Feasibility success metrics providing support for a future trial
Green light (proceed with minor changes) | Amber light (proceed with significant modifications) | Red light (do not proceed) | |
Recruitment | 50 or more patients recruited | 25–49 patients recruited | 24 or fewer patients recruited |
Treatment fidelity | At least 60% of randomised participants receive allocated treatments | At least 40% of randomised participants receive allocated treatments | Less than 40% of randomised participants receive allocated treatments |
Rate of assessment attrition at 3 and 6 months | Less than 30% at 3 and 6 months | Less than 60% at 3 and 6 months | 61% or more at 3 and 6 months |
Qualitative data | Positive opinions and/or feasibility recommendations to improve the follow-on trial. We will hold an end of study workshop with all coinvestigators, site PIs, patient/carer representatives and other stakeholders to present the outcomes and discuss approaches to address issues noted as green or amber and reasons for red lights. |