Table 2 Key feasibility indicators for progression [48, 49]
Key indicator | Go—proceed with RCT | Amend—proceed with changes | Stop—do not proceed unless changes are possible |
|---|---|---|---|
Recruitment rate Target figure: 20 participants | ≥ 70% of target number | 51–69% of target number | ≤ 50% of target number |
Retention rate 75% of the participants randomized to intervention group will complete outcome measures T0, T1, and T2 | ≥ 70% of target number | 51–69% of target number | ≤ 50% of target number |
Compliance | ≥ 80% of target number use the stimulator for at least 2 h (mean) per day | 61–79% of target number use the stimulator for at least 2 h (mean) per day | ≤ 60% of target number use the stimulator for at least 2 h (mean) per day |