Simpson 2011.
| Study characteristics | ||
| Methods |
Effect of adding pharmacists to primary care teams on blood pressure control in patients with type 2 diabetes Patient RCT, conducted in 5 primary care clinics (affiliated with the Edmonton South Side Primary Care Network), Canada Two arms: 1. Control patients (control arm) and 2. Intervention patients (intervention arm) |
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| Participants | Control arm N: 129 Intervention arm N: 131 Diabetes type: type 2 Mean age: 59.1 ± 11.6 % Male: 42.7 Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes |
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| Outcomes | 1) Antihypertensives (ACE inhibitor or angiotensin II receptor blockers), N users (%) Control arm: pre NR (NR), post 6 (5) Intervention arm: pre NR (NR), post 24 (18) 2a) Retinopathy screening (ophthalmologist visit), N screened (%) Control arm: pre NR (NR), post 39 (30) Intervention arm: pre NR (NR), post 31 (24) 2b) Retinopathy screening (optometrist visit), N screened (%) Control arm: pre NR (NR), post 25 (19) Intervention arm: pre NR (NR), post 30 (23) 3) HbA1c, mean % (SD) Control arm: pre 7.3 (1.3), post 7.3 (NR) Intervention arm: pre 7.5 (1.6), post 7.4 (NR) 4) SBP, mean mmHg (SD) Control arm: pre 128.3 (15.7), post 125.8 (NR) Intervention arm: pre 130.4 (14.9), post 123.0 (NR) 5) DBP, mean mmHg (SD) Control arm: pre 73.9 (10.8), post 74.5 (NR) Intervention arm: pre 74.4 (10.0), post 72.1 (NR) 6) LDL, mean mg/dL (SD) Control arm: pre 93.2 (27.8), post 89.3 (NR) Intervention arm: pre 93.6 (30.9), post 84.7 (NR) |
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| Funding source | Operating grant funding was provided by the Canadian Diabetes Association, the Institute of Health Economics, and the Alberta Heritage Foundation for Medical Research (AHFMR) | |
| Notes | — | |
| 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…" |
| Allocation concealment (selection bias) | Low risk | Quote: "...Central randomization service….Pharmacists, analysts, and investigators were unaware of block size and allocation sequence to preserve allocation concealment." |
| Patient's baseline characteristics (selection bias) | Unclear risk | No P values in tables. |
| Patient's baseline outcomes (selection bias) | Unclear risk | They state that baseline blood pressure were the same between both groups. Do not provide a table of characteristics. |
| Incomplete outcome data (attrition bias) | Low risk | Intention‐to‐treat analysis was done with last observation carried forward. Baseline values not provided, however can assume its based on those randomised. Numbers and reasons for loss to follow‐up provided and pretty balanced. The authors also note that those who did not complete the study (in both arms) were similar for all comparisons (P > 0.05 for all comparisons), and that baseline characteristics were the same between those who dropped out for intervention and control. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Blood pressure with automated machine. Outcome assessors were blinded. Allocation concealment was maintained from the pharmacists, analysts and investigators. |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches. |
| Risk of contamination (other bias) | High risk | Quote: "…there was the possibility of 'contamination' or 'cointervention' because both intervention and control patients were drawn from the same primary care team." |
| Other bias | Low risk | Information not available. |