Table 2 ‘Traffic light’ criteria to assess progression to a full trial
Recruitment rate of eligible participants (measuring reach, acceptability) | Frequency of SPEBT (measuring dose, acceptability) | Retention until 6 weeks post-delivery (measuring acceptability) | Findings from qualitative study and acceptability | |
|---|---|---|---|---|
Green | ≥ 50% | ≥ 75%, three or more | ≥ 80% | Progress but will use findings from qualitative study to inform and improve definitive RCT |
Yellow | 30–50% | 50–75%, three or more | 50–80% | Use findings from qualitative study to inform progressing to definitive study depending on guidance from trial steering committee, Sickle Cell Society, PPI group and key stakeholders |
Red | < 30% | < 50%, three or more | < 50% | Will not progress |