10

Actions for Continuous Learning, Best Care, and Lower Costs

Implementing the actions delineated in Chapters 6-9 and achieving the vision of continuous learning and improvement for the health care system will depend on broad leadership by the complex network of decentralized and loosely associated individuals and organizations that make up the current system. Given the complexity of the system and the interconnectedness of its various sectors, no one sector acting alone can bring about the scope and scale of transformative change necessary to develop a system that continuously learns and improves. Each stakeholder brings different strengths, skills, needs, and expertise to the task of improving the system; faces unique challenges; and is accountable for different aspects of the system’s success. Hence, collaboration among individuals and organizations in a given stakeholder group, as well as between stakeholders, will be necessary to produce effective and sustainable change. This chapter summarizes the recommendations presented in Chapters 6 through 9 and then describes the roles of the various stakeholders in the system in implementing these recommendations.

ACHIEVING THE VISION

Based on the findings and conclusions identified in the course of its work, the committee recommends specific actions, supported by the material presented in Chapters 6-9, that will accelerate progress toward continuous learning, best care, and lower costs. The committee’s recommendations are collected below, grouped into three categories as summarized in Box 10-1: foundational elements, care improvement targets, and a supportive

policy environment. Also identified are the stakeholders whose engagement is necessary for the implementation of each recommendation. Each recommendation describes the core improvement aim for the area, followed by specific strategies representing initial steps stakeholders should take in acting on the recommendation. Additional activities will have to be undertaken by numerous stakeholder groups to sustain and advance the continuous improvement required.

Foundational Elements

Recommendation 1: The Digital Infrastructure

Improve the capacity to capture clinical, care delivery process, and financial data for better care, system improvement, and the generation of new knowledge. Data generated in the course of care delivery should be digitally collected, compiled, and protected as a reliable and accessible resource for care management, process improvement, public health, and the generation of new knowledge.

Strategies for progress toward this goal:

• Health care delivery organizations and clinicians should fully and effectively employ digital systems that capture patient care experiences reliably and consistently, and implement standards and practices that advance the interoperability of data systems.
• The National Coordinator for Health Information Technology, digital technology developers, and standards organizations should ensure that the digital infrastructure captures and delivers the core data elements and interoperability needed to support better care, system improvement, and the generation of new knowledge.
• Payers, health care delivery organizations, and medical product companies should contribute data to research and analytic consortia to support expanded use of care data to generate new insights.
• Patients should participate in the development of a robust data utility; use new clinical communication tools, such as personal portals, for self-management and care activities; and be involved in building new knowledge, such as through patient-reported outcomes and other knowledge processes.
• The Secretary of Health and Human Services should encourage the development of distributed data research networks and expand the availability of departmental health data resources for translation into accessible knowledge that can be used for improving care, lowering costs, and enhancing public health.
• Research funding agencies and organizations, such as the National Institutes of Health, the Agency for Healthcare Research and Quality, the Veterans Health Administration, the Department of Defense, and the Patient-Centered Outcomes Research Institute, should promote research designs and methods that draw naturally on existing care processes and that also support ongoing quality improvement efforts.

Recommendation 2: The Data Utility

Streamline and revise research regulations to improve care, promote the capture of clinical data, and generate knowledge. Regulatory agencies should clarify and improve regulations governing the collection and use of clinical data to ensure patient privacy but also the seamless use of clinical data for better care coordination and management, improved care, and knowledge enhancement.

Strategies for progress toward this goal:

• The Secretary of Health and Human Services should accelerate and expand the review of the Health Insurance Portability and Accountability Act (HIPAA) and institutional review board (IRB) policies with respect to actual or perceived regulatory impediments to the protected use of clinical data, and clarify regulations and their interpretation to support the use of clinical data as a resource for advancing science and care improvement.
• Patient and consumer groups, clinicians, professional specialty societies, health care delivery organizations, voluntary organizations, researchers, and grantmakers should develop strategies and outreach to improve understanding of the benefits and importance of accelerating the use of clinical data to improve care and health outcomes.

Care Improvement Targets

Recommendation 3: Clinical Decision Support

Accelerate integration of the best clinical knowledge into care decisions. Decision support tools and knowledge management systems should be routine features of health care delivery to ensure that decisions made by clinicians and patients are informed by current best evidence.

Strategies for progress toward this goal:

• Clinicians and health care organizations should adopt tools that deliver reliable, current clinical knowledge to the point of care, and organizations should adopt incentives that encourage the use of these tools.
• Research organizations, advocacy organizations, professional specialty societies, and care delivery organizations should facilitate the

• development, accessibility, and use of evidence-based and harmonized clinical practice guidelines.
• Public and private payers should promote the adoption of decision support tools, knowledge management systems, and evidence-based clinical practice guidelines by structuring payment and contracting policies to reward effective, evidence-based care that improves patient health.
• Health professional education programs should teach new methods for accessing, managing, and applying evidence; engaging in lifelong learning; understanding human behavior and social science; and delivering safe care in an interdisciplinary environment.
• Research funding agencies and organizations should promote research into the barriers and systematic challenges to the dissemination and use of evidence at the point of care, and support research to develop strategies and methods that can improve the usefulness and accessibility of patient outcome data and scientific evidence for clinicians and patients.

Recommendation 4: Patient-Centered Care

Involve patients and families in decisions regarding health and health care, tailored to fit their preferences. Patients and families should be given the opportunity to be fully engaged participants at all levels, including individual care decisions, health system learning and improvement activities, and community-based interventions to promote health.

Strategies for progress toward this goal:

• Patients and families should expect to be offered full participation in their own care and health and encouraged to partner, according to their preference, with clinicians in fulfilling those expectations.
• Clinicians should employ high-quality, reliable tools and skills for informed shared decision making with patients and families, tailored to clinical needs, patient goals, social circumstances, and the degree of control patients prefer.
• Health care delivery organizations, including programs operated by the Department of Defense, the Veterans Health Administration, and Health Resources and Services Administration, should monitor and assess patient perspectives and use the insights thus gained to improve care processes; establish patient portals to facilitate data sharing and communication among clinicians, patients, and families; and make high-quality, reliable tools available for shared decision making with patients at different levels of health literacy.

• The Agency for Healthcare Research and Quality, partnering with the Centers for Medicare & Medicaid Services, other payers, and stakeholder organizations, should support the development and testing of an accurate and reliable core set of measures of patient-centeredness for consistent use across the health care system.
• The Centers for Medicare & Medicaid Services and other public and private payers should promote and measure patient-centered care through payment models, contracting policies, and public reporting programs.
• Digital technology developers and health product innovators should develop tools to assist individuals in managing their health and health care, in addition to providing patient supports in new forms of communities.

Recommendation 5: Community Links

Promote community-clinical partnerships and services aimed at managing and improving health at the community level. Care delivery and community-based organizations and agencies should partner with each other to develop cooperative strategies for the design, implementation, and accountability of services aimed at improving individual and population health.

Strategies for progress toward this goal:

• Health care delivery organizations and clinicians should partner with community-based organizations and public health agencies to leverage and coordinate prevention, health promotion, and community-based interventions to improve health outcomes, including strategies related to the assessment and use of web-based tools.
• Public and private payers should incorporate population health improvement into their health care payment and contracting policies and accountability measures.
• Health economists, health service researchers, professional specialty societies, and measure development organizations should continue to improve measures that can readily be applied to assess performance on both individual and population health.

Recommendation 6: Care Continuity

Improve coordination and communication within and across organizations. Payers should structure payment and contracting to reward

effective communication and coordination between and among members of a patient’s care team.

Strategies for progress toward this goal:

• Health care delivery organizations and clinicians, partnering with patients, families, and community organizations, should develop coordination and transition processes, data sharing capabilities, and communication tools to ensure safe, seamless patient care.
• Health economists, health service researchers, professional specialty societies, and measure development organizations should develop and test metrics with which to monitor and evaluate the effectiveness of care transitions in improving patient health outcomes.
• Public and private payers should promote effective care transitions that improve patient health through their payment and contracting policies.

Recommendation 7: Optimized Operations

Continuously improve health care operations to reduce waste, streamline care delivery, and focus on activities that improve patient health. Care delivery organizations should apply systems engineering tools and process improvement methods to improve operations and care delivery processes.

Strategies for progress toward this goal:

• Health care delivery organizations should utilize systems engineering tools and process improvement methods to eliminate inefficiencies, remove unnecessary burdens on clinicians and staff, enhance patient experience, and improve patient health outcomes.
• The Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, quality improvement organizations, and process improvement leaders should develop a learning consortium aimed at accelerating training, technical assistance, and the collection and validation of lessons learned about ways to transform the effectiveness and efficiency of care through continuous improvement programs and initiatives.

Supportive Policy Environment

Recommendation 8: Financial Incentives

Structure payment to reward continuous learning and improvement in the provision of best care at lower cost. Payers should structure payment models, contracting policies, and benefit designs to reward care that is effective and efficient and continuously learns and improves.

Strategies for progress toward this goal:

• Public and private payers should reward continuous learning and improvement through outcome- and value-oriented payment models, contracting policies, and benefit designs. Payment models should adequately incentivize and support high-quality team-based care focused on the needs and goals of patients and families.
• Health care delivery organizations should reward continuous learning and improvement through the use of internal practice incentives.
• Health economists, health service researchers, professional specialty societies, and measure development organizations should partner with public and private payers to develop and evaluate metrics, payment models, contracting policies, and benefit designs that reward high-value care that improves health outcomes.

Recommendation 9: Performance Transparency

Increase transparency on health care system performance. Health care delivery organizations, clinicians, and payers should increase the availability of information on the quality, prices and cost, and outcomes of care to help inform care decisions and guide improvement efforts.

Strategies for progress toward this goal:

• Health care delivery organizations should collect and expand the availability of information on the safety, quality, prices and cost, and health outcomes of care.
• Professional specialty societies should encourage transparency on the quality, value, and outcomes of the care provided by their members.
• Public and private payers should promote transparency in quality, value, and outcomes to aid plan members in their care decision making.

• Consumer and patient organizations should disseminate this information to facilitate discussion, informed decision making, and care improvement.

Recommendation 10: Broad Leadership

Expand commitment to the goals of a continuously learning health care system. Continuous learning and improvement should be a core and constant priority for all participants in health care—patients, families, clinicians, care leaders, and those involved in supporting their work.

Strategies for progress toward this goal:

• Health care delivery organizations should develop organizational cultures that support and encourage continuous improvement, the use of best practices, transparency, open communication, staff empowerment, coordination, teamwork, and mutual respect and align rewards accordingly.
• Leaders of these organizations should define, disseminate, support, and commit to a vision of continuous improvement; focus attention, training, and resources on continuous learning; and build an operational model that incentivizes continuous improvement and ensures its sustainability.
• Governing boards of health care delivery organizations should support and actively participate in fostering a culture of continuous improvement, request continuous feedback on the progress being made toward the adoption of such a culture, and align leadership incentive structures accordingly.
• Clinical professional specialty societies, health professional education programs, health professions specialty boards, licensing boards, and accreditation organizations should incorporate basic concepts and specialized applications of continuous learning and improvement into health professions education; continuing education; and licensing, certification, and accreditation requirements.

Given the interconnected nature of the problems to be solved, it will be important to take the actions identified above in concert. To elevate the quantity of evidence available to inform clinical decisions, for example, it is necessary to increase the supply of evidence by expanding the clinical research base; make the evidence easily accessible by embedding it in clinical technological tools, such as clinical decision support; encourage use of the evidence through appropriate payment, contracting, and regulatory policies and cultural factors; and assess progress toward the goal using reliable

metrics and appropriate transparency. The absence of any one of these factors will substantially limit overall improvement. To guide success, progress on the recommendations in this report should be monitored continuously.

Implementing the actions detailed above and achieving the vision of continuous learning and improvement will depend on the exercise of broad leadership by the complex network of decentralized and loosely associated individuals and organizations that make up the health care system. Given the complexity of the system and the interconnectedness of its different actors and sectors, no one actor or sector alone can bring about the scope and scale of transformative change necessary to develop a system that continuously learns and improves. Each stakeholder brings different strengths, skills, needs, and expertise to the task of improving the system, faces unique challenges, and is accountable for different aspects of the system’s success. There is a distinct need for collaboration between and among stakeholders to produce effective and sustainable change.

PATIENTS, CONSUMERS, CAREGIVERS, COMMUNITIES, AND THE PUBLIC

Roles in Learning

As the focus of health care, patients are central to the success of improvement initiatives. Any large-scale change will require the participation of patients as partners, with the system building trust on every dimension. Patients can motivate continuous improvement by setting high expectations for their care in terms of quality, value, and use of scientific evidence and by selecting health care services, clinicians, health care organizations, and plans that meet those expectations. Patients also can promote learning and improvement by engaging in their own care; sharing decision making with their clinicians; and, with the help of their caregivers, directly applying evidence to their self-care and self-management on an ongoing basis. As their needs progress, patients can seek effective and efficient services that align most closely with their goals.

Challenges to Learning

There are several impediments to patients and the broader public playing a central role in improving the health care system. Notably, the culture of health care often does not encourage or support shared decision making. Even when patients are encouraged to play a role in decisions about their care, they often lack understandable, reliable information—from evidence on the efficacy of different treatment options to information on the quality of different providers and health care organizations—that is customized to

their needs, preferences, and health goals. In addition, health care needs to be tailored to a patient’s health literacy, as people have different abilities to obtain, comprehend, and use health information to make care decisions (Brach et al., 2012).

In addition, there are challenges to measuring patient empowerment and patient-centered care. Without accurate and reliable measures, it is difficult to determine whether initiatives aimed at achieving greater patient empowerment are successful or to reward clinicians and health care organizations that provide patient-centered care. Several organizations, such as the National Quality Forum (NQF) and the National Committee for Quality Assurance (NCQA), have begun to address this need with respect to defining and measuring aspects of health care performance that relate to patient-centered care. Once measurement has been accomplished, moreover, there are further challenges in communicating this information to patients in an understandable and relevant format such that it can easily be applied to care decisions. These challenges are beginning to be addressed by several public reporting initiatives, including national initiatives such as Hospital Compare and regional initiatives such as Minnesota Community Measurement and the Wisconsin Collaborative for Healthcare Quality, which have begun to incorporate patient experience metrics into their public reporting efforts.

Opportunities

While the challenges described above are considerable, several opportunities exist for increasing patient involvement in the health care system. Organizations have implemented new methods for gathering patient feedback, from patient advisory councils to surveys; clinicians have introduced new communication and shared decision-making processes; and insurers have begun to account for patient-centeredness in payment. Further, health information technology offers new ways for patients and providers to communicate, and new mobile devices and sensors allow patients to monitor their conditions continuously. Leveraging these opportunities will increase patient involvement in improving health care.

Next Steps

To help achieve a learning health care system, patients will need to play the following roles:

• Engage actively in their own care and health and, where appropriate, that of family members and loved ones through approaches that include questioning, education and lifelong learning, the use

• of information and technology, shared decision making, and self-management of their health and conditions.
• Partner with all stakeholders to ensure that health care meets their needs, as well as those of their community and the public overall.
• Contribute to continuous learning by providing feedback at every level of their care experience.
• Participate in the development of a robust data utility and the use of digital tools for care management and coordination.
• Take advantage of access to information, knowledge, and educational opportunities to become more actively involved in their health.

CLINICIANS AND THEIR TEACHERS

Roles in Learning

The health care professionals who deliver care are cornerstones of any effort to improve health care. These professionals—including more than 800,000-870,000 active physicians, 2.7 million registered nurses, 250,000 pharmacists, and many additional health professionals practicing in the United States during 2010—represent the front lines of health care delivery and the primary interface for patients and consumers (HRSA, 2008; Staiger et al., 2009; U.S. Bureau of Labor Statistics, 2011). Engaging this sector is essential to progress in health care, from expanding the supply of clinical information, to promoting the use of evidence, to involving patients in their care and health.

The roles and responsibilities of clinicians are changing over time. Health care is evolving from a profession in which solo practitioners provided all aspects of care for a patient to one in which a team of clinicians is involved in meeting a patient’s health needs. For example, Medicare patients see an average of seven physicians, including five specialists, split among four different practices (Pham et al., 2007). The changing landscape of medicine necessitates an increased focus on coordinating, sharing information, and working across specialty and professional lines. In this new team-based environment, clinicians across disciplinary lines need to work together to maintain and improve a patient’s health, with different clinicians playing complementary roles based on their training and education (IOM, 2011b).

In addition, there is a trend toward greater transparency and accountability in health care, paralleling a similar trend occurring throughout society. New initiatives are focused on measuring and publicly reporting the quality of clinicians, the quality of hospitals, the prices for medical services, the costs of care episodes, and the health outcomes of different procedures and devices. These metrics are being applied to payment policies, from

value-based insurance design to tiered networks, as an additional lever for accountability. This trend will change clinical practice as clinicians adapt and respond to these external factors.

Challenges to Learning

Although health care professionals strive to provide the best care to their patients, they face many challenges to the consistent delivery of efficient, high-quality care. Current practice experience falls short of this ideal in part because of inefficient workflows and support systems—which result in long delays for such straightforward tasks as patient follow-up and appointment scheduling—and because of the lack of adequate training and infrastructure to support the practice of high-quality care. The proliferation and fragmentation of information, expertise, and care delivery processes greatly compound the complex task faced by health care professionals when they try to deliver the right care at the right time. Moreover, the financial incentives for providers often are misaligned, rewarding volume of services over care quality and health outcomes. Overcoming these obstacles will depend increasingly on a team-based approach to care whereby clinicians coordinate care with each other and with community-based support services.

Opportunities

New methods of educating health care professionals and other health care workers, as well as new models for continuing to develop their competencies, will be needed to support a learning health care system. The current clinical training programs for each profession often operate independently from each other, which may limit an interprofessional view of care and teamwork (IOM, 2003). Education and continuing education need to focus on methods for using new evidence in clinical decision making, engaging in lifelong learning, understanding human behavior and social science, and delivering safe care in an interdisciplinary team environment (AAMC, 2011; Lucian Leape Institute Roundtable on Reforming Medical Education, 2010). To ensure that clinical leaders have the tools necessary to support large-scale improvement, additional opportunities are needed for educating health care workers in organizational management, systematic problem-solving techniques, and process improvement. Initiatives such as the Institute for Healthcare Improvement’s (IHI’s) Open School have been developed to address these needs, although additional projects will be needed to disseminate these tools widely. Additionally, given that effective communication with patients is crucial, clinical education needs to teach methods for communicating information to patients and engaging them actively in the clinical decision-making process.

New technologies and payment policies will assist health care professionals seeking to move toward continuous learning and improvement. The development of a robust information technology infrastructure will enable universal access to electronic health records; allow access to large databases for quality improvement; and enable broader access to decision support tools and knowledge repositories containing updated medical evidence, as well as evidence-based guidelines. Further, new incentives—financial, regulatory, and others—are being tested that would reward providers for applying evidence to patient care, delivering high-quality services, and improving their patients’ health (Bovbjerg and Berenson, 2012).

Next Steps

To help achieve a learning health care system, clinicians and their teachers need to play the following roles:

• Embrace a culture of continuous improvement, with a focus on sharing and learning within and across systems.
• Optimize current educational programs to meet the knowledge and team-based needs of today and tomorrow for clinical care, management, and leadership.
• Optimize the care continuum with careful process design and robust technology.
• Partner with patients and families to set goals and make decisions based on clinical needs, social circumstances, and the degree of control patients prefer in their care, as well as acquire tools and skill sets for explaining clinical concepts, risks, and benefits to patients and their families.
• Collaborate with stakeholders on important health policy questions, such as payment reform and the application of clinical data to improving outcomes.
• Utilize digital health record systems in meaningful ways to capture patient experience and apply decision support at every level of their practice.

PROFESSIONAL SPECIALTY SOCIETIES

Roles in Learning

Bringing together clinicians and providing a forum for action, professional specialty societies play important roles in promoting learning. Many societies create regularly reviewed guidelines that summarize the current state of the science for a specific specialty, with some developing

performance measures that build on those guidelines. Other societies have developed advanced data infrastructures for assessing performance with specific procedures or conditions, such as the registries created by the American College of Cardiology and The Society of Thoracic Surgeons. Still others have developed quality improvement initiatives for improving safety and quality, such as the American College of Surgeons’ National Surgical Quality Improvement Program.

Challenges to Learning

Professional specialty societies seeking to play a greater role in learning face cultural, resource, and technical challenges (Ferris et al., 2007). On the cultural front, there are outstanding questions about the evolving nature of professionalism and the interest in self-regulation. With regard to resource and technical challenges, developing the data infrastructure for registries and quality improvement programs requires substantial investments in resources and significant technical expertise.

Opportunities

Several recent clinician-led initiatives are aimed at improving the value achieved from health care. Some, such as the Choosing Wisely campaign spearheaded by the American Board of Internal Medicine (ABIM) Foundation and nine medical specialty groups, focus on identifying treatments or interventions that may provide little benefit to the general patient population (Cassel and Guest, 2012). The purpose of the campaign is to encourage discussions between patients and clinicians about the benefits and risks of different treatments and diagnostic technologies. This work, building on the Good Stewardship project (Good Stewardship Working Group, 2011), is intended to expand to additional specialty areas over time.

Next Steps

To help achieve a learning health care system, professional specialty societies need to play the following roles:

• Collaborate with other stakeholders to consider the necessary common core data elements and measures for managing high-impact conditions.
• Facilitate, along with other relevant organizations, the development, accessibility, and use of evidence-based clinical practice guidelines.

• Develop measures that can be applied to manage health on both the individual and population levels, assess performance and value, and evaluate the effectiveness of care transitions.
• Collect and make available information on the quality and outcomes of care.

DELIVERY SYSTEM LEADERS

Roles in Learning

Because of their size and care capacities, health care delivery organizations play a critical role in driving improvement in the health care system by using new practice methods, setting standards, and sharing resources and information with other care delivery organizations. In addition, many of these organizations have made significant investments in health information technology and in building their research capacity, which has allowed them to become leaders in generating and using evidence to improve patient care; many academic health centers and health systems have developed substantial research infrastructures for deepening clinical and biomedical understanding. Further, changes in health care have elevated the role of health care organizations in the delivery of care. Whereas many physicians traditionally practiced in small independent practices, physicians have increasingly joined large health care delivery systems over the past several years. As a result, the number of physician practices owned by hospitals increased from 20 percent in 2002 to 55 percent in 2008 (Kocher and Sahni, 2011). Although many physicians continue to work in small practices, the growth in physician employment by health care delivery organizations has made these institutions even more central stakeholders.

Challenges to Learning

Many institutions still struggle to implement sustainable, transformational system changes. They face both external obstacles, such as financial incentives that emphasize quantity of services over quality, and internal challenges in efforts to achieve improvement. To overcome these obstacles and become organizations that continuously learn and improve, they must adopt systematic problem-solving techniques and operational models that encourage and reward sustained quality and improved patient outcomes, and foster leadership and a culture that provide a strong foundation for improvement efforts. The accreditation, certification, and licensure processes for health care organizations provided by the Joint Commission and state agencies may support these efforts. Finally, the lessons learned by pioneer organizations need to be disseminated more broadly so that the entire

system can benefit from the knowledge gained through the initiatives of individual organizations.

Opportunities

Opportunities exist to learn from the many industries that have developed new methods for improving safety, reliability, quality, and value. Organizations have learned how to manage and analyze large volumes of information; how to coordinate large numbers of workers to provide products or services with consistent quality; and how to ensure reliable performance, even under conditions of high risk. A number of these methods could potentially be adapted to health care to improve performance. In doing so, it will be important to consider several factors specific to health care, such as patient diversity and the technical complexity of modern medicine, as well as local factors that could affect implementation.

Next Steps

To help achieve a learning health care system, leaders of health care delivery organizations need to play the following roles:

• Set bold, mission-driven aims for clinical, financial, service, and experience outcomes against a frank assessment of the current reality, and implement those aims with a prioritized, aligned approach.
• Embrace a culture of continuous improvement, with a focus on sharing and learning within and across systems.
• Partner with patients, the public, communities, clinicians, and other stakeholders to, for example, achieve progress on the use of clinical data and patient perspectives to improve care.
• Promote transparency of process and performance.
• Collaborate with organizations within and beyond the traditional health care system to leverage prevention, health promotion, and community-based interventions to expand coordination and improve health.
• Optimize the care continuum with careful, systematic process design and robust technology.
• Develop and adopt tools that deliver clinical knowledge to the point of care.

HEALTH INSURERS

Roles in Learning

In 2010, private health insurance plans provided health benefits for 64 percent of the total U.S. population, and public payers, including Medicare, Medicaid, the Children’s Health Insurance Program, the Department of Defense, and Department of Veterans Affairs health benefits programs, provided coverage to 31 percent (with some individuals receiving coverage from a mix of public and private sources) (DeNavas-Walt et al., 2011). As organizations that interact directly with patients, insurers have the ability to support patients as they seek to maintain healthy behaviors and access quality health care services. Further, insurance company policies determine the financial realities for health care providers and have a strong influence on how providers practice. While traditional reimbursement schedules have rewarded volume of services, recent insurer initiatives tie incentives to care quality or patient health outcomes to reward high performance.

Challenges to Learning

The insurance industry is operating in an environment of rising costs (Auerbach and Kellermann, 2011). In the employer-sponsored insurance market, health care premiums for family coverage have increased by 113 percent over the past decade (Kaiser Family Foundation and Health Research & Educational Trust, 2011). As a result, more families are unable to afford coverage; the number of uninsured Americans rose to 50 million in 2010 (DeNavas-Walt et al., 2011). In addition to the general challenges related to rising costs and waste, insurers face challenges related to new treatments and technologies, the aging of the population, and the increase in chronic conditions. Some insurers have developed new systems for applying evidence to their payment models, contracting policies, and benefit design. Yet these organizations often lack access to sufficient evidence on the efficacy of different treatments and interventions.

Opportunities

Private and public payers have undertaken multiple initiatives to improve value and promote the application of scientific evidence. These initiatives range from value-based purchasing, to medical homes, to accountable care organizations, to value-based insurance design. One notable example is policies on coverage with evidence development, which allow the coverage of new treatments and technologies while an evidence base for their effectiveness is being built. Other initiatives include multipayer claims databases,

such as the Wisconsin Health Information Organization and the Health Care Cost Institute, that support the development of new insights regarding cost and value. These initiatives, many of which have shown success, provide new opportunities to deepen the knowledge base with respect to which payment models work under different circumstances, as well as encourage further innovation in the development of value initiatives.

Recent initiatives to expand the research infrastructure on clinical effectiveness, such as the Patient-Centered Outcomes Research Institute (PCORI), will help address the current gaps in evidence. To this end, PCORI has been allocated funding of $210 million for the first 3 years, rising to $500 million annually from 2014 to 2019 (Washington and Lipstein, 2011). Although it is premature to judge PCORI’s work, increasing the level of knowledge on comparative effectiveness is critical to building a learning health care system.

One noteworthy new body is the Center for Medicare & Medicaid Innovation, which is charged with testing and evaluating innovative payment and delivery system models that could improve care quality while slowing cost growth in Medicare, Medicaid, and the Children’s Health Insurance Program. Although the Patient Protection and Affordable Care Act outlines approximately 20 areas that the Innovation Center could consider at the outset, the legislation provides substantial flexibility for the exploration of different models. Successful models may be diffused to a larger patient population upon approval by the Secretary of Health and Human Services. The Innovation Center’s ultimate goal is to promote the rapid development and diffusion of innovative payment and delivery models that are successful in improving quality and value. Through a number of ongoing initiatives, such as the Partnership for Patients, the Innovation Center will play an important role in improving care delivery and payment policies in Medicare and Medicaid and ensuring that payment policies support continuous learning by clinicians and health care organizations—a critical goal for a learning health care system. Although it is too soon to judge the effectiveness of the Center’s work, the goal of improving payment policies is a critical one.

Next Steps

To help achieve a learning health care system, health insurers need to play the following roles:

• Seek to align incentives in support of high-quality, high-value, evidence-based care, including alignment among multiple payers and across the care continuum.

• Continually improve the value achieved by payment models, contracting policies, and benefit design while minimizing administrative burdens and expanding knowledge about the results of different payment and contracting models.
• Support increased research in clinical effectiveness and cross-industry application of the research results.
• Make longitudinal datasets available for research and public health purposes.
• Promote transparency to support care decisions and improvement efforts.
• Ensure a balanced focus on all outcomes (clinical, financial, service, and experience) and at multiple levels (individual, population).

EMPLOYERS

Roles in Learning

Given that employer-sponsored health insurance covers 55 percent of the population, employers and their employees bear a substantial proportion of health care costs (DeNavas-Walt et al., 2011). In return, they depend on the health care system to ensure that their employees remain healthy and productive. To this end, employers have increasingly supported efforts to improve quality and value by using their purchasing power to drive improvement efforts through contracts with providers and insurers, the design of benefit plans, and the provision of incentives and information for employees. Using such tools, employers can promote the application of evidence to care; encourage the use of high-quality, high-value providers and health care organizations; support positive changes in health behaviors; and expand the use of scientific evidence when employees make care decisions. Many employers have indicated their willingness to support continuous learning and improvement by introducing payment and contracting policies that reward safe, high-quality, high-value care that improves health.

Challenges to Learning

Rising health care costs have eroded employer-sponsored health care coverage and its generosity. Currently, 60 percent of employers offer coverage to their employees. In 2011, employer contributions to health insurance for family coverage averaged more than $4,100, up 230 percent in a decade (Kaiser Family Foundation and Health Research & Educational Trust, 2011). Health care costs have become a major expense for threatening their competitiveness in a global economy. Costs, however, are only part of the problem; employers also consider the return (in terms of

employee health) that they receive from this investment. Yet, recent statistics suggest that substantial waste and inefficiency result in expenditures that do not improve care quality or patient health.

Opportunities

The tools available to employers to improve health care quality and value are limited by a lack of clinical evidence. New efforts to increase the clinical knowledge base, such as PCORI, will help address this challenge.

Next Steps

To help achieve a learning health care system, employers need to play the following roles:

• Use their purchasing power to drive high-quality, high-value health care.
• Actively engage their employees in health and wellness through workplace wellness programs, partnerships, educational resources, and the design of benefit plans.
• Engage with employees to understand their unique values, needs, and expectations.
• Incentivize employees to use high-quality, high-value providers as measured by clinical, financial, service, and experience outcomes.
• Share industry-specific business practices and systematic approaches to process improvement with the health care community in the spirit of learning within and across community partners.

HEALTH RESEARCHERS

Roles in Learning

Health researchers are critical to building the evidence base for care effectiveness and value. These investigators consider both individual treatments and interventions and broader delivery system initiatives, conducting quantitative and qualitative evaluations, cost-benefit analyses, and organizational studies. Given this broad charge, the health researcher community includes those involved in the design and operation of clinical trials, the development of clinical registries and clinical databases, the creation of standards and metrics, modeling and simulation studies, studies of health services and care delivery processes, and the aggregation of study results into systematic reviews and clinical guidelines. This work has been supported by a number of agencies and organizations, including the Agency

for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and PCORI.

Challenges to Learning

This stakeholder group faces several challenges as it works to build knowledge. The financial resources for research and development are limited as a result of economic and budgetary constraints. Further, public awareness of and participation in the clinical research enterprise has recently decreased, with fewer individuals expressing interest in participating in clinical trials (Woolley and Propst, 2005). Investigators also have expressed concern about the ability to share data and glean insights from clinical data because of the current regulatory framework (IOM, 2009a). Results of previous surveys of health researchers suggest that the current formulation and interpretation of privacy rules have increased the cost and time to conduct research, that different institutional interpretations of the Health Insurance Portability and Accountability Act (HIPAA) and associated regulations have impeded collaboration, and that the rules have made it difficult to recruit subjects (Association of Academic Health Centers, 2008; Greene et al., 2006; IOM, 2009a; Ness, 2007).

Transforming the research enterprise will require new efforts to build trust among patients and the public. Building this trust will in turn require increasing confidence in the results of clinical research, being open and honest about the risks and benefits of this type of research, and ensuring confidence in the privacy and security safeguards for health data. Technically, new approaches are needed to reduce the expense and effort of conducting the research, to improve the applicability of its results to clinical decisions, and to identify smaller effects and effects on different populations.

Finally, this sector will need to consider how to accelerate the translation of evidence into practice using technological and nontechnological tools, accounting for the factors that affect the dissemination of initiatives in the health care system. The products of the nation’s clinical data utility and research enterprise are useless unless they are disseminated and put into practice. Yet current systems that generate new clinical knowledge and those that implement such knowledge are largely disconnected and poorly coordinated. Although many effective, evidence-based practices, therapeutics, and interventions are developed every year, only some become widely used in a meaningful way. Overcoming this obstacle will require a focus on the dissemination and translation of research, new partnerships between clinical and health service researchers and clinicians in implementing research results, and additional research into the dissemination and diffusion of scientific evidence in the system.

Opportunities

New efforts to increase the knowledge base on clinical effectiveness, such as PCORI, along with the work of existing research agencies, such as NIH and AHRQ, will help broaden the scope of the clinical research that is undertaken. Further, many research organizations have initiated high-profile efforts to improve the quality and efficiency of clinical trials, including initiatives at NIH and the Food and Drug Administration’s Clinical Trials Transformation Initiative. Based on these efforts and the work of academic research leaders, new types of research trials have been developed, such as pragmatic clinical trials, delayed design trials, and cluster randomized controlled trials (see Chapter 6 for a description of these types of trials) (Campbell et al., 2007; Eldridge et al., 2008; Tunis et al., 2003, 2010). Advanced statistical methods, including Bayesian analysis, allow for adaptive research designs that can learn as a research study advances, making studies more flexible (Chow and Chang, 2008). These new methods are designed to reduce the expense and effort of conducting research, to improve the applicability of research results to clinical decisions, to improve the ability to identify smaller effects, and to offer an alternative when traditional methods are not feasible.

In addition to new research methods, advances in statistical analysis, simulation, and modeling now supplement traditional methods for conducting trials. Given that even the most tightly controlled trials show a distribution of patient responses to a given treatment or intervention, new statistical techniques can help segment results for different populations. Further, new Bayesian techniques for data analysis can disentangle the effects of different clinical interventions on overall population health (Berry et al., 2006). With the growth in computational power, newly developed models can replicate physiological pathways and disease states (Eddy and Schlessinger, 2003; Stern et al., 2008). These models can then be used to simulate clinical trials and individualize clinical guidelines according to a patient’s particular situation and biology, which can improve health status while reducing costs (Eddy et al., 2011). As computational power increases, the potential applications of these simulation and modeling tools will continue to advance.

In addition, novel technologies allow for new means of collecting health care data directly from patients. Enabled by advances in mobile technologies and informatics, patients and consumers now have the ability to be involved in collecting and sharing data on their personal condition. This vision is being realized through biobanks operated by disease-specific organizations, in addition to social networking sites. Examples of social networking sites that aim to promote patient participation in research include PatientsLikeMe^®, Love/Avon Army of Women, and Facebook health

groups. While these patient-initiated approaches face challenges, especially related to bias in self-reporting, data quality, and protection against discrimination, their prevalence can only be expected to increase.

Next Steps

To help achieve a learning health care system, health researchers need to play the following roles:

• Actively engage with care communities to advance understanding of clinical research and clinical trials and thereby enhance balanced consideration of and enrollment in clinical trials.
• Develop and implement new methods for conducting clinical research that overcome the limitations of the traditional research enterprise.
• Partner with patients to build trust in the clinical research enterprise.
• Optimize, through formal and informal structures, the linkages among basic research, clinical research, public health, and care delivery through such means as technology, communities of learning, and cross-industry collaboration.
• Engage in efforts to advance publication and learning as a result of quality improvement efforts.
• Advance the science of dissemination and implementation, with a focus on practical strategies for expanding the diffusion of clinical research.

DIGITAL TECHNOLOGY DEVELOPERS

Roles in Learning

Digital technology developers have emerged to meet the growing demand to capture, store, retrieve, and share information in virtually every aspect of health care. The range of newly digitalized services is remarkable, encompassing products that assist in scheduling and billing, claims processing and payment, supply and equipment inventory maintenance, individual patient records, medication prescribing and tracking, decision support systems, postmarket product monitoring, and disease and treatment registries. Fundamentally, the work of this sector focuses on improving the access of patients and health care providers to reliable, high-quality evidence; enhancing patient-provider communication and interaction; seamlessly and continuously capturing measures of patient health at ever finer levels of granularity; promoting operational effectiveness and efficiency; improving

the ability to manage and analyze large quantities of data; and improving research on clinical effectiveness and quality of care.

Challenges to Learning

Digital technology developers face multiple challenges to increasing the digital resources for health care. One of the greatest challenges is the need to develop standards that foster data sharing and data quality. For example, sharing of electronic health records is impeded by the fact that a variety of such systems are in use, each of which stores data using different methods and in different formats. Overcoming these challenges will require technological solutions, such as interoperability strategies; methods for highlighting the quality of the data; and ways to identify the data’s source, context, and provenance. In addition, given the complex and demanding nature of modern health care practice, it is necessary to ensure that these tools can be seamlessly integrated into providers’ daily workflow without causing disruptions in their clinical routine.

Opportunities

An opportunity to promote the adoption of health information technologies was recently provided by the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act. This legislation formalized the Office of the National Coordinator for Health Information Technology in the Department of Health and Human Services and provided substantial financial incentives for health care providers and hospitals to adopt and use electronic health records. Resources devoted to those programs include $2 billion for programs by the National Coordinator, as well as almost $30 billion in Medicare and Medicaid incentive payments to physicians and hospitals (Blumenthal, 2009; Buntin et al., 2010). Notably, the act encourages not only the adoption but also the meaningful use of such record systems. The criteria for incentive eligibility in the first stage of meaningful use were released by CMS on July 13, 2010. The aim of this stage was to capture clinical data in a standardized format within electronic health records and make the data accessible to authorized users (Blumenthal and Tavenner, 2010). Subsequent stages of meaningful use are currently under development. They will focus on the secure exchange of health information for care coordination and will drive more advanced uses of health information technology systems (Buntin et al., 2010).

Next Steps

To help achieve a learning health care system, digital technology developers need to play the following roles:

• Ensure that electronic health record systems and other digital technologies capture and deliver the core data elements needed to support knowledge generation.
• Partner with patients, the delivery system, insurers, researchers, innovators, regulators, and other stakeholders.
• Collaborate in the development of core datasets for different diseases and conditions to support clinical care, improvement, and research.
• Develop tools that assist individuals in managing their health and health care and that provide opportunities for building communities to support patient efforts.
• Consider interoperability and integration in clinical workflows in designing digital health systems.

HEALTH PRODUCT INNOVATORS AND REGULATORS

Roles in Learning

By conducting clinical research and developing innovative new treatments and interventions, health product innovators play a pivotal role in a learning health care system. In 2010, the biopharmaceutical segment of the market conducted research and development for more than 3,000 products in development (Pharmaceutical Research and Manufacturers of America, 2011). Regulators, including the Food and Drug Administration, play an important role as well in several aspects of the health care system, from the introduction of medical products to surveillance of existing products.

Challenges to Learning

As with other research sectors, these stakeholders face challenges in generating new clinical evidence. The current research paradigm often requires substantial investments of money and time to answer important questions, limiting the amount of research that can be conducted to answer important questions and develop new products. The research enterprise is especially challenged in understanding how different treatments affect patients in everyday settings and in distinguishing the effects of a treatment in different population groups. Regulators similarly face challenges

in providing a regulatory framework that ensures safety and effectiveness throughout a product’s life cycle (IOM, 2009b, 2011a,c).

Opportunities

Health product innovators and regulators will be affected by new developments in the design of health plan benefits, such as the coverage with evidence development designs noted above that provide payment for interventions while evidence on their efficacy continues to be generated. Further, the digital infrastructure will provide new opportunities to gather postmarket surveillance data and identify potential adverse reactions, as well as unexpected indications for a therapy. Finally, the development of new research methods will allow for more granular assessments of a product’s effectiveness, including the patient populations that benefit (or do not), allowing for more effective use of the product. The industry has an opportunity to build on its productive partnerships in clinical effectiveness research to further advance the capacities of the field.

Developments in digital technology allow for new linkages between health product innovators and regulators. Given their interest in the safety and effectiveness of pharmaceuticals, devices, and other products, regulators collect and analyze substantial amounts of data to evaluate whether a product is safe and effective for its indicated use. For the health care system to continuously learn and improve, health care knowledge must continuously be generated. On the regulatory level, evidence on a product’s effectiveness needs to be updated after the product’s introduction. One initiative aimed at addressing this concern is the Food and Drug Administration’s Sentinel Initiative, which is focused on building a national electronic system to monitor the safety of drugs. A related pilot initiative is the Mini-Sentinel network, whose mission is to learn about the barriers and challenges to establishing this type of large-scale product safety monitoring system.

Next Steps

To help achieve a learning health care system, health product innovators and regulators need to play the following roles:

• Build a learning system across the industry, anchored in ethical practice, that allows for the most effective public-private partnerships, learning, and diffusion of innovation.
• Probe the unique systems, processes, and needs of high-quality, high-value health care, and conduct applied research on innovative approaches to meeting those needs.

• Partner with the health care organizations in the communities in which they and their employees live to address identified opportunities for improvement.
• Develop tools that assist individuals in managing their health and health care.

GOVERNANCE

Roles in Learning

All governance groups, from boards of health care organizations to governmental bodies, need to be actively involved in promoting a learning health care system. The leadership of these groups, often in collaborative forms, will be necessary to motivate the actions required to create a learning health care system.

Hospital and health care delivery system boards have a crucial role in guiding their organizations toward continuous learning and improvement. Boards are responsible for the quality of care provided, the financial health and reputation of the organization, oversight of the organization’s executives, and formulation of the organization’s mission (Belmont et al., 2011; Conway, 2008). Better outcomes are associated with organizations in which the board spends time on health care quality concepts, sets a quality agenda, formally monitors quality performance metrics, interacts with staff on strategy, and rewards executive leadership based on measured quality and safety goals (IHI, 2007; Jiang et al., 2009; Vaughn et al., 2006).

Challenges to Learning

As stated earlier, many institutions still struggle to implement sustainable, transformational system changes. The challenges range from health care payment incentives that encourage greater use of health care services to an organizational culture opposed to large-scale change. There also is a need to diffuse the lessons learned by pioneer organizations more broadly, so that the whole system can benefit from the knowledge gained through the initiatives of individual organizations.

Opportunities

As noted earlier, many industries have developed new methods for improving safety, reliability, quality, and value. These methods hold great promise. Encouraging and rewarding their application in health care organizations is an important task of governing bodies.

Furthermore, health care organizations have the opportunity to incorporate and promote learning throughout their governance structures, from governing boards to professional governance bodies. The professional governance bodies, such as a hospital’s medical committee, generally monitor clinical practice patterns and review professional standards, allowing for an opportunity to promote evidence-based practices and highlighting areas within the organization that achieve high performance. Other committees and governance structures in the organization have similar opportunities to encourage continuous improvement from all the organization’s employees.

Next Steps

To help achieve a learning health care system, governing bodies need to play the following roles:

• Embrace a culture of continuous improvement, with a focus on sharing and learning within and across systems.
• Set bold mission-driven aims for clinical, financial, service, and experience outcomes against a frank assessment of the current reality.
• Affirm the primary role of health care organizations in serving their communities by working to improve the care experience, population health, and the value of care.
• Establish vibrant collaboratives, with clear aims and expectations for improvement across the care continuum, connecting community, health care delivery, public health, regulatory, employer, insurer, education, and other key stakeholders.

THE CHALLENGE

Missed opportunities for better health care have real human and economic impacts. If the care in every state were of the quality delivered by the highest-performing state, an estimated 75,000 fewer deaths would have occurred across the country in 2005 (McCarthy et al., 2009; Schoenbaum et al., 2011). Current waste in health care diverts resources from productive uses—estimates suggest almost $750 billion in opportunity costs in 2009 that could be used for improving care on many dimensions (IOM, 2010). It is only through shared commitments, in alignment with a supportive policy environment, that the opportunities offered by science and information technology can be captured. The nation’s health and economic futures—best care at lower cost—depend on the ability to steward the evolution of a continuously learning health care system.

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