Assessment of CONSORT items
| Item | General items | Extended items | ||||
| Not reported | Partially reported | Reported | Not reported | Partially reported | Reported | |
| 1 Title and abstract | ||||||
| 1a Title | 45 | 0 | 55 | 95 | 0 | 5 |
| 1b Abstract | 5 | 35 | 60 | 45 | 55 | 0 |
| 2 Background and objectives | ||||||
| 2a Background | 0 | 10 | 90 | 65 | 25 | 10 |
| 2b Objectives | 10 | 45 | 45 | 5 | 85 | 10 |
| 3 Trial design | ||||||
| 3a Description | 0 | 0 | 100 | |||
| 3b Changes during the trial | ||||||
| 4 Participants | ||||||
| 4a Eligibility criteria | 0 | 0 | 100 | 95 | 5 | 0 |
| 4b Settings and locations | 25 | 75 | 0 | |||
| 5 Interventions | 0 | 0 | 100 | 5 | 0 | 95 |
| 6 Outcomes | ||||||
| 6a Definitions | 10 | 45 | 45 | 20 | 70 | 10 |
| 6b Changes during trial | ||||||
| 7 Sample size | ||||||
| 7a Estimation | 5 | 45 | 50 | 11# | 32# | 58# |
| 7b Interim analyses | 33¶ | 33¶ | 33¶ | 0¶ | 33¶ | 67¶ |
| 8 Sequence generation | ||||||
| 8a Method | 55 | 5 | 40 | |||
| 8b Type and restrictions | 55 | 10 | 35 | |||
| 9 Allocation concealment | 65 | 15 | 20 | |||
| 10 Implementation | 70 | 20 | 10 | |||
| 11 Blinding | Not reported as only one trial was blinded | |||||
| 11a Who? | ||||||
| 11b Similarity of interventions | ||||||
| 12 Statistical methods | ||||||
| 12a Methods | 5 | 25 | 70 | 10 | 5 | 85 |
| 12b Subgroup analyses | ||||||
| 13 Participants flow | ||||||
| 13a Flow chart | 5 | 15 | 80 | |||
| 13b Reasons for losses and exclusion | 10 | 25 | 65 | |||
| 14 Recruitment | ||||||
| 14a Accrual period and follow-up | 0 | 20 | 80 | |||
| 14b Reason for stopping | 5 | 20 | 75 | |||
| 15 Baseline data | 0 | 5 | 95 | |||
| 16 Numbers analysed | 5 | 10 | 85 | |||
| 17 Outcomes and estimation | ||||||
| 17a Estimated effect and confidence interval | 0 | 50 | 50 | 25 | 30 | 45 |
| 17b Absolute and relative effect sizes (binary outcomes) | 15 | 85 | 0 | |||
| 18 Ancillary analyses | 6+ | 31+ | 63+ | |||
| 19 Harms | 0 | 0 | 100 | |||
| 20 Limitations | 10 | 50 | 40 | |||
| 21 Generalisability | 0 | 80 | 20 | |||
| 22 Interpretation | 10 | 30 | 60 | 15 | 55 | 30 |
| 23 Registration | 70 | 0 | 30 | |||
| 24 Protocol | 95 | 0 | 5 | |||
| 25 Funding | 30 | 35 | 35 | |||
Data are presented as %. CONSORT: Consolidated Standards of Reporting Trials. #: not applicable to one article; ¶: not applicable to 14 articles; +: not applicable to four articles.