CONSORT 2025 Statement: Updated Guideline for Reporting Randomised Trials

doi:10.3969/j.issn.1673-5765.2025.05.009

Abstract

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 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 [template for intervention description and replication (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 the 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.
Conclusions 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.

Key words: Randomized trial; Clinical research; Report; Guideline

摘要： 背景设计良好且执行得当的随机试验被认为是评估医疗干预措施效益最可靠的证据。然而，目前此类试验的报告质量并不理想。CONSORT声明于1996年首次发布，并提供了1份随机试验报告应包含的必备条目清单，旨在提高随机试验报告质量。该声明于2001年和2010年进行了两次更新。本文介绍最新的CONSORT 2025声明，旨在反映近期的方法学进展及终端用户的意见反馈。
方法我们对相关文献进行了范围综述，并制定了包括CONSORT相关实证和理论证据的专用数据库，用于生成可能需要修订的清单条目列表。该列表整合了现有CONSORT扩展（不良事件、结局、非药物治疗）主要作者提供的建议、其他相关报告指南[如干预措施描述与复制模板（template for intervention description and replication，TIDieR）]及其他来源（如个人交流）的建议。清单的潜在修订内容通过由317名国际参与者组成的大型在线德尔菲调查（共3轮）进行评估，随后由30名国际专家参与的线上专家共识会议进行进一步的讨论。
结果本次更新对CONSORT清单进行了实质性修订：新增7个条目、修订3个条目、删除1个条目，并整合了若干重要的CONSORT扩展条目。同时，我们对清单结构进行了调整，新增了“开放科学”板块。最终形成的CONSORT 2025声明包含1份含30个条目的随机试验报告信息清单，以及1个用于记录试验参与者的流程图。为了便于推广应用，本次更新还开发了CONSORT 2025声明随机试验报告信息清单的扩展版本，详细列出了每个条目的关键要素。
结论作者、编辑、审稿人及其他潜在用户应在撰写和评估RCT稿件时参考CONSORT 2025声明，以确保试验报告内容清晰、透明。

关键词: 随机试验; 临床研究; 报告; 指南

CLC Number:

Translator: LI Hui, XIE Xuewei. CONSORT 2025 Statement: Updated Guideline for Reporting Randomised Trials[J]. Chinese Journal of Stroke, 2025, 20(5): 620-629.

译者：李辉, 谢雪微. CONSORT 2025声明：随机试验报告指南更新版[J]. 中国卒中杂志, 2025, 20(5): 620-629.

References

[1] ALTMAN D G. Better reporting of randomised controlled trials：the CONSORT statement[J]. BMJ，1996，313（7057）：570-571.
[2] TURNER L，SHAMSEER L，ALTMAN D G，et al. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals？A Cochrane review[J/OL]. Syst Rev，2012，1：60[2025-04-20]. https://doi.org/10.1186/2046-4053-1-60.
[3] GLASZIOU P，ALTMAN D G，BOSSUYT P，et al. Reducing waste from incomplete or unusable reports of biomedical research[J]. Lancet，2014，383（9913）：267-276.
[4] SAVOVIĆ J，JONES H E，ALTMAN D G，et al. Influence of reported study design characteristics on intervention effect estimates from randomized，controlled trials[J]. Ann Intern Med，2012，157（6）：429-438.
[5] BEGG C，CHO M，EASTWOOD S，et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA，1996，276（8）：637-639.
[6] MOHER D，SCHULZ K F，ALTMAN D，et al. The CONSORT statement：revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. JAMA，2001，285（15）：1987-1991.
[7] ALTMAN D G，SCHULZ K F，MOHER D，et al. The revised CONSORT statement for reporting randomized trials：explanation and elaboration[J]. Ann Intern Med，2001，134（8）：663-694.
[8] SCHULZ K F，ALTMAN D G，MOHER D. CONSORT 2010 statement：updated guidelines for reporting parallel group randomized trials[J]. Ann Intern Med，2010，152（11）：726-732.
[9] MOHER D，HOPEWELL S，SCHULZ K F，et al. CONSORT 2010 explanation and elaboration：updated guidelines for reporting parallel group randomised trials[J/OL]. BMJ，2010，340：c869[2025-04-20]. https://doi.org/10.1136/bmj.c869.
[10] CHAN A W，TETZLAFF J M，ALTMAN D G，et al. SPIRIT 2013 statement：defining standard protocol items for clinical trials[J]. Ann Intern Med，2013，158（3）：200-207.
[11] CHAN A W，TETZLAFF J M，GØTZSCHE P C，et al. SPIRIT 2013 explanation and elaboration：guidance for protocols of clinical trials[J/OL]. BMJ，2013，346：e7586[2025-04-20]. https://doi.org/10.1136/bmj.e7586.
[12] PLINT A C，MOHER D，MORRISON A，et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials？A systematic review[J]. Med J Aust，2006，185（5）：263-267.
[13] DECHARTRES A，TRINQUART L，ATAL I，et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews：research on research study[J/OL]. BMJ，2017，357：j2490[2025-04-20]. https://doi.org/10.1136/bmj.j2490.
[14] MOHER D，JONES A，LEPAGE L，et al. Use of the CONSORT statement and quality of reports of randomized trials：a comparative before-and-after evaluation[J]. JAMA，2001，285（15）：1992-1995.
[15] SIMERA I，ALTMAN D G. Writing a research article that is“fit for purpose”：EQUATOR network and reporting guidelines[J/OL]. Ann Intern Med，2009，151（4）：JC2-2[2025-04-20]. https://doi.org/10.7326/0003-4819-151-4-200908180-02002.
[16] HOPEWELL S，BOUTRON I，CHAN A W，et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials[J]. Nat Med，2022，28（9）：1740-1743.
[17] CHAN A W，BOUTRON I，HOPEWELL S，et al. SPIRIT 2025 statement：updated guideline for protocols of randomised trials[J/OL]. BMJ，2025，389：e081477[2025-04-20]. https://doi.org/10.1136/bmj-2024-081477.
[18] MOHER D，SCHULZ K F，SIMERA I，et al. Guidance for developers of health research reporting guidelines[J/OL]. PLoS Med，2010，7（2）：e1000217[2025-04-20]. https://doi.org/10.1371/journal.pmed.1000217.
[19] TUNN R，BOUTRON I，CHAN A W，et al. Methods used to develop the SPIRIT 2024 and CONSORT 2024 statements[J/OL]. J Clin Epidemiol，2024，169：111309[2025-04-20]. https://doi.org/10.1016/j.jclinepi.2024.111309.
[20] NEJSTGAARD C H，BOUTRON I，CHAN A W，et al. A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010[J/OL]. J Clin Epidemiol，2023，155：48-63[2025-04-20]. https://doi.org/10.1016/j.jclinepi.2023.01.003.
[21] ØSTENGAARD L，BARRIENTOS A，BOUTRON I，et al. Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010[J/OL]. Cochrane Evid Synth Methods，2024，2：e12057[2025-04-20]. https://doi.org/10.1002/cesm.12057.
[22] JUNQUEIRA D R，ZORZELA L，GOLDER S，et al. CONSORT harms 2022 statement，explanation，and elaboration：updated guideline for the reporting of harms in randomized trials[J/OL]. J Clin Epidemiol，2023，158：149-165[2025-04-20]. https://doi.org/10.1016/j.jclinepi.2023.04.005.
[23] BUTCHER N J，MONSOUR A，MEW E J，et al. Guidelines for reporting outcomes in trial reports：the CONSORT-outcomes 2022 extension[J]. JAMA，2022，328（22）：2252-2264.
[24] GHOSN L，BOUTRON I，RAVAUD P. Consolidated standards of reporting trials（CONSORT）extensions covered most types of randomized controlled trials，but the potential workload for authors was high
[J/OL]. J Clin Epidemiol，2019，113：168-175[2025-04-20]. https://doi.org/10.1016/j.jclinepi.2019.05.030.
[25] BOUTRON I，ALTMAN D G，MOHER D，et al. CONSORT statement for randomized trials of nonpharmacologic treatments：a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts[J]. Ann Intern Med，2017，167（1）：40-47.
[26] HOFFMANN T C，GLASZIOU P P，BOUTRON I，et al. Better reporting of interventions：template for intervention description and replication（TIDieR）checklist and guide[J/OL]. BMJ，2014，348：g1687[2025-04-20]. https://doi.org/10.1136/bmj.g1687.
[27] HOPEWELL S，CHAN A W，COLLINS G S，et al. CONSORT 2025 explanation and elaboration：updated guideline for reporting randomised trials[J/OL]. BMJ，2025，389：e081124[2025-04-20]. https://doi.org/10.1136/bmj-2024-081124.
[28] BARNES C，BOUTRON I，GIRAUDEAU B，et al. Impact of an online writing aid tool for writing a randomized trial report：the COBWEB（CONSORT-based WEB tool）randomized controlled trial[J/OL]. BMC Med，2015，13：221[2025-04-20]. https://doi.org/10.1186/s12916-015-0460-y.
[29] CHAUVIN A，RAVAUD P，MOHER D，et al. Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool（COBPeer）versus the usual peer-review process：a cross-sectional diagnostic study[J/OL]. BMC Med，2019，17（1）：205[2025-04-20]. https://doi.org/10.1186/s12916-019-1436-0.
[30] PAGE M J，MCKENZIE J E，BOSSUYT P M，et al. The PRISMA 2020 statement：an updated guideline for reporting systematic reviews[J/OL]. Syst Rev，2021，10（1）：89[2025-04-20]. https://doi.org/10.1136/bmj.n71.
[31] DIMAIRO M，PALLMANN P，WASON J，et al. The adaptive designs CONSORT extension（ACE）statement：a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design[J/OL]. Trials，2020，21（1）：528[2025-04-20]. https://doi.org/10.1186/s13063-020-04334-x.
[32] CAMPBELL M K，PIAGGIO G，ELBOURNE D R，et al. CONSORT 2010 statement：extension to cluster randomised trials[J/OL]. BMJ，2012，345：e5661[2025-04-20]. https://doi.org/10.1136/bmj.e5661.
[33] DWAN K，LI T J，ALTMAN D G，et al. CONSORT 2010 statement：extension to randomised crossover trials[J/OL]. BMJ，2019，366：l4378[2025-04-20]. https://doi.org/10.1136/bmj.l4378.
[34] YAP C，SOLOVYEVA O，DE BONO J，et al. Enhancing reporting quality and impact of early phase dose-finding clinical trials：CONSORT dose-finding extension（CONSORT-DEFINE）guidance[J/OL]. BMJ，2023，383：e076387[2025-04-20]. https://doi.org/10.1136/bmj-2023-076387.
[35] KAHAN B C，HALL S S，BELLER E M，et al. Reporting of factorial randomized trials：extension of the CONSORT 2010 statement[J]. JAMA，2023，330（21）：2106-2114.
[36] PIAGGIO G，ELBOURNE D R，POCOCK S J，et al. Reporting of noninferiority and equivalence randomized trials：extension of the CONSORT 2010 statement[J]. JAMA，2012，308（24）：2594-2604.
[37] ZWARENSTEIN M，TREWEEK S，GAGNIER J J，et al. Improving the reporting of pragmatic trials：an extension of the CONSORT statement[J/OL]. BMJ，2008，337：a2390[2025-04-20]. https://doi.org/10.1136/bmj.a2390.
[38] JUSZCZAK E，ALTMAN D G，HOPEWELL S，et al. Reporting of multi-arm parallel-group randomized trials：extension of the CONSORT 2010 statement[J]. JAMA，2019，321（16）：1610-1620.
[39] VOHRA S，SHAMSEER L，SAMPSON M，et al. CONSORT extension for reporting N-of-1 trials（CENT）2015 statement[J/OL]. BMJ，2015，350：h738[2025-04-20]. https://doi.org/10.1136/bmj.h1738.
[40] ELDRIDGE S M，CHAN C L，CAMPBELL M J，et al. CONSORT 2010 statement：extension to randomised pilot and feasibility trials[J/OL]. BMJ，2016，355：i5239[2025-04-20]. https://doi.org/10.1136/bmj.i5239.
[41] PANDIS N，CHUNG B，SCHERER R W，et al. CONSORT 2010 statement：extension checklist for reporting within person randomised trials[J/OL]. BMJ，2017，357：j2835[2025-04-20]. https://doi.org/10.1136/bmj.j2835.
[42] CALVERT M，BLAZEBY J，ALTMAN D G，et al. Reporting of patient-reported outcomes in randomized trials：the CONSORT PRO extension[J]. JAMA，2013，309（8）：814-822.
[43] MANYARA A M，DAVIES P，STEWART D，et al. Reporting of surrogate endpoints in randomised controlled trial reports（CONSORT-surrogate）：extension checklist with explanation and elaboration[J/OL]. BMJ，2024，386：e078524[2025-04-20]. https://doi.org/10.1136/bmj-2023-078524.
[44] MONTGOMERY P，GRANT S，MAYO-WILSON E，et al. Reporting randomised trials of social and psychological interventions：the CONSORT-SPI 2018 extension[J/OL]. Trials，2018，19（1）：407[2025-04-20]. https://doi.org/10.1186/s13063-018-2733-1.
[45] HOPEWELL S，CLARKE M，MOHER D，et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts：explanation and elaboration[J/OL]. PLoS Med，2008，5（1）：e20[2025-04-20]. https://doi.org/10.1371/journal.pmed.0050020.
[46] WELCH V A，NORHEIM O F，JULL J，et al. CONSORT-equity 2017 extension and elaboration for better reporting of health equity in randomised trials[J/OL]. BMJ，2017，359：j5085[2025-04-20]. https://doi.org/10.1136/bmj.j5085.
[47] HIRST A，ALTMAN D G. Are peer reviewers encouraged to use reporting guidelines？A survey of 116 health research journals[J/OL]. PLoS One，2012，7（4）：e35621[2025-04-20]. https://doi.org/10.1371/journal.pone.0035621.
[48] GOODMAN S N，FANELLI D，IOANNIDIS J P A. What does research reproducibility mean？[J/OL]. Sci Transl Med，2016，8（341）：12[2025-04-20]. https://doi.org/10.1126/scitranslmed.aaf5027.