Criteria | Green (Go) | Amber (Amend) | Red (Stop) |
---|---|---|---|
Recruitment | At least 50 eligible participants are identified and agree to take part over 9 months | Between 35 and 49 eligible participants are identified and agree to participation over 9 months | < 35 eligible participants are identified and agree to participation over 9 months |
Consent | At least 40% of eligible potential participants consent to be randomised | 20–39% of eligible potential participants consent to be randomised | < 20% of eligible potential participants consent to be randomised |
Proportion of randomised participants providing 14-week outcome dataa | At least 85% of participants provide outcome data at 14 weeks | 60 to 84% of participants provide outcome data at 14 weeks | < 60% of participants provide outcome data at 14 weeks |
Intervention fidelity | At least 75% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks) | 50 to 74% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks) | < 50% of participants receive the allocated intervention sessions as per protocol (minimum of 4 sessions delivered over 12 weeks) |