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

Bogner 2012.

Study characteristics
Methods Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial
Patient RCT, conducted with patients recruited from 3 primary care practices in Philadelphia, Pennsylvania. Study was conducted in a clinical setting. In USA.
Two arms: 1) Usual care (control arm) and 2) Intervention (intervention arm)
Participants Control arm N: 88
Intervention arm N: 94
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 3 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 7.0 (1.9), post 7.5 (NR)
Intervention arm: pre 7.2 (1.8), post 6.5 (NR)
Funding source This work was supported by American Diabetes Association Clinical Research Award 1‐09‐CR‐07. Dr Bogner was supported by NIMH grant MH082799 and MH047447. Dr Morales was supported by a NIMH‐mentored Career Development Award (MH073903).
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…were randomized within each practice by flip of a coin…"
Allocation concealment (selection bias) Unclear risk Not described.
Patient's baseline characteristics (selection bias) Low risk Information not available.
Patient's baseline outcomes (selection bias) Low risk Quote: "HbA1c (P = 0.51)"
Incomplete outcome data (attrition bias) High risk Only 2 lost to follow‐up in intervention group ~2%
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c methods described.
Assessors were blinded, physicians blinded to those randomised to usual care.
Selective reporting (reporting bias) Low risk Checked protocol and everything proposed was completed.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk Information not available.