Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study.
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BACKGROUND: Evidence is lacking to inform providers' and patients' decisions about many common treatment strategies for patients with end stage renal disease (ESRD). METHODS/DESIGN: The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003-2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006-2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. DISCUSSION: The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies' impact on clinical care and patients' outcomes.
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Boulware, L Ebony, Navdeep Tangri, Patti L Ephraim, Julia J Scialla, Stephen M Sozio, Deidra C Crews, Tariq Shafi, Dana C Miskulin, et al. (2012). Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study. BMC Nephrol, 13. p. 167. 10.1186/1471-2369-13-167 Retrieved from https://hdl.handle.net/10161/8345.
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Dr. Boulware is a general internist, physician-scientist and clinical epidemiologist focused on improving health and health equity for individuals and communities affected by chronic health conditions such as kidney disease. A national thought leader in health equity, she has identified patient, clinician, system, and community-level barriers that result in disparate outcomes for Black and other marginalized individuals. Using pragmatic trials, she has developed successful interventions, shaped guidelines, raised physician awareness and changed clinical practice. Throughout her work, Dr. Boulware has sought to improve transparency and trustworthiness in science and medicine.
Her research has been continuously funded by the National Institutes for Health, the Patient Centered Outcomes Research Institute, and other organizations throughout her career. She has published over 200 manuscripts, book chapters, and editorials, and she mentors numerous students, residents, fellows, and faculty members. Dr. Boulware is an elected member of the American Society for Clinical Investigation, the Association of American Physicians, the National Academy of Medicine, and the American Academy of Arts and Sciences.
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- A.B. Vassar College, 1991
- M.D. Duke University, 1995
- M.P.H. Johns Hopkins Bloomberg School of Public Health, 1999
Dr. Scialla is an Associate Professor of Medicine in Nephrology at Duke University and a faculty member at the Duke Clinical Research Institute. Dr. Scialla trained in Internal Medicine, Nephrology, and Clinical Epidemiology at the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health. Her research focuses on chronic kidney disease (CKD) epidemiology and prevention, with an emphasis on the role of metabolic complications and nutrition. Current studies are focused on treatment and prevention of abnormal phosphate homeostasis, acid-base physiology, diabetic and other forms of kidney disease, and outcomes in end-stage kidney disease.
Dr. Scialla’s work engages a number of study designs including prospective cohort studies, observational comparative effectiveness studies, and patient-oriented physiologic studies. She has worked closely with multiple chronic disease cohorts including the Chronic Renal Insufficiency Cohort (CRIC) Study, the African American Study of Kidney Disease and Hypertension (AASK), the Jackson Heart Study (JHS), and secondary analyses in clinical trials. Studies in electronic health records (EHR) and registries have engaged dialysis EHR data, the United States Renal Data System, and public registries, such as the National Health and Nutrition Examination Survey. Physiologic studies include the Acid Base Complication in CKD Study, secondary analyses in the DASH Mechanism Study, and the newly launched MURDOCK Kidney Health Study.
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