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Open Access Highly Accessed Study protocol

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

L Ebony Boulware124*, Navdeep Tangri3, Patti L Ephraim14, Julia J Scialla5, Stephen M Sozio16, Deidra C Crews16, Tariq Shafi16, Dana C Miskulin7, Jiannong Liu8, Wendy St Peter89, Bernard G Jaar11046, Albert W Wu112, Neil R Powe12, Sankar D Navaneethan13, Karen Bandeen-Roche14 and DEcIDE ESRD Patient Outcomes in Renal Disease Study Investigators

Author affiliations

1 Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205, USA

2 Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA

3 Division of Nephrology, University of Manitoba, Manitoba, Canada

4 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

5 Division of Nephrology, University of Miami Miller School of Medicine, Miami, FL, USA

6 Division of Nephrology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

7 Division of Nephrology, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA, 02111, USA

8 Chronic Disease Research Group, 914 South 8th Street, Minneapolis, MN, USA

9 University of Minnesota, College of Pharmacy, 308 Harvard St. SE, Minneapolis, MN, 55455, USA

10 Nephrology Center of Maryland, 5601 Loch Raven Boulevard, Baltimore, MD, 21239, USA

11 Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

12 San Francisco General Hospital and University of California, San Francisco, 1001 Potrero Avenue, San Francisco, CA, 94110, USA

13 Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA

14 Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

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Citation and License

BMC Nephrology 2012, 13:167  doi:10.1186/1471-2369-13-167

Published: 6 December 2012

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.