Cohen 2011.
Study characteristics | ||
Methods |
Pharmacist‐led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes Patient RCT, conducted with patients selected from VA Medical Center's electronic medical record system, USA Two arms: 1) Controls (control arm) and 2) Cases (intervention arm) |
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Participants | Control arm N: 50 Intervention arm N: 53 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
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Interventions |
Control arm: None Intervention arm: 1) Team changes 2) Patient education 3) Promotion of self‐management |
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Outcomes | 1) Statins, N users (%) Control arm: pre 36 (73), post 40 (82) Intervention arm: pre 37 (74), post 43 (86) 2a) Antihypertensives (ACE inhibitor or angiotensin II receptor blockers), N users (%) Control arm: pre 38 (78), post 37 (76) Intervention arm: pre 40 (80), post 45 (90) 2b) Antihypertensives (calcium channel blocker), N users (%) Control arm: pre 12 (24), post 12 (24) Intervention arm: pre 12 (24), post 17 (34) 2c) Antihypertensives (Diuretic), N users (%) Control arm: pre 14 (29), post 16 (33) Intervention arm: pre 24 (48), post 27 (54) 2d) Antihypertensives (ß‐blocker), N users (%) Control arm: pre 21 (43), post 23 (47) Intervention arm: pre 22 (44), post 25 (50) 3) HbA1c, mean % (SD) Control arm: pre 8.1 (1.4), post 7.9 (NR) Intervention arm: pre 7.8 (1.0), post 7.4 (NR) 4) SBP, mean mmHg (SD) Control arm: pre 136.1 (16.5), post 135.3 (NR) Intervention arm: pre 136.1 (16.8), post 126.9 (NR) 5) LDL, mean mg/dL (SD) Control arm: pre 110.7 (37.2), post 99.2 (NR) Intervention arm: pre 96.1 (25.4), post 86.7 (NR) 6) Controlled hypertension (< 130/80 mmHg), N under control (%) Control arm: pre 16 (33), post 16 (33) Intervention arm: pre 12 (24), post 29 (58) |
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Funding source | This study was funded by the Sandra A. Daugherty Foundation (principal investigator, Dr Wu) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Information not available. |
Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
Patient's baseline outcomes (selection bias) | High risk | LDL (P = 0.024). |
Incomplete outcome data (attrition bias) | High risk | Per‐protocol analysis, baseline based on those analysed, numbers and reasons for loss to follow‐up provided, but numbers excluded due to revoked consent disproportionate, after that numbers lost to follow‐up are the same. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcome: controlled hypertension. Secondary outcome: SBP, HbA1c, LDL. Objective methods not described. Blinding not described. |
Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | No evidence of other bias. |