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to improve research. Patient-initiated data collection initiatives, including social­ networking and information sharing services, have provided important resources for discovery and played a role in better informing patients and investing them in the research enterprise. James Conway of the Institute for Healthcare Improvement explores the potential for greater patient and public engagement to improve health system performance, noting the growing evidence base of how patient engagement could improve a wide array of health and system outcomes, from patient adherence, to clinical outcomes, to financial performance. He proposes a framework to better connect and align the interventions currently under way and encourage and support the development of effective public engagement initiatives. A third paper, by Karen Sepucha of Massachusetts General Hospital, addresses opportunities to better engage patients in treatment decisions through more effective patient–provider communication about patient concerns, expectations, and preferences in order to make shared decision making a routine part of the clinical care encounter.

INVESTING PATIENTS IN THE RESEARCH AND

CONTINUOUS IMPROVEMENT ENTERPRISE

Sharon F. Terry, M.A.

Genetic Alliance

At the center of a learning health system are individuals, families, and communities. As all citizens are eventually members of this stakeholder group, an effective healthcare system must keep this group’s interests paramount. The learning touted as part of the exemplary system must fuel action to transform health care to better serve the needs and interests of individuals, families, and communities, and in essence be accountable and self-correcting. A key component of such a system is a culture that promotes and supports public interest and investment in helping to advance the research enterprise. Although public engagement in health care is often viewed from the narrow perspective of participation in clinical trials, many initiatives currently under way create a very different vision for the range of contributions individuals, families, and communities can make to improve research efforts on the value, science base, and patient experience of health care delivered—from information for basic research to efforts to drive improvements to best practices.

This paper reviews trends in public awareness of and interest in opportunities to contribute to learning about what works in health care, such as improving access to and expanding the use of clinical data, and provides examples of initiatives aimed at supporting patients in these roles. Key lessons learned from current efforts to improve public understanding of the issues

involved and encourage patient contributions to learning in health care are identified, as well as communication strategies that move beyond diseasecentric approaches to increase receptivity and insistence by the public with respect to their engagement and investment in the research enterprise.

A Learning Health System

Individuals, families, and communities, while serving as the primary focus of a learning health system, interact with the system in different ways. Collectively, however, these stakeholders value a system that focuses on prevention and wellness, proper diagnosis, and individualized care. An ideal system therefore requires an intelligent blend of savvy stewards and systems that advance the public’s health on the one hand, and on the other, consumer-initiated and/or consumer-driven tools and resources that aggregate and analyze clinical and other health information over time to help enhance understanding of health and disease.

Progress toward this ideal system requires expanding the current concept of a healthcare system to include promoting health, not simply addressing disease. A robust healthcare system must not only include prevention (Frieden, 2010); it must focus on prevention and wellness if the greatest improvements in both health and the system that serves it are to be realized.

Further, the current healthcare system expends a great deal of resources on treatment and not enough on diagnosis, the highest priority for health care according to innovator Clayton Christensen (Christensen et al., 2008; Frieden, 2010). Diagnosis lends a critical granularity to the treatment process, allowing the individualized medicine in which the public is so interested. Although a great deal of attention is given to genetics and genomics as the backbone of personalized or individualized medicine, it is probably more accurate to assume that all of medicine, properly executed, should be individualized, with genetic and genomic information integrated into the individualized plan. The impact will be felt by the diagnosed; the not yet diagnosed,­ which might be termed the general public; and the public’s health.

Finally, although not an issue at the forefront of public attention, the system needs to be oriented around learning and continuous improvement, or progress toward more efficient and effective health services will continue to be dismally slow.

Beyond Trial Participation:

Enabling Consumer Contributions to Learning and Research

While recognizing the importance of the perspectives of the other system stakeholders, this paper focuses only on the consumer perspective.

elasticum (PXE). PXE International advised a large number of other diseasespecific organizations and determined that the community would be better served with a cost-effective, shared common infrastructure. The community using the BioBank—a number of large and small common and rare disease– specific organizations—brings donors closer to the research enterprise they wish to impact. Researchers using the BioBank can solicit clinical information over time and as needs emerge by making requests to disease-specific organizations (for example, the National Psoriasis Foundation, the Inflammatory Breast Cancer Research Foundation, the Chronic Fatigue and Immune Dysfunction Syndrome Association of America). Thus the gap between research and those waiting for treatment is narrowed. Members of the disease community drive the research through understanding of the day-to-day issues of living with the condition.

Consumer Health Information Systems

Private Access enables individuals to establish granular privacy settings for clinical information that, when properly catalogued, allows researchers to find individuals for specific cohorts. This technology allows individuals to grant “private access” to all or selected portions of their information and thereby determine the information flow with which they are comfortable, mitigating privacy concerns (Lo and Parham, 2010). The controls can be granular down to the data element if desired, enabling individuals to decide whether their genetic, mental health, or any other information they deem sensitive should be shared and if so, with whom. Moreover, the controls are dynamic—anticipating that users will wish to change their settings as their circumstances change and as different needs arise or levels of trust are established. From simple scenarios such as releasing one’s child’s immunization record to a summer camp to making one’s clinical information searchable by selected researchers, this online system provides an important service. It includes a comprehensive audit log and tracking, all consistent with emerging health information technology standards for the coming years. Trusted guides in this system help users establish privacy preferences, which can be difficult to navigate depending on the user’s literacy level.

The healthcare system in the United States (and often abroad as well) can be paternalistic. A highly hierarchical system, with “expert” gate­ keepers in the form of physicians, limits the learning that can be accomplished by the system. A system in which all stakeholders play a role and in which consumers are offered the opportunity to help drive learning is much more nimble. The current healthcare system does not allow the kind of consumer engagement needed for a learning health system. Therefore, it is critical to understand how to better guide people to become empowered and informed consumers.

could be an important catalyst for increasing the learning of the health system in a more dynamic way. In addition, direct-access testing accelerates the examination of social issues and policies around genetic testing and technologies and their delivery.

In considering a learning health system, it is important to include public health. The newborn screening system, probably the nation’s most successful public health program, is an excellent program in which the sharing of information could serve to engage the public in the healthcare system. Most parents do not even know that their child has been screened or that their state has stored the child’s dried residual blood spot. The results have ranged from distrust to lawsuits and destruction of these blood spots. If parents participated in the decision to store blood spots and further, using a dynamic electronic consenting system, consented to levels of use for them, this currently invisible system would enjoy greater support. Integration of the newborns’ screening results with the dried blood spots, dynamic consent for use, and electronic and personal health records can constitute an important learning system for health in the United States. Almost 5 million babies are screened each year, representing 99 percent of the nation’s newborns, so this accomplishment would serve as the basis for a national clinical registry and biological repository system. Efforts such as those of the Genetic Services Branch of the Health Resources and Services Administration and Genetic Alliance’s Newborn Screening Clearinghouse give parents and providers ways of interacting with the system so it can learn from the engagement.

Another federally funded effort, the Genetics for Early Disease Detection and Intervention to Improve Health Outcomes (GEDDI) program of the Centers for Disease Control and Prevention, is also capturing learning in the system to accelerate the usefulness of genomic applications. Understanding that there is far too much information for any clinician to digest in making decisions about the use of genetic and genomic tests, GEDDI is building a knowledge base and using the public participation tool Google Knol to create a body of expert-moderated knowledge that will allow correlations to be drawn and affirmed more quickly than is typical in more traditional models. Ultimately the program is asking when and where genetics can be used for early detection, and answering this question will require consumer participation in the process of understanding what brings value not only for the individual, but also for communities and ultimately the public’s health on a large scale.

Concluding Observations

The activities described in this paper reveal that there is a long way to go in developing the policies necessary to encourage and support patients

becoming invested in the research and continuous improvement enterprise of a learning health system. However, they also indicate an increasing interest among the general public in participating in health care—rather than just being spectators, and given the acceleration of consumer-driven advances in other fields—such as the computer industry, health care will accelerate its learning with increased consumer participation. Indeed, data from the Genetics and Public Policy Center indicate that individuals would like to participate in large data collection efforts in the United States and would like to receive individual results (Kaufman et al., 2008). When individuals in these surveys and town halls were asked whether they would participate if they did not receive individual results, 75 percent said they would be less likely to participate. Regardless of one’s opinion on sharing results, such data indicate that the public would like to participate and learn.

A learning health system is not just a laudable goal but is essential for the health of the nation. At present, we are dependent on antiquated systems that rely on hierarchical gatekeeping. Phenomenal advances have been made in many areas of technology that can support social services. Health care lags behind other domains in its ability to capitalize on the learning available to it. Ultimately, the problem may lie in “knowledge turns,” a term to describe “how well we transform raw ideas into finished products and services” (Savage, 2010). Knowledge turn rates describe many kinds of transactions in this information age. Disruptive insertion of consumers into the equation will ultimately generate faster knowledge turns and accelerate the learning of the health system.

PUBLIC AND PATIENT STRATEGIES TO IMPROVE

HEALTH SYSTEM PERFORMANCE

James B. Conway, M.S., M.A. Institute for Healthcare Improvement

The charter of the IOM Roundtable on Value & Science-Driven Health Care underscores the centrality of the patient. The summary of the Learning Healthcare System workshop refers to both the need for a culture of shared responsibility that includes patients, providers, and researchers and the need for improved communication around the nature of public engagement (IOM, 2007). Widespread federal, state, public, and private position and policy statements, as well as those from healthcare industry leaders, speak to the importance of engagement of the patient, family, public, and community (Berwick, 2009). Excitement about public engagement grows daily, driven as much by financial constraints as by the synergy of engagement and improvements in population health and the healthcare experience. This excitement is being fueled by early successes in communities, organizations,