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Cited by 171Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsClinical practice guidelines implementation

The DOI matches its Crossref record; 474 of the 474 references it cites were found in a registry or an index; 28 of the 453 sources its claims cite were checked for support.

SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials

Open access
Hróbjartsson, Asbjørn, Boutron, Isabelle, Hopewell, Sally, Moher, David, Schulz, Kenneth F, Collins, Gary S, Tunn, Ruth, Aggarwal, Rakesh, Berkwits, Michael, Berlin, Jesse A, Bhandari, Nita, Butcher, Nancy J, Campbell, Marion K, Chidebe, Runcie C W, Elbourne, Diana R, Farmer, Andrew J, Fergusson, Dean A, Golub, Robert M, Goodman, Steven N, Hoffmann, Tammy C, Ioannidis, John P A, Kahan, Brennan C, Knowles, Rachel L, Lamb, Sarah E, Lewis, Steff, Loder, Elizabeth, Offringa, Martin, Ravaud, Philippe, Richards, Dawn P, Rockhold, Frank W, Schriger, David L, Siegfried, Nandi L, Staniszewska, Sophie, Taylor, Rod S, Thabane, Lehana, Torgerson, David J, Vohra, Sunita, White, Ian R, Chan, An-Wen·2025·BMJ
DOI 10.1136/bmj-2024-081660PMC PMC12128891
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Abstract

High quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information. The document is intended to be used in conjunction with the SPIRIT 2025 statement and serves as a resource for researchers planning a trial and for others interested in trial protocols.

Overview

AI snapshot

Written from a shortened version of the paper’s full text (it is longer than we read).

TL;DR

SPIRIT 2025 explanation and elaboration provides updated guidance for reporting protocols of randomised trials, expanding the 34-item SPIRIT 2025 checklist with exemplars, rationale, and references. It is intended to be used with the SPIRIT 2025 statement to improve the completeness and transparency of trial protocols.

Key findings

  • SPIRIT 2025 comprises a 34-item checklist of minimum recommended protocol items, plus a schedule-of-enrolment/interventions/assessments diagram; this E&E explains each item and gives published protocol exemplars.
  • The update was developed using a scoping review, an online Delphi survey with 317 international participants, and a two-day online expert consensus meeting with 30 international experts; SPIRIT 2025 was developed in parallel with CONSORT 2025.
  • The document reports persistent protocol reporting gaps from two 2016 samples of 108 and 292 protocols, including 11% and 17% reporting protocol contributor names, 57% and 78% reporting sponsor name/contact details, and 23% and 32% reporting plans for access to the full dataset.
  • It provides an expanded checklist and a joint SPIRIT-CONSORT website to support implementation.

Methods

  • Guideline development followed EQUATOR Network guidance; briefly, a project database, scoping review of comments, identification of SPIRIT/CONSORT extensions, evidence collection, Delphi survey (317 participants), and a two-day online consensus meeting (30 experts) informed the updated checklists.
  • For this E&E, the authors modelled their approach on the SPIRIT 2013 E&E: each checklist item is presented with at least one exemplar from a protocol, followed by rationale, main issues, and selected references.
  • Exemplars were obtained from public websites, journal publications, and appendices to published trials; references to empirical studies were identified through a continuously updated project database, preferring systematic reviews when available.

Limitations

  • The paper states challenges in balancing brevity and comprehensiveness, generalisability and specificity, and notes that SPIRIT 2025 focuses on the most prevalent design—parallel group randomised trials—although most items apply to other designs.
  • The paper states that some items had little or no identified empirical evidence (e.g., item 1a, Title) and were included based on pragmatic or ethical rationale; it also notes overlap among SPIRIT extensions and the need for better alignment.
  • Evident from the text: this is a guidance/explanation document, not an empirical evaluation of whether SPIRIT 2025 improves protocol quality, and the exemplars are selected examples rather than a systematic sample.

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

Integrity signals

Registry

Crossref · 10.1136/bmj-2024-081660

Cites

474 of 474 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Figures

Fig 1 Schedule of enrolment, interventions, and assessments for SPIRIT 2025 statement. Recommended content can be displayed using various schematic formats. *List target time points and acceptable time windows (eg, 30±3 days) in this row. †Arrow indicates continuous delivery of intervention (eg, drug). ‡Example illustrates delivery of intervention or comparator at discrete time points (eg, psychotherapy). The brackets indicate placeholder text that should be replaced with the actual text for a specific trial. SPIRIT=Standard Protocol Items: Recommendations for Interventional Trials
Fig 1 Schedule of enrolment, interventions, and assessments for SPIRIT 2025 statement. Recommended content can be displayed using various schematic formats. *List target time points and acceptable time windows (eg, 30±3 days) in this row. †Arrow indicates continuous delivery of intervention (eg, drug). ‡Example illustrates delivery of intervention or comparator at discrete time points (eg, psychotherapy). The brackets indicate placeholder text that should be replaced with the actual text for a specific trial. SPIRIT=Standard Protocol Items: Recommendations for Interventional TrialsCC BY · PubMed Central
Fig 2 Participant schedule of enrolment, interventions, and assessments for a randomised trial of lumbar microdiscectomy and postoperative activity restrictions. Adapted from Daly et al285
Fig 2 Participant schedule of enrolment, interventions, and assessments for a randomised trial of lumbar microdiscectomy and postoperative activity restrictions. Adapted from Daly et al285CC BY · PubMed Central

Verification

Claims the paper makes

258 Not checked yet · 37 No basis given · 12 Partly supported · 12 Own interpretation · 10 Own method · 4 Supported · accuracy not yet measured

Verify all 425 references — free account

Show all 128 claims

  • Probably not a substantial claim. 161
  • It may state two separate claims as one. 79
205 of 205

  • The paper relies on this without support.

    Funding agencies, research ethics committees or institutional review boards, regulatory agencies, medical journals, systematic reviewers, and others rely on protocols to appraise the conduct and reporting of clinical trials.

    “Funding agencies, research ethics committees or institutional review boards, regulatory agencies, medical journals, systematic reviewers, and others rely on protocols to appraise the conduct and reporting of clinical trials.”

  • The paper relies on this without support.

    The usefulness of trial results to patients, healthcare providers, and policy makers depends on how well the trial was planned.

    “The usefulness of trial results to patients, healthcare providers, and policy makers depends on how well the trial was planned.”

  • The paper relies on this without support.

    Adequate reporting of a trial protocol conveys that the core methodological and logistical challenges of running the trial have been considered, and possibly dealt with, before the trial commences.

    “Adequate reporting of a trial protocol conveys that the core methodological and logistical challenges of running the trial have been considered, and possibly dealt with, before the trial commences.”

  • The paper relies on this without support.

    Trials are typically funded by drug or device companies or by scientific, private, or governmental foundations or organisations.

    “Trials are typically funded by drug or device companies (ie, industry funded) or by scientific, private, or governmental foundations or organisations (ie, non-industry funded).”

  • The paper relies on this without support.

    The various types of funders differ in their overall agenda, reasons for funding a trial, and propensity to influence the trial.

    “The various types of funders differ in their overall agenda, reasons for funding a trial, and propensity to influence the trial.”

  • The paper relies on this without support.

    A funder will typically provide direct monetary support for a trial, but funding may also be provided indirectly, such as through free trial drugs, equipment, or services.

    “A funder will typically provide direct monitory support for a trial, but funding may also be provided indirectly, such as through free trial drugs, equipment, or services (eg, statistical analysis or use of medical writers) (item 7a).”

  • The paper relies on this without support.

    The more direct the influence a trial funder with a strong interest in a specific study result has on the design, conduct, analysis, and reporting of a trial, the higher is the risk that their interests interfere with the scientific purpose of the trial.

    “The more direct the influence a trial funder (or sponsor) with a strong interest in a specific study result has on the design, conduct, analysis, and reporting of a trial, the higher is the risk that their interests interfere with the scientific purpose of the trial.”

  • The paper relies on this without support.

    Undue influence can result in methodological problems and bias.

    “Undue influence can result in methodological problems (eg, inappropriate comparator group or narrow patient eligibility criteria) and bias.”

  • The paper relies on this without support.

    Information on the types, conduct, and membership of committees helps ensure roles and responsibilities are clearly understood at the onset of the trial and facilitates communication from external parties about the trial.

    “Information on the types, conduct, and membership of such committees helps to ensure that roles and responsibilities are clearly understood at the onset of the trial and facilitates communication from external parties about the trial.”

  • The paper relies on this without support.

    Information on committees enables readers to understand the mandate and expertise of those responsible for overseeing participant safety, trial design, database integrity, and study conduct.

    “Information also enables readers to understand the mandate and expertise of those responsible for overseeing participant safety, trial design, database integrity, and study conduct.”

  • The paper relies on this without support.

    The complexity of a trial, and the need for a clear division of responsibilities and a transparent organisational structure, increase with the number of included sites and participants.

    “The complexity of a trial, and the need for a clear division of responsibilities and a transparent organisational structure, increase with the number of included sites and participants.”

  • The paper relies on this without support.

    Most trial registries allow the full protocol and statistical analysis plan to be included along with the trial’s registration record.

    “Most trial registries allow the full protocol and statistical analysis plan to be included along with the trial’s registration record.”

  • The paper relies on this without support.

    Data sharing increases transparency, facilitates reproducibility, reduces research waste, and provides data for additional exploration.

    “Data sharing increases transparency, facilitates reproducibility, reduces research waste, and provides data for additional exploration.”

  • The paper relies on this without support.

    Access to trial data is sometimes restricted for trial investigators, and not only for individuals outside the trial.

    “Access to the trial data is also sometimes restricted for trial investigators, and not only for individuals outside the trial.”

  • The paper relies on this without support.

    Results from randomised trials might be more reproducible and trustworthy when the complete final dataset can be accessed by multiple investigators who contributed the data.

    “Results from randomised trials might be more reproducible and trustworthy when the complete final dataset can be accessed by multiple investigators who contributed the data.”

  • The paper relies on this without support.

    For some multicentre trials, only the trial steering committee has access to the full trial dataset.

    “For some multicentre trials, only the trial steering committee has access to the full trial dataset.”

  • The paper relies on this without support.

    Many of these trials will allow site investigators to access the full dataset if the steering committee approves a formal request describing their plans.

    “Many of these trials will allow site investigators to access the full dataset if the steering committee approves a formal request describing their plans.”

  • The paper relies on this without support.

    Various types of funders differ in their overall agenda, reasons for funding a trial, and propensity to influence the trial.

    “The various types of funders differ in their overall agenda, reasons for funding a trial, and propensity to influence the trial.”

  • The paper relies on this without support.

    There is no clear consensus on a threshold for when funding from a source with conflicting interests becomes problematic, nor on the characteristics of a possible dose-response association.

    “There is no clear consensus on a threshold for when funding from a source with conflicting interests becomes problematic, nor on the characteristics of a possible dose-response association.”

  • The paper relies on this without support.

    Indirect financial support, such as provision of various medical services, will impact differently on various stages of a trial.

    “Indirect financial support, such as provision of various medical services, will impact differently on various stages of a trial.”

  • The paper relies on this without support.

    Reporting the funding source and the role of the trial funder provides important context for readers of a protocol when ascertaining the feasibility of the trial as well as its overall methodological quality and risk of bias.

    “Reporting the funding source and the role of the trial funder (item 3c) provides important context for readers of a protocol when ascertaining the feasibility of the trial as well as its overall methodological quality (for example, the relevance of the type of comparator intervention and eligibility criteria for patients) and risk of bias (for example, the risk of selective reporting of favourable”

  • The paper relies on this without support.

    Disclosure of interests enables a management plan to be developed and implemented and facilitates full ascertainment of conflicts of interest, risk of bias, and overall methodological quality.

    “Disclosure of interests enables a management plan to be developed and implemented and facilitates full ascertainment of conflicts of interest, risk of bias, and overall methodological quality—for example, the relevance of the type of comparator intervention.”

  • The paper relies on this without support.

    Journal publication remains a key means of reporting trial results.

    “Journal publication remains a key means of reporting trial results.”

  • The paper relies on this without support.

    Open access publishing provides patients, the public, and other interested parties with immediate and free access to read the trial’s results, with reduced copyright barriers.

    “Open access publishing provides patients, the public, and other interested parties with immediate and free access to read the trial’s results, with reduced copyright barriers.”

  • The paper relies on this without support.

    Trials would not be possible without the voluntary contributions of participants.

    “Trials would not be possible without the voluntary contributions of participants.”

  • The paper relies on this without support.

    The ethical and scientific justification for a trial depends on the uncertainty of the benefit or harm of the intervention to be tested, which depends on what is known on the topic before the trial commences.

    “The ethical and scientific justification for a trial depends on the uncertainty of the benefit or harm of the intervention to be tested. This uncertainty depends in turn on what is known on the topic before the trial commences.”

  • The paper relies on this without support.

    Background information is relevant to funders, research ethics committees or institutional review boards, and other groups who evaluate the scientific and ethical basis for trial approval.

    “It is also relevant to funders, research ethics committees or institutional review boards, and other groups who evaluate the scientific and ethical basis for trial approval.”

  • The paper relies on this without support.

    What constitutes usual care differs substantially across clinical settings.

    “What constitutes usual care differs substantially across clinical settings.”

  • The paper relies on this without support.

    The environment in which a trial will be conducted may differ considerably from the setting in which the trial’s results are later used to guide practice and policy.

    “The environment in which the trial will be conducted may differ considerably from the setting in which the trial’s results are later used to guide practice and policy.”

  • The paper relies on this without support.

    The appropriateness of restrictive participant selection depends on the objectives of the trial.

    “The appropriateness of restrictive participant selection depends on the objectives of the trial.218”

  • The paper relies on this without support.

    Composite outcomes increase event rates and statistical power.

    “Although composite outcomes increase event rates and statistical power, their relevance and interpretation can be unclear if the individual component outcomes vary greatly for event rates, direction of effect, importance to patients, or amount of missing data.”

  • The paper relies on this without support.

    The relevance and interpretation of composite outcomes can be unclear if the individual component outcomes vary greatly for event rates, direction of effect, importance to patients, or amount of missing data.

    “Although composite outcomes increase event rates and statistical power, their relevance and interpretation can be unclear if the individual component outcomes vary greatly for event rates, direction of effect, importance to patients, or amount of missing data.”

  • The paper relies on this without support.

    In explanatory randomised trials, the intervention is usually highly standardised, with close monitoring of fidelity and adherence and use of strategies to increase them.

    “In explanatory randomised trials, where the aim is to determine the treatment effect under ideal circumstances, the intervention is usually highly standardised, with close monitoring of fidelity and adherence and use of strategies to increase them.”

  • The paper relies on this without support.

    Low fidelity and adherence can have a substantial effect on statistical power and interpretation of results.

    “Although no consensus exists on the acceptable minimum fidelity and adherence level in explanatory randomised trials, low fidelity and adherence can have a substantial effect on statistical power and interpretation of results.”

  • The paper relies on this without support.

    In pragmatic randomised trials, interventions are usually highly flexible, with less focus on measuring fidelity and adherence and less use of strategies to maintain or improve them.

    “In pragmatic randomised trials, which aim to determine the treatment effect in typical clinical settings, interventions are usually highly flexible, with less focus on measuring fidelity and adherence and less use of strategies to maintain or improve them.”

  • The paper relies on this without support.

    In a randomised trial, a key goal is to have comparable study groups that differ only by the intervention being evaluated.

    “In a randomised trial, a key goal is to have comparable study groups that differ only by the intervention being evaluated.”

  • The paper relies on this without support.

    Assessing fidelity and adherence to the intervention or comparator, or at least recording the most important components, is necessary to understand what was administered to participants.

    “Nevertheless, assessing fidelity and adherence to the intervention or comparator, or at least recording the most important components, is necessary to understand what was administered to participants.”

  • The paper relies on this without support.

    Assessing fidelity and adherence is particularly important for complex interventions when diversity in the implementation of the intervention or comparator is expected.

    “This is particularly important for complex interventions when diversity in the implementation of the intervention or comparator is expected.”

  • The paper relies on this without support.

    Recording key elements of the intervention is essential to provide a relevant description of the intervention that was provided when the trial was completed.

    “This information is essential to provide a relevant description of the intervention that was provided when the trial was completed.”

  • The paper relies on this without support.

    Trials may differ in what is meant by the intervention being evaluated.

    “Trials may differ in what is meant by the intervention being evaluated.”

  • The paper relies on this without support.

    In some trials with a marked explanatory approach, the intervention might be defined narrowly as the experimental intervention tested.

    “In some trials (with a marked explanatory approach), the intervention might be defined narrowly as the experimental intervention tested.”

  • The paper relies on this without support.

    In other trials with a more pragmatic approach, the intervention might be defined as the experimental intervention plus allowed concomitant interventions and procedures, such as rescue interventions.

    “In other trials (with a more pragmatic approach), the intervention might be defined as the experimental intervention plus allowed concomitant interventions and procedures, such as rescue interventions.”

  • The paper relies on this without support.

    In some multicentre trials an intervention could be added to usual care that might differ considerably in content between centres.

    “Also, in some multicentre trials an intervention could be added to usual care that might differ considerably in content between centres (item 15a).”

  • The paper relies on this without support.

    To increase statistical power, harms outcomes are sometimes grouped in a composite outcome.

    “To increase statistical power, harms outcomes are sometimes grouped in a composite outcome (eg, cardiovascular events).”

  • The paper relies on this without support.

    Assessing the risk of bias domain for deviations from the intended intervention requires a clear understanding of deviations that occur as planned in the protocol and deviations that arise owing to the experimental context.

    “Assessing this domain requires a clear understanding of deviations that occur as planned in the protocol and deviations that arise owing to the experimental context.”

  • The paper relies on this without support.

    Key considerations determining the need to report an adverse event to external groups include severity, potential causality, and whether the adverse event represents an unexpected event.

    “Key considerations determining the need to report an adverse event to external groups include severity, potential causality, and whether the adverse event represents an unexpected event.”

  • The paper relies on this without support.

    The sample size calculation is generally based on one primary outcome.

    “The sample size calculation is generally based on one primary outcome.”

  • The paper relies on this without support.

    The results for primary and secondary outcomes can be substantially affected by the choice of methods used for analysis.

    “The results for the primary and secondary outcomes can be substantially affected by the choice of methods used for analysis, which should align with the trial objectives, and, if used, the estimands framework (item 10).”

  • The paper relies on this without support.

    When more than one analysis method is applied to an outcome, there is potential for inappropriately selecting the approach that leads to the most “interesting” finding.

    “When more than one analysis method is applied to an outcome, there is potential for inappropriately selecting the approach that leads to the most “interesting” finding.”

  • The paper relies on this without support.

    Attrition bias can be avoided when outcome data are obtained from all participants and included in the analysis, regardless of adherence to the protocol.

    “Attrition bias can be avoided when outcome data are obtained from all participants and included in the analysis, regardless of adherence to the protocol.”

  • The paper relies on this without support.

    Imputation of missing outcomes does not guarantee avoidance of bias except under strong assumptions about the missing data.

    “Although imputation of missing outcomes would allow an intention-to-treat analysis, it does not guarantee avoidance of bias except under strong assumptions about the missing data.”

  • The paper relies on this without support.

    Methods for handling missing data (including analysis of complete cases only) typically rely on unverifiable assumptions.

    “Methods for handling missing data (including analysis of complete cases only) typically rely on unverifiable assumptions.”

  • The paper relies on this without support.

    If randomised participants with missing data are omitted (a complete case analysis), then the analysis deviates from the intention-to-treat principle and can introduce bias depending on the amount of missing data and the mechanism resulting in the missing data.

    “If randomised participants with missing data are omitted (a complete case analysis), then the analysis deviates from the intention-to-treat principle and can introduce bias (item 27b) depending on the amount of missing data and the mechanism resulting in the missing data.”

  • The paper relies on this without support.

    A complete case analysis diminishes statistical power by reducing the sample size.

    “A complete case analysis also diminishes statistical power by reducing the sample size.”

  • The paper relies on this without support.

    Categorisation of continuous variables to define subgroups leads to loss of information and a reduction of statistical power.

    “Categorisation also leads to the loss of information and a reduction of statistical power.”

  • The paper relies on this without support.

    Cut-off points to define subgroups are often arbitrarily chosen without clinical or biological rationale.

    “Cut-off points to define subgroups are often arbitrarily chosen without clinical or biological rationale.”

  • The paper relies on this without support.

    Personal information about trial participants is acquired during the process of recruitment, eligibility screening, and data collection.

    “Personal information about trial participants is acquired during the process of recruitment, eligibility screening, and data collection.”

  • The paper relies on this without support.

    Much of the personal information collected consists of private details of which many people wish to maintain control, such as health status, personal genotype, and social and family history.

    “Much of this information consists of private details of which many people wish to maintain control, such as their health status, personal genotype, and social and family history.”

  • The paper relies on this without support.

    Provision of care for ancillary needs reflects the fact that participants implicitly, but unavoidably, entrust certain aspects of their health to the research team.

    “Provision of care for ancillary needs reflects the fact that participants implicitly, but unavoidably, entrust certain aspects of their health to the research team.”

  • The paper relies on this without support.

    The scope of entrustment varies depending on the nature of the trial (eg, setting, health condition under study, investigations performed).

    “The scope of entrustment will vary depending on the nature of the trial (eg, setting, health condition under study, investigations performed).”

  • The paper relies on this without support.

    Additional factors that influence the strength of the responsibility to provide ancillary care include participants’ vulnerabilities, uncompensated burdens and harms, the intensity and duration of the participant-researcher relationship, and the degree to which participants are uniquely dependent on the research team for healthcare.

    “Additional factors that influence the strength of the responsibility to provide ancillary care include participants’ vulnerabilities, uncompensated burdens and harms, the intensity and duration of the participant-researcher relationship, and the degree to which participants are uniquely dependent on the research team for healthcare.”

  • The paper relies on this without support.

    Public access to trial protocols enables readers to compare what was planned in a protocol with what was reported in a publication.

    “Public access to trial protocols (in addition to trial publications) enables readers (eg, patients, peer reviewers, editors, healthcare providers, funders, researchers conducting systematic reviews, and guideline developers) to compare what was planned in a protocol with what was reported in a publication.”

  • The paper relies on this without support.

    The review of a clinical trial protocol is typically conducted by a formal research ethics board or committee in accordance with jurisdictional policy.

    “The review is typically conducted by a formal research ethics board or committee (also called an institutional review board) in accordance with jurisdictional policy.”

  • The paper relies on this without support.

    The acquisition and storage of data and biological specimens for ancillary studies are increasingly common in the context of clinical trials.

    “The acquisition and storage of data and biological specimens for ancillary studies are increasingly common in the context of clinical trials.”
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  4. Schulz KF Grimes DA . Essential Concepts in Clinical Research: randomized controlled trials and observational epidemiology. 2nd ed. Elsevier, 2019.
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  8. Fayter D, McDaid C, Ritchie G, Stirk L, Eastwood A. Systematic review of barriers, modifiers and benefits involved in participation in cancer trials. Centre for Reviews and Dissemination report 31. University of York; 2006. Report No 31.

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Metadata

Authors
Hróbjartsson, A., 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., & Chan, A.-W.
Affiliations
  • University of Southern Denmark (DK)
  • Inserm (FR)
  • University of Oxford (GB)
  • Ottawa Hospital Research Institute (CA)
  • University of North Carolina at Chapel Hill (US)
  • Jawaharlal Institute of Post Graduate Medical Education and Research (IN)
  • Rutgers, The State University of New Jersey (US)
  • Society for Applied Studies (IN)
  • University of Toronto (CA)
  • 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)
  • Brigham and Women's Hospital (US)
  • Hospital for Sick Children (CA)
  • MaRS (CA)
  • Duke University (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
Hróbjartsson, Asbjørn
ORCID
Venue
BMJ
Publisher
BMJ
Published
2025-04-28
Volume
389
Pages
e081660
ISSN
1756-1833 (ISSN-L)
DOI
10.1136/bmj-2024-081660
PMC
PMC12128891
OpenAlex
W4409954495
Semantic Scholar
b8007d80648965edd52f9adabbed370abea54993
Cited by
171
References
469
Citations by year
2026: 140 · 2025: 31
FWCI
109.37
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by)
  • Pure Amsterdam UMC (acceptedVersion, cc-by)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion, cc-by)
  • Bond University Research Portal (Bond University) (submittedVersion, cc-by)
  • UCL Discovery (University College London) (submittedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by)
Funders
  • Pfizer (GA6120A8)
  • National Institute for Health and Care Research
  • Department of Health and Social Care
  • University of Queensland
  • Medical Research Council (MC_UU_00004/09)
  • National Health and Medical Research Council (1140756, 1037220)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
trial protocol reporting, reporting guidelines, randomised trials, trial planning, reporting quality

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.

A language model drew the claims from the paper on 2026-10-07, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).

A second model labelled each claim on 2026-10-07 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).

Cited sources are checked with a language model’s help (gpt-6-sol).

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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