Maclean 2009.
| Study characteristics | ||
| Methods |
The Vermont Diabetes Information System: a cluster randomized trial of a population based support system Cluster‐RCT (64 clusters with 132 providers), conducted in a largely rural, community, primary care setting which includes hospital based clinical laboratories in Vermont and adjacent New York State that provide services to community practices, USA Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
|
| Participants | Control arm N: 3526 Intervention arm N: 3886 Diabetes type: type 1 and type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 24 months |
|
| Interventions |
Control arm: None Intervention arm: 1) Audit and feedback 2) Electronic patient registry 3) Clinician reminders 4) Patient education 5) Patient reminders |
|
| Outcomes | 1) Renal screening (creatinine), N screened (%) Control arm: pre 3032 (86), post 2821 (80) Intervention arm: pre 3303 (85), post 3264 (84) 2) HbA1c, mean % (SD) Control arm: pre 7.0 (1.5), post 7.1 (NR) Intervention arm: pre 7.1 (1.4), post 7.3 (NR) 3) SBP, mean mmHg (SD) Control arm: pre NR (NR), post 138.4 (NR) Intervention arm: pre NR (NR), post 137.4 (NR) 4) DBP, mean mmHg (SD) Control arm: pre NR (NR), post 76.4 (NR) Intervention arm: pre NR (NR), post 76.3 (NR) 5) LDL, mean mg/dL (SD) Control arm: pre 107.0 (34.0), post 95.8 (NR) Intervention arm: pre 106.0 (33.0), post 95.0 (NR) |
|
| Funding source | Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK61167 and K24 DK068380) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | They randomised practices in blocks. They do not describe how they generated this sequence within the block size. |
| Allocation concealment (selection bias) | Low risk | Cluster. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Quote: "No significant differences were observed between the two groups at baseline." |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c (P = 0.46); LDL (P = 0.67). |
| Incomplete outcome data (attrition bias) | High risk | Despite intention‐to‐treat analysis and imputations, there were still ~26% lost to follow‐up in the control group and ~32% in the intervention group. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding not described. Primary outcome: HbA1c, objective methods not described. BP not mentioned as primary or secondary, but sphygomanometer used. |
| Selective reporting (reporting bias) | Low risk | Outcomes match those listed in the protocol. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | Information not available. |