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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, Ginny; Brown, Nicholas J L; Carlisle, John; Clarke, Mike; Dicker, Patrick; Dumville, Jo C; Grey, Andrew; Grohmann, Steph; Gurrin, Lyle; Hayden, Jill Alison; Heathers, James; Hunter, Kylie Elizabeth; 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, Lene; Sheldrick, Kyle A; Sydenham, Emma; Torgerson, David; van Wely, Madelon; Wang, Rui; Bero, Lisa; Kirkham, Jamie J.
Afiliação
  • Wilkinson J; Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK jack.wilkinson@manchester.ac.uk.
  • Heal C; Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, 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 Faculty of Biology Medicine and Health, Manchester, UK.
  • Alfirevic Z; Evidence Production and Methods Directorate, Cochrane, London, UK.
  • Avenell A; Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
  • Barbour G; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
  • Brown NJL; Medical Journal of Australia, Sydney, New South Wales, Australia.
  • Carlisle J; Department of Psychology, Linnaeus University, Växjö, Sweden.
  • Clarke M; Anaesthesia and Critical Care, Torbay Hospital, Torquay, UK.
  • Dicker P; Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.
  • Dumville JC; Department of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Grey A; Division of Nursing, Midwifery and 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 L; Department of Medicine, University of Auckland, Auckland, New Zealand.
  • Hayden JA; Evidence Production and Methods Directorate, Cochrane, London, UK.
  • Heathers J; School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
  • Hunter KE; Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada.
  • Lasserson T; Department of Community Health & Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
  • Lam E; SafeBeat Rx Inc, St Louis, Missouri, USA.
  • Lensen S; Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
  • Li T; Evidence Production and Methods Directorate, Cochrane, London, UK.
  • Li W; Independent Lay Member, Cheshire, UK.
  • Loder E; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
  • Lundh A; Department of Ophthalmology, University of Colorado, Denver, Colorado, USA.
  • Meyerowitz-Katz G; Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.
  • Mol BW; BMJ Publishing, London, UK.
  • O'Connell NE; Department of Neurology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
  • Parker L; Centre of Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
  • Redman BK; Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Kobenhavn, Denmark.
  • Seidler L; School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.
  • Sheldrick KA; Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.
  • Sydenham E; Department of Clinical Science, Brunel University, Uxbridge, UK.
  • Torgerson D; Centre for Health and Wellbeing across the Lifecourse, Dept of Health Sciences, Brunel University, London, UK.
  • van Wely M; School of Pharmacy, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.
  • Wang R; Division of Medical Ethics, New York University Grossman School of Medicine, New York, New York, USA.
  • Bero L; Evidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
  • Kirkham JJ; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open ; 14(3): e084164, 2024 Mar 11.
Article em En | MEDLINE | ID: mdl-38471680
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 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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Medicina Baseada em Evidências Limite: Humans Idioma: En Revista: BMJ Open Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Medicina Baseada em Evidências Limite: Humans Idioma: En Revista: BMJ Open Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Reino Unido