Eccles 2007.
| Study characteristics | ||
| Methods |
A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial Cluster‐RCT (58 clusters with 58 providers), conducted in three Primary Care Trusts in the northeast of England, United Kingdom Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 1934 Intervention arm N: 1674 Diabetes type: type 2 Mean age: 66.0 ± 11.5 % Male: 53.0 Longest follow‐up: 15 months |
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| Interventions |
Control arm: 1) Audit and feedback 2) Electronic patient registry Intervention arm: 1) Audit and feedback 2) Electronic patient registry 3) Clinician reminders 4) Patient reminders |
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| Outcomes | 1) Aspirin, N users (%) Control arm: pre 10 (1), post 164 (8) Intervention arm: pre 34 (2), post 308 (18) 2) Antihypertensives (any), N users (%) Control arm: pre 118 (6), post 274 (14) Intervention arm: pre 131 (8), post 415 (25) 3) Retinopathy screening (fundoscopy), N screened (%) Control arm: pre 957 (49), post 977 (51) Intervention arm: pre 721 (43), post 1014 (61) 4) Foot screening, N screened (%) Control arm: pre 892 (46), post 944 (49) Intervention arm: pre 804 (48), post 1127 (67) 5) Renal screening (creatinine), N screened (%) Control arm: pre 928 (48), post 1168 (60) Intervention arm: pre 887 (53), post 1229 (73) 6) HbA1c, mean % (SD) Control arm: pre 7.6 (NR), post 7.4 (NR) Intervention arm: pre 7.8 (NR), post 7.3 (NR) 7) SBP, mean mmHg (SD) Control arm: pre 144.5 (NR), post 144.6 (NR) Intervention arm: pre 145.8 (NR), post 144.2 (NR) 8) DBP, mean mmHg (SD) Control arm: pre 80.2 (NR), post 78.1 (NR) Intervention arm: pre 79.2 (NR), post 77.8 (NR) 9) Smoking cessation, N smokers (%) Control arm: pre 373 (19), post 379 (20) Intervention arm: pre 347 (21), post 358 (21) |
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| Funding source | This study was funded by Diabetes UK, and Northern and Yorkshire Regional NHS R&D Office | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Information not available. |
| Allocation concealment (selection bias) | Low risk | Cluster‐RCT. |
| Provider's baseline characteristics (selection bias) | Low risk | Table 1 shows the baseline characteristics of control and intervention practices and patients. None of the differences in these variables between the intervention and control group are statistically significant. |
| Patient's baseline characteristics (selection bias) | Low risk | Table 1 shows the baseline characteristics of control and intervention practices and patients. None of the differences in these variables between the intervention and control group are statistically significant. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Table 2. No P values provided; clinical comparisons appear similar. There was text stating that baseline comparisons between groups were in additional file 2 but the file was not accessible. |
| Incomplete outcome data (attrition bias) | High risk | Information not available. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Process measures. |
| Selective reporting (reporting bias) | Low risk | Information not available. |
| Risk of contamination (other bias) | Low risk | Cluster‐RCT. |
| Other bias | Low risk | Information not available. |