Jansink 2013.
| Study characteristics | ||
| Methods |
No identifiable HbA1c or lifestyle change after a comprehensive diabetes programme including motivational interviewing: a cluster randomised trial Cluster‐RCT (58 clusters with 58 providers), conducted in general practices in South Eastern part of the Netherlands Two arms: 1. Usual care (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 518 Intervention arm N: 422 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) Case management 2) Clinician education |
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| Outcomes | 1) Retinopathy screening (eye exam), N screened (%) Control arm: pre NR (NR), post 106 (40) Intervention arm: pre NR (NR), post 61 (33) 2) Foot screening, N screened (%) Control arm: pre NR (NR), post 205 (78) Intervention arm: pre NR (NR), post 131 (70) 3a) Renal screening (creatinine), N screened (%) Control arm: pre NR (NR), post 242 (92) Intervention arm: pre NR (NR), post 174 (94) 3b) Renal screening (microalbumin), N screened (%) Control arm: pre NR (NR), post 223 (85) Intervention arm: pre NR (NR), post 163 (88) 4) HbA1c, mean % (SD) Control arm: pre 7.7 (0.7), post 7.4 (1.0) Intervention arm: pre 7.8 (0.9), post 7.3 (0.7) 5) SBP, mean mmHg (SD) Control arm: pre 140.7 (18.0), post 137.8 (15.8) Intervention arm: pre 144.4 (20.3), post 141.5 (17.0) 6) DBP, mean mmHg (SD) Control arm: pre 79.9 (9.9), post 77.6 (9.2) Intervention arm: pre 81.9 (10.6), post 79.5 (8.4) 7) LDL, mean mg/dL (SD) Control arm: pre 96.7 (30.9), post 92.8 (23.2) Intervention arm: pre 108.3 (38.7), post 100.5 (30.9) |
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| Funding source | This study was funded by ZonMW – the Netherlands Organization for Health Research and Development, 945‐16‐113 | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Low risk | Cluster. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | P values not in table and no mention in text. |
| Patient's baseline outcomes (selection bias) | Unclear risk | P values not in table and no mention in text. |
| Incomplete outcome data (attrition bias) | High risk | Large losses, reasons not provided. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcome: HbA1c, objective laboratory methods not described. |
| Selective reporting (reporting bias) | High risk | Secondary outcomes in protocol do not match paper. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | Information not available. |