Table 1 Progression criteria for RCT
Domain | Proceed with RCT | Proceed with changes to protocol | Do not proceed unless problem resolution |
|---|---|---|---|
Recruitment | Recruitment of 30 eligible patients within 6 months | Recruitment of eligible patients within 6–12 months | Unable to recruit 30 patients in 12 months |
Retention | Minimum of 75% retention to follow-up | Minimum of 50 % retention to follow-up | Less than 50% retention to follow-up |
Completion of intervention | At least 50% complete intervention for 40–60 min per day | At least 50% complete intervention for 20–40 min per day | Less than 50% complete intervention for 20 min per day |
Outcome measures acceptability | Able to administer 80% of the outcome measures at each time point | Able to administer 80% of the outcome measures at each time point | Able to administer 80% of the outcome measures at each time point |
Adverse events | No serious therapy-related adverse events during trial | Less than 5 serious therapy-related adverse events during trial | Five or more serious therapy-related adverse events during trial |