From: Abstracts of randomized controlled trials in pediatric dentistry: reporting quality and spin
Item | Criteria and subitems | N (%) |
---|---|---|
1. Title | Identification of the study as randomized | 97 (53.3) |
2. Trial design | Description of the trial design (e.g. parallel, cluster, and crossover) | 64 (35.2) |
3. Participant | Eligibility criteria for participants and the settings where the data were collected | 11 (6.0) |
3a. Eligibility criteria for participants | 151 (83.0) | |
3b. Settings of data collection | 11 (6.0) | |
4. Interventions | Interventions intended for each group | 164 (90.1) |
5. Objective | Specific objective or hypothesis | 180 (98.9) |
6. Outcome 1a | Clearly defined primary outcome for this report | 10 (5.5) |
7. Randomization | How participants were allocated to interventions | 0 (0.0) |
7a. Random assignment | 117 (64.3) | |
7b. Sequence generation | 0 (0.0) | |
7c. Allocation concealment | 0 (0.0) | |
8. Blinding (masking) | Whether or not participants, caregivers and those assessing the outcomes were blinded | 17 (9.3) |
8a. Generic description only (e.g. single-blind, double-blind) | 31 (17.0) | |
9. Numbers randomized | Number of participants randomized to each group | 93 (51.1) |
10. Recruitment Trial status | (e.g. on-going, closed to recruitment and closed to follow-up) | 1 (0.5) |
11. Numbers analysed | Number of participants analysed in each group | 19 (10.4) |
11a. Intention-to-treat analysis or per-protocol analysis | 2 (1.1) | |
12. Outcome 2b | For the primary outcome, a result for each group and the estimated effect size and its precision | 4 (2.2) |
12a. Primary outcome result for each group | 13 (7.1) | |
12b. Estimated effect size | 7 (3.8) | |
12c. Precision of the estimate (e.g. 95% CI) | 7 (3.8) | |
13. Harms | Important adverse events or side effects | 6 (3.3) |
14. Conclusions | General interpretation of the results | 154 (84.6) |
14a. Benefits and harms balanced | 11 (6.0) | |
15. Trial registration | Registration number and name of trial register | 3 (3.8) |
16. Funding | Source of funding | 4 (2.2) |