Table 2 Progression criteria to proceed with the randomised controlled trial
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 of 20 participants with multimorbidity within 3 months | Recruitment of 20 participants with multimorbidity within 3–6 months | 20 participants with multimorbidity are not recruited within 6 months |
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 |
At least 75% complete more than half of the supervised exercise therapy sessions and half of the self-management sessions | At least 50% complete more than half of the supervised exercise therapy sessions and half of the self-management sessions | Less than 50% complete more than half of the supervised exercise therapy sessions and half of the self-management sessions |
At least 80% of participants do not find the outcome assessment so burdensome that they would not participate in the study again | At least 70% of participants do not find the outcome assessment so burdensome that they would not participate in the study again | Less than 70% of participants do not find the outcome assessment so burdensome that they would not participate in the study again |
Improvements in quality of life and function found clinically relevant by at least 50% of the participants | Improvements in quality of life and function found clinically relevant by at least 25% of the participants | Improvements in quality of life and function found clinically relevant by less than 25% of the participants |
No serious intervention-related adverse events during follow up | Less than five serious intervention-related adverse events during follow up | Five or more serious intervention-related adverse events during follow up |