Fogelfeld 2017.

Study characteristics
Methods	Combined diabetes‐renal multifactorial intervention in patients with advanced diabetic nephropathy: proof‐of‐concept RCT (NA clusters and NA providers), conducted in 1) Patients were recruited from the existing patient population in the Cook County Health & Hospitals System (CCHHS) general medicine clinic and specialty diabetes and renal clinics. The study site was the Fantus outpatient clinic (large public hospital system), the primary CCHHS outpatient clinic in Chicago, IL, USA. 2) Intervention delivered by a multifactorial‐multidisciplinary team (an endocrinologist, nephrologist, nurse practitioners, registered dietitians, certified diabetes educator/dietitian, and research coordinator). In United States of America 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (multifactorial‐multidisciplinary intervention) (intervention arm)
Participants	Control arm N: 60 Intervention arm N: 60, NA, NA Diabetes type: 2 Mean age: 57.48 ± 10.6 % Male: 58.35 Longest follow‐up: 24 months
Interventions	Control arm: (usual care) Intervention arm: (multifactorial‐multidisciplinary intervention) 1) Case management 2) Team change 3) Patient education
Outcomes	Lipid lowering drugs Antihypertensive drug Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lLipoprotein Hypertension control Harms
Funding source	The study was supported in part as an investigator‐initiated trial by Sanofi.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported. Stratified randomised controlled trial. Consented patients were randomised into the multifactorial‐multidisciplinary intervention and control as follows: 20, 20 into CKD 3a, 20, 20 into CKD 3b, and 20, 20 into CKD 4 for a total of 60 in intervention and 60 in control.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	The baseline characteristics of both groups are summarised in Table 1. At baseline, there were no significant differences for age, gender, ethnicity and duration of diabetes.
Patient's baseline outcomes (selection bias)	Low risk	The baseline characteristics of both groups are summarised in Table 1. At baseline, there were no significant differences for eGFR, albumin creatinine ratio (ACR), SBP, A1C, and BMI. Nothing reported about the other outcomes of interest (DBP, medication usage, LDL).
Incomplete outcome data (attrition bias)	High risk	The dropout rate was 17.5%, with 23% (14/60) in the intervention and 12% (7/60) in the control. Numbers unbalanced. 8 dropped‐out in the intervention compare to 3 in control. No reasons reported.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	All objective outcomes (statins and antihypertensives usage, HbA1c, blood pressure, LDL) except for hypoglycaemia that is subjective (but secondary outcome).
Selective reporting (reporting bias)	High risk	Prospectively registered protocol (protocol first posted on July 2008, the study started on May 2007, 2 years intervention). The authors only mention the primary outcome in the protocol: "Delay in development in end‐stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) [ Time Frame: 2 years ]" and did not talk about all the secondary outcomes reported in the paper.
Risk of contamination (other bias)	Unclear risk	Both groups had access to the same specialists. Control patients received usual care, which included visits with their primary care physicians and, for most of them, visits with board certified specialists in separate diabetes and renal clinics with visit frequency determined by physicians in the relevant clinics (typically quarterly or 16 visits over two years). Patients in the intervention group had individual visits with the entire study staff (an endocrinologist, nephrologist, nurse practitioners, certified diabetes educator/dietitian and research co‐ordinator).The multifactorial‐multidisciplinary intervention visit frequency was monthly for the first 6 months and bimonthly for the next 18 months for a planned total of 15 clinic visits over two years. Not clear if the same specialists were following patients from the 2 groups.
Other bias	Low risk	No evidence of other bias.