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~' Effects of Clinical Evaluation on the 7 Diffusion of Medical Technology Patterns of medical practice often di- verge from recommendations based on controlled clinical evaluations. This chap- ter views such discrepancies in light of the many forces in addition to clinical evalua- tion that influence the adoption and aban- donment of medical technology. The central question for the chapter can be stated simply: What effect does the evaluation of medical technologies have on their diffusion? The next two sections of the chapter introduce some of the complex- ities of this question and present an ap- proach to assessing the literature that tries to answer it. Following a review of litera- ture about the effect of evaluation on the diffusion of medical technology, the chap- ter summarizes its principal conclusions and offers a few recommendations. The relation between evaluation and diffusion is part of a larger issue of the con- tribution of technology assessment to im- proved health. This review emphasizes the connection between evaluations and physi- Harvey V. Fineberg prepared this chapter. clan behavior, although recognizing that health benefits in many medical situations ultimately depend on the behavior of pa- tients as much as or more than that of phy- . . slclans. EVALUATION In this review, the impact of two general types of evaluation are considered: (l) pri- mary assessments of the consequences of a medical technology and (2) synthetic as- sessments of the implications for clinical practice of the available primary evidence. Both primary and synthetic assessments take a variety of forms. Primary assess- ments range from judgments based on per- sonal experience to multicenter random- ized clinical trials. Synthetic activities range from review articles to meetings of experts for the purpose of reaching consen- sus on a controversial issue. This section deals with the effect of eval- uation on medical care decisions, usually the decisions of physicians. Relatively few studies quantitatively assess the influence of community-based epidemiological stud- ies, data banks, or case studies on changes 176

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EFFECTS OF CLINICAL EVALUATION in physician practice. Many primary and synthetic evaluations are used by regula- tory bodies like the Food and Drug Admin- istration or by third-party payers in reach- ing their policy decisions; these evaluations indirectly and powerfully impinge on clin- ical practice and should be considered by someone. In this chapter no attempt was made to cover the effect of evaluations on decisions about the organization, adminis- tration, and support systems of health in- stitutions, although these too have an indi- rect bearing on medical practices. Nor has an attempt been made to catalog the im- pact of epidemiologic assessments on social policy (as in the areas of toxicology and en- vironmental health) or on public behavior (as in the decline in cigarette smoking) re- lated to health. The emphasis is on physi- cian practices and on the influence of vari- ous forms of clinical evaluation in changing those practices. Primary clinical evaluations could be ar- ranged in a hierarchy according to their freedom from bias, for instance, with the randomized clinical trial (RCT) at the top and then, moving downward, controlled (nonrandomized) studies, series of patients without controls, and personal recollection unaided by systematic record keeping. If even the weakest forms of evaluation count in our lexicon of evaluation, then most clinical practice is based on an evaluation. To refine the question posed at the outset of the chapter, we would like to know whether (and, possibly, to what extent) the more rigorous and powerful forms of pri- mary clinical assessment are more influen- tial than less rigorous forms in shaping medical practice and the policy decisions that affect the use of medical technology. In some instances, of course, a particular technology cannot be studied using the stronger methods, for example, when an RCT is not feasible because of sample size. 177 Diffusion refers to the spread of an inno- vation over time in a social system (Rogers and Shoemaker, 1971~. The concept in- cludes new practices being adopted and old practices being abandoned. Built into the notion of diffusion is the expectation that social change is not instantaneous and that some difference in practice among physicians at a moment in time is therefore reasonable and likely. Many studies of dif- fusion in the social sciences examine situa- tions in which measurable expansion or contraction in a practice occurs over the duration of the study rather than where patterns of practice (possibly including marked variation across individuals, insti- tutions, or geography) are relatively sta- ble. In many studies of diffusion, the correct- ness of knowledge available to the poten- tial adopter is taken for granted. An inno- vation or practice is regarded as objectively and knowably good or bad. The majority of these studies do not relate the nature and quality of evaluative evidence to the spread of a practice over time. Instead, dif- fusion studies tend to focus on characteris- tics of the innovation, characteristics of the potential adopters, communication chan- nels (bringing information to the adopter), the decision-making process, institutional features, and environmental forces that bear on the spread of a practice. Notions of evaluation, if introduced at all, tend to en- ter as attributes of the innovation (for ex- ample, the ease with which it can be tried on an interim basis) rather than as an inde- pendent determinant of the rate or extent of diffusion. Investigators concerned with the impact of scientific evidence on physician beliefs and practices frequently examine the state of practice at a single point in time rather than as a diffusion process over time. The prime interest in many of these studies has been to assess the knowledge and judgment

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178 of physicians rather than to judge critically the effectiveness of a clinical trial in reach- ing or convincing physicians. This discus- sion is especially concerned with studies that relate evaluation and specific evalua- tion methods to changes in practice over time. Determinants of Diffusion Many factors bear on the adoption and abandonment of medical technology. The following discussion identifies 10 sources of influence. The first 4 (prevailing theory, attributes of the innovation, features of the clinical situation, and the presence of an advocate) are relatively insensitive to change by policymakers. The next 3 (prac- tice setting, decision-making process, and characteristics of the potential adopters) may be subject over time to some policy in- fluence. The remaining 3 (environmental constraints and incentives, conduct and methods of evaluation, and channels of communication) are relatively susceptible to influence by policymakers. Each factor is discussed briefly, with the greatest atten- tion given to the last group. Prevailing Theory Prevailing theory and accepted explanations for empirical phenomena appear to have a strong influ- ence on the acceptance of new ideas. Pre- vailing theories may delay the acceptance of ultimately proved innovations. Stern (1927) cites a number of classic examples, such as the resistance to smallpox vaccina- tion by those who held that improved sani- tation was the main cause of a decline in the smallpox rate, disbelief in the manifold consequences of syphilis by those who held to the theory of duality of tuberculosis; and refusal to recognize puerperal fever as a contagious disease by those who subscribed to atmospheric, cosmic, and telluric influ- ences on health. Twentieth century exam- ples include long-delayed acceptance of sa- licylates in the treatment of rheumatoid ASSESSING MEDICAL TECHNOLOGY arthritis (Goodwin and Goodwin, 1982) and a number of advances in cardiopulmo- nary medicine and surgery (Comroe, 1976~. In other cases, appeals to prevailing theory as a rational basis for belief about etiology and treatment of disease appeared to have hastened the acceptance of unsub- stantiated practices that were ultimately discarded. This occurred, for example, in the case of gastric freezing for the treat- ment of duodenal ulcers (Fineberg, 1979) and the conduct of subsequently discarded operations such as surgery for the endo- crine glands and surgery for constipation (Barnes, 1977~. Marks (Ideas as Social Re- forms: The Legacies of Randomized Clini- cal Trials, unpublished report, 1983) ar- gues that relatively new methods of evaluation (like RCTs) are themselves an innovation whose acceptance is influenced by prevailing theory about the nature of clinical evaluation and its role in medical decision making. The Innovation Innovations vary in the benefits and costs they offer the physi- cian and in their compatibility with the physician's experience and style of prac- tice. Diffusion of new practices is presum- ably enhanced by the extent to which they are easy to use, require little effort to learn, impose little change in practice style, are highly remunerative and satisfying, and have no clinically worthy competitors. The Clinical Situation An innovation that solves an important clinical problem and is seen as highly pertinent to practice is likely to be adopted more readily than an otherwise equally attractive innovation that addresses a less pressing or pertinent situation. Advocacy Successful diffusion of new practices often has been attributed to an authoritative advocate who promotes the innovation (Globe et al., 1967; Barnes, 1977; Fineberg, 1979~. Forceful advocates

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EFFECTS OF CLINICAL EVALUATION have wrongly encouraged practices that were subsequently abandoned as ineffec- tive as well as practices that were eventu- ally proved effective. An authority figure who is correct in strongly promoting or op- posing one innovation may turn out to be wrong about a later innovation (Stern, 1927; Comroe, 1976; Fineberg, 1979~. The Potential Adopter Many studies of diffusion and of variation in medical prac- tices seek to explain patterns of practice in terms of physician attributes such as their technical skills, demographic characteris- tics, professional characteristics, socio- metric status, and attitudes toward inno- vation. In principle, changes in medical school admissions policies and in access to various types of specialty training could in time alter attributes of the physician popu- lation. The Practice Setting Several features of the setting and environment in which physicians practice can influence their use of medical technology. Physicians in group practices appear to adopt innovations more rapidly than physicians in solo prac- tice (Williamson, 197S). The size and teaching status of hospitals appear to influ- ence hospital acquisition of equipment, making possible new physician practices (Russell, 1979~. The pattern of practice among colleagues influences the way phy- sicians use available medical technology (Freeborn et al., 1972~. The Decision-Making Process Some medical practice decisions are wholly within the domain of the individual practi- tioner. Others are group decisions, and yet others require a concomitant or prior insti- tutional decision. A decision-making pro- cess that involves more people is likely to require a longer time to reach a conclusion. In a study of three anesthetic practices, the one that required a collective and institu- tional decision (scavenging for waste anes- 179 thetic gases) entailed several years longer delay between awareness and change in practice than was the case for the other two practices in which the physician could take action as an individual (Fineberg et al., 1978, 1980~. Environmental Constraints and Incen- tives Regulatory agencies and medical care insurers exercise direct and indirect control over the diffusion of many medical practices. Examples may be cited at the federal, state, and local levels. At the fed- eral level, the Food and Drug Administra- tion sets standards for the approval of new drugs and medical devices; the Health Care Financing Administration makes in- surance coverage decisions for Medicare patients that may prompt similar action by other third-party payers; and the Centers for Disease Control set the antigenic con- tent and recommended usage of vaccines, among other recommendations for prac- tice. At the state level, certificate-of-need programs, at least in principle, directly in- fluence hospital equipment and services, many of which impinge on clinicians' prac- tices. Locally, institutional review bodies and quality assurance efforts affect deci- sions about medical practices. The climate of malpractice litigation also may alter a clinicians' reliance on certain medical pro- cedures. All such environmental forces shape the opportunities and incentives for change in medical practice. Evaluation and Methods of Evalua- tion The factor that is of central concern in this chapter is the role of formal evalua- tion in shaping the behavior of physicians. Evaluation may act directly on the percep- tions of physicians; it may influence ex- perts who in turn influence physicians (through a channel of communication); or it may influence the policy decisions of reg- ulatory bodies (such as the Food and Drug Administration), or of third-party payers (such as the Health Care Financing Ad-

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180 ministration), and hence alter the environ- ment in which medical practice decisions are made. In this chapter, all three possible chains of influence on physician practices are examined. Many clinicians are not well prepared to deal with quantitative methods in formal evaluations (Berwick et al., 1981~. Debates about the merits of particular evaluations may be the expression of fundamental dis- agreement about the nature and role of controlled clinical trials in medicine (Fein- stein, 1983; Bonchek, 1979; Marks, unpub- lished report, 1983~. Channels of Communication A sub- stantial number of diffusion studies in medicine have examined the ways in which physicians learn about new prac- tices. Investigators are interested in which sources of information and which channels of communication are most influential. Be- cause different channels of communication can to a degree be selected by clinical in- vestigators and potentially enhanced by policymakers, research in this area war- rants elaboration. A large body of early work on channels of communication concerned the dissemi- nation of drugs among medical practition- ers, especially the influence of face-to-face sales representatives and of social networks among physicians (Sherrington, 1965~. These early studies found that direct per- son-to-person contacts by drug company representatives were more influential than other forms of advertising (Caplow, 1954~. This finding has been reaffirmed in recent studies showing that personal representa- tion by pharmacists or, even more effec- tively, by other physicians can influence doctors to be more prudent drug prescrib- ers (Avorn and Soumerai, 1983; Schaffner, 1983~. Studies of how doctors learn about new medical practices, based on physician sur- veys, have found medical journals, discus- sion with colleagues, and continuing edu- ASSESSING MEDICAL TECHNOLOGY cation each to be regarded as important sources, with journals most consistently cited as high (Fineberg et al., 1978; Man- ning and Denson, 1979, 1980; Stross and Harlan, 1981; Market Facts, 1982; Jordan et al., 1983~. One study of physician awareness of pertinent findings published in a journal of a specialty different from their own found that most of those who were aware of the findings learned about them from consultants or colleagues (Stross, 1979~. In a study of three practices in anesthesiology, the channels of commu- nication (papers published in journals, col- leagues, and continuing education) dif- fered more in how many physicians they reached than in their persuasiveness to change practice (Fineberg et al., 1978~. Persuasiveness depended more on the na- ture of the clinical finding being communi- cated than on the channel of communica- tion. Whether formal medical training appears relatively important in conveying new knowledge (Jordan et al., 1983) or rel- atively unimportant (Manning and Den- son, 1979) may depend mainly on the re- cency of the innovation and on the age of the potential adopter. Other studies are be- ginning to assess the influence of National Institutes of Health (NIH) consensus con- ferences on specific physician practices (The Rand Corporation, 1983; Jacoby, Biomedical Technology Information Dis- semination and the NIH Consensus Devel- opment Process, unpublished report, 19834. In thinking about the implications of these studies, several additional points should be borne in mind. First, channels of communication that are perceived to be most effective may be specific to particular types of innovation (e. g., different for drugs than for surgical procedures) and the particular physician audiences (specialists or younger practitioners may be attuned to different channels than generalists or older physicians). Second, what physicians say or believe

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EFFECTS OF CLINICAL EVALUATION influences them may differ from what ac- tually influences them (Avorn et al., 1982~. Third, investigators are unlikely to draw favorable conclusions about the impor- tance of channels of communication that they omit from their survey instruments. If, for example, a survey questionnaire lists "journals, books, conferences, and contin- uing education" as possible responses, then "talking with colleagues" is unlikely to be found important. If a study restricts itself to the social network of physicians in the transmission of information, then the role of journals is not likely to appear very prominent. Fourth, if a channel of communication has been less effective, it may be because few physicians have been exposed to that channel or because that channel is intrinsi- cally unconvincing compared with other sources of information. Continuing medi- cal education, for example, appears to have lesser perceived impact than medical journals. The policy implications are quite different if one believes that the weak showing is because of low exposure to con- tinuing education than if one believes that physicians are not convinced by what they see and hear at such educational programs. Fifth, as time passes after the initial re- lease of new information, different chan- nels of communication may become rela- tively more important as conveyors of information to physicians. The initial re- lease of new findings usually come in the form of a publication or presentation at a professional meeting. Soon after the re- lease of new findings, then, journals (or public news media) may be especially prominent sources (Stross and Harlan, 1981; Market Facts, 1982~. Later, col- leagues and medical teaching conferences may become more prominent than they were earlier (Fineberg et al., 1978; Stross and Harlan, 1979; Jordan et al., 1983~. Thus, in a study of the importance of cl~- ferent channels of communication, find- ings may depend in part on the timing of 181 the study relative to the time the innova- tion was introduced. All physicians are challenged to discern what they need to know from the sea of new medical information that surges around them. Physicians do appear open to the idea of receiving direct mail summaries of new medical findings (Market Facts, 1982~. The success of the brief monthly, The Medical Letter, has spawned a flock of imitators, and at least one medical text- book (Scientific American Medicine) pro- vides monthly updates with short summar- ies of key findings relevant to practice. Channels of communication that convey pertinent, concise information would seem to have a comparative advantage. The ex- panding availability of personal computers in physician homes and offices offers a new medium that can potentially convey evalu- ative information on new and current medical practices. Of course, the physi- cians most resistant to changing their med- ical practices may also be the last ones to install a home computer. Measures of Diffusion and Sources of Data Studies of diffusion and evaluation in- volve a variety of dependent variables, partly determined by the specific objec- tives of the study, partly by the nature of the medical practice being studied, and partly by the data available to the investi- gator. Interest here is in evidence about the di- rect and indirect effects of evaluation on (1) physician beliefs, (2) expert opinion, and (3) clinical practices. Measures of the first typically rely on surveys or interviews with practitioners and express results as a proportion who adhere to certain beliefs at a particular time or at different points in time. Studies of expert opinion may also use survey methods or rely on literature re- views or on recommendations in textbooks, review articles, or other guidelines written

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182 by experts. Studies of medical practices may draw upon many data sources: (1) surveys of physicians or of institutions; (2) information gathered from patients or from the general public, as in the Health Interview Survey of the National Center for Health Statistics (NCEIS); (3) patient medical records; (4) pharmaceutical rec- ords; (5) information from manufacturers of equipment or of medical devices; (6) na- tional practice registries, such as the Na- tional Disease and Therapeutic Index; (7) insurance payment records; and (8) infor- mation from state and national data files on hospitalization and medical proce- dures, such as the NCHS Hospital Dis- charge Survey, reports of the Commission on Professional Hospital Activities, and several statewide data consortia. While admiring the ingenuity of many investigators in finding pertinent data, we should bear in mind limitations and biases lurking in these various measures. Surveys are subject to selection and recall biases. Manufacturer sales data may trace the dis- semination of new equipment, although that is not necessarily coincident with the extent of its use. Records from selected in- surers may be incomplete, and national registries may fail to reflect changing pat- terns of disease classification and new, im- portant though less than major, changes in patient management. The dependent variable in a diffusion study may be expressed as a count or as a proportion. For example, a certain num- ber of pills, number of prescriptions, or number of devices is supplied each year; or a certain fraction of physicians used a drug or a fraction of hospitals have purchased a new piece of equipment. Embedded in each of these dependent variables is a pop- ulation of potential adopters of the prac- tice being studied. The potential target population is explicitly the denominator in a fraction and is left unspecified in the case of counts. In either case, the interpretation of a study depends on an appropriately de- ASSESSING MEDICAL TECHNOLOGY fined target population that is either stable over time or is correctly adjusted over time, as, for example, the target pool of pa- tients varies or the number of trained clini- cians changes. Diffusion as Affected by Evaluation Diffusion may be considered a process of growth and decay over time. In an ideal- ized case, unambiguous new findings of an unequivocally superior innovation, or clear-cut determination of a definitively inferior current practice, would be instan- taneously communicated to all pertinent adopters who would promptly make the appropriate change in practice without any constraints or disincentives. The diffu- sion pattern would be an extremely sharp rise in the case of adoption and an ex- tremely sharp fall in the case of abandon- ment (Figure 4-1A and 4-1B). Evaluations often are not clear-cut, and any of the 10 factors that influence diffu- sion can introduce friction into the system. Empirically, a number of innovations have been found to follow an S-shaped pattern of diffusion (Figure 4-2A). A traditional so- ciometric model accounting for such a pat- tern postulates early adopters and opinion leaders who influence increasing numbers of other physicians to adopt a new prac- tice, leaving some resisters in the end who fail to adopt the innovation (Rogers and Shoemaker, 1971~. Other models invoking different determinants of diffusion (fea- tures of the innovation itself, of the setting for use, of the decision making process, etc.) could also be constructed to account for an observed S-shaped pattern of diffu- sion. Thus, an observed pattern of diffu- sion does not typically indicate the relative contributions of the various possible deter- minants of diffusion. Several studies of the spread! of medical equipment and institutional innovations have shown approximately S-shaped pat- terns of spread with slower initial rise fol-

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EFFECTS OF CLINICAL EVALUATION A. Vertical Adoption IIJ z LLJ ~ ~ O O ~ B. Vertical Abandonment Unequivocally Superior Innovation TIME . Definitively Inferior Current Practice TIME FIGURE 4-1A and 4-1B Idealized diffusion pattern. lowed by an accelerated phase (Fineberg et al., 1977; Fineberg, 1979; Russell, 1979; Office of Technology Assessment IOTA], 1981~. Some studies of the diffusion of new drugs have found a pattern of spread that is initially very rapid (Figure 4-2B) (Warner, 1975; Fineberg and Pearlman, 1981~. Fewer empirical studies have examined the phase of abandonment. Some cases show gradual abandonment (Figure 4-2C) (Fineberg et al., 1980~; others, involving drugs found to be unsafe, show rapid de- cline in usage shortly after release of the findings (Figure 4-2D) (Finkelstein and Gilbert, 1983~. An assessment of the impact of evalua- tion on practice requires a standard for judging impact. Two standards seem plau- sible, one that might be called rational be- havior, and a second that might be called expected behavior. With rational behavior as the standard, emphasis is on the extent to which practice conforms to the findings of evaluation, meaning all adopt for posi- tive evaluations and all abandon for nega- tive evaluations. With expected behavior 183 as the standard, emphasis is on changes in the pattern of diffusion that can be related to evaluation. A clinical evaluation might affect both the rate of adoption or abandonment of a practice and the extent of its ultimate use. Since these changes may be in a direction consistent with the findings of evaluation, though falling short of full conformance, the expected behavior standard is less de- manding than the rational behavior stan- dard. Investigators who base their conclu- sions on a rational standard often intend to judge the behavior of physicians, not the credibility of an evaluation method. An ex- pected behavior standard implicitly recog- nizes that evaluation is only one of many determinants of diffusion. Seeking to establish a relation between an evaluation and a change in diffusion can take the form of answering five kinds of questions: 1. What is the baseline pattern of diffu- sion? In other words, what pattern of adoption or abandonment of pertinent

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184 ASSESSING MEDICAL TECHNOLOGY A. S-Shaped Adoption 6 ~ Lo Z LL ~ ~ O O ~ oh 6 ~ 111 Z ~ 111 Q ~ O O ~ B. Convex Upward Adoption / - TIME ~ C. S-Shaped Abandonment TIME - / TIME - D. Concave Upward Abandonment TIME - FIGURE 4-2A through 4-2D Empirical diffusion patterns. clinical practices would be expected to oc- cur over time if the evaluation in question had not been carried out? 2. What do results of the evaluation, when correctly interpreted, imply about what constitutes appropriate medical care? Do the implications require a change in the use of a medical technology? In ef- forts to discriminate among the effects of different types of evaluation, are the impli- cations from one type of evaluation differ- ent from the implications of others? 3. Are there changes in physician awareness and in the pattern of practice that are consistent with the findings of evaluation (or of one type of evaluation)? 4. What is the temporal relation be- tween evaluation and changes, if any, in the pattern of practice? 5. Is there additional evidence (such as interviews, bibliographic citations, opin- ion surveys, etc.) supporting a connection between an evaluation and change in prac- tice? Answers. to these questions can provide circumstantial evidence about the relation between evaluation and practice, making

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EFFECTS OF CLINICAL EVALUATION a connection seem plausible or implausi- ble, though not established in a rigorous way. A controlled trial of the effectiveness of controlled trials has not been done and is hard to imagine. EVIDENCE ABOUT THE EFFECTS OF EVALUATION ON DIFFUSION The principle body of work used in this analysis consists of 48 papers, reports, books, and other documents that assess the relation between evaluation and medical practice. This highly diverse literature cuts across many medical specialty areas. (A summary of the literature is appended.) Though doubtless incomplete, this collec- tion is sufficiently rich to provide a basis for discussion. Several recent reviews con- cerned with the effects of clinical trials on medical practice aided the bibliographic search (Controlled Clinical Trials, Sep- tember 1982; OTA, 1983; Hawkins, Eval- uating the Benefit of Clinical Trials to Pa- tients, unpublished report, 1983~. The terminology in referring to this lit- erature can be confusing because it consists of studies of the effects of other studies. In the remainder of this chapter, the term study will be reserved for an analysis of the effects of one or more clinical trials, con- sensus exercises, or other forms of clinical evaluation on physician behavior in a par- ticular clinical situation. We use the words practice or clinical practice to mean physi- cian behavior. When referring to a clinical evaluation that is the subject of a study, we will refer to it as a clinical trial or, when appropriate, as a randomized clinical trial (RCT). The discussion is organized in two major categories depending on the directly mea- sured effect of evaluation: (1) effects cli- rectly on physician behavior and (2) effects directly on regulators or third-party pay- ers. 185 Evaluation and Physician Behavior All but two of the reviewed studies deal at least in part with the relation between clinical evaluation and the knowledge, be- liefs, and decisions of physicians. The kinds of evaluation whose effects are examined in these studies fall into two broad groups: primary evaluations, such as randomized clinical trials, which acquire and present new clinical findings; and synthetic evalu- ations, such as consensus conferences, which integrate and interpret available primary evidence. Thirty-eight studies deal at least in part with primary evalua- tions. The Impact of Primary Evaluations on Physicians In attempting to organize evi- dence about the relation between clinical trials and physician decision making, it is useful to distinguish two analytic strategies that may be adopted in a study (Gamier et al., 1982; OTA, 1983; Hawkins, unpub- lished report, 1983~. The first strategy be- gins with a clinical trial or trials and at- tempts to trace its effects on physician awareness or behavior. The second begins with a set of practices or innovations and traces back to the various kinds of evalua- tion that contributed to its development, dissemination, or abandonment. The next two subsections discuss studies that follow the first strategy and examine the effects of clinical trials on physician awareness and clinical decisions. The third subsection re- views studies that follow the second strat- egy and attempt to trace the origin of med- ical opinion or practices. Effects of Clinical Trials on Physician Awareness Two studies are devoted mainly to assessing physician awareness of findings from RCTs (Stross and Harlan, 1979, 1981~. In the first, family physicians and internists attending a continuing med- ical education (CME) course (on an un- specified subject) were asked whether they

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186 were aware of findings about the treat- ment of diabetic retinopathy that had been published 18 months earlier in the Ameri- can journal of Ophthalmology. Two- thirds were not (72 percent of family prac- titioners and 54 percent of internists). Of the minority who did know about the study, two-thirds said they learned about it from an ophthalmologist or colleague. A1- though 70 citations to the controlled trial of treatment for diabetic retinopathy ap- peared in the medical literature between 1976 and 1979, none before 1978 was pub- lished in a general American medical jour- nal unrestricted in geographical or subject scope (Dunn, 1981~. In this case, numerous citations did not ensure the effective com- munication of a scientific finding. More- over, physician awareness would turn out to be no guarantee of improved medical practice. A later evaluation found that 60 percent of internists could not properly di- agnose proliferative diabetic retinopathy and so would be unable to recognize pa- tients to whom the initial RCT applies (Sussman et al., 1982~. In a second study of physician aware- ness, Stross and Harlan (1981) surveyed physicians attending CME courses about their knowledge of results from the Hyper- tension Detection and Follow-up Program (HDFP). This time, 40 percent of family physicians and 60 percent of internists, re- spectively 2 months and 6 months follow- ing publication of the RCT in the Journal of the American Medical Association in 1979, said they were aware of the findings, and most of those had learned about it from the literature. These figures represent awareness among physicians at single points in time for each physician group. Hence, the figures are not revealing about the diffusion over time of knowledge about this RCT, much less about its impact on clinical practices. As in the case of diabetic retinopathy, a later study would raise questions about the translation of this RCT into effective clinical practice, in part be- ASSESSIN(7 MEDICAL TECHNOLOGY cause of inappropriate medication pre- scribed by physicians and in part because of patient nonadherence to prescribed medication regimens (Wagner, 1981~. The management of hypertension illus- trates some of the pitfalls in attempting to draw conclusions about the effects of clini- cal evaluations on physician awareness and medical practice. In 1977, the Joint Na- tional Committee on Detection, Evalua- tion, and Treatment of High Blood Pres- sure recommended an individualized approach to treating patients with mild hypertension. A 1978 survey of physicians in New York City found that 92 percent were routinely starting antIhypertensive medication for patients with mild hyper- tension, a far more aggressive treatment strategy than recommended by the Na- tional Committee (Thomson, 1981~. Re- sults from the Hypertension Detection and Follow-up Program subsequently lent sup- port to the more aggressive treatment strat- egy previously followed by more than nine out of ten physicians in New York City. In this case, a widespread practice that ap- peared unjustified at one time was borne out by a subsequent randomized trial; thus, demonstration of efficacy by an RCT may follow as well as precede prevailing patterns of practice. The optimal strategy for treatment of mild hypertension con- tinues to be controversial, and value judg- ments about the conformance of physician practices to a particular management strategy would seem more hazardous today than perhaps they once appeared. A set of surveys recently commissioned by the National Heart, Lung, and Blood Institute (NHLBI) investigated physician awareness of findings from two specific RCTs and their effects on practice (Market Facts, 1982~. This study design is notewor- thy in that it represents an exceptional ef- fort to obtain data on physician knowledge and attitudes both before and after release of findings in 1980 from an RCT (the Aspi- rin Mvocardial Infarction Study FAMISH

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200 APPENDIX 4-A Continued ASSESSING MEDICAL TECHNOLOGY Reference (Year) Type of Evaluation Source of Data Studied on Effects Findings Studies of Patterns of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts Secondarypre- Marks, unpub- 7 RCTs Published articles, re- Views persistent controver- vention of fished report views, editorials, sies as disputes over cri- myocardial (1983) letters. teria for judging evi- infarction dence, weights accorded different types of evi- dence (RCTs and other), and convictions about RCTs as the single, proper standard for judging merit of prac- tices. Antiplatelet Friedwald and 2 RCTs (aspirin Views of authors. Aspirin not demonstrably agents to Schoenberger myocardial in- effective; methodologic prevent re- (1982) farction study controversies dominate current and anturane anturane trial. myocardial reinfarction trial) infarction Cancer ther- UICC reports; Ar- RCTs and other Views of authors. RCTs have been more use- apy mitage et al. controlled trials ful than non-RCTs in (1978) developing cancer treat- ments. Treatment of Rockette et al. RCTs Views of authors. RCTs have strong effect on breast can- (1982) shaping breast cancer cer treatment. Neurosurgical Haines (1983) 51 RCTs in the lit- Views of authors. Many trials have serious procedures erasure published methodologicshortcom- since 1944 ings and few if any have resolved important clini- cal questions. Therapy for Gehan (1982) Published trials Review of literature. Nonrandomized (rather acute leuke- than randomized) stud- mia ies have been the pri- mary means of establish- ing effectiveness of new therapies between 1948 and 1971. Therapy for Gamier et al. Available literature Opinion of hospital In most cases where there head and (1982) experts plus review is a consensus about neck cancer of literature. treatment at the investi- gators' hospital, it is the result of nonrandomized studies. Innovations in Gilbert et al. Published evalua- Literature review. Of 107 papers assessing in- surgery and (1977) tions of innova- novation, approximately anesthesia tions in surgery one-third are RCTs. and anesthesia Less well-controlled studies are more positive about innovation.

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EFFECTS OF CLINICAL EVALUATION 201 Discharge of Berg and Salis- Comparison group (Blue Cross) Insur- 90% of low-birth-weight low birth bury (1971) (concomitant) ance records. infants are kept in hospi- weight nonrandomized tal longer than neces- trial (plus absence sary; 2 years after publi- of contradictory cation of initial study. evidence in litera- ture) Oral hypogly- Chalmers (1974' RCT (University National Disease and No decline in use of all comic agents Group Diabetes Therapeutic Index oral hypoglycemics 3 in diabetics Project) (NDTI). years after UGDP results published in 1970. Warner et al. Use of all hypoglycemics (1978~; Finkel- drops by 50 % between stein and Gil- third and seventh years bert (1983) after UGDP results pub- lished. Use of tolbu- tamide shows prompt and sharp decline soon after publication of UGDP results. Stilbestrol in Chalmers (1974) 6 controlled trials, Reported marketing 50,000 women per year re- pregnancy one randomized studies. ceived stilbestrol in late to prevent between 1946 1960s. abortion and 1955, show no effect; uncon- trolled studies re- port positive results Bedrest in viral Chalmers (1974) 2 controlled trials Medical records of 10-15 years after the first hepatitis (randomization hospitalized pa- definitive study 49% of unspecified) show tients. university hospital pa- no benefit to tients and 67 Coo of com- bed rest munity hospital patients still being kept at bed rest. Bland diet for Chalmers (1974) 8 studies (type un- Medical records of 35 of 38 physicians admit- duodenal ul- specified) show hospitalized pa- tingpatientswith diag- cer no benefit for ul- tients. nosis of ulcer order cer healing from bland diets (a practice bland diet not substantiated by studies). Tetracyclines Ray et al. (1977) in children Reports of drug tox- Insurance (Medicaid) 5 % of all prescriptions icity in children records in Tennes- (7,000 prescriptions) for see. children under 8 years of age were for tetracy- clines.

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202 APPENDIX 4-A Continued ASSESSING MEDICAL TECHNOLOGY Reference Topic (Year) .Studi~..s of Patt~rn.s of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts Following publication of VA RCT results in 1975, there was a slight de- cline in the proportion of patients with 1-vessel and 2-vessel disease re- ferred for surgery (an ef- fect consistent with find- ings of the study): 1974- 1978- 1975 Type of Evaluation Source of Data Studied on Effects Findings Coronary ar- Fisher and Ken- 7 RCTs tery bypass nedy (1982) graft surgery Prophylactic Wilson et al. RCTs antimicrobials (1982) in gastroin- testinal sur- gery Three practices Fineberg et al. on anesthesi- (1978) ology Referrals for treatment of senile macu- lar degener- ation Internal mam- mary artery ligation Combs (1982) Barsamian (1977~; RCT Fisher and Ken- nedy (1982) Gastric freez- Miao (1977) RCTs and other ing studies Fineberg (1979) Referrals to surgery for CASS Registry within 4 years of Veteran's Adminis- tration (VA) RCT. Survey of surgeons in Scotland. Epidemiologic sur- veys; physiologic findings; nonran- domized con- trolled trials Mailed questionnaire to anesthesiologists, at least 5 years af- ter publication of evaluations. RCT showing bene- Records of Witmer fit of treatment Ophthalmological Institute. Views of authors. Manufacturer records. 1979 1-vessel 38 % 2-vessel 53 % 3-vessel 63.9 % 29.6% 46.7 To 64.3% Most use prophylactic anti- microbiotics in accor- dance with RCTs; 25 % believe definitive proof lacking. Proportion who had adopted new practices at time of survey ranged from 65 to 85 % . Delay between awareness and change was longest for the one practice requir- ing institutional action (scavenging waste gases) . In 6 months following an- nouncement of study results compared to 6 months previous, the number of patient refer- rals tripled and the number of treatable cases doubled. RCT definitively showed procedure to be ineffec- tive. (No quantitative data on utilization of the procedure before defini- tive studies.) RCT definitively showed procedure to be ineffec- tive. Sale of devices stopped sev- eral years prior to ap- pearance of definitive study.

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EFFECTS OF CLINICaL EVALUATION CT scanning Creditor and Car- Availableliterature Hospital records. rett (1979) 203 Acceptance of computed tomographic (CT) scan- ning preceded controlled evaluation. Extracorporeal Fineberg and RCT Views of authors. Early randomized trial support for Hiatt (1979) said to prevent spread of respiratory technology. rr. . 1nsuttlclency Amniocentesis Omenn (1978) Multi-center con- Views of authors. Early multicenter trials trolled trial said to promote wider dissemination. Hyperbaric O2 OTA (1978, 1983) RCT Views of authors. RCT finds procedure inef- for cognitive fective and dampens deficits in physician use. the elderly Treatment of McPherson and RCTs National rates of sur- Physicians persist in using breast can- Fox (1977) gery cited in other radical mastectomy de- cer works. spite evidence from RCTs that simple mas- tectomy plus irradiation is at least as successful. Treatment of OTA (1983) RCTs Survey of surgical Practice has changed in breast can- patterns by Ameri- the direction, though cer can College of Sur- not the degree, indi- geons. cased by RCTs, Percent of breast cancer patients 1972 1981 Radical mastectomy 50 % Modified radical 30 % 70 % Lumpectomy 3 % 8 % (Remainder) presumably represents simple mas- tectomy and possibly other treatments. Beta-blockers OTA (1983); 41 RCTs Views of authors. Small RCTs all show trend after Friedwald and favoring use of beta- myocardial Schoenberger blockers. Widespread infarction (1982) use probably preceded evidence from RCTs. Length of stay Chassin (1983) RCTs other con- NCHS Hospital Dis- LOS for myocardial in- (LOS) for trolled studies charge Survey. farction (MI) in the myocardial and non-RCTs United States declined infarction by one-third between 1968 and 1980. Many studies find shorter stays as safe as longer, though results are not conclu- s~ve.

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204 APPENDIX 4-A Continued ASSESSING MEDICAL TECHNOLOGY Reference Topic (Year) Studies of Patterns of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts Type of Evaluation Source of Data Studied on Effects Findings Treatment of alcohol withdrawal Moskowitz et al. RCTs (1981) Drugs to lower Friedewald and blood lipids Schoenberger (CDP) (1982) Hypertension Friedewald and detection Schoenberger and follow- (1982) up Drug to lower blood lipids (Coronary Drug Proj- ect) Aspirin to re- duce recur- rence of myocardial infarction (AMIS) RCT (CDP) Views of authors. RCT (HDFP) Views of authors. Market Facts (1982) RCT Market Facts RCT (1982) Modern medi- Lambert (1978) Varied cat mistakes Discarded sur- Barnes (1977) gical proce- dures Drugs to lower blood lipids (Coronary Drug Proj- ect) Survey of physicians. Physicians practice was consistent with findings in RCTs prior to ap- pearance of review arti- cles making same recom- mendations. Gradual reduction in use of clofibrate consistent with findings in study. Study should have broad Survey of physicians 4-5 years after trial showing risks and lack of benefit from lipid-lowering agents. Survey of physicians before and after study showing no benefit from aspi- rin following myocardial infarc- tion. Review of literature. Evaluations in liter- Literature between ature 1880 and 1942. Friedman et al. RCT (COP) (1983) National Disease and Therapeutic Index. impact, leading to more aggressive treatment of hypertension. Majority of physicians ei- ther never prescribe lipid-lowering drugs (14 Coo ~ or use them only as secondary therapy (72 % ). 47 % said they were using lipid-lower- ing drugs less often than in the past; 67 % use these drugs more often. Majority of physicians re- mained unaffected by AMIS findings, continu- ing to prescribe aspirin for patients following myocardial infarction. Many medical mistakes oc- cur because of the ab- sence of proper early evaluation. Eventually discarded oper- ations were character- ized by lack of control . , . experience ana In sev- eral cases were sustained in the literature over decades. Prescriptions for all lipid- lowering drugs in the United States rose from 1.5 million in 1970 to 2.3 million in 1975 then fell to 1 million in 1980.

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EFFECTS OF CLINICAL EVALUATION 205 Personal interviews with 1,785 physi- cians from 1979 through 1981 (see Market Facts, 1982). Percentage of physicians prescribing lipid-lower- ing drugs for post-MI patients: 1979 1980 1981 Never prescribe 10.2 17.2 18.0 TRY only as 2 therapy 73.8 74.0 69.2 Sometimes Rx as 1 therapy 15.9 8.8 12.7 Number of physicians 859 296 621 Studies of the Effect of Synthetic Assessment on Knowledge of Physicians NIH consen- Jacoby, unpub- Consensus confer- Telephone surveys of 8-9 % of physicians were sus confer- lished report ence 700 physicians in aware of the Consensus ences on CT (1983) pertinent specialty Development Program scanning areas 2 weeks prior at NIH. Two weeks be- and total hip to conference and 6 fore each conference, replacement weeks after publi- 16 70 of physicians knew cation of confer- ence results in the Journal of the American Medical Association. about the upcoming conference on CT; 7 % knew about the confer- ence on hip joint re- placement. Six weeks after publication of results, 14 % were aware of the conference on CT and 4% aware of the conclusions; 7 % were aware of the con- ference on hip joint re- placement and 1% aware of its conclusions. Most of those aware of study findings had read about them in profes- sional journals. Studies of Effect of Synthetic Assessments on Clinical Practices Guidelines Leff et al. (1979); Recommendation Mail survey of 28 mu- Greater conformity to for tubercu- Leff and Bre- from Public nicipal tuberculosis guidelines on chemopro- losis control win (1981) Health Service, control officers. L}IIV1~1L ~ .1.~1.1 Ad L11~1~ ~- American Tho- racic Society, American Lung Association phylaxis than on diagno- sis and treatment. Medical neces- Blue Cross and Consensus on 42 Insurance claims in Number of claims paid for sity, Blue Blue Shield As- outmoded prac- 1975 and 1978 for tested surgical proce- Cross and sociation (1982) tices, announced Federal Employee cures declined 26%; Blue Shield and disseminated Health Benefits claims paid for listed di- in 1977 Program offered by agnostic procedures de- Blue Cross and . clined 85 % . Blue Shield.

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206 APPENDIX 4-A Continued ASSESSING MEDICAL TECHNOLOGY Reference Topic (Year) Type of Evaluation Source of Data Studied on Effects Findings Studies of Effect of Synthetic Assessments on Clinical Practices Approved uses for cimeti- dine Fineberg and Pearlman (1981) Schade and Donaldson <1981) Cocco and Cocco (1981) NIH consensus Thomson et al. conference (1981) on high blood pres- sure, held in 1977 Treatment of alcohol withdrawal FDA-approved uses NDTI data on drug Many uses of cimetidine in use. practice are not ap- proved by FDA. Medical records. Many uses of cimetidine in practice are not ap- proved by FDA. Consensus confer- ence Moskowitz et al. (1981) Survey of physicians in ambulatory set- tings in New York City. Review articles Survey of physicians. Many uses of cimetidine in practice are not ap- proved by FDA. 90 % of respondents were routinely treating pa- tients with mild hyper- tension in contrast to in- dividualized approach advocated by consensus statement. Physician use practices that were found effec- tive in RCTs and use them before they are recommended in review articles. Studies of the Effects of Clinical Evaluations and Synthetic Assessments on Regulation and Reimbursement PHS adviso- Center for Analy- Review by PHS Estimates of authors. The PHS through National ries to sis of Health Center for Health Care HCFA Practices (1981) Technology made rec- ommendations of non- reimbursement for 21 of 50 procedures reviewed during 1979-1980. All recommendations were accepted by HCFA, though procedures at HCFA did not necessar- ily assure uniform appli- cation throughout the country. Decisions not to reimburse four proce- dures (dialysis for schiz- ophrenia, hyperthermia for cancer, radial kera- totomy for myopia, and endothelial cell photog- raphy) are estimated to produce savings of $312 million to the Medicare program over a 10-year period.

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EFFECTS OF CLINICAL EVALUATION Hyperbaric ox- OTA (1978, 1983) RCT ygen for cognitive deficits in the elderly Drugs to lower Friedman et al. blood lipids (1983) 207 Views of authors. RCTs (CDP and WHO clofibrate trial) RCT shows procedure in- effective; facilitates deci- sion by Medicare and other insurers not to re- imburse. Review of FDA label- Changes in labeling, iden- ing changes for clo- fibrate (Atrom id- S) between 1969 and 1982. tifying more side effects and progressively re- stricting indications for use, are believed due in part to CDP (which as- sessed use in patients with previous MI; results with clofibrate published 1975) and to WHO clofibrate trial (which assessed primary prevention of MI; results published 1978 and 1980~. Major labeling changes in 1979 are at- tributed to both CDP and WHO trial; further restrictions in 1982 re- flect most recent find- ings from WHO trial, with CDP results serving as background. REFERENCES Armitage, P., D. Bardelli, and D. A. G. Galton, et al. 1978. Methods and Impact of Controlled Thera- peutic Trials in Cancer, Part I. UICC Technical Re- port Series, 36, Geneva. Avorn, J., M. Chen, and R. Hartley. 1982. Scien- tific versus commercial sources of influence on the prescribing behavior of physicians. Am. J. Med. 73:4-8. Avorn, J., and S. B. Soumerai. 1983. Improving drug-therapy decisions through educational outreach: A randomized controlled trial of academically based "detailing." N. Engl. J. Med. 308:1457-1463. Barnes, B. 1977. Discarded operations: surgical in- novation by trial and error. Pp. 109-123 in Costs, Risks and Benefits of Surgery, J. P. Bunker, B. A. Barnes, and F. Mosteller, eds. New York: Oxford Uni- versity Press. Barsamian, E. M. 1977. The rise and fall of inter- nal mammary artery ligation in the treatment of an- gina pectoris and the lessons learned. Pp. 212-220 in Costs, Risks and Benefits of Surgery, J. P. Bunker, B. A. Barnes, and F. Mosteller, eds. New York: Oxford University Press. Berg, R. B., and A. J. Salisbury. 1971. Discharging infants of low birth weight: Reconsideration of cur- rent practice. Am. J. Dis. Child. 122:414-417. Berwick, D. M., H. V. Fineberg, and M. C. Wein- stein. 1981. When doctors meet n\umbers. Am. J. Med. 71:991-998. Blue Cross and Blue Shield Association. 1982. An- nouncement of new phase of medical necessity pro- gram. October 12. Memorandum. Chicago, Ill. Bonchek, L. 1979. Are randomized trials appropri- ate for evaluating new operations? N. Engl. J. Med. 301:44 45. Buchwald, H., L. Fitch, and R. B. Moore. 1982. Overview of randomized clinical trials of lipid inter- vention for atherosclerotic cardiovascular disease. Controlled Clinical Trials 3:271-83. Caplow, T. 1954. Market attitudes: A research re- port from the medical field. Harvard Bus. Rev. 30: 105-12. Center for the Analysis of Health Practices, Har- vard School of Public Health. 1981. Impact on health costs of NCHCT recommendations for nonreimburse- ment for medical procedures. Monograph Series. Washington, D.C.: National Center for Health Care Technology.

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208 Chalmers, T. C. 1974. The impact of controlled trials on the practice of medicine. Mt. Sinai J. Med. (NY) 41:753-759. Chalmers, T. C., B. Silverman, E. P. Shareck, A. Ambroz, B. Schroeder, and H. Smith, Jr. 1979. Ran- domized controlled trials in gastroenterology with particular attention to duodenal ulcer. Pp. 223-255 in Report to the Congress of the United States of the Na- tional Commission on Digestive Diseases, Vol. 4, part 2B, DHEW Pub. No. (NIH) 79-2885. Washington, D.C.: Department of Health, Education, and Wel- fare. Chalmers, T. C. 1982. A potpourri of RCT topics. Controlled Clinical Trials 3:285-98. Chassin, M. P. 1983. Health Technology Case Study, 24: Variations in Hospital Length of Stay: Their Relationship to Health Outcomes. OTA-HCS 23. Washington, D.C.: U.S. Congress, Office of Technology Assessment. Christensen, E., E. Juhl, and N. Tygstrup. 1977. Treatment of duodenal ulcer: Randomized clinical trials of a decade (1964-1974). Gastroenterology 73: 1170-1178. 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