Duran 2008.
| Study characteristics | ||
| Methods |
Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice Patient RCT, conducted in St Carlos Hospital, Spain Two arms: 1. Group A (control arm) and 2. Group B (intervention arm) |
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| Participants | Control arm N: 63 Intervention arm N: 63 Diabetes type: type 2 Mean age: 70 (range: 57 to 76) % Male: 70.8 Longest follow‐up: 30 months |
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| Interventions |
Control arm: None Intervention arm: 1) Team changes 2) Clinician education |
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| Outcomes | 1) HbA1c, median % (SD) Control arm: pre 7.2 (1.5), post 7.3 (1.0) Intervention arm: pre 7.2 (2.0), post 7.1 (1.4) 2) SBP, median mmHg (SD) Control arm: pre 140.0 (14.8), post 130.0 (7.4) Intervention arm: pre 145.0 (20.7), post 135.0 (19.3) 3) DBP, median mmHg (SD) Control arm: pre 80.0 (8.9), post 76.0 (6.7) Intervention arm: pre 85.0 (10.4), post 78.0 (8.2) 4) LDL, median mg/dL (SD) Control arm: pre 104.0 (30.4), post 78.0 (12.6) Intervention arm: pre 107.0 (36.3), post 81.0 (20.0) 5a) Controlled hypertension (DBP < 80 mmHg), N under control (%) Control arm: pre 30 (53), post 47 (82) Intervention arm: pre 27 (46), post 51 (86) 5b) Controlled hypertension (SBP < 130 mmHg), N under control (%) Control arm: pre 12 (21), post 29 (51) Intervention arm: pre 14 (24), post 25 (42) 6) Smoking cessation, N smokers (%) Control arm: pre 11 (19), post 7 (12) Intervention arm: pre 11 (19), post 7 (12) |
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| Funding source | The foot care programme was partially supported by grants from the European Union, Sociedad Española de Endocrinología y Nutrición, Fundación Fernandez Cruz and Fundación del Servicio de Endocrinologia y Nutrición | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Table 1: no P values reported, but looks balanced. |
| Patient's baseline outcomes (selection bias) | Low risk | See Table 2, P values > 0.05. |
| Incomplete outcome data (attrition bias) | Low risk | 6 lost in group A (9.5%) and 4 lost in group B (6%), reasons provided. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measurement of outcomes. |
| Selective reporting (reporting bias) | High risk | Retrospectively registered; apolipoprotein A1, apolipoprotein B and bodyweight not reported. |
| Risk of contamination (other bias) | Low risk | Group A treated at hospital and Group B treated at primary healthcare centre; unlikely to have received the same treatment. |
| Other bias | Low risk | No other evidence of risk of bias. |