Table 4.
Discrepancies in primary method of handling protocol deviations, as reported in publications compared with protocols
| Discrepancy and No | Primary method(s) described | |
|---|---|---|
| Protocol | Publication | |
| Not pre-specified in protocol*—11: | ||
| 5 | None | ITT |
| 4 | None | Per protocol |
| 1 | None | ITT and per protocol |
| 1 | None | ITT and as treated |
| Added new method in publication†—3: | ||
| 2 | Per protocol | ITT and per protocol |
| 1 | ITT | ITT and on treatment analysis |
| Omitted protocol-specified method†—2 | ITT and per protocol | Per protocol |
| Changed method†—3 | ||
| 1 | Per protocol | ITT |
| 1 | As treated | ITT |
| 1 | ITT | Per protocol |
| Total discrepancies*—19 | ||
ITT=intention to treat.
*Among 43 trials that described methods of handling protocol deviations in publication. †Among 32 trials that described methods of handling protocol deviations in both publication and protocol.