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Summary In late 198S, as part of planning an "Effectiveness Initiative," the Health Care Financing Administration (HCFA) of the U.S. Department of Heals and Human Services (DHHS) asked the Institute of Medicine (IOM) to con- duct four workshops. The first was intended to identify high-priority clini- cal conditions for this research program; the last three were focused on spe- cific conditions breast cancer, acute myocardial infarction (AMI), and hip fracture. These workshops had three goals: (1) to examine each clinical condition in detail; (2) to identify key patient management topics for each condition that deserve further investigation of effectiveness; and (3) to pro- pose appropriate research strategies or approaches to be used by HCFA and other public and private organizations that conduct effectiveness research. This report presents the IOM committee's recommendations from He AMI workshop. The committee recommended that effectiveness research give separate attention to four nonclinical, or mess, topics. First was the continued improvement of the clinical and diagnostic information available in the HCFA Medicare data bases for effectiveness research. Specifically, the committee recommended the development of methods that will more accu- rately identify AMI patients for any effectiveness studies, such methods to involve both the nature and the extent of damage to the heart. Cases of AME and specific treatments may not be identified in the routine HCFA data set because of coding problems. HCFA has sought to remedy these problems and is developing methods by which the Medicare Peer Review Organization (PRO) agencies might obtain routine clinical data. The com- mittee recommended that the PRO methodology for obtaining such data

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2 EFFECTIVENESS INITIATIVE program be clarified and validated. The committee also encouraged HCFA in its efforts to involve clinicians in the design and evaluation of the data base and to improve the access to these data for qualified investigators. Second, effectiveness research should examine the methods used to strat- ify risk in acute AMI and the effect of these methods on patient manage- ment and outcomes. The committee recommended the funding of extramu- ral research to validate stratification and triage decision methods that would permit determination of effectiveness in clinically important subsets of patients. This includes assessments of comorbidity as a major determinant of risk. Physicians employ a variety of methods to determine risk for indi- vidual patients and to assign patients to diagnostic and treatment modalities. The validity of these stratification methods and the subsets of patients receiving certain tests and treatments should be examined in differing clini- cal environments. The "natural experunents" created by these stratification methods should be analyzed with particular attention to compliance with recommendations from randomized controlled trials, to the use of resources, and to patient outcomes. These observational trials should form the basis for a prospective study to identify a valid, reliable, and practical stratifica- tion method for future effectiveness research. The Bird methodologic topic was attention to the definition and measure- ment of outcomes. The committee recommended study of three related issues: (1) more comprehensive definitions of He elements of outcomes in line with recent developments in the field of health status and quality-of-life measurement; (2) better definitions of alternative "best outcomes" (from the patient's point of view) that take health status and quality of life into account; and (3) expansion of techniques for acquiring data to measure out- comes as they relate to AMI. The committee recommended funkier that DHHS give considerable prior- ity to understanding and developing these methods for use throughout its effectiveness research effort (not just for AMI). Use of reliable and valid generic measures of health status coupled with selected disease-specific measures is an appropriate, desirable, and practical research strategy. For all patients, measures of morbidity (including pain and other symptoms), functional status (including physical capacity and ability to function in daily life), psychological and emotional well-being, social functioning and sup- port networks, and general outlook on health are important. Patient values and preferences need to be taken into account, so it is important to diiTeren- tiate between outcomes and patient preferences for outcomes and to encour- age the acquisition and use of infonnation on patient preferences, given dif- ferent outcomes. The committee recommended that DHHS solicit outside expert opinion to define an adequate, appropriate set of outcome measures

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ACUTE MYOCARDIAL INFARCTION 3 and to propose instruments for measunog these outcomes in effectiveness research both generally and for Am. The committee noted several other outcome issues regarding AMI. There is a need to identify additional clinical outcome measures, such as exercise tolerance or congestive heart failure, to be included in the data base. In the elderly, certain outcomes, such as return to work, may not be as relevant as they are in younger patients, and measurement of other outcomes such as exercise tolerance may be limited by other, noncardiac conditions. The fourth methods issue concerned variations in the patterns of care and use of treatment modalities in different settings. The committee recom- mended that work on understanding patterns of care be supported and that work be linked to issues relating to the three high priority patient manage- ment topics identified for the effectiveness initiative. These studies should consider variations in types of hospitals, geographic regions, and Apes of providers (e.g., generalists or specialists). Although these observations will not directly demonstrate differences in effectiveness, they could form the starting point for detailed prospective studies. The committee also identified three clinical, or patient management, issues that it judged were of high priority for an effectiveness research effort focused on AMI. Two related to risk stratification and the choice and effec- tiveness of diagnostic and therapeutic options; a third focused on throm- bolytic therapy more specifically. First, the committee recommended that research be supported to identify the effectiveness of specific diagnostic and treatment modalities in the Medicare age group, whether alone or in groupings based on risk stratifica- tion methods. Further, they recommended that such investigations start with, but extend beyond, observation of variations of practice patterns and surveillance of specific risk stratification strategies linked to appropriate outcomes. Of particular concern is the vast array of diagnostic tests such as catheterization, exercise testing with or without radionuclide studies, and echocardiography, which themselves can be (and are widely) used for risk stratification or prognostic purposes without good evidence of their appro- priateness or effectiveness among the elderly or, at least, particular sub- groups of elderly patients. Second, the committee recommended that the use of pharmacologic agents, particularly thrombolytic drugs, be monitored in both the inpatient and the outpatient settings. As for other interventions, individual drugs or groups of drugs, alone or in combination with invasive procedures, should be analyzed with regard to variations in outcomes. The clinical effective- ness of many of the Mugs used in AMI remains to be demonstrated in He elderly. Although thrombolytic agents have been shown to be effective in

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4 EFFECTIVENESS INrTIATIVE reducing mortality and short-term morbidity in younger patients and some Medicare patients, the long-term outcomes in the elderly have yet (and need) to be determined. Limitations in the current HCFA data base in recording information about drugs, particularly in the nonhospital setting, also must be overcome. Third, because of the crucial role that risk stratification plays in choosing among diagnostic and therapeutic options for patients with AMI, the com- mittee recommended that explicit attention be directed at ways to assign or stratify risk to individual patients with AMI. The committee had concluded that risk stratification methods are not well established and that doing so was a critical patient management issues bow amenable to, and necessary for, effectiveness research. For instance, outcomes of specific competing therapies, such as angioplasty and thrombolysis, might be tracked according to patient subgroups defined by different risk stratification approaches. Then one (or more) modelers) using stratification parameters based on these comparative analyses could be evaluated as a predictor of outcomes in another group of Medicare patients. If successful, these models could then be applied prospectively.