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http://bura.brunel.ac.uk/handle/2438/28610| Title: | Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions |
| Authors: | Wilkinson, J Heal, C Antoniou, GA Flemyng, E Alfirevic, Z Avenell, A Barbour, V Brown, NJL Carlisle, J Clarke, M Dicker, P Dumville, J Grey, A Grohmann, S Gurrin, LC Hayden, JA Heathers, J Hunter, KE Lasserson, T Lam, E Lensen, S Li, T Li, W Loder, E Lundh, A Meyerowitz-Katz, G Mol, BW O'Connell, NE Parker, L Redman, BK Seidler, AL Sheldrick, KA Sydenham, E Torgerson, DJ van Wely, M Wang, R Bero, L Kirkham, JJ |
| Issue Date: | 11-Mar-2024 |
| Publisher: | BMJ Publishing Group |
| Citation: | Wilkinson, J. et al. (2024) 'Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions', BMJ Open, 14, e084164, pp. 1 - 8. doi: 10.1136/bmjopen-2024-084164. |
| 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. |
| URI: | https://bura.brunel.ac.uk/handle/2438/28610 |
| DOI: | https://doi.org/10.1136/bmjopen-2024-084164 |
| Other Identifiers: | ORCiD: Jack Wilkinson https://orcid.org/0000-0003-3513-4677 ORCiD: Alison Avenell https://orcid.org/0000-0003-4813-5628 ORCiD: Mike Clarke https://orcid.org/0000-0002-2926-7257 ORCiD: Andrew Grey https://orcid.org/0000-0002-7803-0096 ORCiD: Jill Alison Hayden https://orcid.org/0000-0001-7026-144X ORCiD: Kylie Elizabeth Hunter https://orcid.org/0000-0002-2796-9220 ORCiD: Sarah Lensen https://orcid.org/0000-0002-1694-1142 ORCiD: Wentao Li https://orcid.org/0000-0001-8980-0909 ORCiD: Ben W. Mol https://orcid.org/0000-0001-8337-550X ORCiD: Neil E O'Connell https://orcid.org/0000-0003-1989-4537 ORCiD: Lisa Parker https://orcid.org/0000-0001-8635-6953 ORCiD: Emma Sydenham https://orcid.org/0000-0002-1471-4237 ORCiD: Rui Wang https://orcid.org/0000-0002-6622-8134 ORCiD: Lisa Bero https://orcid.org/0000-0003-1893-6651 ORCiD: Jamie J Kirkham https://orcid.org/0000-0003-2579-9325 e084164 |
| Appears in Collections: | Dept of Health Sciences Research Papers |
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| File | Description | Size | Format | |
|---|---|---|---|---|
| FullText.pdf | Copyright information: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. | 727.47 kB | Adobe PDF | View/Open |
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