Publications by authors named "Gene Pennello"

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Intention-to-diagnose and distinct research foci in diagnostic accuracy studies.
Scott R Evans, Gene Pennello, Shanshan Zhang, Yixuan Li, Yike Wang

Lancet Infect Dis· August 2025

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A comparison of Bayesian and score methods for interval estimates of positive/negative likelihood ratios in support of diagnostic device performance evaluation.
Tingting Hu, Berkman Sahiner, Nicholas Petrick, Kenny Cha, Si Wen, Gene Pennello

J Biopharm Stat· June 2025

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DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests.
Ngoc-Ty Nguyen, Gene A Pennello

J Appl Lab Med· September 2024

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Decision region analysis for generalizability of artificial intelligence models: estimating model generalizability in the case of cross-reactivity and population shift.
Alexis Burgon, Berkman Sahiner, Nicholas Petrick, Gene Pennello, Kenny H Cha

J Med Imaging (Bellingham)· January 2024

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Net benefit of diagnostic tests for multistate diseases: an indicator variables approach.
Hani Samawi, Ferdous Ahmed, Gene Pennello, Jingjing Yin

J Biopharm Stat· September 2023

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A causal roadmap for generating high-quality real-world evidence.
Lauren E Dang, Susan Gruber, Hana Lee, Issa J Dahabreh, Elizabeth A Stuart, Gene Pennello

J Clin Transl Sci· September 2023

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B
Bayesian Statistics for Medical Devices: Progress Since 2010.
Gregory Campbell, Telba Irony, Gene Pennello, Laura Thompson

Ther Innov Regul Sci· May 2023

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A Framework for Evaluating the Technical Performance of Multiparameter Quantitative Imaging Biomarkers (mp-QIBs).
Nancy A Obuchowski, Erich Huang, Nandita M deSouza, David Raunig, Jana Delfino, Gene Pennello

Acad Radiol· February 2023

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Multiparametric Quantitative Imaging Biomarkers for Phenotype Classification: A Framework for Development and Validation.
Jana G Delfino, Gene A Pennello, Huiman X Barnhart, Andrew J Buckler, Xiaofeng Wang

Acad Radiol· February 2023

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Multiparametric Quantitative Imaging in Risk Prediction: Recommendations for Data Acquisition, Technical Performance Assessment, and Model Development and Validation.
Erich P Huang, Gene Pennello, Nandita M deSouza, Xiaofeng Wang, Andrew J Buckler

Acad Radiol· February 2023

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Multiparametric Data-driven Imaging Markers: Guidelines for Development, Application and Reporting of Model Outputs in Radiomics.
Xiaofeng Wang, Gene Pennello, Nandita M deSouza, Erich P Huang, Andrew J Buckler

Acad Radiol· February 2023

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Multiparametric Quantitative Imaging Biomarker as a Multivariate Descriptor of Health: A Roadmap.
David L Raunig, Gene A Pennello, Jana G Delfino, Andrew J Buckler, Timothy J Hall

Acad Radiol· February 2023

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I
In Real-World Studies, Comparisons of Predictive Values Are Confounded by Prevalence.
Gene Pennello

Chest· August 2022

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D
Discussion on "Correct and logical causal inference for binary and time-to-event outcomes in randomized controlled trials" by Yi Liu, Bushi Wang, Miao Yang, Jianan Hui, Heng Xu, Siyoen Kil, and Jason C. Hsu.
Gene Pennello, Dandan Xu

Biom J· February 2022

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D
Development and evaluation of safety and effectiveness of novel cancer screening tests for routine clinical use with applications to multicancer detection technologies.
Chyke A Doubeni, Yan Kwan Lau, Jennifer S Lin, Gene A Pennello, Robert W Carlson

Cancer· February 2022

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Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Keynote and panel discussion on communicating heterogeneous treatment effects across populations.
James Heyward, Milena Lolic, Catherine Spong, David Atkins, Gene Pennello

Pharm Stat· September 2021

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Discussion on "Approval policies for modifications to machine learning-based software as a medical device: A study of bio-creep" by Jean Feng, Scott Emerson, and Noah Simon.
Gene Pennello, Berkman Sahiner, Alexej Gossmann, Nicholas Petrick

Biometrics· March 2021

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C
Comparing diagnostic tests on benefit-risk.
Gene Pennello, Norberto Pantoja-Galicia, Scott Evans

J Biopharm Stat· November 2017

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G
Generalized linear mixed models for multi-reader multi-case studies of diagnostic tests.
Wei Liu, Norberto Pantoja-Galicia, Bo Zhang, Richard M Kotz, Gene Pennello

Stat Methods Med Res· June 2017

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B
Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).
Scott R Evans, Gene Pennello, Norberto Pantoja-Galicia, Hongyu Jiang, Andrea M Hujer

Clin Infect Dis· September 2016

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Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory Experience.
Rong Tang, Gene Pennello

Ther Innov Regul Sci· March 2016

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D
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).
Scott R Evans, Daniel Rubin, Dean Follmann, Gene Pennello, W Charles Huskins

Clin Infect Dis· September 2015

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Q
Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.
Nancy A Obuchowski, Anthony P Reeves, Erich P Huang, Xiao-Feng Wang, Andrew J Buckler, Gene Pennello

Stat Methods Med Res· February 2015

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Q
Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.
David L Raunig, Lisa M McShane, Gene Pennello, Constantine Gatsonis, Paul L Carson

Stat Methods Med Res· February 2015

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