Table 4 Summary of progression criteria using traffic light system
Aim | Green | Amber | Red |
|---|---|---|---|
CVT-VT improves the VHI score |  > 20% improvement in VHI score | 10–20% improvement in VHI score |  < 10% improvement in VHI score |
A CVT-VT study is feasible to perform |  > 9 patients completed pre- and post-therapy outcome assessments | 8–9 patients completed pre- and post-therapy outcome assessments |  < 8 patients completed pre- and post-therapy outcome assessments |
CVT-VT is acceptable to patients |  > 9 patients satisfied or very satisfied with therapy they have received | 8–9 patients satisfied or very satisfied with therapy they have received |  < 8 patients satisfied or very satisfied with therapy they have received |
CVT-VT is acceptable to CVT-Ps | CVT-P satisfied or very satisfied with therapy delivered in > 9 patients | CVT-P satisfied or very satisfied with therapy delivered in 5–9 patients | CVT-P satisfied or very satisfied with therapy delivered in < 5 patients |
CVT-VT is acceptable to SLT-VTs (1) |  > 8 out of 10 SLT-VTs satisfied or very satisfied with the outcome of the study |  > 5–8 out of 10 SLT-VTs satisfied or very satisfied with the outcome of the study |  < 5 out of 10 SLT-VTs satisfied or very satisfied with the outcome of the study |
CVT-VT is acceptable to SLT-VTs (2) |  > 8 out of 10 SLT-VTs would support the concept of an RCT of CVT-VT vs SLT-VT based on the outcome of the study |  > 5–8 out of 10 SLT-VTs would support progression to a RCT of CVT-VT vs SLT-VT based on the outcome of the study |  < 5 out of 10 SLT-VTs would support progression to a RCT of CVT-VT vs SLT-VT based on the outcome of the study |
Recruitment rate achieved |  > 9 patients recruited in 6 months | 8–9 patients recruited in 6 months |  < 8 patients recruited in 6 months |