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

Anderson 2010.

Study characteristics
Methods Managing the space between visits: a randomized trial of disease management for diabetes in a community health center
Patient RCT, conducted in 2 community health centres (largest federally qualified health center) in Connecticut serving largely underserved Hispanic/Latino patients, USA
Two arms: 1) Control (control arm) and 2) Intervention (intervention arm)
Participants Control arm N: 149
Intervention arm N: 146
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 12 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Electronic patient registry
3) Patient education
4) Promotion of self‐management
Outcomes 1) Glycated haemoglobin
2) Systolic blood pressure
3) Diastolic blood pressure
4) Low‐density lipoprotein
Funding source Funding for this project was provided by a grant from the Connecticut Health Foundation
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Block randomized in groups of 4 by a computerized algorithm…"
Allocation concealment (selection bias) Unclear risk Not reported (block?).
Patient's baseline characteristics (selection bias) Low risk Quote: "There were no significant differences in the two groups at baseline in regards to sociodemographic variables."
Table and text.
Patient's baseline outcomes (selection bias) High risk HbA1c (P = 0.006).
Incomplete outcome data (attrition bias) High risk They state this was an intention‐to‐treat analysis, but very confusing since final numbers at month 12 do not match with those in table of outcomes at month 12. Baseline based on those randomised. Number for lost to follow‐up provided, but reasons very vague. Number lost to follow‐up much larger in intervention group.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective methods to obtain outcomes not described; blinding not described.
Selective reporting (reporting bias) Low risk < 2005 approach used since no protocol; methods match outcomes.
Risk of contamination (other bias) High risk Quote: "..presence of control and intervention patients in the same clinics were additional weaknesses, which may have led to contamination."
Other bias Low risk Information not available.