Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions
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 topi...
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BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e084164.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Elizabeth Loder |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-25T00:44:42Z |
| format | Article |
| id | doaj.art-f39de58dcec344438e93f2289bdaea65 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-17T01:56:17Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-f39de58dcec344438e93f2289bdaea652025-02-14T17:35:14ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2024-084164Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventionsElizabeth Loder0Jill Alison Hayden1David Torgerson2Tianjing Li3Wentao Li4Rui Wang5Ben W Mol6Lisa Bero7Jamie J Kirkham8Lisa Parker9Mike Clarke10Jo C Dumville11Calvin Heal12Lyle Gurrin13Andreas Lundh14Madelon van Wely15Toby Lasserson16Alison Avenell17Neil E O'Connell18Andrew Grey19Jack Wilkinson20George A Antoniou21Kylie Elizabeth Hunter22Patrick Dicker23Zarko Alfirevic24Ella Flemyng25Sarah Lensen26Emma Sydenham27Ginny Barbour28Emily Lam29Gideon Meyerowitz-Katz30James Heathers31Nicholas J L Brown32John Carlisle33Steph Grohmann34Barbara K Redman35Lene Seidler36Kyle A Sheldrick37The BMJCommunity Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, CanadaYork Trials Unit, Dept of Health Sciences, University of York, York, UKassociate professor1The University of Texas MD Anderson Cancer Center, Houston, TX, USADepartment of Radiology, Peking University First Hospital, Beijing, China4 Obstetrics and Gynecology, Monash Medical School, Clayton, Victoria, AustraliaUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado, USACentre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK13 Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, AustraliaprofessorDivision of Nursing, Midwifery and Social Work, School of Health Sciences, The University of Manchester, Manchester, UK7 Centre for Biostatistics, University of Manchester, Manchester, UKAllergy and Lung Health Unit, Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, AustraliaCochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark1 Reproduction and Development Research Institute, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsEvidence Production and Methods Directorate, Cochrane, London, UKHealth Services Research Unit, University of Aberdeen, Aberdeen, UKDepartment of Clinical Science, Brunel University, Uxbridge, UKassociate professorCentre for Biostatistics, University of Manchester, Manchester, UKManchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UKEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, AustraliaDepartment of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, IrelandDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKEvidence Production and Methods Directorate, Cochrane, London, UKDepartment of Obstetrics and Gynaecology, Royal Women’s Hospital, University of Melbourne, Melbourne, Victoria, AustraliaCochrane Central Production Service, Cochrane, London, UKMedical Journal of Australia, Sydney, New South Wales, AustraliaGI and Liver PPI Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UKSchool of Health and Society, University of Wollongong, Wollongong, New South Wales, AustraliaSafeBeat Rx Inc, St Louis, Missouri, USADepartment of Psychology, Linnaeus University, Växjö, SwedenAnaesthesia and Critical Care, Torbay Hospital, Torquay, UKEvidence Production and Methods Directorate, Cochrane, London, UKDivision of Medical Ethics, New York University Grossman School of Medicine, New York, New York, USAEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, AustraliaFaculty of Medicine, University of New South Wales, Sydney, New South Wales, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/14/3/e084164.full |
| spellingShingle | 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 Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions BMJ Open |
| title | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| title_full | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| title_fullStr | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| title_full_unstemmed | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| title_short | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| title_sort | protocol for the development of a tool inspect sr to identify problematic randomised controlled trials in systematic reviews of health interventions |
| url | https://bmjopen.bmj.com/content/14/3/e084164.full |
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