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Echocardiographic methods, quality review, and measurement accuracy in a randomized multicenter clinical trial of Marfan syndrome

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Abstract
Background: The Pediatric Heart Network is conducting a large international randomized trial to compare aortic root growth and other cardiovascular outcomes in 608 subjects with Marfan syndrome randomized to receive atenolol or losartan for 3 years. The authors report here the echocardiographic methods and baseline echocardiographic characteristics of the randomized subjects, describe the interobserver agreement of aortic measurements, and identify factors influencing agreement. Methods: Individuals aged 6 months to 25 years who met the original Ghent criteria and had body surface area adjusted maximum aortic root diameter(ROOTmax) Z scores > 3 were eligible for inclusion. The primary outcome measure for the trial is the change over time in ROOTmax Z score. A detailed echocardiographic protocol was established and implemented across 22 centers, with an extensive training and quality review process. Results: Interobserver agreement for the aortic measurements was excellent, with intraclass correlation coefficients ranging from 0.921 to 0.989. Lower interobserver percentage error in ROOTmax measurements was independently associated (model R-2 = 0.15) with better image quality (P = .002) and later study reading date (P < .001). Echocardiographic characteristics of the randomized subjects did not differ by treatment arm. Subjects with ROOTmax Z scores >= 4.5 (36%) were more likely to have mitral valve prolapse and dilation of the main pulmonary artery and left ventricle, but there were no differences in aortic regurgitation, aortic stiffness indices, mitral regurgitation, or left ventricular function compared with subjects with ROOTmax Z scores < 4.5. Conclusions: The echocardiographic methodology, training, and quality review process resulted in a robust evaluation of aortic root dimensions, with excellent reproducibility.
Keywords
HEALTHY-CHILDREN, OF-CARDIOLOGY, PEDIATRIC-PATIENTS, CARDIAC STRUCTURES, DILATED CARDIOMYOPATHY, AORTIC ROOT, AMERICAN-SOCIETY, BETA-BLOCKER THERAPY, Marfan syndrome, Aortic root, Interobserver agreement, Echocardiography, WRITING GROUP, RECOMMENDATIONS

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Chicago
Tierney, Elif Seda Selamet, Jami C Levine, Shan Chen, Timothy J Bradley, Gail D Pearson, Steven D Colan, Lynn A Sleeper, et al. 2013. “Echocardiographic Methods, Quality Review, and Measurement Accuracy in a Randomized Multicenter Clinical Trial of Marfan Syndrome.” Journal of the American Society of Echocardiography 26 (6): 657–666.
APA
Tierney, E. S. S., Levine, J. C., Chen, S., Bradley, T. J., Pearson, G. D., Colan, S. D., Sleeper, L. A., et al. (2013). Echocardiographic methods, quality review, and measurement accuracy in a randomized multicenter clinical trial of Marfan syndrome. JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY, 26(6), 657–666.
Vancouver
1.
Tierney ESS, Levine JC, Chen S, Bradley TJ, Pearson GD, Colan SD, et al. Echocardiographic methods, quality review, and measurement accuracy in a randomized multicenter clinical trial of Marfan syndrome. JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY. 2013;26(6):657–66.
MLA
Tierney, Elif Seda Selamet, Jami C Levine, Shan Chen, et al. “Echocardiographic Methods, Quality Review, and Measurement Accuracy in a Randomized Multicenter Clinical Trial of Marfan Syndrome.” JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY 26.6 (2013): 657–666. Print.
@article{4106700,
  abstract     = {Background: The Pediatric Heart Network is conducting a large international randomized trial to compare aortic root growth and other cardiovascular outcomes in 608 subjects with Marfan syndrome randomized to receive atenolol or losartan for 3 years. The authors report here the echocardiographic methods and baseline echocardiographic characteristics of the randomized subjects, describe the interobserver agreement of aortic measurements, and identify factors influencing agreement.
Methods: Individuals aged 6 months to 25 years who met the original Ghent criteria and had body surface area adjusted maximum aortic root diameter(ROOTmax) Z scores > 3 were eligible for inclusion. The primary outcome measure for the trial is the change over time in ROOTmax Z score. A detailed echocardiographic protocol was established and implemented across 22 centers, with an extensive training and quality review process.
Results: Interobserver agreement for the aortic measurements was excellent, with intraclass correlation coefficients ranging from 0.921 to 0.989. Lower interobserver percentage error in ROOTmax measurements was independently associated (model R-2 = 0.15) with better image quality (P = .002) and later study reading date (P < .001). Echocardiographic characteristics of the randomized subjects did not differ by treatment arm. Subjects with ROOTmax Z scores >= 4.5 (36%) were more likely to have mitral valve prolapse and dilation of the main pulmonary artery and left ventricle, but there were no differences in aortic regurgitation, aortic stiffness indices, mitral regurgitation, or left ventricular function compared with subjects with ROOTmax Z scores < 4.5.
Conclusions: The echocardiographic methodology, training, and quality review process resulted in a robust evaluation of aortic root dimensions, with excellent reproducibility.},
  author       = {Tierney, Elif Seda Selamet and Levine, Jami C and Chen, Shan and Bradley, Timothy J and Pearson, Gail D and Colan, Steven D and Sleeper, Lynn A and Campbell, M Jay and Cohen, Meryl S and De Backer, Julie and Guey, Lin T and Heydarian, Haleh and Lai, Wyman W and Lewin, Mark B and Marcus, Edward and Mart, Christopher R and Pignatelli, Ricardo H and Printz, Beth F and Sharkey, Angela M and Shirali, Girish S and Srivastava, Shubhika and Lacro, Ronald V},
  issn         = {0894-7317},
  journal      = {JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY},
  keywords     = {HEALTHY-CHILDREN,OF-CARDIOLOGY,PEDIATRIC-PATIENTS,CARDIAC STRUCTURES,DILATED CARDIOMYOPATHY,AORTIC ROOT,AMERICAN-SOCIETY,BETA-BLOCKER THERAPY,Marfan syndrome,Aortic root,Interobserver agreement,Echocardiography,WRITING GROUP,RECOMMENDATIONS},
  language     = {eng},
  number       = {6},
  pages        = {657--666},
  title        = {Echocardiographic methods, quality review, and measurement accuracy in a randomized multicenter clinical trial of Marfan syndrome},
  url          = {http://dx.doi.org/10.1016/j.echo.2013.02.018},
  volume       = {26},
  year         = {2013},
}

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