67% 的专家组成员同意一项建议时,即达成共识。来自不同国家和不同学科的 84 位专家组成员至少参与了一轮研究。我们就外部效度的定义("外部效度是指试验结果在多大程度上为推广到其他情况(如人群、环境、干预措施、结果或其他相关背景因素的变化)提供了可接受的基础")以及系统综述中评估 RCT 外部效度的 14 项标准达成了共识。这项德尔菲研究的结果为今后的工具开发提供了一个基于共识的参考标准。未来的研究应侧重于调整、试点测试和验证这些标准,以开发用于评估外部有效性的测量工具。
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来源期刊
Research Synthesis Methods
Research Synthesis Methods MATHEMATICAL & COMPUTATIONAL BIOLOGYMULTID-MULTIDISCIPLINARY SCIENCES
CiteScore
16.90
自引率
3.10%
发文量
75
期刊介绍: Research Synthesis Methods is a reputable, peer-reviewed journal that focuses on the development and dissemination of methods for conducting systematic research synthesis. Our aim is to advance the knowledge and application of research synthesis methods across various disciplines. Our journal provides a platform for the exchange of ideas and knowledge related to designing, conducting, analyzing, interpreting, reporting, and applying research synthesis. While research synthesis is commonly practiced in the health and social sciences, our journal also welcomes contributions from other fields to enrich the methodologies employed in research synthesis across scientific disciplines. By bridging different disciplines, we aim to foster collaboration and cross-fertilization of ideas, ultimately enhancing the quality and effectiveness of research synthesis methods. Whether you are a researcher, practitioner, or stakeholder involved in research synthesis, our journal strives to offer valuable insights and practical guidance for your work.
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