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

Cho 2011a.

Study characteristics
Methods Effectiveness and safety of a glucose data‐filtering system with automatic response software to reduce the physician workload in managing type 2 diabetes
Patient RCT, conducted with patients registered with Seoul St. Mary's Hospital, Korea
Two arms: 1) Control group (control arm) and 2) SAVE group (intervention arm)
Participants Control arm N: 41
Intervention arm N: 38
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 6 months
Interventions Control arm:
1) Facilitated relay of clinical information
2) Patient education
3) Promotion of self‐management
Intervention arm:
1) Electronic patient registry
2) Clinician reminders
3) Facilitated relay of clinical information
4) Patient education
5) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 7.4 (0.7), post 7.7 (1.3)
Intervention arm: pre 7.3 (0.7), post 7.7 (0.9)
2) LDL, mean mg/dL (SD)
Control arm: pre 104.4 (34.8), post 92.8 (19.3)
Intervention arm: pre 96.7 (23.2), post 92.8 (19.3)
Funding source The work was supported by a Seoul R&D project grant and the Ministry for Health, Welfare and Family Affairs (A080872)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "…by adaptive randomization." Unclear since they could have used minimisation.
Allocation concealment (selection bias) High risk You can predict the next assignment when you use adaptive randomisation.
Patient's baseline characteristics (selection bias) High risk Quote: "BMI (P = 0.012); duration of diabetes in years (P = 0.031); triglycerides (P = 0.028)."
Patient's baseline outcomes (selection bias) Low risk Quote: "HbA1c (P = 0.1989); LDL (P = 0.789)."
Incomplete outcome data (attrition bias) High risk They state intention‐to‐treat analysis, but they excluded n = 4 who dropped out of the analysis. They provide numbers for dropout and the numbers are equal across arms, but reasons are not provided. Baseline based on randomised.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Secondary outcome: HbA1c, objective laboratory methods not described, outcome assessor not described.
Selective reporting (reporting bias) High risk < 2005 approach used since no protocol; they listed HbA1c as secondary outcome in methods, but they also provide other items such as LDL, HDL, cholesterol, etc. in the results.
Risk of contamination (other bias) High risk Although physician was seeing both types of patients, he only provided feedback to those who used the SAVE programme, but how is this guaranteed?
Other bias Low risk Information not available.