Tang 2014.
Study characteristics | ||
Methods |
Study design: RCT Method of randomisation: random‐number table Setting: an outpatient clinic of a hospital in China Date it was conducted: September 2011‐ March 2013 Follow‐up: 1 year Souce of funding: not reported Conflict of interest: the study authors declare no conflict of interest |
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Participants |
Inclusion/exclusion criteria: people diagnosed with epilepsy, > 16 years of age, took AEDs for > 6 months, and did not take their AEDs at least once over the past 6 months. Sample size: 124 were assigned to education intervention (n = 59) and education and behavioural intervention (n = 65). 56 and 53 participants completed the last assessment of all measures in education and behavioural IG and education only respectively. Age: mean age was 31 years (SD 13.0) in education and behavioural IG and 30 years (SD 11.6) in education only group Gender: men 49% in education and behavioural IG and 59% in education only group |
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Interventions |
Type of intervention: mixed Study defines 2 IGs: the medication education group (group 1) and the medication education with behavioural IG (group 2). Group 1 was initially provided with medication education in the form of oral education and written materials, and this education was reinforced by monthly calls from the pharmacist over the next 6 months. The behavioural intervention provided to group II consisted of a modified medication schedule which was based on cue–dose training therapy |
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Outcomes |
Primary outcome(s) measured: adherence It was assessed by using MMAS‐4 Secondary outcome(s) measured: seizure control, knowledge of AEDs, QoL, number of participants who missed a dose of their AEDs |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using a random‐number table |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar reasons for missing outcome data were reported between groups |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes |
Other bias | Unclear risk | Insufficient rationale or evidence to permit judgement |