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. 2016 Feb 4;2016(2):CD006244. doi: 10.1002/14651858.CD006244.pub3

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
Interventions Intervention: epilepsy nurse specialist providing case management and clinic appointment
Control: standard care from clinic doctors
Outcomes
  • Patient psychosocial outcomes

    • Psychological well‐being from postal questionnaires at 6 months

    • Social functioning from postal questionnaires at 6 months

    • Knowledge of epilepsy from postal questionnaires at 6 months

    • Self management of epilepsy from postal questionnaires at 6 months

    • Satisfaction with care from postal questionnaires at 6 months

  • Carer psychosocial outcomes

    • Psychological well‐being from postal questionnaires at 6 months

    • Knowledge of epilepsy from postal questionnaires at 6 months

    • Satisfaction with care from postal questionnaires at 6 months

  • Medical management across the primary/secondary care interface

    • Seizure frequency from postal questionnaires at 6 months

    • Incidence of side effects from antiepileptic medication from postal questionnaires at 6 months

    • Incidence of injuries from seizures from postal questionnaires at 6 months

    • Use of epilepsy‐related services from postal questionnaires at 6 months

    • General practitioner satisfaction with clinic care for their patient from semi‐structured telephone interview of convenience sample of GPs (time at which conducted not reported)

  • Direct medical costs of care: data extracted from postal questionnaires at 6 months and medical records

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.