CONSORT 2025 statement: Updated guideline for reporting randomised trials.
<h4>Background</h4>Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Rep...
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Public Library of Science (PLoS)
2025-04-01
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| Series: | PLoS Medicine |
| Online Access: | https://doi.org/10.1371/journal.pmed.1004587 |
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| author | Sally Hopewell An-Wen Chan Gary S Collins Asbjørn Hróbjartsson David Moher Kenneth F Schulz Ruth Tunn Rakesh Aggarwal Michael Berkwits Jesse A Berlin Nita Bhandari Nancy J Butcher Marion K Campbell Runcie C W Chidebe Diana Elbourne Andrew Farmer Dean A Fergusson Robert M Golub Steven N Goodman Tammy C Hoffmann John P A Ioannidis Brennan C Kahan Rachel L Knowles Sarah E Lamb Steff Lewis Elizabeth Loder Martin Offringa Philippe Ravaud Dawn P Richards Frank W Rockhold David L Schriger Nandi L Siegried Sophie Staniszewska Rod S Taylor Lehana Thabane David Torgerson Sunita Vohra Ian R White Isabelle Boutron |
| author_facet | Sally Hopewell An-Wen Chan Gary S Collins Asbjørn Hróbjartsson David Moher Kenneth F Schulz Ruth Tunn Rakesh Aggarwal Michael Berkwits Jesse A Berlin Nita Bhandari Nancy J Butcher Marion K Campbell Runcie C W Chidebe Diana Elbourne Andrew Farmer Dean A Fergusson Robert M Golub Steven N Goodman Tammy C Hoffmann John P A Ioannidis Brennan C Kahan Rachel L Knowles Sarah E Lamb Steff Lewis Elizabeth Loder Martin Offringa Philippe Ravaud Dawn P Richards Frank W Rockhold David L Schriger Nandi L Siegried Sophie Staniszewska Rod S Taylor Lehana Thabane David Torgerson Sunita Vohra Ian R White Isabelle Boutron |
| author_sort | Sally Hopewell |
| collection | DOAJ |
| description | <h4>Background</h4>Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users.<h4>Methods</h4>We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts.<h4>Results</h4>We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.<h4>Conclusions</h4>Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent. |
| format | Article |
| id | doaj-art-13dbb1ba330e4065a66ee55da9fe0a0b |
| institution | OA Journals |
| issn | 1549-1277 1549-1676 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Medicine |
| spelling | doaj-art-13dbb1ba330e4065a66ee55da9fe0a0b2025-08-20T02:15:50ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762025-04-01224e100458710.1371/journal.pmed.1004587CONSORT 2025 statement: Updated guideline for reporting randomised trials.Sally HopewellAn-Wen ChanGary S CollinsAsbjørn HróbjartssonDavid MoherKenneth F SchulzRuth TunnRakesh AggarwalMichael BerkwitsJesse A BerlinNita BhandariNancy J ButcherMarion K CampbellRuncie C W ChidebeDiana ElbourneAndrew FarmerDean A FergussonRobert M GolubSteven N GoodmanTammy C HoffmannJohn P A IoannidisBrennan C KahanRachel L KnowlesSarah E LambSteff LewisElizabeth LoderMartin OffringaPhilippe RavaudDawn P RichardsFrank W RockholdDavid L SchrigerNandi L SiegriedSophie StaniszewskaRod S TaylorLehana ThabaneDavid TorgersonSunita VohraIan R WhiteIsabelle Boutron<h4>Background</h4>Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users.<h4>Methods</h4>We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts.<h4>Results</h4>We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.<h4>Conclusions</h4>Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.https://doi.org/10.1371/journal.pmed.1004587 |
| spellingShingle | Sally Hopewell An-Wen Chan Gary S Collins Asbjørn Hróbjartsson David Moher Kenneth F Schulz Ruth Tunn Rakesh Aggarwal Michael Berkwits Jesse A Berlin Nita Bhandari Nancy J Butcher Marion K Campbell Runcie C W Chidebe Diana Elbourne Andrew Farmer Dean A Fergusson Robert M Golub Steven N Goodman Tammy C Hoffmann John P A Ioannidis Brennan C Kahan Rachel L Knowles Sarah E Lamb Steff Lewis Elizabeth Loder Martin Offringa Philippe Ravaud Dawn P Richards Frank W Rockhold David L Schriger Nandi L Siegried Sophie Staniszewska Rod S Taylor Lehana Thabane David Torgerson Sunita Vohra Ian R White Isabelle Boutron CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Medicine |
| title | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
| title_full | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
| title_fullStr | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
| title_full_unstemmed | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
| title_short | CONSORT 2025 statement: Updated guideline for reporting randomised trials. |
| title_sort | consort 2025 statement updated guideline for reporting randomised trials |
| url | https://doi.org/10.1371/journal.pmed.1004587 |
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