Saenz 2012.
Study characteristics | ||
Methods |
Development and validation of a computer application to aid the physician's decision‐making process at the start of and during treatment with insulin in type 2 diabetes: a randomized and controlled trial Cluster‐RCT (14 clusters with 66 providers), conducted in primary care centres in Madrid, Spain Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
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Participants | Control arm N: 332 Intervention arm N: 365 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 18 months |
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Interventions |
Control arm: 1) Clinician education Intervention arm: 1) Electronic patient registry 2) Clinician education 3) Clinician reminders 4) Facilitated relay of clinical information 5) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.8 (1.5), post 7.7 (1.4) Intervention arm: pre 7.9 (1.4), post 7.2 (0.9) |
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Funding source | This work has been partially financed by the FIS‐071131 research grant from the Fund for Health Research of the Ministry of Health and Consumption, Spain | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
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 | In text and table. |
Patient's baseline outcomes (selection bias) | Low risk | Hba1c: In text and table. |
Incomplete outcome data (attrition bias) | Low risk | Assuming no losses? |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | HbA1c: objective laboratory method not reported. |
Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match outcomes. |
Risk of contamination (other bias) | Low risk | Cluster. |
Other bias | Low risk | Information not available. |