AUGUST 2, 2012

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

List of Patient Registries Aims to Improve CER, Orphan Drug Development
The Agency for Healthcare Research and Quality (AHRQ) has proposed to Congress the establishment of a "registry of patient registries" (RoPR). If approved by the Office of Management and Budget (OMB) AHRQ will develop RoPR to allow existing data to be reused to aid in answering research questions. RoPR would contain no healthcare data but would facilitate collaboration between researchers and registry owners. Registry emphasis on establishing common data elements could improve the comparison of patient options. Nancy Dreyer, the Global Head of Scientific Affairs at Quintiles Outcomes, the research company contracted to lead the project, said "Many new drugs have post-marketing safety commitments, so the companies are required to study product users. They're not required to do anything comparative. So imagine you're a consumer, a payer, a physician and you want to say does the new drug work better than lap band or a gastric sleeve or bypass?" Now there will be a registry for drugs and a registry for other obesity therapies to use in developing comparative data, she said. (Inside Health Policy, July 30, 2012)

The Case for a Comparative, Value-Based Alternative to the Patient-Centered Outcomes Research Model for Comparative Effectiveness Research
This editorial suggests that the patient-centered outcomes research (PCOR) model of comparative effectiveness research (CER) may be a suboptimal model for performing clinically relevant research because of the codified constraints placed on researchers. The authors' use their examples from experience to highlight the limitations of the PCOR approach. (Medscape Today [free subscription required], July 31, 2012)

The Affordable Care Act: Implications for Emerging Med Tech Companies
The author of this article suggests that the comparative effectiveness provisions of the Affordable Care Act (ACA) are fairly benign yet the bar has been raised for new devices' regulatory approval and reimbursement. Her advice: "If you are an emerging med tech company executive who thinks he/she should be on top of healthcare reform, but between fundraising and hitting those milestones you just can't get your head around it, don't sweat it too much. If your technology makes sense today in the care of patients, it will probably make sense in the brave new healthcare world." (MEDCITY News, July 19, 2012)

Innovative Coarsened Exact Matching Methodology Provides More Accurate Measurement of Chronic Care Management Program Savings Compared to Traditional Methods
Coarsened Exact Matching (CEM), a statistical method for improving the estimation of causal effects, has proven to be effective in a recent healthcare study. A Population Health Management article reports on a study of 20,116 health plan members over a two-year period that found a greater and more accurate estimated of cost savings for patients in Chronic Care Management (CCM) programs. This was the first application of CEM to a healthcare population in a CCM program. (MarketWatch, July 19, 2012)

Berman Bioethics Institute to Study Informed Consent Options
The Johns Hopkins Berman Institute of Bioethics received funding from the Patient-Centered Outcomes Research Institute (PCORI) to study a streamlined informed consent process for comparative effectiveness research. Nancy Kass, co-principal Investigator and Deputy Director of the Berman Institute, said, "Traditional informed consent has been a barrier to routinely making patient-centered research part of clinical practice. Our project will capture the views of patients, doctors, researchers and other stakeholders about what types of information or formal consent make sense to them." (The JHU Gazette, July 23, 2012)

Who Wants to Practice Effective Healthcare?
This video and transcript by George Lundberg, MD, Editor of Medpage Today, offers opinions on practicing effective healthcare. In particular he points to the Effective Health Care Program (EHC) developed by the Agency for Healthcare Research and Quality (AHRQ). The content rich EHC website can be found at: http://www.effectivehealthcare.ahrq.gov/. (Medpage Today, July 9, 2012)

U.S. Cancer Patients Get Faster Access to More Oncology Drugs than European Patients, According to Tufts Center for the Study of Drug Development
Tufts Center for the Study of Drug Development found US patients get more and newer cancer drugs than their European counterparts. Joshua P. Cohen, research assistant professor at Tufts said, "While greater access to more treatment options is definitely a positive for patients in the U.S., it is not clear if greater access leads to better health outcomes." Cohen also said, "...the evidence-based approach adopted by European systems have improved the affordability of drugs in Europe that are considered to be cost-effective." (MarketWatch, July 10, 2012)

Study Finds Scarcity of Drug Trials in Kids
It has been well recognized that most clinical trials do not include children and teenagers. The reasons are many but the most difficult issue has been the ethics of giving untested drugs to children. A recent study led by Florence T. Bourgeois, MD, of Harvard School of Medicine and Children's Hospital Boston examined 2,400 clinical trials on conditions in which children constitute a large share of the patient population. Only 12% of the trials focused on children even though 60% of the affected patients were kids. These results are in spite of legislation promoting pediatric drug research. More studies, longer studies and studies that follow patients in the "real world" are needed, according to Bourgeois. (Reuters, July 24, 2012)

PCORI Asks for Public Comments on Methodology

The Patient-Centered Outcomes Research Institute (PCORI) is seeking comments on its draft Methodology Report. The draft Report can be found at http://pcori.org/assets/MethodologyReport-Comment.pdf and comments can be made at http://www.pcori.org/survey/methodology-report/.

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Comparative Effectiveness Research and Shared Decision Making

Michael J. Barry, MD
President, Foundation for Informed Medical Decision Making, Boston, MA