Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.
Journal: BMJ open
Volume: 14
Issue: 3
Year of Publication: 2024
Affiliated Institutions:
Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK jack.wilkinson@manchester.ac.uk.
Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Manchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Evidence Production and Methods Directorate, Cochrane, London, UK.
Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Medical Journal of Australia, Sydney, New South Wales, Australia.
Department of Psychology, Linnaeus University, Växjö, Sweden.
Anaesthesia and Critical Care, Torbay Hospital, Torquay, UK.
Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.
Department of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, Ireland.
Division of Nursing, Midwifery and Social Work, School of Health Sciences, The University of Manchester, Manchester, UK.
Department of Medicine, University of Auckland, Auckland, New Zealand.
School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada.
SafeBeat Rx Inc, St Louis, Missouri, USA.
Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Independent Lay Member, Cheshire, UK.
Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
Department of Ophthalmology, University of Colorado, Denver, Colorado, USA.
Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.
BMJ Publishing, London, UK.
Centre of Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.
Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.
Department of Clinical Science, Brunel University, Uxbridge, UK.
School of Pharmacy, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.
Division of Medical Ethics, New York University Grossman School of Medicine, New York, New York, USA.
Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Cochrane Central Production Service, Cochrane, London, UK.
York Trials Unit, Dept of Health Sciences, University of York, York, UK.
Cochrane Gynaecology and Fertility Satellite and Cochrane Sexually Transmitted Infection Group, Cochrane, Duivendrecht, The Netherlands.
Center for Bioethics and Humanities, University of Colorado-Anschutz Medical Campus, Denver, Colorado, USA.
Abstract summary
Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.
Authors & Co-authors:
Wilkinson
Heal
Antoniou
Flemyng
Alfirevic
Avenell
Barbour
Brown
Carlisle
Clarke
Dicker
Dumville
Grey
Grohmann
Gurrin
Hayden
Heathers
Hunter
Lasserson
Lam
Lensen
Li
Li
Loder
Lundh
Meyerowitz-Katz
Mol
O'Connell
Parker
Redman
Seidler
Sheldrick
Sydenham
Torgerson
van Wely
Wang
Bero
Kirkham
Study Outcome
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