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Protocol for the de...
Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions
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- Wilkinson, Jack (author)
- University of Manchester, UK
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- Heal, Calvin (author)
- University of Manchester, UK
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- Antoniou, George A (author)
- Manchester University NHS Foundation Trust, UK;University of Manchester, UK
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- Flemyng, Ella (author)
- Evidence Production and Methods Directorate Cochrane, UK
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- Alfirevic, Zarko (author)
- University of Liverpool, UK
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- Avenell, Alison (author)
- University of Aberdeen, UK
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- Barbour, Ginny (author)
- Medical Journal of Australia, Australia
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- Brown, Nicholas, 1960- (author)
- Linnéuniversitetet,Institutionen för psykologi (PSY)
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- Carlisle, John (author)
- Torbay Hospital, UK
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- Clarke, Mike (author)
- Queen's University Belfast, UK
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- Dicker, Patrick (author)
- Royal College of Surgeons in Ireland, Ireland
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- Dumville, Jo C (author)
- University of Manchester, UK;Manchester Academic Health Science Centre, UK
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- Grey, Andrew (author)
- University of Auckland, New Zealand
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- Grohmann, Steph (author)
- Evidence Production and Methods Directorate Cochrane, UK
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- Gurrin, Lyle (author)
- University of Melbourne, Australia
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- Hayden, Jill Alison (author)
- Dalhousie University, Canada
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- Heathers, James (author)
- SafeBeat Rx Inc, USA
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- Hunter, Kylie Elizabeth (author)
- University of Sydney, Australia
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- Lasserson, Toby (author)
- Evidence Production and Methods Directorate Cochrane, UK
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- Lam, Emily (author)
- Independent Lay Member, UK
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- Lensen, Sarah (author)
- University of Melbourne, Australia
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- Li, Tianjing (author)
- niversity of Colorado, USA
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- Li, Wentao (author)
- Monash University, Australia
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- Loder, Elizabeth (author)
- BMJ Publishing, UK;Brigham and Women's Hospital, USA
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- Lundh, Andreas (author)
- Centre of Evidence-Based Medicine Odense, Denmark;Cochrane, Denmark;University of Southern Denmark, Denmark;Copenhagen University Hospita, Denmark
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- Meyerowitz-Katz, Gideon (author)
- University of Wollongong, Australia
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- Mol, Ben W (author)
- Monash University, Australia
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- O'Connell, Neil E (author)
- Brunel University, UK;Brunel University, UK
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- Parker, Lisa (author)
- University of Sydney, Australia
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- Redman, Barbara K (author)
- New York University Grossman School of Medicine, USA
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- Seidler, Lene (author)
- University of Sydney, Australia
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- Sheldrick, Kyle A (author)
- University of New South Wales, Australia
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- Sydenham, Emma (author)
- Cochrane Central Production Service, UK
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- Torgerson, David (author)
- University of York, UK
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- van Wely, Madelon (author)
- Cochrane Gynaecology and Fertility Satellite and Cochrane Sexually Transmitted Infection Group, Netherlands;Amsterdam University Medical Center, Netherlands
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- Wang, Rui (author)
- Monash University, Australia
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- Bero, Lisa (author)
- University of Colorado, USA
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- Kirkham, Jamie J (author)
- University of Manchester, UK
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(creator_code:org_t)
- BMJ Publishing Group Ltd, 2024
- 2024
- English.
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 14:3
- Related links:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
Keyword
- Psychology
- Psykologi
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Wilkinson, Jack
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Heal, Calvin
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Antoniou, George ...
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Flemyng, Ella
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Alfirevic, Zarko
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Avenell, Alison
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show more...
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Barbour, Ginny
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Brown, Nicholas, ...
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Carlisle, John
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Clarke, Mike
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Dicker, Patrick
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Dumville, Jo C
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Grey, Andrew
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Grohmann, Steph
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Gurrin, Lyle
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Hayden, Jill Ali ...
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Heathers, James
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Hunter, Kylie El ...
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Lasserson, Toby
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Lam, Emily
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Lensen, Sarah
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Li, Tianjing
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Li, Wentao
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Loder, Elizabeth
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Lundh, Andreas
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Meyerowitz-Katz, ...
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Mol, Ben W
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O'Connell, Neil ...
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Parker, Lisa
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Redman, Barbara ...
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Seidler, Lene
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Sheldrick, Kyle ...
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Sydenham, Emma
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Torgerson, David
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van Wely, Madelo ...
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Wang, Rui
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Bero, Lisa
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Kirkham, Jamie J
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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BMJ Open
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Linnaeus University