Table 4.
Protocol violation reporting and protocol violation frequency.
| Protocol Violation Type | Percent (number) of trials | Proportion of Enrolled Participants with PVs Median (range) Calculated from trials with Explicit Reporting |
|---|---|---|
| Enrolment PVs | ||
| Explicit reporting | 12.5% (10/80) | 0.8% (1.6% to 9.1%) |
| Incomplete reporting | 8.8% (7/80) | |
| Absent | 78.8% (63/80) | |
| Randomisation PVs | ||
| Explicit reporting | 8.8% (7/80) | 0.7% (0.04% to 7.7%) |
| Incomplete reporting | 1.3% (1/80) | |
| Absent | 90.0% (72/80) | |
| Study Intervention PVs | ||
| Explicit reporting | 21.2% (17/80) | 1.3% (0% to 13.2%) |
| Incomplete reporting | 21.2% (17/80) | |
| Absent | 57.5% (46/80) | |
| Patient compliance PVs | ||
| Explicit reporting | 47.5% (38/80) | 7% (0.2% to 87%) |
| Incomplete reporting | 25.0% (20/80) | |
| Absent | 27.5% (22/80) | |
| Data Collection PVs | ||
| Explicit reporting | 21.3% (17/80) | 1.7% (0.0% to 16.1%) |
| Incomplete reporting | 18.8% (15/80) | |
| Absent | 60.0% (48/80) | |
Abbreviations: PV - protocol violations.