Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions
Elizabeth Loder,
Jill Alison Hayden,
David Torgerson,
Tianjing Li,
Wentao Li,
Rui Wang,
Ben W Mol,
Lisa Bero,
Jamie J Kirkham,
Lisa Parker,
Mike Clarke,
Jo C Dumville,
Calvin Heal,
Lyle Gurrin,
Andreas Lundh,
Madelon van Wely,
Toby Lasserson,
Alison Avenell,
Neil E O'Connell,
Andrew Grey,
Jack Wilkinson,
George A Antoniou,
Kylie Elizabeth Hunter,
Patrick Dicker,
Zarko Alfirevic,
Ella Flemyng,
Sarah Lensen,
Emma Sydenham,
Ginny Barbour,
Emily Lam,
Gideon Meyerowitz-Katz,
James Heathers,
Nicholas J L Brown,
John Carlisle,
Steph Grohmann,
Barbara K Redman,
Lene Seidler,
Kyle A Sheldrick
Affiliations
Elizabeth Loder
The BMJ
Jill Alison Hayden
Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
David Torgerson
York Trials Unit, Dept of Health Sciences, University of York, York, UK
Tianjing Li
associate professor
Wentao Li
1The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Rui Wang
Department of Radiology, Peking University First Hospital, Beijing, China
Ben W Mol
4 Obstetrics and Gynecology, Monash Medical School, Clayton, Victoria, Australia
Lisa Bero
University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
Jamie J Kirkham
Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
Lisa Parker
13 Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia
Mike Clarke
professor
Jo C Dumville
Division of Nursing, Midwifery and Social Work, School of Health Sciences, The University of Manchester, Manchester, UK
Calvin Heal
7 Centre for Biostatistics, University of Manchester, Manchester, UK
Lyle Gurrin
Allergy and Lung Health Unit, Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
Andreas Lundh
Cochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Madelon van Wely
1 Reproduction and Development Research Institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
Toby Lasserson
Evidence Production and Methods Directorate, Cochrane, London, UK
Alison Avenell
Health Services Research Unit, University of Aberdeen, Aberdeen, UK
Neil E O'Connell
Department of Clinical Science, Brunel University, Uxbridge, UK
Andrew Grey
associate professor
Jack Wilkinson
Centre for Biostatistics, University of Manchester, Manchester, UK
George A Antoniou
Manchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK
Kylie Elizabeth Hunter
Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
Patrick Dicker
Department of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, Ireland
Zarko Alfirevic
Department of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UK
Ella Flemyng
Evidence Production and Methods Directorate, Cochrane, London, UK
Sarah Lensen
Department of Obstetrics and Gynaecology, Royal Women’s Hospital, University of Melbourne, Melbourne, Victoria, Australia
Emma Sydenham
Cochrane Central Production Service, Cochrane, London, UK
Ginny Barbour
Medical Journal of Australia, Sydney, New South Wales, Australia
Emily Lam
GI and Liver PPI Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK
Gideon Meyerowitz-Katz
School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia
James Heathers
SafeBeat Rx Inc, St Louis, Missouri, USA
Nicholas J L Brown
Department of Psychology, Linnaeus University, Växjö, Sweden
John Carlisle
Anaesthesia and Critical Care, Torbay Hospital, Torquay, UK
Steph Grohmann
Evidence Production and Methods Directorate, Cochrane, London, UK
Barbara K Redman
Division of Medical Ethics, New York University Grossman School of Medicine, New York, New York, USA
Lene Seidler
Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
Kyle A Sheldrick
Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.
