Table 2. Compliance of reporting to the standard CONSORT and CONSORT extension checklists.
| Items | Total (n = 318, %) |
Chinese (n = 264, %) |
English (n = 54, %) |
|---|---|---|---|
| 1.Title | 53 (17.7) | 19 (7.2) | 34 (63.0) |
| 2.Structured abstracts | 240 (75.5) | 210 (79.5) | 30 (55.6) |
| 3.Description of the experimental treatment, comparator, care providers, centers and blinding status† | 6 (2.0) | 0 (0.0) | 6 (11.1) |
| 4.Background and rationale | 84 (26.4) | 42 (15.9) | 42 (77.8) |
| 5.Objectives or hypotheses | 267 (84.0) | 217 (82.2) | 50 (92.6) |
| 6.Trial design | 29 (9.1) | 17 (6.4) | 12 (22.2) |
| 7.Changes to methods after trial commencement with reasons | 2 (0.6) | 1 (0.4) | 1 (1.9) |
| 8.Eligibility criteria for participants | 295 (92.8) | 242 (91.7) | 53 (98.1) |
| 9.Eligibility criteria for centers and those performing the interventions† | 4 (1.3) | 0 (0.0) | 4 (7.4) |
| 10.Settings and locations | 271 (85.2) | 234 (88.6) | 37 (68.5) |
| 11.Completely defined pre-specified outcomes | 26 (8.2) | 0 (0.0) | 26 (48.1) |
| 12.Changes to trial outcomes after the trial commenced, with reasons | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 13.How sample size was determined | 24 (7.5) | 2 (0.8) | 22 (40.7) |
| 14.Details of whether and how the clustering by care providers or centers was addressed† | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 15.Interim analyses and stopping guidelines | 2 (0.6) | 0 (0.0) | 2 (3.7) |
| 16.Random allocation sequence | 154 (48.4) | 129 (48.9) | 25 (46.3) |
| 17.How care providers were allocated to each trial group† | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 18.Type of randomization | 34 (11.50) | 12 (4.5) | 22 (68.8) |
| 19.Allocation concealment | 31 (10.5) | 17 (6.4) | 14 (43.8) |
| 20.Implementation of randomization | 15 (4.7) | 1 (0.4) | 14 (25.9) |
| 21.Blinding | 45 (14.2) | 9 (3.4) | 36 (66.7) |
| 22.Co-interventions were blinded to group assignment† | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 23.Similarity of interventions | 11 (3.5) | 0 (0.0) | 11 (20.4) |
| 24.Statistical methods for outcomes | 252 (79.2) | 206 (78.0) | 46 (85.2) |
| 25.Details of whether and how the clustering by care providers or centers was addressed† | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 26.Methods for additional analyses | 14 (4.4) | 1 (0.4) | 13 (24.1) |
| 27.Participant flow diagram | 31 (9.7) | 0 (0.0) | 31 (57.4) |
| 28.Number of care providers or centers and the number of patients treated by each care provider center† | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 29.Losses and exclusions after randomization, together with reason | 29 (9.1) | 0 (0.0) | 29 (53.7) |
| 30.Dates of recruitment and follow-up | 246 (77.4) | 212 (80.3) | 34 (63.0) |
| 31.Why the trial ended or was stopped | 5 (1.6) | 3 (1.1) | 2 (3.7) |
| 32.Baseline data | 149 (46.9) | 103 (39.0) | 46 (85.2) |
| 33.Description of care providers and centers† | 5 (1.6) | 0 (0.0) | 5 (9.3) |
| 34.Numbers analyzed | 210 (66.0) | 173 (65.5) | 37 (68.5) |
| 35.For each primary and secondary outcome, results for each group, and the estimated effect size and its precision | 78 (24.5) | 55 (20.8) | 23 (42.6) |
| 36.For binary outcomes, presentation of both absolute and relative effect sizes is recommended | |||
| 37.Ancillary analyses | 12 (3.8) | 0 (0.0) | 12 (22.2) |
| 38.Harms | 67 (21.1) | 34 (12.9) | 33 (61.1) |
| 39.Limitations | 47 (14.8) | 20 (7.6) | 27 (50.0) |
| 40.Generalizability | 279 (87.7) | 227 (86.0) | 52 (96.3) |
| 41.Generalizability of the trial findings according to the intervention, comparators and patients, etc† | 15 (4.7) | 0 (0.0) | 15 (27.8) |
| 42.Interpretation | 146 (45.9) | 97 (36.7) | 49 (90.7) |
| 43.Take into account the choice of the comparator, lack of or partial blinding, unequal expertise of care providers or centers in each group† | 14 (4.4) | 0 (0.0) | 14 (25.9) |
| 44.Registration | 14 (4.4) | 1 (0.4) | 13 (24.1) |
| 45.Protocol | 15 (4.7) | 1 (0.4) | 14 (25.9) |
| 46.Funding | 95 (29.9) | 65 (24.6) | 30 (55.6) |
| Summarized scores | |||
| Standard CONSORT‡ | 12 (10–14) | 11 (10–14) | 21 (15–25) |
| CONSORT Extension‡ | 3 (3–5) | 3 (3–3) | 4 (3–5) |
†: Items related to CONSORT Extension for Trials Assessing Non-Pharmacological Treatments
‡: Score was showed as Median (interquartile range)