Kooy 2013.

Study characteristics
Methods	Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Equivalence design: (2‐sided confidence interval) Open‐label
Participants	N recruited = 399 N randomised = 399 (134 control, 134 intervention‐1, 131 intervention‐2) N reported outcomes = 381 Mean age 76.5 (SD 6.3), 44.1% men INCLUSION CRITERIA ≤ 65 years old (Mean age 76.5) “We included patients who had started statins at least one year prior to inclusion and were non‐adherent in the year prior to inclusion (refill rate between 50 and 80%).” EXCLUSION CRITERIA “We excluded patients who were not personally responsible for their medication intake or who received their medication in a dosing aid, patients with a life expectancy of less than 6 months and patients younger than 65 years. Life expectancy is difficult to assess but this assessment was based on personal knowledge about the patient and the prescription of drugs used in the palliative phase. Patients who had switched to a different statin in the 540 days before the inclusion date were also excluded.” COUNTRY/SETTING: The Netherlands STUDY PERIOD: Patients recruited between January 2008 and March 2008
Interventions	Number of study centres: 24 community pharmacies Counseling with ERD group (1) “The pharmacist sent patients a written invitation and a follow up phone call was made 14 days after the written invitation. The intervention consisted of two elements: the first and most important element was the application of the stages of change model in non‐adherence counseling. The second element was the Electronic Reminder Device (ERD)." "The 10‐min counseling session by the pharmacist consisted of five phases. The patient received feedback on their previous drug dispensing data (1). Patients were asked if they were aware that they were non‐adherent and reasons for non‐adherence were discussed (2). Patients were informed about the benefits of statin use (3), received an ERD to help them with medication taking (4) and were informed that after one year they would be invited for a follow‐up visit (5). The ERD is a medication reminder device that starts beeping every day at the same time until the patient switches it off. Patients can adjust the time.” ERD group (2) “Patients received the ERD by mail with a written instruction about the use of the device.” Control group (3) “Patients in the control group received usual care. In the Netherlands usual care entails: at the start of therapy, patients receive written and spoken information about the therapy and medication. After about 2 weeks, the patient should return for the first refill. The patient is then asked about his or her experience, concerns and need for information. Patients who use a statin for more than a year do not receive counselling on a regular basis.”
Outcomes	“The pre‐specified primary outcome was refill adherence to statins based on pharmacy dispensing records. Refill adherence was assessed by calculating the proportion of days covered of the 360 days following the index date by dividing the total days’ supply by the number of days of study participation [PDC360 (Hess et al., 2006)].” PRIMARY OUTCOME: refill adherence SECONDARY OUTCOME: discontinuation
Notes	Publication details Commercial funding/non‐commercial funding/other funding: “This trial was funded by Utrecht University.” Stated aim for study “The aim of this study was to assess the effectiveness of an electronic reminder device (ERD) with or without counselling to improve refill adherence and persistence for statin treatment in non‐adherent patients.”
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patients were randomized into one of three groups: the Counseling with ERD group, the ERD group (with written instruction) or the control group (usual care) in a 1:1:1 ratio using a computer generated random number sequence. Patients were randomized in blocks based on baseline medication adherence (above or below 65%) and age [above or below 75 using the minimization method with equal weights assigned to both categories (Scott et al., 2002; Heritier et al., 2005)]."
Allocation concealment (selection bias)	Low risk	See above
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Unblinded "open‐label study"
Incomplete outcome data (attrition bias) All outcomes	Low risk	"A total of 399 patients considered eligible by the pharmacists were randomly assigned to one of the two intervention groups or the control group. Two patients were excluded because they did not fill any prescription after the selection date. A total of 16 patients were excluded because they started receiving medication weekly after the index date."
Selective reporting (reporting bias)	Low risk	All outcomes reported