Objectives, feasibility criteria and key findings
Objectives | Feasibility criteria (if applicable) | Feasibility criterion met and suggested amendments if not met | Outcome |
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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:
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Evaluate completion rates (quantitative) | Feasibility criterion 2: at least 80% of study measures have been completed | Criterion met |
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Measure discontinuation rates across both arms (quantitative) | Feasibility criterion 3: discontinuation rates fall under 20% | Criterion met |
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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:
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Assess the feasibility and acceptability of the study methodology (qualitative) | Feasibility criterion 5: good feasibility and acceptability of the study methodology | Criterion met |
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Explore potential weaknesses of the study design (qualitative) | Suggestions for improvements have been identified, for example,
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Explore the acceptability of the Beyond Words booklet (qualitative) | Feasibility criterion 6: good acceptability of the intervention among participants, carers and health professionals | Criterion met |
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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:
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Monitor the intervention's patterns of use postrandomisation, and explore whether other resources on epilepsy have been used (quantitative) |
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ELDQOL, Epilepsy and Learning Disabilities Quality of Life Scale.