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Recommended Clinical Conditions for the Effectiveness Initiative FIRST TIER In Table 2, we recommend five clinical problem areas as the highest priority conditions for initial investigations of the Effectiveness Initiative and a second tier of clinical conditions Hat could receive later attention. Within the two tiers, the diagnoses are not listed in any priority order, because the precise ordering differed according to the measure of impor- tance used. The top five conditions are acute myocardial infarction; angina (stable and unstable); carcinoma of the breast; congestive heart failure; and hip fracture. As the differences in importance accorded all five conditions are relatively minor, we view them as having essentially equivalent priority. Selecting among them should be done on other grounds, such as key management options of interest and advice from research methods experts. Some specific points raised about the top five conditions are presented in the following sections. We believe that all five conditions meet most, if not all, of the criteria for selection enumerated earlier, especially prevalence and cost. In reaching this conclusion, we relied on three bodies of informa- tion: the clinical and research expertise of the committee members; the results of the homework exercise and the discussion and subsequent votes during the workshop; and data made available by HCFA staff at He workshop (which we assume are widely accessible throughout the agency). The fact that three of the conditions are cardiovascular reflects in part their considerable contribution to overall morbidity and mortality in addi- tion to numerous other issues suggested below. For example, angina is especially common yet responsive to early intervention; acute myocardial infarction represents a medical emergency with many management options in both the acute and post-acute phases; and congestive heart failure, in 12

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13 TABLE 2 Clinical Conditions Judged to Have High Priority for the HCFA Effectiveness Initiative First Tier Second Tier Acute myocardial infarction Angina (stable and unstable) Breast cancer Congestive heart failure Hip fracture Cataracts Depressive disorders Pro static hypert;rophy Transient ischem~c attack with or without occlusion or stenosis of the precerebral arteries addition, is associated with high levels of disability and markedly shortened life expectancy. Hip fracture, by contrast, has low mortality but high potential for disability; it also presents important issues in rehabilitation and long-term care. At least three of these ailments (angina, acute myocardial infarction, and breast cancer) also offer a very good basis for studying how a disease is or should be approached at different points in the natural history of disease and hence in different settings, for different population groups (e.g., distinguished by age), and win different strategies. All of the selected conditions appear to present good opportunities for examining issues related ~ to screemug ant prevention. As mentioned, we also discussed some of the key patient management issues relevant to these conditions: prevention/screening, diagnosis, therapy, rehabilitation, and management of related or secondary problems, such as depression. An important dimension to this work is Hat many different patient management options may be appropriate and yet applied quite differently across the nation. Some of these points are noted below as background for future workshops of external advisory panels (for in- stance, at He proposed meeting of research methods experts).

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14 Acute Myocardial Infarction Acute myocardial infarction was selected for several reasons in addition to the major criteria already mentioned. First, this condition can be very disabling for some individuals and not for others. Second, the unpre- dictability of individual outcome (given that a patient survives the acute event) and response to both diagnosis and therapy is itself a worthwhile topic of investigation. Third, new therapies and new data are bringing about great changes and variations in previously established practice patterns. Other important dimensions to this condition include prevention prog- nosis and role of exercise; speed of diagnosis, resuscitation, initiation of treatment, transport to sites of definitive care (e.g., use of helicopters, prehospital cardiac interventions); management issues (especially those pertinent to elderly or very elderly patients); use of pharmacologic agents (e.g., thrombolytics, antiarrhythmics, and antiplatelet agents); catheter- ization; surgery issues (namely, angioplasty versus bypass); locus of care; rehabilitation (cardiac, general); disability and quality of life (including return to work or daily functioning); and psychological aspects of diagnosis, treatment, and prognosis (anxiety and depression). Angina In addition to meeting the major selection criteria noted above, angina is considered an important sway condition because it offers good, disputable alternatives to management. Physicians are not in agreement about the preferable approaches, and thus good effectiveness analyses offer promise for changing practice patterns. It has a great deal of impact on disability and patient health status. Angina as a clinical syndrome presents a large set of diagnostic issues, such as He comparative utility or desirability of nomnvaslve and invasive tests. Key topics for possible investigation include: risk factors; diagnostic issues techniques such as stress tests, angiograms, and radionuclide tracing; secondary testing to assess prognosis and to modify treatment regimens; treatment issues, including invasive options (angioplasty versus coronary artery bypass surgery), medical treatment versus invasive therapy, and hospitalization questions such as threshold for hospitalization, use of inten- sive care, length of stay; and disability and quality of life with various therapeutic regimens.

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15 Breast Cancer Apart from the main selection criteria, breast cancer takes on added importance because its incidence rises with age. This fact has special implications for morbidity and mortality in the elderly population as it becomes increasingly aged and more predominantly female. Breast cancer is the only cancer diagnosis chosen. We believe that it can serve as a model for HCFA studies of similar diagnosis and management strategies for other neoplastic diseases. Other central topics deserving investigation include: screening issues (e.g., who should be screened, how often); alternative approaches to diag- nosis (e.g., mammography, examination, biopsy; use of mammography for diagnosis versus just for screening); staging of disease; therapeutic ap- proaches, such as medical versus surgical interventions; alternative surgical options how extensive (radical) should surgery be in elderly women; use of radiology; use of adjuvantchemo~erapy; rehabilitation issues, including use and type of prostheses; and emotional dimensions (depression and anxiety). Congestive Heart Failure Congestive heart failure represents one diagnosis drawn from a set of common clinical problems (chronic obstructive pulmonary disease, pneu- monias, and congestive heart failure) characterized by difficult diagnostic questions (e.g., etiology) and complex management issues. This condition meets the need for including a heterogeneous, complicated condition as one of the final set (apart from the selection criteria already noted). We believe that studying such a condition might be difficult solely win existing HCFA data. Therefore, part of the rationale for including such a condition is that it provides a mode! for how to approach similar problem areas in the future (e.g., as a laboratory exercise for me~odologic development, more Can as a means of reaching final answers about effectiveness of interventions). We believe congestive heart failure is somewhat more useful as a study condition than pneumonia because it is a chronic condition, somewhat less heterogeneous in its range of etiologies, and less often a complication of another major but unrelated ailment. It is He most common medical reason for hospitalization among the Medicare population and one of the more common reasons for hospitalization (often repeated admissions) in He last year of life. Thus, we also conclude Hat it offers a special vantage point for studying issues of chronic illness in the last year of life.

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16 Among the key topics we suggest for study are prevention (e.g., treatment of hypertension); diagnostic issues and etiology of illness; medications options, including use of digitalis, vasodilators, and other, newer phar- macologic agents; surgical therapies, including heart transplant; locus of care and threshold of hospitalization; and appropriateness of patient or physician expectations and appropriateness of diagnostic and therapeutic interventions for severely ill patients or those in the last year of life. Hip Fracture Hip fracture is the fifth condition we recommend for early investigation because of its overall high ranking on the major selection criteria. Because this is almost exclusively a disease of the elderly, because there is great consensus about the diagnosis, because it is universally treated in hospital, and because some long-term-care data will be available, we believe that hip fracture offers a good test of what the HCFA data bases and systems can do. In addition, in our judgment, no clear consensus exists about certain aspects of the treatment of hip fracture: length of hospital stay; surgical options (pinning, replacing the femoral head, complete hip replacement); and sequence of surgical interventions. The issues of long-term care and of longer-termfunc~zonal outcomes are especially important here. Other key topics include: prevention (e.g., of osteoporosis, of falls); rehabilitation (prototype programs; short-term and long-term); depression (especially during a long recovery phase); problems of preventing or treating secondary complications (pulmonary emboli, urinary tract infec- tion, pneumonias); and socioeconomic issues related to treatment and rehabilitation (e.g., site of care, length of hospitalization). SECOND TIER We also identified a second tier of four conditions that were judged important, but of lesser priority: cataracts, depressive disorders, prostatic hypertrophy, and transient ischemic attack with or without occlusion or stenosis of the precerebral arteries. Together with the five in the first tier, these conditions were clearly distinguishable from the remaining 30-plus conditions on the original list (Table 1~. Cataracts were viewed as an important area for investigation in part because this progressive disease entity can have a considerable impact on a patient's functioning and ability to carry out ordinary activities. Function- al states and patient satisfaction are the most important endpoints, not

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17 conventional morbidity or mortality statistics. In this instance, the HCFA data bases will not be helpful, and additional data will be required. Further- more, although the diagnosis of cataracts may be quite clear-cut, the decision of when to intervene surgically is not. Major questions are raised about the locus of care (outpatient versus inpatient surgery) and the criteria that should be used in choosing the site for surgery. Finally, major Medicare expenditures are associated with cataract-related interventions. Depressive disorders present other special considerations warranting investigation. Despite the fact that special groups among the elderly may be at extra risk for depression (e.g., loss of spouse, female living alone, poverty status), we do believe that the population at risk is essentially every elderly person. Detection and accurate diagnosis are particular problems. Depression may be an iatrogenic problem in cases where prescription drugs are overused or misapplied, an adjunct to other serious illness, or a major cause of morbidity in its own right. In addition, it is treated principally in the ambulatory setting, by both trained mental health practitioners and others who are not mental health specialists. For these reasons, depressive disorders represent another model for additional data collection and use of other functional endpoints. Prostatic hypertrophy/hyperplasia offers numerous questions for inves- tigation. These center mostly on the major decision of surgical intervention versus conservative medical management, on choice of surgical procedure when surgery is elected, and on greater patient involvement in decision making. This condition has, however, been under intense scrutiny by university researchers and clinicians for several years and is expected to be a major target of investigation in research programs sponsored by the National Center for Health Services Research. For these reasons, we concluded that it probably did not merit inclusion in the top five conditions recommended for the HCFA Effectiveness Initiative. Finally, we combined two of the original conditions (see Table 1, condi- tions 12 and 13) to form the diagnostic category oftransient ischemic attack (TIA) with or without occlusion, believing that Hat entity is more under- standable to the clinical community than the two diagnoses are separately. We judged TIA to be a relatively important study condition in large measure because of tile controversies surrounding prevention and therapy (e.g., the use of carotid endarterectomy). It poses some study issues similar to the management of acute and chronic coronary artery disease (i.e., myocardial infarction and angina) but enough separate questions of diagnosis, manage- ment, and rehabilitation to warrant individual attention.