INSPECT-SR tool for assessing trustworthiness of randomised controlled trials
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.
Authors
- George Athanasios Antoniou (ORCID: https://orcid.org/0000-0001-8209-0406)
- Andreas Lundh (ORCID: https://orcid.org/0000-0002-4982-8680)
- Lisa Parker (ORCID: https://orcid.org/0000-0001-8635-6953)
- Ella Flemyng (ORCID: https://orcid.org/0000-0002-9845-9076)
- Darren Lawrence Dahly (ORCID: https://orcid.org/0000-0003-0110-324X)
- Dorothy Bishop (ORCID: https://orcid.org/0000-0002-2448-4033)
- Alison Avenell (ORCID: https://orcid.org/0000-0003-4813-5628)
- Kyle Alexander Sheldrick (ORCID: https://orcid.org/0000-0002-2198-8025)
- Andrew B. Grey (ORCID: https://orcid.org/0000-0002-7803-0096)
- Madelon van Wely (ORCID: https://orcid.org/0000-0001-8263-213X)
- Ian Hussey (ORCID: https://orcid.org/0000-0001-8906-7559)
- Calvin Heal (ORCID: https://orcid.org/0000-0002-6445-1551)
- Kylie E Hunter (ORCID: https://orcid.org/0000-0002-2796-9220)
- Žarko Alfirević (ORCID: https://orcid.org/0000-0001-9276-518X)
- Steph Grohmann (ORCID: https://orcid.org/0000-0001-5640-1688)
- Jo C Dumville (ORCID: https://orcid.org/0000-0002-6546-3685)
- Sarah F. Lensen (ORCID: https://orcid.org/0000-0002-1694-1142)
- Jana Christopher (ORCID: https://orcid.org/0000-0002-2699-3368)
- Anna H Noel-Storr (ORCID: https://orcid.org/0000-0003-3476-8432)
- Nicholas J. L. Brown (ORCID: https://orcid.org/0000-0003-1579-0730)
- Lyle C. Gurrin (ORCID: https://orcid.org/0000-0001-7052-1969)
- Lisa Anne Bero (ORCID: https://orcid.org/0000-0003-1893-6651)
- Jack Dale Wilkinson (ORCID: https://orcid.org/0000-0003-3513-4677)
- Emily Lam (ORCID: https://orcid.org/0000-0002-1931-2691)
- Jill Alison Hayden (ORCID: https://orcid.org/0000-0001-7026-144X)
- Emma Sydenham (ORCID: https://orcid.org/0000-0002-1471-4237)
- Elizabeth Loder (ORCID: https://orcid.org/0000-0003-1501-2947)
- Virginia M. Barbour (ORCID: https://orcid.org/0000-0002-2358-2440)
- Rachel Richardson (ORCID: https://orcid.org/0000-0003-2848-6260)
- Anna Lene Seidler (ORCID: https://orcid.org/0000-0002-0027-1623)
- Stephanie Weibel (ORCID: https://orcid.org/0000-0003-1900-2535)
- Patrick Dicker (ORCID: https://orcid.org/0000-0002-7942-9314)
- Esmée M Bordewijk (ORCID: https://orcid.org/0000-0001-7983-1613)
- Toby J Lasserson (ORCID: https://orcid.org/0000-0001-9638-2856)
- Vincenzo Berghella (ORCID: https://orcid.org/0000-0003-2854-0239)
- Matthias Wjst (ORCID: https://orcid.org/0000-0002-4974-5631)
- James A. J. Heathers (ORCID: https://orcid.org/0000-0002-0936-026X)
- Jamie J Kirkham (ORCID: https://orcid.org/0000-0003-2579-9325)
- Mike J Clarke (ORCID: https://orcid.org/0000-0002-2926-7257)
- Tianjing Li (ORCID: https://orcid.org/0000-0001-5371-4558)
- Colby J. Vorland (ORCID: https://orcid.org/0000-0003-4225-372X)
- Gideon Meyerowitz‐Katz (ORCID: https://orcid.org/0000-0002-1156-9345)
- Florian Naudet (ORCID: https://orcid.org/0000-0003-3760-3801)
- Barbara K. Redman (ORCID: https://orcid.org/0000-0001-5119-9898)
- Jane A Dennis (ORCID: https://orcid.org/0000-0001-9718-2653)
- Rita F. Redberg (ORCID: https://orcid.org/0000-0001-6281-0250)
- Neil Edward O'Connell (ORCID: https://orcid.org/0000-0003-1989-4537)
- Ben W. Mol (ORCID: https://orcid.org/0000-0001-8337-550X)
- Rui Wang (ORCID: https://orcid.org/0009-0005-1237-6376)
- Jianping Liu (ORCID: https://orcid.org/0000-0002-0320-061X)
- Wentao Li (ORCID: https://orcid.org/0000-0001-8980-0909)
- Helen Frankish
- Tony Aburrow
- Lukas Jung
Institutions
- University of Bern (CH)
- Queen's University Belfast (GB)
- The University of Sydney (AU)
- Dalhousie University (CA)
- Capital District Health Authority (CA)
- Royal Women's Hospital (AU)
- Harvard University (US)
- Royal College of Surgeons in Ireland (IE)
- University of Liverpool (GB)
- Thomas Jefferson University (US)
- University of Auckland (NZ)
- Inserm (FR)
- Queensland University of Technology (AU)
- The University of Melbourne (AU)
- Beijing University of Chinese Medicine (CN)
- University of Southern Denmark (DK)
- University of Aberdeen (GB)
- University of Wollongong (AU)
- Linnaeus University (SE)
- University College Cork (IE)
- Ludwig Boltzmann Gesellschaft (AT)
- Manchester Academic Health Science Centre (GB)
- Frederiksberg Hospital (DK)
- Odense University Hospital (DK)
- Nova Scotia Health Authority (CA)
- University of Manchester (GB)
- UNSW Sydney (AU)
- University of Bristol (GB)
- University of Oxford (GB)
- Manchester University NHS Foundation Trust (GB)
- Helicon Foundation (US)
- Institut de Recherche en Santé, Environnement et Travail (FR)
- Indiana University Bloomington (US)
- Universitätsklinikum Würzburg (DE)
- Primary Health Care (QA)
- National Centre for Clinical Research on Emerging Drugs (AU)
- Institut de Médecine de la Reproduction (FR)
- Cochrane (DK)
- Amsterdam University Medical Centers (NL)
- National Health and Medical Research Council (AU)
- University of Rostock (DE)
- University of Colorado Anschutz Medical Campus (US)
- Indiana University – Purdue University Indianapolis (US)
- Université de Rennes (FR)
- Monash University (AU)
- New York University (US)
- Brunel University of London (GB)
- Technical University of Munich (DE)
- Cochrane (GB)
- University of Amsterdam (NL)
Publication Details
- Journal
- BMJ
- Published
- 2026-09-24
- DOI
- https://doi.org/10.1136/bmj-2026-100611
- Primary Topic
- Meta-analysis and systematic reviews
- Type
- article
- Field-Weighted Citation Impact
- 0.00