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Factors Important for the Selection of Key Patient Management Issues and Related Research Activities Before discussing high priority patient management issues in AMI, the committee briefly reviewed its understanding of the major reasons that AMI had been selected for the Effectiveness Initiative research program. Coronary artery disease is very prevalent among elderly women and men, and AMI is the leading cause of death in the United States for all age groups above 40. However, the individual outcome for those who survive the acute event is less predictable; that is, an AMI can lead to chronic disability in some patients but to little chronic problem in others. New diagnostic and therapeutic interventions have developed rapidly in recent years, and much data from clinical trials of these interventions are accumulating. The multi- ple patterns of treatment for young and elderly AMI patients include many high-cost and high-risk procedures, with little clear relation between specif- ic therapies and long-term outcome, particularly functional health status and psychological aspects. SELECTING PATIENT MANAGEMENT ISSUES Several factors affect the selection of key patient management issues for AMI in elderly patients. These factors are not equally well documented in the clinical, research, or health policy literature. The IOM committee believed, however, Mat all of them were sufficiently important to be consid- ered as the panel identified specific study topics. These factors include: Epidemiologic aspects of AMI among the elderly (e.g., higher or lower prevalence of more advanced coronary disease in particular sub- groups) 25

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26 EFFECTWENESS INITIATWE Important health status and quality-of-life burdens of the illness for elderly patients Different treatment options for the elderly, characterized, for instance, by whether different therapies have different likelihoods of prolonging sur- vival, producing major impairment and disability, or improving the patient's physical functioning, emotional well-being, and independence High degree of professional and clinical uncertainty about some alter- native strategies for managing the care of AMI patients, especially the very elderly Substantial variation across geographic areas in the per-person use of services for AMI, including those related to prevention and management of risk factors; that is, variation beyond that explained by differences in patient characteristics or health resources in the areas Substantial variation across geographic areas or institutions in the out- comes of care for AMI; that is, variation beyond that explained by the dif- ferences in the severity or stage of illness (i.e., case mix) or sociodemo- graphic characteristics of patients Relatively high costs to the Medicare program of reimbursing for the services provided to patients to prevent, diagnose, and treat AMI and to manage postmyocardial infarction care Relatively high out-of-pocket costs to the Medicare beneficiary for services to prevent, diagnose, and treat AMI and to manage posonfarction care that are not covered or are only incompletely covered by the Medicare program. SELECTING RESEARCH TOPICS AND ACTIVITIES Content, Conduct, and Use of Research In specifying research activities focused on high-priority AMI topics, the committee raised three additional points concerning the content, conduct, and use of this research. First, it endorsed four generic areas of concern identified at the 1988 clinical workshop to set priorities for the Effectiveness Initiative: (1) clarification of the implications of the difference between efficacy and effectiveness for the overall purposes of the research program; (2) screening and prevention of the illness; (3) generation and use of reliable and valid outcome measures that relate to functional status and quality of life; and (4) mental and emotional dimensions (cognitive functioning;

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ACUTE MYOCARDIAL INFARCTION 27 anxiety and depression). With respect to the last two, the committee noted that several good measures of health-related quality of life (relating to func- tioning, emotional well-being, and so forth) are currently available or could be adapted for effectiveness research. Second, in principle, several approaches can be used to this research ini- tiative, either sequentially or simultaneously. They fall into the following basic categories (in increasing order of complexity, rigor, and expense): cost, utilization, and outcome monitoring through analysis of administrative data; observational (cross-sectional, case-control, or longitudinal-cohort) studies with a richer data set than that afforded by routinely collected administrative data; quasi-experimental studies and demonstrations; and, potentially, RCTs. In addition, projects based on newer, or nonexperimental techniques, such as meta-analysis, decision analysis, and cost-effectiveness analysis, should be included among the research options. In short, the committee concluded that all these approaches should be considered potential investi- gational methods for effectiveness research. The committee also empha- sized the importance of evaluating beforehand the trade-offs implicit in selecting one approach over another and in pursuing combined approaches. Third, studies on specific illnesses serve as prototypes for examining other, similar conditions. For instance, studies of primary and secondary prevention, early diagnosis and treatment, staging of acute disease in rela- tion to outcome, treatment options, and quality-of-life outcome measures related to AMI provide opportunities to address conceptual and method- ologic issues for other illnesses that are prevalent in the Medicare popula- tion, that have both acute and chronic aspects, or that affect the cardiovascu- lar system. Data Issues The 1988 clinical workshop had questioned the availability and quality of data for effectiveness research in HCFA's existing (or anticipated) a~ninis- trative files. This remained a critical issue, as evidenced by appreciable dis- cussion of the topic by the AMI workshop committee. The committee underlined the importance of HCFA's ability to acquire additional data through special studies, surveys, and patient follow-up aciiv- ities, for several reasons. Data available on pre- and posthospital events, particularly those in physician office records, must be expanded, and prob- lems (e.g., missing data or un~nterpretable information) with office records must be addressed. The relative lack of documentation of deaths that occur before hospitalization or at some time after hospital discharge for AMI

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28 EFFECTIVENESS INTTIATIVE needs to be taken into account. Two substantial problems in coding cod- ing rules for the diagnosis of AMI in hospital records and the lack of flexi- bility and responsiveness in creating new codes for new tests and treatments must be confronted. Considerable effort should be made to enhance the collection of outcome information that is pertinent to elderly AMI patients. For example, return to work or ability to drive a car, outcomes that might be relevant at age 50, may be less important at age 75. The development of the Uniform Clinical Data Set (UCDS) (see the appendix) and the use of the Medicare Peer Review Organizations (PROs) to abstract this information from clinical records were considered. Some committee members raised concern about the accuracy of such records, the value of retrospective abstracting rather than concurrent analysis, and the lack of clinical peer review of both the data set itself and the PRO method- ology. These difficulties were particularly emphasized with regard to risk stratification methodologies and identification of the sequence of diagnostic and therapeutic events. Notwithstanding these concerns, current data sets were considered useful for monitoring variations and trends in the use of tests and treatments and for assessing the relation of certain services to simple short-term outcomes, particularly survival, some complications, and reinfarction. These data would be useful, for example, in looking at differences by geographic region or size and type of hospital. Moreover, claims data may be valuable as a source for generating hypotheses, building a convincing case for more detailed data collection, and constructing decision models that could be test- ed win rigorous study designs.