Table 2 Summary of findings for 14 methodological issues addressed in feasibility research

1. Did the study allow a sample size calculation for the definitive trail?

1, 2, 2b

Although dependent on a small sample, sample size calculations were conducted

Adjusting for an estimated attrition rate of 75%, 88 participants should be recruited in each of 22 clusters (n = 1936)

2. What factors influenced eligibility and what proportion of those approached were eligible?

2a

Some CR centres approached were ineligible due to treating fewer than the minimum number of patients. All staff and patients were considered eligible.

2 out of 22 centres approached were ineligible.

3. Was recruitment successful?

2a

Centre and staff recruited proceeded smoothly. Revised strategy for patient recruitment proved successful.

See data on recruitment and attrition rates in Table 6.

4. Did eligible participants consent?

2a

Consent was obtained successfully.

See data on recruitment and attrition rates in Table 6.

5. Were participant successfully randomised and did randomisation yield equality in groups?

Not applicable to the current study

6. Were blinding procedures adequate?

Not applicable to the current study.

7. Did participants adhere to the intervention?

3c

Adherence to the staff and patient interventions was good

Fidelity measures showed intervention elements and BCTs generally delivered as intended

8. Was the intervention acceptable to participants?

3a

Staff had reservations about the sexual nature of the intervention. Patient perceptions of the intervention were highly positive.

70.6% of patients were very or somewhat satisfied with the education session. Qualitative evidence was supportive.

9. Was it possible to calculate intervention costs and duration?

Staff costs and intervention resource costs were estimated. A full cost-outcome analysis could not be conducted.

Staff costs: €1296 per year

Patient booklets: €200 per year

Training: €400

10. Were outcome assessments completed?

3b

All staff outcome assessments were completed as intended. The patient outcome assessments were modified in response to staff concerns, and T3 patient data were not collected due to time constraints.

See summary of outcome data in Table 11.

11. Were outcome measured those that were the most appropriate outcomes?

Outcome measures were appropriate. However, the patient questionnaire was perceived to be lengthy and repetitive, and staff had concerns about its content

See qualitative data reported in section 11 of the Results

12. Was retention to the study good?

2a

Centre and staff retention was good. Patient retention was problematic.

See data on recruitment and attrition rates in Table 6.

13. Were the logistics of running a multicentre trial assessed?

Yes. Patient recruitment and assessment in a future definitive trial was identified as being resource intensive.

The patient recruitment process derived in this study depended on one-to-one introductions, and a large sample size has been estimated for a definite trial

14. Did all components of the protocol work together?

All intervention components, and their assessment, worked together as intended and integrated smoothly within the existing CR programmes.

Reported problems in the various processes were minimal.