Quantitative imaging biomarkers: A review of statistical methods for technical performance assessment

被引：278

作者：

Raunig, David L. ^{[1
]}

McShane, Lisa M. ^{[2
]}

Pennello, Gene ^{[3
]}

Gatsonis, Constantine ^{[4
]}

Carson, Paul L. ^{[5
]}

Voyvodic, James T. ^{[6
]}

Wahl, Richard L. ^{[7
]}

Kurland, Brenda F. ^{[8
]}

Schwarz, Adam J. ^{[9
]}

Goenen, Mithat ^{[10
]}

Zahlmann, Gudrun ^{[11
]}

Kondratovich, Marina V. ^{[3
]}

O'Donnell, Kevin ^{[12
]}

Petrick, Nicholas ^{[3
]}

Cole, Patricia E. ^{[13
]}

Garra, Brian ^{[3
]}

Sullivan, Daniel C. ^{[14
]}

机构：

[1] ICON Med Imaging, Warrington, PA 18976 USA

[2] NCI, Bethesda, MD 20892 USA

[3] US FDA, CDRH, Silver Spring, MD USA

[4] Brown Univ, Providence, RI 02912 USA

[5] Univ Michigan Hlth Syst, Ann Arbor, MI USA

[6] Duke Univ BIAC, Durham, NC USA

[7] Johns Hopkins Med Inst, Baltimore, MD 21205 USA

[8] Univ Pittsburgh, Pittsburgh, PA USA

[9] Eli Lilly & Co, Indianapolis, IN 46285 USA

[10] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

[11] Hoffman La Roche Ltd, Basel, Switzerland

[12] Toshiba Med Res Inst, Vernon Hills, IL USA

[13] Takaeda, Deerfield, IL USA

[14] Duke Univ, Sch Med, Durham, NC 27706 USA

来源：

STATISTICAL METHODS IN MEDICAL RESEARCH | 2015年 / 24卷 / 01期

关键词：

quantitative imaging; imaging biomarkers; reliability; linearity; bias; precision; repeatability; reproducibility; agreement; CONFIDENCE-INTERVALS; ASSESSING AGREEMENT; RELIABILITY; DEFINITIONS; COEFFICIENT; MEDICINE; POINTS;

D O I：

10.1177/0962280214537344

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers to measure changes in these features. Critical to the performance of a quantitative imaging biomarker in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method, and metrics used to assess a quantitative imaging biomarker for clinical use. It is therefore difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America and the Quantitative Imaging Biomarker Alliance with technical, radiological, and statistical experts developed a set of technical performance analysis methods, metrics, and study designs that provide terminology, metrics, and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of quantitative imaging biomarker performance studies so that results from multiple studies can be compared, contrasted, or combined.

引用

页码：27 / 67

页数：41

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