[1] Title and abstract

Item 1a:

Identification as a randomised trial in the title

Item 1b:

Structured summary of trial design, methods, results, and conclusions

[2] Introduction

Item 2a:

Scientific background and explanation of rationale

Item 2b:

Specific objectives or hypotheses

[3-12] Methods

3. Trial design

Item 3a:

Description of trial design (such as parallel, factorial) including allocation ratio

Item 3b:

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

4. Participants

Item 4a:

Eligibility criteria for participants

Item 4b:

Settings and locations where the data were collected

5. Interventions

Item 5:

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

6. Outcomes

Item 6a:

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

Item 6b:

Any changes to trial outcomes after the trial commenced, with reasons

7. Sample size

Item 7a:

How sample size was determined

Item 7b:

When applicable, explanation of any interim analyses and stopping guidelines

8. Randomisation: sequence generation

Item 8a:

Method used to generate the random allocation sequence

Item 8b:

Type of randomisation; details of any restriction (such as blocking and block size)

9. Allocation concealment mechanism

Item 9:

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

10. Implementation

Item 10:

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

11. Blinding

Item 11a:

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

Item 11b:

If relevant, description of the similarity of interventions

12. Statistical methods

Item 12a:

Statistical methods used to compare groups for primary and secondary outcomes

Item 12b:

Methods for additional analyses, such as subgroup analyses and adjusted analyses

[13-19] Results

13. Participant flow

Item 13a:

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome

Item 13b:

For each group, losses and exclusions after randomisation, together with reasons

14. Recruitment

Item 14a:

Dates defining the periods of recruitment and follow-up

Item 14b:

Why the trial ended or was stopped

15. Baseline data

Item 15:

A table showing baseline demographic and clinical characteristics for each group

16. Numbers analysed

Item 16:

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

17. Outcomes and estimation

Item 17a:

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

Item 17b:

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

18. Ancillary analyses

Item 18:

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

19. Harms

Item 19:

All important harms or unintended effects in each group

[20-22] Discussion

20. Limitations

Item 20:

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

21. Generalisability

Item 21:

Generalisability (external validity, applicability) of the trial findings

22. Interpretation

Item 22:

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidenced

[23-25] Other information

23. Registration

Item 23:

Registration number and name of trial registry

24. Protocol

Item 24:

Where the full trial protocol can be accessed, if available

25. Funding

Item 25:

Sources of funding and other support (such as supply of drugs), role of funders


When referring to the CONSORT-AI guidelines, please cite one of the following articles:

Nature Medicine

The Lancet Digital Health