Central Reading of Ulcerative Colitis Clinical Trial Videos Using Neural Networks

被引:87
作者
Gottlieb, Klaus [1 ]
Requa, James [2 ]
Karnes, William [2 ]
Gudivada, Ranga Chandra [1 ]
Shen, Jie [1 ]
Rael, Efren [2 ]
Arora, Vipin [1 ]
Dao, Tyler [2 ]
Ninh, Andrew [2 ]
McGill, James [1 ]
机构
[1] Eli Lilly & Co, 893 S Delaware St, Indianapolis, IN 46285 USA
[2] Docbot Inc, Irvine, CA USA
关键词
Machine Learning; Computer Vision; Endoscopic Scores; Efficacy End Points; ENDOSCOPIC INDEX; END-POINTS; REAL-TIME; BOWEL; SEVERITY;
D O I
10.1053/j.gastro.2020.10.024
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
BACKGROUND AND AIMS: Endoscopic disease activity scoring in ulcerative colitis (UC) is useful in clinical practice but done infrequently. It is required in clinical trials, where it is expensive and slow because human central readers are needed. A machine learning algorithm automating the process could elevate clinical care and facilitate clinical research. Prior work using single-institution databases and endoscopic still images has been promising. METHODS: Seven hundred and ninety-five full-length endoscopy videos were prospectively collected from a phase 2 trial of mirikizumab with 249 patients from 14 countries, totaling 19.5 million image frames. Expert central readers assigned each full-length endoscopy videos 1 endoscopic Mayo score (eMS) and 1 Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score. Initially, video data were cleaned and abnormality features extracted using convolutional neural networks. Subsequently, a recurrent neural network was trained on the features to predict eMS and UCEIS from individual full-length endoscopy videos. RESULTS: The primary metric to assess the performance of the recurrent neural network model was quadratic weighted kappa (QWK) comparing the agreement of the machine-read endoscopy score with the human central reader score. QWK progressively penalizes disagreements that exceed 1 level. The model's agreement metric was excellent, with a QWK of 0.844 (95% confidence interval, 0.787-0.901) for eMS and 0.855 (95% confidence interval, 0.80-0.91) for UCEIS. CONCLUSIONS: We found that a deep learning algorithm can be trained to predict levels of UC severity from full-length endoscopy videos. Our data set was prospectively collected in a multinational clinical trial, videos rather than still images were used, UCEIS and eMS were reported, and machine learning algorithm performance metrics met or exceeded those previously published for UC severity scores.
引用
收藏
页码:710 / +
页数:12
相关论文
共 28 条
[1]   The 2 [J].
Ahmad, Harris A. ;
Gottlieb, Klaus ;
Hussain, Fez .
GASTROENTEROLOGY REPORT, 2016, 4 (01) :35-38
[2]   Dependence of weighted kappa coefficients on the number of categories [J].
Brenner, H ;
Kliebsch, U .
EPIDEMIOLOGY, 1996, 7 (02) :199-202
[3]   Learning to forget: Continual prediction with LSTM [J].
Gers, FA ;
Schmidhuber, J ;
Cummins, F .
NEURAL COMPUTATION, 2000, 12 (10) :2451-2471
[4]   Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments [J].
Gottlieb, Klaus ;
Daperno, Marco ;
Usiskin, Keith ;
Sands, Bruce E. ;
Ahmad, Harris ;
Howden, Colin W. ;
Karnes, William ;
Oh, Young S. ;
Modesto, Irene ;
Marano, Colleen ;
Stidham, Ryan William ;
Reinisch, Walter .
GUT, 2021, 70 (02) :418-426
[5]   Central Reading of Endoscopy Endpoints in Inflammatory Bowel Disease Trials [J].
Gottlieb, Klaus ;
Travis, Simon ;
Feagan, Brian ;
Hussain, Fez ;
Sandborn, William J. ;
Rutgeerts, Paul .
INFLAMMATORY BOWEL DISEASES, 2015, 21 (10) :2475-2482
[6]   Voting for Image Scoring and Assessment (VISA) - theory and application of a 2+1 reader algorithm to improve accuracy of imaging endpoints in clinical trials [J].
Gottlieb, Klaus ;
Hussain, Fez .
BMC MEDICAL IMAGING, 2015, 15
[7]   The Ulcerative Colitis Endoscopic Index of Severity More Accurately Reflects Clinical Outcomes and Long-term Prognosis than the Mayo Endoscopic Score [J].
Ikeya, Kentaro ;
Hanai, Hiroyuki ;
Sugimoto, Ken ;
Osawa, Satoshi ;
Kawasaki, Shinsuke ;
Iida, Takayuki ;
Maruyama, Yasuhiko ;
Watanabe, Fumitoshi .
JOURNAL OF CROHNS & COLITIS, 2016, 10 (03) :286-295
[8]  
Karnes W, 2018, AM J GASTROENTEROL, V113, pS1532
[9]  
Karnes WE, 2018, GASTROINTEST ENDOSC, V87, pAB258
[10]   The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research [J].
Lai, Edwin J. ;
Calderwood, Audrey H. ;
Doros, Gheorghe ;
Fix, Oren K. ;
Jacobson, Brian C. .
GASTROINTESTINAL ENDOSCOPY, 2009, 69 (03) :620-625