Rothman 2005.

Study characteristics
Methods	A randomized trial of a primary care‐based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes RCT (NA clusters and NA providers), conducted in 1) This randomised trial was conducted at the University of North Carolina General Internal Medicine Practice, which serves a wide socioeconomic range of patients. The practice is staffed by more than 20 attending faculty and 70 medical residents who care for more than 2000 patients with diabetes. 2) Intervention patients received intensive management from clinical pharmacists, a diabetes care co‐ordinator and primary care physicians. In United States of America. 2 arms: 1. Control (one management session and usual care) (control arm) and 2. Intervention (intensive management) (intervention arm)
Participants	Control arm N: 105 Intervention arm N: 112, NA, NA Diabetes type: 2 Mean age: 55.45 ± 12.36 % Male: 43.78 Longest follow‐up: 12 months
Interventions	Control arm: (one management session and usual care) 1) Clinician education 2) Patient education Intervention arm: (intensive management) 1) Case management 2) Team change 3) Electronic patient registry 4) Clinician education 5) Facilitated relay of clinical information 6) Patient education 7) Patient reminders
Outcomes	Anti‐platelet drugs Lipid‐lowering drugs Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Harms
Funding source	This project was completed with support from the Robert Wood Johnson Clinical Scholars Program, the University of North Carolina Program on Health Outcomes, the University of North Carolina Division of General Internal Medicine, University of North Carolina Hospital Performance Improvement Department, University of North Carolina Pharmacy, the Vanderbilt Center for Health Services Research, and the Vanderbilt Diabetes Research and Training Center.
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Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	We randomly assigned patients to the intervention or control group using a random number generator.
Allocation concealment (selection bias)	Unclear risk	Assignment was contained in sealed envelopes (opaque?) that were opened by the study co‐ordinator.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. Baseline characteristics were similar between the 2 groups and revealed a sample with poor glycaemic control, multiple comorbid conditions, and low education and income status (Table 1). However, the intervention patients were slightly older than the control patients (P = 0.05) and more likely to be African American (P = 0.10).
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All other comparisons P > 0.20. Clinical characteristics, including blood pressure, A1C level, and aspirin use, were also similar.
Incomplete outcome data (attrition bias)	Unclear risk	They lost 23 patients out of 217 randomised (10.6%). 10 lost in the control group (9.5%) and 13 in the intervention group (11.6%). Quite low numbers and balanced. Reasons reported and quite similar.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Unclear risk	Aspirin use and adverse events were obtained by self‐report. Unclear for statin (likely self‐reported too). HbA1c and pressure were assessed objectively. Not all outcome assessment was blinded and several measures were based on patient self‐report.
Selective reporting (reporting bias)	High risk	No registered protocol. Methods: For lipids, we measured total and high‐density lipoprotein cholesterol levels in all patients, and low‐density lipoprotein (LDL) cholesterol levels only in patients who required statin therapy. Results: They reported data for total cholesterol but not for HDL and LDL.
Risk of contamination (other bias)	Unclear risk	All patients participated in a 1‐hour management session that was conducted by a clinical pharmacist. This session included diabetes education for the patient, and treatment recommendations were given to the patient’s primary care provider. Improvements in both groups may in part be attributed to regression to the mean or the initial 1‐hour management session. It is possible that communication between pharmacists and physicians for the intervention group have changed physician's approach with their control patients.
Other bias	Low risk	No evidence of other risk of bias.