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Table 2 Frequency distribution of each CONSORT checklist item and subitem in the included 182 abstracts

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)

  1. aOutcome reported in Methods section
  2. bOutcome reported in Results section