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In addition to work by the federal government, the practice of EBM will require numerous public- and private-sector strategies and collaborations. Needed are new approaches to the evaluation and adoption of medical best practices, new methods for drawing appropriate conclusions from vastly expanded data resources, and new approaches for using evidence to improve care and reduce health costs. The process will not be easy, but unlike previous times, there are now widespread calls from healthcare leaders for the reforms needed to develop a system that delivers efficient and effective care.

The IOM has the opportunity to catalyze that change. Healthcare reform will be one of the top domestic issues of the political agenda in the next presidential election, making our focus on EBM and the changing nature of health care very timely.

The roles and responsibilities of all healthcare stakeholders are undergoing transformative change and—whether we approach reform as providers, payers, researchers, health product developers, or consumers—there is much to learn from all who are involved in these collaborative discussions about how to contend with the rapid changes in the healthcare system. Healthcare providers, whether involved in delivering or reimbursing care, face a unique set of challenges as care is increasingly informed by and organized around rapidly evolving evidence.

Developing better approaches to reimbursement and other mechanisms that support the delivery of quality care are at the forefront for all providers, and many pilot projects are already under way. A key consideration, as illustrated throughout this report, is the strong influence of local cultures on practice patterns. They can prevent the infiltration of evidence-based decision making, but they can also lead to great innovation to support the application and development of evidence.

The papers by William W. Stead and George C. Halvorson in Chapters 4 and 6 discuss lessons learned from their efforts to harness electronic health record EHR systems for improved application of evidence in practice and improved capacity for research and discovery, respectively.

However, these local solutions may need restructuring to succeed at a national level. There has been considerable advocacy for sharing best practices nationwide, but it may be necessary to set goals and work backwards to align the systems.

For consumers, access to care is a priority but an additional, emerging challenge will be to ensure that incentives for research and care are properly aligned to support care focused on individual patient needs, circumstances, and preferences. The very nature of patient-physician relationships is also undergoing a rapid change as healthcare data are increasingly captured and made available in various forms through IT.

Patients will be presented with more health information from a variety of sources and, increasingly, they will be pivotal in making decisions about their own health care. As we are reminded by Peter M. Neupert in Chapter 5 , most of health care is self-care and much of the care delivered throughout this country is family-based.

Family health managers and the availability of secure personal health records will be critical to informing and providing increasingly individualized patient care. EBM will also impact researchers. Methodologies to generate evidence are evolving and need to be continually defined and adapted. EHRs will provide the opportunity to quickly gather large amounts of data from real-world practice and produce evidence in real time, but how these data can be used appropriately and effectively will be a major challenge for researchers and practitioners.

Clearly, developing evidence that draws from and informs real-world care practices is a science, and improved methods for modeling and analyzing work processes and decision management are needed. This may require restructuring of the way we fund research. Federal agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Veterans Health Administration, the Centers for Disease Control and Prevention, and others, will be essential components of this dialogue and can demonstrate leadership by partnering across agencies, as well as with others in the private sector.

There is no doubt that the work to transform our healthcare system will be challenging. Many healthcare leaders have been working on improving the system for decades; but we all need to get on with finding a solution now. In the United States the cost of health insurance is rising faster than wages at a rate that is not sustainable, but the quality of care—measured in outcomes, safety, and service—is much lower than it should be. Especially in comparison to other countries, the value of medical care in the United States is low but even among individual states of the United States the variability in the value of health care delivered is dramatic.

Only 10 percent of the states provide high-value care on average, and the value of care in the United States on a whole is well below what should be expected.

Given the current approach to health care, however, these shortfalls are not surprising. Across the healthcare system, competition and rewards are not based on value, and there are scant incentives for patients to seek—or for professionals to provide—high-quality, cost-effective health care.

In reality there is no true healthcare system. There never has been a conscientious attempt to design and maintain a system that would create value. We now have an opportunity to take the steps to develop a vision, create a strategy, and specify goals for a true system of health care in the United States. Yet what should a healthcare system do? In sum, a healthcare system should improve the quality of life and aim to keep people as well as possible, while ensuring that healthcare expenditures are affordable for both individuals and the nation.

In essence, a reformed healthcare system should provide individuals with high-value health and health care. As outlined in Chapters 2 and 3 , these forces include rising and unsustainable costs, wide variations in the quality and cost of health care delivered across the United States, and the complexity of care introduced by the emerging insights from genetic research and the diversity of new health products. Many of the issues discussed throughout this publication are important for moving forward with needed healthcare system reform, but my focus is on key considerations for providers and, to some degree, patients.

Most pressing in this respect is an improved understanding of what constitutes good evidence of effective care and outcomes. For a profession that adopted the scientific method about a century ago, there is alarmingly little evidence for the effectiveness of much of what is taught and practiced today.

To get to an evidence-based, value-driven health system we have to align all of our professional educational programs to teach new systems and capabilities. Introduction to key concepts in EBM should begin, at the very least, at the college level. In addition, the dissemination and incorporation of new knowledge into practice must be accelerated so that it does not require a decade or more for the average provider to adopt new knowledge and skills.

As more and better evidence is developed, effective processes and IT systems are needed to ensure that healthcare practice utilizes best evidence. These systems should also have feedback loops to continuously improve on the evidence.

Systems must be interoperable and scalable and must also incorporate the patient into the decision-making and care provision processes. To be effective, systems must include the proper rewards, incentives, and financing for providers, as well as the means to pay for required processes and IT systems and innovations.

The general public will need education and support to be able to use the copious medical information becoming available, as well as to gain an appreciation for information that is backed by solid evidence. Practitioners need to work with the public to help ensure that we find the right health-care solutions for individual patients.

The complexity of clinical evidence is daunting even for experienced, trained professionals who diagnose and treat disease; but it is far more challenging to the non-expert.

Reducing this complexity is key to empowering patients—not only as better informed consumers of health care, but also as active partners in improving health outcomes. In addition, the right kinds of professional support should be made available to patients, whether through health coaches or other sorts of new professionals who can support and educate patients on the best evidence-based processes for health care and healing.

It is clear that we are still at a rudimentary level of conceptualization and implementation of an evidence-based, value-driven healthcare system and that we still have a long way to go. Finding ways in which patients and providers can be proactive in catalyzing and implementing the needed changes is essential. A learning healthcare system is defined as one in which the usual and customary activities associated with the production, distribution, utilization, and financing of healthcare services result in the simultaneous development and capture of data that are essential to the monitoring and evaluation of health care delivered.

A wide variety of information is contained in these data including, but not necessarily limited to, patient characteristics e.

Through efficient organization and analysis, and provision of findings at the point of care, these data are a rich resource for informed decision making. Two general categories of decisions require an expanded evidence base. The first category includes the use of drugs, devices, and procedures.

The second category concerns the management of care itself, including the organization of care, IT, types and effectiveness of providers, and clinical pathways. Both categories require not only effectiveness information but also comparative effectiveness information, including cost or value. As emphasized in Chapter 2 , attention is needed on the evaluation of drugs, devices, and procedures, as well as on systems of care and the healthcare professionals that are involved in the provision of the care.

One of the major strategies proposed to hasten development of the required evidence base includes migration away from traditional reliance on RCTs and inclusion of a variety of other approaches and data sources. Is the question really black and white, or are there strategies to enhance the types of data being used to build the evidence while at the same time hedging against the pitfalls of lower quality and less reliability?

The papers featured in Chapter 6 offer insights on the opportunities presented by EHRs and clinical registries, as well as some of the challenges of using these data to inform the development of effective healthcare interventions. Public policy has a major role in shaping and driving the development of an improved healthcare system.

The following chapters illustrate the potential of EBM to transform health care, and important policy considerations are detailed in Chapter 7. However, it is vital to keep in mind the substantial challenges inherent to the processes of policy making. In short, these processes are badly in need of repair because they have been corrupted by the corrosive impact of election campaign finance monies. Today, many members of Congress are in a permanent state of running their campaigns for reelection.

Presidential politics has become a billion-dollar enterprise, and one has to wonder what kind of impact that sort of money has on public policy. Is the public being served or sacrificed through this process? As suggested by the opening comments, the IOM Annual Meeting highlighted both the shortfalls of the current system, as well as the tremendous potential for an evidence-driven and value-based health care.

The meeting was structured to provide an overview of the key challenges and opportunities for progress and improvement. Session 1 Chapters 2 and 3 reviewed the need for better medical evidence, characterizing not only the waste and inefficiency endemic to health care and the unsustainable trajectory of healthcare expenditures, but also the challenges presented by medical technologies of increased diversity and complexity and an increasingly sophisticated understanding of genetic contributions to disease.

Challenges faced by patients and providers in using evidence to better guide healthcare decisions were reviewed in Session 2 Chapters 4 and 5. Also considered in these chapters were ways that advances in IT affect opportunities for improved access to health information and decision support. IT will also help transform how evidence is developed. The potential of EHRs, clinical data registries, and new research methods to speed the generation of evidence, as well as drive innovation and the development of tailored therapies were discussed in Session 3 Chapter 6.

The last session of the day was devoted to discussing how policy changes might facilitate better stakeholder alignment on how health care is structured and incentivized to deliver high-value health care.

During the course of the meeting, a number of common themes were identified Box The Changing Nature of Health Care. Common Themes Increasing complexity of health care.

Turn recording back on. Help Accessibility Careers. Show details Institute of Medicine US. Search term. Challenges and Opportunities Mark B. McClellan, M. Elizabeth G. Nabel, M. Cortese, M. Contending with the Changes Michael M. Johns, M. Rowe, M. Iglehart, Health Affairs Public policy has a major role in shaping and driving the development of an improved healthcare system. Increasing complexity of health care. New pharmaceuticals, medical devices, technologies, and predictive data offer much promise for improving health care, but they also introduce high levels of complexity, requiring changes on the parts of both caregivers and their patients.

Unjustified discrepancies in care patterns. The intensity of health-care services delivered for similar conditions varies significantly across geographic regions, particularly in areas that require discretionary decision making. However, the higher-spending regions often do not deliver better-quality care, hence offering substantial opportunity for reduced spending without sacrificing health outcomes.

Importance of better value from health care. Opportunities exist to eliminate wasteful spending with no reduction in health care, as well as to improve the overall health outcomes, but agreement is needed both on what constitutes best care and on what constitutes value in health care. Uncertainty exposed by the information environment. An irony of the information-rich environment is that information important to clinical decision making is often not available, or is provided in forms that are not relevant to the broad spectrum of patients—with differing levels of health, socioeconomic circumstances, and preferences—and the issues encountered in clinical practice.

This is due to too little clinical effectiveness research, to poor dissemination of the evidence that is available, and to too few incentives and decision supports for evidence-based care.

Pressing need for evidence development. More and better evidence—including comparative and longitudinal data—is needed to determine the effectiveness and usefulness of new medical interventions, treatments, drugs, devices, and genetic information.

There is an untapped potential to reduce healthcare costs and improve quality by developing evidence not only for specific medical interventions, but also for the way health care is delivered.

Promise of health information technology. EMRs and clinical data registries offer tremendous potential both to generate new evidence and to augment RCTs.

Addressing privacy and proprietary issues that limit data access and sharing would help to support a system in which EMRs, clinical registries, and other types of electronic data could contribute to building a more robust evidence base. Need for more practice-based research. Shift to a culture of care that learns. To develop best evidence for the delivery of medicine that is geared toward the needs of individual patients, investment is needed into infrastructure for the gathering and analysis of healthcare data and information, as well as standards and protocols to ensure their accuracy and reliability.

This changing role will require healthcare providers and patients to adopt a culture that supports the generation and application of evidence. Effective culture change must also be accompanied by insurance and reimbursement system reform that encourages development and application of the systems necessary.

New model of patient-provider partnership. Leadership that stems from every quarter. Adapting to and taking advantage of the changes in the healthcare environment will take broad leadership. There are only a few exterior modifications you can make to a C3 Corvette that will have as much visual impact as a set of side pipes.

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Know what you know It's futile to predict the economy and interest rates You have plenty of time to identify and recognize exceptional companies Avoid long shots Good management is very important - buy good businesses Be flexible and humble, and learn from mistakes Before you make a purchase, you should be able to explain why you are buying There's always something to worry about - do you know what it is?

Make all of your mistakes early in life. The more tough lessons early on, the fewer errors you make later. Always make your living doing something you enjoy. Be intellectually competitive. The key to research is to assimilate as much data as possible in order to be to the first to sense a major change. Make good decisions even with incomplete information. You will never have all the information you need.

What matters is what you do with the information you have. Always trust your intuition , which resembles a hidden supercomputer in the mind. It can help you do the right thing at the right time if you give it a chance. Don't make small investments. If you're going to put money at risk, make sure the reward is high enough to justify the time and effort you put into the investment decision.

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