PCORnet® Bariatric Study
The use of bariatric surgery as a treatment for severe obesity has increased dramatically over the past two decades, but there have been few high-quality, long-term studies comparing the outcomes of different procedures. More studies are needed in larger, more broadly representative samples to help inform patient and provider decisions about the optimal choice of bariatric surgical procedure in various populations. The main goal of the study is to provide accurate estimates of the one-, three-, and five-year benefits and risks of the three most common bariatric procedures—Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy—with a focus on outcomes that are important to adults and adolescents with severe obesity. The study has two additional goals: 1) the development of infrastructure to support future comparative effectiveness studies using the PCORnet distributed research network, and 2) the identification of patient preferences and opinions.
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PCORnet® Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
Every year 720,000 Americans have a heart attack, and nearly 380,000 die of atherosclerotic cardiovascular disease (ASCVD). Many of the patients who survive develop heart failure, stroke, and/or other cardiovascular complications. Aspirin is a mainstay therapy for patients with ASCVD. Introduced as a medicinal product more than 100 years ago, aspirin significantly reduces ischemic outcomes such as myocardial infarction and stroke in patients with previous cardiovascular events and/or atherosclerosis at a cost of less than a cent per day. However, despite dozens of clinical trials involving more than 200,000 patients, the optimal dose of aspirin—the dose that is most effective in reducing ischemic events in the setting of secondary prevention, balanced by the potential for adverse events such as gastrointestinal bleeding—has not been determined in direct comparative-effectiveness trials.
To identify the optimal dose of aspirin for secondary prevention in patients with ASCVD, we will participate in a pragmatic clinical trial in which 20,000 patients who are at high risk for ischemic events will be recruited from 34 healthcare institutions from across the country and randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. The goals of the ADAPTABLE Study include: 1) comparing the effectiveness of two different doses of aspirin, and 2) comparing the effects of aspirin in selected subgroups of patients, e.g. women vs. men, older vs. younger patients, racial minority patients vs. white patients, patients with vs. without diabetes, and patients with vs. without chronic kidney disease.
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Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR) Study
Westat is conducting a Longitudinal Epidemiologic Assessment of Diabetes Risk (LEADR) Study: Analyzing a Cohort of Electronic Health Records. Westat will assess and monitor the clinical progression to type 2 diabetes—the most common form of diabetes, and progression to other chronic conditions. Westat is leading the effort for this research, which is sponsored by the Centers for Disease Control and Prevention’s Division of Diabetes Translation, with the DARTNet (DN) Institute at the University of Colorado a data vendor for the study. This project is working with existing electronic health records (EHR) where data have already been collected on members of ten health plans located across the U.S; the full data set to be analyzed will include medical record information for up to 9 million patients seen for medical care during 2010-2017. There are seven research questions that will be addressed: 1) Examine the geographic, race/ethnic, and socio economic status (SES)-related disparities in access and uptake of primary prevention approaches for diabetes; 2) Examine the longitudinal relationship between traditional and emerging behavioral and metabolic risk factors and prevention services and the progression to pre-diabetes, diabetes, and diabetes related morbidity; 3) Develop and validate risk equations to predict progression to diabetes and related complications for use in health system datasets; 4) Examine the correlates and barriers to referral and receipt of services for diabetes primary prevention activities/programs/medications and patient outcomes as a result of these services; 5)Examine the extended impact of DM preventive behaviors and services on macro vascular, neuropathic, and aging-related outcomes to those with diabetes and pre-diabetes; 6) For the cohort of patients who can be classified as pre-diabetic, provide analyses of EHR data from patient encounters for: a) prevalence and trends in the occurrence of behavioral and metabolic risk factors; b) levels of referral and receipt of nutritional and lifestyle counseling programs; levels of referral and receipt of community programs; and levels of prescription, use of metformin, and other diabetes preventive medications. Prescriptions for and use of aspirin therapy and statin drugs aimed at preventing vascular morbidity is also of interest for this research area; and finally 7) Estimate the reliability and validity of newly developed variables for risk factors, conditions, and preventive care practices in predicting the progression to diabetes. Several peer reviewed publications will be prepared for each of these 7 research question areas.