Table 1 Management of protocol violations
Type of protocol violation | Definition |
|---|---|
1. Erroneous inclusions | |
2. Poor compliance with the global program sessions | Only one absence, to either session 3 or session 4 of the training program, is tolerated from among the 6 sessions of the global program. In other cases, participants are invited to make up the sessions with another group, in order to limit “program withdrawals.” In the case of an incomplete program, the participants in the intervention group are considered to be non-compliant and deviating from the protocol. |
3. Non-attendance at follow-up visits | Participants who do not attend the annual checkups with the occupational health physician of their workplace or the final physiotherapy assessment are first reminded by mail, then by telephone if necessary. It is important to have access to main criterion data for all participants in order to proceed to intention-to-treat analysis. |
4. Early withdrawal | This can take place by decision of the participant or following the occurrence of an adverse event that calls into question his participation in the study. Withdrawn participants are not replaced. |
5. Missing data concerning the primary outcome (sick leave related to low back pain episode) | These participants cannot be taken into account in the analysis of data. |