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Review of available instruments and methods for assessing quality of life in anti-anginal trials
B D Bliven1, C P Green, J A Spertus
1University of Missouri, Kansas City, USA. bbliven@cctr.umkc.edu
Insights
Patient-centered health status, including quality of life (QOL) and patient preferences, offers a better measure of treatment benefits in coronary artery disease (CAD) clinical trials than traditional endpoints.
Area of Science:
- Cardiology
- Health Outcomes Research
- Clinical Trial Methodology
Background:
- Traditional clinical trial endpoints like morbidity and mortality are insufficient for assessing treatment benefits in coronary artery disease (CAD) where death is rare.
- Health-related quality of life (QOL) and functional status surveys capture patient-reported limitations and their impact on perceived health value.
- Patient preference measures quantify the value patients place on their health status, providing a comprehensive view of treatment outcomes.
Purpose of the Study:
- To review the use of QOL measures in anti-anginal clinical trials for CAD.
- To summarize available QOL assessment approaches, differentiating psychometric and preference-based techniques, and general vs. disease-specific measures.
- To provide a framework for selecting appropriate QOL instruments and methodologies in CAD clinical trials.
Main Methods:
- Review of QOL measures utilized in existing anti-anginal trials for CAD.
- Summary and comparison of psychometric vs. preference-based QOL assessment techniques.
- Discussion of general health vs. disease-specific health measures in the context of CAD.
Main Results:
- QOL measures provide a more accurate appraisal of treatment benefits in CAD compared to traditional endpoints.
- A lack of consensus exists regarding a single, standardized QOL measure for CAD patients.
- Various QOL assessment tools and methodologies are available, each with distinct applications.
Conclusions:
- Patient-centered outcomes, including QOL and preferences, are crucial for evaluating treatment efficacy in CAD.
- A structured framework is needed to guide the selection of appropriate QOL measures and methods in CAD clinical trials.
- Standardized approaches to QOL assessment will enhance the comparability and interpretation of clinical trial results in CAD.
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.