Márquez 2007.
| Study characteristics | ||
| Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: (2‐sided confidence interval) |
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| Participants | N recruited = 220 N randomised = 220 (110 control, 110 intervention) N reported outcomes = 186 Mean age 60.62 years (SD 11 yrs), 59.6% women INCLUSION CRITERIA Outpatients of both sexes, aged between 18 and 75 years Patients who, for the pharmacological treatment of hypercholesterolaemia this indicated the use of lipid‐lowering pills, were recommended the use of simvastatin Patients gave their consent to participate in this study Patients requiring lipid‐lowering medication treatment, as a function of the cardiovascular risk factors and presenting primary prevention, according to Spanish recommended by the Consensus guidelines for the control of blood cholesterol EXCLUSION CRITERIA Patients at baseline needed to control their lipid numbers with 2 or more lipid‐lowering drugs Present known cardiovascular disease Secondary hypercholesterolaemia Side effects and contraindications to the use of statins Pregnant or lactating women COUNTRY/SETTING: Spain STUDY PERIOD: Recruitment between January and June 2006 |
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| Interventions | Number of study centres: 5 Intervention group received calendar reminder of medication taking received at the time of first prescription |
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| Outcomes | PRIMARY OUTCOMES: adherence, serum lipids SECONDARY OUTCOMES: number needed to intervene in order to avoid 1 non‐complier |
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| Notes | Aim: To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of hypercholesterolaemia Funding: N/A Conflicts: None reported Language: Spanish |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation by providing numbers derived from tables by chance |
| Allocation concealment (selection bias) | Low risk | Randomisation performed blind |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 22 participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |