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Assessing quality-of-life outcomes in cardiovascular clinical research

Key Points

  • Quality-of-life (QOL) measurement grew out of work by social scientists and health-services researchers in the 1960s and 1970s to define the value of health-care spending

  • Measuring QOL has some similarity with other forms of clinical testing but, because the objects of measurement are subjective experiences, psychometric tools and theory are used to guide the process

  • The goal of measurement is to use the patterns of responses from patients on QOL scales to marshal evidence that the (unobservable) QOL construct is present at some quantitative level

  • The choice of which instrument to use in a particular area of research or clinical indication is primarily a matter of expert judgment

  • QOL and other patient-reported outcomes are still not measured in most clinical trials of cardiovascular disease

  • A typical approach to QOL measurement is to combine a disease-specific measure that is sensitive to the intervention under study with one or more generic instruments providing normative data

Abstract

The field of quality-of-life (QOL) measurement grew out of attempts in the 1960s and 1970s to connect the ever-increasing levels of public expenditure on technology-based health care for chronic diseases with evidence of the benefits and harms to patients. Most of the concepts, methods, and standards for measuring QOL were derived from psychometrics, but the degree to which current tools adhere to these methods varies greatly. Despite the importance of QOL, patient-reported outcomes are not measured in most cardiovascular clinical trials. Lack of familiarity with QOL measures and their interpretation, and unrealistic expectations about the information these measures can provide, are obstacles to their use. Large clinical trials of revascularization therapy for coronary artery disease and medical treatments for heart failure show small-to-moderate QOL effects, primarily detected with disease-specific instruments. Larger treatment effects, seen in trials of device therapy for heart failure and ablation therapy for atrial fibrillation, have been detected with both generic and disease-specific instruments. A large gap remains between the parameters currently being measured in clinical research and the data needed to incorporate the 'patient's voice' into therapeutic decision-making.

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Figure 1: Wilson–Cleary conceptual quality-of-life model (modified)22.
Figure 2: Rand Medical Outcomes Study health status framework.
Figure 3: Reasons given by patients with angina for limiting daily activities65.
Figure 4: Scales used to measure dyspnoea in clinical trials of acute heart failure.

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Acknowledgements

The author acknowledges his gratitude to Melanie R. Daniels (Howl, Inc., Durham, North Carolina, USA) for her research and editorial work on this project, and to Dr Kevin Weinfurt (Duke University, Durham, North Carolina, USA) for a critical review of an early version of this article.

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Correspondence to Daniel B. Mark.

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The author declares having been a consultant for CardioDx, Gilead, Medtronic, and St. Jude Medical; and receiving research grants from AstraZeneca, Bristol Myers Squibb, Eli Lilly, Gilead, and Medtronic.

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Clinical trials of revascularization versus medical therapy for CAD (DOCX 34 kb)

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Mark, D. Assessing quality-of-life outcomes in cardiovascular clinical research. Nat Rev Cardiol 13, 286–308 (2016). https://doi.org/10.1038/nrcardio.2016.10

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