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Technology and Health Care in an Era of Limits (1992)

Chapter: PART V: IMPLICATIONS FOR PATIENTS

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Suggested Citation:"PART V: IMPLICATIONS FOR PATIENTS." Institute of Medicine. 1992. Technology and Health Care in an Era of Limits. Washington, DC: The National Academies Press. doi: 10.17226/2024.
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Part V Implications for Patients

10 The Patient's Stake in the Changing Health Care Economy Albert G. Mulley, Jr. The focus of this volume is the impact of the changing health care economy on technological innovation. The changing economy affects inno- vation by altering the environment of decision makers changing their in- centives and their perceptions of what is, and will be, valued in health care. Other papers in the volume address such changes from the perspective of health care providers or of those in industry and academia who develop new technologies. The purpose of this paper is to consider the patient's stake in the changing health care economy. Focusing on and fully understanding the patient's perspective can bring a critical advantage, for it is what health care does to and for patients that determines its value. To understand the health care economy, one must understand the deci- sion-making process that determines consumption of medical services and thereby the allocation of health care resources. Two clinical examples will clarify both the patient's role in decision making and the patient's stake in how decision making is affected by the changing economy. These exam- ples, treatment of low back pain and treatment of breast cancer, involve choices that depend both on professional knowledge and on personal value judgments and preferences. As the discussion shows, serious questions can be raised about the adequacy of the professional knowledge base and about whether treatment decisions accurately reflect the preferences of those who must bear the consequences. These problems with the adequacy of the knowledge base and the phy 153

154 ALBERT G. MULLEY, JR. sician's role as the rational agent of the patient in a relationship character- ized by extreme asymmetry of information have been blamed for wide- spread variation in medical practices, which in turn has heightened concerns about the cost and quality of medical care (Wennberg et al., 1982; Mulley, 1990~. These failings of the professional model of resource allocation have motivated policymakers to effect changes in the health care economy. The policy solutions have been drawn from two different kinds of models: the market model and various forms of managed decision making, which have been characterized by Friedson as the bureaucratic model (Priedson, 1990; Mulley, 1991~. These two models are most evident in policies designed to promote efficiency through competition among providers and through direct management of clinical decision making. Each model implies different roles and responsibilities for doctors, patients, and policymakers. Each also portends different opportunities and constraints for innovators who would bring new drugs, devices, or procedures into use. Focusing on what is at stake for patients brings one to the conclusion that objective information is critical not only to good decision making, and ~l~C.~Uy ~c~uur`;c canon, cut also to innovation and diffusion of new technologies. Furthermore, not enough is known about what patients want from their health care system or what health care they would choose if they were provided with objective information and, when necessary, empathic sharing by their physician of the decision-making responsibility. Until such information is obtained, along with reliable assessments of the effectiveness of available and emerging technologies, policymakers and innovators will be "flying blind" along with doctors and patients as they try to make health care more efficient and effective. Hour - Scam ^11~:~_ I~.,^ ~1~_ THE PATIENT'S PREDICAMENT: LOW BACK PAIN All decisions, including those related to health care, are goal oriented. Common health care goals are to maintain good health and functioning, or to relieve morbidity that has decreased well-being or diminished functional capacity. Different people, however, have different life goals shaped by different circumstances, as well as different values and preferences. These in turn shape their particular health care wants and needs. When faced with the risk of, or actual, illness, most people without professional medical training do not have the information necessary to un- derstand their particular health care predicament or the diagnostic and treat- ment options available to them. They must rely on a physician or other professional for this technical information. ~ to ensure that the decision reflects the patient's personal health care goals, he or she must understand and communicate preferences or underlying value judgments, or both, re- garding the relevant health care outcomes.

THE PATIENT'S STAKE 155 Dependence on the health care professional for information and for empathic understanding of values and preferences puts a premium on trust in this relationship. Sometimes the doctor can easily and correctly infer what is best for a particular patient because the decision involves such widely shared goals that it requires little in the way of quality-of-life trade- offs; but these straightforward decisions may well be the exceptions. The following clinical example may offer some insights. Consider the predica- ment of a 41-year-old male physician who exercised regularly and was in excellent health until he suddenly developed low back pain. In the ensuing weeks, back pain was largely replaced by pain in the left leg extending to the ankle; there was minimal weakness of the left hamstring muscles. Bed rest for three weeks provided little relief. A magnetic resonance image disclosed a herniation of the L5-S1 intervertebral disc impinging on the left S1 nerve root. This patient faces a choice between surgery or nonsurgical therapy. If he chooses surgery, the most likely outcome will be symptom relief, but there is a chance of a surgical complication with a serious result, even death. There is also a chance that surgery will fail and that pain will persist or worsen; if it is due to scarring in the wrong place, it may well be perma- nent. If the patient chooses continued nonsurgical therapy, the symptoms may disappear spontaneously, but it is more likely that he will continue to live with discomfort, at least for the next few years. What does this patient need to know to make the right decision? What does his doctor need to know to help him with that process? First, he needs to know the probabilities of the different outcomes noted above. Where does this information come from? Often, such probabilities are derived from the relatively limited experience of the clinician, supplemented by what he learns from others and can glean from the published literature. Based on multiple interviews with scores of back surgeons and physicians, this author can attest to wide variability in the estimates that would be provided to this man. The literature does not offer very much in the way of help. Experi- enced surgeons readily acknowledge an important publication bias that sometimes produces unwarranted enthusiasm for surgery among their younger colleagues. Data are available from only one randomized trial related to this condition; the trial was performed in Norway 20 years ago with a total of 126 patients, 60 of whom were randomly selected to undergo surgery (Weber, 19831. The paucity of information is surprising, considering that approximately 500,000 people face this decision and 200,000 find their way to surgery each year in the United States alone. Furthermore, the results of the Nor- wegian study may not apply to this particular patient. He may be quite different from those patients who were willing to be randomized, with a different clinical syndrome and comorbid factors. As a result, he may face quite different outcome probabilities.

156 ALBERT G. MULLEY, JR. Additional questions can be raised about the adequacy of the informa- tion base, because the clinical decision problem is more complicated than what has been portrayed thus far. There are actually many choices to be made, between new and old diagnostic tests and new and old therapies. The first surgery for herniated disc was performed at Massachusetts General Hospital some 60 years ago; a handful of cases were reported by Mixter and Barr in the New England Journal of Medicine in 1934, some 40 years before the only randomized trial. Consider the technologies that have come and gone, or come and stayed, since that trial: technologies to improve diagnos- tic acumen, such as myelograms (most recently with water-soluble contrast media), discography, computed tomography (CT) scans, and now magnetic resonance imaging, or MRI; added to these are agents or procedures for treatment, such as chymopapain, microsurgery, and even percutaneous re- moval of disc material. When surgeons agree on the need for surgery, they often disagree on which nrooP.rillr~. ~holil~l he Han from the merit a~ in _ ~ ~ ^- 44 ~A ~ 414} ~ A~ ~r 1 1 ~ ~ ~ · · . . ~ . . preaches available Involving variations of discectomy alone, or discectomy combined with laminectomy, foraminotomy, or fusion (Deyo et al., 19911. Because of these differences, and perhaps because of differences in skill, different providers produce different outcomes, which result in different outcome rates. Neither providers nor patients have access to this kind of information in the current health care economy. Even when clinical trials are rigorously conducted, the special skills of an operator or the enthusiasm of an innovator may bias results. Ten years ago, there was considerable interest in the use of chymopapain to treat lumbar disc disease. In 1982, 108 patients were treated in seven centers in a double-blind placebo-control trial. The variation in outcomes reported from these centers was striking. In several centers, administration of a placebo resulted in an outcome equal to or better than chymopapain. In others, chymopapain was dramatically effective; in fact, in one center, 100 percent of active-agent patients were deemed successes, compared with none of the placebo patients. The overall results of the trial were positive, and their submission to the Food and Drug Administration led to approval of the com- pound for treating lumbar disc disease; that was followed by what one skepti- cal surgeon called "an unprecedented stampede with 6,000 orthopedic and necrologic surgeons lined up to take a one-day course on how the extract of papaya juice should be injected into the human back" (Pager, 1984~. Recognition of the inadequate and limited mechanisms available to maintain and enhance the professional knowledge base has led to the establishment of the Agency for Health Care Policy and Research, with its emphasis on outcomes research. The agency's main objective is a continuously improv- ing professional knowledge base complete with outcome probabilities to aid decision making and comparative rates to stimulate examination and im- provement of applications of technology.

THE PATIENT'S STAKE 157 So there are problems with the knowledge base, and clearly patients have a stake in accurate, objective information. But that is not all the patient needs; he must also determine how he feels about the alternative outcomes. Patients who face the same probabilities may make different choices because they assign different values to the same outcomes (Sackett and Torrance, 1978; Mulley, 1 989~. A brief aside is warranted here to introduce a notion that is important in ~. . . . . considering policies drawn from a bureaucratic model of resource alloca- tion. In developing decision guidelines that include patients' preferences for different health outcomes, some number of patients might be inter- viewed. Previous work of this kind has demonstrated repeatedly that in doing so one would find a rather wide distribution of responses. As re- searchers aggregate those responses to incorporate a utility into their deci- sion model or implicit consensus process, they might use an average value. This approach allows them to scale the health states; it also provides prefer- ences for a hypothetical average patient. The clinician's job is not to scale health states but to discriminate among patients who have different relative preferences for the relevant outcomes. The decision analyst might be satisfied with the probabilities and utili- ties-and would choose the alternative with the highest expected utility. But few people make decisions based on expected utility; instead, they exhibit varying degrees of risk aversion when health, or life itself, is at stake. Most people are averse to risk, and there is some evidence that patients are systematically more risk averse than their doctors. The variable time preferences of individuals must also be considered. The evidence that is available suggests that patients with herniated discs do just as well in the long run with or without surgery. The benefit of surgery is quicker relief from symptoms. Patients must thus weigh the value they place on early . . ~. . . ~_ _ relief against a greater nsK o1 1ullg~l-.t;llll ~lllulll~ lull. Interviews with patients who suffer from low back pain have explored the interactions of these patients with their doctors during the treatment These interviews indicate substantial variability decision-making process. in how patients and physicians deal with these difficult communication issues. Generally, patients want information. But they also want to be able to trust their doctors to help them decide what is best for them. This issue is discussed more fully later. THE PATIENT'S PREDICAMENT: EARLY BREAST CANCER Let us consider a second case. A 42-year-old mother of two children considered herself quite healthy until 2 weeks ago when she discovered a suspicious lump in her right breast. She has since had a mammogram, which showed a 2.5-centimeter nodule consistent with cancer. A needle

158 ALBERT G. MULLEY, JR. biopsy confirmed the diagnosis of invasive ductal carcinoma. She has no clinical adenopathy, and her tumor is estrogen-receptor negative. Her axil- lary nodes were negative when examined at the time of surgery. This woman, and about 150,000 like her each year in the United States, face two sequential decisions. Should she have a mastectomy or lumpecto- my and radiation therapy as local treatment? Should she receive adjuvant therapy to reduce the chances of the tumor recurring? She too needs infor- mation. For the first decision, the probabilities are quite straightforward. The best available evidence suggests that the alternative local therapies are equivalent in terms of risk of complications and effectiveness (Fisher et al., 1985~. The decision really hinges on several other factors: how the woman feels about the longer duration of lumpectomy/radiation therapy; how she feels about the risks of having a new tumor or recurrence in the preserved breast; and, most important, how she feels about keeping her breast. For decades, this has been a controversial clinical decision. In the 1890s, William Stuart Halsted reasoned that the best chance for curing breast cancer was offered by wide excision of the breast and surrounding tissue including muscles and lymph nodes. This untested hypothesis domi- nated treatment for 80 years but came under increasing scrutiny in the early 1970s. Throughout the 1970s, the frequency of the Halsted operation de- clined steadily; the procedure was replaced by modified mastectomies that were far less disfiguring. During the 1980s, reports appeared of partial mastectomy or even simple removal of the tumor itself. These breast pres- ervation procedures were not standardized, but when teamed with radiation therapy, they seemed to provide survival benefits equivalent to mastectomy. Some have argued that the slow diffusion of the breast preservation ap- proaches reflects a collective indifference on the part of a largely male profession to the quality-of-life issues important to female patients. Others argue that conservatism is appropriate when the decisions are a matter of life and death. In the United States, data are unavailable on how many women would choose one option or the other. However, there is good evidence to suggest that women generally get the procedure that their sur- geon prefers (Osteen et al., 1992~. The adjuvant therapy decision is equally controversial (Himel et al., 1986~. Until 1988, women without evidence of tumor in their axillary lymph nodes generally were not treated with adjuvant chemotherapy. In that year, however, a clinical advisory was issued by the National Cancer Institute, based on the unpublished results of a randomized trial. When those results were published and were considered in the context of other evidence, the case for adjuvant therapy was less than compelling. Approxi- mately 70 percent of women with early breast cancer are cured by local treatment. But it is impossible to predict which women will or will not have a recurrence; each faces a risk of recurrence of about 4 percent each year. Adjuvant therapy, the evidence suggests, will reduce that risk by

THE PATIENT'S STAKE 159 approximately 30 percent, to a level of about 3 percent (Hillner and Smith, 19913. But adjuvant therapy exacts a heavy toll, conferring significant morbidity for 6 months or longer. Again, there are no data on how many women would choose adjuvant therapy if they were provided with objective information. The communication barriers are formidable. Just one example is the distinction between the absolute and relative risk difference. Should a woman be told that adjuvant therapy will reduce her risk of recurrence by 30 percent (the relative risk difference) or that it will reduce it from an annual rate of 4 percent to 2.8 percent (the absolute risk difference)? Fo- cusing on the risk and the relative reduction makes the benefits seem quite important. Focusing on the absolute risk difference makes the benefits seem smaller and raises a question of whether they justify the harm of chemotherapy. One careful examination of the adjuvant therapy decision-making pro- cess at a tertiary care center (Siminoff et al., 1989) provides some insights about the very real barriers to both communication about therapeutic op- tions and evaluation of new therapeutic regimens. In general, the women who were studied were poorly informed. They tended to substantially over- estimate the benefits of adjuvant therapy as they followed the recommenda- tions of their oncologists. Forty-eight percent of the women In the study were advised to have therapy that would be considered standard for their node status and menopausal status; 98 percent of these women followed that . .. . . recommendation. Thirty percent ot tne women were advised to follow what were considered nonstandard recommendations, which were usually part of a treatment arm of another ongoing trial; 80 percent of these women com- plied with those recommendations. Twenty-two percent of the women were advised to participate in one of three ongoing trials; of these, only 46 per- cent agreed to do so. Close examination of the content of the interviews led the author of this paper to speculate on the reasons for this singular exception to patients' willingness to comply with recommendations. The interviews suggested that the recommendation of the oncologist was often half-hearted or not supported by the information that was communicated. Oncologists often recommended standard or less aggressive nonstandard therapy to women with better prognoses (e.g., fewer positive nodes), and recommended more ns~s~r~.~sive nonstandard theranv to women with worse prognoses. In es- sence. the oncologists often behaved as if the question being addressed by They discussed trade-offs between present and future patients, with the edge always going to the identified former rather than the unidentified latter. Doctors were overly confident about what they knew, and patients were overly optimistic about how much they would benefit. Neither had an incentive to invest in new knowledge. _, _ ~ , the trial had already been answered. ~_

160 ALBERT G. MULLEY, JR. THE PROFESSIONAL MODEL: ROLE AND RESPONSIBILITIES The two exemplary cases discussed above indicate that patients have a stake in a continuously improving base of medical knowledge that depends not only on clinical trials but also on the orderly collection of information from representative clinical practice. They also have a stake in being treat- ed like individuals with wants and needs that may be different from those of seemingly similar people. They need objective information, or a doctor who has such information, as well as help in dealing with the subjective variables that may be as important or more important in determining the care that is best for them. This formulation implies a set of responsibilities for patients and doc- tors and for policymakers. The heaviest burden falls on the medical pro- fession as the keeper of the ever-changing knowledge base. Clearly, it must do a better job of securing and making good use of both outcome probabil- ities and comparative outcome rates. The profession also has the privilege of helping people with some of their most personal decisions. It must do a better job of sharing this collective vicarious experience with those who could benefit. What about patients? The patient's role in this model is not the passive sick role that Parsons described in 1951. Do patients want information? Are they willing to face risks and participate in decision making? A small but interesting body of literature addresses these questions (Brody, 1980; Strull et al., 1984; Ende et al., 1989~. The responses can be fairly summa- rized as "yes" and "it depends." Patients generally want information whether or not they are prepared to bear responsibility for decisions. In fact, a number of anecdotes have been cited repeatedly to make the point that many patients do not want decision-making responsibility, particularly when the condition is serious (Inglefinger, 1980~. The studies that have been conducted, however, provide conflicting evidence. Most studies that have addressed the decision-making question have not assured patients that they will be provided with the information necessary to participate in an informed decision. When that information is provided, patients accept decision-making responsibility. For a woman facing a new diagnosis of breast cancer, it is a difficult time to bear the responsibility for making a decision; nevertheless, when 153 women with early-stage breast cancer were given a choice between breast preservation and mastectomy in Newcastle, England, none declined to decide for herself (Wilson et al., 1988~. Interestingly, 65 percent of the women chose mastectomy; most cited a wish to get the treatment behind them quickly and a reluctance to face the risk of future cancer in the same breast. Furthermore, there is emerging evidence that patient involvement in care has a positive impact on patient reports of treatment outcome and on

THE PATIENT'S STAKE 161 objective measures of it (Greenfield et al., 1985, 1988; Kaplan et al., 1989~. But information is not a substitute for empathy and concern-and alone, it will not establish a basis for trust. For the patient, these may be the most important attributes of a health care encounter. The most consistent finding in the voluminous patient satisfaction literature is that those characteristics of the provider and his or her organization that make care more personal are associated with higher levels of satisfaction (Cleary and McNeil, 19881. Good communication skills, empathy, and caring are the strongest predic- tors of patient-perceived quality of care. What about the role of policymakers? This function legitimately com- prises the need to establish constraints, including economic constraints. More information about what patients want could be valuable in this regard, em- powering policymakers in a way that they have not been empowered before. Policymakers, however, also have the responsibility to provide those mech- anisms and services that constitute public goods. The kind of objective information system described in this paper is a public good. MARKET AND BUREAUCRATIC MODELS: THE PATIENT'S STAKE How have changes in the health care economy changed the patient's stake in that economy? As indicated earlier, the forces of policy change have been moving in two directions, both of which represent efforts to improve efficiency. The first has been toward increased competition-that is, the market model. Such policies shift the burden and responsibility for accurate information to patients. The greatest danger of this approach is that competition may further compromise the quality of information available to patients and to the pro- fession. Proprietary interests, competition on the basis of perceived rather than established quality, and development of unrealistic expectations before the point of sale all conspire against objective information, informed deci- sion making, and efficient resource allocation. Policies that promote com- petition have sanctioned deviations from the professional model that facili- tate persuasion through manipulation of values and preferences as well as selective use of information. The problems for patients are quite different with policies drawn from the bureaucratic model that is, what Wennberg and Barer and Evans else- where in this volume have called "micromanagement of care." Efforts to reduce variation and to reduce induced demand for unnecessary care char- acterize this approach. For patients, the danger here is not so much related to the objectivity of the information used for decision making as it is to the potential for neglecting subjective variables. Value judgments, which are necessarily aggregated in order to make policy decisions, may actually be

162 ALBERT G. MULLEY, JR. unrepresentative of the vast majority of individuals. The resulting policies will be inefficient because some patients will receive care that they them- selves would never choose to receive and others will go without care they want. This is not to say that the health care economy, in this country or in others, does not need real constraints. Management of the supply of care, in the form of decisions to invest or disinvest in the capacity of the system to provide various services to a population, justifiably depends on societal value judgments and group norms. An additional concern about the growing tendency to manage individu- al care decisions is the potential for further depersonalization of care and diminishment of the complex trust relationship between doctors and pa- tients. This relationship is often quite important to many patients as they are made vulnerable by illness, and it is of equal importance to many physi- cians as a source of professional gratification. Silberman addresses these themes in the next paper. REFERENCES Brody, D. S. 1980. The patient's role in clinical decision-making. Annals of Internal Medi- cine 93:718-722. Cleary, P. D., and McNeil, B. J. 1988. Patient satisfaction as an indicator of quality. Inquiry 25:25-36. Deyo, R., Cherkin, D., Loeser, J., Bigos, S., and Ciol, M. 1991. Lumbar spine fusion: Geographic variations, costs and consequences. Clinical Research 39:315A. Ende, J., Kazis, L., Ash, A., and Moskowitz, M. A. 1989. Measuring patients' desire for autonomy: Decision making and information seeking preferences among medical pa- tients. Journal of General Internal Medicine 4:23-30. Pager, C. A. 1984. The age-old back problem. Spine 9:326-328. Fisher, B., Bauer, M., Margolese, R., Poisson, R., Filch, Y., Redmond, C., et al. 1985. Five- year results of a randomized clinical trial comparing total mastectomy with or without radiation in the treatment of breast cancer. New England Journal of Medicine 312:665- 673. Friedson, E. 1990. The centrality of professionalism to health care. Jurimetrics 30:431-445. Greenfield, S., Kaplan, S., and Ware, J. 1985. Expanding patient involvement in care: Effects on patient outcomes. Annals of Internal Medicine 102:520-528. Greenfield, S., Kaplan, S. H., Ware, J. E., Yano, E. M., and Frank, H. J. 1988. Patients' participation in medical care: Effects on blood sugar control and quality of life in diabetes. Journal of General Medicine 3:448. Hillner, B. E., and Smith, T. J. 1991. Efficacy and cost-effectiveness of adjuvant chemother- apy in women with node-negative breast cancer. New England Journal of Medicine 324: 160-168. Himel, H. H., Liberati, A., Gelber, R. D., and Chalmers, T. C. 1986. Adjuvant chemotherapy for breast cancer. Journal of the American Medical Association 256:1148-1159. Inglefinger, F. J. 1980. Arrogance. New England Journal of Medicine 303:1507-1511. Kaplan, S. H., Greenfield, S., and Ware, J. 1989. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Medical Care 27:S110-S127. Mixter, W. J., and Barr, J. S. 1934. Rupture of the intervertebral disc with involvement of the spinal canal. New England Journal of Medicine 211:210-215.

THE PATIENT'S STAKE 163 Mulley, A. G. Jr. 1989. Assessing patients' utilities: Can the ends justify the means? Medical Care 27:S269-S281. Mulley, A. G. Jr. 1990. Medical decision making and practice variation. In: Andersen, T. F., end Mooney, G., eds. The Challenges of Medical Practice Variation. London: MacMill an. Mulley, A. G. Jr. 1991. Finding common ground. HMQ 13: 16-20. Osteen, R. T., Steele, G. D., Jr., Menck, H. M., and Winchester, D. P. 1992. Regional differences in surgical management of breast cancer. CA: The Cancer Journal for Clinicians 42(1):39-43. Parsons, T. 1951. The Social System. New York: Free Press. Sackett, D. L., and Torrance, G. W. 1978. The utility of different health states as perceived by the general public. Journal of Chronic Diseases 31:697. Siminoff, L. A., Petting, J. H., and Abeloff, M. D. 1989. Doctor-patient communication about breast cancer adjuvant therapy. Journal of Clinical Oncology 7:1192-1200. Strull, W. B., Lo, B., and Charles, G. 1984. Do patients want to participate in medical decision-making? Journal of the American Medical Association 252:2990-2994. Weber, H. 1983. Lumbar disc herniation: A controlled, prospective study with ten years of observation. Spine 8: 131 - 140. Wennberg, J. E., Barnes, B. A., and Zubkoff, M. 1982. Professional uncertainty and the problem of supplier-induced demand. Social Science Medicine 16:811-824. Wilson, R. G., Hart, A., and Dawes, P. J. D. K. 1988. Mastectomy or conservation: The patient's choice. British Medical Journal 297:1167-1170.

11 What Is It Like to Be a Patient in the l990s? Charles E. Silberman To be invited to write a paper for this volume is a humbling experience for a layman. Fortunately, the subject I have been assigned what it is like to be a patient is one on which I can honestly claim expertise. My exper- tise comes from what anthropologists might call involuntary participant- observer research, conducted most recently in June of 1990, when I went into shock because of a never-before-reported toxic reaction to niacin. I conducted field research on three prior occasions as well: in November of 1985, when I underwent a laminectomy to relieve nerve compression in the spine; in January of 1988, when I had surgery to remove a malignant pros- tate gland; and 19 days after the prostatectomy, when I was rehospitalized with a brain stem infarct attributed to postsurgical hypercoagulability. I recognize that personal experience can be limiting as well as illumi- nating. Over the past 5 years, I have read widely and deeply in the litera- ture on medical care and health policy; I have accompanied medical school faculty on teaching rounds, observed physicians practicing in fee-for-ser- vice and health maintenance organization (HMO) settings, and in the fash- ion of journalists "picked the brains" of physicians, patients, administrators, policymakers, and researchers. I draw on all this in answering the question, What is it like to be a patient in the 1990s? 165

66 CHARLES E. SILBERMAN THE VIEW FROM THE PATIENT'S SIDE OF THE BED In the ways that matter most, being a patient in the 1990s is exactly like being a patient in the 1980s, 1970s, or 1960s. There is a universality to the experience of illness that transcends differences in time and space, in medi- cal technology, and in the way medical care is organized and financed. Wherever or whenever one is a patient, serious illness presents itself as an assault on one's identity and sense of self-an assault involving disorienta- tion and loss of meaning, erosion of autonomy and control, and fear and dependency. Sickness is a transforming experience as well, and the transformation is most evident when sickness is chronic or progressive or when it leaves us with a permanent disability. Even if "recovery" occurs, however, we do not return to our pre-sickness state; we must adjust to a new way of seeing and relating to the world. This does not mean, however, that to be a patient is to be a victim; no matter how sick or disabled, we retain the ability to . . . . . choose how to respond to the situation in which we find ourselves. Hence sickness can bring gain as well as loss, for example, a more profound appreciation of spouse and children, a deeper religious faith, a clearer sense of what really matters in one's life. For the patient, in short, disease is always an existential process. To the physician, on the other hand, disease is a pathophysiological process under the dominant biomedical model, a process that is abstracted from the patient and his or her sufferings. In the formulation of physician Donald W. Seldin, "Human problems and human agonies are medical prob- lems and medical illnesses only when they can be approached by the theo- ries and techniques of biomedical science." The underlying assumption of this reductionist approach "is that all disease is physiology gone astray. Where there is truly no physiological problem, there is no disease." The extraordinary clarity and detail of the images produced by computed tomog- raphy, or CT, scans, by magnetic resonance imaging (MRI), and by other marvels of diagnostic technology reinforce this tendency to think of disease in purely organic terms (Seldin, 1981; Zucker, 1981; Reiser, 19871. There is a world of difference, therefore, between the way most physi- cians think about disease and the way most patients experience it a differ- ence physicians often discover when they become seriously ill themselves. "I practiced medicine for fifty years before I became a patient," Edward E. Rosenbaum, former chief of rheumatology at Oregon Health Sciences Uni- versity, has written. "It wasn't until then that I learned that the physician and patient are not on the same track. The view is entirely different when you are standing at the side of the bed from when you are lying in it" (Rosenbaum, 1988~. Physicians, for example, sees multiple sclerosis, or MS, as "a slowly progressive CNS [central nervous system] disease characterized by dissem

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s? 167 inated patches of demyelination in the brain and spinal cord, resulting in multiple and varied necrologic symptoms and signs, usually with remis- sions and exacerbations" (Merck Manual, 1987~. That is not how MS pa- tients experience the disease. "What I experience every day is not the demyelination in the white matter of the nervous system," philosopher Kay Toombs explains, "but . . . the ongoing and seemingly relentless diminish- ment of physical abilities which is surely but gradually eroding my indepen- dence. For me multiple sclerosis is the constant effort to overcome my body's resistance in order to carry out the most mundane activities, the frustration of not being able to do the simplest of things . . . and the anguished uncertainty of a perilous future" (Toombs, 19891. I know what Dr. Toombs means. For me, stroke was not "an intra- or extracranial interruption in arterial blood flow" (Merck Manual, 19871. It was the infantilizing inability to stand without collapsing to my left and the consequent inability to walk; it was the unimaginable terror that what al- ready had happened to my hospital roommates and to the other patients in the neurology service would soon happen to me that I would lose the ability to speak intelligibly or think intelligently, or that I would be unable to feed or dress myself. For patients, disease never is just "physiology gone astray." "What happens when my body breaks down happens not just to that body but also to my life, which is lived in that body," writes Arthur Frank, a Canadian medical sociologist who had a massive coronary followed by testicular can- cer. "When the body breaks down, so does the life." Fixing the body "doesn't always put the life back together again," Frank adds, because seri- ous illness "leaves no aspect of life untouched.... Your relationships, your work, your sense of who you are and who you might become, your sense of what life is and ought to be" these all change, and the change is terrifying" (Frank, 1991~. Terrifying, as I can attest, because sickness plunges us into an abyss of meaninglessness. Ad. We can describe our pain, nausea, dizziness, fatigue, malaise, or other symptoms, but we do not know what they signify; we crave explanation, all the more so because we have not completely thrown off the primordial conviction that to be sick is to be possessed by an evil spirit. We turn to our doctors to identify that spirit to explain what is happening as well as to make us better. There is nothing more frightening than to feel that your symptoms cannot be explained-that what is happen- ing to you lies outside the normal course of events. Sickness also is disorienting, for it shatters the web of assumptions on which our lives are based. We take it for granted, for example, that our arms, legs, fingers, feet, and other organs will move according to our (usu- ally unconscious) commands. It is only when that does not happen when we cannot stand without falling, as happened to me after my stroke, or

68 CHARLES E. SILBERMAN when an arm or leg will not move as we wish that we discover how much of our sense of self depends on those assumptions and how disoriented we become when our body turns into an enemy rather than an ally (see, e.g., Gadow, 1982; Murphy, 1987; Toombs, 1988, 1990, 1991, 1992; Mairs, 19909. We take it for granted, too, that we control our own fate that life is predictable and we are immortal and that we can, therefore, plan our own future. We take these assumptions for granted precisely because they are rooted in the most primitive parts of our mind. "EA]t bottom no one be- lieves in his own death," Freud argued. "tI]n the unconscious every one of us is convinced of his immortality" (Freud, quoted in Katz, 1984, p. 217~. But accident and illness force us to acknowledge our impotence and our mortality; as Steve Fishman, a young journalist who has written eloquently about his experiences following a brain hemorrhage, puts it, "Disease gives the lie to the lies we tell ourselves" (Fishman, 1988~. Losing the protection of those "lies" is isolating as well as disorienting; we feel intensely lonely despite our greater dependence on family and friends. As Flannery O'Connor, who contracted lupus at age 25, suggested, "Sick- ness is a place, and it's always a place where there's no company, where no one can follow" (O'Connor, quoted in Stone, 1990~. No wonder so many patients and doctors have so much difficulty com- municating with one another. As John E. Ware, Jr., of the New England Medical Center's Institute for the Improvement of Medical Care and Health puts it, "Doctors and patients are like ships passing in the night" (Ware, quoted in Friedman, 1989~. "In discussing my illness with physicians," Kay Toombs reports, "it has often seemed to me that we have been somehow talking at cross-purposes, discussing different things, never quite reaching one another." For the most part, Dr. Toombs adds, "this inability to com- municate does not result from inattentiveness or insensitivity but from a fundamental disagreement about the nature of illness. Rather than repre- senting a shared reality between us, illness represents two quite distinct realities, the meaning of one being significantly and qualitatively different from the meaning of the other" (Toombs, 1987~. Both realities must be attended to, as physicians often discover when they become seriously ill themselves. Neurologist Oliver Sacks had criti- cized medicine for its "lack of proper attention to the full needs and feel- ings of patients," but he was unprepared for the magnitude of his own needs after surgery to repair "a severe but uncomplicated wound to the muscles and nerves of one leg." "^ -~--^~^ a-- ~~~~~ T 1 ~ r ~1 ~_ ~, ~ --by pnyslclan Dy profession, l had never found myself a patient before, and now I was at once physician and patient," Sacks wrote. "I had imagined my injury . . . to be straightforward and routine, and I was astonished by the profundity of the effects it had: a sort of paralysis and alienation of the leg, . . . an abyss of bizarre, and even

WHAT IS IT LIKE TO BE A PATIENT IN THE 1990s? 169 terrifying, effects.... What seemed, at first, to be no more than a local, peripheral breakage and breakdown now showed itself in a different, and quite terrible, light-as a breakdown of memory, of thinking, of will not just a lesion in my muscle but a lesion in me [emphasis in the original]" (Sacks, 1973, 1984~. The lesion in the self may be deeper and harder to heal than the lesion in the body. THE NEW CONSUMERISM AND TECHNOLOGICAL CHANGE Let me anticipate a question some readers may be asking themselves: Why am I telling you all this? What does the patient' s experience of illness have to do with the questions addressed in the other essays in this volume? Why talk about "the perspective of the patient" in a book that explores the ways in which "the changing health care economy" may affect technologi- cal innovation? To a patient, the answer is self-evident: if this enormous health care enterprise is about anything, it is about serving the needs of patients. And physicians, hospitals, and manufacturers of pharmaceuticals and medical devices cannot serve the needs of patients without knowing what those needs are without understanding how patients experience and think about illness and, therefore, what patients want and expect from medical care. What is self-evident to patients has been anything but self-evident to doctors and other providers. True, physicians, hospital administrators, and manufacturers of pharmaceuticals and medical devices have genuinely sought to meet the needs of patients. But physicians not patients have defined those needs. Physicians have done so, moreover, without asking patients what they want or think they need and without otherwise taking patients' preferences and values into account. "We acknowledge that our common interest is the patient," physician Paul M. Ellwood pointed out in his 1988 Shattuck Lec- ture, "but we represent that interest from such divergent, even conflicting, viewpoints that everyone loses perspective. As a result, the health care system has become an organism guided by misguided choices; it is unsta- ble, confused, and desperately in need of a central nervous system that can help it cope with the complexities of modern medicine" (Ellwood, 1988~. Guided or misguided, the choices have been made by physicians usually without consultation with their patients. Medical practice has been based on the delegated decision-making model and the rational agency the- ory from which it flows. And the rational agency theory, in turn, has been based on the assumption that "doctor knows best" in the formulation of physician/mathematician David M. Eddy, "that whatever a physician de- cides is, by definition, correct." Correct by definition because a number of other assumptions have been

170 CHARLES E. SILBERMAN made: that physicians know the scientifically based norms of practice; that they know the values and preferences of their patients; that physicians are disinterested and objective scientists without preferences or biases of their own; and that they therefore choose for their patients what the patients would have chosen for themselves if they had had the same knowledge. "Like Solomon," Eddy writes, "physicians could receive patients, hear their complaints, and determine the best course of action" without anybody ques- tioning or second-guessing doctors' decisions. On the contrary, "each phy- sician was free, trusted, and left alone to determine what was in the best interest of each patient" (Eddy, 1990~. The other providers of health care have accepted these assumptions and have operated accordingly. . Because physicians have been their primary source of patient refer- rals, hospital administrators have seen physicians, not patients, as their pri- mary customers. As a result, hospitals have been run to satisfy the needs and desires of doctors rather (or more) than the needs and desires of pa- tients. "Hospitals vie for physician affiliations through the provision of services that physicians appreciate," Robinson and Luft (1987) explain. "These include both personal amenities such as convenient parking, office space, and clerical services and, more importantly from an economic perspective, the acquisition of state-of-the-art clinical technologies and support staffs." · Although patients are the ultimate consumers of medications and of most medical devices, physicians generally make the purchasing decisions. Like hospitals, therefore, manufacturers of pharmaceuticals and medical devices have developed their products and built their marketing strategies around the needs and preferences of physicians rather than of patients. The delegated decision-making model is under attack (see the later discussion, "The Revolution in Patient-Doctor Relations"~; hospitals, phar- maceutical manufacturers, and manufacturers of medical devices are being forced to take account of the perspective of patients and to come to terms with their needs and preferences. This is happening in part because patients are demanding it. We live in an age of consumerism-one in which "re- quests" are rapidly translated into "demands," which in turn become "rights." The change is generational as well as cultural; members of the so-called baby boom generation "want far more information, involvement, control, and choice regarding the services they buy, including medical care," than do their elders (Moloney and Paul, 1991a). Patients are increasingly reluc- tant to accept their traditionally passive role; they are making demands and asserting rights, a process that affects the nature, as well as the rate, of technological change. Consider the way in which patient activism is changing the allocation of federal research funds. For example, women's groups have criticized the

WHAT IS IT LIKE TO BE A PATIENT IN THE l990s? 171 tendency of medical researchers to ignore the health needs of women. They have pointed to the fact that large research projects such as the Multiple Risk Intervention Trial, the Health Professionals Follow-Up Study, and the Physician's Health Study have included only male patients, as well as the fact that women do not have the same access as men to critical diagnostic and therapeutic interventions such as kidney dialysis and transplantation, diagnosis of lung cancer, and catheterization for coronary bypass surgery (American Medical Association, Council on Ethical and Judicial Affairs, 1991; Cole and Wentz, 1991; Healy, 1991a). Responding to these complaints, the National Institutes of Health (NIH) recently established an Office of Research on Women's Health to ensure "that research conducted and supported by the NIH appropriately addresses issues regarding women's health" (Healy, 1991a). As NIH director Berna- dine Healy explains, "It is now time for a general awakening. Women have unique medical problems. They have greater morbidity than men and are affected by more debilitating illness" (Healy, l991b). Hence "the NIH has mounted a multidisciplinary, multi-institute intervention study, the Wom- en's Health Initiative, that will address the major causes of death, disability, and frailty among middle-aged and older women, including cardiovascular disease, cancer, and osteoporosis" (Healy, l991b). There is nothing new, of course, about lobbying for more research; the lay lobby organized in the late 1940s by Mary Lasker and Florence Ma- honey helped make NIH the predominant force in biomedical research (Starr, 1982~. Lobbying has become more intense, however, and lobbyists increas- ingly articulate the concerns of patients and their families rather than the concerns of the research community. Witness the emergence of Alzhei- mer's disease as a major focus of research and treatment; since formation of the Alzheimer's Disease and Related Disorders Association (ADRDA) in 1979, federal funding for research on the disease has increased 40-fold, from $4.2 million in 1979 to $80 million in 1989, despite opposition from NIH (Fox, 1989~. Witness, too, the extraordinary increase in federal fund- ing of research on the acquired immune deficiency syndrome (AIDS); by fiscal year 1990, such funding exceeded the amount allocated to research on heart disease and approached the sum allocated to cancer research (Fumento, 19901. Patient activism has also forced significant changes in the way the Food and Drug Administration (FDA) regulates the testing and introduction of new medications. And FDA procedures, in turn, have ramifications beyond the well-being of patients or of pharmaceutical manufacturers. Because the FDA controls the entry of all chemical compounds into clinical research, the agency "inevitably controls and potentially limits the opportunity for . . . scientific progress in medicine" (Oases and Wood, 1989~. Thus, recent changes in FDA procedures provide an important case study of how the

72 CHARLES E. SILBERMAN 'new consumerism" may affect the development and diffusion of medical technology. The FDA is susceptible to pressure because it is expected to balance two conflicting and sometimes incompatible goals: encouraging technolog- ical innovation by making sure that effective remedies become available as quickly and as widely as possible; and protecting patients against ineffec- tive, as well as unsafe, medications and medical devices a mandate that tends to slow the pace of innovation (see, e.g., Kessler, 1989; Lasagna, 1989~. Specifically, the federal Food, Drug, and Cosmetic Act gives the FDA power to require "substantial evidence" that a new medication (and since 1976, a new medical device) is "safe" and "effective" before it can be sold in the United States. Lobbying is almost inevitable because of the wide discretion the FDA enjoys. As Gelijns and Thier (1990) point out, "The Food, Drug, and Cosmetic Act allows considerable latitude for subjective interpretation of the terms 'safety' and 'effectiveness' in determining the acceptable risk- benefit ratio" that a manufacturer must demonstrate before a new drug is approved. Since the 1962 amendment to the act, the FDA has attached a higher priority to protecting patients against new drugs than to making new remedies available; as Louis Lasagna puts it, "The FDA prides itself on being the most demanding regulatory agency in the world and seems re- markably unconcerned about any drug lag that might result from [its] typi- cal snail-like pace" (Lasagna, 1989~. More is involved than pride; until recently, political pressures impelled the FDA to emphasize safety rather than speed. "It is rare for top FDA officials to be called on the congressional carpet for failing to approve a drug but common for them to have to defend having allowed a drug on the market that produced unexpected serious toxicity," Lasagna explains. "As a former FDA examiner put it, 'Any time you approve a new drug, you're wide open for attack. If it turns out to be less effective than the original data showed, they can nail you for selling out to a drug company. If it turns out to be less safe than anybody expected, some congressman or a newspa- per writer will get you. So there's only one way to play it safe turn down the application. Or at least stall for time and demand more research."' Time is the one thing patients with AIDS or other incurable diseases do not have. "When there is no alternative treatment for a life-threatening disease, a greater emphasis may need to be placed on accelerating develop- ment than on ensuring every aspect of safety and effectiveness," David A. Kessler, the physician/lawyer who now serves as FDA commissioner, point- ed out in a 1989 article. The FDA began to shift its emphasis in the early ' ~ ~ ~ -~~~ ~~~ ~~~- rim- Of patients with life- threatening and/or incurable diseases and as a result of ideological pres- sures for deregulation. By creating the category of Group C drugs, the 1980s in response to crowing assertiveness can the nart

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s ? 173 agency allowed desperately ill cancer patients to use promising drugs that were under study but that had not yet been fully tested or approved; the FDA occasionally did the same for patients with other serious or fatal ill- nesses (Young et al., 1988~. A precedent already had been set, therefore, when the full magnitude of the AIDS epidemic became evident. AIDS is different from other diseases because of its virulence and epi demic proportions, and because it affects a well-organized group with con- siderable political skills honed in the struggle for gay rights. The result has been a quantum increase in patient activism and a sharpening of the debate over "a question that has long plagued Ethe FDA]: Do patients who suffer from life-threatening disorders for which there is no treatment have a right to take unproved remedies?" (Kessler, 1989; see also Hamburg and Fauci, 1989). Under pressure from AIDS activists, who "mix antiestablishment poli- tics with a desperate faith in the products of medical technology" (Aronow- itz, 1991), the FDA began to answer in the affirmative. In 1987, for exam- ple, the agency established new "Treatment IND" (investigational new drug) application procedures to bring "promising new drugs to desperately ill patients as early in the drug's development as possible, and well before general marketing would normally provide" (Nightingale, 1987~. Under the new rules, physicians were able to use investigatory drugs to treat patients with "immediately life-threatening diseases" (advanced AIDS, advanced con- gestive heart failure, advanced metastatic refractory cancers) or other "seri- ous diseases" (e.g., Alzheimer's disease, advanced multiple sclerosis, pro- gressive ankylosing spondylitis). The FDA also formalized an earlier policy permitting such patients to import unapproved drugs for their own use and expanded the policy by allowing such imports to be mailed. As David J. Rothman and Harold Edgar (1990) put it, "The agency that refused to per- mit the importation of laetrile to treat cancer is now on the record as saying that consumers are free to import a drug of choice if it is for their own use" (see also Halm and Gelijns, 1991~. Rothman and Edgar interpret this change as acceptance of the notion that patients should be free to make their own decisions about the use of experimental drugs based on their own assessment of benefit and risk. "It is no longer the experts who will decide, unilaterally, which risks are worth assuming," they write. "Instead, the patient, with help from physicians and other consumers, will be determining which drugs to take or not to take in the war against disease." The change is not that far-reaching; the FDA is not relinquishing its authority, nor can it without violating its congressional mandate. The pen- dulum is bound to keep swinging, therefore, and patients and their advo- cates will continue to press the FDA to speed up the approval process and to give patients the right to decide what risks they are willing to assume.

74 CHARLES E. SILBERMAN More is changing, however, than FDA procedures; AIDS activists and following their lead, advocates for patients with Alzheimer's disease, can- cer, and other serious illnesses- have questioned the goals and methods of clinical research. Their questions in turn are forcing clinical researchers and epidemiologists to reexamine their own approach. As a group of prom- inent government and academic AIDS researchers acknowledged in the New England Journal of Medicine, "Statisticians and clinicians involved in the design and conduct of trials of new treatments for the acquired immunodefi- ciency syndrome (AIDS) have realized that some traditional approaches to the clinical-trials process may be unnecessarily rigid and unsuitable for this disease" (Byar et al., 1990~. Specifically, "trials were relentlessly pursued as originally designed, even if data appeared outside the trial suggesting that patients would do better with a different type of management" (Merig- an, 1990~. The criticism is equally applicable to research on other fatal or otherwise incurable diseases. The conduct of AIDS research has changed more rapidly because well- organized AIDS activists have forced creation of "a partnership of patients, their advocates, and clinical investigators in the AIDS Clinical Trials Group." As Thomas C. Merigan of the Stanford University Center for AIDS Re- search explains, "The changes stem from a shared desire that the control group receive the most up-to-date care in all clinical trials a principle developed in cancer therapy." That in turn means that "protocols must be changed in mid-stream" to ensure that none of the patients receive inferior treatment, and that "all patients should have an equal opportunity to enter trials, even if they have disease complications or are members of a small subgroup" (Merigan, 1990~. Some now question the ethical propriety of the randomized clinical trial itself. For example, Hellman and Hellman (1991) argue that "randomized trials often place physicians in the ethically intolerable position of choosing between the good of the patient and that of society." In their view, conflict is inevitable. The practicing physician should be "primarily concerned with each patient as an individual," whereas "the clinical scientist is concerned with answering questions i.e., determining the validity of formally con- structed hypotheses." Thus, the purpose of the randomized clinical trial is "not to deliver therapy," as Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledges. "It's to answer a scientific question so that the drug can be available for everybody once you've established safety and efficacy." Hellman and Hellman urge physi- cians to shun randomized trials and adopt "other techniques of acquiring clinical information" techniques that would enable the doctor to serve the interests of both the patient and scientific knowledge.

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s ? THE DEMAND FOR ACCOUNTABILITY _ ~ 175 Manufacturers of pharmaceuticals and medical devices, as well as phy- sicians and hospital administrators, will pay more attention to patient pref- erences for two other reasons: competitive pressures are requiring, and public and private third-party payers are demanding, that they do so. Be- cause of escalating costs, for example, payers have begun to question the value of the medical care for which they pay. They are asking what the outcomes of medical and hospital care are and whether these are the out- comes patients want or need. The consequences are already apparent. Physicians and hospital admin- istrators no longer enjoy unfettered discretion in choosing the medical equipment and devices they or their patients will use; the Health Care Financing Ad- ministration (HCFA) is beginning to require evidence that a new device is cost-effective before authorizing reimbursement for Medicare patients. As a result, HCFA's coverage decisions are becoming an increasingly impor- tant factor in the development process. These coverage decisions in turn increasingly are based on more than the subjective opinions of panels of medical experts. Instead, "there is a tendency to consider the effects of devices on the quality of life of patients (including their preferences for certain outcomes)" (Gelijns, 1990~. Pharmaceutical manufacturers are facing similar pressures. To control escalating health care expenditures, private and public third-party payers now insist on more extensive evidence that a new drug or device is worth the incremental cost. Drug companies are also discovering that evidence that a drug improves the quality of patients' lives gives it a distinct compet- itive advantage. Hence "drug companies and manufacturers of medical devices have become consumers of quality of life and health status assess- ments" (Bergner, 1990~. Payers' demands for accountability are affecting doctors and hospitals even more than drug companies or manufacturers of medical devices. "Prac- titioners used to justify their clinical choices, if at all, only to each other, and only informally," Berwick and colleagues (1990) write. "Today, man- aged care systems, government agencies, utilization review departments, and payers are scrutinizing care, and with decreasing reluctance asking doc- tors and hospitals to explain what they do and why they do it. Doctors and hospitals used to be able to count on someone paying for whatever they chose to do. No longer [emphasis in original]." The need to control costs is the primary engine of change, but competi- tive pressures to improve quality also play an important role. As Berwick and coworkers point out, "Quality in the modern sense is defined as meeting the need of customers. Who better than the customers can tell us what is needed and how we are doing Lemphasis in original]?" Recognition of the

76 CHARLES E. SILBERMAN importance of this definition is spreading so widely among business firms that Business Week has labeled the 1990s the "Decade of the Customer" (cited in Moloney and Paul, 1991a). This is the "Decade of the Customer" for hospitals, no less than for business firms. Consider the change in hospital architecture and design. "Building hospitals with the patient in mind may not sound revolutionary, but it is revolutionizing design and architecture in American health care," a trade weekly reported in a 1988 article. "Once a puzzle of pale-green hallways, hospitals today are turning toward richer colors, pretty bedspreads, comfortable furniture, atriums, skylights, fountains, courtyards and simple floor plans. It is the natural result of a growing tendency to market medi- cine to the consumer" (Friedman, 1988~. The same tendency is evident in the mushroom growth of hospital mar- keting departments. In 1986, for example, New York's Mount Sinai Medi- cal Center hired Natel K. Matschulat, who had created New York State's "I Love New York" advertising campaign, to fill the new position of vice president for marketing and public affairs. "Miss Matschulat acknowledged that she did not know much about hospitals, but says her experience as director of New York State's promotional campaign will help her 'apply packaged-goods techniques' in selling Mount Sinai to New York," the New York Times reported. The selling has been vigorous. When market research indicated that patients' choices in hospitals are heavily influenced by their judgment of the quality of the doctors who practice in it, Matschulat created a multimil- lion-dollar newspaper, radio, and television advertising campaign describ- ing medical advances for which Mount Sinai doctors have been responsible. To attract more patients to its private rooms, Mount Sinai has employed a concierge to greet patients and provide services such as catering a business meeting in a patient's room; the medical center also supplies private pa- tients with flowers, terry cloth slippers, and reclining chairs, among other amenities. Mount Sinai is simply following the crowd. "We used to be pretty paternalistic, but now we ask consumers what they want and we try to give it to them, whether it's shorter stay maternity care or a guarantee that they'll be seen within 15 minutes when they come to the radiology depart- ment," says Anne Doll, senior vice president for marketing of Miami Valley Hospital in Dayton, Ohio. "Physicians are still the primary gatekeeper," Lauren Barnett of the American Hospital Association explains, "but con- sumers make more of the choices in obstetrics, cosmetic surgery, emergen- cy room admissions, and sports medicine" (Lewin, 1987~. To attract more maternity patients, for example, New York's St. Luke' s-Roosevelt Hospital Center provides free baby blankets, cute T-shirts, and candlelight dinners (shrimp cocktail and filet mignon) in bed.

WHAT IS IT LIKE TO BE A PATIENT IN THE l990s? 177 Marketing gimmicks and cosmetic changes will not suffice; hospitals everywhere are discovering that they must take at least some account of their patients' preferences if they are to maintain, let alone increase, their market share. As Moloney and Paul (199lb) point out, "patients are now more actively involved in choosing their care than the traditional hospital marketing model conceived. Large and growing percentages of patients surveyed report that they are actively involved with their doctor in the choice of a hospital. Others say they chose a hospital or health plan first and then chose a doctor from among those affiliated with the facility. -Many also report they have recently switched hospitals or doctors or are consider- ing doing so." The new competitive environment is persuading many hospitals to re- spond to the needs and preferences of their patients. The first step is to determine what those needs and preferences are. As part of the multimil- lion-dollar Picker/Commonwealth Patient-Centered Care Program, for ex- ample, Louis Harris & Associates surveyed nearly 6,500 patients recently discharged from 62 nonprofit hospitals across the country. (For a discus- sion of the nature of the sample, see Cleary et al., 1991.) In the telephone interview, which lasted an average of 25 minutes and included some 136 questions, patients were asked about their experiences in concrete detail. For example: - get it? · On average, how long after you requested pain medication did you . Did someone explain why important tests were done in a way that you could understand, or not? Before you had tests, did a doctor or nurse explain how much pain or discomfort you would have, or not? · Were you told what you needed to know about when and how to take your medicines at home, or not? Were you told about important side effects to watch for from your medicines, or not? · Did the doctors [nurses] sometimes talk in front of you as if you weren't there? The specificity of the questions makes it possible for hospitals to use the responses to correct specific flaws. For example, the University of Chicago Hospitals found that one patient in four was dissatisfied with pain control, a "problem score" more than double the national average; in check- ing with academic medical centers with better scores, hospital officials found that Chicago had lagged behind the others in installing patient-administered analgesic units. The hospital re-surveyed its patients after expanding the number of patient-administered analgesic units and found a big increase in patient satisfaction. "I wish all problems were as easy to fix as that one," says University of Chicago Hospitals president Ralph Muller (Knox, 1991~. Although many hospitals are reluctant to be surveyed or to use the

78 CHARLES E. SILBERMAN results, the use of patient surveys is bound to spread. The Picker/Common- wealth Patient-Centered Care Program is making the survey available to any hospital that wants to administer it to patients and/or family members. And the for-profit Hospital Corporation of America (HCA), a pioneer in applying "continuous quality improvement" to hospital operations, has be- gun surveying patients at regular 6-month intervals and is using the results to improve hospital operations (Nelson, 1991; Nelson et al., 1989, 1990~. Hospitals may not have a choice. Patients are eager for comparative information. More than 90 percent of the patients responding to the Picker/ Commonwealth survey felt that "information on how patients rate their hospitals" should be made available to the public; most said that such rat- ings would influence their choice of where to go the next time they were hospitalized (Knox, 1991; Moloney and Paul, 1991a). And patients' desire for information is likely to be met; new assessment techniques, along with improved information-processing technology, make it relatively easy to publish patients' ratings. If hospitals do not provide the information, third-party payers will; insurance companies, employers, and government agencies can conduct their own surveys and publish the data, much as the Health Care Financing Administration has been doing for the past several years with hospital mortality rates. In 5 to 7 years, the University of Chicago Hospi- tals' Ralph Muller predicts, "something like Consumer Reports" will pro- vide periodic hospital evaluations to patient/consumers (Knox, 1991~. Hospitals also are beginning to use patients' assessments of their own condition to supplement traditional clinical measures. In the opinion of Jerome Grossman, president of the New England Medical Center, asking patients how they feel and function and using their answers to monitor the quality of care "represents the missing link" in the effort to figure out what constitutes value in medical care (Friedman, 1989~. Indeed, Grossman and his colleagues believe that hospitals must do more than ask patients about their condition; patients' answers must be incorporated into clinical records and used to improve the quality of care. This is no easy matter. "We know how to collect data on patients' functional status and well-being for re- search purposes," says Allyson Ross Davies, director of the New England Medical Center's Department of Quality Assessment. "But if clinicians are to use the information, we have to collect the data more economically and in real time, and we have to learn how to use the data to improve clinical practice."" To do so, Grossman brought Alvin Tarlov, John E. Ware, Jr., Sheldon Greenfield, and Sherrie Kaplan, as well as Davies, to the New 1Interview with Allyson Ross Davies, Ph.D., Boston, December 3, 1990. I am relying also on conversations that day with Alvin Tarlov, M.D., Sheldon Greenfield, M.D., and Sherrie Kaplan, Ph.D., and a telephone conversation with Jerome Grossman, M.D., on November 19, 1990.

WHAT IS IT LIKE TO BE A PATIENT IN THE l990s? 179 England Medical Center's Health Institute. The significance of patient as- sessments will be discussed more fully below. THE REVOLUTION IN PATIENT-DOCTOR RELATIONS The demand for accountability is transforming patient-doctor relations. Patients are not just asking questions; they are demanding an active role in decisions about their own care. This shift from delegated to shared decision making amounts to a Copernican revolution-one that is forcing physicians and hospitals to organize medical care around the perspective of the patient as well as of the physician. A change of sorts began in the 1950s when the courts established the doctrine of "informed consent." In fact, informed consent has had little impact on patient-doctor relations; if anything, it has reinforced the pater- nalism and delegation of authority inherent in the old model (President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research, 1982; Katz, 1984; Green, 1988~. As psychiatrist/lawyer Jay Katz (1984) points out, most patients are informed only about the risks and bene- fits of the treatment their doctor has recommended or has already chosen for them; patients rarely are informed about the risks and benefits of alter- native treatments, including the alternative of doing nothing; and patients almost never are told "about the certainties and uncertainties inherent in most treatment options." Most importantly, conversations with patients are not conducted in the spirit of inviting patients to share with their physicians the burdens of decision. Without such a commitment, dialogue is reduced to a mono- logue. Thus, what passes today for disclosure and consent in physician- patient interaction is largely an unwitting attempt by physicians to shape the disclosure process so that patients will comply with their recommenda- tions (Katz, 1984, p. 26~. In short, informed consent has reinforced the tendency for physicians to talk at their patients rather than with them. Indeed, patients usually do not see the "informed consent" form for a hospitalization, invasive test, and/or surgical procedure until after they have been admitted to the hospital, which is to say, after the crucial decisions have been made. It is not surprising, therefore, that a majority (55 percent) of physicians and an overwhelming majority (79 percent) of patients think the purpose of informed consent is to protect doctors from malpractice suits (Green, 1988~. The changes now underway go far beyond the cosmetic adjustments required by informed consent; patient-doctor relations are being revolution- ized by pressures from within the profession, as well as from without (see the preceding papers by Wennberg and Mulley). The findings of research

180 CHARLES E. SILBERMAN ers such as Wennberg, Eddy, Ware, Greenfield, and Brook and of clinicians such as George L. Engel and Alvan R. Feinstein have destroyed the intellec- tual foundations on which the delegated decision-making model rests. In particular, Wennberg and Eddy have shown that physicians frequently do not know the scientifically correct way to practice medicine-not because of personal ignorance or indifference, but because nobody knows; medical science has enjoyed spectacular success in developing new treatments but has largely ignored the mundane task of evaluating their results. The paucity of information about outcomes imparts a random compo- nent to medical decisions. What illness a patient is diagnosed as having, for example, depends on who is making the diagnosis and when witness the magnitude of inter- and intra-observer variation in the interpretation of sup- posedly "objective" diagnostic tests. As Eddy points out, physicians look- ing at the same x-ray, cardiogram, angiogram, pap smear, pathology speci- men, laboratory finding, or other test result disagree with one another or with their own prior interpretation anywhere from 10 to 50 percent of the time. Comparable variations have been found in the way doctors interpret patient histories and physical examination findings and in the treatments physicians and surgeons recommend when shown the same clinical records (Eddy, 1984, 1990; Eddy and Billings, 19889. How a patient is treated for a given illness also depends on where that patient lives; for the patient, geography-not anatomy is destiny. Witness the large variations Wenub erg has found in the frequency with which pa- tients are hospitalized and/or operated on for the same illness in different communities even communities, such as Boston and New Haven, in which the overwhelming majority of physicians are affiliated with a major teach- ing hospital. "If the clinicians in these academic strongholds do not know the correct way of practicing medicine," Wennberg asks, "who else could know?" The other assumptions on which the delegated decision-making model rests are equally flawed. Specifically, physicians do not know the values and preferences of their patients; nor are physicians disinterested and objec- tive scientists without preferences or biases of their own (see the discussion of this issue below). There is no reason to assume, therefore, that physi- cians choose for their patients what the patients would choose for them- selves. On the contrary, Wennberg, Mulley, and their colleagues have shown that when patients with benign prostatic hypertrophy are given information about the outcomes of alternative treatments and are involved in the deci- sions about their own care, they malice strikingly different choices for them- selves than their physicians make for them. In particular, patients choose surgery far less often and "watchful waiting" far more often than do their doctors. The disjuncture between patient preferences and physician behavior is

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s ? 181 not limited to benign prostatic hypertrophy; it is evident in the care of patients with chronic diseases the patients for whom the bulk of medical expenditures are now incurred (Stewart et al., 1989~. Because they define disease in purely pathophysiological terms (see above), physicians measure success through changes in intermediate outcomes, such as blood pressure, blood sugar levels, or patency of blood vessels. Such measures are incomplete at best and may tell the doctor little about how the patient feels or functions; in conditions such as ulcers, angi- na, arrhythmias, diabetes, spinal stenosis, and disk herniation, among oth- ers, there is little correlation between the severity of the organic disorder and the amount of pain or other symptoms patients experience. Indeed, biomedical data explain only 10 to 25 percent of the variance in patients' functional status or well-being (see, e.g., Fowler et al., 1988; Stewart et al., 1989; Mulley, 1990; Ware, 1990~. By concentrating on intermediate out- comes, physicians "may all too easily spend years writing 'doing well' in the notes of a patient who has become progressively more crippled before their eyes" (Smith, 1983~. That is not how patients define "doing well." Most of the time, patients see the primary goal of medical care as improvement in the quality of their lives preserving or restoring their sense of well-being and their ability to function physically (e.g., to walk a certain distance, climb stairs, dress and feed themselves) and socially (e.g., to perform their usual activities on the job, at home, or with other family and friends). "Improvement in quality of life is not only an important outcome of medical care," John P. Bunker argues, "it is the only intended outcome of most of what we do in medicine" (Bunker, 1990; see also Ware, 1990~. Physicians cannot maintain or improve the functional status of their patients unless they know which patients have what kinds of limitations. Much of the time, physicians do not know. "Health care providers collect data about functioning for virtually every body organ," John E. Ware, Jr., points out, "but none of these measures tell about the function of the entire individual." As a result, "many, if not most, clinicians do not know the functional status and well-being of their patients" (Ware, 1989; see also Connelly et al., 1989; Hall et al., 1989; Calkins et al., 1991~. In a recent study, for example, both patients and their physicians were asked to de- scribe how much difficulty the patient experienced in performing 12 specif- ic physical and social activities. The results were striking: overall, the physicians-one group from UCLA Medical School, a second from Beth Israel Hospital in Boston underestimated or failed to recognize 66 percent of their patients' disabilities (Calkins et al., 1991~. Physicians are no better at detecting and treating depression, which seriously impairs patients' abili- ty to function as well as their overall sense of well-being; the Medical Outcomes Study directed by Ware, Tarlov, and Greenfield found that pri

182 CHARLES E. SILBERMAN mary care physicians detect depression in only one depressed patient in two (Wells et al., 1 989a,b) This "lack of proper attention to the full needs and feelings of patients" is due not to insensitivity or lack of concern on the part of physicians, but to what Alvan R. Feinstein calls "scientific policy," that is, the prevailing mind-set about the kind of information physicians should seek and study. By and large, physicians are taught that what cannot be readily quantified is unimportant; information about the inner thoughts and feelings of patients is considered "soft" or "subjective"-less worthy of scientific attention than "hard" or "objective" data such as the images, numbers, and tracings pro- duced by diagnostic testing equipment. This invidious distinction between "hard" and "soft" data has produced "a deliberate reduction of the human information used in clinical science." In ignoring "soft" data, Feinstein notes, physicians ignore "all the distinctively human reactions-love, hate, joy, sorrow, distress, gratification that differentiate people from animals or molecules" (Feinstein, 1987~. The result is that medicine focuses on outcomes of interest to physi clans, rather than to patients. As Feinstein (1983) puts it, We appraise the palliative treatment of patients with cancer by measuring survival time, tumor size, and other paraclinical indexes. We do not regu- larly measure whether the patient is comfortable or miserable, functional or bed-ridden, vegetating or vibrant. We compare medical and surgical treatment for coronary heart disease by measuring survival time, patency of vessels, eleccrocardiographic changes, and treadmill exercise tests. We do not regularly perform scientifically credible measurements of whether the angina pectoris is still severe, whether the patient was truly made able to return to work, and whether the quality of life has otherwise improved for the patient and his family. This happens, to repeat, not because of ignorance or indifference but because biomedical science axiomatically excludes the human domain. "In order to know the truth of the pathological fact," the historian Michel Fou- cault observes, "the doctor must abstract the patient" (Foucault, 1975~. The biomedical model abstracts the physician as well. In accordance with medicine's nineteenth-century conception of science, the physician is assumed to be an objective, disinterested, and thoroughly neutral observer, and the phenomenon being studied is assumed to be independent of, and unaffected by, the observer. In conducting clinical research, for example, researchers control for patient characteristics but usually ignore differences among physicians; the practice reinforces "the conviction that the physician has no therapeutic effect as a person, but is simply a conduit of pills or procedures." "Holding all physicians as equal in a trial," Spiro (1986) points out, implies "that the physician himself does not matter." These assumptions have been shattered by the development of twenti

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s? 183 eth-century science, especially post-Newtonian physics and evolutionary bi- ology, which has shown that the mere presence of an observer alters the phenomenon being observed (see Odegaard, 1986; Engel, 1988; Bursztajn et al., 1990~. "What we observe is not nature itself," Heisenberg explained, "but the interplay between nature and ourselves. . ." (Heisenberg, 1958~. Since there is no "objective" reality independent of the observer, there can be no invidious distinction between "objective" and "subjective" knowl- edge; nor can physicians be mere conduits through which information and treatments pass. On the contrary, there is a subjective component to objective knowl _ . . . ~ . . ~ ^ ^ . ~ , , ~ _ 1~ 1 1 _ ~ edge: physicians' biases and values affect what they observe as well as what they recommend, and the nature of the physician's relationship with the patient affects the patient's health. Equally important, there is an objec- tive component to what we call subjective knowledge: values and feelings can be studied and measured, although doing so requires different instru- ments and approaches. The hallmark of hard data, after all, is consistency, that is, whether the data can be repeated by the same observer and repro- duced by another. "If repeated observations by the same or different ob- servers yield the same results," physician Richard A. Deyo points out, "the findings have the basic ingredients of 'hardness.' By this criterion, state- of-the-art questionnaires for measuring the quality of life are as hard as many common laboratory measures" (Deyo, l991b). It would be hard to overstate the significance of Deyo's point. Physi- cians now have at their disposal a number of easily used, as well as valid and reliable, instruments for assessing patients' symptoms, functional sta- tus, and sense of well being instruments such as the SF-36 Health Status Questionnaire developed by John E. Ware, Jr., and colleagues, the Dart- mouth Coop Charts, the Duke Health Profile, the Sickness Impact Profile developed by Marilyn Bergner and colleagues, and the Quality of Well- Being Scale (see Lohr, 1992; Stewart and Ware, 1992 forthcoming). The availability of these measures destroys any lingering justification for medi- cine's preoccupation with purely biomedical goals and measures. Clearly, substituting patient-doctor collaboration for the old delegated decision-making model does not mean abandoning "science" for "art." It means broadening the conception of the nature of science to include the knowledge and skills usually lumped together under the rubric "art of care." "The fundamental distinction . . . is not between 'science' and 'art,"' George Engel argues, "but between thinking and proceeding scientifically and not so thinking and proceeding" (Engel, 1988; see also Bursztajn et al., 1990~. Medical questions can be approached scientifically only if medicine follows the standards of twentieth-century science and develops a more inclusive concept of clinical practice what George Engel calls the bio- psychosocial model, Ian R. McWhinney "a patient-centered clinical meth _

184 CHARLES E. SILBERMAN oaf," and others simply "the new paradigm" (see, e.g., Engel, 1977, 1981, 1988; McWhinney, 1988; Bursztajn et al., 1990). That in turn means recog- nizing that medical practice must be a joint undertaking of physician and patient (or physician and patient's surrogate). Indeed, collaboration between patient and physician is both a scientific and ethical imperative. It is an ethical imperative, as Wennberg, Mulley, Eddy, and others point out, because most medical procedures have multiple and contradictory, as well as uncertain, outcomes and because patients dif- fer widely in their attitudes toward risk and uncertainty and in the values they attach to various outcomes. What we have called medical judgments frequently are not that at all; they are value judgments-judgments to which physicians have much to contribute but which they are not eauioned to make on their own. ~, , Collaboration is a scientific imperative as well, because medicine in volves the study and treatment of one person by another (Engel, 19889. Thus, collaboration between doctor and patient should not be limited to the choice of treatments; it should start when the patient first seeks medical help and should continue throughout the clinical encounter. Collaboration is essential, to begin with, to determine why the patient is seeking help. In primary care medicine, in particular, patient-doctor encounters usually are initiated by the patient, for reasons that are not always apparent. Without knowing why the patient has come and patients are not always aware of the real reason themselves-the physician may identify and treat the wrong problem. The risk is increased by the staccato, closed-ended style most physi- cians use in questioning their patients. In analyzing doctor-patient interac- tions, Beckman and Frankel (1984) found that, on average, physicians inter- rupted patients 18 seconds after the patient began to speak; patients were able to complete their opening statements in only 23 percent of the visits. One consequence of these interruptions is the familiar situation in which, just as the physician thinks the office visit is over, the patient asks, "Oh, by the way, Doctor, I've been having this heavy feeling in my chest. Do you think that might be important?" Most of the time patients are not being perverse; they had not been able to get the question out when the doctor was taking their history, or the doctor may not have put them at sufficient ease to enable them to ask a painful or embarrassing question. The only way patients can tell physicians why they are seeking medical help is through dialogue. And productive dialogue cannot occur unless the physician first establishes a relationship with the patient. Thus, "the physi- cian has no alternative but to behave in a humane and empathic manner . . . if the patient is to be enabled to report clearly and fully," Engel writes. "Only then can the physician proceed scientifically; to be humane and em- pathic is not merely a prescription for compassion . . . it is a prerequisite for scientific work in the clinical realm" (Engel, 1988~.

WHAT IS IT LIKE TO BE A PATIENT IN THE 1990s? 185 We pay a heavy economic, as well as human, price for the lack of dialogue and the paucity of collaborative relations between doctors and patients. Specifically, devaluation of information from patients contributes significantly to missed diagnoses; to inappropriate and excessive use of diagnostic tests, medications, and invasive treatments; and to underuse of a significant low-tech "technology," the patient-doctor relationship. In a highly suggestive study, for example, Everitt and colleagues (1990) asked a random sample of primary care physicians how they would treat a 77-year-old patient complaining of insomnia a patient whom they were seeing for the first time. After the physicians were given a brief history, they were asked what additional information they needed in order to choose a treatment. Fewer than half the doctors asked for any information about the patient's sleeping pattern; had they done so, they would have learned that the patient slept seven hours a night. He had "insomnia" because he went to bed each night at 9 p.m. and could not get back to sleep when he awakened at 4 a.m. (The patient also drank two cups of regular coffee at dinner; but fewer than one physician in four asked about his caffeine con sumption.) In short, rudimentary interviewing of the patient would have suggested that the "insomnia" could be addressed without medication; yet only 15 percent of the physicians recommended cutting down on caffeine, going to sleep at a later hour, or some other change in life style. Nearly two-thirds of the physicians recommended a hypnotic or psychoactive drug such as triazolam, flurazepam, temazepam, or amitriptyline in a 77-year-old pa- tient they had never seen before. In a more recent study, the same researchers (Avorn et al., 1991) found a similar pattern in the treatment of an elderly patient with abdominal pain. The physicians prescribed histamine antagonists for someone who smoked 2 packs of cigarettes and consumed 8 aspirin and 5 cups of caffeine a day. The need for a collaborative relationship between doctors and patients is strikingly evident in the care of patients with chronic diseases. With the explosion in outcomes research, there is increasing documentation of the failures of treatments based on exclusively biomedical considerations. For example: The history of medical care for low back pain one of the most common causes of morbidity and absenteeism in the United States involves serial fashions in diagnosis and therapy. Earlier in this century, sacroiliac joint disease was thought to account for many cases of back pain, and this led to many fusions of the sacroiliac joint. Coccydynia was a popular diagnosis that led to a wave of coccygectomies, a procedure now almost completely abandoned. The use of chymopapain injections for herniated lumbar inter vertebral disks enjoyed explosive growth in the early 1980s, but has de clined greatly. Recent clinical trials have challenged the efficacy of many popular treatments, including lengthy bed rest, traction, and transcutaneous

86 CHARLES E. SILBERMAN electrical nerve stimulation. Each of these fashions arose from a seductive pathoanatomical theory, leading to the popularity of a diagnosis that justi fied the corresponding treatment. Such fads are not innocuous; they may lead to unnecessary morbidity and costs, as well as to embarrassment for professionals" (Deyo, 1991a; see also the preceding paper by Mulley). Deyo's observations were made in an editorial commenting on a study showing the worthlessness of the most recent fad, corticosteroid injections into the facet joints (Carette et al., 1991~. One reason purely biomedical approaches often fail is that chronic illnesses involve what Greenfield and colleagues (1988) call "discretionary dysfunctioning." As already noted, the same pathophysiology is associated with widely different effects in different patients; in a sense, patients exer- cise discretion "in determining the extent to which the illness will compro- mise functioning" or affect their overall sense of well-being. Some of this discretionary dysfunctioning depends on the patient's personality and tem- perament and the support he or she receives from family and friends. Much of it depends on factors physicians can influence, such as wheth- er patients follow the prescribed treatment regimen. Physicians call this "compliance," a locution that places the blame for "noncompliance" solely on patients. But patients are not likely to carry out a complicated regimen unless their physicians persuade them of its importance. A lot of persua- sion may be necessary if the medications have disagreeable side effects or if the patient must change deeply ingrained habits, lifestyles, or values. Pa- tients cannot "comply" with a regimen, moreover, if they do not understand it if they do not know, for example, what medications they should take, when they should take them (before, during, or after meals?), or whether they should stop the medication if they feel better or finish the bottle. If the latter, should the prescription be refilled? Clearly, the skill with which physicians relate to patients and communicate with them affects both their willingness and their ability to "comply." How physicians relate to patients affects more than "compliance." In a series of controlled experiments with patients with diabetes, hypertension, and ulcers, Kaplan and colleagues (1989) have shown that when patients are taught to play an active role in the patient-doctor relationship, their health improves as measured, for example, by hemoglobin Alc and diastolic blood pressure as well as by improvements in functional status. "We can thus assert with some confidence," Kaplan and coworkers (1989) write, "that the effects we observed represent a real impact on patients' health that pa- tients 'aren't just saying' that their health is improved." There should be nothing surprising about this finding; the pervasive placebo effect demonstrates the therapeutic power of the patient-doctor re- lationship (Brody, 1980, 1982; also Spiro, 1986~. Curiously, researchers consistently ignore the benefit of the placebo and focus on the difference

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s? 187 between the placebo effect and the supposedly active medication or treat- ment. Yet when so many double-blind controlled clinical trials show al- most as much healing from the placebo as from the drug or procedure being tested, it is hard to escape the conclusion that the healing comes from the placebo as well as or more than-from the drug (Spiro, 1986~. TECHNOLOGICAL INNOVATION AND PATIENT CARE To recapitulate, American medicine is undergoing a change as far-reaching as that ushered in by the introduction of antibiotics a half century ago. This change amounts to a Copernican revolution one that is returning the pa- tient to the center of the medical universe. In choosing treatments, as Wennberg and Mulley have shown, collabo- ration between doctor and patient is an ethical necessity. Much if not most of the time, there is no "right" or "wrong" decision about how to treat a particular condition; the right choice of treatment depends on the preferences and values of the patient in question (see Mulley, in this volume). Replacing the delegated decision-making model with a shared decision- making model is a necessary but insufficient change. Medical practice must involve a shared clinical encounter. Collaboration between patient and doctor should begin when the patient first seeks help and continue through- out the medical encounter. Collaboration is essential for several reasons. First, the patient is a crucial source of information for diagnosis. Sec- ond, patients are equally important sources of information on the effects of treatment, such as reduction in pain or other symptoms or improvement in functional status and well-being. The existence of valid, reliable measures for assessing patients' functional status and sense of well-being makes it scientifically, as well as ethically, intolerable for physicians to fail to be as concerned with their patients' attitudes, feelings, preferences, and values as they are with their physiological status. This shift from disease-centered to patient-centered medicine is bound to change some of the criteria governing the development, adoption, and diffusion of new technology. As I have shown earlier, patient activism has already altered the processes by which FDA approves new drugs and HCFA decides whether to authorize reimbursement for new devices; the same pressures are forcing hospitals to pay attention to the needs and preferences of pa- tients, rather than of physicians. There will be an equally large impact on the nature of the technologies that doctors use. One can already see a growing emphasis on technologies directed at the outcomes of particular interest to patients, such as reduction of pain or speedier recovery. Consider the unprecedented speed with which laparoscopic cholecys- tectomy has been adopted; in a mere 12 to 18 months, the procedure went "from being unavailable in most communities to being a commonly used technique . . . despite very limited published data to substantiate that the

88 CHARLES E. SILBERMAN laparoscopic approach is superior to the traditional procedure" (Wolfe et al., 19919. In a growing number of communities, in fact, it already has become the procedure of choice. The rapid diffusion of this technique is a response, in part, to payers' demands for less costly alternatives to expensive procedures. For the most part, however, diffusion has been driven by patient demand; the reported advantages of the technique "include diminished postoperative pain, . . . more rapid recovery and return to full activity, and a superior cosmetic result" as well as "shorter hospitalization and associated cost" (Wolfe et al., 1991; see also the Southern Surgeons Club, 1991~. Patient demand for the laparoscopic approach was so strong that plans for a prospective random- ized trial at the University of California, Davis, had to be abandoned; pa- tients were unwilling to chance being assigned to the control group (Wolfe et al., 1991). (Laparoscopic technolorrv is new hying ::'n~li'~A to Other 1~;^Ac of abdominal surgery.) Patients want more than reduction in pain and other symptoms; they want more control over their own condition and treatment, as well. Hospi- tals' growing use of self-administered analgesic units represents one Akind of technological response to these desires; giving patients more control over the management of their own pain seems to lead to less, rather than more, use of analgesic medication. Pharmaceutical manufacturers, meanwhile, are avidly searching for al- ternatives to injection for administering insulin, hormones, and other pro- tein-based medications. Self-injection is awkward and inconvenient, and many patients with diabetes dislike having to inject themselves two or three times a day because it symbolizes their dependence and lack of control. Hence manufacturers have stepped up their efforts to develop implantable pumps, patches, and methods for scra~rin~ the merlication into the nnctrilc or lungs (Thompson, 1990). The interactive videodisc technology that Wennberg, Mulley, and col- leagues are developing to inform patients with breast cancer, back pain, benign prostatic hypertrophy, and other conditions about treatment outcomes and to assist them in making decisions about their own care represents still another response to the rise of patient-centered medicine. Patients need help in making the change; the delegated decision-making model is so deep- ly ingrained that patients find it hard to relate to their physicians as equals and to play an active role in decisions ahoy their own rare Awe of the doctor is instilled in us in childhood, when we see our parents defer to the doctor and carry out his or her orders. "In the child's mind, the authority and mysterious power of the doctor supersede the au- thority of the parents," Thomas A. Preston of the University of Washington Medical School has written. "The physician is the only one who is allowed to violate the rules and taboos of the home, entering the bedroom and ~J A _ ~ A ~ ~ ~ ~ ~1 A A ~ V V ~ ~ A-1 AM 1 11 ~ ~ A ~A AA _ ~_~^ _ ^^ ~ ~ ~.$ ~ A U

WHAT IS IT LIKE TO BE A PATIENT IN THE l 990s? 189 physically handling the child's body." By the time we are grown, we have "learned to accept the power of the doctor to set rules, make pronounce- ments, and give orders, and twe have] long since come to believe in the doctor's ability to cure" (Preston, 1986~. Even when we are well, therefore, it is hard for lay people to relate to doctors as equals; and as I have shown above, illness makes us feel vulner- able and dependent, destroying our sense of control over our lives and our bodies. Our dependency is exacerbated by our need for the doctor not only to cure us but, equally important, to help us make sense of what is happen- ina hence the need for reeducation if patients are to learn to relate to ~h~rc1r'~nc in an ~nlit~rinn hilt nonc~nnfrontational way. tJ1A]~ ^~^ ~4 _~ ^, ~ of_ The interactive video technology Wennberg7 Mulley9 and colleagues are using is an enor- mously promising approach.2 Physicians need as much help as patients. Authoritarianism is deeply ingrained in medical education and practice and is powerfully reinforced by the dependency doctors often see in their patients. "Ever since the 1960s, we've been told that the patient must be the colleague of his doctor and that the decision making must be shared equally by them," says Richard Seizer. "Intellectually and philosophically I certainly do agree." Unfortunately, it doesn't quite work out that way. When I try to call the patient in on a consultation and say, "Which alternative would you pre- fer?" invariably the patient says, "What do you mean, which alternative? I want you to tell me what to do. You're the doctor." The only unspoken word is daddy; tell me what to do, daddy. When a person is desperately ill or frightened, there is a certain kind of regression that makes you want to place yourself in someone's loving care. It is the responsibility of the doctor to have the courage to make decisions for the patient, in as kind and wise a way as he can. To be a father or mother and comfort [emphasis in the onginall (Seizer, quoted in Katz, 1984, p. 126~. Selzer's reaction is understandable, but he has misinterpreted his pa- tients' needs. Frequently, a patient "will do his best to push you into the place of parental authority, and he will make use of you as a parental authority to the utmost," Anna Freud told Case Western Reserve Medical School students in a 1964 lecture. "You must understand that." 2Greenfield, Kaplan, and Ware have used a different approach in their controlled experi- ments studying the impact of patient activism on health (see above). In 20-minute sessions immediately preceding their visits to their doctors, patients were given information about their medical record and the treatment alternatives from which their physician would choose. Pa- tients also received "coaching in behavioral strategies for increasing their participation in care during the office visit," including "techniques for improving question-asking and negotiating skills and ways of defusing hostility or intimidation on the part of the physician" (Kaplan et al., 1989; Greenfield et al., 1988).

90 CHARLES E. SILBERMAN On the other hand, you must not be tempted to treat him as a child. You must be tolerant towards him as you would be towards a child and as respectful as you would be towards a fellow adult because he has only gone back to childhood as far as he's ill. He also has another part of his personality which has remained intact, and that part of him will resent it deeply, if you make too much use of your authority [emphasis added]" (Anna Freud, quoted in Katz, 1984, p. 146~. It will not be easy for physicians to learn to treat patients as adults rather than as children. The technology that Wennberg and Mulley are using to educate patients could be used to reeducate physicians, as well. Other technologies may also come into play; as part of his ongoing research on the therapeutic impact of patient-doctor relations, Sheldon Greenfield made a 20-minute film (using conventional VHS technology) to teach phy- sicians how to present treatment alternatives to patients, how to negotiate with patients, how to get passive patients involved in their own care, and so on.3 Patient-centered medicine will affect the development and diffusion of technology in other ways. In particular, a more patient-centered approach to medicine is likely to result in more discriminating use of technology. Until now, clinical practice has often been driven by technology, which imposed a logic of its own. Witness the so-called "cascade effect" in which one perhaps unnecessary diagnostic test leads to another, which leads to another, and so on. Here is a recent description of how the cascade effect works in cardiology. Instead of delving more carefully into the history when a patient presents with unusual chest pain, someone may order an exercise test that shows suspicious changes, leading to an isotope study with suggestive defects in a shadowy image, followed by arteriograms that, predictably, in most cases show some coronary disease, and so on down the cascade, sometimes with disastrous complications that no one wanted or anticipated (James, 1988; see also Mold and Stein, 1986~. All this because of failure to take a careful history. The more tests that are done, of course, the higher the probability that the patient will be found to have some abnormality. And when an abnor- mality is found, the assumption that disease is pathophysiological creates a bias in favor of intervention: "Once a lesion is found there is an irresistible temptation to remove it or fix it." Hence the recurrent cycle of surgical remedies, such as gastric freezing for duodenal ulcers, ligation of the inter- nal mammary arteries for angina, or intragastric balloons for obesity, that are discovered, tried, and then proven worthless at best and harmful at worst. 3Conversation with Sheldon Greenfield, December 3, 1990.

WHAT IS IT LIKE TO BE A PATIENT IN THE 1990s? 191 The tendency to substitute diagnostic tests and surgical procedures for information from, and therapeutic relationships with, patients has been ex- acerbated by the way in which physicians have been reimbursed. By paying doctors far higher fees for tests and procedures than for the same time and effort spent talking to patients, the insurance reimbursement system has given doctors powerful financial incentives to maximize their use of tech- nology and avoid collaborative relationships with patients. The payment system "so favors the biotechnical aspects of care," Moloney and Paul (199lb) write, "that the implicit message to professionals is 'talk to patients on your own time."' The income differentials resulting from the discrepancies in fees have also channeled young physicians away from the primary care disciplines of pediatrics, internal medicine, and family practice and toward procedure-oriented specialties (Physician Payment Review Commission, 1990~. The incentives are changing now as a result of the reform of the Medi- care physician payment system that began in the fall of 1991. The change was proposed by the Physician Payment Review Commission, or PPRC, and mandated by Congress in 1989; although the reform is to be phased in over 5 years, the largest part of the change will be completed by the end of fiscal 1992 (Physician Payment Review Commission, 1991~. Under the new system, Medicare payments to physicians will be deter- mined by the resources needed to provide the service in question. These resources include the physician's time, physical effort, and skill; the mental effort and judgment required; the stress that is involved; and the associated costs of that kind of practice. When implementation of the system is com- plete, fees for primary care services will have risen by 30 percent or more, and there will be comparable reductions in payments for major diagnostic and surgical procedures. (To discourage physicians from performing more procedures to compensate for lower fees, the legislation mandates the estab- lishment of annual "volume performance standards"; if physicians increase volume more rapidly than the standard allows for that year, their fees would be reduced accordingly in the following year.) It is too soon to know whether insurance companies and employers will apply the concept to the private sector, but such an expansion is likely (Ginsburg and Lee, 1991~. Whether limited to Medicare or not, physician payment reform is bound to affect decisions about the use of medical technology. It will do this by creating a level playing field one in which financial incentives neither encourage nor discourage the use of technology. But physician payment reform will encourage the development of a more collaborative patient- doctor relationship by rewarding doctors equally for patient-oriented and procedure-oriented activities. It may also reverse the long-term movement of physicians away from primary care and into procedure-oriented specialties. The need is clear; how rapidly medicine adopts a more patient-centered approach will depend in good measure on the strength of the countervailing

192 CHARLES E. SILBERMAN forces. As Wennberg and Mulley point out in their papers in this volume, the managed care approach to cost control implies different roles and re- sponsibilities for the actors in the health care drama doctors, patients, and policymakers. How different these roles can be was dramatized in late November 1991 when Thomas O. Pyle, the longtime chief executive of the Harvard Community Health Plan, was forced to resign by staff physicians angry over his plan to link their compensation with the number of patient visits they handled. The change would have created pressure on physicians to limit the time they spent with each patient. "Mr. Pyle's resignation underscores tensions that have developed at many health care organizations as competition for corporate and individual customers has intensified," the Wall Street Journal reported. "In August, top executives at Bay State Health Care, another large Boston-area HMO, resigned after a similar dispute con- cerning physician compensation" (Stipp, 1991~. True, many HMOs try to increase physician "productivity" by limiting the time physicians can spend per patient visit. But as Robert Blendon of the Harvard School of Public Health comments, the Harvard Community Health Plan "is supposed to be a special place for special people" (Stipp, 1991~. As Samuel Goldwyn is said to have remarked, predictions are always dangerous-especially about the future. Let me run the risk: the forces underlying the shift toward a more collaborative patient-doctor relationship seem to me to be too powerful to be offset by managed care, which moves decision making away from the patient and his or her physician and toward some anonymous bureaucrat. In the rest of the economy, after all, the trend is toward more account- ability to the customer. "About two decades ago, J. D. Power changed the nature of the automotive marketplace and influenced the future design of cars as well," Moloney and Paul (199lb) point out. "He did so by making consumer ratings of various aspects of new model automobiles widely available to the public." Industry officials warned that this practice would lead to wasteful changes in automotive design, such as larger tail fins and more metallic paint. In fact, consumers proved industry experts wrong, choosing instead cars needing fewer repairs and offering better safety features. Patients are now eager to know how other patients rate their care. They say they would use their neighbors' ratings as a key factor in deciding where to seek care in the future. Can the day be far ahead when employers, insurers, or citizens groups sponsor surveys of patient perceptions of care received under com- peting medical plans, at competing hospitals or group practices, and make those reports available to patients and their insurance sponsors? Or the day when patients and physicians collaborate and medical care is directed toward the outcomes patients want and need.

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The U.S. health care system is in a state of flux, and changes currently under way seem capable of exerting sizable effects on medical innovation.

This volume explores how the rapid transition to managed care might affect the rate and direction of medical innovation. The experience with technological change in medicine in other nations whose health care systems have "single-payer" characteristics is thoroughly examined.

Technology and Health Care in an Era of Limits examines how financing and care delivery strategies affect the decisions made by hospital administrators and physicians to adopt medical technologies. It also considers the patient's stake in the changing health care economy and the need for a stronger independent contribution of patients to the choice of technology used in their care.

Finally, the volume explores the impact of changes in the demand for medical technology in pharmaceutical, medical device, and surgical procedure innovation.

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