Table 1.
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) |
CONSORT for Abstracts: the CONSORT (Consolidated Standards of Reporting Trials) extension guidelines for reporting of RCT abstracts [23]
aOnly the scores of main quality items (no.1 to 9) contributed to the primary outcome (overall quality score, range: 0 to 9); supplementary items (5a, 5b, 6a, 9a) were documented for information purposes only
bDetailed scoring criteria are available in the online Appendix
cA continuous variable, not dichotomous