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Jayashree Kalpathy-Cramer

Publications and source records attributed to Jayashree Kalpathy-Cramer.

At least 19 recordsLinked to original sources

Environment Scan of Generative AI Infrastructure for Clinical and Translational Science

This study reports a comprehensive environmental scan of the generative AI (GenAI) infrastructure in the national network for clinical and translational science across 36 institutions supported by the Clinical and Translational Science Award (CTSA) Program led by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) at the United States. With the rapid advancement of GenAI technologies, including large language models (LLMs), healthcare institutions face unprecedented opportunities and challenges. This research explores the current status of GenAI integration, focusing on stakeholder roles, governance structures, and ethical considerations by administering a survey among leaders of health institutions (i.e., representing academic medical centers and health systems) to assess the institutional readiness and approach towards GenAI adoption. Key findings indicate a diverse range of institutional strategies, with most organizations in the experimental phase of GenAI deployment. The study highlights significant variations in governance models, with a strong preference for centralized decision-making but notable gaps in workforce training and ethical oversight. Moreover, the results underscore the need for a more coordinated approach to GenAI governance, emphasizing collaboration among senior leaders, clinicians, information technology staff, and researchers. Our analysis also reveals concerns regarding GenAI bias, data security, and stakeholder trust, which must be addressed to ensure the ethical and effective implementation of GenAI technologies. This study offers valuable insights into the challenges and opportunities of GenAI integration in healthcare, providing a roadmap for institutions aiming to leverage GenAI for improved quality of care and operational efficiency.

cs.CY

Fair Evaluation of Federated Learning Algorithms for Automated Breast Density Classification: The Results of the 2022 ACR-NCI-NVIDIA Federated Learning Challenge

The correct interpretation of breast density is important in the assessment of breast cancer risk. AI has been shown capable of accurately predicting breast density, however, due to the differences in imaging characteristics across mammography systems, models built using data from one system do not generalize well to other systems. Though federated learning (FL) has emerged as a way to improve the generalizability of AI without the need to share data, the best way to preserve features from all training data during FL is an active area of research. To explore FL methodology, the breast density classification FL challenge was hosted in partnership with the American College of Radiology, Harvard Medical School's Mass General Brigham, University of Colorado, NVIDIA, and the National Institutes of Health National Cancer Institute. Challenge participants were able to submit docker containers capable of implementing FL on three simulated medical facilities, each containing a unique large mammography dataset. The breast density FL challenge ran from June 15 to September 5, 2022, attracting seven finalists from around the world. The winning FL submission reached a linear kappa score of 0.653 on the challenge test data and 0.413 on an external testing dataset, scoring comparably to a model trained on the same data in a central location.

eess.IV

Reproducible Benchmarking for Lung Nodule Detection and Malignancy Classification Across Multiple Low-Dose CT Datasets

Evaluation of artificial intelligence (AI) models for low-dose CT lung cancer screening is limited by heterogeneous datasets, annotation standards, and evaluation protocols, making performance difficult to compare and translate across clinical settings. We establish a public, reproducible multi-dataset benchmark for lung nodule detection and nodule-level cancer classification and quantify cross-dataset generalizability. Using the Duke Lung Cancer Screening (DLCS) dataset as a clinically curated development set, we evaluate performance across LUNA16/LIDC-IDRI, NLST-3D, and LUNA25. Detection models trained on DLCS and LUNA16 were evaluated externally on NLST-3D using free-response ROC analysis. For malignancy classification, we compared five strategies: randomly initialized ResNet50, Models Genesis, Med3D, a Foundation Model for Cancer Biomarkers, and a Strategic Warm-Start (ResNet50-SWS) approach pretrained using detection-derived candidate patches stratified by confidence. Performance was summarized using AUC with 95% confidence intervals and DeLong tests. Detection performance varied substantially by training dataset, with DLCS-trained models outperforming LUNA16-trained models on external NLST-3D evaluation (sensitivity at 2 false positives per scan: 0.72 vs. 0.64; p < 0.001). For malignancy classification, ResNet50-SWS achieved AUCs of 0.71 (DLCS), 0.90 (LUNA16), 0.81 (NLST-3D), and 0.80 (LUNA25), consistently matching or exceeding alternative pretraining strategies. These results demonstrate that dataset characteristics strongly influence lung cancer AI performance and highlight the need for transparent, multi-dataset benchmarking.

cs.CV

Deep Learning-based Prediction of Breast Cancer Tumor and Immune Phenotypes from Histopathology

The interactions between tumor cells and the tumor microenvironment (TME) dictate therapeutic efficacy of radiation and many systemic therapies in breast cancer. However, to date, there is not a widely available method to reproducibly measure tumor and immune phenotypes for each patient's tumor. Given this unmet clinical need, we applied multiple instance learning (MIL) algorithms to assess activity of ten biologically relevant pathways from the hematoxylin and eosin (H&E) slide of primary breast tumors. We employed different feature extraction approaches and state-of-the-art model architectures. Using binary classification, our models attained area under the receiver operating characteristic (AUROC) scores above 0.70 for nearly all gene expression pathways and on some cases, exceeded 0.80. Attention maps suggest that our trained models recognize biologically relevant spatial patterns of cell sub-populations from H&E. These efforts represent a first step towards developing computational H&E biomarkers that reflect facets of the TME and hold promise for augmenting precision oncology.

eess.IV

Patient-specific, mechanistic models of tumor growth incorporating artificial intelligence and big data

Despite the remarkable advances in cancer diagnosis, treatment, and management that have occurred over the past decade, malignant tumors remain a major public health problem. Further progress in combating cancer may be enabled by personalizing the delivery of therapies according to the predicted response for each individual patient. The design of personalized therapies requires patient-specific information integrated into an appropriate mathematical model of tumor response. A fundamental barrier to realizing this paradigm is the current lack of a rigorous, yet practical, mathematical theory of tumor initiation, development, invasion, and response to therapy. In this review, we begin by providing an overview of different approaches to modeling tumor growth and treatment, including mechanistic as well as data-driven models based on ``big data" and artificial intelligence. Next, we present illustrative examples of mathematical models manifesting their utility and discussing the limitations of stand-alone mechanistic and data-driven models. We further discuss the potential of mechanistic models for not only predicting, but also optimizing response to therapy on a patient-specific basis. We then discuss current efforts and future possibilities to integrate mechanistic and data-driven models. We conclude by proposing five fundamental challenges that must be addressed to fully realize personalized care for cancer patients driven by computational models.

physics.med-ph

FUTURE-AI: International consensus guideline for trustworthy and deployable artificial intelligence in healthcare

Despite major advances in artificial intelligence (AI) for medicine and healthcare, the deployment and adoption of AI technologies remain limited in real-world clinical practice. In recent years, concerns have been raised about the technical, clinical, ethical and legal risks associated with medical AI. To increase real world adoption, it is essential that medical AI tools are trusted and accepted by patients, clinicians, health organisations and authorities. This work describes the FUTURE-AI guideline as the first international consensus framework for guiding the development and deployment of trustworthy AI tools in healthcare. The FUTURE-AI consortium was founded in 2021 and currently comprises 118 inter-disciplinary experts from 51 countries representing all continents, including AI scientists, clinicians, ethicists, and social scientists. Over a two-year period, the consortium defined guiding principles and best practices for trustworthy AI through an iterative process comprising an in-depth literature review, a modified Delphi survey, and online consensus meetings. The FUTURE-AI framework was established based on 6 guiding principles for trustworthy AI in healthcare, i.e. Fairness, Universality, Traceability, Usability, Robustness and Explainability. Through consensus, a set of 28 best practices were defined, addressing technical, clinical, legal and socio-ethical dimensions. The recommendations cover the entire lifecycle of medical AI, from design, development and validation to regulation, deployment, and monitoring. FUTURE-AI is a risk-informed, assumption-free guideline which provides a structured approach for constructing medical AI tools that will be trusted, deployed and adopted in real-world practice. Researchers are encouraged to take the recommendations into account in proof-of-concept stages to facilitate future translation towards clinical practice of medical AI.

cs.CY

Deploying clinical machine learning? Consider the following...

Despite the intense attention and considerable investment into clinical machine learning research, relatively few applications have been deployed at a large-scale in a real-world clinical environment. While research is important in advancing the state-of-the-art, translation is equally important in bringing these techniques and technologies into a position to ultimately impact healthcare. We believe a lack of appreciation for several considerations are a major cause for this discrepancy between expectation and reality. To better characterize a holistic perspective among researchers and practitioners, we survey several practitioners with commercial experience in developing CML for clinical deployment. Using these insights, we identify several main categories of challenges in order to better design and develop clinical machine learning applications.

cs.LG

A generalized framework to predict continuous scores from medical ordinal labels

Many variables of interest in clinical medicine, like disease severity, are recorded using discrete ordinal categories such as normal/mild/moderate/severe. These labels are used to train and evaluate disease severity prediction models. However, ordinal categories represent a simplification of an underlying continuous severity spectrum. Using continuous scores instead of ordinal categories is more sensitive to detecting small changes in disease severity over time. Here, we present a generalized framework that accurately predicts continuously valued variables using only discrete ordinal labels during model development. We found that for three clinical prediction tasks, models that take the ordinal relationship of the training labels into account outperformed conventional multi-class classification models. Particularly the continuous scores generated by ordinal classification and regression models showed a significantly higher correlation with expert rankings of disease severity and lower mean squared errors compared to the multi-class classification models. Furthermore, the use of MC dropout significantly improved the ability of all evaluated deep learning approaches to predict continuously valued scores that truthfully reflect the underlying continuous target variable. We showed that accurate continuously valued predictions can be generated even if the model development only involves discrete ordinal labels. The novel framework has been validated on three different clinical prediction tasks and has proven to bridge the gap between discrete ordinal labels and the underlying continuously valued variables.

eess.IV

Longitudinal assessment of demographic representativeness in the Medical Imaging and Data Resource Center Open Data Commons

Purpose: The Medical Imaging and Data Resource Center (MIDRC) open data commons was launched to accelerate the development of artificial intelligence (AI) algorithms to help address the COVID-19 pandemic. The purpose of this study was to quantify longitudinal representativeness of the demographic characteristics of the primary imaging dataset compared to the United States general population (US Census) and COVID-19 positive case counts from the Centers for Disease Control and Prevention (CDC). Approach: The Jensen Shannon distance (JSD) was used to longitudinally measure the similarity of the distribution of (1) all unique patients in the MIDRC data to the 2020 US Census and (2) all unique COVID-19 positive patients in the MIDRC data to the case counts reported by the CDC. The distributions were evaluated in the demographic categories of age at index, sex, race, ethnicity, and the intersection of race and ethnicity. Results: Representativeness the MIDRC data by ethnicity and the intersection of race and ethnicity was impacted by the percentage of CDC case counts for which data in these categories is not reported. The distributions by sex and race have retained their level of representativeness over time. Conclusion: The representativeness of the open medical imaging datasets in the curated public data commons at MIDRC has evolved over time as both the number of contributing institutions and overall number of subjects has grown. The use of metrics such as the JSD support measurement of representativeness, one step needed for fair and generalizable AI algorithm development.

physics.med-ph

MONAI: An open-source framework for deep learning in healthcare

Artificial Intelligence (AI) is having a tremendous impact across most areas of science. Applications of AI in healthcare have the potential to improve our ability to detect, diagnose, prognose, and intervene on human disease. For AI models to be used clinically, they need to be made safe, reproducible and robust, and the underlying software framework must be aware of the particularities (e.g. geometry, physiology, physics) of medical data being processed. This work introduces MONAI, a freely available, community-supported, and consortium-led PyTorch-based framework for deep learning in healthcare. MONAI extends PyTorch to support medical data, with a particular focus on imaging, and provide purpose-specific AI model architectures, transformations and utilities that streamline the development and deployment of medical AI models. MONAI follows best practices for software-development, providing an easy-to-use, robust, well-documented, and well-tested software framework. MONAI preserves the simple, additive, and compositional approach of its underlying PyTorch libraries. MONAI is being used by and receiving contributions from research, clinical and industrial teams from around the world, who are pursuing applications spanning nearly every aspect of healthcare.

cs.LG

Towards More Efficient Data Valuation in Healthcare Federated Learning using Ensembling

Federated Learning (FL) wherein multiple institutions collaboratively train a machine learning model without sharing data is becoming popular. Participating institutions might not contribute equally, some contribute more data, some better quality data or some more diverse data. To fairly rank the contribution of different institutions, Shapley value (SV) has emerged as the method of choice. Exact SV computation is impossibly expensive, especially when there are hundreds of contributors. Existing SV computation techniques use approximations. However, in healthcare where the number of contributing institutions are likely not of a colossal scale, computing exact SVs is still exorbitantly expensive, but not impossible. For such settings, we propose an efficient SV computation technique called SaFE (Shapley Value for Federated Learning using Ensembling). We empirically show that SaFE computes values that are close to exact SVs, and that it performs better than current SV approximations. This is particularly relevant in medical imaging setting where widespread heterogeneity across institutions is rampant and fast accurate data valuation is required to determine the contribution of each participant in multi-institutional collaborative learning.

cs.LG

QU-BraTS: MICCAI BraTS 2020 Challenge on Quantifying Uncertainty in Brain Tumor Segmentation - Analysis of Ranking Scores and Benchmarking Results

Deep learning (DL) models have provided state-of-the-art performance in various medical imaging benchmarking challenges, including the Brain Tumor Segmentation (BraTS) challenges. However, the task of focal pathology multi-compartment segmentation (e.g., tumor and lesion sub-regions) is particularly challenging, and potential errors hinder translating DL models into clinical workflows. Quantifying the reliability of DL model predictions in the form of uncertainties could enable clinical review of the most uncertain regions, thereby building trust and paving the way toward clinical translation. Several uncertainty estimation methods have recently been introduced for DL medical image segmentation tasks. Developing scores to evaluate and compare the performance of uncertainty measures will assist the end-user in making more informed decisions. In this study, we explore and evaluate a score developed during the BraTS 2019 and BraTS 2020 task on uncertainty quantification (QU-BraTS) and designed to assess and rank uncertainty estimates for brain tumor multi-compartment segmentation. This score (1) rewards uncertainty estimates that produce high confidence in correct assertions and those that assign low confidence levels at incorrect assertions, and (2) penalizes uncertainty measures that lead to a higher percentage of under-confident correct assertions. We further benchmark the segmentation uncertainties generated by 14 independent participating teams of QU-BraTS 2020, all of which also participated in the main BraTS segmentation task. Overall, our findings confirm the importance and complementary value that uncertainty estimates provide to segmentation algorithms, highlighting the need for uncertainty quantification in medical image analyses. Finally, in favor of transparency and reproducibility, our evaluation code is made publicly available at: https://github.com/RagMeh11/QU-BraTS.

eess.IV

Estimating Test Performance for AI Medical Devices under Distribution Shift with Conformal Prediction

Estimating the test performance of software AI-based medical devices under distribution shifts is crucial for evaluating the safety, efficiency, and usability prior to clinical deployment. Due to the nature of regulated medical device software and the difficulty in acquiring large amounts of labeled medical datasets, we consider the task of predicting the test accuracy of an arbitrary black-box model on an unlabeled target domain without modification to the original training process or any distributional assumptions of the original source data (i.e. we treat the model as a "black-box" and only use the predicted output responses). We propose a "black-box" test estimation technique based on conformal prediction and evaluate it against other methods on three medical imaging datasets (mammography, dermatology, and histopathology) under several clinically relevant types of distribution shift (institution, hardware scanner, atlas, hospital). We hope that by promoting practical and effective estimation techniques for black-box models, manufacturers of medical devices will develop more standardized and realistic evaluation procedures to improve the robustness and trustworthiness of clinical AI tools.

cs.LG

Three Applications of Conformal Prediction for Rating Breast Density in Mammography

Breast cancer is the most common cancers and early detection from mammography screening is crucial in improving patient outcomes. Assessing mammographic breast density is clinically important as the denser breasts have higher risk and are more likely to occlude tumors. Manual assessment by experts is both time-consuming and subject to inter-rater variability. As such, there has been increased interest in the development of deep learning methods for mammographic breast density assessment. Despite deep learning having demonstrated impressive performance in several prediction tasks for applications in mammography, clinical deployment of deep learning systems in still relatively rare; historically, mammography Computer-Aided Diagnoses (CAD) have over-promised and failed to deliver. This is in part due to the inability to intuitively quantify uncertainty of the algorithm for the clinician, which would greatly enhance usability. Conformal prediction is well suited to increase reliably and trust in deep learning tools but they lack realistic evaluations on medical datasets. In this paper, we present a detailed analysis of three possible applications of conformal prediction applied to medical imaging tasks: distribution shift characterization, prediction quality improvement, and subgroup fairness analysis. Our results show the potential of distribution-free uncertainty quantification techniques to enhance trust on AI algorithms and expedite their translation to usage.

eess.IV

Highdicom: A Python library for standardized encoding of image annotations and machine learning model outputs in pathology and radiology

Machine learning is revolutionizing image-based diagnostics in pathology and radiology. ML models have shown promising results in research settings, but their lack of interoperability has been a major barrier for clinical integration and evaluation. The DICOM a standard specifies Information Object Definitions and Services for the representation and communication of digital images and related information, including image-derived annotations and analysis results. However, the complexity of the standard represents an obstacle for its adoption in the ML community and creates a need for software libraries and tools that simplify working with data sets in DICOM format. Here we present the highdicom library, which provides a high-level application programming interface for the Python programming language that abstracts low-level details of the standard and enables encoding and decoding of image-derived information in DICOM format in a few lines of Python code. The highdicom library ties into the extensive Python ecosystem for image processing and machine learning. Simultaneously, by simplifying creation and parsing of DICOM-compliant files, highdicom achieves interoperability with the medical imaging systems that hold the data used to train and run ML models, and ultimately communicate and store model outputs for clinical use. We demonstrate through experiments with slide microscopy and computed tomography imaging, that, by bridging these two ecosystems, highdicom enables developers to train and evaluate state-of-the-art ML models in pathology and radiology while remaining compliant with the DICOM standard and interoperable with clinical systems at all stages. To promote standardization of ML research and streamline the ML model development and deployment process, we made the library available free and open-source.

eess.IV

Fair Conformal Predictors for Applications in Medical Imaging

Deep learning has the potential to automate many clinically useful tasks in medical imaging. However translation of deep learning into clinical practice has been hindered by issues such as lack of the transparency and interpretability in these "black box" algorithms compared to traditional statistical methods. Specifically, many clinical deep learning models lack rigorous and robust techniques for conveying certainty (or lack thereof) in their predictions -- ultimately limiting their appeal for extensive use in medical decision-making. Furthermore, numerous demonstrations of algorithmic bias have increased hesitancy towards deployment of deep learning for clinical applications. To this end, we explore how conformal predictions can complement existing deep learning approaches by providing an intuitive way of expressing uncertainty while facilitating greater transparency to clinical users. In this paper, we conduct field interviews with radiologists to assess possible use-cases for conformal predictors. Using insights gathered from these interviews, we devise two clinical use-cases and empirically evaluate several methods of conformal predictions on a dermatology photography dataset for skin lesion classification. We show how to modify conformal predictions to be more adaptive to subgroup differences in patient skin tones through equalized coverage. Finally, we compare conformal prediction against measures of epistemic uncertainty.

eess.IV

SplitAVG: A heterogeneity-aware federated deep learning method for medical imaging

Federated learning is an emerging research paradigm for enabling collaboratively training deep learning models without sharing patient data. However, the data from different institutions are usually heterogeneous across institutions, which may reduce the performance of models trained using federated learning. In this study, we propose a novel heterogeneity-aware federated learning method, SplitAVG, to overcome the performance drops from data heterogeneity in federated learning. Unlike previous federated methods that require complex heuristic training or hyper parameter tuning, our SplitAVG leverages the simple network split and feature map concatenation strategies to encourage the federated model training an unbiased estimator of the target data distribution. We compare SplitAVG with seven state-of-the-art federated learning methods, using centrally hosted training data as the baseline on a suite of both synthetic and real-world federated datasets. We find that the performance of models trained using all the comparison federated learning methods degraded significantly with the increasing degrees of data heterogeneity. In contrast, SplitAVG method achieves comparable results to the baseline method under all heterogeneous settings, that it achieves 96.2% of the accuracy and 110.4% of the mean absolute error obtained by the baseline in a diabetic retinopathy binary classification dataset and a bone age prediction dataset, respectively, on highly heterogeneous data partitions. We conclude that SplitAVG method can effectively overcome the performance drops from variability in data distributions across institutions. Experimental results also show that SplitAVG can be adapted to different base networks and generalized to various types of medical imaging tasks.

cs.LG

Improving the repeatability of deep learning models with Monte Carlo dropout

The integration of artificial intelligence into clinical workflows requires reliable and robust models. Repeatability is a key attribute of model robustness. Repeatable models output predictions with low variation during independent tests carried out under similar conditions. During model development and evaluation, much attention is given to classification performance while model repeatability is rarely assessed, leading to the development of models that are unusable in clinical practice. In this work, we evaluate the repeatability of four model types (binary classification, multi-class classification, ordinal classification, and regression) on images that were acquired from the same patient during the same visit. We study the performance of binary, multi-class, ordinal, and regression models on four medical image classification tasks from public and private datasets: knee osteoarthritis, cervical cancer screening, breast density estimation, and retinopathy of prematurity. Repeatability is measured and compared on ResNet and DenseNet architectures. Moreover, we assess the impact of sampling Monte Carlo dropout predictions at test time on classification performance and repeatability. Leveraging Monte Carlo predictions significantly increased repeatability for all tasks on the binary, multi-class, and ordinal models leading to an average reduction of the 95\% limits of agreement by 16% points and of the disagreement rate by 7% points. The classification accuracy improved in most settings along with the repeatability. Our results suggest that beyond about 20 Monte Carlo iterations, there is no further gain in repeatability. In addition to the higher test-retest agreement, Monte Carlo predictions were better calibrated which leads to output probabilities reflecting more accurately the true likelihood of being correctly classified.

eess.IV