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October 1, 2013 Volume 77, Number 10
Policy Matters: Applying Research to Practice - The Promise and Challenge of CER Matthew Popovich, Ph.D.
Thomas R. Miller, Ph.D., M.B.A.



Comparative Effectiveness Research (CER) has become one of the most important and recent developments in health services and health policy research. Briefly, CER can be thought of as research that seeks to improve the effectiveness, efficacy and efficiency of health care by “comparing alternative methods of prevention, diagnosis, treatment, and monitoring of care delivery.”1,2 Although researchers and governments in several European countries have used CER extensively since the 20th century, it was only in 2009 that policymakers and researchers in the United States placed increasing emphasis on this research approach. That year, the American Recovery and Reinvestment Act and, by extension, the Health Information Technology for Economic and Clinical Health Act included more than $1.1 billion worth of funding for CER. The Affordable Care Act, passed the following year, established the Patient-Centered Outcomes Research Institute (PCORI) and, with it, set aside more than $3.5 billion of CER funding through 2019. These funding opportunities have generated multiple studies that physicians, other medical professionals, researchers and patient advocates can use to evaluate patient choice, treatment options and optimal patient care.


Although some anesthesiologists may already be conducting or participating in CER, the significant amount of money earmarked for CER has led researchers and medical professionals to pursue a better grasp on the term and its practical use. As a starting point to assess how physicians may view and understand CER, PCORI recently surveyed the attitudes of primary care clinicians. Of those surveyed, nearly 45 percent reported they were wholly unfamiliar with CER and another 34 percent were only slightly familiar.3


This may not come as a surprise when considering the relative new use of the term. Over the past five years, several patient and medical organizations, peer-reviewed studies and government-affiliated groups have attempted to develop an easily recognizable and understandable definition. The most prevalent definition, developed by the Federal Coordinating Council for Comparative Effectiveness Research (FCCCER), established CER as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.”4 As might be expected, once the surveyors explained CER to the clinicians in the study cited above, participants found a high perceived value of using CER and associated findings in their practice.


Issues in the Conduct of Research


The first part of the FCCCER definition addressed research. The funding for CER has, of course, led to an abundance of studies and clinical trials in recent years (a search for “Comparative Effectiveness Research” on PubMed produced more than 1,000 results; only a handful, however, related to anesthesia care). But while clinical trials are pursued, health policy researchers are contemplating methods of incorporating “cost and cost-effectiveness data (including functional status and quality-of-life outcomes)” as well as other economic consequences into the CER equation.5 The challenge for CER is keeping the “real world” provision within the realm of health policy studies intended to identify opportunities to reduce costs and improve quality of care.


Although there are multiple ways to conduct CER, some research methods may prove more effective and efficient than others. Typical randomized controlled trials (RCTs) take a significant time to conduct, are expensive, and may not account for multiple perioperative interventions that may, taken together, impact patient outcomes. That is, RCTs have poor external validity because they are often not generalizable to other settings and patients. Observational studies, on the other hand, may account for “real world” settings but may lack strong internal validity. That is, estimating treatment effects in retrospective database (e.g., claims data) studies is challenging and often requires sophisticated statistical techniques.


In the past, few options existed for anesthesiologists to conduct or participate in CER. As recently as 2009, an editorial written by Kheterpal in Anesthesiology noted several institutional limitations. Kheterpal listed several of these limitations, including the initial 77-page report by FCCCER that did not include the term “anesthesiology” or “anesthesia,” one Institute of Medicine (IOM) report outlining 100 funding priorities that failed to contemplate “safety of anesthesia, blood products, or different anesthetic options,” and a separate IOM report that identified just four topics where an anesthesiologist could be a principal investigator.6


But previous arguments used to limit anesthesiology contributions to CER may finally be softening, especially as PCORI, the National Institutes of Health (NIH), and other funding research centers encourage research aimed at improving care coordination, patient and caregiver-centered care, patient satisfaction and patient outcomes. In 2009, Kheterpal noted that anesthesiologists, hailed as leaders in patient safety, could use CER to benefit the practice and improve the quality of patient care. He identified the Anesthesia Quality Institute and the Committee on Performance and Outcomes Measurement as having the potential to forward patient safety initiatives under the framework of CER. Second, Kheterpal noted that anesthesiologists were “the only perioperative physicians who perform preoperative comorbidity evaluation and optimization, intraoperative management, and postoperative critical care.” He asked anesthesiologists to use their unique position to seek CER opportunities with surgeons and other medical professionals.7


Dissemination of Information


The second part to the FCCCER definition has implications for patient care, safety and satisfaction. As a reminder, the FCCCER definition requires that the research be developed and disseminated to patients, clinicians and other decision-makers. The direction of PCORI, NIH, and private foundations such as the Commonwealth Fund has recently been to encourage patient- and caregiver-centered care while exploring methods to recognize collaborative work between medical specialties in delivering that care. It should surprise few people that the PCORI survey noted that patients, caregivers and clinicians (at nearly 90 percent) “value research that measures things patients care about” and that 83 percent of patients and 72 percent of clinicians agree that “working directly with researchers can improve the value of medical research.” PCORI also found that a majority of participants were interested in engaging in that sort of research. An opportunity exists to bring these three interests in health care delivery together and to experiment with different mechanisms for engagement and outcome measurement.


Conclusion: Bridging the Research-Practice Gap


Some see the use of CER as playing a role in the shift from evidence-based practice to practice-based evidence. But implementing peer-reviewed studies, research and academic studies into everyday practice may pose a challenge for anesthesiologists in certain practice settings. The activities anesthesiologists conduct on a daily basis – measuring patient experience and discussing quality improvement – contribute to the long-term goals of improving patient outcomes and satisfaction while reducing costs. Regardless, the bridge between research and practice continues to be built. In a future “Policy Matters,” we will discuss the role and importance of cost-effectiveness analysis within CER.


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Matthew Popovich, Ph.D. is ASA Quality Specialist.


Thomas R. Miller, Ph.D., M.B.A. is ASA Director of Health Policy Research.



References:

  1. Memtsoudis SG, Besculides MC, Perioperative Comparative Effectiveness Research. Best Practice & Research Clinical Anaesthesiology 2011;25:535-537.
  2. Dorsey ER, Meltzer, DO. The Economics of Comparative Effectiveness Research. Neurology 2010;75:492-493.
  3. Patient and Clinician Views on CER and Engagement in Research: A Panel Discussion on New PCORI Survey Results. http://www.pcori.org/. Accessed July 30, 2013
  4. Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and the Congress. 30 June 2009.
  5. Sullivan P, Goldmann D. The Promise of Comparative Effectiveness Research. JAMA Jan 2011:305(4);400-401.
  6. The four categories IOM listed in its “Health Care Delivery System” report on CER were: 1.) strategies to reduce healthcare-associated infections; 2.) opioid and nonopioid pain relievers among subjects with acute and chronic pain; 3.) strategies for chronic migraine headaches; and 4.) treatment strategies for low back pain. See Kheterpal, S. Perioperative Comparative Effectiveness Research: An Opportunity Calling. Anesthesiology 2009;111:1180-2.
  7. Kheterpal S. Perioperative Comparative Effectiveness Research: An Opportunity Calling. Anesthesiology 2009;111:1180-2.

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