Warren 1998.
Methods | Randomised controlled trial (6 months follow‐up) | |
Participants | 322 adults with epilepsy and their caregivers Mean age of patient responders was 36 years; 51% were male |
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Interventions | Intervention: epilepsy nurse specialist providing case management and clinic appointment Control: standard care from clinic doctors |
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Outcomes |
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Funding | Information on study funding not reported | |
Notes | Included patients with learning disabilities | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation was centrally coordinated prior to clinician involvement |
Allocation concealment (selection bias) | Low risk | Patients were allocated by sealed envelopes inserted into the case notes of eligible participants by an individual independent to the research and clinical teams. There was no obvious possibility of contamination. |
Blinding (performance bias and detection bias) All outcomes | High risk | There was no blinding reported. The subjective nature of the vast majority of outcomes measured by self reported questionnaire means this may have introduced bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 89% of participants completed questionnaires at the end of the study |
Selective reporting (reporting bias) | Low risk | A great many outcomes were assessed by this report. There is, however, no evidence of selective reporting |
Other bias | Unclear risk | Authors reported a required sample size, but it was not clear if this was the result of a power calculation |
Overall risk of bias | Low risk | There was block randomisation, but no blinding and moderate levels of dropout with differences between both responders and non‐responders and between intervention and control groups. However, these differences were accounted for by statistical analysis |
AED: antiepileptic drug; ESMS: Epilepsy Self Management Scale; QOLIE‐89: Quality of Life in Epilepsy Inventory; SF‐36: 36‐item Short Form Health Survey.