Evans 2010.
Methods | Randomized controlled trial | |
Participants | The study location was Saskatoon, Saskatchewan, Canada 88 participants were randomized to the intervention group and 88 participants were randomized to the control group The inclusion criteria were patients who exhibited any cardiovascular risk factors (hypertension, dyslipidemia, diabetes mellitus, or a previous cardiovascular event), a calculated Framingham risk score (FRS) of at least 15% or a coronary artery disease risk equivalent (coronary artery disease, peripheral artery disease, cerebrovascular disease, or diabetes mellitus) The exclusion criteria were severe psychiatric conditions or dementia, symptomatic heart failure (New York Heart Association class III or IV), terminal illness, concurrent participation in an investigational study, or were pregnant or breastfeeding |
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Interventions | Intervention: PHARMACIST FOLLOW‐UP
The pharmacist established goals for the patient. Goals were documented in the patient records. When any of the risk factors were uncontrolled, the pharmacist alerted the patient by telephone and mail, and the physician was notified through the patient's medical record and face to face (when possible). Patients received continuous follow‐up by the pharmacist at a minimum of every 8 weeks by telephone, mail, electronic mail, or face to face appointments. Mailed letters were reserved for patients who were successfully controlled or had been recently contacted. Information delivered during follow‐up was patient specific and did not require that a standard content be covered. Reasons for follow‐up included 1) To communicate relevant laboratory results, including proximity to individual targets; 2) To monitor clinical status within 7 to 10 days after the initiation or change of a drug; 3) To monitor clinical status within 7 to 10 days after experiencing an adverse event; 4) To ensure that the patient was able to procure necessary follow‐up appointments; 5) To provide patients with clinical goal reminders, disease‐specific information, or timely topics using periodic mailers. Emphasis was placed on conducting short follow‐up contacts that reminded and reinforced the importance of drug adherence and clinical targets. All patients were followed for a minimum of 6 months Control: SINGLE‐CONTACT GROUP Patients met at the beginning of the study with the study pharmacist, and received a booklet about cardiovascular disease. After that meeting they received usual care and had no more contact with the study pharmacist |
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Outcomes | The measures of adherence were calculated based on pharmacy refill records using the proportion of days covered; that is, the sum of the days supply for all statin prescription fills during the study period, divided by the number of days between the index date and the end of the study period The patient outcomes were global cardiovascular risk status as measured by the 10‐year FRS, systolic and diastolic blood pressure, hemoglobin A1C, and cholesterol. FRS was measured by the study pharmacist based on medical record review and a patient interview. Laboratory values were taken from the patient's medical charts |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization lists were stratified by each physician and were created by using a table of random numbers in permuted blocks of 4 (pg 768) |
Allocation concealment (selection bias) | Low risk | Randomization codes were kept in individually sealed envelopes and opened by the study pharmacist at the end of the initial visit (pg 768) |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon) |
Other bias | Low risk | Author's note: we present evidence for bias towards the null |
Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) PHARMACY RECORDS ‐ The pharmacist was not blinded and was the lead investigator of the study |
Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) FRAMINGHAM RISK SCORE ‐ Collected by staff pharmacist who was not blinded and was also lead investigator for the study |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) PHARMACY RECORDS ‐ Patients were not blinded but pharmacy refill records unlikely to be affected |
Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) FRAMINGHAM RISK SCORE ‐ Patients were not blinded; unknown how this may affect this outcome |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY RECORDS ‐ Unclear if other personnel were blind |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) FRAMINGHAM RISK SCORE ‐ Unclear if any other personnel were blind |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY RECORDS ‐ There is not enough information given about the missing data, or if there were additional missing data due to participants not picking up prescription |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) FRAMINGHAM RISK SCORE ‐ Incomplete data evenly spread across conditions; does not seem likely to bias the results |