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7 The Clinical Perspective Paul F. Griner The IOM's core committee, which generated the report on the Effective- ness Initiative, suggested a number of objectives that would be achieved by effectiveness research. First, the knowledge gained would help clinicians in their day-to-day management of patients. Second, it would improve the peer review process. Third, it would aid policymakers in the allocation of Medicare resources. I believe this knowledge will also affect patient participation in decision making and the organization and delivery of health care. The extent to which the knowledge gained from this initiative will be applied in the real world will be determined by a number of very complex factors. Some will affect the provider, some the patient, and some the item within which they both operate. My purpose in this chapter is to suggest some of the issues that I believe require attention if the knowledge gained from the Effectiveness Initiative is to be used to its fullest advantage. ISSUES IN THE USEFULNESS OF EFFECTIVENESS RESEARCH There are five issues in particular that I would like to focus on. First, the knowledge must have attributes that are important to the provider; second, it must be readily accessible; third, it must facilitate patient involvement; fourth, financial incentives must be in line with the directions suggested by the new knowledge; and finally, as I see it, the problem of unbalanced regulation within the health care industry must be corrected. MEETING PHYSICIANS' NEEDS The first requirement bears on the credibility and usefulness of the information to the provider. The need is obvious for accuracy, relevance, and measures 38

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PERSPECTIVES ON EFFECTIVENESS ED OUTCOMES RESEARCH 39 of outcome that go well beyond morbidity and mortality, measures that are meaningful and that do not suffer the constraints of data collected princi- pally for purposes of payment. Not enough has been said, however, about the need for knowledge that is not limited by age and about which practicing physicians feel a sense of ownership. We must have clinical data that span the age distribution of the diseases of interest. Otherwise, we limit our understanding of the natural history of the illness, we miss opportunities to intervene early, and we fail to recognize age-dependent differences in treatment options. All of these deficiencies reduce the usefulness of the knowledge to the practicing physician. This point was made previously by the committee, but it bears repeating. Another reason for the generation of disease-specific data bases that span time and are not age-limited is that these data will require years to amass and to evaluate. We presume, at least we hope, that by that time universal access to health care will have been achieved. Whether such access is financed centrally or is in large part pluralistic, as it is today, insurance benefits cannot be determined equitably if clinical knowledge is limited by age considerations. The need for ownership of the knowledge by practicing physicians is my second point on this first issue. In my opinion, it is a critical element. Knowledge that is generated and evaluated solely by payers or by health services researchers, or both, will be suspect. Medical organizations need to be involved, they need to be empowered, and they need to be ready to promote the knowledge among their members. I note that the committee report reflects on how little is known about what influences the behavior of health care providers. I suggest that there is a fair amount of anecdotal information to support the premise that, if competent providers are given relevant and accurate data, data that they have had a hand in developing, their behavior will be influenced accordingly. Still on the subject of physician ownership and empowerment, we need to recognize that the primary care physician must be the principal recipient of knowledge acquired through the Effectiveness Initiative, whether as a general internist, a family physician, or a general pediatrician. These are the groups that currently feel most disenfranchised as the result of intrusive regulation and draconian reimbursement policies. We need to consider the practice of the generalist: how it is organized, how generalists are reim- bursed, and what elements must be addressed if their practices are to em- brace the knowledge gained from the Effectiveness Initiative. ACCESSIBILITY OF RESULTS The second theme is the need for ready access to data that will aid in clinical decision making. Everyone recognizes the difficulty that physicians

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40 EFFECTIVENESS AND OUTCOMES IN HEALTH CARE have in keeping up with the extraordinarily rapid advances in medical knowledge and the technology to apply that knowledge. It seems clear that the same can be expected with regard to the findings of the Effectiveness Initiative unless the knowledge can be provided in real time and in a usable fashion. It is one thing to impart a few salient points in a peer-reviewed journal; it is quite another to provide a comprehensive data base from which to extract information bearing on the many variables that need to be considered for diagnostic or management decisions regarding an individual patient. We are all aware of prepackaged information currently available for use in a personal computer. Such information is likely to be most effective for relatively straightforward tasks, such as choosing the most cost-effective antibiotic for a particular infection. The more difficult task is the use of information about the host of patient variables that need to be considered in evaluating treatment for options such as balloon angioplasty, bypass surgery, or medical management for the 67-year-old diabetic who has angina, emphysema, and hypertension. For the everyday considerations, primary care physicians will benefit immeasurably from the availability of a comprehensive data base that can be accessed quickly. We have a few prototypes of this kind in this country, such as Duke University's cardiovascular data base. Referring again to physician ownership of new data, a very important step will be to secure the input of practicing physicians into decisions bearing on the nature of the data to be collected, how they are analyzed, and how they might be made most usable. AIDING PATIENT INVOLVEMENT The third point has to do with patient participation in decision making. I am going to be brief here because Albert Mulley goes into this subject later in this volume (1~. Most patients continue to defer to their physicians in selecting the proper treatment option. There would undoubtedly be more patient participation in decision making if we had better knowledge concerning the outcomes of various treatment options. This knowledge would need to be packaged in such a way that the patient could fully understand the issues, explore the benefits and risks of each option, and choose among them according to his or her unique values, values that the physician must not assume. It is quite exciting to see people such as John Wennberg, Albert Mulley, Michael Barry, and others beginning to take advantage of the technology that currently exists by preparing an educational program on treatment options for patients with benign prostatic hypertrophy. Some of my colleagues in urology in Rochester are now in the process of evaluating the efficacy of this approach. The findings will be of great interest to all of us.

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PERSPECTIVES ON EFFECTIVENESS AND OUTCOMES RESEARCH RELATION TO PAYMENT MECHANISMS 41 Now to the fourth point, one of particular concern to me. It has to do with the potential conflict between the findings of effectiveness research and how providers are paid for their services. Under Medicare, hospitals and physicians are paid by the number of units of service they render. Because the price per unit of service is controlled, whether through annual increments below the rate of inflation or whatever, the system responds by attempting to increase the number of units provided to ensure financial stability. Among the results are unnecessary hospitalizations, most of which are not picked up through utilization review; unhealthy competition; unnecessary duplication of technology and other health resources; and, perhaps most important, a slowing down of change in the way services should be organized and delivered to take advantage of out-of-hospital alternatives to care and to enhance continuity of care. Twenty-five years ago, the medical chief resident at Yale-New Haven Hospital, Eli Schimmel, wrote an article published in the Annals of Internal Medicine under the title, "The Hazards of Hospitalization." I have always carried that article with me, physically and in my mind. It is just as relevant today as it was then. No patient should be in the hospital unless it is required. Hospitalization poses a risk. I have the unusual challenge, as well as opportunity, of wearing two hats at the same time the hat of a professional who understands what we should be doing in patient care and the hat of a hospital administrator who has a fiduciary responsibility to ensure the financial vitality of our hospital. These present a conflict of interest. For example, for every open-heart surgery case above a given volume, the hospital averages a profit of $20,000. But it also costs the hospital $45,000 for the treatment of infants weighing less than 2 pounds in the neonatal intensive care unit. We had 43 such babies last year. Forty of them left the hospital alive. That $45,000 average cost is reimbursed at a much lower figure and has to be underwritten one way or another. The surplus from the individual open- heart surgery cases helps to do that. Our volume-driven system obviously has adjusted well, because much of the hospital care that is not necessary can still be shown to be appropriate- or at least not inappropriate. The work of Robert Brook and his colleagues has shown us that. The strength of the Effectiveness Initiative is that, for the diseases that are to be studied, it should be possible to find out what is both appropriate and necessary; that will be particularly helpful, given our interest in increasing patient involvement in decision making. Such findings will almost certainly indicate that fewer rather than more procedures and hospitalizations are in order, at least for patients who are currently receiving care. Unless the reimbursement system is changed from

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42 EFFECTIVENESS AND OUTCOMES IN HEALTH CARE one that is driven by volume to one that provides incentives for more discriminating and coordinated use of health resources, the findings from effectiveness research are going to be accepted grudgingly and implemented slowly. We will continue to see patients hospitalized unnecessarily for cardiac catheterization and many other procedures, or discharged early after their hip fracture without adequate provision for rehabilitation services. Application of the fruits of the Effectiveness Initiative demands reform of the current price-based reimbursement system, reforms that avoid the incentives to do too much. We need to be sure, however, to avoid a response that is too far in the other direction, one that is occasionally seen with global budgeting systems, where too little care can become the risk. UNBALANCED REGULATION My fifth point has to do with regulation. We have, in my opinion, a problem of unbalanced regulation in the health services industry. We have extremely tight regulation of hospitals and of physicians for the hospital component of their practices. We have loose regulation in the out-of-hospital marketplace. The proliferation of freestanding diagnostic and treatment centers is an excellent example of unnecessary duplication of facilities, where opportunities for unneeded services are greatly increased. Future health policy should pay attention to the issue of balanced regulation if we are going to achieve the objectives of the effectiveness initiative. IMPACT OF THE EFFECTIVENESS INITIATIVE Let me close with a word or two about where I think the Effectiveness Initiative will have its greatest impact. For two of the three diseases at the top of HCFA's priority list, there is a disturbing underuse of services. Four of five women at the ages where screening is known to be effective for early detection of breast cancer do not undergo such screening. The majority of poor or near-poor persons have low rates of utilization of diagnostic and therapeutic procedures for their underlying coronary artery disease. I believe the findings of the Effectiveness Initiative will result in an even more strik- ing picture of missed opportunities among these populations. The initiative should help change for the better the general approach to medical practice. After all, the Effectiveness Initiative can address only a limited number of illnesses, perhaps 20, perhaps 50. While better knowledge regarding treatment of these conditions will obviously improve quality and limit health care inflation, it will still account for only a very small fraction of total health care. Built into the Effectiveness Initiative are approaches that eventually should change the very fabric of medical practice. Some of them I have already

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PERSPECTIVES ON EFFECTIVENESS AND OUTCOMES RESEARCH 43 referred to. They include a much stronger role for patients in decisions relating to their health care and greater physician support, perhaps even enthusiasm, for a systematic study of outcomes of care once the value of such heretofore unavailable information is recognized. The Effectiveness Initiative will also facilitate the incorporation of functional assessment and quality-of-life measures into the day-to-day practice of medicine, measures that are so greatly lacking now. I believe that, in the long run, these results of the Effectiveness Initiative are going to be among its greatest contributions, contributions that go far beyond the knowledge gained through specific attention to given illnesses. I conclude by simply repeating the caution that I began with: the ultimate impact of the products of this initiative will be determined by the extent to which they address important requirements of the provider, are readily accessible, promote patient involvement, are accompanied by a reimbursement system that provides incentives, not constraints, for their application, and are facilitated by more balanced regulation. REFERENCE 1. Mulley, A.G. Applying Effectiveness and Outcomes Research to Clinical Practice. Pp. 179-189 in Electiveness and Outcomes in Health Care. Heithoff, K.A. and Lohr, K.N. eds. Washington, D.C.: National Academy Press, 1990.