APRIL 17, 2012

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

PCORI Outlines a Patient-Centered Vision for Research and Methodology in JAMA Theme Issue on Comparative Effectiveness Research
The Patient-Centered Outcomes Research Institute's focus on patients' needs in comparative effectiveness research (CER) has been touched upon in two articles of the Journal of the American Medical Association's April 18 issue. PCORI leaders wrote in the journal that this would lead to an improvement in clinical decision-making and patient outcomes. (pcori.org, April 17, 2012)

Treat Patients as Individuals and Not as Numbers
James Stacey Taylor writes for The Korea Times that potentially life-saving drugs might not find their way into patient's hands if they are deemed not to be cost-effective. This, in Taylor's words, equates to the cost of the drug outweighing the value of your life. In his view, this is the reality of healthcare in the UK and is now on the cards in America as part of Obama's multi-pronged health reform bill of 2010. (The Korea Times, March 16, 2012)

Doctor Panels Recommend Fewer Tests for Patients
A group of nine medical specialty boards has recommended that 45 common tests and procedures be performed by physicians less often, and that physicians should urge patients to question these services if they are offered. This is a move that is likely to alter treatment standards in hospitals and doctors' offices nationwide. (The New York Times, April 4, 2012)

Drug Data Shouldn't Be Secret
This op-ed piece from The New York Times calls for greater transparency in the research involving pharmaceuticals, citing the missing, unpublished and inaccessible data for the anti-influenza drug Tamiflu during the height of the swine flu scare in 2009. (The New York Times, April 10, 2012)

How Neurology Can Keep Patients Front and Center in Research Outcomes
A new priority for the American Academy of Neurology (AAN) will be one of the research goals recently outlined by the Patient-Centered Outcomes Research Institute (PCORI), concerning communication with patients and dissemination of evidence-based best practices to facilitate patient participation in health care decisions. In a March 5 letter to PCORI, AAN President Bruce Sigsbee, MD, stated that the goal of communication and dissemination is "most concordant" with the current efforts of the AAN and has the organization's support as a highest priority. (Neurology Today, April 10, 2012)

ECRI Institute PSO Announces Release of Updated Patient Safety Event Collection and Reporting System
ECRI Institute Patient Safety Organization (PSO) has released a new version of its adverse event collection and reporting system. This release is fully compliant with the Agency for Healthcare Research and Quality (AHRQ) Common Formats Version 1.1 and includes the latest formats for health information technology (HIT) reporting. ECRI Institute has continued to update and improve its web-based patient safety reporting system since first operating as an AHRQ-certified PSO. ECRI Institute PSO's reporting system, designed to capture both near misses and serious adverse events, currently has more than 100,000 events in its database. (ECRI Institute, April 10, 2012)

Children's Hospital Alliance Expands Comparative Effectiveness Database
Child Health Corporation of America (CHCA) is seeking to improve its administrative and clinical database, known as the Pediatric Health Information System+ (PHIS) in a bid to confront the daunting task of normalizing and standardizing the disparate feeds from the six participating children's hospitals. This could change the way children's hospitals perform comparative effectiveness research and generate evidence for researchers. (Healthcare Informatics, April 11, 2012)

Drugs of Limited Benefit Against Urine Leakage
A government-commissioned study has discovered that not much data exists which supports the case that drugs for urge urinary incontinence improve quality of life or have differences in comparative efficacy. Randomized clinical trials were reviewed and indicated that 8.5% to 13% of patients achieved continence with the different drugs, whereas adverse effects led to discontinuation of treatment in as many as 6.3% of cases. (medpage Today, April 12, 2012)

PPACA: IRS Proposes PCORI Fee Regulations
Health plan fees that will fund a new Patient-Centered Outcomes Research Trust Fund are starting to be collected by the Internal Revenue Service (IRS). The department is preparing to release a notice of proposed rulemaking for the Patient-Center Outcomes Research Institute (PCORI) funding mechanism in the Federal Register. (LifeHealthPRO, April 13, 2012)

Using Comparative Effectiveness Research to Inform Policymaking

Alternative treatments or diagnostic options for the same condition are assessed by comparative effectiveness research (CER) and this type of research can be informative for clinicians and patients as a way to inform decisions about treatment and care. It may well influence policymaking, such as decisions over which treatments to cover and at what price. (The Commonwealth Fund, April 5, 2012)

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Comparative Effectiveness Research and Personalized Medicine

Amy Miller
Vice President, Public Policy, Personalized Medicine Coalition, Washington, DC