Table 2.
Modified CONSORT checklist and adherence in the 88 trials
| Item | Description | No description | Inadequate description | Adequate description |
|---|---|---|---|---|
| 1 | Collected data on harms and benefits stated in title and abstract | 0 (0) | 34 (39) | 54 (61) |
| 2 | Collected data on harms and benefits stated in the introduction | 0 (0) | 62 (71) | 26 (30) |
| 3 | Explicit definition of eligibility criteria for participants | 0 (0) | 1 (1) | 87 (99) |
| 4 | Description of settings/locations where data were collected | 1 (1) | 35 (40) | 52 (59) |
| 5 | Details of intervention intended for each group and how/when they were administered | 3 (3) | 6 (7) | 79 (90) |
| 6 | Specific objectives and hypotheses | 0 (0) | 3 (3) | 85 (97) |
| 7 | Clearly defined primary and secondary outcome measures, and (when applicable) any methods used to enhance quality of measurements | 0 (0) | 20 (23) | 68 (77) |
| 8 | List addressed adverse events with definitions for each | 13 (15) | 34 (39) | 41 (47) |
| 9 | Clarify how harms‐related data were collected | 17 (19) | 21 (24) | 50 (57) |
| 10 | How sample size was determined and (when applicable) explanation of any interim analyses and stopping rules | 12 (14) | 0 (0) | 76 (86) |
| 11 | Method used to generate the random allocation sequence, including details of any restriction | 20 (23) | 4 (5) | 64 (73) |
| 12 | Method used to implement the random allocation sequence, clarifying whether sequence was concealed until interventions were assigned | 21 (24) | 3 (3) | 64 (73) |
| 13 | Who generated the allocation sequence, who enrolled participants, who assigned participants to their groups | 53 (60) | 4 (5) | 31 (35) |
| 14 | Details of blinding of subjects | 49 (56) | 0 (0) | 39 (44) |
| 15 | Details of blinding of treatment providers | 55 (63) | 0 (0) | 33 (38) |
| 16 | Details of blinding of assessors | 43 (49) | 1 (1) | 44 (50) |
| 17 | Details of blinding of data analysts | 64 (73) | 0 (0) | 24 (27) |
| 18 | How the success of masking was assessed | 66 (75) | 0 (0) | 22 (25) |
| 19 | Statistical methods used to compare groups for primary outcome(s); methods for additional analyses | 0 (0) | 7 (8) | 81 (92) |
| 20 | Describe plans for presenting and analysing information on harms | 23 (26) | 11 (13) | 54 (61) |
| 21 | Flow chart describing patient numbers at different stages | 22 (25) | 1 (1) | 65 (74) |
| 22 | Flow of participants described in text; describe protocol deviations from study as planned together with reasons | 0 (0) | 24 (27) | 64 (73) |
| 23 | Dates defining the periods of recruitment and follow‐up | 5 (6) | 2 (2) | 81 (92) |
| 24 | Describe withdrawals due to harms and their experiences with allocated treatment | 35 (40) | 12 (14) | 41 (47) |
| 25 | Baseline demographic and clinical characteristics of each group | 1 (1) | 6 (7) | 81 (92) |
| 26 | Number of participants in each group included in each analysis; use of intention‐to‐treat principle. State results in absolute numbers when feasible | 27 (31) | 1 (1) | 60 (68) |
| 27 | Provide the denominators for analyses on harms | 11 (13) | 20 (23) | 57 (65) |
| 28 | Complete reporting of results and estimated effect size and its precision | 0 (0) | 15 (17) | 73 (83) |
| 29 | Multiple testing and corrections, indicating those prespecified and those exploratory | 16 (18) | 0 (0) | 72 (82) |
| 30 | All important adverse events or side‐effects in each intervention group/patient | 10 (11) | 21 (24) | 57 (65) |
| 31 | Present the absolute risk per arm and per adverse event type, grade, and seriousness, and present appropriate metrics for recurrent events, continuous variables and scale variables | 11 (13) | 33 (38) | 44 (50) |
| 32 | Describe any subgroup analyses and exploratory analyses for harms | 69 (78) | 2 (2) | 17 (19) |
| 33 | Balanced discussion of own study results | 0 (0) | 34 (39) | 54 (61) |
| 34 | Balanced discussion of generalizability of study results | 78 (89) | 0 (0) | 10 (11) |
| 35 | Balanced discussion in comparison with overall evidence | 0 (0) | 32 (36) | 56 (64) |
Values in parentheses are percentages.