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November 2018

The Evolution of Patient-Reported Outcomes in Clinical Trials and Management of Patients With Coronary Artery Disease: 20 Years With the Seattle Angina Questionnaire

Author Affiliations
  • 1Saint Luke’s Mid America Heart Institute, University of Missouri, Kansas City
JAMA Cardiol. 2018;3(11):1035-1036. doi:10.1001/jamacardio.2018.2849

For patients with coronary artery disease (CAD), the principal treatment goals are to reduce cardiac events, eradicate angina, and optimize quality of life.1 However, despite the importance of patients’ symptoms, function, and quality of life, most CAD treatment trials have focused on hard outcomes of death or myocardial infarction or on surrogate measures of repeated revascularization, risk factor reduction, or changes in ejection fraction. Over the past 20 years, there has been a movement to also measure patient-reported outcomes (PROs) to understand the effect of treatment on patients’ health status. To support this effort, a 19-item version of the Seattle Angina Questionnaire (SAQ) was introduced in 1994, and a shortened 7-item version was created in 2014.2,3 While there was initial reluctance to accept the SAQ as a legitimate clinical outcome because of concerns about the vagueness of angina and the survey’s 4-week recall period, it has been well validated against daily angina assessments4 and used in more than 1800 studies of more than 1 million patients. Importantly, the SAQ is disease specific, which means that it is designed to explicitly quantify the symptoms, function, and quality of life associated with CAD. As a result, it is quite sensitive to change and in some trials has been the only metric to show a difference between treatments (eg, coronary stenting vs medical therapy in the COURAGE study).5

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