Table 2 Progression criteria for assessing feasibility of trial design
Variable | Progression criteria | |||
|---|---|---|---|---|
Red | Amber | Green | ||
Recruitment | Percentage of participants approached willing to participate | < 5% | 5–20% | > 20% |
Percentage of participants screened actually recruited | < 50% | 50–75% | > 75% | |
Number of participants recruited | < 8 | 8–16 | > 16 | |
Number of participants recruited within timeframe (1 year) | < 2 | 2–15 | > 15 | |
Retention | Percentage of participants still on study medication at follow-up assessment 1 | < 30% | 30–60% | > 60% |
Percentage of partially active* trial participants at follow-up assessment 1 | < 50% | 50–80% | > 80% | |
Percentage of partially active trial participants at follow-up assessment 2 | Not subject to progression criteria | |||
Adherence | Pill count (compliance) over 81 days | < 50% | 50–80% | > 80% |