Comparative Effectiveness Research

Measuring quality. Comparing effectiveness. Both will be at the fore of nephrology talk this year.

Over $1 billion in funding was appropriated for comparative effectiveness research (CER) through 2009’s American Reinvestment and Recovery Act. Research priorities set by the Institute of Medicine declared racial and ethnic health disparities—a prominent issue for nephrology—high on the list. The category “genitourinary systems” was near the bottom of the list, but project areas for grant funding include comparisons of dialysis modalities.

True to its name, CER can be quite effective in research with kidney disease populations, said Wolfgang Winklemeyer, MD, ScD, director of clinical research for Stanford University’s Division of Nephrology and chair of the ASN’s Comparative Effectiveness Task Force. Randomized clinical trials, seen as the gold standard, have historically excluded chronic kidney disease patients and often do not reflect the “real world” of everyday clinical practice. In contrast, CER methods focus on trials done in normal settings with larger, more diverse populations, and compare a “usual care” group (instead of the typical placebo group) with groups receiving interventions.

Several research projects exemplify the spirit of CER by using clinical or community settings and testing new strategies against usual care, said Ebony Bouleware, MD, associate director for the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins. These research projects include a nurse coordinated care model, a computerized drug alert program, and timing of initiation for erythropoiesis-stimulating agent (ESA) treatment in nondialysis chronic kidney disease.

Systematic reviews also fit under the CER umbrella. Steve Brunelli, a nephrologist and renal epidemiologist at Brigham and Women’s Hospital, analyzedthe past year’s many studies focusing on dialysis. Many asked more questions than they answered. This year will likely see more studies designed to clarify best practices for dialysis patients in modality and access choice, timing of treatment initiation, and management of infections and comorbidities.

Watch for news from the Patient Created Outcomes Research Institute (PCORI) this year. Created through an appropriation in the Affordable Care Act. PCORI is unique in that, although federal monies were appropriated, it acts as a nonprofit, independent entity, led by four committees under a Board of Governors. While not directly funding CER, PCORI will be responsible for improving health care delivery through funding projects that help develop methodologies for CER to ultimately guide patients to make informed decisions based on “high integrity, evidence-based information,” said Neil Powe, MD, a member of the Institute of Medicine’s (IOM) Committee on CER Prioritization and vice chair of medicine at the University of California San Francisco.

Interest in this type of research is soaring. The first call for proposals in November 2011 received 1400 applicants for 40 available awards. Hopes are high that this new organization will be able to take a focused patient and stakeholder-centered approach to refining, creating, and testing methods that can ultimately be used as practice models for CER.

Winkelmayer, Boulware, Brunelli, and Powe all spoke about CER and its use in nephrology practice during the public policy sessions at Kidney Week 2011.

January 2012 (Vol. 4, Number 1)