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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| Název: | 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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| Autoři: | 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. |
| Přispěvatelé: | University of Aberdeen.Aberdeen Centre for Evaluation, University of Aberdeen.Institute of Applied Health Sciences, University of Aberdeen.Other Applied Health Sciences, University of Aberdeen.Aberdeen Centre for Women’s Health Research |
| Zdroj: | medRxiv BMJ Open BMJ Open, Vol 14, Iss 3 (2024) Wilkinson, J, Heal, C, Antoniou, G A, Flemyng, E, Alfirevic, Z, Avenell, A, Barbour, G, Carlisle, J, Clarke, M, Dicker, P, Dumville, J C, Grey, A, Grohmann, S, Gurrin, L, Heathers, J, Hunter, K E, Lasserson, T, Lensen, S, Li, T, Loder, E, Lundh, A, Meyerowitz-Katz, G, Mol, B W, O'Connell, N E, Redman, B K, Seidler, L, Sheldrick, K A, Sydenham, E, Torgerson, D, van Wely, M, Bero, L & Kirkham, J 2024, 'Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions', BMJ Open, vol. 14, no. 3, pp. e084164. https://doi.org/10.1136/bmjopen-2024-084164 |
| Informace o vydavateli: | Cold Spring Harbor Laboratory, 2023. |
| Rok vydání: | 2023 |
| Témata: | Consensus, Evidence-Based Medicine, Informed Consent, Evidence-Based Medicine/methods, Folkhälsovetenskap, global hälsa och socialmedicin, R Medicine, Public Health, Global Health and Social Medicine, STATISTICS & RESEARCH METHODS, Article, 3. Good health, Research Design, Randomized Controlled Trial, Research Methods, Medicine, Humans, Systematic Review, National Institute for Health Research (NIHR), Randomized Controlled Trials as Topic, Systematic Reviews as Topic |
| Popis: | IntroductionRandomised 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 analysisThe 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. |
| Druh dokumentu: | Article Other literature type |
| Popis souboru: | application/pdf; Electronic |
| ISSN: | 2044-6055 |
| DOI: | 10.1101/2023.09.21.23295626 |
| DOI: | 10.1136/bmjopen-2024-084164 |
| Přístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/37873409 https://pubmed.ncbi.nlm.nih.gov/38471680 https://doaj.org/article/f39de58dcec344438e93f2289bdaea65 https://pure.amsterdamumc.nl/en/publications/88d1757b-b28f-41c0-bb0c-1133ffcc4dd2 https://doi.org/10.1101/2023.09.21.23295626 http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-128696 https://bura.brunel.ac.uk/handle/2438/28610 |
| Rights: | CC BY taverne URL: http://creativecommons.org/licenses/by/4.0/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: http://creativecommons.org/licenses/by/4.0/. |
| Přístupové číslo: | edsair.doi.dedup.....32640abf5109c8aa6f853ea7e06d1d73 |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | IntroductionRandomised 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 analysisThe 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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| ISSN: | 20446055 |
| DOI: | 10.1101/2023.09.21.23295626 |