The New Health Dialogue

(Reposted with updated links to the Lewin Group CER symposium.)

We all know why we need comparative effectiveness research -- to have verified, scientific information about the best treatment options. Now we want to talk about how to use the research to facilitate informed health care decision-making.  We attended a panel discussion called Improving Medical Decisions Using Comparative Effectiveness Research, sponsored by the Friends of Cancer Research. One theme was how the success of comparative effectiveness research is contingent on both coordination of health information technology and on cooperation among health entities and government agencies. There were a lot of panelists, we’ll hit some highlights.

The new health reform law creates the Patient-Centered Outcomes Research Institute (PCORI --or ‘pickory,’-- according to the panel). It will have a mixed public-private board, including four physicians. Agency for Healthcare Research and Quality (AHRQ) Director Dr. Carolyn Clancy said the law states that the board can set research priorities, but they must be aligned with the larger national quality strategy. Having an overall strategy, Clancy said, is a big departure from past approaches to this type of research.

Setting priorities won’t be easy. For example, clinical trials are the "crown jewel," as Dr. Clancy put it, but they are enormously expensive. This means that the outcomes research institute will have to carefully choose research -- and resource -- priorities. Jean Slutsky, director of the AHRQ Center for Outcomes and Evidence, said that “research questions should drive [comparative effectiveness research] design, then drive funding decisions.” Louis Jacques, director of the Coverage and Analysis Group at CMS, warned that the research institute must not overlook issues -- like wound care -- that may not have a big advocacy group behind it but still warrant study. Richard Hodes, director of the National Institute on Aging, said the new research institute should have the flexibility to embrace new priorities when appropriate, and that it could extend into research and recommendations not only on specific treatments but on the health care delivery system itself.

The need to share information came up again and again. Several federal agencies do forms of comparative effectiveness research. How should this be coordinated -- rather than siloed or duplicated -- in the future? Slutsky for instance argued it would be a waste to let the research and dissemination infrastructure at an agency (like AHRQ, for example) break down. She said it's better to keep a trained and capable staff in place as we move forward, and figure out how to best share findings. Dr. Francis Collins, director of the National Institutes of Health, suggested that the current administration was unlikely to tolerate inter-agency “turf wars” that could lead to duplicative research and wasted resources.

Health information technology is vital to comparative effectiveness research, both because it will enhance communication and become a research tool itself. For instance, in the absence of clinical trials, HIT can be utilized to determine statistical relationships and zero in on best practices. Brett Davis, the senior director of Oracle Health Sciences, predicted a transformation of Health IT during the next decade, and said the next step may be to integrate various data -- patient-reported, insurance claims, and electronic health records -- and “tease out statistical relationships.” Amol Navathe, medical officer at HHS, agreed, stating, “There are probably more applications for this data than we can imagine.” Bill Dalton, Director of the H. Lee Moffitt Cancer Center and Research Institute, said that 90 percent of his patients have shown willingness to share their data for research, so long as they feel confident they have some “ownership of their own information,” and could someday get useful feedback.

The panelists agreed that what will really matter is how well the research becomes part of shared decision making between patient and physician. “The impact of this work will be judged in terms of impact on patient care and lives…not in terms of scientific and academic contributions,” said Dr. Clancy. Jesse Goodman,  acting deputy commissioner for Science and Public Health at the FDA, noted that findings have to be made available to doctors and patients in ways they can understand. (The study released alongside the event, which used Cancer As A Case Study,  had similar findings.) Goodman emphasized the importance of engaging patients and communities in conjunction with comparative effectiveness research -- “patients have a right to know if more expensive intervention is going to make them healthier or not.”

That wasn't the only comparative event we checked out recently. Dr. David Blumenthal, the National Coordinator for Health Information Technology, presented his views on the connection between research and Health IT at a Lewin Group CER symposium. He emphasized the potential, stressing that what we as a nation are attempting to do has not yet been accomplished by any country. He explained that someday, physicians could be able to do a real time query to advise a patient on treatment options. (For example, out of all patients in R region with both W and Y disease and C complications, X percent respond best to this treatment.) It will be an ever-evolving and long process. Before we can rely on comparative effectiveness data, we need to trust that patients are offering accurate information, which is contingent on security and privacy, which, in turn, relies on the systems themselves. And so on.

Bottom line? Comparative effectiveness research will mean working together to find, and make available, the best medical information possible.