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

Frei 2014.

Study characteristics
Methods Implementation of the chronic care model in small medical practices improves cardiovascular risk but not glycemic control
Cluster‐RCT (30 clusters), conducted in primary care physicians (PCPs) participating in routine primary care of unselected patients, Switzerland
Two arms: 1. Control (control arm) and 2. Intervention (intervention arm)
Participants Control arm N: 164
Intervention arm N: 162
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) Team changes
3) Electronic patient registry
4) Clinician education
5) Clinician reminders
6) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 7.6 (1.1), post 7.3 (1.0)
Intervention arm: pre 7.8 (1.5), post 7.6 (1.2)
2) SBP, mean mmHg (SD)
Control arm: pre 137.8 (16.8), post 137.5 (16.9)
Intervention arm: pre 140.3 (18.4), post 136.4 (17.5)
3) DBP, mean mmHg (SD)
Control arm: pre 78.7 (10.2), post 79.2 (11.2)
Intervention arm: pre 83.1 (10.4), post 79.6 (9.9)
4) LDL, mean mg/dL (SD)
Control arm: pre 96.7 (42.5), post 100.5 (38.7)
Intervention arm: pre 108.3 (42.5), post 104.4 (38.7)
Funding source This study was supported by grants from the Swiss Academy of Medical Sciences (grants RRMA 8‐09 and RRMA 13/10) and from the Margrit und Ruth Stellmacher Foundation
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomly generated As and Bs and attached #1 to #30 to them; they then put these tickets into an envelope and tickets for intervention and allocation.
Allocation concealment (selection bias) Low risk Cluster.
Provider's baseline characteristics (selection bias) High risk Control group had more primary care physicians (PCPs) working in single‐handed practices.
Patient's baseline characteristics (selection bias) Unclear risk In text, but P values not in table.
Patient's baseline outcomes (selection bias) Unclear risk Baseline differences for outcomes was not reported.
Incomplete outcome data (attrition bias) High risk Lost to follow‐up ~9% in N1 and ~4% in N2; reasons are imbalanced for "patients nor reliable, almost double in intervention group."
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective laboratory methods not described.
Selective reporting (reporting bias) High risk Secondary outcomes do not match protocol.
Risk of contamination (other bias) Low risk Cluster.
Other bias Low risk Information not available.