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Table 1 Summary of findings against 14 methodological issues for feasibility research

From: A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

Methodological issues Findings Evidence
1. Did the feasibility/pilot study allow a sample size calculation for the main trial? Achieved even though sample was small 16 out of target of 50 participants achieved in feasibility study
103 per group indicated for main trial
2. What factors influenced eligibility and what proportion of those approached were eligible? Ineligibility for randomization was mainly due to participant refusal 31 out of 66 approached were eligible
3. Was recruitment successful? Recruitment was very difficult. Issues at center, clinician, and participant levels Centers showed low enthusiasm.
Clinicians failed to identify participants
Eligible participants not willing to take part (11/31 withdrew pre-randomization)
4. Did eligible participants consent? Low conversion to consent 16 (52%) randomized out of 31 eligible participants
5. Were participants successfully randomized and did randomization yield equality in groups? Worked well Equal sized groups, well-balanced on the minimization variables
6. Were blinding procedures adequate? Where used, blinding worked well Self-reported evidence from gynecologists suggests blinding of POPQ measurement was successful
7. Did participants adhere to the intervention? Good adherence to PFMT appointments and less so to diaries Physiotherapy appointments attended: n = 5, 62.5%; n = 4, 12.5%; n = 3, 12.5%; n = 2, 12.5%
Exercise diaries returned: n = 4, 50%; n = 3, 25%; n = 2, 12.5%; n = 0, 12.5%
8. Was the intervention acceptable to the participants? Not directly assessed but low numbers recruited suggest some difficulty 15 eligible participants decided not to be randomized once all information was available
9. Was it possible to calculate intervention costs and duration? Assessed in the linked trial Cost of PFMT: £170 for mean of 4.2 appointments attended
10. Were outcome assessments completed? Outcome measures used did assess main areas of interest See summary of outcome data in Table 2
11. Were outcomes measured those that were the most appropriate outcomes? Sexual problems questionnaire completion poor Only 25% of participants completed all items at baseline
12. Was retention to the study good? Once recruited retention was good Response rates:
6-month questionnaire: 100% I, 87.5% C
7-month questionnaire: 75% I, 37.5% C
Symptom diary completion: 62.5% I, 37.5% C
6-month appointment: 87.5% I, 50% C
7-month appointment: 75% I, 37.5% C
Agreed to pessary removal: 66.7% I, 33.3% C
13. Were the logistics of running a multicenter trial assessed? Some centers recruited better than others. The center that recruited well had a dedicated local recruiter Center 1: 15 participants (dedicated recruiter)
Center 2: 1 participant
Center 3: 0 participants
Center 4: 0 participants
14. Did all components of the protocol work together? Components had strong synergy There were no difficulties identified in the various processes and the researcher’s ability to implement them. For example, if participants were recruited, they were easily randomized and their care moved forwards to the appropriate trial arm.
  1. Methodological issues based on Shanyinde et al. [15]. C, control; I, intervention; PFMT, pelvic floor muscle training; POP-Q, pelvic organ prolapse quantitation.