Items/Supplementary itemsa | Criteria/Contentb |
---|---|
1. Design | Explicit description of the trial design (e.g. parallel, cluster, crossover) |
2. Participants | Eligibility criteria for participants |
3. Setting | Settings where the data were collected |
4. Interventions | Interventions intended for each group |
5. Outcome | Clearly defined primary/main outcome(s) for the trial |
5a. Time point | When was the primary/main outcome(s) assessed |
5b. No. of outcomes c | The number of described primary/main outcome(s) |
6. Random assignment | Clear statement that participants were allocated to groups in a randomised manner |
6a. Unit of randomisation | Description of the unit of randomisation (e.g. patients, schools, communities) |
7. Sequence generation | Method used for random sequence generation |
8. Allocation concealment | Method used for allocation concealment |
9. Blinding (Masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment |
9a. Generic blinding | Generic description only (e.g. single-blind, double-blind) |