Table 2

Reporting of each CONSORT checklist item and subitem in the included 176 abstracts

ItemsCriteria and subitemsN (%)
1. TitleIdentification of the study as randomised52 (29.5)
2. AuthorsContact details for the corresponding author0 (0)
3. Trial designDescription of the trial design (eg, parallel, crossover)57 (32.4)
4. ParticipantEligibility criteria for participants and the settings where the data were collected16 (9.1)
4a. Eligibility criteria for participants170 (96.6)
4b. Settings of data collection16 (9.1)
5. InterventionsInterventions intended for each group130 (73.9)
6. ObjectiveSpecific objective or hypothesis170 (96.6)
7. Outcome*Clearly defined primary outcome for this report28 (15.9)
8. RandomisationHow participants were allocated to interventions0 (0)
8a. Random assignment176 (100)
8b. Sequence generation0 (0)
8 c. Allocation concealment0 (0)
9. Blinding (masking)Whether or not participants, caregivers and those assessing the outcomes were blinded14 (8.0)
9a. Generic description only (eg, single blind, double blind)45 (25.6)
10. Numbers randomisedNo of participants randomised to each group79 (44.9)
11. RecruitmentTrial status (eg, ongoing, closed to recruitment, closed to follow-up)41 (23.3)
12. Numbers analysedNo of participants analysed in each group24 (13.6)
12a. Intention-to-treat analysis or per-protocol analysis12 (6.8)
13. OutcomeFor the primary outcome, a result for each group and the estimated effect size and its precision0 (0)
13a. Primary outcome result for each group11 (6.3)
13b. Estimated effect size5 (2.8)
13 c. Precision of the estimate (eg, 95% CI)3 (1.7)
14. HarmsImportant adverse events or side effects22 (12.5)
15. ConclusionsGeneral interpretation of the results172 (97.7)
15a. Benefits and harms balanced10 (5.7)
16. Trial registrationRegistration no and name of trial register6 (3.4)
17. FundingSource of funding162 (92.0)
  • *Outcome reported in Methods section.

  • †Outcome reported in Results section.

  • CONSORT, Consolidated Standards of Reporting Trials.