Therefore, the Commission recommends bolstering public and private sector funding of basic, clinical, prevention, and health services research; strengthening the scientific evidence base for health care practices through further collaboration in technology assessment and research targeted to filling gaps in existing knowledge; and encouraging dissemination of innovations that have been demonstrated to be effective.
Collaborative arrangements between researchers and public and private sector organizations supporting research should be developed to provide additional funding for research, make patients available for approved clinical trials, and provide training opportunities. Private sources, including pharmaceutical and health care supply manufacturers, health plans, and foundations, are increasingly important for funding health care research. A summit meeting of key leaders in research, including academic health centers, government, health plans, health care professionals, pharmaceutical and equipment manufacturers, and not-for-profit foundations is a positive first step in furthering collaborative relationships. In addition, the NIH Clinical Research Panel's interim recommendations provide a strong starting point for enhancing training and career opportunities for researchers.
Research should be targeted to address areas where the greatest improvements in health and functional status of the population can occur and where gaps in knowledge exist. The establishment of national aims for improvement can provide guidance in setting an appropriate research agenda. Research should be focused on preventing, diagnosing, and treating conditions that are prevalent, costly, and where needed improvements are most likely to occur.
Public and private sector organizations should pursue greater collaboration in conducting health care technology assessments. The current pluralistic approach to technology assessment can be improved through developing an online directory of existing and ongoing technology assessments and developing a process for organizations relying on technology assessments to provide feedback to researchers regarding areas where additional research is needed to evaluate the effectiveness of health care practices.
More complete and rapid dissemination of effective health care practices should be supported by encouraging public and private organizations to share knowledge of innovations, synthesize evidence on effective health care practices, develop practice protocols, disseminate information, and provide technical assistance to practitioners. Synthesizing the existing clinical literature and developing practice guidelines are essential steps in support of evidence-based health care practices. To encourage their acceptance, practice guidelines should be developed by credible sources, allow for local adaptation, actively involve local clinical leaders, and enable practitioners to use clinical judgment in determining their applicability to particular patients. Because merely disseminating information has proven insufficient to ensure the widespread diffusion of effective health care practices, these efforts should be accompanied by technical assistance and implementation programs that encourage the adoption of effective health care practices.
Prevention and health services research also require increased support. Prevention research can identify effective approaches to prevent the onset of illness, injury, and disability. Public health and community-based research efforts, including surveillance and epidemiology, play a critical role in improving prevention efforts, providing evidence of disease trends, and identifying risk factors that contribute to poor health and functioning.
Major structural changes continue in health care, as most health care is now financed through a variety of managed care arrangements, the delivery of care increasingly occurs in outpatient settings, and health care organizations restructure to contain costs and provide quality patient care. Health services research can provide the rigorous evaluation necessary to assess the effects of these ongoing dynamic changes on costs, quality, and access. In addition, health services research is critical to the goal of evidence-based health care in its focus on assessing outcomes, cost-effectiveness, and appropriateness of new and existing health practices and developing new quality improvement approaches.
While there is significant overlap, there are differences in the locus and sources of funding of the different types of health care research. For example, academic health centers, health plan-based research centers, and other private research centers conduct a wide range of research activities, but each emphasizes research at different points on the continuum. Academic health centers generally focus on basic and translational research with an emphasis on clinical research, including clinical trials. Health plan-based research centers often focus on clinical and health services research that will have direct applicability to the care provided for conditions common among their enrollees. There is also an important role and need for increased emphasis for research conducted in primary care and ambulatory settings where an increasing share of health care is delivered. Federally qualified health centers, including community health centers, migrant health centers, and rural health clinics, also provide an important venue for conducting public health research. Private research centers highlight applied research that supports the development of new commercial health care products. Publicly sponsored funds are directed toward more basic health care research and prevention, whereas private funding sources, including major contributions from pharmaceutical and other manufacturers and subsidies from the clinical services provided within a research setting, are largely dedicated to applied research.
In addition to investing in research aimed at developing and assessing effective health care practices, a similar commitment should be dedicated to research on preventing the onset of health care conditions. For example, the President has proposed $25 million in initial funding in fiscal year 1999 for Prevention Research Centers to bolster the $125 million that the Centers for Disease Control and Prevention dedicated in fiscal year 1998 to prevention research activities. These Prevention Research Centers would develop a collaborative network of academic centers committed to research that benefits public health through enhancing prevention and focusing on behaviors that put Americans at risk for chronic health conditions.
Researchers increasingly have relied upon private sources and clinical revenues for funds. Funds for health research and development increased by 10.5 percent annually between 1984 and 1994 (Mechanic and Dobson, 1996), but the source of research money has shifted from predominantly public sector (45 percent of funds in 1993 compared to 56 percent in 1983) to private sector sources (50 percent in 1993 compared to 39 percent in 1983) (NIH, 1996). The pharmaceutical industry, for example, invests $19 billion a year in research (Bello, 1997).
In addition, academic health centers face increased competition from private research centers as a greater share of funding flows to these entities from industry sources. One analyst estimates that these contract research organizations currently manage one-half to three-quarters of Phase III and Phase IV clinical trials (Blumenthal and Meyer, 1996). Although the portfolio of health care research conducted by academic health centers and private research centers often differs, traditional research institutions are facing increased competition not only in the funds available for research, but also in the increasing array of organizations available to provide research capability.
The supply of trained researchers poses another concern. A declining number of health care professionals pursuing careers in research has led some analysts to refer to clinical investigators as an "endangered species" (Thompson and Moskowitz, 1997). The high educational debt burden facing most medical school graduates -- often exceeding $100,000 -- makes it difficult for many to accept typically lower paid research positions, and nurses and other health care professionals also face difficulties in pursuing careers in research. Furthermore, as the number of applications for NIH grants has increased and the average term of funding for approved grants has become longer, the share of new grant applications that successfully receive NIH funding has declined. As a result, young clinical investigators, in particular, may find it more difficult to receive grant funding that allows them to establish their careers in research (Pew, 1996). This has led some analysts to propose debt forgiveness programs for students pursuing research careers, additional training programs, and expanded career recognition for researchers. The NIH Clinical Research Panel's interim report recommends that NIH:
Established clinical researchers also face increasing pressure to expand their clinical practices, often at the expense of the time they are able to dedicate to their research (Mechanic and Dobson, 1996). A case study of seven academic health centers found that "all were placing less emphasis on their teaching and research functions" (Blumenthal and Meyer, 1996).
The extent to which third-party payments are available for patients in clinical trials varies widely. Many health plans pay for the care either because they are unaware it is provided in a research context or because they explicitly approve coverage of such care. Other health plans pay for standard care that would have been provided outside of research protocols, but exclude costs that they determine are associated with research. Some health plans choose to deny payment for care within clinical trials because of their experimental nature or due to lack of evidence of the safety, efficacy, or cost-effectiveness of the care. For example, it is Medicare's policy not to reimburse routine patient care costs for beneficiaries enrolled in a clinical trial. A survey of physicians participating in cancer clinical trials, however, suggests that Medicare reimbursement denials are rare (GAO, 1997). The President's fiscal year 1999 budget proposes a 3-year demonstration that would provide Medicare coverage of patient care costs associated with NIH-sponsored cancer treatment clinical trials, but other clinical trials would remain ineligible for Medicare reimbursement.1
In addition, public health, prevention, and health services research efforts in particular require better availability of community and patient-level data. Assessing outcomes and evaluating the effectiveness of health care interventions, monitoring disease trends and the impact of prevention programs, and assessing the effects of dynamic changes in health care delivery systems depend on ready access to timely, comparable, and comprehensive data. The Federal Government should continue to coordinate with private entities to enhance the public availability of such data for research and other purposes while maintaining rigorous standards of confidentiality to protect consumers (see also Chapter 14).
The trend toward most consumers being enrolled in health plans that require or encourage the use of a network of health care facilities and practitioners provides both opportunities and challenges for researchers seeking to establish enrollment in clinical trials and gain access to data. Managed care plans with large, integrated networks of enrollees can provide a fertile source of research opportunities, including a large base of patients for conducting research, the ability to track care across different settings and practitioners, and the availability of data to assess outcomes (Platt, 1997). But, to the extent that academic health centers and other research facilities are not represented in health plan networks, the flow of patients into clinical trials is curtailed. Similarly, the shift from inpatient to ambulatory care settings has complicated identifying and evaluating patients and obtaining comparable, accessible data for research purposes.
There are examples of existing collaborative arrangements between health plans and clinical researchers. A survey identified 20 HMO-based research centers with 1996 budgets of $93 million (Nelson, Quiter, and Solberg, 1998). Such research centers include those sponsored by Group Health Cooperative of Puget Sound, Harvard Pilgrim Health Care, and Kaiser Permanente. In exchange for funding, health plans are able to target research priorities to areas of particular concern to their enrollees and to have the research occur within the setting of their plan. Similarly, academic health centers increasingly are affiliating with managed care plans or developing their own integrated delivery networks to allow for continued support of clinical research. These trends provide the foundation for closer collaborative working relationships between health plans and researchers.
Other efforts also are being undertaken to encourage more fruitful collaborative arrangements between researchers and funding sources. NIH has initiated ongoing dialogs with managed care plans, the pharmaceutical industry, and philanthropic organizations seeking further collaborative efforts among these groups to support research (NIH, 1996). The American Association of Health Plans (AAHP) has endorsed a statement that supports patients having access to NIH-approved clinical trials and health plans establishing linkages with such trials, including, if plans choose to participate, covering associated routine patient care costs (AAHP, 1997). In addition, AHCPR and AAHP are collaborating to provide $7 million in support of evaluations of outcomes in the care of chronic disease in different care settings.
Finally, a recent proposal calls for convening a clinical research summit of key leaders in research, Federal agencies, health plans, and manufacturers to (1) establish a process for setting broad national goals in research, (2) seek enhanced flexibility in using Federal/State funding, (3) restructure clinical research training, and (4) annually report progress in achieving goals (Thompson and Moskowitz, 1997). The Association of American Medical Colleges and the American Medical Association have initiated planning for such a summit to be held in late 1998. While these discussions are good initial efforts, timeframes should be set for tangible agreements to be established and collaborative arrangements implemented in the near future (such as 1 year).
In general, technology assessments are conducted independently by health plans to make benefit coverage determinations, manufacturers to identify research needs and support marketing efforts, and health care delivery organizations to develop treatment protocols and make equipment purchasing decisions (Rettig, 1997). More than 50 public and private sector organizations conduct technology assessments, including Federal and State agencies, gateway.html organizations, health plans, professional societies, health industry manufacturers, and hospitals (Kamerow, 1997). Increased collaboration and cooperation would reduce unwarranted duplication, provide more consistency in health plans' coverage decisions and health care professionals' practices, and better target resources to assessing health care practices that have not yet been demonstrated to be effective. Furthermore, collaborative efforts among government, health plans, hospitals, and manufacturers would enable technology assessments to be undertaken that would be too expensive for a single entity to pursue (IOM, 1994; PPRC, 1994).
Several collaborative efforts have been developed. The Technology Evaluation Center, a collaborative effort of the Blue Cross and Blue Shield Association and Kaiser Permanente, provides technology assessments to member plans that can use the information in making coverage decisions (Gleeson, 1997). Other health plans, such as Prudential and Aetna, also maintain programs to conduct technology assessments, and other independent centers provide these services for health plans and other organizations (Rettig, 1997). A new initiative of the Agency for Health Care Policy and Research, evidence-based practice centers, is intended to promote the development of syntheses of clinical research to provide information for public and private organizations to use in developing practice guidelines, performance measures, and other quality improvement approaches (AHCPR, 1997).
Further cooperation in performing technology assessment could be achieved by establishing an online directory of existing and ongoing assessments. This information would enable better public dissemination of evidence of the effectiveness of health care practices and prevent unnecessary duplication in performing technology assessments. In addition, better processes should be developed to allow feedback from organizations performing and relying on technology assessments to researchers to improve the scientific evidence that supports health care practices.
An "extension service" model, in which professionals with technical expertise regarding effective practices are available to provide a bridge in knowledge between researchers and practitioners, has been effective in other industries (such as agriculture) and health care (such as the use of academic detailing). The Agricultural Extension Service, developed to disseminate the research findings of agricultural colleges to farmers by way of county agents, has been cited as a model of effective diffusion of technical research to practitioners in the field. County agents provided technical assistance by translating technical research into practical methods and promoted these methods for farmers to adopt. Lessons learned from the Agricultural Extension Service model include:
Applying these lessons to health care suggests a need for closer collaboration between clinical researchers, health plans, and health care practitioners (as discussed above) and enhanced efforts to synthesize and translate clinical research innovations into practice protocols (discussed below).
The development and dissemination of practice guidelines based on evidence of clinical effectiveness, however, have not proven sufficient to lead to widespread change in health care professionals' behavior. Studies have found a significant lag between the publication of a clinical advance and its adoption into clinical practice. For example, a Florida study regarding the mandated dissemination of practice guidelines on cesarean sections concluded that "the mere dissemination of practice guidelines by a state agency may not achieve either the magnitude or the specificity of the results desired without an explicit and thorough guideline implementation program" (Studnicki et al., 1997). Similar findings elsewhere have led to a recognition of the need to ensure that information on effective health care practices is not merely disseminated, but that the information is distributed in a manner that encourages its adoption and includes follow-up programs and efforts targeted to individual providers.
Although many guidelines have been developed by highly credible organizations, the local adaptation of guidelines is an important factor in their adoption by health practitioners. Adapting guidelines allows local clinical input by practitioners, who can in turn encourage the use of the guidelines; incorporates specific needs of the plan's enrolled population; validates the need for the guideline with local plan information that may be more credible to the health practitioners who will be called upon to adapt their practices; and counters a sense of threat posed by external mandates. This direct involvement of local clinical leaders in assessing the need for guidelines is particularly important because "physicians are more likely to alter divergent behavior if they are involved in the process of assessing their own practices" (Kassirer, 1993). Local adaptation of nationally developed guidelines, however, may in some cases compromise the integrity of the guideline or undermine the goal of minimizing variation in health care practices.
Further experimentation should focus on designing appropriate methods to encourage changes in clinicians' behaviors that reinforce effective health care practices. General examples of these approaches include education (e.g., academic detailing, continuing education programs, and practice guidelines); feedback (e.g., peer comparisons on outcomes and use); participation of health care professionals in improvement efforts (e.g., practice-based research networks); administrative interventions (e.g., computerized decision support systems); and financial incentives to reward quality performance (Greco and Eisenberg, 1993).
The collaborative sharing of knowledge regarding innovations in effective patient care should be encouraged among health care delivery organizations, health plans, and practitioners because maintaining proprietary knowledge of advances can stymie the diffusion of effective health care practices that would benefit patients. Current public and private sector efforts, such as the funding of evidence-based practice centers by the AHCPR and the reformed quality improvement organizations providing services to HCFA and other group purchasers, are positive steps furthering the dissemination of effective health care practices. Examples of ongoing public, private, and collaborative efforts to synthesize research on how to improve health care and disseminate these findings are summarized in Table 1.
Examples of Efforts To Better Disseminate
Health Care Improvements
|NIH Consensus Development Program||Federal Government-sponsored panels of clinical experts||Consensus-based guideline development||Conferences, Consensus and Technology Assessment Statements|
|Cochrane Collaboration||International network of practitioners and academic institutions||Meta-analyses of randomized clinical trials and other research||Computerized dissemination of research syntheses|
|Evidence-Based Practice Centers||Public-private partnership (AHCPR, academic health centers, professional societies)||Develop evidence reports and technology assessments in broad health areas||Evidence reports to guide public and private sector development of practice guidelines|
|National Guideline Clearinghouse||Public-private partnership (AHCPR/AMA/AAHP)||Catalog available practice guidelines||Intended to provide Internet availability of practice guidelines|
|Professional societies (e.g., American College of Physicians' Clinical Efficacy Assessments)||Professional associations||Consensus- or evidence-based guideline development||Journals and other professional association publications, continuing education programs|
|U.S. Preventive Services Task Force||Federal Government-sponsored panel of health care experts||Evidence-based guidelines on clinical preventive services||Publishes and periodically revises Guide to Clinical Preventive Services|
|CDC-sponsored programs (e.g., Task Force on Community Health Services)||Federal Government-sponsored panels of clinicians, public health officials, and experts||Consensus and evidence-based guidelines on preventive services and community-based interventions||Published guidelines, such as Reports and Recommendations Series of Morbidity and Mortality Weekly|
|Practice-based research networks, (e.g., Dartmouth Cooperative)||Voluntary networks of independent clinicians||Practitioners' participation in research/dissemination in practice settings||Involvement of practitioners in research and applying methods in practice setting|
|Quality Improvement Organizations (also known as Peer Review Organizations)||Not-for-profit organizations in all 50 States that contract with HCFA and other group purchasers||Conduct improvement projects to assess practice patterns, implement improvements, measure outcomes, and provide feedback||Organizations involved in projects on prevention, disease management, analysis, utilization review, evaluation, and program integrity|
|Institute for Healthcare Improvement (also sponsors Group Practice Improvement Network and Quality Management Network)||Private, not-for-profit organization||Collaborative efforts of health care organizations to identify, synthesize, and apply evidence-based best practices, track implementation||Participating organizations apply and test innovations in practice settings, broader dissemination through Breakthrough Series|
American Association of Health Plans, "AAHP's Board Votes to Work With NIH to Advance Nation's Research Agenda" and "Health Plans' Role in Patient-Centered Clinical Research Expanding," June 1997.
Association of American Medical Colleges, Academic Medicine: Institutions, Programs, and Issues (Washington, DC: 1997).
Bello, Judith H., testimony before the Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, November 18, 1997.
Blumenthal, David, and Gregg S. Meyer, "Academic Health Centers in a Changing Environment," Health Affairs 15(2):200-215, 1996.
Conway, Ann C., Robert B. Keller, and David E. Wennberg, "Partnering with Physicians to Achieve Quality Improvement," Joint Commission Journal of Quality Improvement 21(11):619-626, 1995.
Department of Health and Human Services, Report by the Task Force for the Initiative on the Future of Academic Health Centers (October 7, 1997).
Eisenberg, John, testimony before the Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, November 18, 1997.
General Accounting Office, Cancer Clinical Trials: Medicare Reimbursement Denials, GAO/HEHS-98-15R (October 14, 1997).
Gleeson, Susan, testimony before the Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, December 16, 1997.
Greco, Peter J., and John M. Eisenberg, "Changing Physicians' Practices," New England Journal of Medicine 329(17):1271, 1993.
Institute of Medicine, Medical Innovation at the Crossroads, Volume 4: Adopting New Medical Technology (Washington, DC: National Academy Press, 1994).
Kamerow, Douglas, testimony before the Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, December 16, 1997.
Kassirer, Jerome P., "The Quality of Care and the Quality of Measuring It," New England Journal of Medicine 329(17):1263, 1993.
Kassirer, Jerome P., and Marcia Angell, "The Internet and the Journal," New England Journal of Medicine 332(25):1709-1710, 1995.
Mechanic, Robert E., and Allen Dobson, "The Impact of Managed Care on Clinical Research: A Preliminary Investigation," Health Affairs 15(3):72-89, 1996.
National Institutes of Health, Department of Health and Human Services, Interim Report of the NIH Director's Panel on Clinical Research (December 1996).
Nelson, Andrew F., Elaine S. Quiter, and Leif I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs 17(1):128-138, 1998.
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Pew Charitable Trusts, Trends in U.S. Funding for Biomedical Research (San Francisco: Center for the Health Professions at the University of California, 1996).
Physician Payment Review Commission, Coverage Decisions and Technology Assessment, Annual Report to Congress, 1994 (Washington, DC: 1994).
Platt, Richard, testimony before Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, November 18, 1997.
Rettig, Richard A., testimony before Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, December 16, 1998; and Health Care in Transition: Technology Assessment in the Private Sector (Santa Monica, CA: RAND, 1997).
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Studnicki, James, Randall J. Remmel, et al., "The Impact of Legislatively Imposed Practice Guidelines on Cesarean Section Rates: The Florida Experience," American Journal of Medical Quality 12(1):62-68, 1997.
Thompson, James N., and Jay Moskowitz, "Preventing the Extinction of the Clinical Research Ecosystem," Journal of the American Medical Association 278(3):241-245, 1997.
Van de Ven, Andrew H., testimony before Subcommittee on a Quality Improvement Environment, Advisory Commission on Consumer Protection and Quality in the Health Care Industry, September 9, 1997.
Wasson, John H., Steven W. Kairys, Eugene C. Nelson, et al., "Adolescent Health and Social Problems: A Method for Detection and Early Management," Archives of Family Medicine 4(1):51-56, 1995.