Experts Challenge Medtech Research Models

InHealth summit reveals need for advanced methods to assess the value of health technologies 

Health technology research, evidence, and policy were the key topics of discussion earlier this month, when InHealth sponsored a special health technology summit, “Evidence and Reform: Healthcare Policy and the Challenges of Health Technology Research,” in Washington, DC. The conference was among the events marking InHealth’s fifth anniversary.

The day-long summit brought together medtech industry leaders, academic researchers, and clinical professionals to explore the dimensions of health technology research needed by healthcare policymakers for the successful and ongoing reform of America’s healthcare system.

Summit presenter Bill Fox, JD (left), executive director of the National Center for Patient Interactive Research (Philadelphia), discusses healthcare research methods as summit chair and moderator Robert J. Rubin, MD, clinical professor of medicine at  Georgetown University, member of the InHealth board of directors, and chair of the InHealth research council, takes notes.

The emerging role of comparative effectiveness research (CER) for assessing healthcare procedures and related technologies was a recurring focus. “Good trials are fundamental,” said Naomi Aronson, PhD, executive director of the Technology Evaluation Center, and director of the Evidence-Based Practice Center, for the Blue Cross-Blue Shield Association (Chicago). “But in the context of comparative effectiveness—in actual practice—that is not alone enough. We need to understand comparators, we need to understand the context of the delivery of care, we need to understand behaviors around care, and we need to be able to have effective management of healthcare systems that deliver care, in order to truly have effectiveness and value.”
 
“When we in the Institute of Medicine (IOM) took on the issue of comparative effectiveness research about four years ago, we realized one thing very quickly,” said J. Michael McGinnis, MD, senior scholar and director of the evidence-based medicine roundtable at the Institute of Medicine. “Comparative effectiveness research was not going to be more money for serial randomized controlled trials that cost $100 million and take five years. Comparative effectiveness research was going to have to move toward a continuous, dynamic process of learning throughout the course of clinical care. So we have spent most of our time over the last couple of years focusing on what a learning healthcare system is.”

For the future of such a system, McGinnis said, “we’re going to see a much greater emphasis on transparency as to costs, outcomes, and value; comparative effectiveness of various interventions from a life cycle perspective; real-time information availability; data accessibility; and practice and research linkages.”

While acknowledging the importance of CER, few of the summit’s presenters expressed unqualified support for the method. “Yes, it is possible that technology assessment could radically improve the quality of medicine,” said John F. P. Bridges, PhD, assistant professor of health policy and management in the Bloomberg School of Public Health at Johns Hopkins University. “But it is quite often misused and misguided.”

Bridges noted that comparative effectiveness research has already received more than $1 billion in federal funding through the Department of Health and Human Services, the Institute of Medicine, and the Agency for Healthcare Research and Quality (AHRQ). “Despite all this money for comparative effectiveness research, the government has been very reluctant to actually do the right type of research, which is to ask people what they want,” he said.

One concern that resonated with conference attendees is the possibility that overreliance on comparative effectiveness research may shortchange policymakers on critical information needed to guide healthcare reform.  “Comparative effectiveness research can help clinicians determine the appropriate course of treatment for an individual patient, but it is not a tool that should alone determine public policy,” said Martyn Howgill, InHealth’s executive director. “While clinical evidence is valuable, lawmakers also need to understand the broader socioeconomic impact of healthcare policies and procedures.”

Summit panelists participated in a lively discussion on evidence in the media (from left): A. Mark Fendrick, MD, professor of  internal medicine and health management and policy at the University of Michigan Medical Center, and co-editor in chief of the American Journal of Managed Care; Mark McCarty, Washington editor of Medical Device Daily; and John J. Whyte, MD, vice president for continuing medical education for the Discovery Health Channel.

Several of the summit panelists discussed alternative research methods to address the perceived weaknesses of comparative effectiveness research, especially with regard to the social and economic benefits of healthcare technologies. “I want to think about a different type of comparative effectiveness, and that’s one that’s patient based,” said Bridges. “The key to comparative effectiveness—just as with any type of technology assessment—is to involve the patient in every step. They are the end-consumer, and that’s who we need to be focusing on.”

When used in healthcare, cost-effectiveness analysis usually relies on assigning value to a particular course of treatment—usually measured in units such as quality-adjusted life years. By way of contrast, presenter John E. Calfee, PhD, resident scholar at the American Enterprise Institute (Washington, DC), examined the utility of cost-benefit analysis (CBA), a research method based on measuring subjects’ willingness to pay for the goods or services under study. “When you look at willingness to pay, you actually want to know what people would be willing to pay—to live longer, to be able to move around easier, to suffer less pain, and so on,” said Calfee.

“In principal, CBA includes all the basic factors like mortality or enabling people to live longer, plus all the other benefits or costs associated with a technology—pain and suffering, impact on the family, impact on the workplace, and so forth. And you can add factors like convenience,” noted Calfee. “Why do you do that? Because it makes sense to incentivize the things that in fact you would be willing to pay for if they were made available.”

 “There is no agreement about comparative effectiveness assessments,” observed conference chair and moderator Robert J. Rubin, MD, a clinical professor of medicine at Georgetown University and chair of the InHealth research council. “We heard people who think that comparative effectiveness research is a good thing, and people who remain a little skeptical. I think the jury is still out.”

InHealth’s summit was the latest in a series of educational programs sponsored by the institute to promote the exchange of ideas about the role of medical technology innovation in society, the economy, and the lives of individuals. The event was designed to increase understanding of how rapidly advancing healthcare technologies are contributing to the enhancement of healthcare systems in the United States and around the world by improving patient outcomes, productivity, and quality of life.

Copies of the panelist presentations from the InHealth summit, “Evidence and Reform,” are available via the InHealth Web site at www.inhealth.org/2009summit_presentations.