Li 2013.
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 authors declare no conflict of interest. |
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Participants |
Inclusion exclusion criteria: (1) age ≥13 and <65 years and constant receipt of phenobarbital monotherapy. The exclusion criteria
included patients with severe mental retardation or neurologic diseases or psychosis; and patients receiving another one or two 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 Caracteristics: Mean duration since diagnosis was 12.3 years (median 14) in the IG and 10.6 years (median 12) in the CG. |
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Interventions |
Type of intervention: mixed A 4 components 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. |
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Outcomes | Primary outcome(s) measured: adherence, seizure control and avoiding lifestyle‐precipitated seizures. Adherence and lifestyle each was 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 that an identified problem will introduce bias |