JULY 10, 2012

Welcome to the Comparative Effectiveness Update eNewsletter
This issue is sponsored by the Quality Colloquium

What the Healthcare Ruling Means for Biomedical Research
The decision by the Supreme Court to uphold the majority of the Affordable Care Act (ACA) has significant implications for biomedical research including comparative effectiveness research. Provisions of the law preserved that are of interest (but not necessarily welcome) to the research community include 1) an abbreviated FDA approval pathway for "biosimilar" drugs, 2) the NHI's Cures Acceleration Network, 3) continuation of the Patient-Centered Outcomes Research Institute (PCORI), 4) the Physician Payment Sunshine Act, and 5) cuts of $153 billion in Medicare and Medicaid payments to teaching hospitals over ten years. (SmartPlanet, June 28, 2012)

EVINCI Results Could Lead to 75 Percent Reduction of Invasive Procedures for Patients with Suspected CAD
The results of a study by the European Society of Cardiology's (ESC) Working Group on Nuclear Cardiology and Cardiac CT were released on June 26, 2012 in Madrid, Spain. The EValuation of INtegrated Cardiac Imaging (EVINCI) study's preliminary results indicate that the prevalence of "significant" coronary artery disease in patients with chest pain symptoms is lower than expected in Europe. Importantly it also finds that for as much as 75% of this population, an accurate non-invasive screening could eliminate the need for cardiac catheterization. As a result of this study, a web-based educational tool, eduCAD has been developed to aid cardiologists in selecting the most appropriate imaging test for diagnosing ischemic heart disease. (Eureka Alert, June 26, 2012)

Which Maria Garcia? Bipartisan Center Seeks to Improve Patient Data Matching
The Bipartisan Policy Center (BPC) is urging efforts to better match patient data across settings to improve research studies noting that the error rate can be as high as 20%. The problem is highlighted by the example of 2,488 patients named Maria Garcia in Harris County, Texas; 233 with the same birth date. Recommendations included standardizing data fields, establishment of accuracy benchmarks, sharing best practices, increasing shared services to promote standardization, etc. (FierceHealthIT, June 27, 2012)

A Survey of Informatics Platforms that Enable Distributed Comparative Effectiveness Research Using Multi-institutional Heterogenous Clinical Data
This article from the July 2012 journal Medical Care presents an analysis of six large-scale, recently funded comparative effectiveness research (CER) studies focused on informatics platform development efforts in order to assist investigators in understanding why informatics platforms are required and to compare and contrast platforms used in these studies. The authors identify six generic steps necessary in any CER project. (Medical Care, July 2012)

Partnership to Improve Patient Care Issues Statement on SCOTUS Ruling
The Partnership to Improve Patient Care (PIPC) was formed in 2008 to support proposals to expand the government's role in comparative effectiveness research (CER). PIPC issued a statement on the Supreme Court's recent ruling upholding the majority of the Affordable Care Act. In its statement, PICP emphasizes the fact that there is widespread recognition that CER efforts to date have failed to be patient-centered and that past efforts have been largely unsuccessful in assisting patients and physicians in making informed decisions. PICP will continue its efforts to ensure that Patient-Centered Outcomes Research Institute (PCORI) will focus on improved quality, not simply cutting costs. (Partnership to Improve Patient Care, June 28, 2012)

Faced with Lagging Hip Implant Studies, Experts Push National Device Registry
A new study in the New England Journal of Medicine reports manufacturers of metal-on-metal hip implants initiated FDA mandated post-market studies for only 24 of 104 products last year. The authors express hope that proposed legislation on device reform will avert such lags in the future. They also are urging Congress to pursue development of a comprehensive national device post-market registry. (Inside Health Policy, June 28, 2012)

CER: Friend or Foe?
This comment piece from The Hospitalist posits that while physicians generally object to the rigid guidelines implied by comparative effectiveness research (CER) as the loss of professional autonomy and the introduction of cookbook medicine, the impact of healthcare costs on the economy and the future of the country may make such arguments less important to an increasing number of physicians.. The elaboration of CER to smaller subsets of patients also makes such research increasingly relevant to individual patients, weakening the argument from physicians that the research "doesn't apply to my patient." (The Hospitalist, June 2012)

Grants Encourage Patient Engagement in Research
The University of Massachusetts has received PCORI (Patient-Centered Outcomes Research Institute) funding for three projects totaling in excess of $2 million, all of which encourage more patient engagement during research. The three projects include 1) evidenced-based cancer screening decisions for patients, 2) an adaptive smoking cessation computer system, and 3) creating practice guidelines for screening lung and prostate cancer, a key step in translating comparative effectiveness research into clinical practice. (UMASS Now, June 25, 2012)

Building a Learning Health Care System

A July supplement to Medical Care focuses on the Electronic Data Methods (EDM) Forum. Researchers participate in EDM to share experiences and learning on the use of electronic clinical data for improving care and making informed decisions. The supplement addresses analytic methods, clinical informatics and data governance. To view the supplement, click here.

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Evidence-Informed Health policy: Limiting Rationing and Increasing Health Value for Dollar through CER

Mark Gibson
Center for Evidence-Based Policy, Portland, Oregon