Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .
Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences.
OBJECTIVE We sought to examine patients ' preferences regarding the design of diabetes trials . Specifically , do patients prefer trials to focus on patient-important outcomes ( vs. surrogate outcomes ) and provide practical/pragmatic answers ( vs. mechanistic/explanatory answers ) ? STUDY DESIGN AND SETTING We mailed a question naire to a stratified r and om sample of 4,796 patients with diabetes receiving care from 371 primary care clinicians in the US Midwest . Medical record review provided data on hemoglobin A1c ( HbA1c ) . Descriptive statistics , logistic regression , and multiple regression techniques were used for analysis . RESULTS We received completed surveys from 2,036 patients ( response rate of 42.5 % ) . On average , respondents were 65 years old , had 11 years of diabetes , and had excellent glycemic control ( HbA1c=7 % ) . Most patients ( > 75 % ) chose patient-important outcomes rather than HbA1c as their first choice for a trial primary outcome and preferred a practical trial design . Patients with poor glycemic control ( HbA1c>8.0 % ) were more likely to prefer HbA1c as a primary end point ( odds ratio : 1.5 ; 95 % confidence interval : 1.1 , 2.1 ) . CONCLUSION Individuals with diabetes report a strong preference for practical trials measuring the effect of treatments on patient-important outcomes . To our knowledge , this is the first report of patients endorsing key elements of the comparative effectiveness agenda
Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .