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

Heisler 2014.

Study characteristics
Methods Comparison of community health worker‐led diabetes medication decision‐making support for low‐income Latino and African American adults with diabetes using e‐health tools versus print materials
Patient RCT, conducted in a community health centre in Detroit, serving Latino and African American low‐income, USA
Two arms: 1. Print materials (control arm) and 2. iDecide (intervention arm)
Participants Control arm N: 95
Intervention arm N: 93
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 3 months
Interventions Control arm:
1) Case management
2) Patient education
3) Promotion of self‐management
Intervention arm:
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.3 (2.2), post 7.9 (1.9)
Intervention arm: pre 8.2 (1.9), post 7.8 (1.7)
Funding source Agency for Healthcare Research and Quality and National Institute of Diabetes and Digestive and Kidney Diseases
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned by a computer program, through use of a random‐sequence algorithm, into 1 of 2 study groups.
Allocation concealment (selection bias) Low risk Web‐based (central allocation).
Patient's baseline characteristics (selection bias) High risk Education (P < 0.001), difficulty with written info (P = 0.03), confident completing forms (P = 0.003).
Patient's baseline outcomes (selection bias) Low risk Secondary outcome: HbA1c (P = 0.58).
Incomplete outcome data (attrition bias) Low risk ~6% lost in both arms, reasons provided and seem balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Secondary outcome: HbA1c, used objective laboratory methods, measured using Bayer DCA2000+ point of care analyser.
Selective reporting (reporting bias) Low risk Matches protocol.
Risk of contamination (other bias) High risk Same community centre, with community health workers (CHWs) providing intervention and control, possible contamination?
Other bias Low risk Information not available.