Houweling 2009.
| Study characteristics | ||
| Methods |
Diabetes specialist nurse as main care provider for patients with type 2 diabetes Patient RCT, conducted in diabetes outpatient clinics at 2 hospitals in The Netherlands Two arms: 1. Standard care (control arm) and 2. NSD ‐ nurse specialised in diabetes (intervention arm) |
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| Participants | Control arm N: 43 Intervention arm N: 50 Diabetes type: type 2 Mean age: 61.5 ± 10.6 % Male: 46.4 Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Team changes 3) Patient education |
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| Outcomes | 1) Statins, N users (%) Control arm: pre 13 (34), post 26 (68) Intervention arm: pre 21 (46), post 25 (54) 2) Antihypertensives (any), N users (%) Control arm: pre 21 (55), post 27 (71) Intervention arm: pre 31 (67), post 39 (85) 3) HbA1c, mean % (SD) Control arm: pre 8.6 (1.3), post 7.7 (NR) Intervention arm: pre 8.9 (1.2), post 7.4 (NR) 4) SBP, mean mmHg (SD) Control arm: pre 156.3 (19.9), post 152.3 (NR) Intervention arm: pre 154.9 (23.3), post 146.3 (NR) 5) DBP, mean mmHg (SD) Control arm: pre 85.6 (9.4), post 83.2 (NR) Intervention arm: pre 86.6 (10.9), post 85.2 (NR) 6) LDL, mean mg/dL (SD) Control arm: pre 104.4 (38.7), post 81.2 (NR) Intervention arm: pre 100.5 (34.8), post 88.9 (NR) 7) Controlled hypertension (< 140/90 mmHg), N under control (%) Control arm: pre 9 (24), post 9 (24) Intervention arm: pre 10 (22), post 12 (26) |
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| Funding source | Financial sponsors: the Medical Research Fund Zwolle, the Steering Committee Care Renewal from the Isala Clinics, The Dutch Ministry of Health, Welfare and Sport and the Langerhans Foundation | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quasi‐randomised. |
| Allocation concealment (selection bias) | Low risk | The patient population was randomised using non‐transparent closed envelopes, with sequential numbers enclosed. Participants with even numbers were assigned to the intervention group, and those with odd numbers were assigned to the control group. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Table 1. No P values provided, looks balanced. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Table 1. No P values provided, looks balanced. |
| Incomplete outcome data (attrition bias) | Low risk | See Figure 1: 4 lost in intervention group (8%) and 5 lost in control group (12%). |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure of all outcomes. |
| Selective reporting (reporting bias) | Unclear risk | No protocol available, however all outcomes in methods reported in results. |
| Risk of contamination (other bias) | Low risk | Groups were followed by different personnel, contamination unlikely. |
| Other bias | Low risk | None identified. |