Validation of the GetReal Trial Tool – Facilitating discussion and understanding more pragmatic design choices and their implications

The GetReal Trial Tool is a decision support tool to assess the impact of design choices on generalizability of clinical trials to routine clinical practice, while taking into account the risk of bias, precision, acceptability and operational feasibility. This study describes the validation of the G...

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Bibliographic Details
Published in:Contemporary clinical trials 2023-02, Vol.125, p.107054-107054, Article 107054
Main Authors: Boateng, Daniel, Kumke, Thomas, Vernooij, Robin, Goetz, Iris, Meinecke, Anna-Katharina, Steenhuis, Charlotte, Grobbee, Diederick, Zuidgeest, Mira G.P.
Format: Article
Language:English
Subjects:
Clinical Trials as Topic
Decision Support Techniques
GetReal trial tool
Humans
Operational challenges
Pragmatic trials
Real world evidence
Research Design
Trial
Trial decision tool
Trial design
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Summary:The GetReal Trial Tool is a decision support tool to assess the impact of design choices on generalizability of clinical trials to routine clinical practice, while taking into account the risk of bias, precision, acceptability and operational feasibility. This study describes the validation of the GetReal Trial Tool. Twelve experts took part in the GetReal Trial tool validation using the protocols of 6 trials conducted with pragmatic elements. The tool entails 7 domains with a total of 43 questions. A pooled Kappa statistic (95% CI) using random effects model was estimated using Open Meta (analyst) software. The possible operational challenges were collated and discussed with the trialists that conducted the trials. Agreement in the design choices made for the trial protocols was >50% for all the trials and all teams reached consensus during discussion. The pooled Kappa statistic (95% CI) was 0.236 (0.154–0.318). The GetReal Trial tool highlighted several operational challenges, of which almost half had been experienced previously by the trialists. Out of 25 additional operational challenges mentioned by the trialists, 76% were already highlighted by the tool. The tool was considered helpful to optimize trials right from the design stage. The GetReal Trial Tool helps to scrutinize the choice of study design in the light of Real World Evidence generation. The tool identifies most of the operational challenges experienced by trialists to date. The tool serves the intended purpose of facilitating discussion and understanding more pragmatic design choices and their implications. •Pragmatic trials can be a valuable alternative to traditional RCT's or observational research.•The conduct of pragmatic trials comes with challenges at all phases.•Pragmatic trial protocols assessed with the tool provides an overview of trail related challenges.•The GetReal Trial tool helps to scrutinize the choice of design trials in the light of RWE.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2022.107054