Chamorro 2011.
Methods | Randomized controlled trial | |
Participants | The study location was in 9 community pharmacies of Granada, Spain 44 participants were randomized to the intervention group and 41 participants were randomized to the control group The inclusion criteria were patient presenting to the pharmacy to file a prescription in their name for one or more of antihypertensives, anti‐dyslipidemia, cardiovascular prevention, antidiabetics at moderate or high CV risk The exclusion criteria were BP > 180/110, history of MI within 3 months, on cardiac rehabilitation, terminally ill, low CV risk, refusing consent. They were excluded if their physician prescriber did not see fit to include them in the pharmacotherapy follow‐up |
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Interventions | Intervention: PHARMACOTHERAPY FOLLOW‐UP
The intervention consisted of follow‐up of the patients by the pharmacist. He gave written and oral information about cardiovascular prevention and adherence to the patients in the first interview. The pharmacist adopted a pharmacotherapy follow‐up program, for 4 visits over 16 to 18 weeks. The final assessment was at 32 weeks Control: EDUCATION This procedure consisted of health education, written and oral material all given in 1 session at enrollment |
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Outcomes | The measure of adherence was the Morisky‐Green‐Levine (MGL) test. A patient was considered adherent when they answered all questions correctly. Adherence was measured at baseline, 16 weeks, and 32 weeks in the control group and the intervention group by a pharmacist. Adherence in each group was calculated in terms of the percentage of patients who were achievers with the therapy The patient outcomes were blood pressure and cholesterol level. Blood pressure was considered to have achieved the therapeutic goal when values were under 140/90 mm Hg, or under 130/80 mm Hg in patients with diabetes, renal failure and acute myocardial infarction. Cholesterol levels were considered to have achieved the therapeutic goal in primary prevention when values were under 200 mg/dl and in secondary prevention under 175 mg/dl. The measures were made for control group at baseline, 16 weeks, and 32 weeks. The intervention group was assessed at the baseline, 2 to 4 weeks, 6 to 8 weeks, 16 to 18 weeks, and 32 weeks.They were made by the same pharmacist |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided about the sequence generation process |
Allocation concealment (selection bias) | Low risk | Centralized randomization |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Other bias | Unclear risk | The information in the article was insufficient to determine if there were other types of bias |
Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE MGL ‐ Blinding not mentioned; self report |
Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ No blinding statement |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE MGL ‐ self report ‐ subjective measure ‐ patient not blinded |
Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ No blinding statement |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE MGL ‐ Blinding not mentioned; self report |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ No blinding statement |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE MGL ‐ Missing data not reported |
Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ Not reported |