Viewpoints of investigator on CONSORT 2025 statement-updated guideline for reporting randomized trials

Introduction

On April 14, 2025, The BMJ, JAMA, The Lancet, Nature Medicine, and PLoS Medicine simultaneously published the updated Consolidated Standards of Reporting Trials (CONSORT) 2025 statement, accompanied by an explanatory and elaboration article in The BMJ. The updated CONSORT 2025 consists of a 30-item checklist of essential reporting items and a participant flow diagram, reflecting recent methodological advancements and user feedback. It aims to improve the use, understanding, and dissemination of CONSORT, providing authors with guidance to enhance the completeness and transparency of randomized trial reports (1-6).

In this editorial, we briefly summarize the aims, development, and recent updates of CONSORT, evaluate the application of CONSORT 2025 in clinical practice, and analyze limitations in its development from an investigator’s perspective. Additionally, we discuss challenges and offer recommendations for the use of CONSORT 2025 to inform clinical practice in randomized trials and future updates of the guideline.

Aim, development, and update of CONSORT

As well-designed and well-conducted randomized trials represent the highest-quality evidence for the effectiveness of healthcare interventions, the CONSORT statement was developed to ensure transparent, complete, and high-quality reporting (2).

To address the problem of incomplete and unclear reporting of randomized trials observed in the early 1990s, the CONSORT statement was first published in 1996, with subsequent updates in 2001 and 2010 (7-10). More than a decade has passed since the release of the CONSORT 2010 Statement. Periodic updates are essential to incorporate methodological advancements and user feedback, culminating in the current CONSORT 2025 update. Over the course of its three major revisions, the CONSORT statement has been incrementally improved, featuring an increasingly comprehensive checklist and the addition of a participant flow diagram. In CONSORT 2010, approximately 20 CONSORT extensions had been developed, while the updates to these expanded versions for CONSORT 2025 are still ongoing.

Based on CONSORT 2010, the main changes to CONSORT 2025 include seven newly added checklist items, three revised items, one deleted item, and several integrated items from key CONSORT extensions. These changes primarily include: (I) enhanced transparency regarding statistical analysis plans, funding, and conflicts of interest; (II) explicit requirements for data and material accessibility and sharing; (III) detailed descriptions of patient and public involvement at all stages of the trial; (IV) clearer definitions and assessments of both systematic and non-systematic harms; and (V) requirement of other changes, and group or number of participants to clear and transparent randomized trials.

Application of CONSORT 2025 in clinical practice

Investigators and physicians utilizing CONSORT 2025 should pay particular attention to several important aspects. First, it is strongly recommended to consult the CONSORT 2025 Explanation and Elaboration document alongside the main guideline to ensure a thorough understanding of its contents and recent changes. Second, CONSORT 2025 serves not only as a guideline for writing, reporting, and evaluating manuscripts of randomized trials, but also as a crucial instruction for trial design. Prior to initiating randomized trials, both CONSORT and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) should be thoroughly understood and adhered to, especially with respect to the newly added item 8, which emphasizes patient or public involvement in the design, conduct, and reporting of trials. Third, before finalizing the design of a randomized trial, investigators and physicians should select the most appropriate version of CONSORT 2025 based on the specific trial design and detail situation. CONSORT 2025 provides a guidance for all of the randomized trials, but focuses on the most common type, the two-group parallel design. Specialized trial designs require adherence to relevant expanded versions. Until the updated expanded versions are released, the existing CONSORT extensions should be used. Finally, throughout the trial design process, investigators should anticipate the challenges associated with conducting and reporting trials in accordance with the updated guideline, particularly regarding newly revised items. Adequate resources, such as funding, research personnel, comprehensive protocols, and contingency plans, should be secured in advance.

Limitations of the development process of CONSORT 2025

Relationship with SPIRIT guidelines

On April 28–29, 2025, JAMA, The Lancet, The BMJ, Nature Medicine, and PLoS Medicine simultaneously published the updated guideline for protocols of randomized trials of the SPIRIT 2025 statement, with an evidence-based checklist of 34 minimum items and a diagram (11). As the SPIRIT and CONSORT statements are conceptually linked, with overlapping content and similar dissemination and implementation strategies, the two groups have formed into one group, and updated the SPIRIT 2013 and CONSORT 2010 statements together to further align checklist and protocol. Both CONSORT and SPIRIT are living guidelines to improve clinical trial quality, but with distinct focuses. CONSORT ensures transparent reporting of completed randomized trials in publications, mainly covering design, methods, and results. SPIRIT guides the design of ethical and scientifically rigorous trial protocols before trials begin (12). Together, they cover the full trial process from planning to publication. However, approximately 10 items overlap directly (e.g., design, intervention, outcome), and some indirectly in data analysis, which may add workload for investigators. Furthermore, the 2-week gap between the release dates of the guidelines means investigators may need to work with the updated CONSORT and the legacy SPIRIT concurrently.

Feasibility concerns regarding patient involvement requirements

The updated guideline emphasizes the inclusion of patients or public representatives at all stages of clinical trial design, implementation, and interpretation of results. However, this requirement may unintentionally introduce educational and socioeconomic selection biases. Given the global disparity in health literacy, patient representatives are likely to be disproportionately drawn from more highly educated and higher-income populations. Such systemic biases may lead to skewed health preference data. For example, highly educated participants in oncology trials may favor aggressive therapies over conventional treatments, which could compromise the generalizability of trial efficacy assessments to broader patient populations (13).

Challenges in transitioning between versions

According to the International Committee of Medical Journal Editors guidelines, ongoing trials should adhere to the reporting standards under which they were originally registered. However, CONSORT 2025 does not specify a detailed implementation date or provide guidance concerning the coexistence period of the old and new versions. Given the substantial number of ongoing randomized trials globally, abrupt enforcement of the 2025 criteria risks rendering long-term studies non-compliant. Premature adoption may result in rejection of manuscripts by journals enforcing the new standards, while prolonged transition periods may introduce heterogeneity in quality assessment.

Implementation barriers

The updated version of CONSORT undoubtedly demands greater effort and higher standards from investigators, journal editors, and peer reviewers. The implementation of CONSORT 2025 necessitates enhanced expertise among journal editors and peer reviewers to critically appraise adherence to its updated criteria. Editors and reviewers must now determine whether authors have substantively addressed reporting standards, such as the assessment of harms or specifying the number of participants for each primary and secondary outcome, rather than merely inserting checklist-compliant phrases. This gap risks incentivizing a “box-ticking” approach, whereby investigators and physicians mechanically replicate standardized language without contextualizing trial-specific challenges.

Standardization needs for multilingual adaptations

Current translations of CONSORT 2010 rely on decentralized regional initiatives and cover no more than 15 countries. In other non-English-speaking countries and regions, users are required to translate CONSORT themselves, potentially resulting in misunderstandings and inconsistencies in critical terminology. To enhance cross-cultural applicability, it is necessary for the CONSORT Working Group to actively engage more non-English-speaking experts in future updates.

Recommendations for implementation of CONSORT 2025

Although CONSORT 2025 aims to enhance the transparency and quality of clinical trial reports, several limitations and challenges persist that require targeted strategies for effective implementation. First, participation methods should be simplified, and standardized templates should be developed to assist investigators in recording perspectives of diverse stakeholder groups, thereby ensuring greater representativeness, especially in light of the mandatory requirement for patient involvement (14). Second, it is advisable to establish a transition period during which both the old and updated versions can be used, since mandatory immediate adoption may create compliance risks for ongoing trials. Trials registered prior to the transition deadline should be allowed to continue utilizing the previous version with additional explanations regarding any discrepancies, whereas newly registered trials must comply fully with the updated guidelines. Third, the newly introduced requirements for statistical analysis, harm assessment, and other details may result in merely superficial compliance. Therefore, step-by-step guidelines and examples of high-quality trial reports should be included as supplementary materials in future updates (15). Additionally, it is recommended that future updates to CONSORT and SPIRIT be released simultaneously to avoid confusion. Finally, measures such as regular specialized training sessions and the involvement of professional academic editors and reviewers should be implemented to further enhance the effectiveness of CONSORT 2025 adoption.

Summary

CONSORT enhances the clarity and transparency of randomized trial reporting and accurately reflects the design, conduct, and analysis of trials (16). Despite its advancements, the CONSORT 2025 Statement still exhibits certain limitations and faces some challenges in its application. Consequently, investigators, authors, editors, reviewers, and other potential users are encouraged to collaborate in efforts to improve trial quality and contribute to the ongoing development of CONSORT.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Journal of Thoracic Disease. The article did not undergo external peer review.

Funding: This study was supported by the 2025 Shanghai Municipal Health System Party Building Research Project (No. wj2025074).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-871/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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