tions of this chapter explore the use of health-related quality-of-life measures in MCSS clinical trials and studies, examine the importance of disease-specific domains and measures, and set forth conclusions of the Institute of Medicine (IOM) committee.
Researchers and clinicians evince much interest in knowing about the quality of life of patients exposed to unconventional forms of therapy for life-threatening conditions. Many of these patients have prolonged hospitalizations, extensive diagnostic testing, and multiple failures of drug therapy. Patients with life-threatening conditions frequently report feelings of anxiety, fear, depression, and loss of control (Cooper et al., 1986); these feelings and the importance patients attach to them need to be considered in assessing treatment options and their outcomes.
Quality-of-life measures can be especially important in assessing the outcomes of care for patients receiving therapies that carry high risks of negative consequences (Falotico-Taylor et al., 1989). Families of these patients are also subject to a considerable range of emotions (e.g., anger, depression, denial, disengagement, guilt) that, in turn, may affect the quality of life of the patient (Christopherson, 1986).
The history of earlier efforts to treat end-stage heart disease patients with mechanical circulatory support devices reflects many emotional and ethical concerns about the clinical and technological environments (Galletti, 1984; Shaw, 1984; Swazey et al., 1989). That history has heightened concern for the “person” with an illness, such as end-stage heart disease, and has confirmed the importance of patients' preferences for balancing quantity of life with quality of life. These preferences are particularly significant when MCSS implantation limits or restricts future treatment options, should the device fail or the patient elect to stop maintaining the device.
“Proximate clinical indicators” or clinical endpoints combine measures of both outcomes and processes of care (IOM, 1991a). They assess care close to the time that treatment is provided and thus take on critical meaning for patients whose life expectancy may be no greater than six months. Patient preferences for health-related quality-of-life outcomes at these interim points of treatment can yield valuable information for care. Additionally, the interaction of the patient and physician has itself been documented as affecting the health status of patients (IOM, 1990; IOM, 1991a).