Klingeman 2017.
Study characteristics | ||
Methods |
Type 2 diabetes specialty clinic model for the accountable care organization era RCT (NA clusters and NA providers), conducted in 1) Intervention conducted at an advanced type 2 specialty clinic model nested in the University of Michigan Endocrinology Clinic. 2) Intervention delivered by the clinical team consisting of an endocrinologist and a nurse educator. In United States of America. 2 arms: 1. Control (standard endocrinology clinics) (control arm) and 2. Intervention (type 2 specialty endocrinology clinic model) (intervention arm) |
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Participants | Control arm N: 30 Intervention arm N: 30, NA, NA Diabetes type: 2 Mean age: 54.365 ± 12.5 % Male: 53.35 Longest follow‐up: 12 months |
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Interventions |
Control arm: (standard endocrinology clinics) Intervention arm: (type 2 specialty endocrinology clinic model) 1) Case management 2) Clinician reminder 3) Patient education 4) Promotion of self‐management 5) Patient reminders |
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Outcomes | Lipid‐lowering drugs Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Harms |
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Funding source | University of Michigan. Supported by Michigan Center for Diabetes Translational Research (MCDTR). | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported. Patients were randomised 1:1, to the experimental or standard endocrinology clinics. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | High risk | Table 1. Caucasian race and hypertension comorbidity have significant P values. Quote: "More Caucasian individuals were seen in the experimental arm compared to the control (96.6% vs. 76.8%; P < 0.05)." |
Patient's baseline outcomes (selection bias) | High risk | Table 1. HbA1c has a significant P value. Quote: "Initial A1c in the experimental arm was statistically higher than the control (9.5 ± 0.9% vs. 8.9 ± 0.8%; P < 0.05)." |
Incomplete outcome data (attrition bias) | High risk | Overall, 60 patients participated in the study (30 in each arm), of whom 44 (73.3%) finished the 1 year follow‐up with the endocrinology clinic (24 in the experimental and 20 in the control arms; P = 0.2). Overall, they lost 27% of patients, with 33% in the control group and 20% in the intervention group. High and quite unbalanced numbers. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | No clear primary outcome in the paper. HbA1c and BP were objectively measured. Method to collect statin use and severe hypoglycaemic events are not reported. Unmasked randomised controlled clinical trial. |
Selective reporting (reporting bias) | High risk | Prospectively registered protocol. They reported data for HbA1c at 0, 4, 8 and 12 months, while it was supposed to be only at 12 months in the protocol. No data reported about total cholesterol, LDL, triglycerides, all cause mortality, quality of life, insulin therapy satisfaction in the paper. |
Risk of contamination (other bias) | Low risk | Patient randomised. Unlikely that control patients met with the endocrinologist meeting only with patients in the intervention group. Quote: "Participants randomized to the control arm (n = 30) were provided a usual endocrine care in the Endocrinology Clinic of the University of Michigan (excluding the experimental model care clinic endocrinologist)". However, endocrinologists were all working in the same endocrinology clinic so communication might have happened. |
Other bias | Low risk | No evidence of other bias. |