Tang 2014.
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 authors declare no conflict of interest |
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Participants |
Inclusion/exclusion criteria: people diagnosed with epilepsy, older than 16 years of age, took antiepileptic drugs for more than six months, and did not take their AEDs at least once over the past six months. Sample size: 124 were assigned to education intervention (n = 59) and education and behavioural intervention (n = 65). 56 and 53 patients completed the last assessment of all measures in education and behavioural intervention group and education only respectively. Age: mean age was 31 years (SD13.0) in education and behavioural intervention group and 30 years (SD 11.6) in education only group. Gender: men 49% in education and behavioural intervention group and 59% in education only group. |
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Interventions |
Type of intervention: mixed Study defines 2 intervention groups: the medication education group (group I) and the medication education with behavioural intervention group (group II). Group I 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 the four‐item Morisky Medication Adherence Scale (MMAS‐4). Secondary outcome(s) measured: seizure control, knowledge of AEDs, quality of life and the 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 | No missing outcome data are reported |
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 whether an important risk of bias exists |
AED: antiepileptic drug; AGAS: Antiretroviral General Adherence Scale; CG: control group; CI: confidence interval; IG: intervention group; MEMS: Medication Event Monitoring System; OR: odds ratio; SD: standard deviation; TAU: treatment as usual.