Table 2.
Compliance of Reporting to the Standard CONSORT Checklist
| Item | Description | No. (%) of trials clearly reported | ||
|---|---|---|---|---|
| Total (n=174) |
Chinese (n=137) |
English (n=37) |
||
| 1a | Identification as a randomised trial in the title | 33 (19.0) | 5 (3.6) | 28 (75.7) |
| 1b | Structured summary of trial design, methods, results, and conclusions | 168 (96.6) | 135 (98.5) | 33 (89.2) |
| 2a | Scientific background and explanation of rationale | 158 (90.8) | 121 (88.3) | 37 (100.0) |
| 2b | Specific objectives or hypotheses | 138 (79.3) | 103 (75.2) | 35 (94.5) |
| 3a | Description of trial design including allocation ratio | 29 (16.7) | 14 (10.2) | 15 (40.5) |
| 3b | Important changes to methods after trial commencement, with reasons | 5 (2.9) | 0 (0) | 5 (13.5) |
| 4a | Eligibility criteria for participants | 146 (83.9) | 110 (80.3) | 36 (97.3) |
| 4b | Settings and locations where the data were collected | 162 (93.1) | 131 (95.6) | 31 (83.8) |
| 5 | The interventions for each group with sufficient details to allow replication | 165 (94.8) | 129 (94.2) | 36 (97.3) |
| 6a | Completely defined pre-specified primary and secondary outcome measures | 154 (88.5) | 118 (86.1) | 36 (97.3) |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | 2 (1.1) | 1 (0.7) | 1 (2.7) |
| 7a | How sample size was determined | 27 (15.5) | 3 (2.2) | 24 (64.9) |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | 3 (1.7) | 0 (0) | 3 (8.1) |
| 8a | Method used to generate the random allocation sequence | 87 (50.0) | 63 (46.0) | 24 (64.9) |
| 8b | Type of randomisation; details of any restriction | 66 (37.9) | 39 (28.5) | 27 (73.0) |
| 9 | Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned | 30 (17.2) | 6 (4.4) | 24 (64.9) |
| 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 18 (10.3) | 1 (0.7) | 17 (45.9) |
| 11a | If done, who was blinded after assignment to interventions and how | 32 (18.4) | 7 (5.1) | 25 (67.6) |
| 11b | If relevant, description of the similarity of interventions | 32 (18.4) | 9 (6.6) | 23 (62.2) |
| 12a | Statistical methods used to compare groups for primary and secondary outcomes | 164 (94.3) | 129 (94.2) | 35 (94.6) |
| 12b | Methods for additional analyses | 12 (6.9) | 0 (0) | 12 (32.4) |
| 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 121 (69.5) | 90 (65.7) | 31 (83.8) |
| 13b | For each group, losses and exclusions after randomisation, together with reasons | 46 (26.4) | 21 (15.3) | 25 (67.6) |
| 14a | Dates defining the periods of recruitment and follow-up | 139 (79.9) | 116 (84.7) | 23 (62.2) |
| 14b | Why the trial ended or was stopped | 0 (0) | 0 (0) | 0 (0) |
| 15 | A table showing baseline demographic and clinical characteristics for each group | 104 (59.8) | 75 (54.7) | 29 (78.4) |
| 16 | For each group, number of participants | 160 (92.0) | 127 (92.7) | 33 (89.2) |
| 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision | 125 (71.8) | 93 (67.9) | 32 (86.5) |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 3 (1.7) | 1 (0.7) | 2 (5.4) |
| 18 | Results of any other analyses performed | 11 (6.3) | 0 (0) | 11 (29.7) |
| 19 | All important harms or unintended effects in each group | 44 (25.3) | 23 (16.8) | 21 (56.8) |
| 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 41 (23.6) | 15 (10.9) | 26 (70.3) |
| 21 | Generalisability of the trial findings | 26 (14.9) | 17 (12.4) | 9 (24.3) |
| 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 104 (59.8) | 69 (50.4) | 35 (94.6) |
| 23 | Registration number and name of trial registry | 16 (9.2) | 3 (2.2) | 13 (35.1) |
| 24 | Where the full trial protocol can be accessed, if available | 9 (5.2) | 2 (1.5) | 7 (18.9) |
| 25 | Sources of funding and other support, role of funders | 57 (32.8) | 33 (24.1) | 24 (64.9) |