Marquez Contreras 2004.
| Methods | A controlled, randomized clinical trial was conducted in 6 primary care centers in the Huelva province of Spain | |
| Participants | 126 people diagnosed with hypercholesterolemia according to Spanish Consensus criteria were chosen: 63 in control group and 63 in intervention group. Recruitment took place from January to June 2001 | |
| Interventions | The control group (CG) of 63 patients, who received the doctor's normal treatment, which included oral information about hypercholesterolemia, advice about its control, brochures about dietary recommendations, 3 month‐long prescriptions for a cholesterol‐lowering medication, and titration of that medication if indicated at 3 months The intervention group (IG) of 63 patients received this care, and in addition, received a telephone call at 7 to 10 days, 2 months, and 4 months. The goal of the intervention was to establish the level of compliance, categorize this as adequate or inadequate, and make recommendations based on that. Level of compliance was determined by comparing the number of pills consumed to the number that should have been consumed (calculated using self reported information about the number of pills remaining, number of pills dispensed, and fill date of the prescription). Compliance was defined as taking 80% to 110% of the pills that should have been taken thus far. Compliant patients were congratulated and encouraged to continue their good level of compliance as it would lower their risk of heart disease. Noncompliant patients were notified their behavior was considered noncompliant and encouraged to better comply with therapy as it would lower their risk of heart disease |
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| Outcomes | Pills were counted in person at 3 and 6‐month follow‐up visits to estimate compliance over the previous 3 months. Cholesterol, triglycerides, HDL‐C and LDL‐C were measured at the start, and at the 3rd and 6th months | |
| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random number tables (pg 88) |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned (pg 88) |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No other bias noted |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) PILL COUNT ‐ Double‐blinding is present (pg 449) |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ Double‐blinding is mentioned (pg 449) |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) PILL COUNT ‐ Patients took medication in to be counted so they are aware of this measure |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ Double‐blinding is mentioned (pg 449) |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) PILL COUNT ‐ Key personnel blinding is not mentioned in the article |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ Double‐blinding is mentioned (pg 449) |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) PILL COUNT ‐ Although follow‐up seems balanced it is difficult to say whether this had an effect on results |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ Although the dropouts seem balanced, it is hard to tell if this had an effect on results |