Learning What Works Infrastructure Required for Comparative Effectiveness Research: Workshop Summary (2011) / Chapter Skim
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Appendix A: Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care
Appendix A: Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care
Pages 333-438
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Appendix A Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care AN ISSUE OVERVIEW IOM ROUNDTABLE ON EVIDENCE-BASED MEDICINE September 2007 version. This Issue Overview was prepared at the request of the IOM Roundtable Working Group on Sustainable Capacity by J
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to conduct or support comparative effectiveness research (CER) activities.
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International Activities in Clinical Effectiveness Research 3. Potential Model: Federally Funded Research and Development Centers 4.
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Potential Model: Federal Reserve 7. The Business Case for Comparative Effectiveness Research: A Commissioned Analysis
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, Lisa Payne-Simon (Blue Shield of California Foundation) , Diana Petitti (University of Southern California)
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2007. Learning what works best: The nation's need for evidence on comparative effectiveness in health care.
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Medical care decisionmaking is now strained, at both the level of the individual patient and the level of the population as a whole, by the growing number of diagnostic and therapeutic options for which evidence is insufficient to make a clear ∗ Jack Rowe, Columbia University (Chair) ; Adam Bosworth, Google; Helen Darling, National Business Group on Health; Michael Johns, Emory University; Steve MacMillan, Stryker Corporation; Mark McClellan, AEI-Brookings; Richard Platt, Harvard University; Steve Udvarhelyi, Independence Blue Cross; Bill Weldon, Johnson & Johnson; Janet Woodcock, FDA.
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. Similarly, wide geographic variations have been reported for conditions such as hip fracture, colorectal cancer, and acute myocardial infarction as well as end-of-life care [6]
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Of the nation's more than $2 trillion annual health expenditure -- nearly half of it borne by government -- currently less than 0.1 percent [15, 16] is invested in assessing the comparative effectiveness of available interventions.
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Over the long term, substantial changes will emerge in the way the nation goes about generating and applying evidence for clinical decision making. A learning healthcare system is one in which the clinical research paradigm depends more judiciously on the serial conduct of randomized controlled trials -- important, but often too expensive, untimely, and of limited applicability -- and draws more heavily on electronic health records (EHRs)
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Engaging the immediate need for a much stronger and sustained capacity to meet the need for guidance on the clinical effectiveness of medical interventions is the subject of this paper. Discussion follows on the perspectives of the various stakeholders, the current capacity and activities on clinical effectiveness research, the key functional needs to be met, and, finally, some possible approaches to addressing the issues, including consideration of decision principles, governance, funding, and public support.
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Most of the challenge in this respect is in ramping up the capacity to generate and apply the necessary evidence, but other issues related to patient perceptions must also be addressed. Because some patients may view the results of comparative effectiveness studies as potentially limiting to their choices, care must be taken in the application and interpretive processes to ensure understanding and appropriateness.
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Especially as healthcare delivery organizations become more skilled in team management and as they build systems to improve and measure the consistency of the care with established performance standards, the rate-limiting factor will be the baseline information on the comparative effectiveness of available options. Healthcare Manufacturers The sector with the largest economic stake in better capacity to generate and apply information about the effectiveness of clinical interventions is the healthcare manufacturing sector -- the companies that make the pharmaceuticals, devices, and biological products that provide the backbone for much of health care and its progress.
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. The larger insurers maintain analytic staffs to assess the existing literature, and most also contract with organizations that conduct formal systematic reviews, but such reviews are limited by the shallowness of primary research studying the effectiveness of interventions in a practical setting -- either compared to a placebo or to other alternative
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In addition, the Food and Drug Administration, which is required by law to make its judgments based on the safety and efficacy of a given intervention, is increasingly under pressure to provide perspectives on the relative advantages of proposed new approaches but generally lacks the studies on which to base such counsel. CURRENT ACTIVITIES IN CLINICAL EFFECTIVENESS RESEARCH Activities currently under way to assess the effectiveness of healthcare interventions may be generally characterized as broad, based in multiple loci, largely uncoordinated, far short of the need, and under-resourced.
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Comparative Effectiveness Within the overall umbrella of clinical effectiveness research, the most practical need is for studies of comparative effectiveness, the comparison of one diagnostic or treatment option with one or more others. In this respect, primary comparative effectiveness research involves the direct generation of clinical information on the relative merits or outcomes of one intervention in comparison with one or more others, and secondary comparative
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, under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) , for comparative effectiveness research, the issue for which the shortfall is greatest.
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Even accounting for the support from all involved public and private institutions, the aggregate national commitment to assessing the effectiveness of clinical interventions is likely well under 1 percent -- far below the standard that any company would expect to invest in work to evaluate and improve its products. Primary Clinical Effectiveness Research At the federal level, several agencies of the Department of Health and Human Services (HHS)
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AHRQ, the lead federal agency for health services research, has a mandate from section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act along with a related $15 million appropriation to perform research with a focus on the outcomes, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and healthcare services. The provision has led to the creation of AHRQ's Effective Health Care Program, which has three components: synthesizing existing studies into Comparative Effectiveness Reports by Evidence-based Practice Centers; developing evidence, including research aimed at filling knowledge gaps about treatment effectiveness (DEcIDE centers)
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. Large healthcare systems, such as large health maintenance organizations, also have the capacity to use both their clinical and administrative data systems for primary clinical effectiveness research -- some sponsored out of their own resources, others sponsored by NIH or commercial concerns.
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Evidence Synthesis Much of the work to marshal evidence for conclusions about clinical effectiveness takes the form not of primary data generation and analysis but of systematic reviews and meta-analyses of existing studies. Such secondary clinical effectiveness research is sponsored and conducted by a variety of organizations with overlapping and intersecting activities and interests, including federal agencies, state agencies, insurer and insurer-related organizations, independent assessment centers, professional groups and societies, university centers, and consortia.
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, through which health plans utilize comparative analysis when developing formularies. Currently, most clinical practice guidelines are produced in association with physician specialty societies and published through multiple modalities.
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Because there are scant resources for the support of primary comparative effectiveness research (CER) -- head-to-head studies -- much of the work done is secondary evidence synthesis.
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The primary limitation on systematic reviews of the comparative effectiveness of various interventions is the paucity of primary research results on which to draw. There are also several general categories of issues in need of additional systematic evaluation both for determinations related to the evidence, where it exists, and recommendations relating to additional studies needed.
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So the need exists both for additional support for systematic reviews of comparative effectiveness and for application of consensus approaches and standards.
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Chief among the needs in this respect is the development of new study designs and statistical tools that will allow an expanded use of electronic health records in order to generate insights on clinical effectiveness. As our ability to manage large quantities of data electronically continues to increase, the use of electronic records to drive observational databases and registries will increase.
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One existing resource of this sort is clinicaltrials.gov, described earlier as a mechanism for registering all clinical trials, both to increase patient recruitment as well as to facilitate information gathering once the trials are in process or have been recently completed. Perhaps even more important than the prospects for benefits from linking clinical trial work are the potential benefits from linking clinical data.
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, so does the prospect for the availability of information of sufficient scale to provide much earlier insights into sub-group safety and effectiveness issues not fully resolved before an intervention's introduction into practice. An intermediate variation on this theme is the development of patient registries to monitor the performance of new interventions as they are introduced into new populations for which pre-introduction trial evidence is suggestive of effectiveness, but not conclusive -- as in the CMS initiative on Coverage with Evidence Development.
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9. Guidance for coverage and funding The goal of increasing the capacity for research on comparative effectiveness is to improve the basis for medical decision making at many levels, not the least of which is for those who must make determinations on funding and coverage for interventions.
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2 LEARNING WHAT WORKS evidence in hand. One of the problems in the current fragmented and underresourced activities to establish clinical effectiveness is that studies focused on the issue of efficacy and safety for product approval purposes often lack the information needed for coverage decisions down the line -- e.g., how well an intervention works in different sub-populations, or how results apply to populations with multiple, interacting conditions and treatments, or how it compares to alternatives.
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In the meantime, and even when that capacity is in place, much stronger investment in dedicated comparative studies is essential. Various organizations and recent public articles have called for a quantum increase -- several billion dollars -- in the level of investment in comparative effectiveness research and the creation of a sustainable new capacity to ensure that the highest priorities are addressed most effectively and efficiently and that new approaches are developed to accelerate the pace, reliability, and consistency of the results [41, 46, 47]
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The notion of independence is central because of past instances of political will intervening in scientific processes, as is scientific credibility to the patients and health professionals who will ultimately determine the success of the work. Presented below are several approaches to developing the sustainable capacity needed for studies on the comparative effectiveness of healthcare diagnosis and treatment.
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In this scenario, the expectation would be for AHRQ to receive gradually increased appropriations for its comparative effectiveness research program, NIH to steadily increase its priority on investing in clinical effectiveness research as part of its Roadmap Initiative, industry working earlier with FDA and payers in conversations to anticipate post-market needs from the outset of pre-market testing, CMS to expand its Coverage with Evidence Development initiative, and insurers and manufacturers to increase their investment in comparative effectiveness research. The formation of an interagency collaborative is one that might seek to utilize the strengths of the individual agencies while reducing the burden on any single agency.
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NIH has strong credibility and experience with both primary and secondary clinical effectiveness research. However, the structure of NIH with institute divisions that each have oversight on their specific research agendas, combined with the mandate of the NIH to conduct basic and translational research, is less in line with the outcomes-oriented approach of comparative effectiveness research.
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Consumer Product Safety Commission (CPSC) The CPSC is a three-commissioner independent agency charged with ensuring the safety of consumer products.
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Privately Funded Entity A clinical effectiveness research entity could be established entirely with private funds. The primary advantage of a private sector approach is that it would be perceived as not being unduly influenced by the government and political considerations.
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It has been successful in encouraging R&D investments and, if paired with the development of an independent mechanism for shared governance, pooling, priority setting, and quality control, could provide a basis for expansion of the work needed. Public-Private Funded Entity User Fee Public Model One of the most prominent examples of shared public-private funding in the health arena is the user fee model to expedite the review of drug and biological products.
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Limits have been placed on competition for other government or commercial business with the intent of fostering a strategic relationship between an FFRDC and its sponsor as well as limiting the potential for conflict of interest that this special access may create. Existing FFRDCs fall into four general categories: policy-focused study and analysis centers (e.g., the National Defense Research Institute, administered by RAND, and the Homeland Security Institute, administered by Analytic Services, Inc.)
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in a 7-year study collecting clinical, radiological, and biological data from 5,000 patients with osteoarthritis; and the Grand Challenges in Global Health, a $450 million project administered by the FNIH and prompted by a $200 million commitment from the Bill & Melinda Gates Foundation, with contributions from the U.K. Wellcome Trust and the Canadian Institutes of Health Research, supporting 43 separate research projects aimed at solving the 14 most important challenges in global health.
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Department of Transportation, and other organizations interested in the effectiveness of transportation tools and strategies. Applying this model for a program of comparative effectiveness research would place responsibility with the Institute of Medicine (IOM)
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DECISION AND IMPLEMENTATION CONSIDERATIONS Establishment of a substantially expanded capacity for clinical and comparative effectiveness research will need to address a variety of implementation considerations, including, if established as a new entity, those related to funding, governance, priority setting, research conduct, and finding validation. Some of the relevant principles and administrative issues in identifying the organization's location, support, structure, and function include those that follow.
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Vesting of responsibility for this work ought therefore to be placed, if not in an organization with a history of protecting against such influence, then in one that can construct the necessary procedural firewalls between the processes of policy and priority setting and the design, conduct, and reporting of the scientific studies.
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With a publicprivate funded approach, proportionately matching contributions could be structured in a variety of ways, including blending small set-asides from Medicare fund expenditures, from private health insurance premiums, or
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Summary of Common Approaches to the Independent Model Because of the challenges to the notion of increasing comparative effectiveness research primarily through a straightforward federal appropriation to the Agency for Healthcare Research and Quality -- difficulty of marshaling an appropriation at a level commensurate with the need, lack of political independence, limited ability to draw on other agencies -- much of the recent discussion has focused on independent models, often with blended public and private funding. Table A-4 reviews some possible features of the three such models most commonly discussed: an agency (including an agency-linked FFRDC)
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to give the work quasi-insulated status. b ISO, independent scientific organization (e.g., Institute of Medicine, on the model of the NAS Transportation Research Board)
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Although most discussions of this approach do not propose the same legislated mandates related to oversight, accountability, and reporting that are vested in the Federal Reserve Board, there are clear advantages to the creation of a capacity with similar independence and reach. In addition to a governing board for priority setting and budget allocation, some versions of this scenario would vest this board with operating
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The principal disadvantage is that, since one of its basic principles is the notion of the desirability of a firewall to ensure the integrity of the science, the relationship between the governing board and the National Academy of Sciences would have to be solidly established. CONCLUDING OBSERVATIONS As ever-increasing options evolve in health care, current gaps in knowledge and practice about which care works best will persist or worsen without the appropriate information on which to base healthcare decisions.
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Clinical effectiveness research, through establishing the best practices in health care, serves as the cornerstone of quality improvement, and an increased ability to determine what has the most clinical utility will drive faster and more rigorous quality improvements. As electronic health records move from concept to reality, the need for coordinated efforts for clinical effectiveness research will become even more pressing but also more feasible.
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2005. Prescription Drug User Fee Act (PDUFA)
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2006. Can a center for comparative effectiveness information suc ceed?
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, under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) , for comparative effectiveness research, the issue for which the shortfall is greatest.
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Primary Clinical Effectiveness Research In this respect, primary clinical effectiveness research refers to the specific design and implementation of structured research protocols to produce data on the results of one or more diagnostic or therapeutic interventions of interest. Examples include certain randomized controlled trials, practical clinical trials, cluster randomized trials, observational studies, and cohort studies, including registries.
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In this respect, primary comparative effectiveness research involves the direct generation of clinical information on the relative merits or outcomes of one intervention in comparison to one or more others, and secondary comparative effectiveness research involves the synthesis of primary studies to allow conclusions to be drawn. Secondary comparisons of the relative merits of different diagnostic or treatment interventions can be done either directly, through collective analysis of the results of multiple head-to-head studies, or indirectly, in which case the treatment options have not been directly compared to each other in a clinical evaluation, and inferences must be drawn based on the relative effect of each intervention to a specific comparison, often a placebo.
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Efforts are under way through the network of regional health information organizations (RHIOs) to advance the progress and interoperability of electronic health data systems, which will enhance the capacity for primary clinical effectiveness research [3-5]
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, which allowed an increased accuracy in the determination of diabetes prevalence in the VA population and which has the potential for significant contributions to insights on the comparative effectiveness of interventions [11]
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In general, the FDA does not require comparative effectiveness information to grant market approval of an agent or innovation. Veterans Health Administration The VHA has a strong clinical research program as a result of its 157 medical centers and more than 1,300 ambulatory, residential, and homeand community-based sites of care, and a state-of-the-art computerized clinical data system with 8 million patient records that allows the rendering of large quantities of patient data for analyses on a wide variety of clinical research topics.
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Among federal agencies, AHRQ carries a mandate through section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) , and a related $15 million appropriation, to perform research with a focus on the outcomes, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and healthcare services.
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Comparative effectiveness studies initiated through DEcIDE include atypical vs. conventional antipsychotic medications, beta-adrenergic antagonists, new therapies for glucose control in diabetes mellitus, and extended use of clopidogrel in drug-eluting stents.
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, have the capacity to use both their clinical and administrative data systems for primary clinical effectiveness research -- some sponsored out of their own resources, others sponsored by NIH or commercial concerns. Kaiser Permanente, Geisinger Health, and Group Health, for example, have efforts to utilize their large databases for improved understanding of what works best for which patients.
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Payer-Related Data Consortia If they are appropriately linked, health insurance claims can also provide a potentially strong resource for assessing the clinical effectiveness of various interventions. In July 2006 the AQA Alliance and the Hospital Quality Alliance (HQA)
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Much of the work to marshal evidence for conclusions about clinical effectiveness takes the form not of primary data generation and analysis, but of systematic reviews and meta-analyses of existing studies. Such secondary clinical effectiveness research is sponsored and conducted by a variety of organizations with overlapping and intersecting activities and interests, including federal agencies, state agencies, insurer and insurer-related organizations, independent assessment centers, professional groups and societies, university centers, and consortia.
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Now part of the AHRQ Effective Healthcare Program, EPCs produce studies that span broad issues ranging from clinical to social and behavioral, economic, and other healthcare organization and delivery issues. The EPCs often compare the relative effectiveness of different treatments, including drugs, and also identify gaps in the research.
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State Agencies Certain states have established programs to conduct technology assessments and systematic reviews to assist in their decisions about Medicaid coverage approaches and the policies of state health insurance agencies. California, for example, has established the California Health Benefits Review Program with a legislative mandate to analyze the medical, financial, and public health impacts of proposed changes in mandated health benefits.
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In addition, these larger groups will consult with appropriate specialty societies and academic centers for guidance and help on clinical effectiveness research. Smaller plans and state and regional Blue Cross/Blue Shield organizations generally do not maintain this analytic capacity and instead look elsewhere for guidance.
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Professional Groups and Societies Many clinicians rely on clinical practice guidelines for advice on best practices for specific clinical situations, in some cases providing advice on how to choose between options. Currently, most clinical practice guidelines are produced in association with physician specialty societies and published through multiple modalities.
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have formed to develop standards for evidence syntheses and clinical practice guidelines. Other consortia involved in coordinating their work on clinical effectiveness research
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Health Affairs.
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APPENDIx TWO INTERNATIONAL ACTIVITIES IN CLINICAL EFFECTIVENESS RESEARCH Clinical effectiveness assessment activities have utility that crosses national borders. A growing involvement in technology assessment and clinical effectiveness evaluation has developed internationally.
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CADTH operates as an independent, not-for-profit organization with three main programs: Health Technology Assessment (HTA) , Common Drug Review (CDR)
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has been operating in Germany since October 2004 as an independent, non-profit organization responsible for the evaluation of diagnostic and therapeutic services, pharmaceuticals, clinical practice guidelines, and healthcare services. It also makes recommendations to disease management programs, and disseminates information to patients and consumers.
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Three centers guide the programs at NICE: the Centre for Public Health Excellence, which develops public health guidance; the Centre for Clinical Practice, which develops clinical practice guidelines; and the Centre for Health Technology Evaluation, which assesses new and existing medicines, treatments, and procedures. The assessment process involves a technical committee (the Technology Appraisal Committee)
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. Functions under exploration include facilitation of networking, identification of opportunities for joint assessments and priority setting, development of methodology, gathering and dissemination of information, and educational activities.
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Organized around disease topics, the Cochrane Collaboration now has more than 4,500 systematic reviews in its database. Among the 12 Cochrane centers worldwide, one is based in the United States, at Johns Hopkins Bloomberg School of Public Health.
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According to the OFPP, federal agencies should only establish an FFRDC when the agency determines that "[e] xisting alternative sources for satisfying agency requirements cannot effectively meet the sponsor's special research and development needs." FFRDC funding comes from the organization within the sponsoring agency requesting the work or from a line item on congressionally appropriated budgets of the sponsoring agency.
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Examples of recently published reports include Review of Military Health Benefit Design, China's Military Modernization and the 3 Information summarized from NDRI Web site http://www.rand.org/nsrd/ndri.html and links therein.
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Purpose Established in 2004, HSI evaluates homeland security systems and technologies during development, deployment, and use for DHS and its operating elements. HSI has four core competencies: systems evaluations; technology assessments; operational assessments; and resource and support analyses.
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competitiveness. Science and technology issues addressed by STPI include national security, homeland security, critical infrastructure protection, health and the environment, space and transportation, information/telecommunication infrastructure and technology, education and training, physical sciences, engineering and technology, research and development portfolio, and development of new analytic methods and tools.
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National security and homeland security work is also funded by the NNSA Office of Defense Nuclear Nonproliferation, the Department of Homeland Security, various Department of Defense sponsors, and other federal agencies. The National Aeronautics and Space Administration, Nuclear Regulatory Commission, National Institutes of Health, Environmental Protection Agency, California state agencies, and private industry provide additional LLNL funding.
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The Office of the Director at NCI through its Office of Scientific Operations develops and coordinates contractor requirements, providing overall scientific administrative management and program planning. The Office of the Director for the Center for Cancer Research (CCR)
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Output Aerospace has been involved in almost all national-security launch and satellite programs. For example, in fiscal year 2005 Aerospace pro 8 Information summarized from the Aerospace Corporation Web site http://www.aero.
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APPENDIX A vided oversight to 43 operational launches for the Space Missile Systems Center and the Air Force. Aerospace also provides technical analyses and assessments.
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Brief descriptions of three PPPs are provided below, with information on their governance structures, funding mechanisms, and output. The three PPPs are the Biomarkers Consortium, the Osteoarthritis Initiative, and Grand Challenges in Global Health.
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Steering committees, which are content area focused, identify and oversee specific project activities. Project teams determine priorities and implement projects.
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. According to the FNIH, private-sector funding is $3.2 10 Information summarized from the FNIH Web site http://www.fnih.org/programs/research_ environment/osteoarthritis.shtml and the OAI Web site http://www.oai.ucsf.edu/datarelease/Study Overview.asp.
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As of 2005, there were 43 research projects under way in 33 countries, each working toward scientific or technical breakthroughs in one of seven project areas to improve vaccines, create new vaccines, control insect vectors, improve nutrition, limit drug resistance, cure infection, and measure health status. Partners GCGH partners include the Bill & Melinda Gates Foundation, the Canadian Institutes of Health Research (CIHR)
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; and activities of the Marine Board. The Cooperative Research Programs Division houses the transportation research activities that parallel in funding and approach several proposals for support and conduct of comparative effectiveness research under the auspices of the IOM/NRC.
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. The National Cooperative Highway Research Program, started in 1962, was the first continuing research management activity of the NRC.
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Established as an entity independent from the federal government, the Federal Reserve promotes economic stability through formulating monetary policy, overseeing and regulating banks, and providing financial services to depository institutions, all with minimal political pressure. The three major components of the Federal Reserve -- the board of governors, 12 regional federal reserve banks, and various member banks located throughout the country -- work in concert to carry out its charge.
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Also, rates charged by the discount window, the Federal Reserve facility for lending to eligible depository institutions, can be augmented to encourage or discourage borrowing and, consequently, lending. In addition to formulating monetary policy, through the Truth in Lending Act, the Electronic Funds Transfer Act, and the Fair Housing Act, the board of governors oversees member banks as well as the 12 federal reserve banks.
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As of June 30, 2005, there were 1,861 national banks and 903 state-chartered Federal Reserve member banks.14 APPENDIx SEVEN THE BUSINESS CASE FOR COMPARATIVE EFFECTIVENESS RESEARCH A Commissioned AnAlysis Michael Chernew Professor, Department of Health Care Policy Harvard Medical School Mark Fendrick Professor, Department of Internal Medicine University of Michigan Medical School March 2007 Acknowledgment: We thank David Helms, Sean Tunis, Peter Juhn, and reviewers from the Institute of Medicine for their helpful comments.
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While acquiring the scientific evidence to improve medical decision making may seem a daunting task, an investment in a clinical research agenda with the specific aim of determining the right medical intervention for the right person at the right time is critical to ensure a more efficient system. Comparative effectiveness research (CER)
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was devoted to health services research, of which only a small fraction is likely directed to CER. AHRQ received only $15 million for CER as part of the Medicare Modernization Act.
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Because CER is merely a tool, the impact of CER ultimately depends on how it is used -- whether it is used to inform decision makers as part of efforts to improve the way markets function or else is implemented in specific clinical areas such as guideline development or in a broader application such as health benefit design. No matter how CER is utilized, it is imperative that outputs from CER address both the clinical and financial effects, since in some instances improvements in health will require incremental expenditures.
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In some cases, the use of a diagnostic test could reduce overall costs (e.g., T-wave alternans testing prior to implantable coronary defibrillator insertion) , and in other cases diagnostic tests may be unnecessary (e.g., upper gastrointestinal endoscopy in suspected ulcer disease)
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A similar critical challenge for the health services research community is to devise systems to limit use to the set of patients for whom the service provides value, thereby eliminating overuse. The fundamental tenet of clinical medicine is primum non nocere, "first do no harm." In today's complex environment this principle should extend beyond the clinician-patient relationship to include health systems operations.
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ii. Inappropriate use The second body of research that addresses waste in the system attempts to directly measure how frequently certain medical services are delivered for medically inappropriate indications.
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. These studies often examine a specific intervention (e.g., upper gastrointestinal endoscopy or percutaneous coronary angioplasty)
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b. Underuse Paradoxically, while overuse in the healthcare system is common, underuse of medical services rigorously determined to provide substantial clinical benefit is also widespread.
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It is well established that the tradeoff between access to medical care and how to pay for it is a complex and extremely political issue. Fourth, high healthcare costs are also associated with declining rates of health insurance coverage [22]
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Manufacturers that have the potential to make important clinical advances can thrive in a lowwaste environment. Moreover, relative to other cost containment efforts that may impact manufacturers, efforts to reduce unnecessary use of certain medical products may be preferable.
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This underscores the need for a CER agenda that is able to measure health and economic impact on a granular level that will ultimately target those specific circumstances when certain interventions should and should not be used. While the evidence examines both under- and overuse of selected medical services, one cannot accurately predict the net effect of a more efficient system on expenditures.
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Whether these are manifested by fewer insured individuals or by the underinsurance of those with some type of benefits, CER provides the knowledge base by which providers of high-value services can advocate their continued use, using accepted scientific approaches to make their case. The findings of research that directly compares the pros and cons of available treatment options from numerous perspectives will be important for clinical practice, regardless of the cost containment/benefit reform approaches being considered.
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The status quo has been unable to align quality improvement and cost containment initiatives. In fact, in some instances they actually compete with one another, contributing directly to ineffiency [29]
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Health Affairs Web Exclusive, W457-475.
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Health Services Research 40(4)
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