Marquez Contreras 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was Huelva‐Costa, Spain 110 participants were randomized to the intervention group and 110 participants were randomized to the control group The inclusion criteria were ambulatory patients of both sexes between the ages of 18 and 80, prescribed lipid‐lowering medication, consented to participate in the study, receiving lipid‐lowering medication in accordance with Spanish recommendations The exclusion criteria were patients taking more than one lipid‐lowering medication, having secondary hyper‐cholesterol, pregnant or lactating women, with disorders that could compromise the results of the study, participating in other studies, patients residing with others on the same medication |
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| Interventions | Intervention: CALENDAR REMINDER
The patients in the intervention group were mailed a calendar as a reminder of medication taking. The calendar was double‐sided. On one side, there was a calendar where the patient could mark with an x the days of the months when they should be taking their medication. On the other side, there was information about the next visits, treatment recommendations, and a place to insert lipid analysis info Control: USUAL TREATMENT Patients received treatment as usual as provided by a family physician |
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| Outcomes | The measures of adherence were MEMS containers. The MEMS containers were filled at baseline and 12 weeks. Patients were asked to bring MEMS in to sessions at 12 and 24 weeks. This was the primary adherence measure The patient outcomes were biochemical measures obtained via blood tests. Lipid measurements were calculated. The degree of control of dyslipidemia was measured according to the therapeutic guidelines |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A random numbers table was used (pg 662) |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment of 'Low risk' or 'High risk'; method of allocation not specified |
| Selective reporting (reporting bias) | Unclear risk | Study protocol is not available |
| Other bias | Low risk | The study appears to be free of other sources of bias |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) MEMS ‐ This is an open study but MEMs is unlikely to be affected by outcome assessors |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) LIPID LEVELS ‐ Open study but this is an objective measure |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) MEMS ‐ This is an open study |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) LIPID LEVELS ‐ Open study but this is an objective measure |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) MEMS ‐ This is an open study but MEMs is unlikely to be affected by key study personnel |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) LIPID LEVELS ‐ Open study but this is an objective measure |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) MEMS ‐ Missing data have been imputed using appropriate methods. Missing data relatively balanced across groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) LIPID LEVELS ‐ Missing data have been imputed using appropriate methods. Number of dropouts is relatively balanced across both groups |