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) |
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Participants | Control arm N: 41 Intervention arm N: 38 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
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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 |
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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) |
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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. |