Sonnichsen 2010.
| Study characteristics | ||
| Methods |
The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster‐randomised controlled trial Cluster‐RCT (6 clusters with 92 providers), conducted in 275 eligible primary care physicians with a contract with the public health insurance in Austria (province of Salzburg), Austria Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 840 Intervention arm N: 654 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Clinician education 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) Retinopathy screening (eye exam), N screened (%) Control arm: pre NR (NR), post 430 (51) Intervention arm: pre NR (NR), post 461 (71) 2) Foot screening, N screened (%) Control arm: pre NR (NR), post 379 (45) Intervention arm: pre NR (NR), post 479 (74) 3) HbA1c, mean % (SD) Control arm: pre 7.3 (1.3), post 7.1 (NR) Intervention arm: pre 7.5 (1.5), post 7.1 (NR) 4) SBP, mean mmHg (SD) Control arm: pre 139.0 (17.0), post 138.3 (NR) Intervention arm: pre 141.0 (19.0), post 138.5 (NR) 5) DBP, mean mmHg (SD) Control arm: pre 82.0 (10.0), post 81.4 (NR) Intervention arm: pre 83.0 (11.0), post 81.8 (NR) 6) LDL, mean mg/dL (SD) Control arm: pre 111.0 (35.2), post 109.4 (NR) Intervention arm: pre 111.0 (37.1), post 111.4 (NR) |
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| Funding source | Paracelsus Medical University, Public Health Insurance of Salzburg, Salzburg Savings Bank, Roche Diagnostics | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…computerised sequence generation." |
| Allocation concealment (selection bias) | Low risk | Cluster. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not provided. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Quote: BMI (P = 0.01); cholesterol (P = 0.02). |
| Patient's baseline outcomes (selection bias) | Low risk | Quote: HbA1c (P = 0.10); LDL (P = 0.78); SBP (P = 0.12); DBP (P = 0.41). |
| Incomplete outcome data (attrition bias) | High risk | Intention‐to‐treat and per‐protocol analysis. For intention‐to‐treat analysis, after randomisation, n = 6 general practitioners (GP) practices withdrew before recruiting patients, and n = 5 in intervention group were excluded since they withdrew consent and did not provide baseline values. They excluded these values and considered it an intention‐to‐treat analysis. Numbers and reasons for lost to follow‐up provided. Percentages are similar. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | High risk | Primary: HbA1c. Secondary: BP, lipids, eye and foot exams. Objective methods not described. Blinding was not possible in the study (unblinded). |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches with manuscript. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | None. |