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

Liu 2019.

Study characteristics
Methods Effect of intensive nursing education on the prevention of diabetic foot ulceration among patients with high‐risk diabetic foot: a follow‐up analysis
RCT (NA clusters and NA providers), conducted in 1) Department of Orthopedics, Center of Diabetic Foot, Beijing Shijitan Hospital, Capital Medical University, NO. 10, Tie Yi Road, Yang Fang Dian, Haidian District, Beijing 100038, People’s Republic of China. 2) Not reported but acknowledgments thank doctors and nurses in China
2 arms: 1. Control (conventional care) (control arm) and 2. Intervention (transitional care) (intervention arm)
Participants Control arm N: 142
Intervention arm N: 142, NA, NA
Diabetes type: 2
Mean age: 58.75 ± 11.3
% Male: 57.4
Longest follow‐up: 24 months
Interventions Control arm: (conventional care)
1) Patient education
2) Promotion of self‐management
Intervention arm: (transitional care)
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. P values provided and all above 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 3. P values provided under each pre intervention case/control dimer (not the right column).
Incomplete outcome data (attrition bias) Low risk All patients enrolled were followed up for 2 years. No mention of loss.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measures for HbA1c, BP, LDL.
Selective reporting (reporting bias) Unclear risk No published protocol. Methods match outcomes.
Risk of contamination (other bias) Unclear risk Patients randomised at a single location. Considerable likelihood of contamination. No mention of who is providing intervention.
Other bias Low risk None identified.