O'Connor 2009a.
| Study characteristics | ||
| Methods |
Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial Clustered RCT (123 clusters and 123 providers), conducted in 1) The study was conducted at HealthPartners Medical Group, an 18‐clinic multispecialty group that provides care to 8000 adults with diabetes in Minnesota, United States of America 4 arms: 1. Control (no intervention ‐ group A) (control arm) and 2. Intervention 1 (patient) (intervention arm), 3. Intervention 2 (physician) (intervention arm), 4. Intervention 3 (both) (intervention arm) |
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| Participants | Control arm N: 3703 Intervention arm N: 847, 869, 1041, 946 Diabetes type: not reported Mean age: 56.1 ± 12.1 % Male: 54 Longest follow‐up: 12 months |
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| Interventions |
Control arm: (no intervention) Intervention arm: (patient) 1) Patient education 2) Patient reminders Intervention arm: (physician) 1) Audit and feedback 2) Clinician reminders Intervention arm: (both) 1) Audit and feedback 2) Clinician reminders 3) Patient education 4) Patient reminders |
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| Outcomes | Glycated haemoglobin Low‐density lipoprotein |
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| Funding source | This project was supported through funding from the Agency for Healthcare Research and Quality (Grant 5 U 18HS11919‐02) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. Before randomisation, 67 consenting physicians were blocked into groups of 3 based on 1) same specialty (family medicine or internal medicine) and 2) whether they provided care to 50 vs 50 or more diabetic patients. |
| Allocation concealment (selection bias) | Low risk | Clustered RCT. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Only number of eligible patients reported, but P > 0.05. |
| Patient's baseline characteristics (selection bias) | High risk | Table 1, P values < 0.05 for age and sex. |
| Patient's baseline outcomes (selection bias) | High risk | See Table 1, P < 0.05 for insulin use, glucose intervention eligible. |
| Incomplete outcome data (attrition bias) | High risk | Large amount of dropouts. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | No information. |
| Selective reporting (reporting bias) | Low risk | No information. |
| Risk of contamination (other bias) | Low risk | No information. |
| Other bias | Low risk | None. |