Outcome | Method | Success criteria | Timing | |||
---|---|---|---|---|---|---|
Stop | Continue, modify protocol | Continue without modification but monitor closely | Continue without modifications | |||
Acceptability of methodology | Recruitment and retention rates as below | Â | Â | Â | Â | End of recruitment (week 8) |
Compliance | Mean attendance <10 sessions | Mean attendance <14 sessions | Mean attendance 14 sessions | Mean attendance 14+ sessions | End of intervention (week 22) | |
End interviews | Unfavourable views, serious concerns | Unfavourable views, suggestions for modification | Favourable views, suggestions for modification | Favourable views, no concerns | 1 month post-intervention (week 26) | |
Feasibility of recruitment processes | Screening rates | Identify <50 potentially eligible subjects | Identify <100 potentially eligible subjects | Identify 100–128 potentially eligible subjects | Identify >128 potentially eligible subjects | End of recruitment |
Recruitment rates | Recruit <50% of sample size | N <25 in 8wks, <5% per week | N = 25–30 in 8wks, <13% per week | N = 30 in 8wks, 13% per week or greater | End of recruitment | |
Participation rates | Participation rate <5% | Participation rate 5–15% | Participation rate 15–25% | Participation rate 25% or greater | 6 months post-intervention | |
Retention rates | Attrition >75% | Attrition 50–75% | Attrition 30 − 50% | Attrition <30% | 6 months post-intervention | |
End interviews | N/A | Major suggestions to improve recruitment processes | Minor suggestions to improve recruitment processes | No suggestions to improve expressed | 1 month post-intervention (week 26) | |
Identify number of eligible participants, participant rates and retention rates | Number identified by HCPs | <50 identified | 50–100 identified | 100–128 identified | >128 potentially eligible identified | End of recruitment |
Number expressing interest | <30 express interest | 30–40 express interest | 40–60 express interest | >60 express interest | End of recruitment | |
Number providing consent | <15 provide consent | 15–25 provide consent | 25–30 provide consent | 30 provide consent | End of recruitment post-intervention, 3 and 6 months post-intervention | |
Number lost to follow up | Attrition >75% | Attrition 50–75% | Attrition 30–50% | Attrition <30% | ||
Researcher time and costs per participant | Researcher diary | N/A | Researcher time exceeds allocated time requiring additional study support | Researcher time and cost only just covers time required | Researcher time and cost fully covers time required | 6 months post-intervention |
Appropriate outcome measures | Variability of outcome Estimate of control mean and SD of change | No difference or clinically important difference favouring control detected based on confidence limits | Difference cannot be detected based on confidence limits but data suggest improvement favouring intervention | Difference can be detected based on confidence limits | Clinically important difference can be detected based on confidence limits | End of intervention |
Intervention components | Therapist adherence | Adherence <50% | Adherence <50% | Adherence 50–75% | Adherence >75% | End of intervention |
End interviews | Serious concerns expressed regarding intervention | Major suggestions to adapt intervention | Minor suggestions to adapt intervention | No concerns or suggestions to adapt intervention | ||
Intervention adherence | Therapist self-rated adherence Video-rated adherence | Adherence <25% | Adherence 25–50% | Adherence 50–75% | Adherence >75% | End of intervention |
Estimate of cost of intervention and services received | Therapist time CSRI | Cost significantly greater than usual care, no potential to modify intervention, no indication of benefits | Cost is greater than usual care - intervention may be modified, but outcomes suggest some benefits | Cost is greater than usual care but outcomes strongly suggest benefits | Cost is equivalent to or slightly greater than usual care, outcomes strongly suggest benefits | 6 months post-intervention |