Kardas 2013.
| Study characteristics | ||
| Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: (2‐sided confidence interval) Open‐label |
|
| Participants | N recruited = 198 N randomised = 198 (89 control, 107 intervention) N reported = 196 Mean age 59.6 ± 9.1 years, 75.5% women INCLUSION CRITERIA Outpatients with untreated hyperlipidaemia (total cholesterol ≥ 250 mg/dL) aged 40 ‐ 80 years (59.6 ± 9.1 years) were enrolled EXCLUSION CRITERIA Mental illness, dependence on other people’s care, and/or medication taking, being at risk of not completing the study due to alcoholism, psychoactive substance abuse, homelessness etc., porphyria, unstable angina, NYHA class III or IV heart failure, acute infections, liver disease (cirrhosis), or significantly elevated transaminases (level ≥ 3 times above the normal values), allergy to simvastatin, or any other known contraindications to its use, pregnancy, and lactation. COUNTRY/SETTING: primary care centers in Poland STUDY PERIOD: Not reported |
|
| Interventions | CONTROL GROUP All patients who were enrolled in the study were prescribed simvastatin at the initial dose of 20 mg to be taken once daily in the evening INTERVENTION GROUP Intervention group received counselling every 8 weeks and were instructed to adopt routine evening activity as a reminder |
|
| Outcomes | PRIMARY OUTCOME: adherence expressed as Medication Possession Ratio, calculated as the proportion of the number of days during which the participant was in possession of simvastatin, over the total number of days of the follow‐up period. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants lost to attrition |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |