Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: The DEcIDE patient outcomes in end stage renal disease study

Ebony L. Boulware, Navdeep Tangri, Patti L. Ephraim, Julia J. Scialla, Stephen M. Sozio, Deidra C. Crews, Tariq Shafi, Dana C. Miskulin, Jiannong Liu, Wendy St Peter, Bernard G. Jaar, Albert W. Wu, Neil R. Powe, Sankar D. Navaneethan, Karen Bandeen-Roche

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Abstract

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.

Original languageEnglish (US)
Article number167
JournalBMC Nephrology
Volume13
Issue number1
DOIs
StatePublished - 2012

Bibliographical note

Funding Information:
This project is supported by the DEcIDE Network AHRQ contract number HHSA290200500341I, Task Order #6. Dr. Shafi was supported by K23DK083514 from the National Institute of Diabetes and Digestive and Kidney Diseases. AHRQ Disclosure: Identifiable information, on which this report, presentation, or other form of disclosure is based, is confidential and protected by federal law, Section 903(c) of the Public Health Service Act, 42 USC 299a-1(c). Any identifiable information that is knowingly disclosed is disclosed solely for the purpose for which it has been supplied. No identifiable information about any individual supplying the information or described in it will be knowingly disclosed except with the prior consent of that individual. The authors declare that they have no competing interests.

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