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

Furler 2017.

Study characteristics
Methods Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial
Clustered RCT (74 clusters and 162 providers), conducted in 1) General practices in Victoria, Australia. 2) General practitioner, practice nurse, registered nurse with diabetes educator credentials in Australia
2 arms: 1. Control (usual care) (control arm) and 2. Intervention (Stepping Up model of care) (intervention arm)
Participants Control arm N: 115
Intervention arm N: 151, NA, NA
Diabetes type: 2
Mean age: 61.83 ± 9.97
% Male: 61.23
Longest follow‐up: 12 months
Interventions Control arm: (usual care)
Intervention arm: (Stepping Up model of care)
1) Case management
2) Team change
3) Clinician education
Outcomes Glycated haemoglobin
Funding source Funding from the Australian National Health and Medical Research Council (project grant application: APP1023738). The study was also supported by an educational/research grant by Roche Diabetes Care, the RACGP Foundation RACGP/Independent Practitioner Network Grant and received in‐kind support from Sanofi.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The study statistician computer‐generated stratified block randomisation sequences with varying block sizes (4, 6 and 8) before recruitment.
Allocation concealment (selection bias) Low risk Cluster‐RCT with randomisation occurring at one time.
Provider's baseline characteristics (selection bias) Unclear risk Table 1. No indication of statistically significant differences between groups for the patient baseline outcomes.
Patient's baseline characteristics (selection bias) Low risk Table 1. No P value s provided, yet no indication of statistically significant differences between groups for the patient baseline outcomes.
Patient's baseline outcomes (selection bias) Unclear risk Table 1. Triglycerides were indicated as significantly different between groups in the Table 1 note.
Incomplete outcome data (attrition bias) Low risk 9/115 lost in control group (7.8%) and 9/151 lost in intervention group (6%).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure of HbA1c.
Selective reporting (reporting bias) Low risk Prospectively registered protocol. Methods match outcomes.
Risk of contamination (other bias) Low risk Cluster‐randomised. Quote: "strengths include the cluster randomised design, minimising the risk of contamination"
Other bias Low risk None identified.