Wu 2006.
| Methods | Randomized controlled trial | |
| Participants | The study location was Prince of Wales Hospital, Shatin, Hong Kong 219 participants were randomized to the intervention group and 223 participants were randomized to the control group The inclusion criteria were patients receiving polypharmacy defined as 5 or more chronic medications on at least 2 consecutive visits to the clinic who were found to be non‐compliant upon first assessment by pharmacist The exclusion criteria were patients who spoke non‐Cantonese dialects or a different language, had conditions that prevented effective communication or patients who lived in nursing homes with supervised treatment |
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| Interventions | Intervention: INCREASED SUPERVISION BY PHARMACIST
Patients in the intervention group received 10 to 15‐minute telephone calls from the pharmacist at the midpoint between clinic visits, normally scheduled at intervals of 2 to 4 months, throughout the study period. During the telephone calls the pharmacist asked about the patient's current medication regime, clarified misconceptions, explained the nature of side effects, reminded patients of next appointment, reinforced importance of compliance with medications and relevant aspects of self care and encouraged patients to share side effects, self initiated change in regimen, or other concerns with the doctors at next follow‐up Control: USUAL CARE Patients in the control group continued with usual care, which for clinically stable patients meant follow‐up at intervals of 2 to 4 months, with each consultation lasting 10 to 15 minutes |
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| Outcomes | The measures of adherence were assessed at the screening visit, screening visit, enrolment/randomization visit, and at the end of the 2‐year study period. Adherence was assessed through a direct structured questionnaire by a pharmacist that asked the patient to describe their regimen by drug dosages, frequency, and number of pills taken at different times of the day. They were asked whether they had missed any doses; changed their regimens in terms of doses, frequency, and timing; or had drugs left over. This information was checked against the dispensing information on the Health Authority's clinical management system to calculate a Compliance Score = (number of drugs that the patient was fully compliant with)/(total number of prescribed drugs) x 100 (%). A patient who complied with all prescribed drugs had a compliance score of 100%, whereas one who complied with only 3 of the 6 drugs had a compliance score of 50% The patient outcome was mortality. 2 senior doctors confirmed the causes of death by reviewing medical records and examining death certificates with an accountability of 100%. Secondary outcomes were changes in the rate of admission to hospital, number of emergency room visits, hospital stay in the 2 years before and after the screening visit. Hospital admissions, emergency room attendance, and drug dispensing information were computerized and accessed through the clinical management system |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomization. "At the enrolment visit, we reassessed eligible patients for compliance. The pharmacist was blinded to the randomisation codes, which were computer generated by our statistician and sealed in envelopes labelled with consecutive numbers. The envelopes were opened by the clinic nurse in an ascending manner, and patients were allocated to the intervention or control group." (pg 2) |
| Allocation concealment (selection bias) | Low risk | "The pharmacist was blinded to the randomisation codes, which were computer generated by our statistician and sealed in envelopes labelled with consecutive numbers. The envelopes were opened by the clinic nurse in an ascending manner, and patients were allocated to the intervention or control group." (pg 2) |
| 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 | Low risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ (pg 2) The pharmacist was blinded to the randomization codes |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) MORTALITY ‐ Outcome measurement not likely to be influenced by lack of blinding |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Patients likely to be unblinded due to the nature of the intervention. Subjective measure |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) MORTALITY ‐ Outcome measurement not likely to be influenced by lack of blinding |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) MORTALITY ‐ Outcome measurement not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No loss to follow‐up. The authors also report the outcomes for 60 patients initially screened prior to randomization |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) MORTALITY ‐ No loss to follow‐up. Death rates were not similar |