Table 5.
Reporting quality of each CONSORT checklist item and subitem by funding status
| Items | Criteria and subitems | Funded by industry (n=46), n (%) |
Not funded by industry/unreported (n=130), n (%) |
Risk ratio (95% CI) |
| 1. Title | Identification of the study as randomised | 24 (52.2) | 28 (21.5) | 0.41 (0.27 to 0.63) |
| 2. Authors | Contact details for the corresponding author | 0 (0) | 0 (0) | NE |
| 3. Trial design | Description of the trial design (eg, parallel, crossover) | 22 (47.8) | 35 (26.9) | 0.56 (0.37 to 0.85) |
| 4. Participant | Eligibility criteria for participants and the settings where the data were collected | 3 (6.5) | 13 (10.0) | 1.53 (0.46 to 5.14) |
| 4a. Eligibility criteria for participants | 43 (93.5) | 127 (97.7) | 1.05 (0.96 to 1.13) | |
| 4b. Settings of data collection | 3 (6.5) | 13 (10.0) | 1.53 (0.46 to 5.14) | |
| 5. Interventions | Interventions intended for each group | 38 (82.6) | 92 (70.8) | 0.86 (0.72 to 1.02) |
| 6. Objective | Specific objective or hypothesis | 45 (97.8) | 125 (96.2) | 0.98 (0.93 to 1.04) |
| 7. Outcome* | Clearly defined primary outcome for this report | 12 (26.1) | 16 (12.3) | 0.47 (0.24 to 0.92) |
| 8. Randomisation | How participants were allocated to interventions | 0 (0) | 0 (0) | NE |
| 8a. Random assignment | 46 (100) | 130 (100) | NE | |
| 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 | 8 (17.4) | 6 (4.6) | 0.27 (0.10 to 0.72) |
| 9a. Generic description only (eg, single blind, double blind) | 25 (54.3) | 20 (15.4) | 0.28 (0.17 to 0.46) | |
| 10. Numbers randomised | No of participants randomised to each group | 16 (34.8) | 63 (48.5) | 1.39 (0.90 to 2.15) |
| 11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 11 (23.9) | 30 (23.1) | 0.97 (0.53 to 1.77) |
| 12. Numbers analysed | No of participants analysed in each group | 6 (13.0) | 18 (13.8) | 1.06 (0.45 to 2.51) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 2 (4.3) | 10 (7.7) | 1.77 (0.40 to 7.78) | |
| 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 (8.7) | 7 (5.4) | 0.62 (0.19 to 2.02) | |
| 13b. Estimated effect size | 1 (2.2) | 4 (3.1) | 1.42 (0.16 to 12.34) | |
| 13c. Precision of the estimate (eg, 95% CI) | 1 (2.2) | 2 (1.5) | 0.71 (0.07 to 7.62) | |
| 14. Harms | Important adverse events or side effects | 15 (32.6) | 7 (5.4) | 0.17 (0.07 to 0.38) |
| 15. Conclusions | General interpretation of the results | 43 (93.5) | 129 (99.2) | 1.06 (0.98 to 1.15) |
| 15a. Benefits and harms balanced | 8 (17.4) | 2 (1.5) | 0.09 (0.02 to 0.40) | |
| 16. Trial registration | Registration no and name of trial register | 2 (4.3) | 4 (3.1) | 0.71 (0.13 to 3.74) |
| 17. Funding | Source of funding | 46 (100) | 116 (89.2) | 0.89 (0.84 to 0.95) |
*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.