Skip to main content
. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Volume 2001.

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
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