Table 4.
Reporting quality of each CONSORT checklist item and subitem by type of intervention
| Items | Criteria and subitems | Pharmacological (n=44), n (%) |
Non-pharmacological (n=132), n (%) |
Risk ratio (95% CI) |
| 1. Title | Identification of the study as randomised | 20 (45.5) | 32 (24.2) | 0.53 (0.34 to 0.83) |
| 2. Authors | Contact details for the corresponding author | 0 (0) | 0 (0) | NE |
| 3. Trial design | Description of the trial design (eg, parallel, cross-over) | 19 (43.2) | 38 (28.8) | 0.66 (0.43 to 1.03) |
| 4. Participant | Eligibility criteria for participants and the settings where the data were collected | 2 (4.5) | 14 (10.6) | 2.33 (0.55 to 9.87) |
| 4a. Eligibility criteria for participants | 40 (90.9) | 130 (98.5) | 1.08 (0.98 to 1.19) | |
| 4b. Settings of data collection | 2 (4.5) | 14 (10.6) | 2.33 (0.55 to 9.87) | |
| 5. Interventions | Interventions intended for each group | 39 (88.6) | 91 (68.9) | 0.78 (0.67 to 0.91) |
| 6. Objective | Specific objective or hypothesis | 44 (100) | 126 (95.5) | 0.95 (0.92 to 0.99) |
| 7. Outcome* | Clearly defined primary outcome for this report | 12 (27.3) | 16 (12.1) | 0.44 (0.23 to 0.87) |
| 8. Randomisation | How participants were allocated to interventions | 0 (0) | 0 (0) | NE |
| 8a. Random assignment | 44 (100) | 132 (100) | 1.00 (1.00 to 1.00) | |
| 8b. Sequence generation | 0 (0) | 0 (0) | NE | |
| 8 c. Allocation concealment | 0 (0) | 0 (0) | NE | |
| 9. Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded | 5 (11.4) | 9 (6.8) | 0.60 (0.21 to 1.70) |
| 9a. Generic description only (eg, single blind, double blind) | 27 (61.4) | 18 (13.6) | 0.22 (0.14 to 0.36) | |
| 10. Numbers randomised | No of participants randomised to each group | 17 (38.6) | 62 (47.0) | 1.22 (0.80 to 1.84) |
| 11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 12 (27.3) | 29 (22.0) | 0.81 (0.45 to 1.44) |
| 12. Numbers analysed | No of participants analysed in each group | 8 (18.2) | 16 (12.1) | 0.67 (0.31 to 1.45) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 2 (4.5) | 10 (7.6) | 1.67 (0.38 to 7.32) | |
| 13. Outcome† | For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) | 0 (0) | NE |
| 13a. Primary outcome result for each group | 4 (9.1) | 7 (5.3) | 0.58 (0.18 to 1.90) | |
| 13b. Estimated effect size | 1 (2.3) | 4 (3.0) | 1.33 (0.15 to 11.61) | |
| 13c. Precision of the estimate (eg, 95% CI) | 1 (2.3) | 2 (1.5) | 0.67 (0.06 to 7.17) | |
| 14. Harms | Important adverse events or side effects | 17 (38.6) | 5 (3.8) | 0.10 (0.04 to 0.25) |
| 15. Conclusions | General interpretation of the results | 40 (90.9) | 132 (100) | 1.10 (1.00 to 1.21) |
| 15a. Benefits and harms balanced | 8 (18.2) | 2 (1.5) | 0.08 (0.02 to 0.38) | |
| 16. Trial registration | Registration no and name of trial register | 2 (4.5) | 4 (3.0) | 0.67 (0.13 to 3.52) |
| 17. Funding | Source of funding | 40 (90.9) | 122 (92.4) | 1.02 (0.91 to 1.13) |
*Outcome reported in Methods section.
†Outcome reported in Results section.
CONSORT, Consolidated Standards of Reporting Trials; NE, not estimable due to zero cell counts.
Bold values are those indicating statistical significance.