Ibinda 2014.
Study characteristics | ||
Methods |
Study design: RCT Method of randomisation: via computer Setting: Kenya Date it was conducted: recruitment started August 2009 Follow‐up: 1 year Source of funding: Wellcome Trust Conflict of interest: the study authors declare no conflict of interest |
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Participants |
Inclusion/exclusion criteria: included people of all ages who had active convulsive epilepsy, defined as at least 2 unprovoked convulsions, with 1 in the 12 months prior to being assessed. Sample size: 738 participants; IG = 370; CG = 368. Analysis was done for 303 participants in the IG and for 278 participants in the CG who were observed at both the beginning and the end of the study. Assays of AEDs were done on 105 in the IG and 86 in the CG who provided blood samples. Age: mean age in IG 19 years (SD 17.4) and 19.5 (SD 15.6) in CG Gender: female 47.2 % of IG and 49.6% in CG |
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Interventions |
Type of intervention: educational A 1‐day educational programme on epilepsy, types of seizures, causes of epilepsy, effects of epilepsy on child development, treatment of epilepsy, side effects of drugs, drug safety, what to do during a seizure, when to take a person with epilepsy to hospital, prevention of epilepsy, what a person with epilepsy can and cannot do and advice for families. In addition, a brochure detailing all of the topics discussed was given to each participant. The intervention was designed and delivered by a team of epilepsy researchers and field staff. |
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Outcomes |
Primary outcome(s) measured: adherence It was assessed by plasma drug concentrations and self‐report using the 4‐item MMAS. Both measurements were compared between the baseline and the end of the study. Secondary outcome(s) measured:seizure frequency and KEBAS |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation was reported |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit clear judgement |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The laboratory technicians conducting the assays were blinded to the randomisation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing outcome data are reported and are likely to be related to true outcome |
Selective reporting (reporting bias) | Low risk | The study protocol is available and all prespecified outcomes of interest have been reported |
Other bias | High risk | Authors indicated that improved adherence in both groups could be explained by the sharing of knowledge between groups.Also, those who did not give blood samples to assess drug levels held significantly more traditional religious and cultural beliefs, and believed that AEDs caused epilepsy than those who provided blood samples. |