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

Ridsdale 1997.

Methods Randomised controlled trial (approximately 6 months follow‐up)
Participants 251 adults with epilepsy recruited from 6 general practices in the South Thames region of England
Mean age of participants was 51 years; 54% were male
Interventions Intervention: special epilepsy nurse in primary care
Control: usual care
Outcomes
  • Questionnaire responses at first appointment (baseline) and approximately three months after the second appointment (which was offered three months after initial appointment) measuring:

    • Impact on patient knowledge

    • Satisfaction with advice

    • Psychological well‐being

  • Recording of 'key variables' extracted from the clinical records before and after the intervention

Funding Study funded by the Nuffield Provincial Hospitals Trust and the National Society for Epilepsy
Notes Excluded people with a diagnosis of learning or language disability
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details of randomisation provided
Allocation concealment (selection bias) Unclear risk Details of allocation concealment were not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk None of the participants, clinicians or assessors appeared to have been blinded. For some outcomes (from questionnaires), this may have introduced bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Clinical data were extracted from the notes of 92% subjects
Selective reporting (reporting bias) Unclear risk Outcomes were defined broadly as "Questionnaire responses and recording of key variables extracted from the clinical records before and after the intervention". It is unclear if findings were selectively reported
Other bias High risk Power calculations and the required sample size were not reported. There was no obvious possibility of contamination. Trialists told participants in the intervention group that they would attend a 'neurology clinic', which may have been interpreted as specialist care. Potentially this belief may have improved patient outcomes over and above the effects of the intervention from the epilepsy nurse specialist
Overall risk of bias Unclear risk A lack of clarity about randomisation and blinding and moderate levels of dropout