Table 1.
Item | Description |
---|---|
1. Title or Abstract | The title or the abstract states the study is a randomized controlled trial. |
2. Introduction | Appropriate description of the scientific background and explanation of the rationale. |
Methods: | |
3. Participants | Eligibility criteria for participants are clearly described. |
4. Interventions | Precise details of the interventions intended in each group are provided. |
5. Outcomes | Clear definition of primary and secondary outcome measures is provided. |
6. Objectives | Specific objectives or research question or hypotheses are stated. |
7. Sample size | Clear description on how the sample size was determined is given. |
8. Randomization sequence generation | The method used to generate the random allocation sequence is stated. |
9. Randomization implementation | The separation of generator of the allocation sequence and executor is described. |
10. Statistical methods | Statistical methods used to compare groups for primary outcomes, subgroup analyses or adjusted analyses were properly described. |
Results: | |
11. Participants flow | Number of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for primary outcome are given. |
12. Recruitment | Dates defining the periods of recruitment and follow-up are provided. |
13. Baseline data | Baseline demographic and clinical characteristics of each group are properly described. |
14. Outcomes and estimation | For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95% CI) is provided. |
15. Adverse events | All important adverse events or side effects in each intervention group are described. |
* Item 6 (Objectives) was excluded from OQS.