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

DiIorio 2009.

Study characteristics
Methods Study design: RCT
Method of randomisation: not reported
Setting: 3 clinics in a large south‐eastern metropolitan area of the USA
Date it was conducted: not reported
Follow‐up: 12 weeks
Source of funding: Emory University Research Committee
Conflict of interest: not reported
Participants Inclusion/exclusion criteria: 18 years, were able to understand and speak English, had telephone access and were mentally stable
Sample size: 22
Gender: 15 were men (68.2%)
Age: mean age was 43 years (SD 13.51)
Interventions Type of intervention: behavioural
5 motivational intervention sessions were conducted: 1 face‐to‐face and 4 telephone‐based. For each session, a specially trained nurse used a script that included key aspects of self‐management and discussed medication management with the participant. The nurse began by asking a general question about medication‐taking practices.Those who reported problems with medication were provided support. A goal and action plan of at least one strategy to improve adherence was developed. Participants were encouraged to develop their own solutions and to devise an action plan. Then, the nurse asked the participant to select 1 or 2 other self‐management components (information, seizure, safety and lifestyle issues) that were important to him or her. The rest of discussion aimed at identifying barriers and facilitators of desired behaviours, eliciting change strategies and building confidence.
Outcomes Primary outcome(s) measured: adherence
It was measured via MEMS cap (presented as percentage of doses taken and percentage of doses taken on time), and self‐reported adherence by using AGAS.
Secondary outcome(s) measured: outcome expectancy (a judgement of the likely consequences of practising self‐management strategies and epilepsy self‐management), self‐efficacy and knowledge of epilepsy (medical and social aspects).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk No information on concealment was reported
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 Unclear risk Insufficient reporting of attrition/exclusions to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk Inadequate sample size could increase the likelihood of a type II error and other bias