Table 2.
Reporting of CONSORT flow diagram items for parallel group trials (n = 236)
| Reported * | Not reported | Unclear | |
|---|---|---|---|
| Enrolment | |||
| Assessed for eligibility (overall) | 191 (81%) | 43 (18%) | 2 (1%) |
| Excluded (overall) | 168 (71%) | 64 (27%) | 4 (2%) |
| Not meeting inclusion criteria | 136 (57%) | 54 (23%) | 46 (20%) |
| Declined to participate | 157 (66%) | 56 (24%) | 23 (10%) |
| Other reasons | 141 (60%) | 55 (23%) | 40 (17%) |
| Randomized (overall) | 231 (98%) | 2 (1%) | 3 (1%) |
| Allocation | |||
| Allocated to intervention (per group) | 223 (94%) | 7 (3%) | 6 (3%) |
| Received allocated intervention (per group) | 95 (40%) | 120 (51%) | 21 (9%) |
| Did not receive allocated intervention (per group) | 91 (38%) | 117 (50%) | 28 (12%) |
| Reported reasons did not receive intervention | 76 (32%) | 133 (55%) | 27 (11%) |
| Follow up | |||
| Lost to follow up (per group) | 158 (67%) | 47 (20%) | 31 (13%) |
| Reported reasons lost to follow up | 93 (40%) | 116 (49%) | 27 (11%) |
| Discontinued intervention (per group) | 145 (61%) | 46 (20%) | 45 (19%) |
| Reported reasons discontinued intervention | 128 (54%) | 65 (28%) | 42 (18%) |
| Analysis | |||
| Included in main analysis (per group) | 128 (54%) | 108 (46%) | |
| Excluded from main analysis (per group) | 82 (35%) | 154 (65%) | |
| Reported reasons excluded | 78 (33%) | 128 (67%) | |
* Directly reported or could be inferred from the flow diagram.