Browsing by Author "Pencina, Michael"

Now showing 1 - 2 of 2
  • Thumbnail Image
    ItemOpen Access
    Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.
    (Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography, 2016-12) Crowley, Anna Lisa; Yow, Eric; Barnhart, Huiman X; Daubert, Melissa A; Bigelow, Robert; Sullivan, Daniel C; Pencina, Michael; Douglas, Pamela S

    Background

    There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results.

    Methods

    Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study.

    Results

    The studies varied in approaches to reproducibility testing, sample size, and metrics assessed and values reported. Reported metrics included mean difference and its SD (n = 7 studies), ICC (n = 5), CV (n = 4), and Bland-Altman limits of agreement (n = 4). Once de novo estimates of all missing indices were determined, reasonable reproducibility targets for each were identified as those achieved by the majority of studies. These included, for LV end-diastolic volume, ICC > 0.95, CV < 7%, and coverage probability > 0.93 within 30 mL; for LV ejection fraction, ICC > 0.85, CV < 8%, and coverage probability > 0.85 within 10%; and for LV mass, ICC > 0.85, CV < 10%, and coverage probability > 0.60 within 20 g.

    Conclusions

    Assessment of data quality in echocardiographic clinical research is infrequent, and methods vary substantially. A first step to standardizing echocardiographic quality reporting is to standardize assessments and reporting metrics. Potential benefits include clearer communication of data quality and the identification of achievable targets to benchmark quality improvement initiatives.
  • Thumbnail Image
    ItemOpen Access
    The Project Baseline Health Study: a step towards a broader mission to map human health.
    (NPJ digital medicine, 2020-01) Arges, Kristine; Assimes, Themistocles; Bajaj, Vikram; Balu, Suresh; Bashir, Mustafa R; Beskow, Laura; Blanco, Rosalia; Califf, Robert; Campbell, Paul; Carin, Larry; Christian, Victoria; Cousins, Scott; Das, Millie; Dockery, Marie; Douglas, Pamela S; Dunham, Ashley; Eckstrand, Julie; Fleischmann, Dominik; Ford, Emily; Fraulo, Elizabeth; French, John; Gambhir, Sanjiv S; Ginsburg, Geoffrey S; Green, Robert C; Haddad, Francois; Hernandez, Adrian; Hernandez, John; Huang, Erich S; Jaffe, Glenn; King, Daniel; Koweek, Lynne H; Langlotz, Curtis; Liao, Yaping J; Mahaffey, Kenneth W; Marcom, Kelly; Marks, William J; Maron, David; McCabe, Reid; McCall, Shannon; McCue, Rebecca; Mega, Jessica; Miller, David; Muhlbaier, Lawrence H; Munshi, Rajan; Newby, L Kristin; Pak-Harvey, Ezra; Patrick-Lake, Bray; Pencina, Michael; Peterson, Eric D; Rodriguez, Fatima; Shore, Scarlet; Shah, Svati; Shipes, Steven; Sledge, George; Spielman, Susie; Spitler, Ryan; Schaack, Terry; Swamy, Geeta; Willemink, Martin J; Wong, Charlene A
    The Project Baseline Health Study (PBHS) was launched to map human health through a comprehensive understanding of both the health of an individual and how it relates to the broader population. The study will contribute to the creation of a biomedical information system that accounts for the highly complex interplay of biological, behavioral, environmental, and social systems. The PBHS is a prospective, multicenter, longitudinal cohort study that aims to enroll thousands of participants with diverse backgrounds who are representative of the entire health spectrum. Enrolled participants will be evaluated serially using clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, and other health-related measurements. An initial deeply phenotyped cohort will inform the development of a large, expanded virtual cohort. The PBHS will contribute to precision health and medicine by integrating state of the art testing, longitudinal monitoring and participant engagement, and by contributing to the development of an improved platform for data sharing and analysis.