THE ASSESSMENT OF OUTCOMES AND THEIR CLIN ICAL RELEVANCE IN CARDIOVASCULAR-DISEASE - SPECIFIC EMPHASIS ON QUALITY-OF-LIFE MEASUREMENT

Over the last decade, changes in health care delivery and concern with costs and with dramatic variations in practice between regions, insti tutions and even physicians at the same institution have led the admin istrators and health politicians to focus on the outcomes of medical c are. The Agency for Health Care Policy and Research was established wi th the objective of fostering research on the outcomes of medical inte rventions and on the development of guidelines. The Agency supports st udies based not only on standard outcomes such as mortality and morbid ity, but also on quality of life and patient satisfaction. The Patient Outcome Research Teams (PORTs) projects are the showcase displays of the Agency, and their goals are to identify and analyze the outcomes a nd costs of alternative interventions for a given clinical condition, in order to determine the most effective and cost-effective means to p revent, diagnose, treat, or manage it and develop and test methods for reducing inappropriate or unnecesary variations. Three PORTs are focu sed on the following cardiovascular conditions: acute myocardial infar ction, chronic ischemic heart disease and stroke. There are many situa tions in which randomized clinical trials are not feasible and large-s cale observational studies are necessary to generate information about what happens in the real practice. This information deepens the under standing of practical effectiveness as opposed to theoretical efficacy since trials do not always measure all the outcomes of interest to pa tients and physicians. One way to solve the problem of inaccurate data of observational studies is by establishing a specific registry to me asure in an efficient way key patient characteristics, process of care elements and relevant outcomes. The Cardiac Surgery Reporting System is a registry that collects clinical data on all patients undergoing c ardiac surgery in New Pork State. This registry has produced reliable and valid measures of quality and hospitals and cardiac surgery progra ms throughout New York use this information to improve outcomes for th eir patients. Health related quality of Life can be a useful outcome m easure in the assessment of clinical effectiveness. However, there are still many methodological questions regarding the validity and sensit ivity of quality of life measurement an optimal study design calls for caution in the interpretation of current results and makes refinement of methodological issues a desirable goal. Nevertheless, apparently v alid studies of cardiovascular diseases and interventions using health related quality of life as an outcome measures have been reported whe re such measures have provided information about undesirable side effe cts of medications and the impact of the intervention on the health re lated quality of life. Moreover, some of these studies have identified different patterns of health care as leading to different quality of life outcomes. Thus, quality of life measurement appears as a technolo gy which holds promise for the future assessment of clinical effective ness.