6


Moving Forward

INTRODUCTION

Expanded capacity to develop and apply insights from comparative effectiveness research (CER) is central to providing better information for healthcare decisions of patients and their caregivers, understanding how to appropriately tailor care of individual patients, and ensuring greater overall value of health care delivered. The wide range of challenges and needs—with respect to the work, information and data networks, and workforce required for CER—discussed at the workshop helped identify some initial priorities for immediate action. The pace of progress depends on aligning incentives, encouraging needed culture change, and developing tools to better support both the generation of insights from care through CER and the seamless application of findings in clinical decision making.

Given the large scope and scale of transformation needed, moving forward will require a long-term strategy that prioritizes and sequences needs, engages all stakeholders, and builds sustained, cross-sector support. The final session of the workshop featured discussion of key elements of a roadmap, quick hits, and opportunities to build support. This chapter includes a synthesis of this session’s discussion, as well as an overview of the workshop’s common themes and possible follow-up actions to be considered for ongoing multistakeholder involvement through the Institute of Medicine (IOM) Roundtable on Value & Science-Driven Health Care.



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6 Moving Forward INTRODUCTION Expanded capacity to develop and apply insights from comparative effectiveness research (CER) is central to providing better information for healthcare decisions of patients and their caregivers, understanding how to appropriately tailor care of individual patients, and ensuring greater overall value of health care delivered. The wide range of challenges and needs— with respect to the work, information and data networks, and workforce required for CER—discussed at the workshop helped identify some initial priorities for immediate action. The pace of progress depends on aligning incentives, encouraging needed culture change, and developing tools to bet- ter support both the generation of insights from care through CER and the seamless application of findings in clinical decision making. Given the large scope and scale of transformation needed, moving forward will require a long-term strategy that prioritizes and sequences needs, engages all stakeholders, and builds sustained, cross-sector support. The final session of the workshop featured discussion of key elements of a roadmap, quick hits, and opportunities to build support. This chapter includes a synthesis of this session’s discussion, as well as an overview of the workshop’s common themes and possible follow-up actions to be con- sidered for ongoing multistakeholder involvement through the Institute of Medicine (IOM) Roundtable on Value & Science-Driven Health Care. 

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 LEARNING WHAT WORKS THE ROADMAP—POLICIES, PRIORITIES, STRATEGIES, AND SEQUENCING Maximizing the returns on the considerable investment of time, human resources, and money inherent to expanding CER capacity will require an understanding of the broad range of policy needs, how existing resources might be best deployed, and a sense for how quickly various elements can be taken to the scale needed. Stuart Guterman, senior program director for the Commonwealth Fund’s Program on Medicare’s Future, outlines six broad policy areas in need of consideration: data, methods, workforce, organization, translation, and financing. Guterman noted that a roadmap for progress would identify clear end goals for each area, priority needs within and between categories, and key actors or existing infrastructure that could help initiate the activities needed. The following summarizes key points from workshop discussions to provide a starting point. ata. Capacity is needed to produce data relevant to healthcare D • decision making by providers, patients, payers, and policy makers; to ensure that the value of data is maximized by integrating these data and establishing sustainable system linkages; and to develop systems that make data and information available to appropriate users when, where, and how they are needed. While these data exist to some extent, attention needs to be focused on current gaps and how emerging health information technologies (HITs) might be applied to meet new data needs. As electronic health record (EHR) capacity is adopted across the nation, the focus should be on ensuring their usefulness—beyond billing and administration— for research and decision support. For existing resources, work to integrate and link disparate data sources and develop standards will provide an important foundation for progress, but enhanced data sharing among stakeholders will require attention to privacy and data stewardship issues. ethods. Research approaches are needed that meet the needs of M • CER end users by providing timely information that is relevant to real-world patients and decisions faced at the point of care. Prior- ity needs include a better understanding of current methods most useful for particular questions, the development of methodological standards for these approaches, and investment to accelerate new innovative methods that enable real-time analysis and learning. Infrastructure to support methods development and to streamline the conduct of clinical research will help accelerate this work. ersonnel development. A cadre of professionals is needed—from P • across healthcare sectors—dedicated to and trained in the use of

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 MOVING FORWARD tools and techniques for developing and applying comparative effectiveness information. Current training and education programs need to be reevaluated on how they might be best aligned with the workforce needs of CER, and investment could be targeted to orga- nizations and investigators that foster the type of multidisciplinary and translational activities characteristic of CER. Clarification of the scope and anticipated scale of research needs will help guide resource use. rganization. Prioritization and coordination across the many O • organizations engaged in various aspects of evidence development— primary research, synthesis, and translation—will enable more effi- cient production of needed information. Assessment of capacities that would most benefit from centralized coordination is para- mount, as is the exploration of the governance and funding struc- tures that might facilitate greater public–private collaboration around issues of common concern. ranslation. Additional focus is needed to ensure evidence is applied T • in healthcare decision making. A focus on processes, tools, and related capacities that ensures the broader application of evidence in clinical decision making might begin with an immediate focus on guidelines development processes. Also suggested are efforts to bring research closer to the practice environment and enable learn- ing in the postmarket environment. inancing. Sufficient and sustained funding will be needed to estab- F • lish and support CER and its application as an integral part of the U.S. healthcare system. While funding mechanisms will depend in part upon the nature of any entity charged with this work, imme- diate attention can be focused on other funding mechanisms, such as incentives and grants, that might be better structured to support advances in the development and application of comparative effec- tiveness information. Comments by three respondents highlighted specific opportunities. Elaine Collier, assistant director for clinical research at the National Cen- ter for Research Resources, suggested that the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) program could play a role in expanded CER by virtue of its fundamental focus on infra- structure development targeting a variety of areas: using informatics to advance research; engaging physicians, patients, and other stakeholders in developing a better understanding of how advances in health care are made; training the next generation of investigators and supporting profes- sional development; transforming processes and making them more effec- tive across institutions; and emphasizing rigor and quality of studies in

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 LEARNING WHAT WORKS study design, biostatistics, and clinical research ethics. The CTSA program could help foster the development of transformational strategies locally at individual institutions as well as help disseminate these successful strategies at a national level. Jane Horvath, senior director for global public policy at Merck, sug- gested giving attention to ensuring adequate support for the many infra- structure needs identified. The development of a national electronic data system for health care, for example, requires the development of a sound business model and funding through private channels or consensus on such a resource as a social good to be supported largely by public funds. Device and pharmaceutical manufacturers can contribute to CER and help to fill evidence gaps, but emphasis is also needed on supporting the innovation these companies bring to the system. Changes in public policies, such as patent law, licensure, and Stark regulations, might help to support CER by stimulating premarket research and the generation of more data prior to a product being licensed. Bruce H. Hamory, executive vice president and chief medical officer emeritus at Geisinger Health System, suggested that guidelines are needed that better ensure that evidence development results in lowered costs and better health care in the real world. Existing registries for cardiovascular disease were cited as resources that truly inform patient decision making, and Hamory emphasized the central importance of resolving data gover- nance and privacy regulation issues to facilitate the development of similar resources. Other priorities from his perspective included the development of new models for information sharing, infrastructure for CER-related train- ing, accelerated translation of studies into evidence, and models of financing tied to patient benefits and cost reductions. COMMON THEMES IN WORKSHOP DISCUSSIONS Common themes reoccurring in the 2 days of discussion are summa- rized in Box 6-1, and elaborated in the text that follows: C are that is effective and efficient stems from the integrity of the • infrastructure for learning. The number of medical diagnostics and treatments available to patients and caregivers is increasing, but the knowledge about their effectiveness—in particular, their compara- tive effectiveness—is not keeping pace. This is in part a function of the rate of change, but it is also a product of capacity that is both underdeveloped and, as several participants noted, substantially fragmented, which leads to gaps, inefficiencies, and inconsistencies in the work. The accelerating rate of change in the interventions requiring effectiveness assessment compels a substantial shoring up

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9 MOVING FORWARD in the level of effort, the nature of the effort, and the coordination of the effort in order to produce the necessary insights into the right care for different people under different circumstances. C oordinating work and ensuring standards are key components of • the evidence infrastructure. Several presentations highlighted the point that substantial activity is currently under way in effective- ness research, including work on comparative effectiveness, but the activities are fragmented and often redundant in both struc- ture and function. The fact that the application of evidence lags behind its production is in part a function of the disparate and “siloed” approaches between and within organizations seeking and developing information. The notions of infrastructure for evi- dence development therefore also include the capacity for greater coordination in the setting of study priorities; the development of BOX 6-1 Infrastructure Required for Comparative Effectiveness Research: Common Themes • are that is effective and efficient stems from the integrity of the in- C frastructure for learning. • oordinating work and ensuring standards are key components of the C evidence infrastructure. • earning about effectiveness must continue beyond the transition from L testing to practice. • imely and dynamic evidence of clinical effectiveness requires bridg- T ing research and practice. • urrent infrastructure planning must build to future needs and C opportunities. • eeping pace with technological innovation compels more than a K head-to-head and time-to-time focus. • eal-time learning depends on health information technology R investment. • eveloping and applying tools that foster real-time data analysis is an D important element. • trained workforce is a vital link in the chain of evidence A stewardship. • pproaches are needed that draw effectively on both public and pri- A vate capacities. • fficiency and effectiveness compel globalizing evidence and local- E izing decisions.

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20 LEARNING WHAT WORKS systematic decisions for the conduct of CER, systematic reviews, and guideline development; and ensuring the consistent translation of developed information. The identification of priority conditions, evaluation, and evidence gaps is needed in order to target limited resources, especially for high-cost or high-volume procedures and interventions. L earning about effectiveness must continue beyond the transi- • tion from testing to practice. “The learning process cannot stop when the label is approved,” one meeting participant pointed out. Premarket testing for the safety and effectiveness of various interventions cannot assess the results for all populations or the circumstances of use and differences in practice patterns, so gath- ering information as interventions are applied in practice settings should represent a key focus in designing the infrastructure to learn which care is best. Local coverage decisions and private insurer use of coverage with evidence development approaches were cited as opportunities to learn as a part of the care process. T imely and dynamic evidence of clinical effectiveness requires • bridging research and practice. The historical insulation of clinical research from the regular delivery of healthcare services evolved to facilitate data capture and control for confounding factors. With the prospect of electronically enhanced data capture, and statisti- cal approaches to improve analysis, as well as increasing demand to keep pace with technologic innovation, this divide increasingly limits the usefulness of research results. Efforts are under way to better engage health delivery organization, practitioners, patients, and the community in research prioritization, conduct and results dissemination. C urrent infrastructure planning must build to future needs and • opportunities. Research is often driven more by the methods than the questions. In fact, both are important, and infrastructure plan- ning must account for both the key emerging healthcare ques- tions and the key emerging CER opportunities. Emerging questions include those related to the management of multiple co-occurring chronic diseases of increasing prevalence in an aging population, the improved insights into individual variation relevant to both treatments and diagnostics, and the impact of innovation in short- ening the lifecycle of any particular intervention. Emerging tools include innovations in trial design, the development of new statisti- cal approaches to data analysis, and the development of electronic medical and personal health records. K eeping pace with technological innovation compels more than a • head-to-head and time-to-time focus. Much of the current discus-

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2 MOVING FORWARD sion about CER has emphasized the need for more clinical trials and more head-to-head studies. Although there are numerous examples of diagnostic and treatment interventions for which such studies are needed, the notion of a research process that essentially offers periodic and static determinations is inherently limited. Especially with the rapid pace of change in the nature of interventions and the difficulty, expense, and time required to develop studies—and the challenges of ensuring the generalizability of results in the face of limitations of traditional approach to randomized controlled trials (RCTs)—a first-order priority for effectiveness research is the estab- lishment of infrastructure for a more dynamic, real-time approach to learning. Leveraging new tools, such as HIT, should allow for a more networked and distributed approach to information sharing and evidence creation. R eal-time learning depends on HIT investment. It was noted that • collecting data is the most time-intensive part of trials and stud- ies, and information technology (IT) is critical to streamlining this work. Moreover, it is the key to accelerated learning from broader- based clinical experience. We heard that “[t]he type of learning needed cannot be paper based.” The increasing complexity of the factors involved in understanding the effectiveness of clinical options under different circumstances requires a blend of data- base access and computing power that can only be provided from broadly applied HIT. Although not in itself sufficient to produce the information required for better medical care management, it is a necessity for the continuous improvement expected of a learning health system. A policy framework for privacy and security will be necessary to build and maintain public trust that information will be protected as it is shared. D eveloping and applying tools that foster real-time data analysis • is an important element. The scope and scale of evidence needs suggests that innovation is needed across the range of research methods, from making clinical trials faster and less expensive to moving beyond RCTs to better address practical circumstances, using registries, observational databases, and other emerging data resources. If full advantage is to be taken of HIT, statistical tools and analytic algorithms that can be embedded in databases to allow real-time insights will be important. Similarly, tools are needed that will allow findings to be drawn from databases built on different vendor platforms, using semantic technology to integrate currently disparate medical data, in order to develop the next generation of statistical tools for the analysis of clinical data, including the

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22 LEARNING WHAT WORKS building of models that allow insights to be generated by virtual studies. A trained workforce is a vital link in the chain of evidence stew- • ardship. As in many other domains, progress in CER will relate to the capacity to develop and maintain the broad and diversely skilled workforce needed. Mention was often made of that factor as a determining element as well for progress in development of the learning health system. Given the pace of change in the num- ber and variety of clinical interventions as well as in the tools and approaches to assessing them, there is a need to ensure that these developing opportunities are matched by the skills of the work- force. This includes training and education in the methodologies of research design, translating research, guideline development, and maintaining and mining clinical records. But it also includes atten- tion to reorienting the education of frontline caregivers around their emerging responsibilities for access, interpretation, and dis- cussion with patients of a dynamic evidence base, as well as help- ing to ensure the availability and integrity of the clinical data that shape conclusions on evidence. A pproaches are needed that draw effectively on both public and • private capacities. Several times in the course of the meeting it was pointed out that although the total investment in CER in the United States is substantial, it is inefficient because of the absence of a vehicle for common priority setting and coordination of efforts and because the work on effectiveness done by private companies in product development and testing is usually not accessible to the broader community. In aggregate, private investment often far exceeds public investment in assessing a given intervention, but even when available, studies associated with an enterprise with a commercial stake may be viewed suspiciously. Several models are in development to establish public–private collaborative efforts to improve the efficiency and effectiveness of the work. E fficiency and effectiveness compel globalizing evidence and local- • izing decisions. Two presentations featured international work, including the Cochrane Collaboration on evidence synthesis, and efforts in Ontario, Canada, to develop and apply insights about the comparative effectiveness of clinical interventions. Reference was made throughout the meeting to work going on elsewhere in the world and, in particular, to work at the National Institute for Health and Clinical Excellence in the United Kingdom. This brought clearly into play the need to ensure that, where possible, common work to assess an intervention’s clinical effectiveness—or collective work to assess the body of evidence—be collaborative

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2 MOVING FORWARD and well coordinated across boundaries, while also being mindful that different cultural and policy environments may lead to differ- ent decisions at the local level. KEY FACTORS AND NEEDS Workshop speakers described a number of implications of the current state of play for the development of an infrastructure for CER (Box 6-2). These included the following: everal elements are involved in infrastructure development . S • Developing the infrastructure for CER has at least five dimen- sions: putting in place the physical capacity (i.e., the hardware); developing the analytic tools and methods; training the workforce; establishing processes for efficient and effective operation; and shaping the strategy for attention and phasing. Presentations at the meeting described and discussed in qualitative terms the needs and challenges in each of these dimensions and offered “opening bid” quantitative estimates on the needs for the IT infrastructure, as well as for investments in human capital. Refinements of these first approximations will be needed, as will additional clarity on the BOX 6-2 Key Factors and Needs for Expanded Comparative Effectiveness Research Capacity • Several elements are involved in infrastructure development: o utting in place the physical capacity (i.e., the hardware), p  o developing the analytic tools and methods,  o training the workforce needed,  o establishing processes for efficient and effective operation, and  o shaping the strategy for attention and phasing.  • S trategies and priorities for infrastructure application include the following: o conduct of systematic reviews,  o conduct of primary research,  o clinical registry resources,  o introduction of health information technology throughout practice,  o fostering public and private collaboration, and  o keeping focus on the utility and impact of a networked world. 

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2 LEARNING WHAT WORKS analytic tools, processes, and strategies for a stronger infrastructure for research into effective health care. S trategies and priorities for infrastructure application. The dimen- • sions noted above represent in certain ways the functional dimensions of relevance to the infrastructure that is needed for effectiveness research. There are phasing considerations as well, in part driven by the ability and need to take actions even without additional resources and in part driven by the time required to set in motion the necessary activities. Suggestions for key strategies and priorities for progress included the following: o onduct of systematic reviews. There is an immediate need to C  improve the conduct, coordination, and consistency of system- atic reviews—a point that, in effect, echoed the recommenda- tions of the 2008 IOM report Knowing What Works in Health Care: A Roadmap for the Nation, presented by a member of that committee. o onduct of primary research. Similarly, the approach to pri- C  mary research on effectiveness needs a more systematic means of determining priorities, better tools and more streamlined designs, and a deeper bench workforce to do the work. o linical registry resources. In making the transition to a pat- C  tern of real-time, continuous learning in health care—in effect, creating a beta approach to clinical data systems that generate learning—the technologies for clinical registries and in the field of registry development, maintenance, and improvement will need to be strengthened. I ntroduction of HIT throughout practice. In the area of IT  o development, the issues include the need to install appropriate hardware in virtually every clinical setting, the incorporation into operating software of design elements that are pegged to research activities and embedded analytic tools, the incorpora- tion of design elements used in decision assistance, and training of the required workforce to work with this technology. oostering public and private collaboration. A longer-term devel- F  opment needed to sustain the growth and improvement of the infrastructure will include the design of approaches that foster meaningful public and private collaboration in support of the research activities. o eeping focused on the usefulness and impact of a networked K  world. Also important to guide strategy development for the long term are approaches designed to take advantage of the resources emerging in our increasingly networked world—the opportunities for which hints are provided by recent develop-

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2 MOVING FORWARD ments, such as the Patients Like Me Web site, the health main- tenance organization research group, the registries of the Society of Thoracic Surgeons, and even information made available by such resources as Google and Wikipedia. QUICK HITS—THINGS THAT CAN BE DONE NOW Long-term support for CER will benefit from quick hits or actions that can be taken now with near-term results that might help demonstrate the benefit of CER. To open the session, W. David Helms, president and CEO of AcademyHealth, noted several opportunities for collaborative efforts by stakeholders to lay the groundwork for a national capacity for CER. These efforts should target accelerating congressional action to establish a plat- form for CER and increasing federal funding for CER; articulating the case for CER (e.g., developing a database that better characterizes the volume and costs of current CER work, drawing upon Health Services Research Projects in Progress database, clinicaltrials.gov, the Cochrane Collaborative, and others); examining models for national capacity (e.g., the Canadian Health Services Research Foundation’s $100 million support for enhanced knowledge transfer); and educating state policy representatives and Med- icaid officials about the potential and needs for CER. Work can also begin immediately to build up the needed workforce—through a reexamination of funding and support streams, alignment of education and training pro- grams around a broad array of research methods, and development of the means for improved communication across disciplines (e.g., clarification of terminology and methods). [Note: Subsequent to this meeting, Congress increased the national capacity for CER with the establishment, in the ACA of 2010, of Patient-Centered Outcomes Research Institute, previously described.] Two respondents also offered recommendations, and a summary of these comments. Lynn Etheredge, a consultant with the rapid learning project at George Washington University, suggested an immediate focus on new technologies. While potentially offering new benefits to medical care, collectively these products are also a primary driver of healthcare cost increases. A national system to collect and analyze information about these products in the postmarket environment would enhance our understanding of safety and effectiveness is real-world populations. Existing infrastructure that might be used to accelerate the development of such a system includes the authority conferred to the Food and Drug Administration for the Sentinel System, and the Centers for Medicare & Medicaid Services (CMS) Coverage with Evidence Development policies. A national research plan could guide requirements for reporting to a new national data registry that would collect from the point at which a prod-

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2 LEARNING WHAT WORKS uct or drug is first introduced into the market or is covered by Medicare. Second, Etheredge noted the need to develop a national biobank initiative to begin work to relate genetic information with clinical data collected via EHRs. This will potentially improve diagnoses as well as our under- standing of the heterogeneity of treatment responses. A national biobank could be based in large part on data resources currently in place, includ- ing the NIH compilation of genomewide association studies and genetic data available from major healthcare providers. Similar resources could be constructed for specific diseases, drawing on the considerable progress already evident in the development of such resources as the Alzheimer’s Disease Neuroimaging Network and the cancer Biomedical Informat- ics Grid. Progress could also be accomplished in linking Medicaid data on disabled and chronically ill patients nationally. Another potential model is the Oregon Community Health Information Network, which is engaged in bringing Electronic Privacy Information Center applications to its safety-net clinics. Third, Etherege cited the huge potential in develop- ing programs focused on Medicaid populations. Nationally, databases and EHRs will cover most populations except the Medicaid, disabled, and high-needs populations. Given the billions of dollars spent each year on dual eligibles (Medicare and Medicaid users), a small initial investment in better understanding the care of this population is needed. He suggested that starting up research registries and databases using just some of the states that could look in detail at the seriously disabled and chronically ill populations would be a feasible project with immediate returns. David Shulke, executive vice president of the American Health Qual- ity Association, suggested that the existing national network of Medicare Quality Improvement Organizations (QIOs) could be used to ensure the translation and application of evidence into practice. Currently providers and practitioners find it difficult to find, integrate, and use new data in clini- cal practice. The QIOs are a national network of organizations or private contractors that facilitate the adoption of evidence-based medicine and could easily also be used to facilitate the use of comparative effectiveness information. He urged that this be factored into the next Medicare contract cycle, which starts in 2011. Other suggestions during the open discussion included a demonstration project on the use of personal health records to promote patient involve- ment in the management of their own chronic disease and an exploration of evidence available in other countries. The Independent Drug Information System—a stakeholder partnership that engages providers, insurers, and patients—and the Pragmatic Approach to Comparative Effectiveness group, which is exploring the use of Bayesian techniques to streamline the efficient generation of new knowledge, were both suggested as important new initia- tives that might serve as models for various aspects of CER capacity.

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2 MOVING FORWARD Issues for Possible Roundtable Follow-Up Throughout the course of discussions, a number of items were identi- fied as candidates for follow-up attention by the Roundtable on Value & Science-Driven Health Care: B etter characterization of the elements of the infrastructure. Build- • ing on the work sponsored by the Roundtable on workforce needs and IT infrastructure, continue to improve the initial estimates and pursue similar assessments related to requirements for new analytic tools and methods, establish processes for efficient and effective operation of the fields of work, and shape the strategy for attention and phasing. Include examples of effective work at the institutional level. C larification of the nature of the “prework” needed for a more • systematic approach to the necessary RCTs. Even though a more practical portfolio of research approaches is essential, the RCT offers the key standard for the rigor required for certain circum- stances. Their most effective deployment requires attention to issues of the criteria indicating the need for an RCT, the issues and priorities to be assessed, the best structure of the research ques- tions, and improved approaches to trial design, conduct, and data collection. M ore focus on the infrastructure needed for guideline develop- • ment, implementation, and evaluation. Several issues could be productively engaged, including transparency and collaboration across professional groups on improving consistency in the meth- ods, standards, rules, and participants in guideline development and approaches to implementation. S hare meeting discussions with organizational stakeholders in ele- • ments of the infrastructure. Examples given included the National Quality Forum, the Association of American Medical Colleges, the Association of Academic Health Centers, the Quality Improvement Program, and CMS/Department of Health and Human Services in the context of development of the 10th QIO statement of work, the American Hospital Association Quality Forum, International Society for Pharmacoeconomics and Outcomes Research, and pro- vider groups. evote additional attention to data stewardship issues. Because D • the basic resource for effectiveness research is the clinical data system, the Roundtable needs to catalyze more discussion on the integrity of this resource, including issues of maintenance, privacy, and data ownership.

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2 LEARNING WHAT WORKS I dentify possible incentives. Look at how subsidies and reimburse- • ment regulations can stimulate increased use of HIT in medical care, increased use of HIT for application of evidence, and increased use of HIT for the development of evidence. E xpand engagement of the business case and demand function • for infrastructure investment. Give additional attention to the eco- nomic or business case for employers to appreciate the investment and its necessity in improving value from health care, the case for more attention by states, the case for the personal health record deployment to drive more patient–provider interaction, and work on the consequences of not investing. M ore focus on the issues of strategies and infrastructure for • implementing findings on effectiveness. Since evidence is virtually useless if not applied, the Roundtable could give more attention to understanding the infrastructure needs for effective guideline implementation. S ponsor discussions on training and health professions education • reorientation. With greater appreciation for team-based, networked information stewardship roles by caregivers, the health professions groups should be recruited for collaborative consideration of the training implications. P rovide information on the Roundtable’s Web site. The resources • of the workshop presentations and discussions should be posted on the Web site—slides, links, and speaker contact information. Building Support Although an enhanced focus on CER will build upon the existing infrastructure and activities, it still marks a significant shift in the nation’s approach to clinical research and practice. Healthcare stakeholders gener- ally view CER as an important tool for ensuring that healthcare decisions are based on the best science; but additional work is needed to effectively communicate between stakeholders and with the public and policy makers about needed investments and potential returns from CER. Mary Woolley from Research!America led an open discussion session on opportunities to build support for the wide-ranging investments and developments articu- lated throughout the workshop. Her comments along with suggestions offered by three respondents are summarized below. Four fundamental requirements for building support are important to consider: (1) clarity about the ultimate goal, (2) understanding the target audience, (3) ensuring all stakeholders are involved, and (4) understanding the context. Using this framework, Woolley offered several suggestions on key opportunities to build support for expanded development and use of

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29 MOVING FORWARD CER. Much of the discussion about needs for infrastructure requires an inside knowledge of the specific aspects of health care. However, a simply stated goal, such as “By 2020 at least 90 percent of all clinical decisions will be based on the best available evidence,” is fairly easy to understand and might therefore serve as a better way to frame the many needs articu- lated during this workshop to all stakeholders—including the public and policy makers. Making the case will face challenges as CER is in some sense a fundamental change in current and long-held practices in research and health care. Developing support will therefore require broad consensus and clarity about the fundamental CER value proposition and agreement about core goals. Strategies for change must therefore factor in the need for value acceptance and culture change. Also necessary is clarity about the target audiences, as effective com- munications need to be tailored to the interests and concerns of different stakeholders. For each audience, there are various keys to building sup- port: anticipating questions, but also listening carefully to questions posed in order to better understand the needs of a particular audience; engaging in clear communication and crisp, well-conceived messaging; and keeping in mind that those not engaged in CER-related work, specifically includ- ing the public and policy makers, are not as well versed as stakeholders in the terminology and concepts of CER. Woolley offered an example from personal experience: that health outcomes, while a commonly used term within healthcare policy, was simply not understood well by the media and other audiences. A simple language shift to “better health” was more read- ily understood and perceived as speaking directly to the public’s interests. Personal stories, effective metaphors, sound bites, and strong, crisp mes- sages need to replace large reports laden with jargon. Immediate wins, or quick hits, that help to illustrate the potential of CER will also be essential to building support. Understanding public opinion (which needs to be constantly gauged) and the context for com- munications is also important. As of July 2008, research has demonstrated that the American public continues to be concerned about the cost of health care, and ranks it as the top long-term challenge facing the nation. How might communications about healthcare reform and CER better reflect or illustrate key opportunities to address these concerns? Communication should not be unidirectional, but rather it should be structured to fully engage all stakeholders involved in infrastructure building. Such broad engagement will require the identification and strong support of champions who can lead the effort as well as the commitment of all interested stakeholders in taking action. Educating legislators about the importance and relevance CER is one aspect of this work, but speaking to other audiences—including those in our own social networks—will be instrumental in developing the broad-based support needed. Fine-tuning

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0 LEARNING WHAT WORKS communications strategies as lessons are learned about their effectiveness will strengthen the overall effort. Respondent Stephen Gorshow, from the Aetna coverage policy unit, observed that individual participation in health plans inherently creates a unique opportunity for the plan to follow members over the continuum of health care. He suggested, however, that the fact that individuals obtain care from multiple providers creates gaps in the quality of care, an issue that calls for research to determine the extent and impact of this problem, albeit with adherence to principles of patient privacy. Particularly in an era of consumer-directed health plans, and toward a goal of encouraging healthy practices among individuals, research is also needed to determine the effects that changes in benefit design have on health-related behaviors. Similarly, benefit issues need to be researched in ways that inform intelli- gent decisions about what should and should not be covered. In addition, research should be conducted to determine the optimal balance between cost-sharing by health plan members and protection for the plan against the high cost of the high-tech care available today for more serious ill- nesses. Also advocated is a broader buy-in to available guidelines for wise use of high-tech radiology as well as study of the driving forces behind the need for private insurers to conduct programs to stem the overuse of such technologies. These areas of needed research are directly relevant to how patients experience health care, and they may therefore also be important in improving communications with patients about the benefits of compara- tive effectiveness. A second respondent, David Longnecker, director of healthcare affairs at the Association of American Medical Colleges, emphasized the impor- tance of having clear, distinct goals as an important tool for building sup- port for CER. Large, big-picture goals are necessary, but smaller interim goals can also help drive rapid progress. In this respect, while it is important to develop a research enterprise that can begin to narrow the many gaps in evidence, streamlining and supporting the translation of research into prac- tice might be an area where progress can be made quickly. An important interim goal might therefore be to significantly improve the application of known evidence; to that end, research is needed on how to best motivate and support physicians and health professionals to implement evidence- based care. In addition, Longnecker suggested some “quick hits” that might be helpful in building support. The Department of Veterans Affairs EHRs, National Consortium of Clinical Databases, and the Dartmouth Atlas databases are existing data resources that could be mined now to expand comparative effectiveness knowledge. Also, citing how the work of the Leapfrog group in improving quality was greatly accelerated by CMS pay- ment policies, Longnecker suggested that strategies are needed, particularly financial rewards for practitioners, to help move CER forward.

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 MOVING FORWARD A third respondent, Eva Powell, director of the Health Information Technology Project at the National Partnership for Women and Fami- lies, observed that while consumer advocacy organizations are in favor of moving CER forward, the issue of preserving and protecting patient privacy rights remains of paramount importance. Indeed, she argued, the fundamental validity of data is dependent on privacy being protected. Powell advocated for reframing the conversation around patient privacy, shifting it from a focus on barriers to participation in studies to a mindset that underscores the essential importance, for the greater good, of study participation. To ensure transparency in this realm, an agreed-on set of standards and a policy framework that covers all participating entities is required, as are changes in Health Insurancc Portability and Accountability Act legislation. Consumers do not have all the information or the simple tools needed to become fully engaged in CER. Some work is already under way to educate and communicate with the public and consumers, but additional efforts are needed to ensure that the media is also educated. Because of their work with local constituencies, QIOs are possible conduits to the public and the media on health and health quality issues. In developing messages about the benefits of CER in terms of its value to consumers, a value case from the consumer perspective needs to be articulated and disseminated. Important to understand in this regard is that making such a case on the basis of improving efficiency or cost does not resonate with consumers, as efficiency is often perceived by consumers as an attempt to deny them care and, while recognizing that cost is important, consumers tend to be wary of decision making based solely on cost. Value in health care, which includes consideration of the benefits received by patients, is more likely to resonate with consumers.

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