Table 2

Objectives, feasibility criteria and key findings

ObjectivesFeasibility criteria (if applicable)Feasibility criterion met and suggested amendments if not metOutcome
Evaluate the recruitment rate and number of eligible patients recruited (quantitative)Feasibility criterion 1: rate of eligible patients recruited is higher than 60%Criterion not met overall (although target recruitment was met)
Amendments:
  • Extend recruitment period

  • Develop materials to increase recruitment of patients with severe learning disabilities

  • Target recruitment was met (n=40)

  • Per cent of patients recruited from all those screened: 25%

  • Per cent of patients recruited from eligible screened patients: 34%

Evaluate completion rates (quantitative)Feasibility criterion 2: at least 80% of study measures have been completedCriterion met
  • 85% of all study measures were completed.

Measure discontinuation rates across both arms (quantitative)Feasibility criterion 3: discontinuation rates fall under 20%Criterion met
  • No discontinuations with the exception of one death (unrelated to the study)

Assess the variability of the primary outcome measure (quality of life) (quantitative)Feasibility criterion 4: the likely location of the improvement in the primary outcome (quality of life) is at least 10%.Criterion partially met
Amendments:
  • Omit medication subscale

  • Develop an epilepsy knowledge measure

  • The 80% CI of the effect size excludes zero in favour of the intervention group on ELDQOL behaviour (T1; T3) and mood subscales (T1; T3).

  • The 80% CI of the effect size includes the target effect size (10% improvement) for ELDQOL behaviour (T3).

Assess the feasibility and acceptability of the study methodology (qualitative)Feasibility criterion 5: good feasibility and acceptability of the study methodologyCriterion met
  • Qualitative data indicated high acceptability and feasibility of the study methods.

Explore potential weaknesses of the study design (qualitative)Suggestions for improvements have been identified, for example,
  1. Reduce and alter questionnaire material

    • Remove 12-week follow-up assessment as there was most missing data (23%)

    • Remove medication side-effects subscale of ELDQOL

    • Develop and add epilepsy knowledge measure

  2. Provide several completion formats for follow-up questionnaires

    • Option to complete an online questionnaire or answer questions over the phone

  3. Minimise missing data at 20 weeks

    • 20-week questionnaire will be completed during a study visit with the research nurse

  4. Understand how booklet is used by participants and carers

    • Conduct observations of booklet use at 20-week follow-up

Explore the acceptability of the Beyond Words booklet (qualitative)Feasibility criterion 6: good acceptability of the intervention among participants, carers and health professionalsCriterion met
  • High levels of acceptability of the booklet in intervention group

  • Use of booklet perceived to be feasible in routine care

To explore the feasibility of collecting resource use and quality of life data (quantitative)Feasibility criterion 7: collection of resource use and quality of life data is feasible, and the increase in treatment cost will be minimal.Criterion partially met amendments:
  • Costs may be lower in a full-scale trial as the training costs are apportioned per participant.

  • Good rates of data completion and minimal data cleaning was required.

  • The mean per participant cost of the intervention was £122.

  • Preliminary cost-effectiveness analysis indicates no significant difference between the two groups.

Monitor the intervention's patterns of use postrandomisation, and explore whether other resources on epilepsy have been used (quantitative)
  • 86% of participants used the booklet at least once more at home.

  • The number of participants in the intervention group (n=21) reporting to have used the intervention on the follow-up questionnaires decreased over time from 15 (4 weeks) to 12 (12 weeks) to 10 (20 weeks)

  • Minimal use of other education/information resources

  • ELDQOL, Epilepsy and Learning Disabilities Quality of Life Scale.