medRxiv : the preprint server for health sciences · 2025

INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials.

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Wilkinson Jack, Heal Calvin, Flemyng Ella, Antoniou Georgios A, Aburrow Tony, Alfirevic Zarko, Avenell Alison, Barbour Virginia, Berghella Vincenzo, Bishop Dorothy V M, Bordewijk Esmée M, Brown Nicholas J L, Christopher Jana, Clarke Mike, Dahly Darren, Dennis Jane, Dicker Patrick, Dumville Jo, Frankish Helen, Grey Andrew, Grohmann Steph, Gurrin Lyle C, Hayden Jill A, Heathers James A J, Hunter Kylie E, Hussey Ian, Jung Lukas, Lam Emily, Lasserson Toby J, Lensen Sarah, Li Tianjing, Li Wentao, Liu Jianping, Loder Elizabeth, Lundh Andreas, Meyerowitz-Katz Gideon, Mol Ben W, Naudet Florian, Noel-Storr Anna, O'Connell Neil E, Parker Lisa, Redberg Rita F, Redman Barbara K, Richardson Rachel, Seidler Anna Lene, Sheldrick Kyle, Sydenham Emma, van Wely Madelon, Vorland Colby J, Wang Rui, Weibel Stephanie, Wjst Matthias, Bero Lisa, Kirkham Jamie J

Аннотация

The integrity of evidence synthesis is threatened by problematic randomised controlled trials (RCTs). These are RCTs where there are serious concerns about the trustworthiness of the data or findings. This could be due to research misconduct, including fraud, or due to honest critical errors. If these RCTs are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To address this problem, the INSPECT-SR (INveStigating ProblEmatic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of RCTs. This will allow problematic RCTs to be identified and excluded from systematic reviews. This paper describes the development of INSPECT-SR. The tool and an associated guidance document are presented.

INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials.

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Аннотация