CER: What it means in reform debate, future practice
Three NEJM articles weigh the pros and cons of
comparative-effectiveness research. Is CER the villain of the piece, or
the future hero of health care reform?
Comparative-effectiveness research (CER) is emerging as an important
element in the Obama administration’s efforts to change the way
health care is delivered in the United States. In the American
Reinvestment and Recovery Act, $1.1 billion was included for
CER—the evaluation of medications, medical procedures and devices,
and diagnostic tests based on efficacy, safety, and ultimately
cost—and this concept is a part of many plans being floated for
health care reform (HCR) on Capitol Hill. In this week’s New
England Journal of Medicine, three Commentary articles take a look
at the views of both proponents (CER will better inform
clinicians’ decisions) and opponents (the idea removes free-market
competition and threatens personal choice) of the concept.
The first
article, by Aanand Naik and Laura Petersen, highlights the
importance of implementation strategies where CER is concerned. The
amount of current funding for medical research, the authors point out,
is large; however, the real challenge is translating research into
practice that actually reaches the bedside in a timely manner. Previous
research, such as randomized trials, do not generally compare one
treatment with another in terms of benefit for the patient. The authors
cite the improvement in the safety and quality of primary percutaneous
coronary intervention (PCI) over fibrinolytic therapy in controlled
clinical settings. These findings were slow to be implemented into
routine care. A shift, the authors conclude, is needed from the
“science of recommendation to a science of implementation.”
They advocate for an implementation research and development program to
be put in place, such as in the Agency for Healthcare and Research
Quality’s three-tiered model of
evidence translation, which includes: (1) T1, clinical efficacy
research; (2) T2, comparative-effectiveness and health services
research; and (3) T3, implementation research.
Jerry
Avorn, in the second article, declares that the debate itself
reveals much about the issues that will surround the research and
application of CER in the years to come. One reason to implement
CER, he notes, is that health care policymakers currently have no
systematic way of collecting or disseminating information on which goods
and services differ in terms of efficacy, safety, and
cost-effectiveness. Any corporation, he notes, would gladly spend the
relative pittance required to find out whether it was “getting its
money’s worth” from its purchases, so why would health
care be any different, considering CER funding is only
one-twentieth of 1% of the $2 trillion annual health expenditure? Avorn
pokes holes in the countering voices contributing an “avalanche of
nonfacts” that have personified CER to be an “imaginary new
federal body with broad powers;” in reality, he says, comparative
studies are only threatening to “makers and sellers of costly
goods and services that offer no benefit over existing
alternatives,” and are in no way a demonstration of
Big-Brotheresque government over freedom of choice in health care.
The
final article concludes that CER in no way threatens
personalized medicine. Authors Alan Garber and Sean Tunis write that
“far from impeding personalized medicine, CER offers a way to
hasten the discovery of the best approaches to personalization,
providing more and better information with which to craft a management
strategy for each individual patient.” He brings up genomic
medicine, noting that while its implications are powerful, there is a
lack of adequately designed studies in play to assess the clinical
utility of genomic testing; once again, CER would address precisely this
problem. In fact, CER could help clarify the best data to collect in
future clinical studies and which forms of evidence are most useful to
health care decision makers when choosing treatment options.
Related resources on www.pharmacist.com
Beth Farnstrom (bfarnstrom@aphanet.org)
Posted May 8, 2009, 4:00 pm EDT
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