Planas 2012.
Study characteristics | ||
Methods |
Evaluation of diabetes management program using selected HEDIS measures Patient RCT, conducted in a regional community pharmacy chain in Tulsa, Oklahoma, USA Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
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Participants | Control arm N: 27 Intervention arm N: 38 Diabetes type: unclear/not reported Mean age: NR ± NR % Male: NR Longest follow‐up: 9 months |
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Interventions |
Control arm: 1) Patient education 2) Promotion of self‐management Intervention arm: 1) Case management 2) Team changes 3) Clinician education 4) Patient education 5) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.8 (1.0), post 7.9 (0.9) Intervention arm: pre 7.6 (1.0), post 7.1 (1.0) 2) SBP, mean mmHg (SD) Control arm: pre 141.1 (24.9), post 140.2 (20.0) Intervention arm: pre 139.2 (17.9), post 124.0 (16.9) 3) DBP, mean mmHg (SD) Control arm: pre 75.3 (12.6), post 74.9 (10.3) Intervention arm: pre 78.1 (10.3), post 73.7 (9.9) 4) LDL, mean mg/dL (SD) Control arm: pre 94.4 (38.2), post 90.5 (31.3) Intervention arm: pre 109.3 (36.8), post 97.3 (24.1) 5) Controlled hypertension (< 130/80 mmHg), N under control (%) Control arm: pre 5 (23), post 5 (23) Intervention arm: pre 6 (20), post 16 (53) |
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Funding source | American Society of Health‐System Pharmacists Research and Education Foundation, the American Pharmacists Association Foundation, and USA Drug Stores | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Previously generated random number list. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | BMI (P < 0.05); all other characteristics were similar between groups. |
Patient's baseline outcomes (selection bias) | Unclear risk | Not reported in text or table. |
Incomplete outcome data (attrition bias) | High risk | Large losses from both arms, reasons not provided. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: BP, using a aneroid sphygmomanometers at resting for period of 5 minutes. HbA1c measured using fingerstick DCA 2000, LDL using fingerstick Cholestech LDX, point of care after fasting for 9 to 12 hours. |
Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match results. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | No evidence of other bias. |