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Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.
Wilkinson, Jack; Heal, Calvin; Antoniou, George A; Flemyng, Ella; Alfirevic, Zarko; Avenell, Alison; Barbour, Virginia; Brown, Nicholas J L; Carlisle, John; Clarke, Mike; Dicker, Patrick; Dumville, Jo; Grey, Andrew; Grohmann, Steph; Gurrin, Lyle C; Hayden, Jill A; Heathers, James; Hunter, Kylie E; Lasserson, Toby; Lam, Emily; Lensen, Sarah; Li, Tianjing; Li, Wentao; Loder, Elizabeth; Lundh, Andreas; Meyerowitz-Katz, Gideon; Mol, Ben W; O' Connell, Neil E; Parker, Lisa; Redman, Barbara K; Seidler, Anna Lene; Sheldrick, Kyle A; Sydenham, Emma; Torgerson, David J; van Wely, Madelon; Wang, Rui; Bero, Lisa; Kirkham, Jamie J.
Afiliação
  • Wilkinson J; Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Heal C; Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Antoniou GA; Manchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK.
  • Flemyng E; Division of Cardiovascular Sciences, School of Medical Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
  • Alfirevic Z; Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Avenell A; Emeritus Professor, University of Liverpool, UK.
  • Barbour V; Health Services Research Unit, University of Aberdeen, UK.
  • Brown NJL; Medical Journal of Australia, Sydney, Australia.
  • Carlisle J; Department of Psychology, Linnaeus University, Växjö, Sweden.
  • Clarke M; Perioperative Medicine, Torbay hospital, UK.
  • Dicker P; Department of Epidemiology and Public Health, Royal College of Surgeons in Ireland.
  • Dumville J; Northern Ireland Methodology Hub, Queen's University Belfast, Northern Ireland.
  • Grey A; Division of Nursing, Midwifery & Social Work, School of Health Sciences, The University of Manchester, Manchester, UK.
  • Grohmann S; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
  • Gurrin LC; Department of Medicine, University of Auckland, Auckland, New Zealand.
  • Hayden JA; Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Heathers J; School of Population and Global Health, The University of Melbourne, Australia.
  • Hunter KE; Department of Community Health & Epidemiology, Faculty of Medicine, Dalhousie University, Canada.
  • Lasserson T; SafeBeat Rx Inc, USA.
  • Lam E; Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
  • Lensen S; Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Li T; Independent lay member, unaffiliated, Cheshire, UK.
  • Li W; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Loder E; Department of Ophthalmology, University of Colorado Anschutz Medical Campus.
  • Lundh A; Department of Obstetrics and Gynaecology, Monash University, VIC, Australia.
  • Meyerowitz-Katz G; The BMJ, London, UK.
  • Mol BW; Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.
  • O' Connell NE; Cochrane Denmark & Centre for Evidence-Based Medicine Odense, Department of Clinical Research, University of Southern Denmark, Denmark.
  • Parker L; Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.
  • Redman BK; School of Health and Society, University of Wollongong, Wollongong, Australia.
  • Seidler AL; Monash University, Clayton, Victoria, Australia.
  • Sheldrick KA; Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK.
  • Sydenham E; Centre for Health and Wellbeing across the Lifecourse, Dept of Health Sciences, Brunel University London, UK.
  • Torgerson DJ; School of Pharmacy, Charles Perkins Centre, The University of Sydney, Australia.
  • van Wely M; Division of Medical Ethics, New York University Grossman School of Medicine, New York, NY.
  • Wang R; Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
  • Bero L; Faculty of Medicine, University of New South Wales, Australia.
  • Kirkham JJ; Cochrane Central Production Service, UK.
medRxiv ; 2023 Nov 13.
Article em En | MEDLINE | ID: mdl-37873409
ABSTRACT

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 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, 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.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article