VOLUME 3 - ISSUE 33
DECEMBER 7, 2012



Welcome to the Comparative Effectiveness Update eNewsletter
Editor: Philip L. Ronning
This issue is sponsored by the National Pay for Performance Summit



Life-saving Role of Heart Attack Centers Confirmed in New Study
Researchers from the Imperial College London have found that primary angioplasty reduces the death rate from heart attacks by 22% according to a new study released in Circulation Cardiovascular Quality and Outcomes. Dr. Iqbal Malik, one the authors from the National Heart and Lung Institute at Imperial, said, "There has been some debate in the cardiology community about whether it is worthwhile to run specialist heart attack centers, despite evidence from clinical trials that they save lives. This study resolves an important question. We must strive to make sure everyone in the UK has access to the best emergency treatment in the event of a heart attack." (MedicalXpress, November 13, 2012)

Why Studies that Compare Treatments Lack Impact
Pauline Chen, MD, a noted author (Final Exam) and regular New York Times columnist, discusses here the practical limitations of comparative effectiveness research, noting that many useful and potential cost-saving findings fail to change doctors' practice and patient care. She summarizes the results of an analysis from Health Affairs (Five Reasons That Many Comparative Effectiveness Studies Fail to Change Patient Care and Clinical Practice) in an easily read column. "But perhaps the most common reason for these studies' failures came down to dollars," Chen says. "In the current health care system, clinicians are rewarded for doing and ordering more. Pharmaceutical and medical device firms reap fortunes from physicians' orders, and a single change could cost them billions. Studies that endorse anything less than another expensive procedure or a newer and more expensive medication or the latest device are often destined for failure or a protracted struggle against drug and device companies that are willing to put up a costly fight." She also cites Justin, W. Timbie, PhD, a policy researcher from RAND, several times whose perspective is similar. Timbie says, "The incentives are all out of whack. The current system favors treatments that are well paid, not necessarily those that are most effective." (New York Times, November 8, 2012)

Patient-Centered Outcomes Research Institute Issues Call for Applications to Fund Up to $12 Million in Projects to Improve Research Methods
The Patient-Centered Outcomes Research Institute (PCORI) has released a funding announcement to support research that addresses methodological gaps in patient-centered outcomes research (PCORI). PCORI is looking to fund up to 14 contracts in an amount totaling $12 million. Joe Selby, PCORI's Executive Director, said, "Our goal is to improve this field of research by building data infrastructure, improving analytic methods, and training researchers, patients and other stakeholders to participate in the conduct of research." Application materials for this Project Funding Announcement (PFA), due January 31, 2012, can be downloaded from the "Funding Opportunities" section of PCORI's website. (PR Newswire, November 16, 2012)

Heart Failure Drug Shows Less Effect in Real World vs. Clinical Trials
Researchers from Duke Medicine have found notable differences in aldosternoe antagonist therapy for older heart failure patients between results from clinical trials versus what occurs in actual practice. The study, published November 28, 2012 in the Journal of the American Medical Association found fewer benefits than original studies reported which indicates that doctors need to model the types of patient and procedures from the clinical trials while prescribing drugs in practice. (HealhCanal.com, November 27, 2012)

IT Tools Help Turn Research into Clinical Practice
The National Institutes of Health (NIH) has funded and developed open-source applications encouraging the use of electronic health records (EHRs) for use by Practice-Based Research Networks (PBRNs). The initiative is the result of the collaboration of 11 PBRNs in the US and the UK. In a paper (A Model for the Electronic Support of Practice-Based Research Networks) published in the Annals of Family Medicine the leaders of the electronic Primary Care Research Network (ePCRN) describe their software designed to "enhance the growth and to expand the reach of PBRN research." There are currently 150 PBRNs encompassing approximately 67,000 physicians in the U.S. (InformationWeek Healthcare, December 3, 2012)

Protected 'Power Naps' Prove Helpful for Doctors in Training to Fight Fatigue
Kevin Volpp, MD, PhD, from the Philadelphia VA Medical Center and professor of Medicine and Health Care Management, Perelman School of Medicine and the Wharton School, University of Pennsylvania, and lead author of a study on sleep patterns for doctors in training, said, "Within the last two years, we've seen sweeping changes in guidelines regulating the number of hours that first-year residents can work as they continue their medical training." He went on to say, "Based on a report from the Institute of Medicine in 2009 recommending protected sleep periods when residents work duty periods of up to 30 hours, we wanted to determine whether offering these protected sleep periods, akin to a power nap, would offer a practical alternative." July 2011 saw changes imposed by the Accreditation Council on Graduate Medical Education (ACGME) prohibiting first-year residents from working more than 16 hours at a time. "This study provides the first evidence that contrary to long held cultural beliefs within the medical community, young doctors are embracing the importance of sleep and looking for ways to increase their own performance to better treat their patients," said David F. Dinges, PhD, professor of Psychology in Psychiatry and Chief, Division of Sleep and Chronobiology at the University of Pennsylvania. This research on the implementation of protected sleep periods for residents who are assigned to overnight shifts in a hospital represents a viable tool in preventing fatigue and alleviating the physiological and behavioral effects of sleep deprivation among these doctors in training according to an article in the December 5th edition of the Journal of the American Medical Association. Because the current study did not look directly at patient outcomes, additional comparative effectiveness research will be important when considering adoption of widespread protected sleep periods. (MedicalXpress, December 4, 2012)

Health Care Community Helps PCORI Take the Next Step
Joe Selby, MD, Executive Director of the Patient-Centered Outcomes Research Institute (PCORI ), announced that the PCORI had established its national research priorities, thereby satisfying one of its foundational requirements according to the Affordable Care Act, which established the entity. PCORI is expecting to commit $96 million in research contract by the end of the year. "We often hear," Selby said, "that it takes an astounding 17 years for medical research to be fully incorporated into practice. By funding research on topics that are particularly important and relevant to the healthcare community, and accelerating the adoption of that research through effective dissemination efforts, we can provide patients and those who care for them with better information that will lead to better outcomes." (Health Affairs, December 4, 2012)

Obamacare's Rationers Employ the "It's Good for You" Defense
In a surprising OP/ED piece from Forbes, Sally C. Pipes, President, CEO and Taube Fellow in Health Care Studies at the Pacific Research Institute, strikes a hard pose in opposition to comparative effectiveness research (CER). Noting that the Affordable Care Act allocates $3.5 billion toward CER, Pipes claims that "CER is nothing more than a backdoor route to healthcare rationing. Such research will almost certainly be used to not-so-subtly influence treatment decisions." Pipes goes on to say, "At its best, comparative-effectiveness research can give doctors and patients additional information on their treatment options. But when that research crosses into the realm of cost-effectiveness, patients suffer." (Forbes, November 26, 2012)





Comparative Effectiveness: Rationing Health Care or Reforming It?


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Facilitating and Measuring Successful Patient Engagement in CER

Patricia Deverka , MD, MS, MBE
Center for Medical Technology Policy, Baltimore, MD