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 |
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Interventions | Intervention: special epilepsy nurse in primary care Control: usual care |
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Outcomes |
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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 |