 Q: Most people might have assumed that medicine has always been “evidence-based.” How do you envision the concept of evidence-based medicine?
A: The relationship between medical evidence and medical practice is not as strong as people may think. With our technological opportunities today, especially in health information technology, we can do much better.
Physicians make healthcare decisions based on the knowledge they obtained in their training, and then from published clinical trial results and peer-reviewed studies. But the information they act on may be incomplete or outdated, and physicians may not always have easy access to the kind of data and detail that they need to make the best decisions. We can provide better support for them, but we need to build a better system for doing that.
Leaders in the field today believe we can successfully apply more uniform standards in the way clinical evidence of best medical practices is collected, analyzed and communicated. An evidence-based system would help predict outcomes based on data from millions of patient encounters in day-to-day medical practice, backing up medical decisions with the experience of an entire system of medical professionals.
At the same time, evidence based medicine is not meant to take a cookie-cutter approach. In real-life situations, there will be quality-of-life issues, patient preferences, and of course the experience and instinct of the experienced physician that will go into medical decisions. It does not usurp the judgment of the physician, but provides him or her with the tools needed to make a fully informed decision.
Q: What needs to be put in place to make our healthcare system more evidence-based?
A: We will need healthcare information systems that create feedback loops between clinical outcomes and healthcare decisions. With the leadership of the healthcare professions, we’ll also need to establish standards for collecting and using evidence from daily medical practice. Finally, we’ll have to find ways to disseminate good evidence to put it back into practice as quickly as possible.
This is a job that must be done collaboratively – with payers, providers and consumers all at the table. While we have moved quite some distance toward establishing more robust healthcare information systems, much work remains to be done to reach a consensus on how to collect and disseminate clinical evidence.
Q: What is the “learning healthcare system”?
A: The “learning healthcare system” is a term that has been used to describe a vision of the future in which healthcare information technology enables the collection of medical evidence from the day-to-day practice of medicine. In other words, it’s a method that uses healthcare delivery itself as a platform for rapid progress and more effective healthcare, because researchers will be able to analyze huge amounts of data on thousands or tens of thousands of patients to determine what the outcomes have been from specific approaches to particular medical conditions. A system like this, combined with a vigorous ongoing enterprise of controlled clinical trials, can enable us to learn much more rapidly which treatments work best, and for whom.
Q: How does personalized healthcare contribute to affordable healthcare?
A: Personalized healthcare emphasizes the efficient use of resources – delivering the right treatments to the right patients at the right time. Sometimes today, medicine can be a virtual “trial and error” process. If we can be more precise and effective from the beginning, we can save valuable time and money by cutting down on office visits, avoiding expensive procedures, even reducing the number of hospitalizations due to serious adverse drug reactions. The ability to treat individual patients more effectively, and perhaps earlier in the onset of disease, also means the time course of their treatment may be shorter, so more expensive interventions may be avoided. Personalized medicine also supports preventive interventions, and staying well is clearly our Number One goal.
It isn’t only about what the medical establishment can do with personalized medicine to make healthcare more affordable – it’s also about what we as individuals will be empowered to do with a better knowledge of our own risks, so that we can make more effective lifestyle decisions to improve our health.
And further, personalized medicine can increase the confidence with which we measure the quality and value of the care we receive, so we can use that information to help create a more affordable, value-based healthcare system.
In the end, value and quality are the key words. If we can achieve a healthcare system that delivers the good quality and outcomes for each patient, based on our best scientific knowledge at that point in time, we will have built a high-value healthcare system. That’s the goal we should be aiming for, and the goals of personalized healthcare are at the heart of achieving that result.
Q: How important or integral is personalized healthcare to the effort in fixing the U.S. healthcare system?
A: Personalized healthcare is not an add-on to the effort in fixing the U.S. healthcare system. It is integral to ensuring more effective delivery of care and better system of quality measurement. The concept of personalized healthcare can help us align our progress in basic science, health information technology and evidence development, and aim that progress at the benefit of the individual patient. “Personalized healthcare” describes the result we want, it puts the right tools before us, and it keeps the focus in the right place – on the patient and on the care-giver who serves the patient.
Q: HHS has just released its first report on Personalized Healthcare. What are the most critical aspects of that Report?
A: I’m happy to report that, throughout HHS, activity is moving ahead rapidly to support genomic medicine in particular and Personalized Healthcare more broadly.
Our new report is entitled “Personalized Health Care: Opportunities, Pathways, Resources,” and it’s about developing a common vision of our opportunities – especially realizing the combination of benefits from genomic medicine, health IT and evidence-based care, when all of these are working together.
The report is also about the tasks we face in bringing Personalized Healthcare to fruition. It identifies key “pathways” we need to pursue – a “best effort” now to identify a consensus summary of the many different jobs that we need to have underway, and how they inter-relate.
Finally, the Report is our first inventory of HHS-supported activities that are important for achieving Personalized Healthcare. There’s substantial work underway, and substantial further work planned.
Our Report is part of the Initiative I’ve launched within HHS to help us achieve Personalized Healthcare for Americans. The initiative is about helping coordinate the Department’s activities. It’s also about addressing cross-cutting issues that need to be raised and resolved.
At its heart, Personalized Healthcare is information-based healthcare – information at a new level, giving us new capabilities. We’re talking about powerful information. And we need not only to develop that information through our scientific resources, and make it useful through our technological resources – but also, we need to take care to use it correctly – and avoid misuse.
For personal information, we need to be sure that security and confidentiality are protected. For our clinical trial data, we need to be sure researchers have productive access, and the opportunity to reap the rewards from true innovation. For genetic tests, we need the right regulatory structure and the right supports for healthcare professionals in using them. And to develop new evidence from medical practice, we need not just the technology, but also all the kinds of groundwork I mentioned earlier.
As our Report makes clear, a key role for government is helping achieve common standards – especially in the field of health information technology. And that work is underway, through our American Health Information Community, and through its working group on Personalized Healthcare. One area of special importance is the field of clinical decision support – how to translate what we learn, quickly and effectively, so that patients and professionals can work together to put it into practice.
Q: Changing the practice of medicine seems like a tall order, whether it is introducing concepts of evidence based medicine or personalized medicine. How will HHS and the government help to win hearts and minds to bring about change?
A: The government is one player, and we can have an important part in convening and helping bring about standards in several areas. But Personalized Health Care is a goal for all of us, and collaboration has to be the name of this game.
I believe that the “hearts and minds” of Americans are absolutely ready for change. Each of us wants high quality healthcare, at an affordable cost, so I don’t think the concept of value is hard for any of us to understand. And I believe that the American people will embrace the logic of evidence-based medicine and the huge potential of personalized healthcare that identifies what is unique about each of us. Today’s conference on 21st Century Medicine – with the health professions, the academic community, industry, patients and government all taking part – demonstrates that all of us want to play a role in this transformation.
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