Ridsdale 2018.
Study characteristics | ||
Methods |
Study design: multicenter RCT Method of randomisation: online randomisation system. Randomisation occurred in blocks of 2 (1:1 IG: CG) and stratified by treatment centre. Setting: London and South East England Date it was conducted: between December 2013 and August 2016. Source of funding: the National Institute for Health Research Conflict of interest: the study authors declare no conflict of interest. |
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Participants |
Inclusion/exclusion criteria: patients aged ≥ 16 years, epilepsy for ≥ 1 year, prescribed AEDs, reporting at least 2 seizures (of any type) in the previous year, able to give informed consent, answer questionnaires in English, and attend a 2‐day course. Excluded patients with psychogenic nonepileptic seizures or due to acute illness or substance misuse, serious psychiatric illness or a terminal condition, or if they were currently participating in other epilepsy‐related research. Sample size: The SMILE training programme plus TAU (n = 205) versus TAU only (n = 199) At 12 months, 81.9% of participants remained in the study (IG: 79.5% (n = 163); TAU: 84.4% (n = 168)) Age: 41.7 years (SD 14.1) Gender: 219 (54.2%) female |
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Interventions |
Type of intervention: educational Self‐management education for people with poorly controlled epilepsy (SMILE [UK]) is a group‐based education course. There are 9 modules in the course, such as living with epilepsy;and basic knowledge about seizures. The course was delivered by an epilepsy nurse specialist and an EEG technician for 16 h over 2 consecutive days. The premise of the course was to communicate information and to encourage participants (people with poorly controlled epilepsy, with carers also invited) to share their own experiences with others through the use of interactive discussion, presentation slides, the use of flip‐chart. Participants were given a workbook containing course content to use during the sessions and to take home. |
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Outcomes |
Primary outcome: epilepsy‐specific QoL Secondary outcomes: seizure frequency scales, seizure recency (number of days since last seizure), HADS for psychological distress (anxiety and depression), Impact of Epilepsy, Stigma of Epilepsy, Medication Adherence, medication adverse effects extracted from the QOLIE‐31‐P, and self‐mastery and control |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Online system |
Allocation concealment (selection bias) | Low risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participants’ healthcare providers were blind. Staff organising the courses were not involved in data collection and not blind. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researcher who completed follow‐up assessments were blind. The statistician remained blind until the end of the analysis |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across groups with similar reasons for missing data |
Selective reporting (reporting bias) | Low risk | The study protocol is published, including similar outcomes |
Other bias | Low risk | The study seems to be free of other sources of bias |