Sub-questions | 4a. Change or clarify the trial’s primary outcome measures? (yes, n = 8) | 5a. Change or clarify the statistical analysis? (yes, n = 69) | 6a. Include any additional analyses? (yes, n = 94) | 7a. Modify the overall conclusion? (yes, n = 60) |
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Who requested the change? n (%)a | ||||
Editor | 3 (38%) | 22 (32%) | 29 (31%) | 35 (58%) |
Reviewer | 8 (100%) | 39 (57%) | 77 (82%) | 31 (52%) |
Statistician | 0 (0%) | 32 (46%) | 21 (22%) | 6 (10%) |
Do not know | 0 (0%) | 2 (3%) | 0 (0%) | 2 (3%) |
What changes or clarifications were requested? n (%)a | ||||
Change of the primary outcome measure | 2 (25%) | n/a | n/a | n/a |
Clarification of the primary outcome measure | 2 (25%) | n/a | n/a | n/a |
More cautious conclusion | n/a | n/a | n/a | 53 (88%) |
Stronger conclusion | n/a | n/a | n/a | 2 (3%) |
Other | 4 (50%) | n/a | n/a | 5 (8%) |
Did you fulfil the request? n (%) | ||||
Yes | 5 (62.5%) | 66 (96%) | 83 (88%) | 54 (90%) |
No | 3 (37.5%) | 3 (4%) | 11 (12%) | 6 (10%) |
What was your main motivation to fulfil the request? n (%)a | ||||
Improvement of the reporting of the trial | 4 (50%) | n/a | n/a | 32 (53%) |
Improvement of the statistical methods/analysis | n/a | 38 (55%) | 30 (32%) | n/a |
Avoiding rejection of the paper | 2 (25%) | 30 (44%) | 49 (52%) | 29 (48%) |
Other | 3 (38%) | 16 (23%) | 31 (33%) | 4 (7%) |
How did you judge the request? (1 = not problematic to 10 = very problematic) | ||||
Mean (SD) | 6.8 (3.1) | 3.6 (2.4) | 3.7 (2.6) | 3.5 (2.2) |
Median | 7.5 | 3.0 | 3.0 | 3.0 |
Range | 2–10 | 1–10 | 1–10 | 1–10 |
Does the published article indicate that the analyses have not been pre-specified in the protocol? n (%) | ||||
Yes | n/a | n/a | 22 (23%) | n/a |
No | 72 (77%) |