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

Varney 2014.

Study characteristics
Methods Effect of hospital‐based telephone coaching on glycaemic control and adherence to management guidelines in type 2 diabetes, a randomised controlled trial
RCT (NA clusters and NA providers), conducted in 1) Diabetes Clinic of St Vincent’s Hospital Melbourne 2) telephone coaching, delivered by a dietitian in Australia
2 arms: 1. Control: (usual care) (control arm) and 2. Intervention: (telephone coaching) (intervention arm)
Participants Control arm N: 47
Intervention arm N: 47, NA, NA
Diabetes type: 2
Mean age: 61.5 ± 11
% Male: 68
Longest follow‐up: 12 months
Interventions Control arm: (usual care)
Intervention arm: (telephone coaching)
1) Case management
2) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Funding source "The publication of these results would not be possible without the generous financial support of the St Vincent’s Hospital, Research Endowment Fund."
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated block randomisation was undertaken to obtain a one‐to‐one balanced design.
Allocation concealment (selection bias) Unclear risk Allocation blinding was maintained until randomisation, after which participants and the principal researcher were informed of randomisation outcome.
Patient's baseline characteristics (selection bias) Low risk Table 1, P values provided. Age and ethnicity < 0.05, all others balanced.
Patient's baseline outcomes (selection bias) Low risk Table 1, P values provided and greater than 0.05.
Incomplete outcome data (attrition bias) High risk 11 lost in control group (24%), 12 lost in intervention (26%).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure for HbA1c, BP and LDL.
Selective reporting (reporting bias) High risk Protocol prospectively registered. Results for smoking cessation not reported at 6 or 12 months. Outcomes only provided for 12‐month follow‐up, protocol states 18‐month follow‐up.
Risk of contamination (other bias) High risk Being unblinded, it is also possible that knowledge of group assignment influenced outcomes through favourable expectations associated with randomisation to the intervention group.
Other bias Low risk None.