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. 2017 Feb 3;2017(2):CD008312. doi: 10.1002/14651858.CD008312.pub3

Peterson 1984.

Methods Study design: RCT
Method of randomisation: coin‐toss randomisation.
Setting: outpatient clinic at a hospital in Australia.
Date it was conducted: not reported.
Follow‐up: 4 weeks and 6 months.
Source of funding: Astra Pharmaceuticals (pty) ltd supplied Dosetts
Conflict of interest: not reported.
Participants Inclusion/exclusion criteria: people who were consecutive attenders at outpatient clinics during the study period, who were responsible for their own medication and who possessed a hospital pharmacy prescription book.
Sample size: 53 participants were recruited. At follow‐up, 2 participants from the control group and 1 from the intervention group had not returned to the clinic and were excluded from the analysis.
Gender: 15 (58%) men were included in the intervention group and 15 (56%) in the control group.
Age: median age was 35 years (range 19 to 74) in the IG and 28 years (range 18 to 64) in the CG.
Gender: female 44% in the IG and 42% in CG.
Interventions Type of intervention: mixed
Intervention group participants were counselled on the goals of anticonvulsant therapy and the importance of good adherence in achieving these goals; a schedule of medication‐taking was devised that corresponded with participants' everyday habits; participants were given a copy of an educational leaflet; each participant was provided with a 'Dosett' medication container (pill organiser) and was counselled on its use; participants were instructed to use a medication/seizure diary; and participants were reminded by mail of upcoming appointments and of missed prescription refills.
Outcomes Primary outcome(s) measured: adherence
It was assessed by (1) changes in plasma anticonvulsant levels (provided that the participant's medication regimen had not been altered in the preceding 2 weeks), (2) a check of the participant's prescription record book to determine prescription refill frequency (if refill frequency was 1 or more weeks later than expected at least once during the previous 6 months, the participant was considered non‐adherent) and (3) participant appointment‐keeping frequency (those who had attended all scheduled appointments in the previous 6 months were considered compliant).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Coin toss 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 physicians were blinded to the allocated interventions
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The information on blinding of other parties (e.g. outcome assessors) was not 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 Unclear risk Insufficient rationale or evidence that an identified problem will introduce bias