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Statement on Health Care Research and Quality Improvement

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John Eisenberg, M.D., Administrator, AHCPR

President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, Quality Improvement Environment Subcommittee, November 18, 1997, Washington, D.C.


The Need for Information To Improve Quality
Challenges Facing Clinical and Health Services Research
Policy Options for Supporting Research
Examples of Collaborative Efforts
What Is Needed Now
The Role of Clinical Trials in Quality Improvement


Thank you for the opportunity to address the Advisory Commission's Subcommittee on Quality Improvement Environment on the critically important issue of health care research related to quality improvement.

The day after tomorrow—after the Commission completes the final stretch of deliberations on the Consumer Bill of Rights—it will engage an equally important task. While it is certainly important that we protect consumers' access to health care, it is also important that they have access to health care that is worth having access to—high quality health care that will make a difference in their lives.

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The Need for Information To Improve Quality

We can do a lot better for our patients. As was noted at a recent Institute of Medicine (IOM) conference, "some studies suggest that a fourth of hospital deaths may be unnecessary, one-third of some hospital procedures may expose patients to risk without improving their health, one-third of drugs prescribed may not be indicated, and one-third of abnormal lab tests have no followup." Also consider the recent work by other researchers, who have studied errors in clinical practice.

  • In a study of tertiary care hospitals, 28% of all adverse drug events—but 42% of those considered life-threatening or serious—were judged preventable (Bates, Cullen, Laird, et al., 1995).
  • Bedell and colleagues (1991) reported that at a university teaching hospital, 14% of cardiac arrests in which resuscitation was attempted followed an iatrogenic complication. Nearly two thirds of these events might have been prevented by stricter attention to the patient's history, findings on physical examination, and laboratory data.
  • Researchers for the Harvard Medical Practice Study (Brennan, Leape, Laird, et al., 1991) found that adverse events occurred in nearly four out of 100 hospitalizations, and that over a quarter of these events were due to negligence.

These conclusions, like that of many leaders in health care quality today, are that errors less often result from an individual making a mistake than from system-wide failures.

The improvement in health care quality will depend not only on traditional methods like excellence in education, continuing education, professional standards and principled practice behavior, as important as they are. It will also depend on our developing the science of clinical practice, on our taking a fresh look at ways of measuring and improving care, and on our holding both the practice of medicine and the practice of quality improvement to the same levels of scrutiny and evidence as we hold technical clinical innovations.

In a market-oriented health care system, we need information to inform choice at three levels—choice of plan, choice of provider, and choice of service. Without information that provides the evidence that a plan, a provider or a service will be beneficial, how can consumers or patients make informed choices? How can they make the market work for them? As Nan Hunter said at the Commission meeting last month, "Information plus choice equals power." That is the best bumper sticker for health care quality I could imagine. We do need to protect consumers' rights to access and choice, but we also need to assure that they have the information to choose wisely and that the options from which they choose provide high quality clinical care.

One of the perennial debates in this Nation has focused on the appropriate role of government in the market and in the economy. This has particularly been the case as markets and industries have gone through major changes—industry a century ago, financial markets three-quarters of a century ago, and so on. Today, as the health care industry undergoes its transformation toward more integrated systems of care and assumption of risk by provider groups and organizations, it is small wonder that we are debating the nature of that market, how consumers can use it most effectively, and the appropriate role of government in helping consumers benefit from the products and services the market has to offer.

As we think about the roles that government might play in assuring the quality of care in a market-oriented health care system, one in which information and choice are the keys to patients' access to quality health care, six roles come immediately to mind.

  • First, government can protect the rights of consumers, especially their rights of access to care.
  • Second, government can assure that information is available to consumers—and those acting on behalf of consumers—in choosing a health plan, or information for patients choosing a doctor or hospital, or selecting a diagnostic test or a treatment. Government can provide this information, or just be sure that the data are available through some other mechanism.
  • Third, in partnership with the private sector, government can ensure that the quality of care provided is measured, and that these measures are available to provide useful input and feedback to health plans, consumers, policymakers and providers.
  • Fourth, as a value-based purchaser, government can demand high quality health care for those for whom it is buying care, like Medicare beneficiaries or Federal employees.
  • Fifth, government can assure high quality care by walking the walk, even as it talks the talk. Government can improve health care quality by providing high quality care, for example in the Veterans Administration, in the military, and in community health centers.
  • And finally, government can build the foundation for quality care by sponsoring and carrying out research to measure quality and research to improve quality.

And it is this final role—a role that goes to the heart of what the Agency for Health Care Policy and Research (AHCPR) does—that brings me before you today.

Having spent a career in academic health centers, I joined the Clinton Administration and Donna Shalala's Department of Health and Human Services 7 months ago. My responsibility—as Administrator of the Agency for Health Care Policy and Research—is to help this relatively new agency—only 7 years old—fulfill its mission of generating and disseminating information that improves the quality of our health care system.

Another hat that I wear is that of Senior Advisor to Secretary Shalala on quality health care. AHCPR has been designated by Secretary Shalala as the Department of Health and Human Services' lead agency on quality of care. And as many of you already know, the responsibility of serving as liaison between the Department and the President's Advisory Commission is ours as well.

As the famous medical sociologist Renee Fox has written, there are two levels of uncertainty in health care—not knowing the facts about what is effective and not knowing whether anyone knows. AHCPR exists to fulfill the public responsibility of government to know—to provide the evidence that is needed about what works and doesn't work in health care practice and about how practice can be improved, resting on the evidence.

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Challenges Facing Clinical and Health Services Research

To accomplish our mission, we recognize the need to deal with the many challenges facing clinical and health services research today. Some of these challenges have perennial standing, but what is new is the rapidly changing organization of health care delivery, especially with the growth of health plans and the growth of integrated systems of delivering care.

In 1988, Andrea Kabcenell and I published an article entitled, "Organized Practice and the Quality of Medical Care" (Inquiry 1988; 25:78-89). We concluded that "the relationship between the organization of medical care and its quality transcends the question of the ownership of an organization and the distribution of its revenues. The increasingly organized nature of medical practice, whether for profit or not, offers both potential enhancements and barriers to the quality of care."

The trend toward organized practices has accelerated in the intervening decade, and the opportunity to use the changing nature of the industry to the benefit of the nation's health continues. As we wrote in 1988, "Instead of perceiving larger and more complex organizations as the destruction of high-quality medical practice, physicians can pool their professional power to ensure that the highest standards of professional responsibility are maintained." It is my belief in the opportunity that the changing nature of our industry offers for evidence-based practice, for information that guides choice, and for critical review and improvement of health care quality based on research that motivated me to accept Secretary Shalala's offer to work with her.

Even when confronting the shared goal of improving health care quality, health plans and researchers may approach the challenges differently. Plans may focus on the applied, on the immediately useful, on what translates into practice today. Researchers may seek the same, but are also tugged in other directions—to discover new insights, uncover new problems, and examine new solutions with rigorous and scientific inquiry. Each approach can contribute a great deal to the other, but the research enterprise requires certain key elements:

  • Training of researchers. An IOM survey (1995) found that many employers representing integrated health systems, pharmaceutical companies, consulting groups, and health insurers planned to double their complement of health services researchers by the year 2000. If the job market is a measure of workforce needs, then clearly health services researchers are in demand. On the supply side, others have also observed that the number of physicians choosing research careers has fallen. These trends point to the importance of ensuring an adequate pipeline for training our next generation of clinical and health services researchers. This involves not only support for trainees, but also for their institutions to support the multi-disciplinary environment for training and early career development.
  • Support for their research. At academic health centers, the financing for clinical and health services research has required not only Federal and industry support, but also internal cross-subsidies. However, the source of these subsidies, particularly surplus clinical income, is becoming more difficult to identify as academic health centers encounter lower payments under discounts to managed care health plans, support the higher costs of caring for more seriously ill patients, and shoulder a substantial portion of the continuing burden of uncompensated costs of caring for the indigent and uninsured. It is likely that the surplus clinical funds that are available will be claimed by those recognizing the need for the academic health center to invest in its clinical network, in clinical information systems, and in ambulatory care facilities. Less is likely to be available to train new investigators, to provide seed money for young investigators, and to sustain senior investigators. Under these pressures, academic health centers have made increasing clinical demands upon research faculty. Secretary Shalala appointed a task force in the Department to investigate the needs of academic health centers and that review will be available shortly.
  • Access to patients. With more patients in closed networks, concerns have arisen that researchers will have increasing difficulties in identifying and recruiting patients for their studies. Faced with the prospect of their health plan or insurer denying payment for patients opting into a clinical research program, patients may be less likely to enroll into clinical trials.
  • Access to data. As health plans increasingly use their administrative databases and patient survey data to plan market strategy, these data have often become guarded as proprietary. As plans capitate physician groups, there is less need for claims data which, in the past, was used not only to reimburse providers, but to serve as a database for researchers. The Medicare database has been particularly useful in this regard. The challenge will be to find ways in which researchers can still gain access to necessary data to conduct, publish, and share their research findings. Of course, the responsibility of researchers and those involved in quality improvement programs to preserve the confidentiality of these data is critical in abiding by the principles that the Commission has espoused on privacy.
  • Access to primary care laboratories. Just as important, researchers must develop means of collaborating with health plans, so that these networks can serve as primary care laboratories to test approaches to improve quality. A number of leading health plans have begun to work with the National Institutes of Health (NIH) to develop networks for clinical trials of new technologies. We know from previous work supported by AHCPR that these networks can serve as important laboratories to test the effectiveness of existing clinical services as well as to evaluate the impact of quality interventions. Many of our most pressing questions in primary care and in health care quality research can be answered only in these community-based settings.
  • Clinical information systems. Boosted by a mandate for administrative simplification under the Health Insurance Portability and Accountability Act (HIPAA), there is growing attention to, as well as investment in, clinical information systems. While protecting patient confidentiality where necessary, these systems could provide an important data source for clinical and health services researchers.

Together these factors make up the bricks and mortar, the infrastructure required for clinical and health services research. Without attention to each, we will not find shelter nor solution to the problems of underutilization, overutilization and inappropriate use of health care services.

In any economy there are public goods, those that anyone can enjoy whether he or she paid for them or not. One of the most important public goods in the health care economy is knowledge that emanates from scientific research, research that underpins the science of quality measurement and quality improvement. This research spans a continuum from the foundations of biologic research to clinical and health services research.

Research is empowering. Clinical research leads to better treatments. Measuring quality gives consumers and group purchasers the information required for choice. To compete on quality, health plans will want to apply the potential for improvements garnered from clinical and health services research to change practice. Put simply, clinical and health services research enables the health care market to work better.

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Policy Options for Supporting Research

In my view, it is the responsibility of government, in partnership with the private sector, to ensure that the science that underpins health care quality is available to those who follow us as clinicians, patients, managers and policymakers. It is particularly important to this Commission's agenda that one type of research—the design, testing and translation of measures of quality and methods of improving quality—be fostered. The improvement of quality will mature as the assessment of quality matures in a way that promotes effective, efficient, and reliable measurement, reporting, and improvement. Government can contribute to this partnership in at least five critical ways.

First, government supports and conducts basic research underpinning the science of quality measurement and quality improvement. Resting on the strong foundation of outstanding biologic research by our colleagues such as those at NIH, AHCPR supports health services research about the effectiveness and outcomes of care that serves as an essential building block for quality measurement.

Second, government can put science into practice by developing measurement tools and instruments and testing them on an ongoing basis to ensure their reliability, validity, and usefulness in improving the quality of health care services.

Third, as the work of this Commission shows, government can convene consumers, group purchasers, plans, insurers, researchers and others to work for the public good, such as the development of a core set of measures for comparing health plans. Government can ensure an open process and neutral ground.

A fourth, and unique, contribution of government is that the research, measures, and tools developed by us and our partners are in the public domain, available for all to use. By keeping measures and tools in the public domain, we raise the floor and level the playing field on which health plans, hospitals, and providers compete to improve quality. By funding research and publishing its results in the public domain, we encourage the sharing of best practices, that is, collaboration in a system of competition. By translating research into action, the products of scientific inquiry can be made available through appropriate methods of dissemination and distribution of research results.

A fifth major role of government is the implementation of quality measures within Government health programs. The Government is the largest purchaser of health care in the nation, accounting for more than 43 percent of health care dollars spent in this country, and is entrusted with the care of many of this nation's most vulnerable citizens. In the care that it purchases and the care that it provides, government can help to assure that the products of research are translated into action in the delivery of health care services.

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Examples of Collaborative Efforts

A few examples of collaborative research activities may demonstrate ways in which this partnership can translate research into improved tools for quality improvement:

  • Support the development of quality measures. In the area of child health, AHCPR, the Maternal and Child Health Bureau and the Health Care Financing Administration (HCFA) are funding the National Committee for Quality Assurance (NCQA) to pursue quality measures of relevance to children and adolescents. This funding will support the collaboration of NCQA and the Foundation for Accountability (FACCT) in the development, testing and implementation of child health measures, as well as their inclusion in future versions of the Health Plan Employer Data and Information Set (HEDIS).
  • Build the foundation for evidence-based practice. AHCPR has worked with the American Academy of Pediatrics to develop an evidence report on attention-deficit hyperactivity disorder,and with the American College of Cardiology and the American Heart Association to develop an evidence report on valvular heart disease. Along with evidence reports on colorectal cancer screening and the management of chronic headache pain, these reports served as prototypes for a new AHCPR initiative, the Evidence-based Practice Program. AHCPR has awarded 12 five-year contracts to institutions that will serve as Evidence-based Practice Centers (EPCs). The EPCs will review all the relevant scientific literature on health care topics assigned to them by AHCPR, receive input from other government agencies and the public, and conduct additional analyses when appropriate.
  • Encourage information exchange over best practices. In the fall of 1998, AHCPR, with the American Medical Association (AMA) and the American Association of Health Plans (AAHP), plan to launch a National Guideline Clearinghouse™. The Clearinghouse will provide access to the widest selection of guidelines available from public and private organizations by establishing an independent, interactive Web site.
  • Broaden the reach and direction of health services research. Together with the AAHP's Foundation, AHCPR will provide up to $7 million over a 3-year period to support studies that determine the impact of different features of health plans on outcomes and on the quality of care provided to patients with chronic illness. This is consistent with our belief that the organizational changes introduced by managed care should be evaluated in a scientific manner, as we would with clinical interventions, to understand the impact that they have on the health of patients, especially those with chronic disease.
  • Extend the work of Federal Government-supported investigators. Through an AHCPR-sponsored Patient Outcome Research Team, investigators discovered that only a minority of patients with atrial fibrillation who are at increased risk of embolic strokes receive the appropriate anticoagulation treatment. Through a jointly sponsored trial, funded by AHCPR and Dupont Merck, these investigators are now testing the effectiveness of interventions to improve the delivery and safety of anticoagulation therapy in managed care settings.
  • Deliver information products and tools. Since 1992, the AHCPR Clearinghouse has distributed over 27 million publications. As examples, the Pacific Business Group on Health distributed the Agency's booklets on back care to all the employers they represent, and the AHCPR-funded Consumer Assessment of Health Plans Survey (CAHPS®) is undergoing demonstration in several States and in the Medicare program.
  • Provide the seed for new products. Through a consortium of research grantees, AHCPR and HCFA have supported the development of CAHPS®. The CAHPS® instrument will be pilot tested and refined for public domain use, and the CAHPS® Survey User Network will provide technical assistance to others in using this product.
  • Support the conduct of clinical trials. AHCPR has supported over 30 clinical trials and has partnered with NIH and the Veterans Administration to support inclusion of health related quality of life (HRQL) measures and cost-effectiveness analysis in their research. These measures adopt and translate the fundamental work by health services researchers on measuring quality of life and health outcomes beyond simple mortality, morbidity and physiologic measures. Most recently this collaboration has been undertaken in the National Emphysema Treatment Trial, a randomized controlled trial to evaluate the effectiveness of lung volume reduction surgery.

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What Is Needed Now

Still, with all of our efforts, we have only just begun. To build a robust research enterprise that will support continuously improving health care for Americans, we must tackle several research challenges. A short list might include, but not be limited to:

  • Building the quality toolbox. We must fill the measure gap, for we cannot improve what we cannot measure. We especially need better measures for complex and chronic illnesses, that recognize cultural differences, for children in general and children with special health care needs, for those with disabilities, and for those who suffer from mental health or substance abuse problems. We also need global measures that summarize performance across various disease-specific measures.
  • Understanding and promoting organizational change for quality. We need to move beyond comparisons of fee-for-service and managed care to more useful units or levels of analysis. Even the terms are confusing, since fee-for-service and managed care are not mutually exclusive; many managed care organizations pay their doctors under fee-for-service arrangements. We need to move beyond "pockets of improvement" to organization-wide change. To do so, we need to understand the impact of particular features of managed care delivery systems and how they relate to quality. What are the determinants of organizational behavior and the process of organizational change?
  • Integration into clinical practice. To translate research into useful information and into clinical practice, we need to foster collaborations between researchers and health plans. The Dartmouth COOP, Ambulatory Sentinel Practice Network (ASPN) and Pediatric Research in Office Settings (PROS) network suggest another model worth considering. These are all practice-based research networks, comprised largely of physician practices, each collecting data on research questions that the network considers important to improving practice. In some, the participating clinicians generate the research questions, so the answers are more likely to be considered clinically relevant for their practices.

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The Role of Clinical Trials in Quality Improvement

AHCPR recognizes the value of clinical trials in improving health care quality. We have the responsibility of evaluating medical technology for our colleagues at HCFA; our Evidence-based Practice Centers will provide valuable assessments of the evidence about clinical services that can improve the quality of care in areas of medical uncertainty; and we are responsible for supporting the U.S. Preventive Services Task Force. In each of these activities, we seek the best available evidence to help clinicians and patients make decisions about which services to use, when and for which patients.

We also use clinical trials methods in some of our own sponsored research. Although there are several types of research upon which we rely, we generally hold clinical trials as the highest form of evidence. In this way, clinical trials are the foundation of evidence-based practice in American medicine. The results of these research efforts have led both to breakthrough advances in diagnosis, prevention and treatment, as well as to cost-savings in the health care system.

Clinical trials do not always involve "experimental" therapy, nor is experimental therapy always studied using a clinical trial design. Clinical trials may also compare two existing, already approved treatments for relative efficacy or for their effectiveness and cost-effectiveness, and this is often the nature of the clinical research that we sponsor. We need, as a Nation, to ensure that there is adequate support for both clinical and health services research—research funded by the NIH, the Centers for Disease Control and Prevention (CDC) and AHCPR that will enhance health care quality. The activities of other Federal agencies also contribute to this knowledge base. This is an important element in the Nation's health research agenda.

But the difficult decisions for this Commission have not revolved around debates about whether clinical trials benefit society or hold promise for some individuals. The question has been: who should pay? And the answer is far from simple, even for those of us who are the strongest advocates for clinical trials as an important component of the quality improvement agenda. I will not take a position in this debate today, but I do want to urge that we clarify the terms of the discussion. I am convinced that a substantial part of what seems to be disagreement is, in fact, a difference in how the elements of the discussion are being framed.

What is a clinical trial? Typically, a clinical trial refers to a prospective, planned investigation involving a sufficient number of patients to evaluate an experimental intervention in comparison to a control and/or existing treatment(s). Usually, patients are randomized into the experimental or control arms of the study, hence the term "randomized controlled trial."

First, all trials are not equal. One might imagine, at one end of the spectrum, the sophisticated, multi-center randomized controlled trial of an important new clinical service (or several established ones) with Federal sponsorship by a research agency, reviewed and approved by a critical panel of scientific peers, approved by an Institutional Review Board (IRB) for ethical and procedural standards, conducted under the oversight of a panel for outside review of the trial's implementation, and committed to releasing its findings in a peer-reviewed journal. These are the standards used, for example, by many clinical trials sponsored by the National Cancer Institute or the Veterans Affairs Cooperative Studies Program. At the other end of the spectrum, the advocate of a controversial service might decide to collect some information to compare his patients with those treated with an alternative treatment. In between are randomized controlled trials sponsored by industry under strict guidelines for their design and conduct by the Food and Drug Administration (FDA), randomized trials that are conducted by clinicians without external support but with IRB approval, and trials that are not randomized but rather allow patients to select which arm of the study they will enter. Before deciding that entry into a trial should be afforded all patients, or that a trial's costs should always be covered, the types of trials that are being discussed should be more clearly articulated.

Similarly, the costs that are to be covered can range from minimal to monumental. In some trials, the patients are receiving standard care, but one intervention is added that will have little impact on overall costs (or could even make care less expensive). For example, pain management after surgery is unlikely to add substantial costs, and it would make little sense to deny coverage for the surgery on the grounds that the patient was in a clinical trial. In other instances, the principal intervention may be randomized, but the patient would have required care in any case, such as is often the case with the use of different combinations of chemotherapeutic agents for cancer patients. Costs might be increased, at least in the short term, by introducing a more expensive intervention, or by introducing a treatment when none would otherwise be available.

Which costs should be covered by the research sponsor and which should be covered by the party responsible for covering the costs of medical care? Almost all would agree that the research sponsor should cover the costs of research design, trial organization, randomization, data analysis, and reporting results. Most would agree that the third-party payer (the plan, the insurance company, etc.) should pay for standard care that is part of its package of covered services. But who should cover the costs of the intervention itself; the additional costs of hospitalizations, diagnostic tests or followup visits required by the protocol; the cost of complications of the experimental intervention (especially if those complications require services that would normally be covered); the costs of transportation or lodging required by the patient and family? I know personally how difficult it can be to identify and enumerate these costs, having spent several years before joining AHCPR carrying out costing and cost-effectiveness analyses of clinical trials. There is too little unbiased literature on the cost of clinical services in a clinical trial. This uncertainty clouds the debate about who should pick up the costs.

Adding to the complexity is the spectrum of possible payment arrangements. A clinical trial might be eligible for coverage at a particular hospital, at selected centers of excellence, or within a particular health delivery system. For example, through an Inter-Agency Agreement with the National Cancer Institute (NCI), the Department of Defense (DoD) offers patients the opportunity to participate in clinical trials for cancer. They can do so either in the direct care system of 120 military hospitals or, in limited circumstances, under the care of civilian providers reimbursed through TRICARE/CHAMPUS. Coverage is limited to Phase II and Phase III clinical trials for cancer. Under this arrangement, DoD pays for all medical care required as a result of participation in approved clinical trials, but NCI foots the costs of non-treatment research activities associated with participation in clinical trials (including, but not limited to "data collection activities, management and analysis of the data, salaries of the research nurses, and the cost of the investigational agents"). Similarly, the Veterans Administration (VA) has entered into an agreement with NCI. Again the VA would assume the costs of all medical care associated with the clinical trial, but the NCI would provide funding for the research costs of participation.

As these negotiated arrangements indicate, there are many components to cost sharing between the clinical trial research sponsor and the health plan or insurer. In 1996, Blue Cross and Blue Shield Association (BC/BS) established the Pediatric Cancer Network. Through centers selected on quality-based facility standards and on-site review, BC/BS beneficiaries can participate in cooperative, multi-institutional clinical trials for pediatric cancer. In the case of some medical devices, the implantation of a next generation pacemaker might be such a modest incremental change that a third-party payer might cover the investigational device itself. In still other arrangements, the health plan might pick up both the costs of research and clinical care rather than face adverse publicity, state benefit mandates for unproven treatments, or litigation.

These complexities suggest an important role for technology assessment in determining future coverage. When does experimental therapy become standard practice? One approach is to limit coverage to centers where ongoing data is collected to evaluate a service's effectiveness and complications outside a trial, such as has been done with heart transplant surgery. Another alternative, which maintains the requirement for randomization as well as evaluation, is to offer conditional coverage, such as coverage contingent on patients being entered into a clinical trial sponsored by an approved organization.

The Lung Volume Reduction Surgery trial is a case in point. Medicare beneficiaries can receive coverage for lung volume reduction surgery (LVRS)—an investigational procedure that removes damaged, non-functional lung tissue from patients in the last stages of emphysema—by entering a randomized trial. HCFA discovered that providers billed for LVRS using codes that are assigned to other types of lung surgery that are covered by the program. At the time, there was only one published article available, and it described the short-term experiences of only 20 patients. HCFA denied coverage for the procedure, but requested that AHCPR conduct a full technology assessment. Drawing upon published and unpublished data on 3,000 LVRS procedures from 27 hospital centers, the Agency found that "it could not reasonably be concluded at this time that the objective data permit a logical and scientifically defensible conclusion regarding the risks and benefits of LVRS." Based on AHCPR's findings and recommendations, the National Heart, Lung and Blood Institute of NIH in collaboration with HCFA have undertaken a multi-center, randomized clinical study of the effectiveness of LVRS. Medicare will cover the patient care costs of beneficiaries who participate in the study, and NIH will coordinate the clinical trial and pay for the research costs. In addition, AHCPR is funding a cost-effectiveness analysis of the LVRS trial.

Thus, the issue of financial support for clinical services that are provided in a clinical trial is not a simple matter. Are we discussing standard care for patients in a federally funded, peer-reviewed trial, or all clinical costs in a non-randomized comparison of two services by the advocate for one of them? We need a better nosology for the types of costs and trials that are being discussed, as well as more information about the magnitude of these costs given the different definitions that might be used.

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To conclude, the President's Advisory Commission has a rare opportunity to signal the importance of clinical and health services research to improving the quality of health care in this nation. Research will enhance the quality of care that we can provide, and enable us to measure and improve the quality of care we do provide. I believe that few enterprises return so much for so little investment. But it will take just that—investment in our researchers, their institutions, and their work. As the Department of Health and Human Services' lead agency on quality, we look forward to the opportunity to respond to the recommendations that you will send to the President.


Bates DW, et. al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. Journal of the American Medial Association 274(1):29-34, July 5, 1995.

Bedell SE, Deitz DC, Leeman D, and Delbanco TL. Incidence and characteristics of preventable iatrogenic cardiac arrests. Journal of the American Medical Association 265(21):2815-2820, June 5, 1991.

Brennan TA, et. al. Incidence of adverse drug events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. New England Journal of Medicine 324(6):370-3767, February 7, 1991.

Eisenberg JM, Kabcenell A. Organized practice and the quality of medical care. Inquiry 25(1):78-89, 1988.

Field M, Tranquada R, Feasley J (Institute of Medicine). Eds. Health Services Research: Work Force and Education Issues. Washington, DC: National Academy Press, 1995.

Leape LL. Error in medicine. Journal of the American Medical Association 272(23):1851-1857, December 21, 1994.

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