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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
Participants Control arm N: 332
Intervention arm N: 365
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 18 months
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
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)
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.