|
| Reporting quality using items from the CONSORT statement (n = 40 studies) | No. of positive trials | % | 95% CI | Cohen’s Kappa | 95% CI |
|
| “Randomised” in the title or abstract | “Randomised” in the title or abstract | 35 | 88 | 77 to 99 | 0.77 | 0.63 to 0.91 |
| Background | Adequate description of the scientific background and explanation of rationale | 36 | 90 | 80 to 99 | 0.84 | 0.72 to 0.96 |
| Trial design | Description of trial design (such as parallel and factorial) including the allocation ratio | 7 | 18 | 5 to 31 | 0.81 | 0.68 to 0.94 |
| Participants | Description of the eligibility criteria for participants | 21 | 53 | 37 to 69 | 0.70 | 0.55 to 0.85 |
| Interventions | Details of the interventions intended for each group(refer Table 2) | — | — | — | — | — |
| Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 31 | 78 | 64 to 92 | 0.59 | 0.43 to 0.75 |
| Sample size | Description of sample size calculation | 2 | 5 | 0 to 12 | 1 | — |
| Randomisation | (a) Method used to generate the random allocation sequence | 13 | 33 | 18 to 48 | 0.70 | 0.55 to 0.85 |
| (b) Type of randomisation details of any restriction | 0 | 0 | — | — | — |
| Allocation concealment | Description of the method used to implement the random allocation sequence assuring the concealment until interventions were assigned | 0 | 0 | — | — | — |
| Implementation | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 3 | 8 | 0 to 17 | 0.36 | 0.20 to 0.51 |
| Blinding | If done, who was blinded after assignment to interventions | | | | | |
| (a) Participants | 0 | | | | |
| (b) Care providers | 0 | | | | |
| (c) Outcome assessors | 1 | 3 | 0 to 9 | 1 | — |
| Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses | 34 | 85 | 73 to 97 | 0.47 | 0.31 to 0.63 |
| Flow chart | Details on the flow of participants through each stage of the trials | 2 | 5 | 0 to 12 | 1 | — |
| Recruitment | Dates defining the periods of recruitment and follow-up | 27 | 68 | 53 to 83 | 0.58 | 0.41 to 0.74 |
| Baseline data | An outline of baseline demographic and clinical characteristics of each group | 29 | 73 | 58 to 88 | 0.78 | 0.64 to 0.92 |
| Intent-to-treat analysis | Number of participants in each group included in each analysis and whether it was done by “intention-to-treat” | 0 | 0 | — | 1 | — |
| Outcomes and estimation | For each primary and secondary outcome, summary of results for each group was given as well as the estimated effect size and its precision (e.g., 95% CI) | 40 | 100 | — | 1 | — |
| Ancillary analyses | Clear statement of whether subgroup/adjusted analyses were prespecified or exploratory | 0 | 0 | — | 1 | — |
| Adverse events | Description of all important adverse events in each group | 7 | 18 | 5 to 30 | 0.92 | 0.83 to 1 |
| Clinical trials register | Whether to conduct clinical trial registration | 1 | 3 | 0 to 9 | 1 | — |
| Funding | Fund support | 8 | 20 | 7 to 33 | 0.92 | 0.81 to 1 |
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