McErlean, M;
Samways, J;
Godolphin, PJ;
Chen, Y;
(2022)
The reporting standards of randomised controlled trials in leading medical journals between 2019 and 2020: a systematic review.
Irish Journal of Medical Science (1971 -)
10.1007/s11845-022-02955-6.
(In press).
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Abstract
Randomised controlled trials (RCTs) are the gold standard study design used to evaluate the safety and effectiveness of healthcare interventions. The reporting quality of RCTs is of fundamental importance for readers to appropriately analyse and understand the design and results of studies which are often labelled as practice changing papers. The aim of this article is to assess the reporting standards of a representative sample of randomised controlled trials (RCTs) published between 2019 and 2020 in four of the highest impact factor general medical journals. A systematic review of the electronic database Medline was conducted. Eligible RCTs included those published in the New England Journal of Medicine, Lancet, Journal of the American Medical Association, and British Medical Journal between January 1, 2019, and June 9, 2020. The study protocol was registered on medRxiv (https://doi.org/10.1101/2020.07.06.20147074). Of a total eligible sample of 498 studies, 50 full-text RCTs were reviewed against the CONSORT 2010 statement and relevant extensions where necessary. The mean adherence to the CONSORT checklist was 90% (SD 9%). There were specific items on the CONSORT checklist which had recurring suboptimal adherence, including in title (item 1a, 70% adherence), randomisation (items 9 and 10, 56% and 30% adherence) and outcomes and estimation (item 17b, 62% adherence). Amongst a sample of RCTs published in four of the highest impact factor general medical journals, there was good overall adherence to the CONSORT 2010 statement. However there remains significant room for improvement in areas such as description of allocation concealment and implementation of randomisation.
| Type: | Article |
|---|---|
| Title: | The reporting standards of randomised controlled trials in leading medical journals between 2019 and 2020: a systematic review |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1007/s11845-022-02955-6 |
| Publisher version: | https://doi.org/10.1007/s11845-022-02955-6 |
| Language: | English |
| Additional information: | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
| Keywords: | CONSORT, Randomised controlled trial (RCT), Reporting guidelines |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10144701 |
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