Table 4 Progression Criteria for RCT
Domain | Proceed with RCT | Proceed, but changes to the protocol need to be discussed | Do not proceed with main trial unless the problem can be solved |
|---|---|---|---|
Recruitment | Recruitment of 30 participants with OA within 3 months | Recruitment of 30 participants with OA within 3–6 months | 30 participants with OA are not recruited within 6 months |
Retention | At least 75% retention of participants through follow up | At least 50% retention of participants through follow up | Less than 50% retention of participants through follow up |
Completion of Intervention | At least 75% complete more than half of the intervention | At least 50% complete more than half of the intervention | Less than 50% complete more than half of the intervention |
Outcome Measures Acceptability | At least 80% of participants do not find the outcomes so burdensome that they would not participate in the study again | At least 70% of participants do not find the outcomes so burdensome that they would not participate in the study again | Less than 70% of participants do not find the outcomes so burdensome that they would not participate in the study again |
Function and/or Quality of Life Improvement | Improvements in function and/or quality of life found by at least 50% of the participants | Improvements in function and/or quality of life found by at least 25% of the participants | Improvements in function and/or quality of life found by less than 25% of the participants |
Adverse events | No serious care-related adverse events during follow up | Less than five serious care-related adverse events during follow up | Five or more serious care-related adverse events during follow up |