Vadstrup 2011.
| Study characteristics | ||
| Methods |
Effect of a group‐based rehabilitation programme on glycaemic control and cardiovascular risk factors in type 2 diabetes patients: The Copenhagen Type 2 Diabetes Rehabilitation Project Patient RCT, conducted in outpatient clinic and general practitioners, Denmark Two arms: 1. Individual group (control arm) and 2. Rehabilitation group (intervention arm) |
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| Participants | Control arm N: 70 Intervention arm N: 73 Diabetes type: type 2 Mean age: 58.0 ± 10.0 % Male: 59.0 Longest follow‐up: 6 months |
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| Interventions |
Control arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.8 (0.9), post 7.2 (NR) Intervention arm: pre 7.9 (0.8), post 7.6 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 145.0 (17.0), post 138.9 (NR) Intervention arm: pre 146.0 (18.0), post 141.2 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 84.0 (9.0), post 81.0 (NR) Intervention arm: pre 85.0 (10.0), post 82.4 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 100.5 (38.7), post 96.6 (NR) Intervention arm: pre 104.4 (34.8), post 100.5 (NR) |
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| Funding source | The study was supported by grants from the Jascha Foundation, the Research Foundation of Bispebjerg University Hospital, the Copenhagen Capital Region Research Foundation, National Board of Health, the Ministry of Health and Prevention, GlaxoSmithKline, Servier Denmark, Grosserer Chr. Andersen and Ingeborgs Scholarship, and the Department of Endocrinology at Bispebjerg University Hospital. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Patient's baseline characteristics (selection bias) | High risk | Not mentioned in text or table. |
| Patient's baseline outcomes (selection bias) | Low risk | P values for baseline outcome values not provided. |
| Incomplete outcome data (attrition bias) | High risk | ~17% lost to follow‐up in N1 and ~12% in N2. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Method described for HbA1c, although unsure if outcome assessor was blinded, as they do not explicitly state that. |
| Selective reporting (reporting bias) | High risk | Not all secondary outcomes addressed in protocol are addressed in paper. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | None identified. |