Outcome | Red: major revision prior to full trial | Amber: continue to full trial with changes | Green: continue to full trial without changes |
---|---|---|---|
Enrolment rate (target: 60 enrolled after 18 months) | < 60 % of eligible patients enrolled | 60–80% of eligible patients enrolled | > 80% of eligible patients enrolled |
Retention rate | < 70% complete 18-month follow-up | 70–80% complete 18-month follow-up | > 80% complete 18-month follow-up |
Questionnaire and assessment compliance | < 80% completion of all questionnaires and assessments | 80–90% completion of all questionnaires and assessments | > 90% completion of all questionnaires and assessments |
Adverse events | Score of < 3 on a 7-point Likert scale indicating total impact of all adverse events | Score of 3 or 4 on a 7-point Likert scale | Score of ≥ 5 on a 7-point Likert scale. |