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2025 · Preprint · medRxiv : the preprint server for health sciences

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

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

Describes development of INSPECT-SR, a structured assessment tool and guidance for checking the trustworthiness of randomized trials considered for systematic reviews.

Preprint; this version has not been peer reviewed.

Open-science resources

Resource verification & source notes
  • Free full text (PMC): The complete article body was retrieved from the public NCBI PMC JATS endpoint. This confirms free access; reuse permissions depend on the individual article license.
  • Preprint: PubMed identifies this record as a preprint and PMC serves its full manuscript.
  • INSPECT-SR guidance: Concept record resolves to version21908737 containing INSPECT-SR-Guidance.pdf and ianhussey/inspect-sr-guidance-v1.1.2.zip; this verifies guidance, not trial-level data.

Publication details

Research themes

Research integrity

clinical-trials · evidence-synthesis

Author affiliations & identifiers
  • Jack Wilkinson: Centre for Biostatistics, Manchester Academic Health Science Centre, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK. · ORCID 0000-0003-3513-4677
  • Calvin Heal: Centre for Biostatistics, Manchester Academic Health Science Centre, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK.
  • Ella Flemyng: Cochrane Central Executive, London, UK.
  • Georgios A Antoniou: Manchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK.; Division of Cardiovascular Sciences, School of Medical Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
  • Tony Aburrow: Cochrane Central Executive, London, UK.
  • Zarko Alfirevic: University of Liverpool, UK.
  • Alison Avenell: Aberdeen Centre for Evaluation, University of Aberdeen, UK.
  • Virginia Barbour: Medical Journal of Australia and Faculty of Health, Queensland University of Technology, Brisbane, Australia.
  • Vincenzo Berghella: Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, USA.
  • Dorothy V M Bishop: Department of Experimental Psychology, University of Oxford, UK.
  • Esmée M Bordewijk: Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
  • Nicholas J L Brown: Department of Psychology, Linnaeus University, Sweden.
  • Jana Christopher: FEBS Press, Heidelberg, Germany.
  • Mike Clarke: Centre for Public Health, Queen's University Belfast, Belfast, UK.
  • Darren Dahly: HRB Clinical Research Facility, School of Public Health, University College Cork, Cork, Ireland. · ORCID 0000-0003-0110-324X
  • Jane Dennis: University of Bristol, UK.
  • Patrick Dicker: Department of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Ireland.
  • Jo Dumville: School of Health Sciences, University of Manchester, Manchester, UK.
  • Helen Frankish: The Lancet, London, UK.
  • Andrew Grey: University of Auckland, Auckland, New Zealand.
  • Steph Grohmann: Research Integrity Editor, Cochrane, London, UK.
  • Lyle C Gurrin: School of Population and Global Health, The University of Melbourne.
  • Jill A Hayden: Department of Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada.; Novia Scotia Health, Halifax, Nova Scotia, Canada.
  • James A J Heathers: Medical Evidence Project, Center for Scientific Integrity, NY, USA.
  • Kylie E Hunter: NHMRC Clinical Trials Centre, University of Sydney, Australia. · ORCID 0000-0002-2796-9220
  • Ian Hussey: Institute of Psychology, University of Bern, Switzerland. · ORCID 0000-0001-8906-7559
  • Lukas Jung: Independent researcher, Heidelberg, Germany. · ORCID 0009-0007-9174-1494
  • Emily Lam: Independent Lay Member, Unaffiliated, Cheshire, UK.
  • Toby J Lasserson: Cochrane Central Executive, London, UK.
  • Sarah Lensen: Department of Obstetrics, Gynaecology and Newborn Health, Royal Women's Hospital, University of Melbourne, Australia.
  • Tianjing Li: Department of Ophthalmology, University of Colorado Anschutz Medical Campus, USA.
  • Wentao Li: National Perinatal Epidemiology and Statistics Unit, Centre for Big Data Research in Health and School of Clinical Medicine, The University of New South Wales, Sydney, Australia.
  • Jianping Liu: Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China. · ORCID 0000-0002-0320-061X
  • Elizabeth Loder: The BMJ, UK.; Harvard Medical School, Boston, MA, USA.
  • Andreas Lundh: Cochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark .; Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark.
  • Gideon Meyerowitz-Katz: University of Woolongong, NSW, Australia.
  • Ben W Mol: Department of Obstetrics Gynaecology, Monash University, Melbourne, Australia.
  • Florian Naudet: Univ Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S, Rennes, France.; Institut Universitaire de France (IUF), Paris, France. · ORCID 0000-0003-3760-3801
  • Anna Noel-Storr: Cochrane Central Executive, London, UK.
  • Neil E O'Connell: Department of Health Sciences, Centre for Health and Wellbeing Across the Lifecourse, Brunel University of London, United Kingdom. · ORCID 0000-0003-1989-4537
  • Lisa Parker: Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Australia.
  • Rita F Redberg: Department of Medicine, UCSF Philip Lee Institute for Health Policy Studies, USA.
  • Barbara K Redman: New York University Grossman School of Medicine, New York, USA.
  • Rachel Richardson: Cochrane Central Executive, London, UK.
  • Anna Lene Seidler: Department of Child and Adolescent Psychiatry, University Medical Centre Rostock, Rostock, Germany; German Center for Child and Adolescent Health (DZKJ), partner site Greifswald/Rostock, Rostock, Germany.
  • Kyle Sheldrick: Spine Labs, Faculty of Clinical Medicine, University of New South Wales.
  • Emma Sydenham: Cochrane Central Editorial Service, London, UK.
  • Madelon van Wely: Centre for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, Amsterdam, The Netherlands.
  • Colby J Vorland: Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, USA.
  • Rui Wang: NHMRC Clinical Trials Centre, University of Sydney, Australia.
  • Stephanie Weibel: University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Würzburg, Germany.
  • Matthias Wjst: Institut für KI und Informatik in der Medizin, Lehrstuhl für Medizinische Informatik, Klinikum rechts der Isar, Grillparzerstr. 18, D-81675 München, Germany.
  • Lisa Bero: Center for Bioethics, and Humanities, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Jamie J Kirkham: Centre for Biostatistics, Manchester Academic Health Science Centre, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK. · ORCID 0000-0003-2579-9325

Versions & associated materials

These items belong to this research work. Their individual titles, author lists, and source identifiers are preserved below.

INSPECT-SR Guidance

Guidance · 2026 · Zenodo

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

DOI: 10.5281/zenodo.21905597

Related materials

Source notes
  • CV abbreviates the ordered author list with ellipses; replace with complete authoritative list before displaying full authors.

Metadata sources: PubMed, OpenAlex, CV, Google Scholar. Classification is an editorial interpretation of the title, abstract, and supplied CV.