Reviewgold2022

Identification of tools used to assess the external validity of randomized controlled trials in reviews: a systematic review of measurement properties

Andrés Jung · Julia Balzer · Tobias Braun · Kerstin Luedtke

24 citations0/0 files storedBMC Medical Research Methodology

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Meta-analysis and systematic reviews Health Education and Validation Delphi Technique in Research

Abstract

BACKGROUND: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of the terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs. It was further, to evaluate the quality of identified tools and to recommend the use of individual tools to assess the external validity of RCTs in future systematic reviews. METHODS: A two-phase systematic literature search was performed in four databases: PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies investigating the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. RESULTS: 38 publications reporting on the development or validation of 28 included tools were included. For 61% (17/28) of the included tools, there was no evidence for measurement properties. For the remaining tools, reliability was the most frequently assessed property. Reliability was judged as "sufficient" for three tools (very low certainty of evidence). Content validity was rated as "sufficient" for one tool (moderate certainty of evidence). CONCLUSIONS: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a better suitable tool. TRIAL REGISTRATION: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D .

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References

2016Rayyan—a web and mobile app for systematic reviews 2021PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews 2010CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials 1998The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.2010The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes 2010The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study 2020JBI Manual for Evidence Synthesis 2018COSMIN guideline for systematic reviews of patient-reported outcome measures

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