Mepicat. Care ‘May 1992, Vol. 30, No. 5, Supplement Recent Developments and Future Issues in the Use of Health Status Assessment Measures in Clinical Settings SHELDON GREENFIELD, MD,* AND EUGENE C. NELSON, DSc, MPHt This paper provides a broad overview of the assessment of health status in clinical practice in three parts. Yesterday: The nation has undergone a paradigm shift in health-related thinking, The former paradigm emphasized only dis- ease; the new emphasizes health, functioning, well-being, and disease. Mea- sures of health and disease have evolved to reflect the new paradigm. Many are designed for clinical settings, based on measurement science, and are relatively brief. These newer measures have been used to document the natural history of disease, evaluate treatment effectiveness, and improve clinical case manage- ment. Today: Two barriers block full-scale use in clinical settings. The first barrier involves the meaning and interpretation of health status scores. Pa- tients’ scores are influenced by several types of patient mix variables and the timing of measurements. Interpretation is enhanced by valid normative data displaying the variability in health status among homogenous patient groups. The second barrier is utilization and mainstreaming. It involves all of the is- sues associated with changing the day-to-day behavior of clinicians and pro- viders’ routine processes to facilitate routine use of health status measures in clinical settings. Tomorrow: In the next decade, the nation will attempt to over- haul the health care system. As it does so, it will struggle with many issues: 1) clarifying the true aim of health care; 2) standardizing measures of health across patients, providers, and settings to evaluate benefit; 3) establishing cause and effect among structural-input factors, care delivery processes, and health outcomes valued by society; and 4) determining if and when cost containment actions have adverse effects on health outcomes. In this context, the importance of interpreting change in health status has a central role. Key words: health status assessment measures; health status. (Med Care 1992; 30:MS23-MS41) The first two health status conferences!” have set the stage for the next phase in this field, which is moving health status measure- *From The Health Institute, New England Medical Center, the Department of Medicine, Tufts University, and Harvard School of Public Health, Boston, Massa- chusetts, { From the Hospital Corporation of America, Nash- ville, Tennessee. Address correspondence to: Sheldon Greenfield, MD, Senior Scientist, The Health Institute, New En- gland Medical Center Hospitals, 750 Washington Street, Box 345, Boston, MA 02111, ment from research spheres into practice en- vironments, The phenomenal measurement research of many investigators has allowed us to advance to the point where we can accurately and efficiently measure the over- all health of a given patient or population. However, contemplating the use of these in- struments for practice and health policy takes us into new realms—realms in which other major health service initiatives have failed or are stuttering because of a daunting gap between methodologic research, on the one hand, and implementation in medical MS23GREENFIELD AND NELSON practice, on the other. In this paper, there- fore, our focus will be not only on the histori- cal documentation of the value of health status measures but also on the next steps— the obstacles to using health status measures in clinical practice, and the strategies that can be used to overcome these obstacles. Bold and visionary as researchers in this field have been, we now must approach these next steps with care. We have learned at least one painful lesson from experiences in cost containment? and other sources: in- formation, and especially information not tai- lored to the particular practice environment, will not, by itself, change physician behavior and thereby improve health care or health. Sim- ply giving a ballplayer his batting average in mid-season, or a student her test average be- fore an exam, or a doctor a summary of the patient’s health—without consideration of the steps necessary to act on that informa- tion—will be wasteful, counterproductive, and disillusioning. Hasty and externally pressured initiatives may foster cynicism, cast distrust on health status, and attenuate its enormous potential for monitoring and improving outcomes and effectiveness in the American health system. Past writings have provided extensive re- views of the conceptual basis, measurement characteristics, and potential uses of health status measures in clinical settings." This paper reviews selected highlights of recent advances in these areas, and then explores several key issues that stand in the way of routine use of health status measures in clin- ical settings. The organization of this paper reflects what we view as three phases of evolution of health status assessment. The first phase has been going on for more than 10 years, and has centered on conceptualizing and measuring health status in its multiple man- ifestations, and examining the “validity” or “meaningfulness” of health status measures in terms of their ability to reflect the pa- tient’s true state of health, The second and third phases are now MS24 ‘MEDICAL CARE about to begin. The second phase focuses on the interpretation of health status results at the clinical level, addressing the critical ques- tions of sensitivity and specificity. These ask not only whether the patient's actual health is reflected in the health status measure- ment, but also how much of that health sta- tus relates to the health care received. The sensitivity question pertains to whether the physician’s ability to affect various aspects of treatment is reflected in the health status scores. If, at a given visit, physicians alter a medication regimen and thereby improve sexual function of their patients, can they be assured that outcome scores will change? If clinicians take a therapeutic action that de- creases shortness of breath, reduces pain from an arthritis flare, hastens the healing of a skin ulcer—will these improvements mod- ify the summary scores in a health status measure? The specificity issue plagues clini- cians: is health status specific to the care they are able to deliver, or is it due to factors beyond their control that have little to do with medical care as such? Figure 1 conveys this notion, distinguishing among fixed dis- ease, mutable health, and nonhealth-care factors. The third phase has, for the most part, not yet begun. This involves physicians and other providers actively using health status measures to plan care by obtaining, through such instruments, information they do not have now or do not have handy. It involves motivating physicians to try to improve pa- tient health status by using these instru- ments to match treatments to needs and to monitor patient status in a systematic way. Yesterday: Evolution of Health Status Assessment What are the main roots that bring us to the issues of today, the need for interpreta- tion of health status information by pro- viders, and the issues of tomorrow, the incor- poration of health status assessment intoVol. 30, No. 5, Supplement Fixed Disease eg, Immutable, permanent, vonetble dee and aly Functioning & Well-Being /Non Health-Care Mutable Health Status ep anole apes sacar eae a Age income, ving skit oeaais Fic, 1. Elements of health status and the target of health care, routine day-to-day practice? For brevity, we will answer this question with highly selec- tive examples, emphasizing basic concepts, recent advances in health assessment mea- sures, and examples of their uses in clinical settings. Before proceeding, it may be help- ful to offer definitions of key terms. Health Status Assessment: We define this as the measurement or evaluation of the health of an individual or a patient; it may include traditional biologic indicators, but it emphasizes indicators of physical function- ing, mental health, social functioning, and other health-related concepts such as pain, fatigue, and perceived well-being. Health-Related Quality of Life: This is a nonspecific term that is often used synony- mously with the term health status. Health- related quality of life is narrower than gen- eral quality of life. The latter includes the impacts of food, shelter, safety, living stan- dard, social and physical environmental fac- tors, etc,’ Clinical Settings: The locations in which most health care is delivered, such as medi- cal practices, ambulatory care centers, out- patient clinics, hospitals, and nursing homes. RECENT DEVELOPMENTS AND FUTURE ISSUES Outcome Measures: Indicators of patients’ evaluations of changes in patient health sta- tus, including health-related quality of life and mortality, and indicators of or patients’ evaluations of the quality of health care.” Basic Concepts: From Disease to Health We are witnessing a subtle yet fundamen- tal paradigm shift in the nation’s health-re- lated thinking. The former paradigm em- phasized only disease; the new emphasizes health, functioning, and well-being, as well as disease, The former focused primarily on medical care; the new on health care. The former measured disease only, based on pathophysiologic disturbance; the new measures of health are based on function- ing, well-being, and quality of life, as well as physiology. The former viewed the physi- cian as the healer of disease; the new views the physician as the promoter of health, as well as the healer, The former separated quality from cost; the new seeks the best “value,” that is, best outcomes at affordable cost. This paradigm shift is neither as complete nor as contrasting as described. It is very real, however, and has prompted us to change our thinking about the concept of health to encompass more than the absence of disease. In addition to biologic homeosta- sis, health is now considered to include phys- ical, mental, and social functioning, per- ceived well-being, and even vitality and en- ergy. When the World Health Organization de- fined health in 1948 to include complete physical, mental, and social well-being, the definition struck many as utopian.” Today this view of health is coming close to being accepted as conventional wisdom. Indeed, it shapes public policy. For example, Healthy People 2000" states: A central purpose . . . is to increase the proportion of Americans who live long and health lives. . . . It means a full range of functional capacity at each life stage, from infancy through old age, allowing one the MS25