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7
Improved Decisionmaking by Patients and Clinicians: The Committee View

Paul F. Griner

Many people at the conference summarized by these proceedings are very knowledgeable about the issues on which I was asked to comment. Some of my observations, therefore, may seem superficial, and I apologize for that in advance. My intent in this paper, however, is to be more broad than deep.

I would like to begin by paraphrasing a point made elsewhere (Schroeder, 1991). In the opinion of the Institute of Medicine (IOM) committee, the assurance of quality of health care to the people of this country will be achieved through some combination of three things. First is knowledge—better knowledge of the effectiveness of specific medical practices. Second is the refinement of that knowledge in such a way that it is possible to make a decision about its appropriateness for the individual patient. Third is the flawless execution of the various diagnostic and treatment plans that are derived from new knowledge—flawless execution, not only by providers, but throughout the entire system in which the care is provided.

In the real world we know that not all of these criteria are achieved simultaneously. We have suggested in our report (IOM, 1990) that although the general level of care to Medicare recipients in this country appears to be quite good, there are major weaknesses. There are patients who are not receiving care—underutilization of services. There are patients, perhaps as many or more, who are receiving unnecessary or inappropriate care—overutilization. Then there is a middle group of patients who are receiving care that is both appropriate and necessary but by means that are flawed in one way or another. These are the reasons for one of the ten committee recommendations, namely, that Congress should direct the Secretary of the Department of Health and Human Services to support, expand, and improve research in and the knowledge base on efficacy, effectiveness,



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Medicare: New Directions in Quality Assurance 7 Improved Decisionmaking by Patients and Clinicians: The Committee View Paul F. Griner Many people at the conference summarized by these proceedings are very knowledgeable about the issues on which I was asked to comment. Some of my observations, therefore, may seem superficial, and I apologize for that in advance. My intent in this paper, however, is to be more broad than deep. I would like to begin by paraphrasing a point made elsewhere (Schroeder, 1991). In the opinion of the Institute of Medicine (IOM) committee, the assurance of quality of health care to the people of this country will be achieved through some combination of three things. First is knowledge—better knowledge of the effectiveness of specific medical practices. Second is the refinement of that knowledge in such a way that it is possible to make a decision about its appropriateness for the individual patient. Third is the flawless execution of the various diagnostic and treatment plans that are derived from new knowledge—flawless execution, not only by providers, but throughout the entire system in which the care is provided. In the real world we know that not all of these criteria are achieved simultaneously. We have suggested in our report (IOM, 1990) that although the general level of care to Medicare recipients in this country appears to be quite good, there are major weaknesses. There are patients who are not receiving care—underutilization of services. There are patients, perhaps as many or more, who are receiving unnecessary or inappropriate care—overutilization. Then there is a middle group of patients who are receiving care that is both appropriate and necessary but by means that are flawed in one way or another. These are the reasons for one of the ten committee recommendations, namely, that Congress should direct the Secretary of the Department of Health and Human Services to support, expand, and improve research in and the knowledge base on efficacy, effectiveness,

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Medicare: New Directions in Quality Assurance and outcomes of care and to support a systematic effort to develop clinical practice guidelines and standards of care. FIRST-ORDER RESEARCH Let us examine how we might address this recommendation through improved decisionmaking. We can start with what we might refer to as first-order research: the need for better knowledge of the relationships between treatments and outcomes of care. Some generic issues warrant attention. For example, better markers of outcomes of care are needed. Fortunately, most patients survive their treatments, and the majority do not have complications. The current markers that we have of morbidity and mortality are not sufficiently sensitive to give us the full spectrum of information needed to judge outcomes. The work by Greenfield and Ware1 on measures of quality of life and functional status is a good example of current research that is helping to address this problem, and the IOM report indicates that more work of this kind is needed. Such markers immediately suggest opportunities to generate clinical data of a longitudinal nature, that is, observations over time and across settings. Disease-specific issues also arise. Given more than one approach to the management of a specific clinical problem, what are the outcomes associated with each approach, those that are good and those not so good? We will refer, in a moment, to the work that people such as Jack Wennberg2 have done that points to the lack of knowledge of effectiveness as an explanation for the tremendous variation in patterns of medical practice across settings throughout the country. How do we achieve such knowledge? We cannot expect to conduct classical randomized clinical trials (RCTs) to address very many of the outstanding questions; RCTs are too expensive and take too long. The report points to another alternative, and that is to take advantage of what David Eddy refers to as experiments of nature. The opportunity exists to look at the outcomes of care rendered to a large population of patients with a given condition in such a way that the outcomes of various treatment approaches can be compared among subgroups after adjustments for important variables. 1   Editors' Note: The reference is to a long-running project, the "Medical Outcomes Study," begun at the RAND Corporation and now located at the New England Medical Center. The principal investigators include Sheldon Greenfield and John E. Ware, Jr. 2   Editors' Note: The reference is to the body of research in geographic variations in use of health care services and outcome and effectiveness research pioneered by John Wennberg of Dartmouth Medical College. See also the papers in this monograph by Mulley (1991) and Wennberg (1991).

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Medicare: New Directions in Quality Assurance A few national clinical data bases do address this need. Two are very disease-specific and comprehensive. They have been developed over a period of 15 years. I refer to the medical information system of the American Rheumatism Association (ARAMIS) data base and to the Duke Cardiovascular Data Base. These systems have been helpful in addressing critical questions relating to the management of patients with rheumatologic and cardiovascular disorders respectively, but they are limited by being very disease-specific. We can look at the other extreme of large data bases that cut across many diseases. These include the Medicare files of the Health Care Financing Administration (HCFA), regional Blue Cross data bases, and some of the state-mandated data bases such as the Statewide Planning and Research Cooperative System (SPARCS) in New York State. These data bases are excellent for administrative and business purposes, but they are not well developed for purposes of the clinical relationships that we are seeking. Thus, the IOM report includes a set of caveats concerning the need for comprehensive clinical data bases that can help address many of the questions that remain outstanding in medical practice for common clinical conditions. As these data bases are developed, we need to remind ourselves of several essential elements. First is the amount of clinical information necessary to control for important variables, such as severity of illness and comorbidity. Second is longitudinality, the ability to capture outcome data over time. Third is flexibility to meet the needs of various oversight organizations as well as those involved in research and development. We have heard questions from Dr. Jencks3 and Mr. Webber4 about how one may apply a single data base in ways that will meet the need of multiple agencies. This is indeed a critical issue. To illustrate: there is at Mayo Clinic a large office that coordinates the pre-certification requirements for as many as 1,000 different payers throughout the United States, all of which have different pre-certification programs! APPLYING THE RESULTS OF EFFECTIVENESS RESEARCH TO PATIENT CARE Let us move to the second area of research, the need to individualize the knowledge gained from effectiveness research. How do we accomplish 3   Steven Jencks, M.D., Chief Scientist, from the HCFA Office of Research and Demonstrations. 4   Andrew Webber, Executive Vice President, American Medical Review Association, the organization that represents the Medicare Peer Review Organizations.

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Medicare: New Directions in Quality Assurance this? For the sake of simplicity, we will assume that for a given number of patients with a specific medical problem, current knowledge permits us to say the following: for about one-third of the patients who are receiving a particular treatment, the treatment is clearly appropriate; another one-third are receiving the treatment for reasons that are not appropriate; and for the remaining one-third, we do not know what is appropriate. In this second-level research, the challenge is to increase the number in the first group, reduce the inappropriate number, and apportion more of those in the gray area to either the appropriate or the inappropriate category. The obvious first step in addressing this challenge is to eliminate care that is already known to be inappropriate. The bigger challenge is to reduce the size of the gray zone. That can only come from better knowledge of the relationship between the processes and the outcomes of health care. It requires new knowledge that does not currently exist and reinforces once again the critical importance of the kind of work that people such as John Wennberg and others are doing in the area of effectiveness research. SHARED DECISIONMAKING We need to add an important element here, and that is the personal variable. If we are truly to individualize the knowledge gained from outcomes research, we must engage the patient more effectively in the process of decisionmaking. Only the patient can assign value to the specific benefits and risks of a particular treatment option. The challenge here is to provide the information to the patient in a way that both educates and quantifies. The IOM report comes back repeatedly to this objective. Its accomplishment may well be the most important contribution to health care over this decade. Successfully implemented, better practitioner-patient decisionmaking should improve patient satisfaction. It should reduce costs. It should temper the problem of medical liability. It should also improve physician satisfaction. BARRIERS AND INCENTIVES TO IMPROVEMENT Up to this point, we have referred to the need for a better understanding of outcomes of treatments. We have talked about approaches that are needed to help individualize this knowledge. Next is the issue of the execution of care: the need to identify and address factors in the system that either help to achieve or prevent health care of good quality. Reimbursement is one. How health care is financed and reimbursed will influence the achievement of quality. Financing mechanisms that limit access to appropriate services will result in underuse and eventually constrain quality. Those that cover unnecessary procedures will result in overuse, as will reimbursement mechanisms that reward providers on the basis of the volume of services.

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Medicare: New Directions in Quality Assurance Another important challenge that the IOM report repeatedly addresses is how to make medical information regarding effective and appropriate strategies available to physicians and patients in a convenient fashion. The work of Mulley, Wennberg, and their colleagues with their prototype interactive video disk for patients to review options concerning the management of benign prostatic hypertrophy is an important step in this direction. Are there incentives that will stimulate a change in physician behavior where needed? Education alone may not be sufficient. Careful study of the factors that influence physician behavior represents an additional area of inquiry recommended in the report. Finally, the IOM committee stressed the need to develop systems to measure the quality of care across settings, and it put a particular emphasis on ambulatory care. Opportunities to improve quality are being lost through inability to assess and intervene early in the natural history of an illness in a patient whose hospitalization might have been prevented. SUMMARY These, then, are the areas that warrant attention if we are to improve practitioner and patient decisionmaking: better understanding of the links between the process and outcomes of care; making the best possible use of current effectiveness research; engaging patients more effectively in decisionmaking about their own care; and overcoming several informational barriers and obstacles. The need is great to identify funds for the work required. For this, I look particularly to the Agency for Health Care Policy and Research, HCFA, perhaps private foundations, and possibly other private sector organizations such as insurance companies and industry. I have not touched on the role of the consumer in addressing important issues bearing on health policy. How universal access can be achieved, how the organization and delivery of health services can be improved, how an equitable benefits structure can be derived from knowledge relating to appropriateness and effectiveness, and how best to make choices between competing priorities are all issues that demand consumer participation. The paper by Rother (Rother, 1991) comments more fully on these areas. REFERENCES Institute of Medicine. Medicare: A Strategy for Quality Assurance. Volumes I and II. Lohr, K.N., ed. Washington, D.C.: National Academy Press, 1990. Mulley, A.G. A Patient Outcomes Orientation: The Committee View. Pp. 63-72 in Medicare: New Directions in Quality Assurance. Donaldson, M.S., Harris-Wehling, J., and Lohr, K.N., eds. Washington, D.C.: National Academy Press, 1991. Rother, J. Improved Decisionmaking by Patients and Clinicians: A Response. Pp. 54-58 in Medicare: New Directions in Quality Assurance. Donaldson, M.S.,

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Medicare: New Directions in Quality Assurance Harris-Wehling, J, and Lohr, K.N., eds. Washington, D.C.: National Academy Press, 1991. Schroeder, S.A. The Institute of Medicine Report. Pp. 7-14 in Medicare: New Directions in Quality Assurance. Donaldson, M.S., Harris-Wehling, J., and Lohr, K.N., eds. Washington, D.C.: National Academy Press, 1991. Wennberg, J.E. A Patient Outcomes Orientation: A Response. Pp. 73-78 in Medicare: New Directions in Quality Assurance. Donaldson, M.S, Harris-Wehling, J., and Lohr, K.N., eds. Washington, D.C.: National Academy Press, 1991.