Table 1 Criteria for progression to main trial
Red | Amber | Green | |
|---|---|---|---|
Recruitment | |||
% of target number of participants recruited (target: 60; 12 month recruitment period) | < 70% | 70–99% | 100% |
Adherence | |||
% of recruited participants who adhere to their allocated intervention | < 65% | 65–84% | 85–100% |
Retention | |||
% of recruited patients with follow-up data | < 65% | 65–84% | 85–100% |
Signal of efficacy | |||
Results for primary clinical outcome and safety | CI for effect estimate for primary clinical outcome that does not include a clinically important difference or evidence of significant harm | CI for effect estimate for primary outcome that is mostly negative or evidence of potential harm | CI for effect estimate for primary outcome that is mostly positive and no evidence of potential harm |