Domain | Protocol N=20 | Report N=77 |
Sample size | ||
Not specified in registry or publication | 1 (5.0%) | 0 |
Deviation (any) | 6 (30.0%) | 47 (61.0%) |
Deviation ≥1% | 5 (25.0%) | 47 (61.0%) |
Deviation ≥20% | 5 (25.0%) | 36 (46.8%) |
Deviation ≥50% | 4 (20.0%) | 25 (32.5%) |
Deviation ≥100% | 4 (20.0%) | 2 (2.6%) |
Setting (centre) | ||
Not specified in registry or publication | 5 (25.0%) | 22 (28.6%) |
Deviation (any) | 8 (40.0%) | 21 (27.3%) |
Inclusion criteria | ||
Not specified in registry or publication | 0 | 3 (3.9%) |
Deviation (any) | 12 (60.0%) | 54 (70.1%) |
Exclusion criteria | ||
Not specified in registry or publication | 0 | 8 (10.4%) |
Deviation (any) | 10 (50.0%) | 46 (59.7%) |
Masking | ||
Not specified in registry or publication | 9 (45.0%) | 28 (36.4%) |
Deviation (any) | 0 | 7 (9.1%) |
Masking upgraded in publication | 0 | 5 (6.5%) |
Masking downgraded in publication | 0 | 2 (2.6%) |
Primary outcome | ||
Not specified in registry or publication | 0 | 4 (5.2%) |
Deviation in nature of primary outcome (any) | 11 (55.0%) | 34 (44.2%) |
New primary outcome introduced in publication | 8 (40.0%) | 18 (23.4%) |
Registered primary outcome omitted in publication | 8 (40.0%) | 23 (29.9%) |
Secondary outcome in registry described as primary outcome in publication | 0 | 7 (9.1%) |
Primary outcome in registry described as secondary outcome in publication | 9 (45.0%) | 15 (19.5%) |
Not specified time frame of primary outcome in registry or publication (if no deviation in nature of primary outcome) | 2 (10.0%) | 7 (9.1%) |
Deviation in time frame of primary outcome in registry or publication (if no deviation in nature of primary outcome) | 1 (5.0%) | 6 (7.8%) |