Summary of the findings against 14 methodological issues for feasibility research
| Methodological issues | Findings | Evidence |
| 1. Did the feasibility study allow a sample size calculation for the main trial? | No | No, as the effect size on the chosen primary outcome was too small. |
| 2. What factors influenced eligibility and what proportion of those approached were eligible? | A proportion of patients were too unwell or too distressed to be approached | Only eligible patients were approached |
| 3. Was recruitment successful? | Recruitment was difficult, issues with comprehensive identification of patients | NYHA assignment differed between the two sites |
| 4. Did eligible participants consent? | Good conversion to consent | Thirty-eight recruited out of 81 eligible, consent rate of 46.9% |
| 5. Were participants successfully randomised and did randomisation yield equality in groups? | Not investigated in this study | Not investigated in this study |
| 6. Were blinding procedures adequate? | Not investigated in this study | Not investigated in this study |
| 7. Did participants adhere to the intervention? | Good adherence to IPOS completion | Thirty-eight patients recruited, 25 completed IPOS, 13 LTFU |
| 8. Was the intervention acceptable to the participants? | Minimal amount of missing IPOS data (6.4%); acceptability explored in qualitative interviews | Patients and nurses found the intervention acceptable and feasible |
| 9. Was it possible to calculate intervention costs and duration? | Cost of the intervention was not assessed | Costs for resource utilisation were assessed for participant service use (not reported here) |
| 10. Were outcome assessments completed? | Where participants persisted, there was no missing data as outcome data were collected on the telephone | There was no missing data for baseline and outcome measures |
| 11. Were outcomes measured those that were the most appropriate outcomes? | Outcomes consistent with the theory underpinning the intervention were used11 | See summary of outcome data in table 3 |
| 12. Was retention to the study good? | Once recruited, retention was good | Response rates: Time point one questionnaire (24/25) Time point two questionnaire (23/25) Time point three questionnaire (23/25) |
| 13. Were the logistics of running a multicentre trial assessed? | Recruitment was slow at one site until challenges were identified and addressed. The presence of the researcher at each site positively influenced the logistical running of study | Site 1: 14 patients, eight caregivers Site 2: nine patients, two caregivers |
| 14. Did all components of the protocol work together? | Components worked well together | There were no difficulties identified in the various processes and the researcher’s ability to implement them. Patients once recruited were readily identified. |
Methodological issues based on Shaniyinde et al35 and Bugge et al.34
IPOS, Integrated Palliative care Outcome Scale; LFTU, lost to follow-up; NYHA, New York Heart Association.