The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial
Author(s)
Type
Journal Article
Abstract
Background
Stress echocardiography (SE) is dependent on subjective interpretations. As a prelude to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial, potential sites were required to submit two SE, one with moderate or severe left ventricular (LV) myocardial ischemia and one with mild ischemia. We evaluated the concordance of site and core lab interpretations.
Methods
Eighty-one SE were submitted from 41 international sites. Ischemia was classified by the number of new or worsening segmental LV wall motion abnormalities (WMA): none, mild (1 or 2) or moderate or severe (3 or more) by the sites and the core lab.
Results
Core lab classified 6 SE as no ischemia, 35 mild and 40 moderate or greater. There was agreement between the site and core in 66 of 81 total cases (81 %, weighted kappa coefficient [K] =0.635). Agreement was similar for SE type - 24 of 30 exercise (80 %, K = 0.571) vs. 41 of 49 pharmacologic (84 %, K = 0.685). The agreement between poor or fair image quality (27 of 36 cases, 75 %, K = 0.492) was not as good as for the good or excellent image quality cases (39 of 45 cases, 87 %, K = 0.755). Differences in concordance were noted for degree of ischemia with the majority of discordant interpretations (87 %) occurring in patients with no or mild LV myocardial ischemia.
Conclusions
While site SE interpretations are largely concordant with core lab interpretations, this appears dependent on image quality and the extent of WMA. Thus core lab interpretations remain important in clinical trials where consistency of interpretation across a range of cases is critical.
Stress echocardiography (SE) is dependent on subjective interpretations. As a prelude to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial, potential sites were required to submit two SE, one with moderate or severe left ventricular (LV) myocardial ischemia and one with mild ischemia. We evaluated the concordance of site and core lab interpretations.
Methods
Eighty-one SE were submitted from 41 international sites. Ischemia was classified by the number of new or worsening segmental LV wall motion abnormalities (WMA): none, mild (1 or 2) or moderate or severe (3 or more) by the sites and the core lab.
Results
Core lab classified 6 SE as no ischemia, 35 mild and 40 moderate or greater. There was agreement between the site and core in 66 of 81 total cases (81 %, weighted kappa coefficient [K] =0.635). Agreement was similar for SE type - 24 of 30 exercise (80 %, K = 0.571) vs. 41 of 49 pharmacologic (84 %, K = 0.685). The agreement between poor or fair image quality (27 of 36 cases, 75 %, K = 0.492) was not as good as for the good or excellent image quality cases (39 of 45 cases, 87 %, K = 0.755). Differences in concordance were noted for degree of ischemia with the majority of discordant interpretations (87 %) occurring in patients with no or mild LV myocardial ischemia.
Conclusions
While site SE interpretations are largely concordant with core lab interpretations, this appears dependent on image quality and the extent of WMA. Thus core lab interpretations remain important in clinical trials where consistency of interpretation across a range of cases is critical.
Date Issued
2015-12-18
Date Acceptance
2015-12-15
Citation
Cardiovascular Ultrasound, 2015, 13
ISSN
1476-7120
Publisher
BioMed Central
Journal / Book Title
Cardiovascular Ultrasound
Volume
13
Copyright Statement
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
License URL
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Stress echocardiography
ISCHEMIA Trial
Interpretation variability
Left ventricular myocardial ischemia
Image quality
OPTIMAL MEDICAL THERAPY
MYOCARDIAL-INFARCTION
ADMISSION ELECTROCARDIOGRAM
EXERCISE ECHOCARDIOGRAPHY
LABORATORY INTERPRETATION
OBSERVER AGREEMENT
DISEASE
ASSOCIATION
TOMOGRAPHY
COURAGE
Aged
Clinical Laboratory Techniques
Diagnostic Tests, Routine
Echocardiography, Stress
Female
Humans
Male
Middle Aged
Myocardial Ischemia
Observer Variation
Reproducibility of Results
Sensitivity and Specificity
Single-Blind Method
Ventricular Dysfunction, Left
Cardiovascular System & Hematology
1103 Clinical Sciences
Publication Status
Published
Article Number
47