Methods |
Cluster‐randomized trial with pharmacies as the unit of randomization. 2 of the 16 pharmacies were located 2 blocks apart in the same rural community. To minimize the risk of sample contamination between these 2 pharmacies, they were included in the same study group. One pair from the same community were assigned as a block. 8 pharmacies were randomly placed in the treatment group and 8 pharmacies were randomly to be in the control group. Pharmacists from 5 of the 8 treatment pharmacies completed the practice enhancement program and began enrolling patients into the study |
Participants |
Ambulatory elderly (> or = 65 years of age) patients (n = 60) covered under Alberta Health & Wellness's senior drug benefit plan and who were concurrently using 3 or more medications according to pharmacy profiles |
Interventions |
In intervention group, pharmacists used the Pharmacist's Management of Drug‐Related Problems (PMDRP) instrument to summarize the information collected during the patient interview and prepared a "SOAP" record (Subjective, Objective, Assessment, and Plan) to document actions and follow‐up. Pharmacists at control pharmacies continued to provide traditional pharmacy care |
Outcomes |
Adherence to medication regimens was assessed using a 4‐item self report measure. Health‐related quality of life was assessed using the SF‐36 health survey. The SF‐36 has been used extensively to evaluate the success of clinical interventions |
Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomization of pharmacies were done by the study statistician, blinded. Sequence generation not described |
Allocation concealment (selection bias) |
Low risk |
Allocation was centrally performed, but by the statistician, who was blinded |
Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
Other bias |
Low risk |
The study seems to be free of other types of bias |
Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ SURVEY ‐ This is a subjective measure; there is no information on blinding |
Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (HRQOL) ‐ The article does not state if the telephone survey personnel were blinded. (pg 4) A telephone survey of patients was administered by the Population Research Lab at the University of Alberta at baseline (time 1; before the intervention); mid‐point (time 2; 6 to 7 months after the intervention); and the conclusion of the study (time 3; 12 to 13 months after baseline). Respondents were asked to provide such information as demographics, self reported adherence, expectations, satisfaction with pharmacy services, and patient HRQOL |
Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ SURVEY ‐ Patients would have been aware of the additional attention paid by the intervention group pharmacists |
Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (HRQOL) ‐ This is a subjective measure; there is no information on blinding |
Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ SURVEY ‐ Pharmacists would have been aware of their own group assignment |
Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (HRQOL) ‐ Pharmacists would have been aware of group memberships |
Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ SURVEY ‐ Reasons for the patients who did not complete all 3 interviews are not given |
Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HEALTH‐RELATED QUALITY OF LIFE (HRQOL) ‐ Reasons for the patients who did not complete all 3 interviews are not given |