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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

SCImago Journal Rank (SJR) 2016: 1.000
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1437-4331
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Volume 48, Issue 12 (Dec 2010)

Issues

Statistical methods for assessment of added usefulness of new biomarkers

Michael J. Pencina
  • Department of Biostatistics, Boston University, Boston, MA, USA
  • NHLBI's Framingham Heart Study, Framingham, MA, USA
  • Harvard Clinical Research Institute, Boston, MA, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ralph B. D'Agostino
  • Department of Mathematics and Statistics, Boston University, Boston, MA, USA
  • NHLBI's Framingham Heart Study, Framingham, MA, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ramachandran S. Vasan
  • School of Medicine, Boston University, Boston, MA, USA
  • NHLBI's Framingham Heart Study, Framingham, MA, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2010-08-18 | DOI: https://doi.org/10.1515/CCLM.2010.340

Abstract

The discovery and development of new biomarkers continues to be an exciting and promising field. Improvement in prediction of risk of developing disease is one of the key motivations in these pursuits. Appropriate statistical measures are necessary for drawing meaningful conclusions about the clinical usefulness of these new markers. In this review, we present several novel metrics proposed to serve this purpose. We use reclassification tables constructed on the basis of clinically meaningful disease risk categories to discuss the concepts of calibration, risk separation, risk discrimination, and risk classification accuracy. We discuss the notion that the net reclassification improvement (NRI) is a simple yet informative way to summarize information contained in risk reclassification tables. In the absence of meaningful risk categories, we suggest a ‘category-less’ version of the NRI and integrated discrimination improvement as metrics to summarize the incremental value of new biomarkers. We also suggest that predictiveness curves be preferred to receiver operating characteristic curves as visual descriptors of a statistical model's ability to separate predicted probabilities of disease events. Reporting of standard metrics, including measures of relative risk and the c statistic, is still recommended. These concepts are illustrated with a risk prediction example using data from the Framingham Heart Study.

Clin Chem Lab Med 2010;48:1703–11.

Keywords: calibration; discrimination; integrated discrimination improvement; net reclassification improvement; reclassification; risk prediction

About the article

Corresponding authors: Michael J. Pencina, PhD, Department of Biostatistics, Boston University, Framingham Heart Study, Harvard Clinical Research Institute, 111 Cummington St., Boston, MA 02215, USA Phone: +1 617-358-3386, Fax: +1 617-353-4767, Ramachandran S. Vasan, MD, DM, FACC, Boston University School of Medicine, Framingham Heart Study, 73 Mount Wayte Avenue, Suite 2, Framingham, MA 01702-5803, USA Phone: +1 508-935-3450,


Received: 2010-02-11

Accepted: 2010-06-18

Published Online: 2010-08-18

Published in Print: 2010-12-01


Citation Information: Clinical Chemistry and Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.340.

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Medicinal Research Reviews, 2014, Volume 34, Number 3, Page 503
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Nature Reviews Nephrology, 2013, Volume 9, Number 8, Page 478
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Journal of Cardiovascular Translational Research, 2013, Volume 6, Number 4, Page 449
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Diabetes Research and Clinical Practice, 2013, Volume 101, Number 3, Page 255
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Arthritis Care & Research, 2013, Volume 65, Number 4, Page 526
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Clinica Chimica Acta, 2013, Volume 419, Page 102
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David Salat, Anna Penalba, Teresa García-Berrocoso, Mireia Campos-Martorell, Alan Flores, Jorge Pagola, Alejandro Bustamante, Manuel Quintana, Dolors Giralt, Carlos Molina, José Alvarez-Sabín, and Joan Montaner
Cerebrovascular Diseases, 2013, Volume 35, Number 3, Page 220
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International Journal of Cardiology, 2013, Volume 168, Number 2, Page 1644
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Current Cardiovascular Risk Reports, 2013, Volume 7, Number 2, Page 126
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Nephrology Dialysis Transplantation, 2013, Volume 28, Number 6, Page 1447
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Thrombosis and Haemostasis, 2012, Volume 109, Number 5, Page 808
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The American Journal of Cardiology, 2013, Volume 111, Number 3, Page 432
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Journal of the American College of Cardiology, 2012, Volume 60, Number 21, Page 2170
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International Journal of Cardiology, 2013, Volume 168, Number 1, Page 396
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The American Journal of Emergency Medicine, 2013, Volume 31, Number 1, Page 215
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International Journal of Stroke, 2013, Volume 8, Number 6, Page 484
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American Journal of Kidney Diseases, 2012, Volume 60, Number 5, Page 804
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International Journal of Endocrinology, 2012, Volume 2012, Page 1
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European Heart Journal, 2012, Volume 33, Number 18, Page 2297
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Annals of Medicine, 2013, Volume 45, Number 2, Page 141
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Journal of Bone and Mineral Research, 2012, Volume 27, Number 4, Page 797
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American Journal of Epidemiology, 2012, Volume 175, Number 7, Page 715
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European Journal of Heart Failure, 2012, Volume 14, Number 3, Page 268
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JACC: Cardiovascular Imaging, 2012, Volume 5, Number 2, Page 131
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Clinical & Experimental Allergy, 2011, Volume 41, Number 12, Page 1656
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International Journal of Clinical Practice, 2011, Volume 65, Number 12, Page 1221
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Pharmacological Research, 2011, Volume 64, Number 1, Page 11
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International Journal of Cardiology, 2011, Volume 150, Number 2, Page 224
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Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 7
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Journal of Medical Biochemistry, 2011, Volume 30, Number 3
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PROTEOMICS - Clinical Applications, 2011, Volume 5, Number 5-6, Page 241
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European Journal of Heart Failure, 2011, Volume 13, Number 6, Page 579
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Clinical Chemistry and Laboratory Medicine, 2010, Volume 48, Number 12

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