Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary (2009)

The third goal of the workshop was to consider suggestions and possibilities for cross-sector work. The process of developing background papers on the work and possibilities of each sector, as well as the workshop itself, brought together a wide variety of interests and voices. The papers of the sector groups—patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employers and employees, and individuals involved with information technology (IT)—provided important contextual information for workshop discussions. Key elements of those papers included an overview profile of each sector, a description of the key evidence-related activities within the purview of that sector, and a sample set of sectoral initiatives and priorities that could help transform health care. Finally, each sector was asked to suggest areas for possible collaboration and cooperation with other sectors. The key priorities identified by each sector were presented by sector representatives during the 2-day workshop.

In the course of the discussions at the workshop, sector participants identified pressing challenges in the development and application of evidence for use in health care from their unique perspectives. Substantial overlaps in priority activities emerged, as did specific areas in which the sectors were uncertain about how best to proceed. Importantly, however, participants agreed that the spirit of the sectoral strategies process as well as the nature of the workshop discussions was unique and refreshing. Few

platforms for cross-sector discussion exist, and participants considered the opportunity to meet in the neutral venue provided by the Roundtable on Evidence-Based Medicine important to accelerating improvement in the healthcare system. This chapter summarizes workshop discussion that focused on and highlighted the potential impact of collaborative work. What follows is not intended to be an exhaustive exploration of the subject matter, but rather a synopsis of what participants stated during the workshop including suggested opportunities for Roundtable action.

Several important considerations drive the sector participants’ interest in collaborative action. Clearly, collaboration is needed to accomplish what no single sector can achieve on its own. Furthermore, joining in common work offers the representatives of each sector a means to define common goals, set priorities for applying evidence to improve health care, and identify practical ways to move to action. Importantly, too, collaborative work holds the fundamental potential to expand basic knowledge and understanding of the use of evidence in medicine by collecting and distilling data from multiple practice settings and observational perspectives. Working jointly was also seen as a way for the sectors to help ensure that the limited resources available for evidence-based initiatives can be distributed equitably and cost-effectively. Moreover, in the spirit of the Roundtables, cross-sector cooperation can help ensure that all voices in health care are given a chance to contribute to and participate in transformational initiatives. Finally, working together was seen as a means to resolve the ill-founded misperceptions and stereotypes about other sectors. However, collaboration is more than just a tool. Indeed, for the scope of reforms that are needed across health care today, a mutual effort among sectors is nothing short of an imperative. Many reforms simply will not take place without input and buy-in from different stakeholder groups. A number of possible activities for multisectoral collaboration identified for Roundtable consideration during the workshop are discussed below.

An initial set of potential cooperative Roundtable projects focus on the articulation and, whenever possible, the establishment of agreement on commonly held values and principles related to evidence-based medicine (EBM), including the related tasks of setting standards and establishing a common language and terminology for EBM. Workshop participants refer-

enced agreement among the multiple sectors on fundamental assumptions and key elements of the value proposition in health care and on principles guiding the application and use of evidence as priorities for providing a foundation on which additional agreements can be built.

Because general agreement on the principles of EBM and common understanding of a basic language for EBM are essential for further reform, several workshop participants proposed additional discussions similar to those described here to foster a greater consensus on the standards to be used in EBM. Suggestions included collective work to design standards for the practice of EBM, product development and approval, patient care decisions, the collection and use of data, the implementation of studies, and the terminology used in the field of EBM and technology.

Cooperative work involving multiple sectors was noted as necessary for development of a common language through which various sectors can speak to each other productively about areas in which they have similar concerns. An example given was IT, in which there is a critical need for a common vocabulary and lexicon, including redundancy-reducing protocols for entering information into electronic health records and terms that can be widely recognized across platforms and applications.

Joint projects across sectors are also vital to improved thinking and practice about financial issues in evidence-based health care, particularly areas such as reimbursements and incentives. Collaborative dialogues will help establish principles governing how evidence is integrated into coverage decisions—for example, in cases that might include the denial of access to medicines or might promote the swift introduction of a new technology with evidence of superior benefit. Moreover, dialogues among the sectors will create a feedback loop that can better link evidence, performance, and results with reimbursement rates and the establishment of incentives. In turn, these conversations will drive appropriate cultural and procedural changes in the healthcare system. Cross-sector projects could foster agreement on processes for translating research into improved policies for coverage and provider payment.

Agreement on basic principles, standards, and language was noted by many as having a cumulative effect, fostering an environment of openness and transparency across the healthcare system. Collaboration among sectors could bring heightened transparency to the judging of evidence in the process of making medical policy decisions. Similarly, the collaborative process could bring welcome transparency and enhanced trust in considerations of coverage and payment policies. Cross-sector collaborations could result in greater access to databases, storehouses of medical knowledge, guidelines for evidence-based practice, information about decision support systems, comparative performance statistics, and other important data. Such open cooperation among sectors will facilitate

the development of better quality and efficiency measurements, standards, and guidelines for EBM.

Initial Roundtable collaborative efforts could focus on developing, clarifying, and articulating a shared vision of how evidence can best be brought to bear to improve health care. As has been noted, many participants supported the development of a national problem list and an inventory of best practices as priority areas for action. Many also believed that a shared vision would be further defined and inculcated through the establishment of an independent body for consideration of comparative effectiveness that engages all stakeholders in the development of more transparent and consistent approaches to judging evidence, especially in the context of decision making regarding medical policy, and provision of a neutral venue in which controversial issues can be resolved.

In addition to a coordinating entity, the development of capacity related to data and research methods might also be an important focus. Joint work among the sectors could perhaps expand the sources of data from which evidence is derived to draw data more directly from practice settings and other sources of observational data. A research-focused collaboration might work to implement studies designed to investigate systems changes or behavioral approaches that can be used to improve the translation of evidence-based guidelines into clinical practice or to look at the effectiveness of understudied interventions.

Research is also needed on innovative approaches to encourage the broader use of evidence-supported healthcare decision making among physicians, perhaps with links to outcomes evaluations. Cross-sector projects fostered by Roundtable members might provide an opportunity for controversial or highly innovative research to be discussed and conducted safely. Similarly, it was felt that such collaborations might provide a means to focus attention on research-oriented questions that no one sector can address effectively on its own, such as the development of evidence-based guidelines for patients with complex medical challenges (e.g., multisystem diseases).

As a specific example, the representative from the regulatory sector spoke to an interest in working with other members of the healthcare community to enhance the ability to identify problems with medical products and disseminate information as quickly as possible. Agencies within the U.S. Departments of Health and Human Services, Defense, and Veterans Affairs, for example, have begun to explore the feasibility of creating a distributed, electronic, national medical product safety initiative. Such a sentinel network would help make information about the safe and effective use of medical products accessible to patients and healthcare professionals

in a timely and efficient fashion. The network would be assembled through public–private collaborations and would connect to existing efforts rather than require the creation of a new system.

Broad collaboration among sectors is also vital for success in building a stronger IT infrastructure in health care and warrants more attention by the Roundtable in the view of many participants. Workshop participants emphasized stronger practice support systems for healthcare professionals and for the rapid design of an interoperable technology that enables providers to have ready access to the variety of information available across the healthcare system. Participants specifically noted the need for cross-sector support for broader access to electronic health records, particularly to help smaller healthcare practices adapt the systems and processes that larger practices now use.

Collaboration was noted as essential to the development of new tools, products, and methodologies driven by IT. The potential of IT to advance the goals of linking evidence more definitively and broadly with health care can hardly be overstated. Collaborative input from multiple sectors in work to build, improve, and share IT-based tools—including electronic health records, registries, and interoperable systems—will ensure that these tools can support the specific needs of all sectors. Contributions from many sectors, for example, might also result in the kind of innovation needed to develop a new format for technology appraisals that allows the integration of ratings of clinical and cost-effectiveness in ways that can support value-based insurance benefits and guide patient and clinician decision making toward higher value.

Productive new thinking about IT-based ways to share information expeditiously throughout the healthcare system, such as procedures for sharing alerts about medications, is also seen as critical to the development of IT-based tools to assess quality in health care. An IT-focused collaborative could serve as an effective channel for the distribution of models of good practices. In addition, cross-sector work in IT could improve the patient experience through the use of such applications as personal health records that promote patient safety, systems that give patients better access to their own records, processes that improve the security and privacy of patient records, and procedures that reduce duplicative efforts and result in cost savings. Cooperation among sectors is also critical to the development of the next generation of IT tools, whose capacities are not yet known.

Input from a wide variety of sectors mobilized by Roundtable members might help ensure that evidence-based tools and products for healthcare consumers are straightforward, are easy to use, and fully meet the needs of

the end users. Such tools could help consumers weigh the risks and benefits of various treatment options and explain the evidence behind coverage decisions. Specific target groups could include retirees, frequent users of health care, and those with limited English proficiency or health literacy. Similarly, conversations among sectors could lead to the development of new methodologies—perhaps supporting large population studies that use electronic health records—and the collective exploration of their benefits.

The central importance of healthcare providers in driving the adoption of evidence-based practice was underscored by the range of opportunities identified for collaboration—within the healthcare provider sector and between that and other sectors—around issues important to all healthcare professions. Primary among these was possible convening by the Roundtable of professional organizations to discuss issues such as the transformation of healthcare professions education to one that emphasizes just-in-time and lifelong learning, as well as approaches to credentialing that better support evidence-based practice. Other areas mentioned for collaborative work included initiatives to improve the development of comparative effectiveness information, practice workflow efficiency, and decision support systems as well as initiatives to promote shared decision making.

A primary opportunity underscored by several participants to support and engage healthcare providers is through the development of better information to help guide clinical decision making. Research on the comparative risks and benefits of competing interventions would benefit from collective work among researchers, clinicians, and healthcare professionals to identify research questions, research priorities, and opportunities to draw research closer to the clinical practice environment. Also, there are opportunities to speed the development of information about clinical best practices as well as the clinical decision support systems needed to accelerate the adoption and use of such information.

Workshop participants viewed the patient-provider relationship as paramount in health care and suggested that improving and supporting productive communication at the point of care would provide opportunities to improve the delivery of appropriate care. Work is needed to improve understanding of how information is best communicated to patients and clinicians as well as how best to support their engagement in shared decision making.

Collaboration also sets the stage for sectors to work together to support a stronger national presence of EBM. Virtually all commenters believed

that the sectoral strategies process provided an important starting point for progress and that participants should work within and between sectors to expand the sphere of cross-sector involvement and action on the opportunities identified.

Several participants discussed the possible impact of a multisector effort to design and implement a national strategy to educate important audiences, ranging from opinion leaders and policy makers to the general public, about what EBM is, what its goals are, and why it is important. Research might explore the need for better communication about EBM, perhaps by prioritizing the questions to be addressed or suggesting strategies that can be used to appropriately educate select audiences. Work already under way was described that engages multiple sectors in developing refined methods of communicating evidence to consumers both to educate them about health care informed by evidence and to assist them with decision making. Such efforts might focus on ways to better educate patients to manage their own care, such as the development of training programs to help them find accurate information about medications. Education programs could also be targeted to physicians and other healthcare providers to better educate them about the value of evidence-based decision making and to influence clinical behaviors so that providers consider the evidence more broadly. Another appropriate use of collaborative education would be public information and education strategies that pique the public’s demand for evidence-supported health care.

Cross-sector collaboration is seen as an appropriate means of designing and implementing public information outreach programs and marketing campaigns. As part of such efforts, the sectors would work together to increase media understanding of EBM and their level of attention to the application of evidence in medicine. One sector cited an example of a current multistakeholder collaborative, the Alliance for Better Health Care, which promotes comparative effectiveness research and its dissemination through advocacy. Its goals include increased federal funding for comparative effectiveness research; the identification of knowledge gaps and the prioritization of areas for further research; and the broad dissemination of research findings to clinicians, patients, and others in formats that diverse audiences can understand.

If collaboration is an important tool in educating the public about the use of evidence in health care, it is also necessary for ensuring that individuals better engage the use of evidence in clinical care. In this regard, cross-sector partnerships will be necessary to balance evidence in health care with such factors as the effects of demographics, genomics, patient preferences, and family history. Such joint projects might advocate the concept of using observational patient data as evidence, encourage the development of patient materials to support consumer adoption of EBM concepts

and practices, and support the development of robust methods that would allow the inclusion of patient values and preferences in complex decision making. A related dimension would focus on the generation of broad-based evidence of the safety and efficacy of procedures or products in controlled populations and the generation of evidence with a high degree of relevance to individual patients and specific patient subgroups. Another aspect would center on understanding the proper role of evidence in healthcare decisions in terms of patient care versus, for example, policy or reimbursements.

Overall, the spirit conveyed at the workshop was of a sense of opportunities for a variety of sectors to work together productively to link evidence and the practice of health care, and the important facilitative role that the Roundtable can play in this effort. Although participants recognized that collaboration implies a certain amount of give and take and that countless barriers might hinder such work, truly important innovations are within reach, and now is the time for sectors to join together to advance policies and practices to ensure that evidence is applied more broadly, more consistently, and more effectively to all decisions in health care.

Comments offered at the workshop’s conclusion summarized and emphasized the pressing and well-established concerns common to all sectors, particularly the following:

• Rising costs and limited resources. Whether they are borne by those receiving or providing care or accrued during research on or the development of treatments and therapies, participants cited costs as limiting factors for access to and innovation in health care.

• System inefficiencies. The quality of health care in the United States is uneven and delivered by a system characterized by inefficiency and waste. The existing evidence is poorly applied, and the delivery of care for similar conditions varies widely throughout the country. Standards for care, healthcare system components, and even research are often inconsistent.

• Increasing complexity. Whether it is because of the increased importance of genetic variation, the rapidly evolving landscape of medical technologies, or the growing prevalence of chronic disease, medicine is becoming increasingly complex.

• Expanding evidence gap. Across the practice of health care, information is lacking for many key personal health or policy decisions. The “inference gap” between the evidence available and that needed to treat real-world populations will only widen as new

interventions are introduced into the marketplace and health care moves further in the direction of personalized treatments.

• Limited system capacity and flexibility. The number of questions that need to be addressed to ensure appropriate care continues to expand exponentially, rendering impractical the current approach to the development of evidence. Although randomized controlled trials are important in certain circumstances, they cannot provide all the necessary information. The availability of technologies lags the demand. Whether through habit or for other reasons, evidence is not getting translated to the extent that it needs to be or distributed as widely as it should be.

• Entrenched cultures. Health care has various customs and practices that often are not conducive to reform. Caregiving and caregivers are often “siloed,” with inadequate communications among the various functional areas of the healthcare system. Information is not shared as widely as it should be within specific healthcare systems, let alone between systems, contributing to inefficiency and distrust in the system. In general, providers, patients, and other sectors do not yet believe that the development of evidence is an activity relevant to their experience in the routine delivery of care.

In addition, participants revisited a number of the common themes that recurred throughout discussions on key advances and issues, on which stakeholders could work together (Box 4-1).

• Build trust and collaboration. How can the distrust that has emerged in health care—for example, distrust between and among patients and providers, providers and insurers, insurers and manufacturers, and manufacturers and regulators—be reduced? Health care depends for its effectiveness on the close cooperation of all parties involved. Building trust and facilitating transformative change will require broader-based collaboration and cooperative stakeholder engagement.

• Foster agreement on “value” in health care. What constitutes value in health care: reduced death or disease, better function, less pain, a better sense of well-being, fewer hospital days, or lower costs? Although all participants agreed on the centrality and importance of the value achieved from health care, different groups think of value in different ways. A multistakeholder effort is needed to drive clarity and consensus on the principles and elements of value common to all stakeholders.

• Improve public understanding of evidence. What can be done to improve public understanding, acceptance, and demand for

evidence-based care? Too often, people perceive that certain common terms such as “evidence based,” “research,” “medical necessity,” and “risk” suggest a restrictive or experimental element to their care. A systematic and coordinated communication strategy is needed to better convey the central concepts that medical evidence is dynamic, that evidence-based medicine is the provision of care that the evidence suggests is best for any given patient at any given point in time, and that health care is a joint patient-provider endeavor.

• Characterize the impact of shortfalls in the evidence. What might be the tangible impact of broad improvements in the availability and application of appropriate evidence for healthcare decisions for patients, for providers, and for society? Documenting the consequences of provision of care on the basis of too little evidence or the potential benefits of providing care on the basis of the right evidence is a prerequisite to obtaining an improved understanding of and demand for evidence-based care and stakeholder activation.

• Identify the priorities for evidence development. Which medical care dilemmas represent the most challenging and pressing needs for better comparative information and guidance for choices among the available and the emerging diagnostic and treatment options? The first step to a systematic and coordinated effort to conduct the

most important assessments is identification of the priorities as a sort of consensus national problem list and research agenda of the most pressing issues for medical care decisions.

• Improve the level, quality, and efficiency of research. How can the healthcare system take better advantage of emerging clinical record resources to gain insights into the evidence? Policies that facilitate the ability to use clinical data to monitor the effectiveness of interventions are needed. Novel approaches to the conduct of clinical trials are also needed. A more structured lexicon for “best practices” in undertaking observational studies may be necessary.

• Clarify and promote transparency. What principles define openness in health care, clinical research, the interpretation of evidence, coverage decisions, regulatory policy, marketing practices, oversight, and the governance of use of clinical data? Consensus is needed to establish common principles of transparency and standards for how they should be applied in each sector. One starting point might be with principles for evidence interpretation.

• Establish principles for the interpretation and use of evidence. What guiding principles related to application of the available evidence might be used to help decision makers determine when they should apply a proposed diagnostic or treatment intervention? Decisions about market approval, insurance coverage, provider use, and patient acceptance are all informed by some interpretation of the evidence. Clarity on the guiding principles is important.

• Improve engagement in the full life cycle of interventions. How should assessments and decisions on proposed healthcare services be tailored to ensure that each stage of the development and application process for a given intervention builds efficiently to the next? Many factors are at play for each intervention—for example, similarity to previously tested interventions, the safety and effectiveness of an intervention for some populations but not others, the availability of biomarkers that are predictive of efficacy, and costs that vary by scale and stage of application or by the need for later services. Facilitating innovation, access, and effective information gathering while emphasizing patient safety, appropriate application, improved outcomes, and efficiency will require a set of life cycle-oriented decision-making rules that are more carefully considered than they are at present.

• Focus on frontline providers. What are the key levers that might help ensure that both primary care and specialty providers are taking full and appropriate advantage of the best available evidence in the care that they provide? Accelerating the translation of clinical research into practice involves addressing matters of

professional education, credentialing, licensure, practice support, economic incentives, patient acceptance, and the culture of care. It will require the central and coordinated involvement of the organizations that represent those providers.

• Foster a trusted intermediary for evidence. How can patients, providers, healthcare organizations, employers, insurers, and others know when they have the best evidence on which to base the healthcare decisions they make? In this information age, health-related information is constantly presented through news reports, marketing, professional organizations, journals, and the Internet; but it is often confusing and even contradictory. A trusted information source—one that is independent but that engages all stakeholders—is needed to identify gaps; set priorities; establish standards; and guide the development, interpretation, and dissemination of evidence on clinical effectiveness.

• Build the capacity to meet the demand. What mechanism is necessary to close the current and emerging gaps in evidence on the relative effectiveness of various interventions, to ensure the quality and integrity of the studies used to establish the evidence, and to provide a sustained capacity to meet the need? Currently, the combined resources of the various public and private organizations involved in studying comparative clinical effectiveness meet but a small and scattered fraction of the demand. The centrality of the problem to the quality and efficiency—the viability, according to some—of the nation’s healthcare system may require the creation of a new independent entity devoted to this work.

• Create incentives for change. What practice-based economic and policy incentives might help enhance the next generation of new evidence and transform the ability and commitment of providers to use the best available evidence and more fully engage patients in the clinical decision-making process? Approaches include alignment of purchasing incentives accordingly when value is determined; use of the reimbursement power of insurers and other financial incentives to generate new insights from medical care (e.g., coverage with evidence development); and the linkage of purchaser and payer decisions to performance incentives for best practices, outcomes, and the better secondary use of routinely collected data.

• Accelerate advances in health information technology. What can stakeholders do to accelerate the nation’s progress toward the goal of the universal application of interoperable—or functionally accessible—personal and organizational electronic health records, as well as toward the goal of providing real-time electronic access

to the best information available? Health information technology can facilitate the development of learning networks and accelerate the generation of evidence, enable data aggregation and utilization, deliver evidence to the point of care, and expand research capacities. Coordinated stakeholder action—and financial incentives—should be able to speed the progress necessary on both basic interoperability issues (e.g., standards and vocabulary) and, possibly, the development of more radical data search innovations.

Finally, in reflecting on priority next steps for Roundtable consideration, a number of opportunities were mentioned, including the following:

• Development of a priority assessment inventory. Termed a “national problem list” by meeting participants, this is a multisector collaborative effort to develop criteria and a list of the diagnostic and treatment interventions that might be viewed as particularly important for the development of comparative effectiveness studies. The list will serve as a means of illustrating and prompting discussion on the key evidence gaps and on the design, support, and execution of the studies needed.

• Pursue agreement on the value proposition. Identify key concepts and elements to be considered in assessing and characterizing value from health care, setting the stage for discussions on approaches to assessing those elements and applying to add perspective and inform decision making. An IOM workshop, Value in Healthcare: Accounting for Cost, Quality, Safety, Outcomes and Innovation, was convened in November 2008, with publication of the workshop summary expected in 2009.

• Identify common principles for evidence interpretation and use. Identify the core principles underpinning activities in interpretation and use of evidence, as background for discussion of the implications and of the ways the principles might be applied in the development of a framework adaptive to different circumstances related either to the evidence base or the condition of interest.

• Foster cooperative data sharing. Several issues are important in this regard: platform compatibilities, standards, economic incentives and disincentives, the regulatory and privacy environment. Health Insurance Portability and Accountability Act issues are being addressed by an IOM Committee expected to issue its report and recommendations in 2009, including those related to the use of clinical data for knowledge development. The Roundtable’s February 2008 meeting, Clinical Data as the Basic Staple of Healthcare

Learning: Creating and Protecting a Public Good, addressed a number of the other issues related to sound data stewardship. And collaborative work has been sponsored by the Roundtable on mining electronic health records for postmarket surveillance and clinical safety and effectiveness insights.

• Pursue a public communication initiative on evidence-based medicine. Use the Roundtable membership’s collective communication expertise to explore improving terminology and advancing public awareness on the nature and importance of evidence in medical care, the key needs, and the centrality of patient and provider communication around the state of the evolving evidence for individual treatment choices. The Roundtable’s Evidence Communication Collaborative has a working group actively working on a communication initiative proposal.

• Support progress on a trusted intermediary for evidence promotion. The Roundtable’s Sustainable Capacity working group oversaw the development of a comprehensive Issue Brief, framing the issues and options under discussion related to enhancement of the national capacity to develop, evaluate, organize, validate, and disseminate information on the comparative effectiveness of health interventions. Technical assistance and related information is provided on an ongoing basis to the various policy discussions of the issue.

• Identify the potential from best practices in the use of evidence. It is important to assess and underscore the best practices in evidence development and application, including consideration of ongoing methods of identifying and disseminating those best practices. A working group is underway to characterize the potential returns from implementing certain established best practices.

• Enlist front-line healthcare providers more effectively. Charge the sectoral working group on providers with proposing approaches to convening a coalition of provider groups, perhaps under Roundtable auspices, to consider sustained, coordinated work on health professions education, testing, credentialing, and practice setting tools and structure to improve focus, accessibility, use, and generation by providers of the best evidence. A Roundtable collaborative of providers is being formed to engage this issue.

The issues and questions heard throughout the workshop explicitly underscored the importance of the unique approach of the Roundtable’s activities: convening disparate stakeholders and sectors to engage in issues about which they have common concerns but, as yet, little collective

vision or will to drive the changes needed. Participants noted frequently the sense of the opportunity presented by the sectoral strategies process and were encouraged to expand the sphere of engagement of each of their sectors in the priority issues and initiatives. Real prospect exists for moving forward on common ground, but it will take diligence, commitment, and leadership.

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