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. 2020 Oct 22;2020(10):CD008312. doi: 10.1002/14651858.CD008312.pub4

Li 2013.

Study characteristics
Methods Study design: RCT
Method of randomisation: simple randomisation (random selection software)
Setting: 2 rural communities of western China
Date it was conducted: between September 2009 and December 2012
Follow‐up: 1 year
Source of funding: not reported
Conflict of interest: the study authors declare no conflict of interest.
Participants Inclusion exclusion criteria: age ≥ 13 and < 65 years and constant receipt of phenobarbital monotherapy
The exclusion criteria: patients with severe mental retardation or neurologic diseases or psychosis; and patients receiving another 1 or 2 AEDs in addition to phenobarbital as additional therapy.
Sample size: the study included a sample of 200 participants with epilepsy for each group (IG and CG). After a 12‐month follow‐up, 183 cases were retained in IG and 177 in CG.
Gender: 105 male in IG and 99 male in CG.
Age: mean age was 36.6 years (median 38) in the IG and 39.4 years (median 40) in the CG
Other characteristics: mean duration since diagnosis was 12.3 years (median 14) in the IG and 10.6 years (median 12) in the CG
Interventions Type of intervention: mixed
A 4‐component programme. First, intensive education that included explanation of epilepsy, emphasising the importance of receiving appropriate AED treatment and taking medication regularly. Second, consultation services where clinical providers and telephone support were available for participants at any time. Third, reminders in the form of keeping a simple record with a specifically‐designed card. Fourth, participants received repeated (> 3 times at each attending clinic) reminders about medical adherence every month.
Outcomes Primary outcome(s) measured: adherence, seizure control and avoiding lifestyle‐precipitated seizures. Adherence and lifestyle were each graded on a 6‐point scale with possible scores and measured and compared between the groups before and after the intervention.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Simple randomisation was reported
Allocation concealment (selection bias) Unclear risk No information on concealment was reported
Blinding of participants and personnel (performance bias)
All outcomes Low risk The study designers, local physicians and data analyst were blinded to the intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit clear judgement
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 to permit judgement