STRUCTURED ABSTRACT Objectives To determine whether presentation, risk assessment, testing choices, and results differ by sex in stable symptomatic outpatients with suspected coronary artery disease (CAD). Background Although established CAD presentations differ by sex, little is known about stable, suspected CAD. Methods Characteristics of 10,003 men and women in the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial were compared using chi-square and Wilcoxon rank sum tests. Sex differences in test selection and predictors of test positivity were examined using logistic regression. Results Women were older (62.4 years vs. 59.0) and more likely to be hypertensive (66.6% vs. 63.2%), dyslipidemic (68.9% vs. 66.3%), and to have a family history of premature CAD (34.6% vs. 29.3) (all p-values<0.005). Women were less likely to smoke (45.6% vs. 57.0%; p<0.001), while diabetes prevalence was similar (21.8% vs. 21.0%; p=0.30). Chest pain was the primary symptom in 73.2% of women vs. 72.3% of men (p=0.30) and was characterized as “crushing/pressure/squeezing/tightness” in 52.5% of women vs. 46.2% of men (p<0.001). Compared to men, all risk scores characterized women as lower risk, and providers were more likely to characterize women as having low (<30%) pre-test probability for CAD (40.7% vs. 34.1%; p<0.001). Compared with men, women were more often referred to imaging tests (adjusted OR 1.21; 95% CI 1.01–1.44) than non-imaging tests. Women were less likely to have a positive test (9.7% vs. 15.1%; p<0.001). Although univariate predictors of test positivity were similar, in multivariable models, age, BMI, and Framingham risk score were predictive of a positive test in women, while Framingham and Diamond and Forrester risk scores were predictive in men. Conclusion Patient sex influences the entire diagnostic pathway for possible CAD, from baseline risk factors and presentation to noninvasive test outcomes. These differences highlight the need for sex-specific approaches to CAD evaluation.

Clinical core laboratories, such as Echocardiography core laboratories, are increasingly used in clinical studies with imaging outcomes as primary, secondary, or surrogate endpoints. While many factors contribute to the quality of measurements of imaging variables, an essential step in ensuring the value of imaging data includes formal assessment and control of reproducibility via intra-observer and inter-observer reliability. There are many different agreement/reliability indices in the literature. However, different indices may lead to different conclusions and it is not clear which index is the preferred choice as an overall indication of data quality and a tool for providing guidance on improving quality and reliability in a core lab setting. In this paper, we pre-specify the desirable characteristics of an agreement index for assessing and improving reproducibility in a core lab setting; we compare existing agreement indices in terms of these characteristics to choose a preferred index. We conclude that, among the existing indices reviewed, the coverage probability for assessing agreement is the preferred agreement index on the basis of computational simplicity, its ability for rapid identification of discordant measurements to provide guidance for review and retraining, and its consistent evaluation of data quality across multiple reviewers, populations, and continuous/categorical data.

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