Table 1 Table to illustrate criteria for progression from feasibility study to a definitive trial
Progression criteria | Measurement | Green | Amber | Red |
|---|---|---|---|---|
Phase 2 | ||||
Recruitment | Number of participants recruited within 6 months | 15–20 | 10–15 | < 10 |
Eligibility | Proportion of those screened that are eligible | > 75% screened are eligible | Minor changes to eligibility criteria would increase the number to > 75% | Majority of those screened are ineligible or changes to inclusion criteria required would prohibit meaningful results |
Initial consent | Proportion of eligible participants who consent | > 70% | 50–69% | < 50% |
Consent to intimate examination | Proportion of those enrolled who consent to intimate examination of PFM | > 70% | 50–69 % | < 50% |
Attendance | Number of scheduled appointments attended by participants | > 75% | 50–75% | < 50% |
Data completion | Follow-up questionnaire collected at 3-month review | > 75% | 50–75% | < 50% |
Follow-up questionnaires collected at 6-month review | > 60% | 30–60% | <30% | |
Phase 3 | ||||
Recruitment process | Qualitative process evaluation | Most participants find the recruitment process acceptable or minor changes requested | Participants views on acceptability conflicting or larger changes required | Most participants find the recruitment process unacceptable or the changes required are unrealistic |
Acceptability of intervention | Qualitative process evaluation | Most participants find the intervention acceptable or would request only minor alterations | Views on acceptability conflicting or major revisions needed | Most participants find the intervention unacceptable or changes required are not feasible |
Acceptability of outcome measures | Qualitative process evaluation | Most participants find the questionnaires acceptable or would request only minor alterations | Views on acceptability conflicting or major revisions needed | Most participants find the questionnaires unacceptable or changes required are not feasible |
Choice of venue | Qualitative process evaluation | Most participants find the venue acceptable or would request only minor alterations | Views on acceptability conflicting or major revisions needed | Most participants find the venue unacceptable or changes required are not feasible |
Use of Squeezy App | Qualitative process evaluation | Most participants find use of a smartphone app easy and beneficial as a reminder for PFMT | Fewer than half find use of a smartphone app beneficial | Most participants find use of a smartphone app not helpful or easy to use |
Acceptability of being randomised in a future trial | Qualitative process evaluation | Most participants would accept being randomised for interventions in a future trial | Most would accept being randomised for interventions if there was an option to receive the intervention post RCT | Most participants would not accept being part of a control group in an RCT |