NOVEMBER 14, 2012

Welcome to the Comparative Effectiveness Update eNewsletter
Editor: Philip L. Ronning
This issue is sponsored by the National Pharma Council's "Myth of Average" Conference

Heart Devices Often Approved without Comparisons
Many new health devices such as valves and stents are approved for use by the Food and Drug Administration (FDA) without showing that they offer any benefits beyond existing treatments. Rita Redberg, MD, of the University of California, San Francisco, the author of a new study in the Journal of the American Medical Association, says, "This really leaves open the question of, 'are you better off with this new device or whatever conventional therapy is already?'...[F]rom a patient point of view, you're taking a lot more risk with a device, so the harms are potentially much greater." Redberg, whose team published the work, went on to say, "So it's really very important to know that the device is an improvement over what you could have had." Redberg, who is also editor of the Archives of Internal Medicine and a member of the FDA's Drug Administration Circulatory System Devices Panel, was "surprised and disappointed" that only 40% of approved cardiac devices had been in studies comparing them to other treatments, be they implant, medication or surgical procedure. FDA spokeswoman Michelle Bolek says that Congress has authorized the FDA to take the "least burdensome provision" to approve devices to ensure that patients are not denied access to new technology. (Reuters, November 8, 2012)

Studies Link IV Connectors to Patient Safety
Two new comparative effectiveness studies have found the likelihood of serious bloodstream infections (250,000 catheter-related bloodstream infections or CBRSIs occur annually in US hospitals with a mortality rate as high as 20%) is closely linked to the type of IV connector used. Devices that are highly dependent on technique produce higher infection rates while zero displacement IV connectors outperformed the other connectors (a split septum connector, two neutral displacement connectors, and a positive displacement device). (Newswise, November 6, 2012)

PCORI Board Member Harlan Weisman, MD, on Why Methods Matter for Industry
PCORI Board Member Harlan Weisman, MD highlights how the pharmaceutical and device manufacturing industry will benefit from PCORI's draft Methodology Report. (PCORINews, August 2, 2012)

PCORI's Problem: Reasons Are Not Causes
In this Health Affairs Blog David Introcaso, PhD a health policy consultant based in Washington DC, questions the likelihood that the Patient-Centered Outcomes Research Institute (PCORI) can be truly "patient-centered" given the limitations of the current and accepted paradigm which "assumes evidence or knowledge is produced and then communicated and disseminated" in a linear fashion. He argues that changing practice is relational and not entirely evidence-based. He notes that hand washing has been well demonstrated yet adherence rates are as low as 30%. Joe Selby, MD, MPH, PCORI's executive director responds at http://healthaffairs.org/blog/2012/11/05/enhancing-communication-to-advance-research-and-practice-is-among-pcoris-key-priorities/. (Health Affairs Blog, November 5, 2012)

Head Lice Lotion Safe, Effective
According to a November 1, 2012 New England Journal of Medicine article, two new phase III randomized, double blind trials have shown a single, 10-minute application of topical ivermectin (Sklice) without nit combing was effective and safe for killing head lice, resulting in higher percentages of patients remaining lice free through two weeks of follow-up. (MedPage Today, October 31, 2012)

WHO Calls for Health Policy-Makers to Follow Evidence-based Research
Saying they represent a "unique milestone in the evolution of health policy and systems research," the World Health Organization (WHO) has launched two new documents which detail the importance of evidenced-based research and how to implement it. The two documents are Changing Mindsets and Options for Actions. The release came at the Second Global Symposium on Health Systems Research held near Beijing. WHO has identified three aims: 1) to facilitate the unification of both research and decision-making, instilling the importance of research into decision-makers at all levels of the health system, 2) to clarify both the scope and role of health policy and systems research to help stakeholders understand its significance, and 3) to serve as an "agent for change," actively boosting the influence of policy and systems research in achieving universal health coverage throughout the world. (PM Live, November 1, 2012)

Patient-Centered Outcomes Research Institute Names Johns Hopkins Professor and CMS Advisor to Head Program on Improving Healthcare Systems
Chad Boult, MD, MPH, MBA, an internationally recognized authority on caring for patients with chronic conditions, has been named to head the Patient-Centered Outcomes Research Institute's (PCORI's) program on Improving Healthcare Systems. Romana Hasnain-Wynia, PhD (Health Disparities Research), and David Hickam, MD, MPH (Comparative Assessment of Options) have also recently been named to their positions. PCORI is still seeking program leads for Communication and Dissemination Research and Research Infrastructure. (PCORI, October 31, 2012)

Experts Call for More Rigorous Evidence
A Science Policy Briefing from the European Science Foundation calls for greater awareness among health professionals of the benefits of health technology assessment. "It is imperative, morally, socially and economically, that healthcare received by patients in Europe is based on the best scientific evidence," said Professor Liselotte Højgaard. "It is unacceptable for patients to be given treatments which have not been adequately assessed, or to not be offered treatments that have been shown to be the most effective." Højgaard went on to say, "Stakeholders must insist on implementing this recommendation as an ethical imperative. Over 50 per cent of clinical studies are never published in full, and more than 30 per cent of trial interventions are not sufficiently well described; there is too much biased under-reporting of studies that have disappointing results." (BiomedME.com, October 26, 2012)

Comparative Effectiveness of Intravenous Connectors

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The Role of Comparative Effectiveness Research in Value-Based Insurance Design

A. Mark Fendrick, MD
University of Michigan Center for Value-Based Insurance Design, Ann Arbor, MI