President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry

Building the Capacity To Improve Quality

Chapter Eleven
Fostering Evidence-Based Practice and Innovation

Improving the quality of American health care and enhancing Americans' health requires a commitment to delivering health care based on sound scientific evidence and continuously innovating new, effective health care practices and preventive approaches. The lack of evidence supporting effective health care practices contributes to inappropriate care as highlighted in Chapter 1. Encouraging evidence-based practice, and thereby promoting appropriate, effective health care, requires a robust health care research enterprise, careful assessments of the effectiveness of health care technologies and practices, and approaches to encourage the widespread dissemination of effective health care.

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.


A Robust Research Enterprise

A robust health care research enterprise, including basic, clinical, health services, and prevention research, is critical to improving the quality of health care. Health care research has the potential to develop better treatments to improve health status and functional capacity; identify preventive approaches to avoid illness, injury, and disability; and evaluate effective, high-quality approaches to delivering care. As the health care system undergoes dynamic changes, however, health care research faces a variety of challenges, including competitive pressures on the network of research centers, a shortage of trained investigators, and difficulty in enrolling patients in clinical trials. Resolving these concerns requires continued public commitment to supporting research and increased collaboration between researchers and public and private sector organizations that provide research funds.

Research Infrastructure and Workforce

Expanded public and private funding of health care research needs to be accompanied by a robust research infrastructure and a workforce of highly qualified investigators. The highly competitive health care market poses challenges to academic health centers and may threaten the subsidies that clinical revenues provide for research and education (HHS, 1997). One study estimates that clinical services delivered by medical school faculty raised more than $800 million in 1993 that was used to subsidize clinical research -- an amount equal to about one-fifth of the funding medical schools received from NIH grants (AAMC, 1997). The costs that academic health centers incur due to their research and teaching functions, as well as the disproportionate share of uncompensated care that many provide, leads to charges that have been estimated to be as much as 15 percent to 35 percent higher than community hospitals, even after adjusting for case-mix differences (Skirboll, 1997; Blumenthal and Meyer, 1996). These higher charges can make it difficult for academic health centers to compete with other health care delivery organizations.

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).

Enrollment in Clinical Trials and Data Availability

Researchers report concerns about maintaining access to patients for clinical research. The current ambiguity in payment responsibility between the patient's health plan and research sources is complicated by the difficulty in assessing whether marginal costs result from a research protocol or standard patient care. In addition, the willingness of third parties to make reimbursement may depend on whether a clinical trial is NIH-funded or approved or has been reviewed by an external institutional review board. More clarity and consistency in the definition of investigational or experimental treatments may resolve some of the existing ambiguity in payment responsibility (Eisenberg, 1997).

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.

Technology Assessment Needed

A commitment to evidence-based health care requires that health care procedures, devices, pharmaceuticals, and other technologies be assessed for their clinical efficacy, cost-effectiveness, appropriateness, and outcomes. Because many new health care innovations and existing health care practices have only limited clinical evidence demonstrating their effectiveness, a key challenge is increasing the evidence base supporting the best approaches for improving the public's health. Developing this evidence base will require a long-term commitment to develop evaluations of the effectiveness of health care practices. Technology assessment -- broadly applied to include health care procedures and techniques as well as equipment and drugs -- is an important process that draws on evidence generated by all forms of health care research to evaluate the clinical and cost effectiveness of new innovations as well as existing health care practices. While much of the focus of technology assessment in the private sector has been on supporting health plans' coverage decisions, it also is a valuable tool for aiding the diffusion of effective health care practices through experimentation and adaptation of new innovations and providing health practitioners with evidence regarding their effectiveness.

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.

Disseminating Effective Practices

Once effective health care innovations are identified, effective approaches to disseminate these practices need to be developed. These include establishing guidelines for the use of effective health practices, disseminating this information, and providing technical assistance to help health organizations and practitioners adopt effective health practices. Ultimately, however, the diffusion of effective health care practices depends on health organizations and practitioners changing established practices and adopting new innovations. This often requires health care organizations to change their culture to encourage innovation internally, collaboratively share knowledge of innovations, and be receptive to incorporating and adapting innovations in their practices (see Chapter 12). The success of such voluntary collaborative efforts among health care professionals is demonstrated by efforts such as the Northern New England Cardiovascular Disease Study Group, Maine Medical Assessment Foundation, and Dartmouth Primary Care Cooperative Information Project (O'Connor et al., 1996; Conway, Keller, and Wennberg, 1995; Wasson et al., 1995).

Table 1:
Examples of Efforts To Better Disseminate
Health Care Improvements

Institution Type Role Approach
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


Agency for Health Care Policy and Research, Department of Health and Human Services, AHCPR Selection of Topics for Evidence-based Practice Centers (Rockville, MD: 1997).

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.

O'Connor, Gerald T., Stephen K. Plume, Elaine M. Olstead, et al., "A Regional Intervention to Improve the Hospital Mortality Associated With Coronary Artery Bypass Graft Surgery: The Northern New England Cardiovascular Disease Study Group," Journal of the American Medical Association 275(11):841-846, 1996.

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).

Rogers, Everett M., Diffusion of Innovations, 4th edition (New York: Free Press, 1995).

Skirboll, Lana R., "The Impact of Managed Care on Research: The Changing Face of Medicine," Academic Medicine 72(9): 778-779, 1997.

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.


  1. In addition, the Health Care Financing Administration and the National Institutes of Health are collaborating to conduct a randomized clinical study of the effectiveness of lung volume reduction surgery, with Medicare paying the inpatient care costs for participating beneficiaries.

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Last Revised: Sunday, July 19, 1998