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

Yang 2013.

Study characteristics
Methods Primary prevention of macroangiopathy in patients with short‐duration of type 2 diabetes by intensified multifactorial intervention
Patient RCT, conducted with patients recruited from the First Affiliated Hospital of Dalian Medical University, China
Two arms: 1. Conventional group (control arm) and 2. Intensive group (intervention arm)
Participants Control arm N: 75
Intervention arm N: 75
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 84 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Patient education
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.7 (1.7), post 8.0 (2.0)
Intervention arm: pre 8.9 (1.7), post 7.1 (1.2)
2) SBP, mean mmHg (SD)
Control arm: pre 128.8 (11.3), post 127.8 (12.1)
Intervention arm: pre 129.1 (15.2), post 120.7 (9.6)
3) DBP, mean mmHg (SD)
Control arm: pre 76.9 (6.4), post 79.4 (8.5)
Intervention arm: pre 79.8 (11.8), post 76.2 (4.4)
4) LDL, mean mg/dL (SD)
Control arm: pre 116.0 (20.1), post 117.2 (7.4)
Intervention arm: pre 115.6 (23.6), post 106.3 (16.6)
Funding source This research was supported by funds from the National Key Research Project for the Tenth Five‐Year Plan (2001BA702B01), the National Key Research Project for the Eleventh Five‐Year Plan (2006BAI02B08), and the Key Research Project of Liaoning Province Bureau of Science and Technology (2002225003‐6)
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) Unclear risk Not reported in text or table.
Patient's baseline outcomes (selection bias) Unclear risk Not reported.
Incomplete outcome data (attrition bias) Low risk ~9% lost in N1 and ~6% in N2, however reasons for losses not provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Primary and secondary were not any of our outcomes of interest.
HbA1c was measured using high performance liquid chromatography. SBP, DBP, LDL: objective measures not reported.
Selective reporting (reporting bias) High risk Protocol not retrievable.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk Information not available.