View in EDS

CONSORT 2025 statement: updated guideline for reporting randomised trials.

Saved in:
Bibliographic Details
Title: CONSORT 2025 statement: updated guideline for reporting randomised trials.
Authors: Hopewell, Sally (AUTHOR), Chan, An-Wen (AUTHOR), Collins, Gary S (AUTHOR), Hróbjartsson, Asbjørn (AUTHOR), Moher, David (AUTHOR), Schulz, Kenneth F (AUTHOR), Tunn, Ruth (AUTHOR), Aggarwal, Rakesh (AUTHOR), Berkwits, Michael (AUTHOR), Berlin, Jesse A (AUTHOR), Bhandari, Nita (AUTHOR), Butcher, Nancy J (AUTHOR), Campbell, Marion K (AUTHOR), Chidebe, Runcie C W (AUTHOR), Elbourne, Diana (AUTHOR), Farmer, Andrew (AUTHOR), Fergusson, Dean A (AUTHOR), Golub, Robert M (AUTHOR), Goodman, Steven N (AUTHOR), Hoffmann, Tammy C (AUTHOR)
Source: Lancet. May2025, Vol. 405 Issue 10489, p1633-1640. 8p.
Subjects: Randomized controlled trials, Open scholarship, Documentation standards, Research methodology, Research protocols
Abstract: 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. 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 (eg, 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. 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. 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. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
FullText Text:
  Availability: 0
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 184890217
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: CONSORT 2025 statement: updated guideline for reporting randomised trials.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Hopewell%2C+Sally%22">Hopewell, Sally</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chan%2C+An-Wen%22">Chan, An-Wen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Collins%2C+Gary+S%22">Collins, Gary S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hróbjartsson%2C+Asbjørn%22">Hróbjartsson, Asbjørn</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moher%2C+David%22">Moher, David</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schulz%2C+Kenneth+F%22">Schulz, Kenneth F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tunn%2C+Ruth%22">Tunn, Ruth</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aggarwal%2C+Rakesh%22">Aggarwal, Rakesh</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Berkwits%2C+Michael%22">Berkwits, Michael</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Berlin%2C+Jesse+A%22">Berlin, Jesse A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bhandari%2C+Nita%22">Bhandari, Nita</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Butcher%2C+Nancy+J%22">Butcher, Nancy J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Campbell%2C+Marion+K%22">Campbell, Marion K</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chidebe%2C+Runcie+C+W%22">Chidebe, Runcie C W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Elbourne%2C+Diana%22">Elbourne, Diana</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Farmer%2C+Andrew%22">Farmer, Andrew</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fergusson%2C+Dean+A%22">Fergusson, Dean A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Golub%2C+Robert+M%22">Golub, Robert M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Goodman%2C+Steven+N%22">Goodman, Steven N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hoffmann%2C+Tammy+C%22">Hoffmann, Tammy C</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. May2025, Vol. 405 Issue 10489, p1633-1640. 8p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Open+scholarship%22">Open scholarship</searchLink><br /><searchLink fieldCode="DE" term="%22Documentation+standards%22">Documentation standards</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Research+protocols%22">Research protocols</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. 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 (eg, 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. 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. 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=184890217
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S0140-6736(25)00672-5
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 8
        StartPage: 1633
    Subjects:
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Open scholarship
        Type: general
      – SubjectFull: Documentation standards
        Type: general
      – SubjectFull: Research methodology
        Type: general
      – SubjectFull: Research protocols
        Type: general
    Titles:
      – TitleFull: CONSORT 2025 statement: updated guideline for reporting randomised trials.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Hopewell, Sally
      – PersonEntity:
          Name:
            NameFull: Chan, An-Wen
      – PersonEntity:
          Name:
            NameFull: Collins, Gary S
      – PersonEntity:
          Name:
            NameFull: Hróbjartsson, Asbjørn
      – PersonEntity:
          Name:
            NameFull: Moher, David
      – PersonEntity:
          Name:
            NameFull: Schulz, Kenneth F
      – PersonEntity:
          Name:
            NameFull: Tunn, Ruth
      – PersonEntity:
          Name:
            NameFull: Aggarwal, Rakesh
      – PersonEntity:
          Name:
            NameFull: Berkwits, Michael
      – PersonEntity:
          Name:
            NameFull: Berlin, Jesse A
      – PersonEntity:
          Name:
            NameFull: Bhandari, Nita
      – PersonEntity:
          Name:
            NameFull: Butcher, Nancy J
      – PersonEntity:
          Name:
            NameFull: Campbell, Marion K
      – PersonEntity:
          Name:
            NameFull: Chidebe, Runcie C W
      – PersonEntity:
          Name:
            NameFull: Elbourne, Diana
      – PersonEntity:
          Name:
            NameFull: Farmer, Andrew
      – PersonEntity:
          Name:
            NameFull: Fergusson, Dean A
      – PersonEntity:
          Name:
            NameFull: Golub, Robert M
      – PersonEntity:
          Name:
            NameFull: Goodman, Steven N
      – PersonEntity:
          Name:
            NameFull: Hoffmann, Tammy C
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 03
              M: 05
              Text: May2025
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-print
              Value: 01406736
          Numbering:
            – Type: volume
              Value: 405
            – Type: issue
              Value: 10489
          Titles:
            – TitleFull: Lancet
              Type: main
ResultId 1