Helde 2005.
Methods | Randomised controlled trial (2 years follow‐up with general satisfaction measured 3 months after this) | |
Participants | 114 adult patients attending a neurological clinic in Trondheim, Norway Mean age of participants was 35 and 40 years in intervention and control arms respectively; 42% were male |
|
Interventions | Intervention: group education programme plus follow‐up teaching and support from an epilepsy nurse Control: "conventional treatment according to individual needs" |
|
Outcomes | Primary outcome
Secondary outcomes
|
|
Funding | Study supported by a grant from Glaxo‐SmithKline, Norway | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block randomisation |
Allocation concealment (selection bias) | Unclear risk | Randomisation was coordinated by a research centre, but the authors gave no further details of how the trial conducted randomisation, what blocks it used, or how it concealed allocation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Neither clinicians nor participants were blinded. However, interviews were conducted (and presumably analysed) by independent research assistants blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 97% of participants were included in the intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Outcomes were stated to be outcomes derived from the QOLIE‐89 questionnaire. All scores are reported |
Other bias | High risk | Small study with only 28 randomised participants. Power calculations and required sample size were not reported. Some differences in baseline characteristics are noted (proportion living alone and receiving one antiepileptic drug) |
Overall risk of bias | Low risk | Computer generated block randomisation, no blinding, and relatively low levels of dropout with most participants included in the intention‐to‐treat analysis |