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Cited by 460Meta-analysis and systematic reviewsDelphi Technique in ResearchStatistical Methods in Clinical Trials

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

Open access
Chan, An-Wen, Boutron, Isabelle, Hopewell, Sally, Moher, David, Schulz, Kenneth F, Collins, Gary S, Tunn, Ruth, Aggarwal, Rakesh +31 more·2025·BMJ
DOI 10.1136/bmj-2024-081477PMC PMC12035670
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Abstract

Importance: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Objective: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. Design: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Findings: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Conclusions and relevance: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

AI snapshot

Written from the paper’s full text.

TL;DR

SPIRIT 2025 is an updated evidence-based guideline for minimum items to address in randomised trial protocols, replacing SPIRIT 2013. It provides a 34-item checklist, a schedule-of-assessments diagram, and expanded explanation and elaboration materials.

Key findings

  • The updated SPIRIT 2025 statement consists of a checklist of 34 minimum protocol items plus a diagram illustrating the schedule of enrolment, interventions, and assessments.
  • The update process involved 317 Delphi participants and 30 experts at a consensus meeting; it led to two new protocol items, revision of five items, deletion/merger of five items, and integration of key items from other reporting guidelines.
  • Notable changes include a new open science section, greater emphasis on harms and on describing interventions/comparators, and a new item on patient and public involvement in trial design, conduct, and reporting.
  • SPIRIT 2025 supersedes SPIRIT 2013, which “should no longer be used or cited.”

Methods

  • The authors conducted a scoping review of literature from 2013 to 2022 and a broader search for empirical and theoretical evidence from 2013 to 2024, producing the SPIRIT-CONSORT Evidence Bibliographic database; this was enriched with recommendations from SPIRIT/CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment) and TIDieR, plus user feedback.
  • Potential modifications were rated in a three-round international online Delphi survey with 317 participants; high agreement was defined as at least 80% of respondents rating importance as high (4 or 5) or low (1 or 2).
  • A two-day online consensus meeting in March 2023 was attended by 30 invited international experts; the executive group then drafted and finalised the checklist after further review.

Limitations

  • The paper states that SPIRIT 2025 is a minimum standard focused on the most common two-group parallel randomised trial and may not encompass every protocol item relevant for a particular trial; factorial trials and trials evaluating patient-reported outcomes have additional considerations.
  • The paper states that existing SPIRIT extensions should continue to be used until a process aligns them with SPIRIT 2025.
  • The paper states that SPIRIT 2025 is intended to promote transparency and description of what is planned, not to prescribe trial design or conduct, and should not be used to appraise trial quality; it also does not focus on protocol format.
  • Evident from the text: no prospective evaluation of SPIRIT 2025’s effect on protocol completeness or trial outcomes is reported; potential impacts are described as potential, with prior evidence cited mainly for SPIRIT 2013.

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

Integrity signals

Registry

Crossref · 10.1136/bmj-2024-081477

Cites

50 of 50 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 26 cited sources checked · 0 supported · 0 flagged

  • Findingcitation

    It is feasible to address all SPIRIT 2025 checklist items in a single protocol document, as illustrated by the examples we identified from existing protocols for every item.

    “It is feasible to address all SPIRIT 2025 checklist items in a single protocol document, as illustrated by the examples we identified from existing protocols for every item.28”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [28] source

      Not checked in the free run.

  • Premisecitation

    Meta-research reviews of protocols have found improved completeness of protocol content after SPIRIT 2013 was introduced.

    “Meta-research reviews of protocols have found improved completeness of protocol content after SPIRIT 2013 was introduced.10 11 48 49”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites 10 11 48 49

      Not checked in the free run.

  • Interpretationcitation

    Improved completeness of protocols may improve the efficiency of external review by reducing avoidable queries to investigators about incomplete or unclear protocol related information.

    “Improved completeness of protocols may improve the efficiency of external review by reducing avoidable queries to investigators about incomplete or unclear protocol related information.50 51”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites 50 51

      Not checked in the free run.

  • Interpretationcitation

    These benefits of SPIRIT based protocols can only be fully realised when trial protocols are routinely made publicly available through trial registries (eg, PDF upload), journals, and online repositories.

    “These benefits of SPIRIT based protocols can only be fully realised when trial protocols are routinely made publicly available through trial registries (eg, PDF upload), journals, and online repositories.7 54 55”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites 7 54 55

      Not checked in the free run.

    • Rests on an assumption: High quality protocols provide important information about trial methods and conduct that is usually not available in trial registries or publications reporting completed trials.
  • Interpretationcitation

    Adherence to SPIRIT 2025 may help ensure that protocols contain the requisite information for critical appraisal and trial interpretation by peer reviewers, funders, REC/IRBs, and journals.

    “Further, adherence to SPIRIT 2025 may help ensure that protocols contain the requisite information for critical appraisal and trial interpretation by peer reviewers, funders, REC/IRBs, and journals.7”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] source

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  • Classified as probably not a substantial claim. 32
  • May combine two claims. 17

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

    Findingnone given

    Item 29 was added on trial monitoring, replacing the prior item on auditing.

    “Item 29: added item on trial monitoring (replaces prior item on auditing)”
    Quote in the paperNot a substantial claim

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

    Findingreasoning

    To facilitate implementation, the authors developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.

    “To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.”
    • Also stated in: § Updated SPIRIT 2025 statement · plain
      “To present the recommendations in diverse formats, we also developed an expanded version of the SPIRIT 2025 checklist with bullet points of key issues to consider for each item (appendix 1), as done with other initiatives.29 30 31”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [29] source

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    • cites [30] source

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    • cites [31] source

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

    Findingnone given

    The update harmonised the wording between SPIRIT and CONSORT checklist items and clarified the wording of some items.

    “We have also harmonised the wording between SPIRIT and CONSORT checklist items and clarified the wording of some items.”
    Quote in the paperNot a substantial claim

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

    Findingnone given

    Item 11 was added on how patients and the public are involved in the design, conduct, and reporting of the trial.

    “Item 11: added item on how patients and the public are involved in the design, conduct, and reporting of the trial”
    Quote in the paperNot a substantial claim

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

    Findingown data

    The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants.

    “The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants.”
    • Also stated in: § Updated SPIRIT 2025 statement · plain
      “The SPIRIT 2025 statement comprises a checklist of 34 minimum protocol items (table 1) and a diagram illustrating the schedule of enrolment, interventions, and assessments (fig 1).”
    Quote in the paperSubstantial claim

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

    Findingown data

    Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting.

    “Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting.”
    Quote in the paperSubstantial claim

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

    Findingown data

    A two-day online consensus meeting was held in March 2023, attended by 30 invited international experts.

    “Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting.”
    • Also stated in: § Methods · plain
      “The Delphi survey results were then discussed at a two-day online consensus meeting in March 2023, attended by 30 invited international experts representing a range of relevant groups.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The update process led to the addition of two new protocol items, revision to five items, deletion of three items, merger of two items, and integration of key items from other relevant reporting guidelines.

    “The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines.”
    • Also stated in: § Main changes · plain
      “We added two new checklist items, revised the content of five items, deleted three items, merged two items, and integrated key items from CONSORT Harms 2022,24 SPIRIT-Outcomes 2022,25 and TIDieR27 into the main checklist and explanatory document.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [24] source

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    • cites [25] source

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    • cites [27] source

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

    Findingnone given

    The update restructured the SPIRIT checklist and created a new open science section consolidating items critical to promoting access to information about trial methods and results, including trial registration; sharing of the full protocol, statistical analysis plan, and de-identified participant level data; and disclosure of funding sources and conflicts of interest.

    “We also restructured the SPIRIT checklist and created a new open science section consolidating items critical to promoting access to information about trial methods and results, including trial registration; sharing of the full protocol, statistical analysis plan, and de-identified participant level data; and disclosure of funding sources and conflicts of interest.”
    Quote in the paperSubstantial claim

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

    Findingown data

    The 317 Delphi participants represented a broad range of roles in clinical trials, including statisticians/methodologists/epidemiologists (n=198), trial investigators (n=73), systematic reviewers/guideline developers (n=73), clinicians (n=58), journal editors (n=47), and patients and members of the public (n=17), with numbers not mutually exclusive.

    “Participants represented a broad range of roles in clinical trials, including statisticians/methodologists/epidemiologists (n=198), trial investigators (n=73), systematic reviewers/guideline developers (n=73), clinicians (n=58), journal editors (n=47), and patients and members of the public (n=17) (numbers are not mutually exclusive).”
    Quote in the paperNot a substantial claim

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

    Findingcitation

    The accompanying SPIRIT 2025 explanation and elaboration document provides background and context for each checklist item along with examples of good reporting.

    “An accompanying SPIRIT 2025 explanation and elaboration document provides background and context for each checklist item along with examples of good reporting.28”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [28] source

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

    Findingcitation

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

    “The expanded checklist comprises an abridged version of elements presented in the SPIRIT 2025 explanation and elaboration document,28 with examples and references removed.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [28] source

      Not checked in the free run.

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

    Findingown data

    317 individuals participated in the Delphi consensus process.

    “Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting.”
    • Also stated in: § Methods · plain
      “A total of 317 participants were recruited through professional research networks, societies, and the project website.”
    Quote in the paperNot a substantial claim

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

    Interpretationreasoning

    Widespread adoption of SPIRIT 2025 as a common standard across REC/IRBs, funding agencies, regulatory agencies, and journals could simplify the work of trial investigators and sponsors because a SPIRIT based protocol would then fulfil the harmonised application requirements of multiple groups.

    “Widespread adoption of SPIRIT 2025 as a common standard across REC/IRBs, funding agencies, regulatory agencies, and journals could simplify the work of trial investigators and sponsors because a SPIRIT based protocol would then fulfil the harmonised application requirements of multiple groups.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Gaps in protocol content can lead to avoidable protocol amendments, inconsistent or poor trial conduct, and lack of transparency in terms of what was planned and implemented.

    “Gaps in protocol content can lead to avoidable protocol amendments,13 inconsistent or poor trial conduct, and lack of transparency in terms of what was planned and implemented.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] source

      Not checked in the free run.

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

    Interpretationreasoning

    Adherence to SPIRIT 2025 may promote high quality trial design and implementation because SPIRIT is used during the planning stage of a trial.

    “In addition to improved reporting, adherence to SPIRIT 2025 may promote high quality trial design and implementation because SPIRIT is used during the planning stage of a trial.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Better protocols can help study personnel to implement the trial consistently across sites.

  • May combine two claims.

    Premisecitation

    Trial protocols vary in their completeness and often do not adequately describe important elements including primary outcomes, treatment allocation methods, blinding, adverse event measurement, sample size calculations, data analysis methods, dissemination policies, and roles of sponsors and investigators.

    “However, trial protocols vary in their completeness and often do not address key elements of design and conduct.”
    • Also stated in: § Introduction · plain
      “Despite the central role of protocols, there is substantial variation in the completeness of protocol content.10 11 Many trial protocols do not adequately describe important elements including the primary outcomes, treatment allocation methods, use of blinding, measurement of adverse events, sample size calculations, data analysis methods, dissemination policies, and roles of sponsors and Investig”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [10] source

      Not checked in the free run.

    • cites [11] source

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    • cites [12] source

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

    Interpretationnone given

    SPIRIT 2025 addresses the minimum content of a protocol, focusing on the most common type of randomised trial-the two-group parallel design.

    “SPIRIT 2025 addresses the minimum content of a protocol, focusing on the most common type of randomised trial—the two-group parallel design.”
    Quote in the paperSubstantial claim

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

    Premisecitation

    The SPIRIT statement was first published in 2013 as guidance to improve the completeness of trial protocols.

    “The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.”
    • Also stated in: § Introduction · plain
      “In response to these protocol deficiencies, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidance was first published in 2013.14 15”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [14] source

      Not checked in the free run.

    • cites [15] source

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

    Interpretationreasoning

    Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

    “Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: A complete, transparent, and accessible protocol is critical for the planning, conduct, reporting, and external review of randomised trials.

  • May combine two claims.

    Interpretationcitation

    High quality protocols addressing all SPIRIT items may also help to reduce the number and burden of protocol amendments during the trial-many of which can be avoided with careful consideration of key issues when developing the protocol.

    “High quality protocols addressing all SPIRIT items may also help to reduce the number and burden of protocol amendments during the trial—many of which can be avoided with careful consideration of key issues when developing the protocol.13 33”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites 13 33

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

    Premisecitation

    Harmonising the reporting recommendations could help improve usability and adherence.

    “Harmonising the reporting recommendations could help improve usability and adherence.18”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [18] source

      Not checked in the free run.

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

    Interpretationcitation

    SPIRIT 2025 encompasses and builds upon recommendations from the International Council for Harmonization Good Clinical Practice E6(R3) guidance and 2024 Declaration of Helsinki, including the Declaration of Helsinki's requirement that the protocol address potential conflicts of interest and provision of post-trial care.

    “SPIRIT 2025 encompasses and builds upon recommendations from the International Council for Harmonization Good Clinical Practice E6(R3) guidance36 and 2024 Declaration of Helsinki,32 including the Declaration of Helsinki’s requirement that the protocol address potential conflicts of interest and provision of post-trial care.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [36] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. International Council for Harmonisation (ICH) harmonised guideline: Guideline for good clinical practice, E6(R3). 6 January 2025. https://www.ich.org/page/efficacy-guidelines.

      Not checked in the free run.

    • cites [32] source

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

    Study design and conductcitation

    The authors followed the EQUATOR Network guidance for developers of health research guidelines.

    “In brief, we followed the EQUATOR Network guidance for developers of health research guidelines.21”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [21] source

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

    Interpretationnone given

    Most of the SPIRIT items are relevant to any type of trial.

    “However, most of the SPIRIT items are relevant to any type of trial.”
    Quote in the paperNot a substantial claim

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

    Interpretationcitation

    SPIRIT 2025 has been designed to complement and enhance the expanding trial registration requirements mandated by legislation, journals, and funding policies.

    “SPIRIT 2025 has been designed to complement and enhance the expanding trial registration requirements mandated by legislation, journals, and funding policies.35”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [35] source

      Not checked in the free run.

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

    Interpretationreasoning

    The checklist does not focus on the protocol format, which is often subject to local regulations or practice.

    “The checklist also does not focus on the protocol format, which is often subject to local regulations or practice.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationnone given

    SPIRIT 2025 supersedes the SPIRIT 2013 statement.

    “The SPIRIT 2025 statement supersedes the SPIRIT 2013 statement, which should no longer be used or cited.”
    Quote in the paperSubstantial claim

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

    Interpretationnone given

    The main purpose of SPIRIT 2025 is to promote transparency and an adequate description of what is planned-not to prescribe how a trial should be designed or conducted.

    “The main purpose of SPIRIT 2025 is to promote transparency and an adequate description of what is planned—not to prescribe how a trial should be designed or conducted.”
    Quote in the paperSubstantial claim

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

    Interpretationnone given

    The explicit incorporation of an open science section in the SPIRIT checklist will support the growing global push for greater transparency and sharing of trial materials and outputs to facilitate evidence synthesis and reproducibility of research.

    “The explicit incorporation of an open science section in the SPIRIT checklist will support the growing global push for greater transparency and sharing of trial materials and outputs to facilitate evidence synthesis and reproducibility of research.”
    Quote in the paperNot a substantial claim

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

    Interpretationreasoning

    Widespread endorsement and adoption of SPIRIT 2025 have the potential to enhance transparency and translation to better healthcare.

    “Widespread endorsement and adoption of the updated recommendations have the potential to improve protocol content and implementation; facilitate registration, oversight, and appraisal of trials; and ultimately enhance transparency and translation to better healthcare.”
    Quote in the paperNot a substantial claim

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

    Interpretationreasoning

    This provides an opportunity to improve the validity and successful completion of trials by reminding investigators about important issues to consider before the study begins.

    “This provides an opportunity to improve the validity and successful completion of trials by reminding investigators about important issues to consider before the study begins.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationnone given

    The SPIRIT 2025 statement incorporates new evidence and emerging perspectives to ensure that the guidance remains relevant to users.

    “The SPIRIT 2025 statement incorporates new evidence and emerging perspectives to ensure that the guidance remains relevant to users.”
    Quote in the paperSubstantial claim

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

    Interpretationreasoning

    Widespread endorsement and adoption of SPIRIT 2025 have the potential to improve protocol content and implementation.

    “Widespread endorsement and adoption of the updated recommendations have the potential to improve protocol content and implementation; facilitate registration, oversight, and appraisal of trials; and ultimately enhance transparency and translation to better healthcare.”
    Quote in the paperNot a substantial claim

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

    Interpretationnone given

    SPIRIT 2025 will continue to serve as an educational resource for new investigators, trainees, peer reviewers, and REC/IRB members.

    “SPIRIT 2025 will continue to serve as an educational resource for new investigators, trainees, peer reviewers, and REC/IRB members.”
    Quote in the paperNot a substantial claim

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

    Interpretationreasoning

    Widespread endorsement and adoption of SPIRIT 2025 have the potential to facilitate registration, oversight, and appraisal of trials.

    “Widespread endorsement and adoption of the updated recommendations have the potential to improve protocol content and implementation; facilitate registration, oversight, and appraisal of trials; and ultimately enhance transparency and translation to better healthcare.”
    Quote in the paperNot a substantial claim
36 of 36

  • The paper relies on this without support.

    A complete, transparent, and accessible protocol is critical for the planning, conduct, reporting, and external review of randomised trials.

    “The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review.”
    “A complete, transparent, and accessible protocol is critical for the planning, conduct, reporting, and external review of randomised trials”

  • The paper relies on this without support.

    The SPIRIT 2013 and CONSORT 2010 statements were conceptually linked with overlapping content and implementation strategies.

    “As the SPIRIT 2013 and CONSORT 2010 statements were conceptually linked with overlapping content and implementation strategies, the two groups decided to merge into the joint SPIRIT-CONSORT executive group and to update both checklists simultaneously.”

  • The paper relies on this without support.

    Better protocols can help study personnel to implement the trial consistently across sites.

    “Better protocols can also help study personnel to implement the trial consistently across sites.”

  • The paper relies on this without support.

    High quality protocols provide important information about trial methods and conduct that is usually not available in trial registries or publications reporting completed trials.

    “High quality protocols provide important information about trial methods and conduct that is usually not available in trial registries or publications reporting completed trials.”
4 of 4

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The system's features align with emerging trial protocol guidance (SPIRIT-AI; SPIRIT 2025).

    “These features align with emerging trial protocol guidance (SPIRIT-AI; SPIRIT 2025).15,16”

    From Transforming oncology clinical trial matching through neuro-symbolic, multi-agent AI and an oncology-specific knowledge graph: a prospective evaluation in 3804 patients (2026) · cites this paper as [16]

    The Scope of SPIRIT 2025 section describes guidance on the minimum content of randomised-trial protocols, and the References section identifies SPIRIT-AI as an extension for protocols involving artificial intelligence (page numbers unavailable). The paper does not describe the citing system’s features, so it cannot establish that those features align with either guideline. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • SPIRIT 2025 consists of a 34-item checklist of the minimum recommended protocol items and a diagram illustrating the schedule of enrolment, interventions, and assessments.

    “an international group developed and published the updated SPIRIT 2025 statement13—consisting of a 34 item checklist of the minimum recommended protocol items (table 1); a diagram illustrating the schedule of enrolment, interventions, and assessments (fig 1).”

    From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [13]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Claimed data-access merger is absent from item 26

    Minor

    The paper says the item on trial investigators' access to data was merged into item 26, but item 26 addresses data handling and access to data-management procedures, not investigators' access to trial data.

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Authors
Chan, A.-W., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D. R., Farmer, A. J., 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. J., Vohra, S., White, I. R., & Hróbjartsson, A.
Affiliations
  • University of Toronto (CA)
  • Inserm (FR)
  • University of Oxford (GB)
  • Ottawa Hospital Research Institute (CA)
  • University of North Carolina at Chapel Hill (US)
  • UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  • 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)
  • Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  • 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)
  • 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)
  • University of Southern Denmark (DK)
Corresponding author
Chan, An-Wen
ORCID
Venue
BMJ
Publisher
BMJ
Published
2025-04-28
Volume
389
Pages
e081477
ISSN
1756-1833 (ISSN-L)
DOI
10.1136/bmj-2024-081477
PMC
PMC12035670
OpenAlex
W4409878505
Semantic Scholar
b25ba6e6e04e13b6436a8810b68d757fd853d913
Cited by
460
References
50
Citations by year
2026: 358 · 2025: 102
FWCI
294.22
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, cc-by)
  • University of Birmingham Research Portal (University of Birmingham) (acceptedVersion, cc-by)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion, cc-by)
  • Pure Amsterdam UMC (submittedVersion, cc-by)
  • Bond University Research Portal (Bond University) (submittedVersion, cc-by)
Funders
  • National Institute for Health and Care Research
  • Department of Health and Social Care
  • Medical Research Council (MR/W020483/1)
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
trial protocol reporting, randomised trials, patient and public involvement, open science, trial design and conduct, reporting guidelines, CONSORT, TIDieR, Delphi consensus
MeSH terms
Clinical Trial Protocols as Topic, Delphi Technique, Humans, Research Design, Randomized Controlled Trials as Topic, Consensus, Checklist

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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