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

Nishita 2012.

Study characteristics
Methods Empowered diabetes management: Life coaching and pharmacist counseling for employed adults with diabetes.
Patient RCT, conducted with patients recruited through community means ‐ newspaper, HR departments, health fairs, etc., intervention took place in public places. In USA.
Two arms: 1. Control (control arm) and 2. Treatment (intervention arm)
Participants Control arm N: 62
Intervention arm N: 128
Diabetes type: type 1 and type 2
Mean age: 48.5 ± 9.8
% Male: 37.4
Longest follow‐up: 12 months
Interventions Control arm:
1) Patient education
Intervention arm:
1) Case management
2) Team changes
3) Patient education
4) Promotion of self‐management
5) Financial incentives
Outcomes 1) HbA1c, mean % (SE)
Control arm: pre 7.7 (0.2), post 7.8 (0.1)
Intervention arm: pre 7.8 (0.2), post 7.6 (0.1)
Funding source The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Centers for Medicare and Medicaid Services (Grant No. CFDA No. 93.769).
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 Sealed envelopes, but opaque?
Patient's baseline characteristics (selection bias) Low risk Reported in text and table.
Patient's baseline outcomes (selection bias) Low risk HbA1c, P = 0.77.
Incomplete outcome data (attrition bias) High risk ~16% lost to follow‐up in control; ~35% in intervention. Balance seems okay since 3:1 ratio, but reasons not provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Primary outcome: HbA1c and others, no objective laboratory methods described.
Selective reporting (reporting bias) Low risk < 2005 approach used since no protocol; methods match results.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk No evidence of other bias.