Simpson 2011.
| Methods | Randomised trial | |
| Participants | 260 participants with diabetes (intervention 131: control 129). Primary care clinics in Edmonton, Canada Year of study: February 2006 to January 2009. |
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| Interventions | The intervention programme began with an in‐person visit with a study pharmacist to identify all prescription, nonprescription, complementary, and alternative medications. Pharmacists measured the patient’s height, weight, heart rate, and blood pressure. Blood pressure was measured according to the Canadian Hypertension Education Program recommendations using an automated machine. Pharmacists then formulated guideline‐concordant recommendations to optimise medication management of blood pressure and other cardiovascular risk factors. These recommendations were discussed with the primary care physician who was responsible for authorising medication changes. The pharmacist then worked independently with the patient to implement these changes. Frequency: Once at beginning of year Duration: 1 year |
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| Outcomes | HbA1c Systolic BP Diastolic BP United Kingdom Prospective Diabetes Study (UKPDS) Risk Engine Score |
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| Notes | Funding source: Canadian Diabetes Association, the Institute of Health Economics, and the Alberta Heritage Foundation for Medical Research. Conflict of interest:None of the agencies were involved in the design and conduct of the study; collection, management, and interpretation of the data; and preparation, review, or approval of the manuscript. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A central randomization service provided computer generated random sequences stratified by the primary care clinic for treatment allocation." |
| Allocation concealment (selection bias) | Low risk | Quote: "Pharmacists, analysts, and investigators were unaware of the block size and allocation sequence to preserve allocation concealment" |
| Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Low risk | Unblinded participants, but little cause for concern here due to objective outcomes |
| Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Quote: "a randomized controlled trial with blinded ascertainment of outcomes" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis. Between group attrition < 10% Missing data were replaced by carrying the last observation forward. |
| Selective reporting (reporting bias) | Low risk | Main outcomes clearly specified and reported |
| Other bias | Low risk | None |