Table 4 Changes in CONSORT sub-items between preprint and peer-reviewed journal publication (n = 78)
From: Transparency and reporting characteristics of COVID-19 randomized controlled trials
Consort item | Reported, no change | Not reported, no change | Added | Removed | Not applicable |
|---|---|---|---|---|---|
Section 6a | |||||
 Clear primary outcome | 70 (90%) | 3 (4%) | 2 (3%) | 3 (4%) | 0 (0%) |
 Variable of interest | 69 (88%) | 1 (1%) | 0 (0%) | 0 (0%) | 8 (10%)a |
 How the outcome was assessed | 62 (79%) | 8 (10%) | 0 (0%) | 0 (0%) | 8 (10%)a |
 The analysis metric | 70 (90%) | 0 (0%) | 0 (0%) | 0 (0%) | 8 (10%)a |
 The summary measure for each study group | 58 (74%) | 9 (12%) | 3 (4%) | 0 (0%) | 8 (10%)a |
 Time point of interest for analysis | 63 (81%) | 4 (5%) | 2 (3%) | 1 (1%) | 8 (10%)a |
 Who assessed the outcome | 33 (42%) | 32 (41%) | 4 (5%) | 1 (1%) | 8 (10%)a |
Sections 8a and 9 | |||||
 Method of sequence generation | 71 (91%) | 4 (5%) | 3 (4%) | 0 (0%) | 0 (0%) |
 Mechanism allocation concealment | 51 (65%) | 20 (26%) | 6 (8%) | 1 (1%) | 0 (0%) |
Section 11a/b | |||||
 Who was blinded | 25 (32%) | 6 (8%) | 5 (6%) | 0 (0%) | 42 (54%)b |
 How the blinding was performed | 31 (40%) | 4 (5%) | 1 (1%) | 0 (0%) | 42 (54%)b |
 Similarities of the characteristics of the interventions | 18 (23%) | 11 (14%) | 4 (5%) | 1 (1%) | 44 (56%)b |
Section 13 a/b | |||||
 Flow chart | 66 (85%) | 8 (10%) | 4 (5%) | 0 (0%) | 0 (0%) |
 Participants randomized | 75 (96%) | 2 (3%) | 1 (1%) | 0 (0%) | 0 (0%) |
 Participants who received treatment | 68 (88%) | 8 (10%) | 2 (3%) | 0 (0%) | 0 (0%) |
 Participants lost to follow-up | 77 (99%) | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) |
 Participants who discontinued intervention | 51 (65%) | 23 (29%) | 3 (4%) | 1 (1%) | 0 (0%) |
 Participants analyzed | 76 (97%) | 2 (3%) | 0 (0%) | 0 (0%) | 0 (0%) |
Section 17a | |||||
 Result | 74 (95%) | 2 (3%) | 1 (1%) | 1 (1%) | 0 (0%) |
 Difference in estimated effect | 49 (63%) | 24 (31%) | 4 (5%) | 1 (1%) | 0 (0%) |
 Precision of the estimated effect | 48 (62%) | 1 (1%) | 0 (0%) | 0 (0%) | 29 (36%)c |
Section 19 | |||||
 List of harms addressed | 43 (55%) | 29 (37%) | 4 (5%) | 2 (3%) | 0 (0%) |
 Mode of data collection | 37 (47%) | 31 (40%) | 6 (8%) | 4 (5%) | 0 (0%) |
 Time frame of surveillance | 35 (45%) | 33 (42%) | 6 (8%) | 4 (5%) | 0 (0%) |
 Person responsible making attribution | 30 (38%) | 39 (50%) | 5 (6%) | 4 (5%) | 0 (0%) |
 Participant withdrawals due to harm | 32 (41%) | 43 (55%) | 1 (1%) | 2 (3%) | 0 (0%) |
 Results of each harm type | 67 (86%) | 8 (10%) | 2 (3%) | 1 (1%) | 0 (0%) |
Section 23 | |||||
 Registration number | 75 (96%) | 0 (0%) | 0 (0%) | 3 (4%) | 0 (0%) |