A priori defined criteria to assess progress during the internal pilot phase of the PANDA-S trial
Continue as planned | Implement remedies and continue, with protocol amendments as needed | Discuss the feasibility of continuing with the Programme Steering Committee | |
Recruitment | ≥80% of the target participants by 6 months (n≥160) | ≥50%, <80% of the target participants by 6 months | <50% of the target participants by 6 months |
Follow-up rate (6 weeks) | ≥70% retention | ≥50%, <70% retention | <50% retention |
Risk of participation bias (baseline similarity) | <15% difference in participant characteristics | >15% difference in participant characteristics | – |
PANDA-S, Prognostic And Diagnostic Assessment of Shoulder Pain.