SynthesisBMC medical research methodology2022
Identification of tools used to assess the external validity of randomized controlled trials in reviews: a systematic review of measurement properties.
Synthesis in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Advancing genetic counselling in Southern Africa: Unveiling opportunities for inclusive healthcare and genomic education for Angola.Saudi medical journal · 2025Pooled it
- Randomized controlled trials comparing gastric bypass, gastric band, and sleeve gastrectomy: A systematic review examining validity and applicability to wider clinical practice.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2024Pooled it
- The Methodological Quality of Studies Investigating the Acute Effects of Exercise During Hypoxia Over the Past 40 years: A Systematic Review.Frontiers in physiology · 2022Pooled it
- Large trials of psychosocial interventions: examples from individual placement and support.International journal of public health · 2026Review
- EU-HTA Guidance for Clinical Validity: Misconceptions and Flawed Processes.Journal of market access & health policy · 2025Article
- Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale.PloS one · 2024Article
- Towards a framework for systematic reviews of the prevalence of exposure to environmental and occupational risk factors.Environmental health : a global access science source · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInternal 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.
methodsA 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.
results38 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).
conclusionsBased 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 registrationProspective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D .
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.