Item | Description | Scored as “yes”, N (%) | Scored as “unclear”, N (%) | Scored as „no“, N (%) |
---|---|---|---|---|
1. Title | Identification of the study as randomized | 382 (61) | 0 | 240 (39) |
2. Authors | Contact details for the corresponding author | 102 (16) | 0 | 520 (84) |
3. Trial design | Description of the trial design (e.g., parallel, cluster, non-inferiority) | 114 (18) | 0 | 508 (82) |
Methods | ||||
4. Participants | Eligibility criteria for participants and the settings where the data were collected | 523 (84) | 0 | 99 (16) |
5. Interventions | Interventions intended for each group | 603 (97) | 0 | 19 (3) |
6. Objective | Specific objective or hypothesis | 563 (91) | 0 | 59 (9) |
7. Outcome | Clearly defined primary outcome for this report | 295 (47) | 0 | 327 (53) |
8. Randomization | How participants were allocated to interventions | 17 (3) | 594 (96) | 11 (1) |
9. Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment | 302 (49) | 0 | 320 (51) |
Results | ||||
10. Numbers randomized | Number of participants randomized to each group | 145 (23) | 0 | 477 (77) |
11. Recruitment | Trial status | 56 (9) | 566 (91) | 0 |
12. Numbers analyzed | Number of participants analyzed in each group | 48 (8) | 0 | 574 (92) |
13. Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | 581 (93) | 0 | 41 (7) |
14. Harms | Important adverse events or side effects | 128 (21) | 0 | 494 (79) |
15. Conclusions | General interpretation of the results | 597 (96) | 0 | 25 (4) |
16. Trial registration | Registration number and name of trial register | 127 (20) | 0 | 495 (80) |
17. Funding | Source of funding | 1 (0.2) | 0 | 621 (99.8) |