CONSORT 2025: The Updated Trial Reporting Guideline and What It Requires of Authors

In April 2025, the CONSORT statement received its first comprehensive revision in fifteen years. The update was published simultaneously in five major medical journals: The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine. That kind of coordinated launch is unusual, and it signals something about how seriously the reporting guidelines community wanted the update taken. The CONSORT 2025 checklist adds seven new items, revises three existing ones, removes one, and restructures the whole document around a new open science section. Its companion guideline, SPIRIT 2025, covering the content of randomized trial protocols rather than reports, was released around the same time.

If you have been writing and submitting trial papers over the past year, you have probably noticed that more journals now ask for the CONSORT 2025 checklist rather than the 2010 version. Some journals still accept either, but the direction is clear. Understanding what the 2025 version actually requires, not just that a checklist exists, will save you revision cycles and help you avoid common gaps that reviewers are increasingly trained to spot.

Why 2010 Had Run Its Course

The 2010 CONSORT statement was solid work for its time, but the research environment it was written for looked quite different from today's. Open data was aspirational rather than expected. Pre-registration of statistical analysis plans was uncommon outside of large regulatory trials. Patient involvement in trial design was not yet an established expectation in most fields. And the scale of harms under-reporting in published trials had not yet been fully documented. Each of these gaps became more visible over the following decade as journals, funders, and regulatory agencies accumulated evidence of the reporting problems the old checklist could not catch.

The revision process involved over 300 individuals in a Delphi consensus exercise and a formal expert meeting, drawing on feedback from trialists, statisticians, methodologists, patient advocates, journal editors, and CONSORT extension leads. Fifteen years of evidence on where published trials consistently fell short shaped which gaps the new items target. The result is a checklist that is harder to satisfy with boilerplate text, because several of the new items require manuscript-specific information that cannot be copy-pasted from a template.

The New Open Science Section

The most structural change in CONSORT 2025 is not a single item. It is the grouping of several items into a new dedicated section on open science. This section brings together trial registration, the statistical analysis plan, and data sharing. The logic is that these three things address the same underlying problem from different angles: readers should be able to evaluate whether the analysis they are reading reflects the trial that was registered and planned, and should be able to re-examine the underlying data if needed.

Trial registration was already in the 2010 checklist. The 2025 version asks for more than just the registration number. It expects reporting of the registry name, a hyperlink, and enough detail for readers to locate the original registration record. Where there is a gap between what was registered and what was reported, authors are now expected to explain why. That explanation belongs in the manuscript, not in a cover letter that disappears once the paper is submitted.

The statistical analysis plan (SAP) item asks authors to state where the pre-specified analysis plan can be accessed. For trials that registered a SAP in a public repository or linked one to their registration record, this is a straightforward citation. For trials where the SAP was not made public, the item still expects authors to describe how the analysis approach was determined and whether it changed from what was planned. This is not a technicality. Selective outcome reporting remains one of the most common and most consequential forms of reporting distortion in published trials, and transparent SAP reporting is one of the few checks against it that does not require peer reviewers to track down original registration documents manually.

Data Sharing as a Mandatory Checklist Item

Perhaps the most consequential single addition to CONSORT 2025 is the data sharing item. Previous versions of CONSORT had no explicit requirement for authors to address whether participant-level data would be available. The 2025 checklist now asks authors to state where and how individual de-identified participant data, statistical code, and any other supporting materials can be accessed.

This does not mean all trials must share all data. What it means is that every trial paper must now contain a statement that addresses the question. If data will be shared, the statement should specify the repository (common choices include Dryad, Zenodo, the Open Science Framework, and journal-specific repositories such as BMJ Open Data), the conditions of access, and a timeline. If data cannot be shared because of consent constraints, regulatory barriers, or institutional policy, the statement should say so specifically. A statement that reads only 'data available on reasonable request' no longer satisfies the 2025 requirement, because it is not clear where to send that request, who decides what is reasonable, or whether any data has ever been released in response to such requests.

Many journals that adopt CONSORT 2025 map this item directly to their own data availability policy fields in the submission system. If your journal uses a structured submission form with a data availability section, what you enter there should be consistent with what appears in the manuscript. Discrepancies between those two locations create editorial delays.

Patient and Public Involvement

A genuinely new addition to the 2025 checklist is the item on patient and public involvement (PPI). The item asks authors to describe how patients and members of the public were involved in the design, conduct, and reporting of the trial. This reflects a shift that has been building in UK-funded research since the Patient and Public Involvement requirements of the National Institute for Health and Care Research, and in North American research following guidance from organizations like the Canadian Institutes of Health Research, but it is now a formal reporting expectation rather than a funding condition.

For many existing and ongoing trials, the honest answer to this item will be limited. PPI was not systematically built into trial design in most fields before it became a funding requirement. CONSORT 2025 does not demand that every trial report extensive patient involvement. It asks that authors accurately describe what involvement occurred. That could mean a brief note that patient partners reviewed the participant information sheet, or that lived experience advisors helped define the primary outcome as something meaningful to the people being studied. It could also mean none, stated clearly. A vague claim that the trial was informed by patient experience without specifying who was consulted, how, and at what stage is not what the item is looking for.

For prospective trials that have not yet recruited, thinking through the PPI item during the protocol stage, with the help of SPIRIT 2025 (discussed below), is more productive than retrofitting a statement at the time of manuscript writing.

Harms, Site Eligibility, and Conflicts of Interest for Authors

Three other new items address different parts of the trial reporting picture. The harms item asks authors to describe how harms and other unintended effects were identified and collected during the trial. Under-reporting of adverse events in published trials has been documented extensively in the literature. The 2010 checklist mentioned harms but without specific requirements for describing the assessment method. The 2025 version requires enough detail for readers to evaluate whether the harms data is likely to be complete. That means stating whether adverse events were assessed by systematic inquiry at each visit, spontaneous reporting, or some other approach, and whether there were pre-specified definitions for serious adverse events.

The site eligibility item is more granular. Multi-site trials vary enormously in how sites are selected, trained, and monitored. Criteria that affect which sites could participate (geographic requirements, minimum patient volume, required infrastructure, level of investigator experience) can meaningfully affect generalizability and should be reported. This item matters most for pragmatic trials and trials with complex or specialist delivery requirements.

The conflict of interest item for manuscript authors is narrower in scope but addresses a genuine transparency gap. CONSORT 2010 covered funding sources but did not explicitly require disclosure of financial conflicts of interest held by the individuals writing up the results. CONSORT 2025 adds this as a distinct item, separate from the trial funding statement. Authors who hold equity stakes, consulting arrangements, speaker bureau memberships, or other financial relationships with the trial sponsor or comparator manufacturer are now expected to disclose these in the manuscript, not only in a separate form or cover letter.

What Was Revised and What Disappeared

The 2025 revision also revised three existing items, though the changes are more editorial than substantive. The revised items sharpen the language around randomization allocation (to better account for stratification and minimization procedures), statistical methods (to reflect modern analysis practices including pre-specified subgroup analyses and sensitivity analyses), and blinding (to more clearly require reporting of the mechanism and whether it was actually maintained). Authors who have written trial papers recently will recognize these as areas where vague reporting has been common.

One item from the 2010 checklist was deleted. Rather than speculating about which specific item was removed, the safest approach is to download the current CONSORT 2025 checklist from the EQUATOR Network website and compare it directly to your draft. The explanation and elaboration document, which is as important as the checklist itself, was also updated and published alongside the 2025 statement. The explanation document is what distinguishes adequate from inadequate reporting for each item, and reading it for the items most relevant to your trial design is time well spent.

SPIRIT 2025: Aligning Your Protocol From the Start

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is the sister guideline to CONSORT. Where CONSORT governs reporting of published results, SPIRIT governs the content of trial protocols. The 2025 update brought SPIRIT into alignment with CONSORT 2025, which matters because the two documents should describe the same trial in a consistent way. If your protocol pre-specifies a primary outcome, your CONSORT-compliant manuscript should report that same outcome as the primary. The alignment between the two documents is how readers and reviewers can verify that what was registered, what was planned, and what was published are coherent.

SPIRIT 2025 has a 34-item checklist, with two new items added, five items revised, and five items deleted or merged. The new items parallel changes in CONSORT 2025: there is now a SPIRIT item on how patients and the public will be involved in trial design, conduct, and reporting, and the harms and intervention description sections were expanded. A new open science section also appears in SPIRIT 2025, asking protocols to address pre-publication of the protocol and plans for data sharing.

For researchers early in a trial, using SPIRIT 2025 to structure the protocol is the most efficient path to CONSORT 2025 compliance later. The two checklists map onto each other closely enough that a well-structured SPIRIT protocol makes much of the CONSORT manuscript writing straightforward. If your trial is registered and your protocol is complete but you have never formally assessed it against SPIRIT, the explanation and elaboration documents for both guidelines are where you should start before writing the results manuscript.

How Journals Are Implementing the 2025 Updates

Not all journals moved immediately to mandate CONSORT 2025 at submission. Some high-volume journals updated their author instructions within weeks of the April 2025 publication. Others are in a transition period that accepts either version. By early 2026, the majority of journals that had previously required CONSORT compliance had updated their checklists to reference the 2025 version, though the pace varied by publisher.

Journals under the BMJ Publishing Group, JAMA Network, and Lancet family moved relatively quickly. Springer Nature journals varied by title. Many open access mega-journals such as PLOS ONE and BMC-series journals updated their submission system checklists to reflect the new items, and some now include specific fields in the submission form that correspond directly to the new open science section. Checking the current author instructions of your target journal, rather than assuming based on what you last submitted there, is the only reliable way to know which version is required.

Peer reviewers are also being trained differently. Several of the journals that published the original CONSORT 2025 statement circulated guidance to their reviewer pools explaining the new requirements. Reviewers who were previously comfortable accepting vague data availability statements or absent PPI descriptions may now flag these as required revisions on first round. That shift in reviewer expectations is what makes it worth addressing these items substantively in your original submission rather than treating them as boxes to tick at the last step.

Using the Checklist Without Gaming It

Every reporting guideline faces the same adoption problem: once a checklist becomes a submission requirement, authors can satisfy it with technically compliant but substantively empty text. The CONSORT 2025 explanation and elaboration document was written partly to close that gap, by defining what constitutes adequate reporting for each item. Still, the temptation to paste boilerplate is real under deadline pressure.

The most useful way to use the CONSORT 2025 checklist is to work through it as a reader rather than as a compliance officer. For each item, ask yourself whether a methodologist who knows nothing about your trial could understand from your manuscript text what actually happened. The harms item is a good test case. 'Adverse events were monitored throughout the trial' tells the reader almost nothing. 'Adverse events were solicited at each study visit using an open-ended question and the MedDRA system organ class dictionary, and serious adverse events were defined per ICH E6 guidelines and reported to the data safety monitoring board within 24 hours' tells a reader enough to evaluate the completeness of your safety data.

The checklist cell for each item should reference the specific page number or section of your manuscript where that information appears, not just a check mark. Reviewers and editors who use the CONSORT checklist as an actual editorial tool (and more are doing so now) will go to those page numbers. If the information is not there, or is present in watered-down form, you will receive a revision request. Submitting a checklist that accurately maps to your manuscript text, even if some items require honest 'not applicable' or 'data not shared' responses, is more credible than one where every box is checked but the citations lead nowhere.

A Practical Note for Ongoing and Recently Completed Trials

If your trial was designed and registered before April 2025, several of the new CONSORT items may apply retrospectively in ways that are inconvenient. The data sharing item is the most common friction point. If your trial consent form did not specifically address data sharing, you may be limited in what you can actually make available. In that situation, the correct approach is to state the constraint precisely: 'The participant consent form used in this trial did not include provisions for data sharing. The data cannot therefore be made openly available, but a summary of anonymized results is available from the corresponding author.' That is not ideal, but it is honest and it satisfies the new item because it gives readers a specific and truthful answer.

The patient involvement item is similarly retrospective for most trials already in progress. If PPI was not built into your design, say so briefly and accurately. If it was present informally but not documented, document what you can recall and be clear about the limits of that description. Future trials registered from late 2025 onward, and certainly those registered now, should treat the SPIRIT 2025 items on PPI and data sharing as design-stage decisions, not manuscript-stage additions.

Further Reading