Item | Descriptiona |
---|---|
1. Title or Abstract | Identification as a randomized trial in the title and a structured summary of the trial design, methods, results, and conclusions. |
Introduction | |
2. Background | Scientific background and explanation of rationale. |
3. Objectives | Specific objectives or hypotheses. |
Methods | |
4. Participants | Eligibility criteria for participants. |
Settings and locations where the data were collected | |
5. Interventions | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered. |
6. Outcomes* | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed. |
7. Sample Size | How sample size was determined.When applicable, explanation of any interim analyses and stopping guidelines. |
8. Randomization: Sequence Generation | Method used to generate the random allocation sequenceType of randomisation; details of any restriction (such as blocking and block size). |
9. Randomization: Implementation | There is mention of: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions? |
10. Statistical Methods | Statistical methods used to compare groups for primary and secondary outcomes. |
Methods for additional analyses, such as subgroup analyses and adjusted analyses. | |
Results | |
11. Participants Flow | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome. |
For each group, losses and exclusions after randomisation, together with reasons. | |
12. Recruitment | Dates defining the periods of recruitment and follow-up |
Why the trial ended or was stopped. | |
13. Baseline Data | A table showing baseline demographic and clinical characteristics for each group. |
14. Outcomes and Estimates | For each primary and secondary outcome, results 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 sizes is recommended. | |
15. Harms | All important harms or unintended effects in each group |