Comparative-effectiveness Research and Imaging: Insights and Ambitions

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In addition to extending coverage to an estimated 31 million US residents, the recently passed HR 3590, the Patient Protection and Affordable Care Act, has ensured a future for comparative-effectiveness research (CER) by legislating funding, at $500 million per year, for the indefinite future. The stimulus bill launched the CER initiative with seed funding and required the Institute of Medicine (IOM) to identify a list of high-priority CER topics. Most recently, an article by VanLare et al¹ described a five-step process for determining how to translate those 100 priorities into a portfolio of specific research projects (see Additional Reading).

ImagingBiz spoke with one of the authors, Harold C. Sox, MD, cochair of the IOM committee to set national priorities for CER, about its role in decision making, its potential use in answering imaging questions, and the recent controversial mammography recommendations of the US Preventive Services Task Force (USPSTF), which he chaired in the early 1990s.

“Anybody who is making coverage decisions, as well as physicians and patients, is going to benefit from CER because it’s going to help to make better decisions. Better evidence should mean better decisions.”

— Harold C. Sox, MD, chair of the IOM committee to set national priorities for comparative-effectiveness research

Sox spent his career preparing for his current position as cochair of the IOM committee. His many years of practicing medicine and studying medical decision making began in Northern California, where he served as chief of general internal medicine and director of ambulatory care at Palo Alto VA Medical Center, after which he chaired the department of medicine at Dartmouth Medical School from 1988 through 2001. Most recently, he completed eight years as the editor-in-chief of Annals of Internal Medicine. He also has served on numerous public-health and coverage-advisory committees, including chairing the USPSTF from 1990 through 1995 and the Medicare Coverage Advisory Committee for CMS from 1999 through 2003.

Sox is understandably cautious, choosing his words with deliberation and carefully clarifying questions. The subject of comparative-effectiveness research has proven to be a lightning rod for health-reform dissenters, who characterized the proposed CER board as a death panel during the debate. Sox is not reserved, however, about the potential of CER to add clarity to medical decision making.

“The health legislation, now the law of the land, states that there shall be a national CER institute, which will be public–private in governance,” he says. “It will be funded by a per–insured-head tax on Medicare and on private insurance companies. This tax will provide a source of continuing year-to-year funding that won’t be dependent on congressional appropriations, and that’s really a big deal. It means there will be a substantial CER effort going on for the indefinite future.”

A common misconception about the CER board is that it will make coverage decisions, even though the language in the Senate bill states that the information generated would be used as part of the body of evidence that would include research not funded by CER money. “There was a lot of concern in the media that CER results would be directly linked to coverage decisions and would deny people care that they really need,” Sox notes. “In truth, CER is going to generate more evidence for organizations that do make coverage decisions, but that evidence will be part of a larger body of evidence, not the sole determinant of coverage policy.”

In fact, as the CER effort moves forward, Sox predicts that the evidence will permit a more nuanced and personalized approach to whether a patient gets a particular treatment or test. “Currently, with coverage decisions, either you get it or you don’t, but in fact, as we look at things more closely, we are going to find that it is not that simple,” Sox says. “Patients with certain characteristics may do better with a test that, for the average person, would not be the preferred choice. I can see some more subtle coverage decision making happening as we learn better how to choose the best test or treatment for a particular patient with a particular profile of clinical findings.”

Imaging Applications and USPTF

When asked how CER might be applied to the problem of inappropriate imaging, Sox begins by explaining that in the clinical setting, he thinks of testing as changing probabilities. For instance,