Comparison between protocols and full reports
| Domain | RCT full reports N=7 |
| Sample size | |
| Not specified in protocol or report | 0 |
| Deviation (any) | 6 (85.7%) |
| Deviation ≥1% | 6 (85.7%) |
| Deviation ≥20% | 5 (71.4%) |
| Deviation ≥50% | 3 (42.9%) |
| Deviation ≥100% | 0 |
| Setting (centre) | |
| Not specified in protocol or report | 2 (28.6%) |
| Deviation (any) | 3 (42.9%) |
| Inclusion criteria | |
| Not specified in protocol or report | 0 |
| Deviation (any) | 4 (57.1%) |
| Exclusion criteria | |
| Not specified in protocol or report | 0 |
| Deviation (any) | 3 (42.9%) |
| Masking | |
| Not specified in protocol or report | 1 (14.3%) |
| Deviation (any) | 1 (14.3%) |
| Masking upgraded in report | 1 (14.3%) |
| Masking downgraded in report | 0 |
| Primary outcome | |
| Not specified in protocol or report | 0 |
| Deviation in nature of primary outcome (any) | 3 (42.9%) |
| New primary outcome introduced in report | 1 (14.3%) |
| Registered primary outcome omitted in report | 1 (14.3%) |
| Secondary outcome in protocol described as primary outcome in report | 1 (14.3%) |
| Primary outcome in protocol described as secondary outcome in report | 2 (28.6%) |
| Not specified time frame of primary outcome in protocol or report (if no deviation in nature of primary outcome) | 0 |
| Deviation in time frame of primary outcome in protocol or report (if no deviation in nature of primary outcome) | 2 (28.6%) |
RCT, randomised controlled trial.