Márquez 1998.
| Study characteristics | ||
| Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: 2‐sided confidence interval Open‐label |
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| Participants | N recruited = 110 N randomised = 110 (55 control, 55 intervention) N reported outcomes = 108 Mean age years 55.7 (intervention group), 56.1 years (control group) INCLUSION CRITERIA a) outpatients of both sexes from 18 ‐ 75 years old b) diagnosed with new or uncontrolled hypercholesteraemia that can be treated according to the recommendation of the Spanish Society of Arteriosclerosis. c) patients in whom pharmacological treatment of hypercholesteraemia is indicated by fluvastatin and can be initiated as new drug treatment d) agree to participate in the study by written and verbal consent EXCLUSION CRITERIA a) patients who want to join the study to control their lipid levels or get lipid‐lowering drugs b) secondary hypercholesteraemia c) patient is known to have side effects from statins d) contraindicated for fluvastatin use or hypersensitive to fluvastatin e) pregnant or breastfeeding women f) patients in a pathological situation which could interfere with the study (i.e. disabled, alcoholic, drug user, chronic diseases) g) unwilling to grant informed consent or poor co‐operation is expected h) patients who have participated in other studies from this investigation i) having a cohabitant who is taking the same lipid‐lowering medication used in the study COUNTRY/SETTING: primary care centers in Spain STUDY PERIOD: Patients enrolled between January and March 1997 |
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| Interventions | Number of study centres: Primary Care setting INTERVENTION GROUP "HE (Health Education) was monitored by a) a group HE session and b) back‐up letter sent to their homes." CONTROL GROUP "received HE from their family doctor" |
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| Outcomes | TIME OF OUTCOME MEASUREMENTS: Pill counts over 4 months PRIMARY OUTCOME: compliance SECONDARY OUTCOMES: lipid levels, adverse effects |
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| Notes | Commercial funding/non‐commercial funding/other funding: Not reported Stated aim for study: "To analyse the efficacy of Health Education (HE) through group session with postal back‐up in furthering compliance with therapy for Lipidemias." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Low risk | Randomisation performed blind |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Generator and outcome assessor blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 2 were excluded for having no measurement count tablets |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |