Table 1

Summary of the findings against 14 methodological issues for feasibility research

Methodological issuesFindingsEvidence
1. Did the feasibility study allow a sample size calculation for the main trial?NoNo, 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 approachedOnly eligible patients were approached
3. Was recruitment successful?Recruitment was difficult, issues with comprehensive identification of patientsNYHA assignment differed between the two sites
4. Did eligible participants consent?Good conversion to consentThirty-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 studyNot investigated in this study
6. Were blinding procedures adequate?Not investigated in this studyNot investigated in this study
7. Did participants adhere to the intervention?Good adherence to IPOS completionThirty-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 interviewsPatients and nurses found the intervention acceptable and feasible
9. Was it possible to calculate intervention costs and duration?Cost of the intervention was not assessedCosts 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 telephoneThere 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 goodResponse 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 studySite 1: 14 patients, eight caregivers
Site 2: nine patients, two caregivers
14. Did all components of the protocol work together?Components worked well togetherThere 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 al 35 and Bugge et al.34

  • IPOS, Integrated Palliative care Outcome Scale; LFTU, lost to follow-up; NYHA, New York Heart Association.