CONSORT reporting guideline for writing clinical trial research articles

The CONSORT reporting guideline helps authors write randomised clinical trial articles that can be understood and used by a wide audience. This page summarises CONSORT and how to use it.

Journals endorsing CONSORT 600+

CONSORT: Consolidated Standards of Reporting Trials

Version: CONSORT 2025 v1.1. This is the latest version ✅

How to use this reporting guideline

You can use reporting guidelines throughout your research process.

• When writing: consult the full guidance when writing manuscripts, protocols, and applications. The summary below provides a useful overview, and each item links to fuller guidance with explanations and examples.
• After writing: Complete a checklist and include it with your journal submission.
• To learn: Use CONSORT and our training to develop as an academic and build writing skills.

However you use CONSORT, please cite it.

Applicability criteria

You can use this reporting guideline if you are writing a report of a trial where participants have been randomly assigned to one or more groups receiving a healthcare treatment or treatments being tested, or to a comparison group (control group) receiving usual care, a placebo, or no treatment.

You can also use this reporting guideline to:

• write up trials of other types of (non healthcare) interventions if group allocation is randomised.
• review the reporting of a randomized, controlled trial article, but not for appraising the quality of its design or conduct.

Do not use this CONSORT if you are:

• writing an observational research article, use STROBE cohort, STROBE case control or STROBE cross sectional instead.
• writing a proposal or protocol for a trial, use SPIRIT instead
• appraising the quality of a randomised trial, use an appraisal tool like the CASP Randomised Controlled Trial Checklist

Use TREND if you are writing a report of a nonrandomized evaluation of behavioral and public health interventions.

There are several extensions to CONSORT which should be used in addition to the generic guideline, these include:

• CONSORT for abstracts,
• CONSORT harms,
• CONSORT outcomes,
• TIDieR for intervention description,
• CONSORT for social and psychological interventions,
• CONSORT for non pharmocological interventions,
• CONSORT for pragmatic trials.

Other extensions can be found here

For appraising the quality of a study’s design or conduct, consider an appraisal tool like the CASP Randomised Controlled Trial Checklist

Summary of guidance

Although you should describe all items below, you can decide how to order and prioritize items most relevant to your study, findings, context, and readership whilst keeping your writing concise. You can read how CONSORT was developed in the FAQs.

Item name	What to write
Title and Abstract
1a. Title	Identification as a randomised trial.
1b. Structured Abstract	Structured summary of the trial design, methods, results, and conclusions.
Open Science
2. Trial Registration	Name of trial registry, identifying number (with URL) and date of registration.
Protocol and statistical analysis plan	Where the trial protocol and statistical analysis plan can be accessed.
4. Data sharing	Where and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessed.
5. Funding and Conflicts of Interest
5a. Funding	Sources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis, and reporting of the trial.
5b. Conflicts of interest	Financial and other conflicts of interest of the manuscript authors.
Introduction
6. Background and rationale	Scientific background and rationale.
7. Objectives	Specific objectives related to benefits and harms.
Methods
8. Patient and public involvement	Details of patient or public involvement in the design, conduct and reporting of the trial.
9. Trial Design	Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and framework (eg, superiority, equivalence, non-inferiority, exploratory).
10. Changes to trial protocol	Important changes to the trial after it commenced including any outcomes or analyses that were not pre-specified, with reason.
11. Trial Setting	Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted.
12. Eligibility Criteria
12a. Participants	Eligibility criteria for participants.
12b. Other	If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons, physiotherapists).
13. Intervention and comparator	Intervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (eg, intervention manual) can be accessed.
14. Outcomes	Prespecified primary and secondary outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome.
15. Harms	How harms were defined and assessed (eg, systematically, non-systematically).
16. Sample Size
16a. How sample size was determined	How sample size was determined, including all assumptions supporting the sample size calculation.
16b. Interim analyses and stopping criteria	Explanation of any interim analyses and stopping guidelines.
17. Randomisation
17a. Sequence Generation	Who generated the random allocation sequence and the method used.
17b. Type of Randomisation	Type of randomisation and details of any restriction (eg, stratification, blocking, and block size).
18. Allocation concealment mechanism	Mechanism used to implement the random allocation sequence (eg, central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assigned.
19. Implementation	Whether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequence.
20. Blinding
20a. Who was blinded	Who was blinded after assignment to interventions (eg, participants, care providers, outcome assessors, data analysts).
20b. How blinding was achieved	If blinded, how blinding was achieved and description of the similarity of interventions.
21. Statistical methods
21a. Comparing groups	Statistical methods used to compare groups for primary and secondary outcomes, including harms.
21b. Definition of who is included in each analysis	Definition of who is included in each analysis (e.g., all randomised participants), and in which group.
21c. Missing Data	How missing data were handled in the analysis.
21d. Additional Analyses	Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing pre-specified from post hoc.
22. Participant flow, including flow diagram
22a. Participant Numbers	For each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome.
22b. Losses and exclusions	For each group, losses and exclusions after randomisation, together with reasons.
23. Recruitment
23a. Dates	Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms.
23b. Reasons for stopping recruitment	If relevant, why the trial ended or was stopped.
24. Intervention and comparator delivery
24a. As Administered	Intervention and comparator as they were actually administered (eg, where appropriate, who delivered the intervention/comparator, whether participants adhered, whether they were delivered as intended (fidelity)).
24b. Concomitant Care	Concomitant care received during the trial for each group.
25. Baseline Data	A table showing baseline demographic and clinical characteristics for each group.
26. Numbers analysed, outcomes, and estimation	For each primary and secondary outcome, by group: * the number of participants included in the analysis. * the number of participants with available data at the outcome time point. result for each group, and the estimated effect size and its precision (such as 95% confidence interval). * for binary outcomes, presentation of both absolute and relative effect size.
27. Harms	All harms or unintended events in each group.
28. Ancillary Analyses	Any other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post hoc.
Discussion
29. Interpretation	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence.
30. Limitations	Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses.

Including the appropriate EQUATOR checklist as part of your submission goes a long way to help establish trust between authors, editors, and reviewers. That’s why our editorial team ensures that applicable reporting checklists are completed during the peer review process, with a completed checklist at submission greatly helping editors and peer reviewers to assess the work.

Adrian Aldcroft

Editor in Chief, BMJ Open

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