Initial Functional and Economic Status of Patients with Mult’nressel Coronary Artery Disease Randomized in the Bypass Angioplaq Revascularization Investigation (BARI) Mark A. Hlatky, MD, Edgar D. Charles, PhD, Fred Nobrega, MD, Kathryn Gelman, MPH, lain Johnstone, PhD, Joseph Melvin, MS, Thomas Ryan, MD, Robert Wiens, MD, Bertram Pitt, MD, Guy Reeder, MD, Hugh Smith, MD, Patrick Whitlow, MD, George Zorn, MD, David J. Frid, MD, Daniel B. Mark, MD, MPH, and the BARI Study Group Randomized trials of coronary angioplasty and by- pass surgery have hypothesized that these proce- dures will have equivalent long-term rates of death and myocardial infarction. Functional status, quality of life, employment, and healthcare cost will there- fore be critical measures of the efficacy of these altemat’we revascularization procedures. Patients at 7 sites in the Bypass Angioplasty Revasculari- zation Investigation (BARI) were enrolled in an an- cillary Study of Economics and Quality of life (SEQOL). Physical function was assessed by the Duke Activity Status Index and emotional status by the Mental Health Inventory. Employment patterns and health care utilization were also measured at study entry and at 3-month intervals in follow-up. The 934 patients enrolled in SEQOL were similar to the 895 remaining BARI randomized patients. Most patients (63%) aged 164 years were working, and almost all working patients (96%) intended to return to work. Patients aged 265 years had lower house- hold incomes but better health insumnce covemge. Overall health ratings were significantly correlated with both physical and emotional status (p ~0.001). Patients enrolled in SEQOL are representative of the overall BARI population. Data collected in SEQOL will provide a detailed picture of the physical, emo- tional, and economic well-being after coronary an- gioplasty and bypass surgery. (Am J Cardioll995;75:34C~l C) andomized R controlled clinical trials have tradi- tionally emphasized endpoints that assess pro- gression of the underlying disease process, most notably cardiac death and nonfatal myocardial infarction, as well as the extent of coronary athero- sclerosis, left ventricular function, and myocardial ischemia. These endpoints are important to clinical From the Department of Health Research and Policy and Department of Medicine. Stanford Universitv School of Medicine, Stanford, Califor- nia (M.A.H., K.G.); Department of Health Economics, School of Public Health, and Department of Surgery, School of Medicine, University of Alabama, Birmingham, Alabama (E.D.C., G.Z.); Depart- ment of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania (K.G., I.J.); Department of Medi- cine, Boston University School of Medicine, Boston, Massachusetts (T.R.); Department of Medicine, Saint Louis University School of Medicine, Saint Louis, Missouri (R.W.); Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan (B.P.); Department of Medicine, Mayo Medical School, Rochester, Minnesota (G.R., F.N.); Department of Cardiology, Cleveland Clinic Foundation. Cleveland. Ohio (P.W.); Department of Medicine, Duke University School of Medicine, Durham, North Carolina (D.B.M., D.F.). A complete list of the BARI Investigators has been published in Circulation 1991;84(suppl V):V-23-V-27. This study was supported by a grant from the Robert Wood Johnson Foundation, Princeton, New Jersey. Additional support from the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Address for reprints: Mark A. Hlatky, MD, Stanford University School of Medicine, HRP Redwood Building, Room 264, Stanford, California 943055092. 34c THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 75 MARCH 23, 1995 researchers because they provide insight into the effect of therapy on the underlying pathophysiol- ogy of disease and are measured using objective laboratory tests. Some of the goals of therapy that are of particular importance to patients have not, however, been routinely measured in clinical trials, especially functional capabilities, quality of life, ability to maintain employment, and the cost of health care. During the development phase of the Bypass Angioplasty Revascularization Investigation (BARI), the investigators had 2 reasons for strongly supporting incorporating functional status, quality of life, employment, and cost as endpoints in this multicenter randomized trial of coronary angio- plasty and coronary bypass surgery. First, these endpoints were recognized as important outcome measures in and of themselves. Second, these endpoints would be particularly important if the rates of cardiac death and nonfatal myocardial infarction proved to be equivalent. Consequently, the investigators agreed to collect core measures of these endpoints at all BAR1 centers and to encour- age an ancillary Study of Economics and Quality of Life (SEQOL) to collect more detailed measures