Taveira 2010.
| Study characteristics | ||
| Methods |
Pharmacist‐led group medical appointment model in type 2 diabetes Patient RCT, conducted in VA (Veterans Affairs) Medical Center’s electronic medical record system, USA Two arms: 1. Usual care (control arm) and 2. VA‐MEDIC ‐ Veterans Affairs Multi‐disciplinary Education and Diabetes Intervention for Cardiac risk reduction (intervention arm) |
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| Participants | Control arm N: 54 Intervention arm N: 64 Diabetes type: type 2 Mean age: 64.5 ± 10.3 % Male: 95.7 Longest follow‐up: 4 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.9 (1.1), post 7.9 (NR) Intervention arm: pre 8.1 (1.5), post 7.2 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 137.2 (17.5), post 135.5 (NR) Intervention arm: pre 131.1 (18.8), post 123.8 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 74.2 (9.8), post 75.2 (NR) Intervention arm: pre 74.4 (10.8), post 67.9 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 92.8 (34.8), post 85.0 (NR) Intervention arm: pre 92.8 (34.8), post 81.5 (NR) 5a) Controlled hypertension (DBP < 80 mmHg), N under control (%) Control arm: pre 37 (73), post 35 (69) Intervention arm: pre 40 (69), post 51 (88) 5b) Controlled hypertension (SBP < 130 mmHg), N under control (%) Control arm: pre 17 (33), post 20 (39) Intervention arm: pre 35 (60), post 38 (66) 6) Smoking cessation, N smokers (%) Control arm: pre 7 (14), post 7 (14) Intervention arm: pre 20 (34), post 17 (29) |
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| Funding source | This work was supported in part by Rhode Island Foundation (Dr Wu). Additional supports include American College of Clinical Pharmacy Astra‐Zeneca Health Outcomes Research Award (Dr Taveira), American Society of Health Systems Pharmacists and Education Foundation Federal Services Research Grant Program (Dr Cohen), VA HSR&D Merit Review Award IAB 06‐269 (Dr Taveira, Dr Cohen, Dr Wu), VA HSR&D Career Development Award 04‐123 (Dr Pirraglia), and Targeted Research Enhancement Program grant (TRP 04‐179) from the Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs (Dr Friedmann). | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were assigned to the VA‐MEDIC arm or usual care arm using simple coin toss randomisation. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | High risk | Table 2. Age P value less than 0.05, no education information. |
| Patient's baseline outcomes (selection bias) | High risk | Table 2. Several P values less than 0.05. |
| Incomplete outcome data (attrition bias) | Low risk | 3 lost in control, 6 lost in intervention. No reasons provided. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure of all outcomes. |
| Selective reporting (reporting bias) | High risk | Retrospectively registered protocol. Several other outcomes were reported than were listed in protocol. |
| Risk of contamination (other bias) | High risk | Information not available. |
| Other bias | Unclear risk | Participants in both groups saw primary care physicians at the VA Medical Center; unclear if physicians treated patients in both groups ‐ may have influenced care of participants in control group. |