Edelman 2015.

Study characteristics
Methods	Nurse‐led behavioral management of diabetes and hypertension in community practices: a randomized trial RCT (NA clusters and NA providers), conducted in 1) Patients receiving care in 9 primary care practices (community fee‐for‐service) in the Duke Clinical Research Institute Primary Care Research Consortium (PCRC). Practices comprised both physician and mid‐level primary care providers, trained in either general internal medicine or family medicine, and located in either urban or rural settings. 2) Intervention provided by nurses. In United States of America. 2 arms: 1. Control (non‐tailored phone calls) (control arm) and 2. Intervention (tailored phone calls from nurses) (intervention arm)
Participants	Control arm N: 184 Intervention arm N: 193, NA, NA Diabetes type: 2 Mean age: 58.7 ± 9.64 % Male: 45.4 Longest follow‐up: 24 months
Interventions	Control arm: (non‐tailored phone calls) Intervention arm: (tailored phone calls from nurses) 1) Case management 2) Patient education 3) Promotion of self‐management
Outcomes	Glycated haemoglobin Systolic blood pressure
Funding source	This research was supported by grant number R01DK074672 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was based on a computer‐generated randomisation sequence maintained by the study data manager at a site separate from the site of patient enrollment (stated in reference 12 of the paper).
Allocation concealment (selection bias)	Low risk	The randomisation sequence was integrated with the study tracking database; once an eligible patient was enrolled in the study and baseline assessment was completed, the data manager could populate the randomisation field in the tracking database with the patient’s group assignment by clicking a button. The data manager then contacted patients by phone with their randomisation assignment (stated in reference 12 of the paper).
Patient's baseline characteristics (selection bias)	Low risk	Patient characteristics in the intervention and control arms were similar at baseline (Table 1).
Patient's baseline outcomes (selection bias)	Low risk	Patient characteristics in the intervention and control arms were similar at baseline (Table 1).
Incomplete outcome data (attrition bias)	High risk	78% of patients completed the 12‐month follow‐up, and 263 patients (70 %) reached the primary 24‐month endpoint. 30% lost. Reasons reported and balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcomes of interest are all objective (HbA1c and SBP). Study staff responsible for data collection remained blinded to randomisation assignments throughout the study. Primary care providers also remained blinded to patient randomisation status, unless a patient chose to reveal his/her assignment.
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol (protocol first posted in September 2009 before data analysis, recruitment began on June 2009, 2 years intervention). All outcomes of interest are reported.
Risk of contamination (other bias)	Unclear risk	A single nurse with extensive experience in case management delivered both the tailored behavioural intervention and the attention control. Calls content was tightly scripted, designed to limit the potential for productive interaction between nurse and patient, and was informed by standard guidelines as stated on government websites. Used an attention control; most previous studies of disease management for DM and/or HTN have used usual care controls (including their previous studies in HTN). The reason for attention controls is precisely the concern that contact time with the patient, independent of content of intervention, may be a potent intervention, and theoretically this could explain the A1c result (decreased in control).
Other bias	Low risk	No evidence of other bias.