Using Risk of Bias 2 to assess results from randomised controlled trials: guidance from Cochrane.

Autor:	Flemyng E; Cochrane Evidence Production and Methods Directorate, Cochrane, London, UK., Moore TH; Population Health Sciences, University of Bristol Medical School, Bristol, UK.; NIHR Applied Research Collaboration West at University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Boutron I; Inserm, INRAE, Centre de Recherche Epidémiologie et StatistiqueS Université Paris Cité, Université Paris Cité and Université Sorbonne Paris Nord, Paris, France.; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France., Higgins JP; Population Health Sciences, University of Bristol Medical School, Bristol, UK.; NIHR Applied Research Collaboration West at University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Hróbjartsson A; Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark., Nejstgaard CH; Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark., Dwan K; Evidence Production and Methods Directorate, Cochrane, London, UK Kerry.dwan@york.ac.uk.; Centre for Reviews and Dissemination, University of York, York, UK.
Jazyk:	angličtina
Zdroj:	BMJ evidence-based medicine [BMJ Evid Based Med] 2023 Aug; Vol. 28 (4), pp. 260-266. Date of Electronic Publication: 2023 Jan 24.
DOI:	10.1136/bmjebm-2022-112102
Abstrakt:	A systematic review identifies, appraises and synthesises all the empirical evidence from studies that meet prespecified eligibility criteria to answer a specific research question. As part of the appraisal, researchers use explicit methods to assess risk of bias in the results' from included studies that contribute to the review's findings, to improve our confidence in the review's conclusions. Randomised controlled trials included in Cochrane Reviews have used a specific risk of bias tool to assess these included studies since 2008. In 2019, a new version of this tool, Risk of Bias 2 (RoB 2), was launched to improve its usability and to reflect current understanding of how the causes of bias can influence study results. Cochrane implemented RoB 2 in a phased approach, with users of the tool informing guidance development. This paper highlights learning for all systematic reviewers (Cochrane and non-Cochrane) from the phased implementation, highlighting differences between the original version of the tool and RoB 2, consideration of reporting systematic review protocols or full review reports that have used RoB 2, and some tips shared by authors during the pilot phase of the implementation. Competing Interests: Competing interests: EF is employed by Cochrane. During the development of the manuscript, KD and THM were employed by Cochrane. JPTH, IB, AH and CHN are leads of the Cochrane Bias Methods Group. JPTH, IB and AH were part of the development team for the RoB 2 tool. (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu