Russell 2019.

Study characteristics
Methods	Clinical outcomes of an integrated primary‐secondary model of care for individuals with complex type 2 diabetes: a non‐inferiority randomised controlled trial RCT (NA clusters and NA providers), conducted in 1) This trial was conducted across 2 hospitals (control group) and 3 intervention sites (Beacon clinic, intervention group) in Brisbane, Australia. As a pragmatic trial, it was implemented within routine clinical practice. 2) Beacon model of integrated care delivered by a multidisciplinary team including 2 general practitioners (GPs) with special interests, an endocrinologist and a diabetes nurse educator (DNE). In Australia. 2 arms: 1. Control (gold‐standard hospital‐based specialist outpatient clinics) (control arm) and 2. Intervention (Beacon clinic with integrated care and upskilled GP) (intervention arm)
Participants	Control arm N: 83 Intervention arm N: 269, NA, NA Diabetes type: 2 Mean age: 55.7 ± 9.5 % Male: 61 Longest follow‐up: 12 months
Interventions	Control arm: (gold‐standard hospital based specialist outpatient clinics) 1) Facilitated relay of clinical information Intervention arm: (Beacon clinic with integrated care and upskilled GP) 1) Case management 2) Team change 3) Clinician education 4) Clinician education
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Hypertension control Harms
Funding source	This research was funded by the Australian National Health and Medical Research Council (NHMRC) under the Centre of Research Excellence in Quality and Safety in Integrated Primary–Secondary Care (Grant ID: GNT1001157)
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was achieved through a bespoke secure internet‐based randomisation program, designed by the study statistician.
Allocation concealment (selection bias)	Low risk	Researchers were masked only during the allocation process. Randomisation was achieved through a bespoke secure internet‐based randomisation program, designed by the study statistician.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. They only report data for intention‐to‐treat sample.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. They only report data for intention‐to‐treat sample. Data reported and only education has a star symbol (*) with a significant P value (under 0.05).
Incomplete outcome data (attrition bias)	High risk	This non‐inferiority randomised controlled trial was conducted across 2 hospitals and 3 intervention sites in Brisbane, Australia. A third hospital withdrew early in recruitment because of low referral rates of eligible participants. The per‐protocol population (main primary outcome analysis) was confined to individuals who completed the 12‐month study protocol or were discharged having met clinical targets, yielding a sample of 55/83 in usual care (34% lost) and 185/269 in the intervention (31% lost). High numbers lost.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	HbA1c (main outcome), LDL and blood pressure (secondary outcomes) were all objectively assessed. Safety endpoints included hypoglycaemic events collected as self‐reported questionnaire data at 6 and 12 months (but secondary outcomes). Unlikely that patients were blinded to intervention.
Selective reporting (reporting bias)	Unclear risk	Prospectively registered protocol and a protocol was published in 2013 (reference 10). They only provide data for secondary outcomes at 12 months, and not at 6 months as specified in the registered protocol. They do not report smoking status, retinopathy and foot complications, and other outcomes after the intervention.
Risk of contamination (other bias)	Low risk	Patient‐randomised. Intervention and control delivered in different clinics. Quote: "This trial was conducted across two hospitals (control) and three intervention sites (Beacon clinics) in Brisbane, Australia". Different endocrinologists were involved in control and intervention group. Quote: "The endocrinologist supervising and co‐consulting with GPs from the 3 Beacon clinics previously worked within the hospital outpatient clinics". Diabetes nurse educator likely saw patients in control group. Quote: "The DNE is specifically skilled in case co‐ordination and comfortable working independently between clinics". However unlikely they did specialised screening appointment with control patients.
Other bias	Low risk	No evidence of other bias.