Table 2

Comparison between registration records and publications

DomainProtocol
N=20
Report
N=77
Sample size
 Not specified in registry or publication1 (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 publication5 (25.0%)22 (28.6%)
 Deviation (any)8 (40.0%)21 (27.3%)
Inclusion criteria
 Not specified in registry or publication03 (3.9%)
 Deviation (any)12 (60.0%)54 (70.1%)
Exclusion criteria
 Not specified in registry or publication08 (10.4%)
 Deviation (any)10 (50.0%)46 (59.7%)
Masking
 Not specified in registry or publication9 (45.0%)28 (36.4%)
 Deviation (any)07 (9.1%)
 Masking upgraded in publication05 (6.5%)
 Masking downgraded in publication02 (2.6%)
Primary outcome
 Not specified in registry or publication04 (5.2%)
 Deviation in nature of primary outcome (any)11 (55.0%)34 (44.2%)
  New primary outcome introduced in publication8 (40.0%)18 (23.4%)
  Registered primary outcome omitted in publication8 (40.0%)23 (29.9%)
  Secondary outcome in registry described as primary outcome in publication07 (9.1%)
  Primary outcome in registry described as secondary outcome in publication9 (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%)