The Lung Image Database Consortium (LIDC): ensuring the integrity of expert-defined "truth".
OBJECTIVE
Computer-aided diagnostic (CAD) systems fundamentally require the opinions of expert human observers to establish "truth" for algorithm development, training, and testing. The integrity of this "truth," however, must be established before investigators commit to this "gold standard" as the basis for their research. The purpose of this study was to develop a quality assurance (QA) model as an integral component of the "truth" collection process concerning the location and spatial extent of lung nodules observed on computed tomography (CT) scans to be included in the Lung Image Database Consortium (LIDC) public database.


METHODS
One hundred CT scans were interpreted by four radiologists through a two-phase process. For the first of these reads (the "blinded read phase"), radiologists independently identified and annotated lesions, assigning each to one of three categories: "nodule >or=3 mm," "nodule <3 mm," or "non-nodule >or=3 mm." For the second read (the "unblinded read phase"), the same radiologists independently evaluated the same CT scans, but with all of the annotations from the previously performed blinded reads presented; each radiologist could add to, edit, or delete their own marks; change the lesion category of their own marks; or leave their marks unchanged. The post-unblinded read set of marks was grouped into discrete nodules and subjected to the QA process, which consisted of identification of potential errors introduced during the complete image annotation process and correction of those errors. Seven categories of potential error were defined; any nodule with a mark that satisfied the criterion for one of these categories was referred to the radiologist who assigned that mark for either correction or confirmation that the mark was intentional.


RESULTS
A total of 105 QA issues were identified across 45 (45.0%) of the 100 CT scans. Radiologist review resulted in modifications to 101 (96.2%) of these potential errors. Twenty-one lesions erroneously marked as lung nodules after the unblinded reads had this designation removed through the QA process.


CONCLUSIONS
The establishment of "truth" must incorporate a QA process to guarantee the integrity of the datasets that will provide the basis for the development, training, and testing of CAD systems.
Armato
Samuel G
SG
Department of Radiology, The University of Chicago, MC 2026, The University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USA. s-armato@uchicago.edu
Roberts
Rachael Y
RY
McNitt-Gray
Michael F
MF
Meyer
Charles R
CR
Reeves
Anthony P
AP
McLennan
Geoffrey
G
Engelmann
Roger M
RM
Bland
Peyton H
PH
Aberle
Denise R
DR
Kazerooni
Ella A
EA
MacMahon
Heber
H
van Beek
Edwin J R
EJ
Yankelevitz
David
D
Croft
Barbara Y
BY
Clarke
Laurence P
LP
D019992:Databases as Topic / Q000592:standards*; D003936:Diagnosis, Computer-Assisted / Q000592:standards*; D006801:Humans; D051188:Knowledge Bases; D008175:Lung Neoplasms / Q000000981:diagnostic imaging*; D015588:Observer Variation; D011785:Quality Assurance, Health Care; D011871:Radiology / Q000592:standards; D011873:Radiology Information Systems / Q000592:standards; D003074:Solitary Pulmonary Nodule / Q000000981:diagnostic imaging; D014057:Tomography, X-Ray Computed / Q000592:standards*