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, 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
Centre for Biostatistics, Manchester Academic Health Science Centre, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK.
Cochrane Central Executive, London, UK.
medRxiv. 2025 Sep 5:2025.09.03.25334905. doi: 10.1101/2025.09.03.25334905.
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.
存在问题的随机对照试验（RCT）会威胁证据综合的完整性。这些RCT在数据或研究结果的可信度方面存在严重问题。这可能是由于包括欺诈在内的研究不当行为，或者是由于诚实的严重错误。如果这些RCT未被发现，它们可能会被无意中纳入系统评价和指南中，从而可能扭曲其结果。为了解决这个问题，已经开发了INSPECT-SR（在系统评价中调查有问题的临床试验）工具来评估RCT的可信度。这将使有问题的RCT能够被识别并从系统评价中排除。本文描述了INSPECT-SR的开发过程。还介绍了该工具及相关指导文件。
