INSPECT-SR tool for assessing trustworthiness of randomised controlled trials
Abstract
The integrity of evidence synthesis is threatened by problematic randomised controlled trials, where there are serious concerns about the trustworthiness of the data or findings. Such concerns could be due to research misconduct, including fraud, or due to honest critical errors. If these trials are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To resolve this problem, the INSPECT-SR (Investigating Problematic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of randomised controlled trials. This tool will help researchers to identify and exclude problematic trials from systematic reviews. This article describes the development of INSPECT-SR and presents the tool and an associated guidance document.
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BibTeX
@article{wilkinson2026inspectsr,
title = {{INSPECT-SR tool for assessing trustworthiness of randomised controlled trials}},
author = {Jack Wilkinson and Lisa Bero and Calvin Heal and Ella Flemyng and Georgios Antoniou and Tony Aburrow and Zarko Alfirevic and Alison Avenell and Virginia Barbour and Vincenzo Berghella and Dorothy Bishop and Esmée Bordewijk and Nicholas Brown and Jana Christopher and Mike Clarke and Darren Dahly and Jane Dennis and Patrick Dicker and Jo Dumville and Helen Frankish and Andrew Grey and Steph Grohmann and Lyle Gurrin and Jill Hayden and James Heathers and Kylie Hunter and Ian Hussey and Lukas Jung and Emily Lam and Toby Lasserson and Sarah Lensen and Tianjing Li and Wentao Li and Jianping Liu and Elizabeth Loder and Andreas Lundh and Gideon Meyerowitz-Katz and Ben Mol and Florian Naudet and Anna Noel-Storr and Neil O'Connell and Lisa Parker and Rita Redberg and Barbara Redman and Rachel Richardson and Anna Lene Seidler and Kyle Sheldrick and Emma Sydenham and Madelon van Wely and Colby Vorland and Rui Wang and Stephanie Weibel and Matthias Wjst and Jamie Kirkham},
journal = {BMJ - British Medical Journal},
year = {2026},
month = sep,
doi = {10.1136/bmj-2026-100611},
url = {https://univ-rennes.hal.science/hal-05796768v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - INSPECT-SR tool for assessing trustworthiness of randomised controlled trials
AU - Jack Wilkinson
AU - Lisa Bero
AU - Calvin Heal
AU - Ella Flemyng
AU - Georgios Antoniou
AU - Tony Aburrow
AU - Zarko Alfirevic
AU - Alison Avenell
AU - Virginia Barbour
AU - Vincenzo Berghella
AU - Dorothy Bishop
AU - Esmée Bordewijk
AU - Nicholas Brown
AU - Jana Christopher
AU - Mike Clarke
AU - Darren Dahly
AU - Jane Dennis
AU - Patrick Dicker
AU - Jo Dumville
AU - Helen Frankish
AU - Andrew Grey
AU - Steph Grohmann
AU - Lyle Gurrin
AU - Jill Hayden
AU - James Heathers
AU - Kylie Hunter
AU - Ian Hussey
AU - Lukas Jung
AU - Emily Lam
AU - Toby Lasserson
AU - Sarah Lensen
AU - Tianjing Li
AU - Wentao Li
AU - Jianping Liu
AU - Elizabeth Loder
AU - Andreas Lundh
AU - Gideon Meyerowitz-Katz
AU - Ben Mol
AU - Florian Naudet
AU - Anna Noel-Storr
AU - Neil O'Connell
AU - Lisa Parker
AU - Rita Redberg
AU - Barbara Redman
AU - Rachel Richardson
AU - Anna Lene Seidler
AU - Kyle Sheldrick
AU - Emma Sydenham
AU - Madelon van Wely
AU - Colby Vorland
AU - Rui Wang
AU - Stephanie Weibel
AU - Matthias Wjst
AU - Jamie Kirkham
PY - 2026
DA - 2026/09/24
JO - BMJ - British Medical Journal
DO - 10.1136/bmj-2026-100611
UR - https://univ-rennes.hal.science/hal-05796768v1
AB - The integrity of evidence synthesis is threatened by problematic randomised controlled trials, where there are serious concerns about the trustworthiness of the data or findings. Such concerns could be due to research misconduct, including fraud, or due to honest critical errors. If these trials are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To resolve this problem, the INSPECT-SR (Investigating Problematic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of randomised controlled trials. This tool will help researchers to identify and exclude problematic trials from systematic reviews. This article describes the development of INSPECT-SR and presents the tool and an associated guidance document.
SN - 1756-1833
ER -