Houweling 2011.
| Study characteristics | ||
| Methods |
Can diabetes management be safely transferred to practice nurses in a primary care setting? A randomised controlled trial Patient RCT, conducted in a group practice with 5 GPs in north east region of The Netherlands Two arms: 1. General practitioner ‐ GP (control arm) and 2. Practice nurse ‐ PN (intervention arm) |
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| Participants | Control arm N: 114 Intervention arm N: 116 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 14 months |
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| Interventions |
Control arm: None Intervention arm: 1) Team changes 2) Clinician education |
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| Outcomes | 1) Foot screening, N screened (%) Control arm: pre NR (NR), post 13 (27) Intervention arm: pre NR (NR), post 34 (57) 2) HbA1c, mean % (SD) Control arm: pre 7.4 (1.3), post 7.4 (NR) Intervention arm: pre 7.6 (1.3), post 7.5 (NR) 3) SBP, mean mmHg (SD) Control arm: pre 161.3 (24.8), post 155.7 (NR) Intervention arm: pre 157.5 (20.4), post 150.1 (NR) 4) DBP, mean mmHg (SD) Control arm: pre 87.0 (11.2), post 86.0 (NR) Intervention arm: pre 87.2 (10.7), post 84.0 (NR) 5) Controlled hypertension (< 140/90 mmHg), N under control (%) Control arm: pre 19 (18), post 22 (21) Intervention arm: pre 17 (17), post 26 (25) |
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| Funding source | This study was sponsored by the Medical Research Fund Zwolle, the Steering Committee Care Renewal form the Isala Clinics, and the Dutch Ministry of Health, Welfare and Sport | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "…containing sequential numbers." Even assigned to intervention and odd assigned to control, i.e. not random. |
| Allocation concealment (selection bias) | Low risk | Quote: "The patient population was randomised using non‐transparent, closed envelopes containing sequential numbers. Subjects 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) | High risk | Similar for all, except intervention group had more patients with feet at risk vs control group. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | ~13% lost to follow‐up in intervention vs ~8% in control. Also more withdrawals as reasons for lost to follow‐up in intervention group. Did a per‐protocol analysis. Provided reasons for loss to follow‐up in flow diagram, although numbers are not similar, and the number who were lost to follow‐up due to withdrawal was much higher compared to control group. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | High risk | Measurement not described and outcome assessors not blinded. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; outcomes match those in methods. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |