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Cited by 1,195Meta-analysis and systematic reviewsDelphi Technique in ResearchStatistical Methods in Clinical Trials

CONSORT 2025 statement: updated guideline for reporting randomised trials

Open access
Hopewell, Sally, Chan, An-Wen, Collins, Gary S, Hróbjartsson, Asbjørn, Moher, David, Schulz, Kenneth F, Tunn, Ruth, Aggarwal, Rakesh +31 more·2025·BMJ
DOI 10.1136/bmj-2024-081123PMC PMC11995449
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Abstract

Background: 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. Methods: 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. Results: 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. Conclusion: 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.

AI snapshot

Written from the paper’s full text.

TL;DR

CONSORT 2025 is an updated reporting guideline for randomised trials, replacing CONSORT 2010 with a 30-item checklist, a participant flow diagram, and an expanded checklist. It adds seven items, revises three, deletes one, integrates items from key CONSORT extensions, and adds an open science section.

Key findings

  • The update added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment) and TIDieR; it also restructured the checklist with a new open science section.
  • CONSORT 2025 consists of a 30-item checklist and a flow diagram; an expanded checklist with bullet points eliciting critical elements of each item was also developed.
  • New items include data sharing (item 4), author conflicts of interest (item 5b), patient/public involvement (item 8), eligibility criteria for sites and intervention deliverers (item 12b), harms assessment (item 15), analysis population and missing data handling (items 21b, 21c), and intervention/comparator delivery and concomitant care (items 24a, 24b).
  • A Cochrane review cited in the paper found that 25 of 27 CONSORT checklist items were more completely reported in CONSORT-endorsing versus non-endorsing journals, based on 50 evaluations of 16,604 trials; the paper notes a causal effect cannot be proven.

Methods

  • Guideline update followed EQUATOR Network guidance; methods included a scoping review, a project-specific database (SCEBdb), and recommendations from lead authors of key CONSORT extensions and TIDieR.
  • Potential changes were assessed in a three-round international online Delphi survey with 317 participants in round 1, 303 in round 2, and 290 in round 3; participants rated inclusion on a 5-point Likert scale and could provide free-text comments.
  • Results were discussed at a two-day online expert consensus meeting of 30 invited international experts (1–2 March 2023), followed by a two-day in-person executive writing meeting in Oxford (25–26 April 2023); Zoom polls were advisory and no formal consensus threshold was specified.

Limitations

  • Stated: CONSORT 2025 and SPIRIT 2025 do not include recommendations for designing, conducting, or analysing trials, and CONSORT 2025 is not meant to be used as a quality assessment instrument.
  • Stated: CONSORT 2025 provides guidance for all randomised trials but focuses on the most common type, the two-group parallel design; it also does not suggest a rigid structure for reporting.
  • Stated: the paper notes that a causal effect cannot be proven for the association between journal endorsement of CONSORT and better reporting; consensus polls at the expert meeting were advisory and no formal consensus threshold was specified.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1136/bmj-2024-081123

Cites

50 of 50 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 18 cited sources checked · 0 supported · 0 flagged

  • Interpretationreasoning

    A causal effect of CONSORT endorsement on reporting quality cannot be proven.

    “However, a causal effect cannot be proven.”
    Quote in the paperNot a substantial claim
  • Premisecitation

    Having a clear and transparent trial protocol is important because it prespecifies the methods used in the trial, such as the primary outcome, thereby reducing the likelihood of undeclared post hoc changes.

    “Similarly, having a clear and transparent trial protocol is important because it prespecifies the methods used in the trial, such as the primary outcome, thereby reducing the likelihood of undeclared post hoc changes.5”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] COMPARE. Tracking switched outcomes in clinical trials. https://www.compare-trials.org/ [accessed 26 May 2021].

      Not checked in the free run.

  • Premisecitation

    The introduction of CONSORT within journals has been shown to be associated with improved quality of reports of randomised trials.

    “The introduction of CONSORT within journals has been shown to be associated with improved quality of reports of randomised trials.”
    • Also stated in: § Introduction · hedged
      “Some evidence shows that journal endorsement of CONSORT is associated with better reporting and that reporting is improving over time.2 13 14 15”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [2] source

      Not checked in the free run.

    • cites [13] source

      Not checked in the free run.

    • cites [14] source

      Not checked in the free run.

  • Premisecitation

    Incomplete reporting may be associated with biased estimates of intervention effects.

    “and that incomplete reporting may be associated with biased estimates of intervention effects.4”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [4] source

      Not checked in the free run.

  • Premisecitation

    The completeness of reporting of randomised trials is inadequate.

    “However, there is overwhelming evidence that the quality of reporting is not optimal.”
    • Also stated in: § Introduction · boosted
      “However, extensive evidence displays that the completeness of reporting of randomised trials is inadequate2 3”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [2] source

      Not checked in the free run.

    • cites [3] source

      Not checked in the free run.

  • Classified as probably not a substantial claim. 46
  • May combine two claims. 12

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Item 3 was revised to include where the statistical analysis plan can be accessed in addition to the trial protocol.

    “Item 3: revised item to include where the statistical analysis plan can be accessed in addition to the trial protocol.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Findingnone given

    Items related to reporting of how harms were assessed and analysed (items 7, 15, 21a, 23a, 27), how outcomes were measured and analysed (items 14, 26), and how the intervention and comparator were actually administered and by whom (item 24) were integrated from key CONSORT extensions.

    “Addition of items related to reporting of how harms24 were assessed and analysed (items 7, 15, 21a, 23a, 27), how outcomes25 were measured and analysed (items 14, 26), and how the intervention27 28 and comparator were actually administered and by whom (item 24).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Item 26 was revised to specify for each primary and secondary outcome the number of participants included in the analysis and the number of participants with available data at each time point for each treatment group.

    “Item 26: revised item to specify for each primary and secondary outcome—the number of participants included in the analysis and the number of participants with available data at each time point for each treatment group.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    The CONSORT 2025 statement supersedes the CONSORT 2010 statement.

    “The CONSORT 2025 statement supersedes the CONSORT 2010 statement, which should no longer be used.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Findingreasoning

    The CONSORT 2025 statement added items to define who is included in each analysis and in which group (item 21b), and how missing data were handled in the analysis (item 21c).

    “Item 21: added items to define who is included in each analysis (eg, all randomised participants) and in which group (item 21b), and how missing data were handled in the analysis (item 21c).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The CONSORT 2025 statement added an item on how patients and/or the public were involved in the design, conduct, and/or reporting of the trial (item 8).

    “Item 8: added item on how patients and/or the public were involved in the design, conduct, and/or reporting of the trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The wording of some CONSORT checklist items was clarified and simplified.

    “Clarified and simplified wording of some items.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The CONSORT 2025 checklist includes three revised checklist items.

    “We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingreasoning

    An expanded version of the CONSORT 2025 checklist was developed, with bullet points eliciting critical elements of each item.

    “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.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The expanded checklist comprises an abridged version of elements presented in the CONSORT 2025 explanation and elaboration document, with examples and references removed.

    “The expanded checklist comprises an abridged version of elements presented in the CONSORT 2025 explanation and elaboration document,29 with examples and references removed (see appendix 2).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The wording of some CONSORT checklist items was aligned with that of SPIRIT checklist items and vice versa.

    “Aligned wording of some CONSORT checklist items with that of SPIRIT checklist items and vice versa.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    The deleted checklist item was on generalisability of trial findings, which is now incorporated under trial limitations (item 30).

    “Deleted item on generalisability of trial findings, which is now incorporated under trial limitations (item 30).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Findingreasoning

    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.

    “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.”
    • Also stated in: § Scope of CONSORT 2025 · plain
      “The CONSORT 2025 statement comprises a 30-item checklist and provides a minimum set of items to be included in a report of a randomised trial (table 1) and a diagram for documenting the flow of participants through a trial (fig 1).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    The CONSORT explanation and elaboration document was updated and extensively revised.

    “We have also updated the CONSORT explanation and elaboration document,29 which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The CONSORT 2025 statement added an item on data sharing (item 4).

    “Item 4: added item on data sharing, including where and how individual de-identified participant data, statistical code, and any other materials can be accessed.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    CONSORT 2025 provides guidance for reporting all randomised trials but focuses on the most common type, the two-group parallel design.

    “CONSORT 2025 provides guidance for reporting all randomised trials but focuses on the most common type, the two-group parallel design.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The CONSORT 2025 checklist includes seven new checklist items.

    “We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The CONSORT 2025 statement added an item on eligibility criteria for sites and for individuals delivering the interventions, where applicable (item 12b).

    “Item 12b: added item on eligibility criteria for sites and for individuals delivering the interventions, where applicable”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The CONSORT 2025 statement added an item on financial and other conflicts of interest of manuscript authors (item 5b).

    “Item 5b: added item on financial and other conflicts of interest of manuscript authors.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The CONSORT 2025 statement added an item on how harms and other unintended effects were assessed (item 15).

    “Item 15: added item on how harms and other unintended effects were assessed.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The CONSORT checklist was restructured with a new section on open science.

    “We also restructured the CONSORT checklist, with a new section on open science, which includes items that are conceptually linked, such as trial registration (item 2), where the trial protocol and statistical analysis plan can be accessed (item 3), sharing of de-identified participant level data (item 4), and funding and conflicts of interest (item 5).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One checklist item was deleted from CONSORT 2025.

    “We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Findingnone given

    The CONSORT 2025 statement added an item on intervention delivery, including how the intervention and comparator were actually administered (item 24a) and details of concomitant care received during the trial (item 24b).

    “Item 24: added item on intervention delivery, including how the intervention and comparator were actually administered (item 24a) and details of concomitant care received during the trial (item 24b).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    Several items from key CONSORT extensions were integrated into CONSORT 2025.

    “We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Item 10 was revised to include reporting of important changes to the trial after it commenced, including any outcomes or analyses that were not prespecified.

    “Item 10: revised item to include reporting of important changes to the trial after it commenced, including any outcomes or analyses that were not prespecified.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    The content of CONSORT 2025 focuses on reporting items related to the internal and external validity of randomised trials.

    “Rather, the content of CONSORT 2025 focuses on reporting items related to the internal and external validity of randomised trials.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    CONSORT urges clarity and transparency of reporting which reflects the actual trial design, conduct, and analysis.

    “CONSORT urges clarity and transparency of reporting which reflects the actual trial design, conduct, and analysis.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    With CONSORT 2025, the authors do not suggest a rigid structure for the reporting of randomised trials.

    “With CONSORT 2025, we do not suggest a rigid structure for the reporting of randomised trials.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    CONSORT 2025 is not meant to be used as a quality assessment instrument.

    “Importantly, however, CONSORT 2025 is not meant to be used as a quality assessment instrument.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    CONSORT 2025 and SPIRIT 2025 do not include recommendations for designing, conducting, or analysing trials.

    “It is important to note that CONSORT 2025 and SPIRIT 2025 do not include recommendations for designing, conducting, or analysing trials”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    Updating the SPIRIT and CONSORT statements together was an opportunity to align reporting in both checklists and to provide users with consistent guidance in the reporting of trial design, conduct, and analysis, from the trial protocol to final publication.

    “Updating the SPIRIT and CONSORT statements together was also an opportunity to align reporting in both checklists and to provide users with consistent guidance in the reporting of trial design, conduct, and analysis, from the trial protocol to final publication.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The list of potential changes to the CONSORT checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants who responded to round 1, 303 to round 2 and 290 to round 3.

    “This list of potential changes was presented to end users for feedback in a large international online Delphi survey, involving 317 participants who responded to round 1, 303 to round 2 and 290 to round 3.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    A broad range of end user roles were represented in the Delphi survey, including statisticians/methodologists/epidemiologists (n=198), systematic reviewers/guideline developers (n=73), trial investigators (n=73), clinicians (n=58), journal editors (n=47), and patient representatives (n=17).

    “A broad range of end user roles were represented, the most frequent being statisticians/methodologists/epidemiologists (n=198), systematic reviewers/guideline developers (n=73), trial investigators (n=73), clinicians (n=58), journal editors (n=47), and patient representatives (n=17) (numbers not mutually exclusive).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Premisecitation

    SPIRIT and CONSORT are living guidelines and it is vital that the statements are periodically updated to reflect new evidence, methodological advancements, and feedback from users; otherwise, their value and usefulness will diminish over time.

    “SPIRIT and CONSORT are living guidelines and it is vital that the statements are periodically updated to reflect new evidence, methodological advancements, and feedback from users; otherwise, their value and usefulness will diminish over time.16”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [16] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The methods used to update the CONSORT statement followed the EQUATOR Network guidance for developers of health research guidelines.

    “The methods used to update the CONSORT statement followed the EQUATOR Network guidance for developers of health research guidelines19 and have been described in detail elsewhere.20 21”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [19] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.

    “Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [33] source

      Not checked in the free run.

    • cites [34] source

      Not checked in the free run.

    • cites [35] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Premisecitation

    Harmonising the reporting process should improve usability and adherence, and lead to more-complete reporting.

    “Harmonising the reporting process should improve usability and adherence, and lead to more-complete reporting.17”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The Delphi survey results were presented and discussed at a two-day online expert consensus meeting attended by 30 invited international participants representing the different stakeholder groups included in the Delphi survey.

    “The Delphi survey results were then presented and discussed at a two-day online expert consensus meeting via Zoom, on 1 and 2 March 2023, attended by 30 invited international participants representing the different stakeholder groups included in the Delphi survey.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    During the expert consensus meeting, each new and modified CONSORT checklist item was discussed and agreement sought, with anonymous polls used to help establish support where opinions differed; no formal consensus threshold was specified.

    “During the meeting, each new and modified CONSORT checklist item was discussed and agreement sought. An anonymous poll via Zoom was used to help establish the level of support for items where the discussion indicated differing opinions; these polls were advisory and no formal consensus threshold was specified.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Premisecitation

    High quality reporting is an important step when considering issues related to reproducibility.

    “High quality reporting is an important step when considering issues related to reproducibility.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [50] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Interpretationnone given

    Transparent reporting of trial results can reveal deficiencies in research if they exist and allow better estimates of their prevalence and severity.

    “In addition, transparent reporting of trial results can reveal deficiencies in research if they exist and allow better estimates of their prevalence and severity.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    The recommendations contained in CONSORT 2025 and SPIRIT 2025 can help researchers in the design, conduct, and analysis of their trial by highlighting key issues to consider.

    “but nevertheless the recommendations contained here can help researchers in the design, conduct, and analysis of their trial by highlighting key issues to consider.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationcitation

    An explicit description of what was done and what was found, without ambiguity or omission, best serves the interests of all readers.

    “An explicit description of what was done and what was found, without ambiguity or omission, best serves the interests of all readers.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [9] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    Readers, peer reviewers, clinicians, guideline writers, patients and the public, and editors can also use CONSORT 2025 to help them appraise the reporting of randomised trials.

    “Readers, peer reviewers, clinicians, guideline writers, patients and the public, and editors can also use CONSORT 2025 to help them appraise the reporting of randomised trials.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationnone given

    Full data and code sharing offers another, higher level of transparency.

    “Full data and code sharing offers another, higher level of transparency”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Interpretationreasoning

    Clear and transparent reports of trial protocols should in turn facilitate properly designed and well conducted trials.

    “Thus, clear and transparent reports of trial protocols should in turn facilitate properly designed and well conducted trials.”
    Quote in the paperNot a substantial claim
46 of 46

  • The paper relies on this without support.

    Randomised trials, when appropriately designed, conducted, analysed, and reported, are generally considered the highest quality evidence in evaluating healthcare interventions.

    “Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions.”
    “Randomised trials, when appropriately designed, conducted, analysed, and reported, are generally considered the highest quality evidence in evaluating healthcare interventions.”

  • The paper relies on this without support.

    To interpret a randomised trial accurately, readers need complete and transparent information on its methods and findings.

    “- To interpret a randomised trial accurately, readers need complete and transparent information on its methods and findings”

  • The paper relies on this without support.

    Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are thoroughly and accurately reported.

    “Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are thoroughly and accurately reported.”
3 of 3

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Authors
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D., Farmer, A., Fergusson, D. A., Golub, R. M., Goodman, S. N., Hoffmann, T. C., Ioannidis, J. P. A., Kahan, B. C., Knowles, R. L., Lamb, S. E., Lewis, S., Loder, E., Offringa, M., Ravaud, P., Richards, D. P., Rockhold, F. W., Schriger, D. L., Siegfried, N. L., Staniszewska, S., Taylor, R. S., Thabane, L., Torgerson, D., Vohra, S., White, I. R., & Boutron, I.
Affiliations
  • University of Oxford (GB)
  • University of Toronto (CA)
  • UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  • University of Southern Denmark (DK)
  • Ottawa Hospital Research Institute (CA)
  • University of North Carolina at Chapel Hill (US)
  • Jawaharlal Institute of Post Graduate Medical Education and Research (IN)
  • Centers for Disease Control and Prevention (US)
  • Rutgers, The State University of New Jersey (US)
  • Society for Applied Studies (IN)
  • University of Aberdeen (GB)
  • Miami University (US)
  • London School of Hygiene & Tropical Medicine (GB)
  • Northwestern University (US)
  • Stanford University (US)
  • Bond University (AU)
  • MRC Clinical Trials Unit at UCL (GB)
  • University College London (GB)
  • University of Exeter (GB)
  • University of Edinburgh (GB)
  • Harvard University (US)
  • Hospital for Sick Children (CA)
  • Inserm (FR)
  • MaRS (CA)
  • Duke Medical Center (US)
  • University of California, Los Angeles (US)
  • South African Medical Research Council (ZA)
  • University of Warwick (GB)
  • MRC/CSO Social and Public Health Sciences Unit (GB)
  • St. Joseph’s Healthcare Hamilton (CA)
  • University of York (GB)
  • University of Alberta (CA)
Corresponding author
Hopewell, Sally
ORCID
Venue
BMJ
Publisher
BMJ
Published
2025-04-14
Volume
389
Pages
e081123
ISSN
1756-1833 (ISSN-L)
DOI
10.1136/bmj-2024-081123
PMC
PMC11995449
OpenAlex
W4409483458
Semantic Scholar
7f1e783582c3c41e2044ce7c9caf2cdc7ec69d5f
Cited by
1,195
References
51
Citations by year
2026: 904 · 2025: 290 · 2024: 1
FWCI
755.57
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
  • Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion, cc-by)
  • Pure Amsterdam UMC (submittedVersion, cc-by)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by)
  • Bond University Research Portal (Bond University) (submittedVersion, cc-by)
Funders
  • University of Miami
  • Northwestern University
  • Ottawa Hospital Research Institute
  • London School of Hygiene and Tropical Medicine
  • McMaster University
  • Bond University
  • University of Alberta
  • University of Exeter
  • University of Warwick
  • University College London
  • University of Oxford
  • University of Glasgow
  • University of Aberdeen
  • South African Medical Research Council
  • Hospital for Sick Children
  • Centers for Disease Control and Prevention
  • Medical Research Council
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
reporting guidelines, randomised trials, trial reporting quality, CONSORT checklist, CONSORT extension, harms reporting, non-pharmacological treatment, open science, TIDieR, Delphi consensus
MeSH terms
Delphi Technique, Humans, Publishing, Research Design, Randomized Controlled Trials as Topic, Guidelines as Topic, Checklist, Research Report

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-07.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-07.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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