Randomised trial reports should now follow CONSORT 2025, which replaced CONSORT 2010. Its checklist has 30 items, up from 25: seven are new, three were rewritten and one was dropped. Additions cover data sharing, patient and public involvement and the assessment of harms, and an open science section now sits straight after the title and abstract.
For trial authors who learned the 2010 checklist, this guide maps every old item number to 2025 and lists what to check. Participant flow, now item 22, is covered box by box in how to draw a CONSORT 2025 flow diagram.
What CONSORT 2025 added, revised and deleted
The statement counts seven new items; its summary box (box 1) lists them as items 4, 5b, 8, 12b, 15, 21 (21b and 21c) and 24 (24a and 24b).
| Change | CONSORT 2025 items | What it covers |
|---|---|---|
| New | 4, 5b, 8, 12b, 15 | Data sharing; authors' conflicts of interest; patient and public involvement; site and provider eligibility; how harms were defined and assessed |
| New | 21b, 21c, 24a, 24b | Who each analysis includes; missing data; the intervention and comparator as actually delivered; concomitant care |
| Completely revised | 3, 10, 26 | Statistical analysis plan added; changes after the trial began, including outcomes or analyses not prespecified; numbers analysed and with available data |
| Deleted | None (2010 item 21) | Generalisability, now part of limitations in item 30 |
| Integrated: harms | 7, 15, 21a, 23a, 27 | How harms were assessed and analysed, from CONSORT Harms 2022 |
| Integrated: outcomes | 14, 26 | How outcomes were measured and analysed, from CONSORT-Outcomes 2022 |
| Integrated: intervention | 24 | How the intervention and comparator were actually administered, and by whom |
The statement names two further sources: the non-pharmacological treatment extension and the Template for Intervention Description and Replication (TIDieR). All four still exist as separate guidelines.
CONSORT 2025 adds an open science section after the title and abstract
CONSORT 2010 placed registration, protocol and funding last, under "Other information". CONSORT 2025 moves them into the new section, which runs: registration (item 2), the protocol and statistical analysis plan (item 3), data sharing (item 4, new), funding (item 5a) and authors' conflicts of interest (item 5b, new). The explanation and elaboration (E&E) paper says registration moved there for prominence. Our guide to the acknowledgements and funding statement covers the funding wording.
Write one data sharing statement for CONSORT 2025 item 4 and the ICMJE
The International Committee of Medical Journal Editors (ICMJE) asks for two things. Trial-results manuscripts sent to ICMJE journals from 1 July 2018 need a data sharing statement, and trials whose enrolment opened on 1 January 2019 or later must also record the plan in the registry, as the ICMJE trial registration page explains.
The statement must say whether de-identified individual participant data (IPD), including data dictionaries, will be shared; "undecided" is not acceptable. It also covers what data, which related documents, when, for how long, and by what access criteria. CONSORT 2025 item 4 adds statistical code and other materials, and asks where and how they can be accessed. One statement can answer both lists; our guide to writing a data availability statement covers data other than trial IPD. ICMJE asks for any later change to the plan in both the statement and the registry record. The template below is our own wording, not ICMJE or CONSORT text; replace every bracket.
Data sharing. De-identified individual participant data, with the data dictionary, [will / will not] be shared.
[if shared:] Shared items: [datasets or variables] and [the statistical code / the protocol / the statistical analysis plan / other materials — keep those that apply]. Available from [date] for [period] at [repository or platform, with URL], to [who may apply] for [types of analysis], through [access process].
[if not shared:] [the reason they cannot be shared].
[if applicable:] The record [registration number] in [registry] states the same plan.
Map each CONSORT 2010 item number to CONSORT 2025
This table follows web appendix 1 of the CONSORT 2025 statement; use it to carry page references across from a 2010 checklist. Some 2010 rows were merged and one was split, so they do not pair one to one.
| CONSORT 2010 | CONSORT 2025 | Topic in 2025 |
|---|---|---|
| 1a, 1b | 1a, 1b | Identification as a randomised trial; structured abstract |
| 2a | 6 | Background and rationale |
| 2b | 7 | Objectives, now related to benefits and harms |
| 3a | 9 | Trial design, now with its framework, such as superiority or non-inferiority |
| 3b and 6b | 10 | Changes to the protocol after the trial began |
| 4a | 12a | Eligibility criteria for participants |
| 4b | 11 | Trial setting |
| 5 | 13 | Intervention and comparator |
| 6a | 14 | Outcomes, with measurement variable, analysis metric, aggregation method and time point |
| 7a, 7b | 16a, 16b | Sample size; interim analyses and stopping guidelines |
| 8a, 8b | 17a, 17b | Sequence generation; type of randomisation |
| 9 | 18 | Allocation concealment |
| 10, split | 17a and 19 | Who generated the sequence; who enrolled and assigned participants |
| 11a, 11b | 20a, 20b | Blinding |
| 12a | 21a | Statistical methods, now including harms |
| 12b | 21d | Additional analyses, prespecified or post hoc |
| 13a, 13b | 22a, 22b | Participant flow; losses and exclusions |
| 14a, 14b | 23a, 23b | Recruitment and follow-up dates; why the trial ended |
| 15 | 25 | Baseline data, laid out in how to build Table 1 |
| 16, 17a and 17b | 26 | Numbers analysed, outcomes and estimation |
| 18 | 28 | Ancillary analyses |
| 19 | 27 | Harms |
| 20 | 30 | Limitations, now including generalisability |
| 21 | Deleted | Generalisability, folded into 30 |
| 22 | 29 | Interpretation |
| 23 | 2 | Trial registration |
| 24 | 3 | Protocol and statistical analysis plan |
| 25 | 5a | Funding |
| None | 4, 5b, 8, 12b, 15, 21b, 21c, 24a, 24b | New in 2025 |
A page reference that served the merged 2010 items 16, 17a and 17b may not cover all of item 26. For each outcome and group, item 26 asks for the number analysed, the number with available data, the result, and the effect size with its precision.
Check the new and changed CONSORT 2025 items before you submit
Tick each line against your manuscript. All lines but the last are CONSORT 2025 items that are new or reworded; items 3 and 21c also appear in our guide to writing the Methods section.
- Item 2: registry name and number, plus the URL and date of registration, which 2025 adds, and whether results are already posted or published.
- Item 3: where the statistical analysis plan can be read, as well as the protocol.
- Item 4: where and how data, code and materials can be accessed, or why they cannot.
- Item 5b: each author's financial and other conflicts of interest, or that there are none.
- Item 8: how patients, carers or the public were involved in design, conduct or reporting; if they were not, say so and why.
- Item 10: changes after the trial began, with timing and reasons, and any outcomes or analyses not prespecified.
- Item 12b: if applicable, eligibility criteria for sites and for those delivering the interventions, such as surgeons.
- Item 15: how harms were defined and assessed, by whom, at which time points, and any grading system.
- Item 21b: who is included in each analysis, and in which group.
- Item 21c: how missing data were handled, the assumed mechanism with its justification, and any sensitivity analyses.
- Item 24a: who delivered the intervention and comparator, adherence, and whether they were delivered as intended.
- Item 24b: concomitant care in each group that could have affected the outcome.
- Item 26: by group, numbers analysed and with available data; for binary outcomes, both absolute and relative effect sizes.
- Item 27: all harms in each group; if no adverse events were identified, say so.
- Not an item: the explanation and elaboration paper recommends saying whether and how artificial intelligence tools were involved in writing the manuscript.
Item 8 has no CONSORT 2010 text to carry across. This two-case wording is our own, not CONSORT's.
Patient and public involvement. [patients / carers / members of the public] were involved in [the design / the conduct / the reporting] of this trial by [what they did at each stage].
[if none:] Patients and the public were not involved in the design, conduct or reporting of this trial because [reason].
SPIRIT 2025 and CONSORT 2025 now share an open science structure
One joint group revised SPIRIT and CONSORT side by side, aligning the wording of several paired items so a protocol and its report correspond. SPIRIT 2025 has 34 items, supersedes the 2013 version and has its own open science section. These items pair directly.
| Topic | SPIRIT 2025 (protocol) | CONSORT 2025 (report) |
|---|---|---|
| Trial registration | 4, which also asks for the intended registry if not yet registered | 2 |
| Protocol and statistical analysis plan | 5, worded identically | 3 |
| Data sharing | 6, how data will be accessible | 4, how data can be accessed |
| Funding; conflicts of interest | 7a funding; 7b conflicts of principal investigators and steering committee members | 5a funding; 5b conflicts of the manuscript authors |
| Patient and public involvement | 11, details of or plans for involvement | 8 |
Carry these sections forward, turning each plan into what happened; our guide to writing a research protocol covers the protocol side.
Move a draft written to the 2010 checklist onto CONSORT 2025
- Download the 2025 checklist and expanded checklist from the SPIRIT–CONSORT Group.
- Re-map each page reference with the CONSORT 2010-to-2025 mapping table, then report the new items that have no 2010 counterpart.
- Say what was not done or was changed, and check that the manuscript, protocol, statistical analysis plan and registry record agree.
- Cite the statement (Hopewell et al., 2025; doi:10.1136/bmj-2024-081123) and the E&E (doi:10.1136/bmj-2024-081124). The statement appeared in five journals with identical content, so any version may be cited.
- Upload the completed checklist as supplementary material, giving the page number for each item; the statement strongly recommends this.
For a trial design with its own CONSORT extension, use the existing version of that extension until it is aligned with CONSORT 2025; the extensions page shows which are. Our guide to pilot and feasibility studies covers one extension not yet reissued for 2025.
At Directive Publications, the author guidelines ask you to match a trial manuscript to CONSORT on the EQUATOR Network; they do not specify a version. Trials must be prospectively registered, with the number in the abstract. Our data availability policy asks trial authors for the ICMJE IPD sharing statement, and the author guidelines ask every author to declare conflicts of interest, even if none. No policy page of ours mentions patient and public involvement; report item 8 because CONSORT 2025 asks for it. If you find an error in this guide, report the problem to us.