Table 1 Description of overall quality of reporting items
Item | Description |
|---|---|
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 sequence Type 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 |
Additional Items | |
16. Ethical Issues | The approval of an ethics committee and obtaining of informed consent from participants are stated |
17. Flowchart | A flowchart of participants in each stage of the RCT (randomization, allocation, follow-up, and analysis for primary outcome) is provided |