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

Li 2016.

Study characteristics
Methods Impact of "Conversation Maps" on diabetes distress and self‐efficacy of Chinese adult patients with type 2 diabetes: a pilot study
RCT (NA clusters and NA providers), conducted in 1) Department of Health Education, Jiangsu Province Hospital on Integration of Chinese and Western Medicine, Nanjing, Jiangsu, People’s Republic of China 2) a trained diabetes educator took on the role as the facilitator of Diabetes Conversation Map in China
2 arms: 1. Control (traditional education) (control arm) and 2. Intervention (Diabetes Conversation Maps‐based education) (intervention arm)
Participants Control arm N: 26
Intervention arm N: 27, NA, NA
Diabetes type: 2
Mean age: 62.4 ± 9.85
% Male: 53.4
Longest follow‐up: 7 months
Interventions Control arm: (traditional education)
1) Patient education
Intervention arm: (Diabetes Conversation Maps‐based education)
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed by computer‐generated random numbers.
Allocation concealment (selection bias) Low risk Group assignments were delivered in sealed, opaque envelopes generated by off‐site study staff.
Patient's baseline characteristics (selection bias) Low risk Table 1 ‐ P values provided and all greater than 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 1 ‐ P values provided and all greater than 0.05.
Incomplete outcome data (attrition bias) Low risk Borderline. 4 lost to control (15%), 3 lost in intervention (11%). Reasons for loss provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure for HbA1c.
Selective reporting (reporting bias) Unclear risk No protocol registered. Methods match outcomes.
Risk of contamination (other bias) Unclear risk Patient‐randomised. Same educator provided educational sessions for both groups.
Other bias Low risk No evidence of other bias.