title: Review of available instruments and methods for assessing quality of life in anti-anginal trials.
abstract: Collection of patient-centred health status is a method for quantifying patient outcome in the context of clinical trials for the treatment of coronary artery disease (CAD). Traditional clinical trial end-points, such as morbidity and mortality, fail to adequately measure the health-related outcomes of disease states for which death is a rare occurrence. Health-related quality of life (QOL) and functional status surveys allow measurement of the general, and/or disease-specific, health-related limitations experienced by patients. Measures of patient preference, in turn, quantify the effects these health-related limitations have on the overall value patients ascribe to their current health state. Together, these outcomes measures may provide a more accurate appraisal of the benefit conferred by treatment. Currently, selection of the appropriate outcomes measures and methodological approaches for a clinical trial is complicated by the lack of consensus on a single quality of life measure for use with patients with (CAD). This article outlines the use of QOL measures in anti-anginal trials done to date and summarises the approaches currently available for assessing QOL, including the differences between psychometric and preference-based techniques, and general and disease-specific health measures. In conclusion, a framework is provided for selecting the appropriate instruments and methodology in the context of the clinical trial.
authors.affiliation: University of Missouri, Kansas City, USA. bbliven@cctr.umkc.edu
authors.forename: B D
authors.initials: BD
authors.lastname: Bliven
authors.forename: C P
authors.initials: CP
authors.lastname: Green
authors.forename: J A
authors.initials: JA
authors.lastname: Spertus
mesh_terms: D000787:Angina Pectoris / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D003327:Coronary Disease; D006304:Health Status; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011788:Quality of Life; D012107:Research Design