Ma 2009.

Study characteristics
Methods	Case management to reduce risk of cardiovascular disease in a county health care system Patient RCT, conducted in 4 San Mateo Medical Center outpatient clinics, USA Two arms: 1. UC ‐ usual care (control arm) and 2. CM ‐ case management (intervention arm)
Participants	Control arm N: 207 Intervention arm N: 212 Diabetes type: type 2 Mean age: 55.1 ± 9.6 % Male: 34.4 Longest follow‐up: 16 months (mean)
Interventions	Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management
Outcomes	1) HbA1c, mean % (SD) Control arm: pre 7.7 (1.7), post 8.0 (NR) Intervention arm: pre 7.6 (1.7), post 7.6 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 135.1 (20.2), post 137.7 (NR) Intervention arm: pre 132.7 (19.4), post 128.5 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 79.6 (10.1), post 76.6 (NR) Intervention arm: pre 79.6 (10.6), post 73.6 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 104.2 (31.8), post 89.3 (NR) Intervention arm: pre 104.2 (33.6), post 93.6 (NR)
Funding source	This study was primarily supported by research award R01 HL070781 from the National Heart, Lung, and Blood Institute. It was also supported with resources and the use of facilities at the Veterans Affairs Palo Alto Health Care System. Additional resources were received from the SMMC, which provided guidance on the design, implementation, and reporting of the project.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported. Participants were equally randomised to the CM or the UC group, using the permuted block method (block size = 6) stratified by sex and ethnicity (Hispanic vs non‐Hispanic) within each clinic.
Allocation concealment (selection bias)	Low risk	Concealment of treatment allocation was achieved by having study staff who were not involved in the recruitment, intervention, and assessment generate the sequence of treatment allocations and prepare randomisation letters. The letters were sealed in sequentially numbered opaque envelopes and opened firsthand by patients at randomisation, after completion of the baseline assessment.
Patient's baseline characteristics (selection bias)	High risk	See Table 1. Patients in the CM group, however, were less likely to have completed eighth grade (P = 0.02).
Patient's baseline outcomes (selection bias)	Low risk	Table 1 ‐ P values > 0.05.
Incomplete outcome data (attrition bias)	High risk	38 lost in control group (18%) and 40 lost in intervention group (19%), reasons provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Objective measurement of outcomes.
Selective reporting (reporting bias)	High risk	Retrospectively registered, does not mention any secondary outcomes.
Risk of contamination (other bias)	Low risk	Nurse and dietician case managers had access only to intervention participants, unlikely that control group received case management intervention.
Other bias	Low risk	No other evidence of risk of bias.