Predictive automation is a pervasive and archetypical example of the digital economy. Studying how Americans evaluate predictive automation is important because it affects corporate and state governance. However, we have relevant questions unanswered. We lack comparisons across use cases using a nationally representative sample. We also have yet to determine what are the key predictors of evaluations of predictive automation. This article uses the American Trends Panel’s 2018 wave ($n=4,594$) to study whether American adults think predictive automation is fair across four use cases: helping credit decisions, assisting parole decisions, filtering job applicants based on interview videos, and assessing job candidates based on resumes. Results from lasso regressions trained with 112 predictors reveal that people’s evaluations of predictive automation align with their views about social media, technology, and politics.
{"title":"Do Americans Think the Digital Economy is Fair? Using Supervised Learning to Explore Evaluations of Predictive Automation","authors":"E. Lehoucq","doi":"10.6339/22-jds1053","DOIUrl":"https://doi.org/10.6339/22-jds1053","url":null,"abstract":"Predictive automation is a pervasive and archetypical example of the digital economy. Studying how Americans evaluate predictive automation is important because it affects corporate and state governance. However, we have relevant questions unanswered. We lack comparisons across use cases using a nationally representative sample. We also have yet to determine what are the key predictors of evaluations of predictive automation. This article uses the American Trends Panel’s 2018 wave ($n=4,594$) to study whether American adults think predictive automation is fair across four use cases: helping credit decisions, assisting parole decisions, filtering job applicants based on interview videos, and assessing job candidates based on resumes. Results from lasso regressions trained with 112 predictors reveal that people’s evaluations of predictive automation align with their views about social media, technology, and politics.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spatio-temporal filtering is a common and challenging task in many environmental applications, where the evolution is often nonlinear and the dimension of the spatial state may be very high. We propose a scalable filtering approach based on a hierarchical sparse Cholesky representation of the filtering covariance matrix. At each time point, we compress the sparse Cholesky factor into a dense matrix with a small number of columns. After applying the evolution to each of these columns, we decompress to obtain a hierarchical sparse Cholesky factor of the forecast covariance, which can then be updated based on newly available data. We illustrate the Cholesky evolution via an equivalent representation in terms of spatial basis functions. We also demonstrate the advantage of our method in numerical comparisons, including using a high-dimensional and nonlinear Lorenz model.
{"title":"High-Dimensional Nonlinear Spatio-Temporal Filtering by Compressing Hierarchical Sparse Cholesky Factors","authors":"Anirban Chakraborty, M. Katzfuss","doi":"10.6339/22-jds1071","DOIUrl":"https://doi.org/10.6339/22-jds1071","url":null,"abstract":"Spatio-temporal filtering is a common and challenging task in many environmental applications, where the evolution is often nonlinear and the dimension of the spatial state may be very high. We propose a scalable filtering approach based on a hierarchical sparse Cholesky representation of the filtering covariance matrix. At each time point, we compress the sparse Cholesky factor into a dense matrix with a small number of columns. After applying the evolution to each of these columns, we decompress to obtain a hierarchical sparse Cholesky factor of the forecast covariance, which can then be updated based on newly available data. We illustrate the Cholesky evolution via an equivalent representation in terms of spatial basis functions. We also demonstrate the advantage of our method in numerical comparisons, including using a high-dimensional and nonlinear Lorenz model.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The article presents a methodology for supervised regionalization of data on a spatial domain. Defining a spatial process at multiple scales leads to the famous ecological fallacy problem. Here, we use the ecological fallacy as the basis for a minimization criterion to obtain the intended regions. The Karhunen-Loève Expansion of the spatial process maintains the relationship between the realizations from multiple resolutions. Specifically, we use the Karhunen-Loève Expansion to define the regionalization error so that the ecological fallacy is minimized. The contiguous regionalization is done using the minimum spanning tree formed from the spatial locations and the data. Then, regionalization becomes similar to pruning edges from the minimum spanning tree. The methodology is demonstrated using simulated and real data examples.
{"title":"Supervised Spatial Regionalization using the Karhunen-Loève Expansion and Minimum Spanning Trees","authors":"Ranadeep Daw, C. Wikle","doi":"10.6339/22-jds1077","DOIUrl":"https://doi.org/10.6339/22-jds1077","url":null,"abstract":"The article presents a methodology for supervised regionalization of data on a spatial domain. Defining a spatial process at multiple scales leads to the famous ecological fallacy problem. Here, we use the ecological fallacy as the basis for a minimization criterion to obtain the intended regions. The Karhunen-Loève Expansion of the spatial process maintains the relationship between the realizations from multiple resolutions. Specifically, we use the Karhunen-Loève Expansion to define the regionalization error so that the ecological fallacy is minimized. The contiguous regionalization is done using the minimum spanning tree formed from the spatial locations and the data. Then, regionalization becomes similar to pruning edges from the minimum spanning tree. The methodology is demonstrated using simulated and real data examples.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Skyler Gray, Matthew J. Heaton, D. Bolintineanu, A. Olson
For spatial kriging (prediction), the Gaussian process (GP) has been the go-to tool of spatial statisticians for decades. However, the GP is plagued by computational intractability, rendering it infeasible for use on large spatial data sets. Neural networks (NNs), on the other hand, have arisen as a flexible and computationally feasible approach for capturing nonlinear relationships. To date, however, NNs have only been scarcely used for problems in spatial statistics but their use is beginning to take root. In this work, we argue for equivalence between a NN and a GP and demonstrate how to implement NNs for kriging from large spatial data. We compare the computational efficacy and predictive power of NNs with that of GP approximations across a variety of big spatial Gaussian, non-Gaussian and binary data applications of up to size $n={10^{6}}$. Our results suggest that fully-connected NNs perform similarly to state-of-the-art, GP-approximated models for short-range predictions but can suffer for longer range predictions.
{"title":"On the Use of Deep Neural Networks for Large-Scale Spatial Prediction","authors":"Skyler Gray, Matthew J. Heaton, D. Bolintineanu, A. Olson","doi":"10.6339/22-jds1070","DOIUrl":"https://doi.org/10.6339/22-jds1070","url":null,"abstract":"For spatial kriging (prediction), the Gaussian process (GP) has been the go-to tool of spatial statisticians for decades. However, the GP is plagued by computational intractability, rendering it infeasible for use on large spatial data sets. Neural networks (NNs), on the other hand, have arisen as a flexible and computationally feasible approach for capturing nonlinear relationships. To date, however, NNs have only been scarcely used for problems in spatial statistics but their use is beginning to take root. In this work, we argue for equivalence between a NN and a GP and demonstrate how to implement NNs for kriging from large spatial data. We compare the computational efficacy and predictive power of NNs with that of GP approximations across a variety of big spatial Gaussian, non-Gaussian and binary data applications of up to size $n={10^{6}}$. Our results suggest that fully-connected NNs perform similarly to state-of-the-art, GP-approximated models for short-range predictions but can suffer for longer range predictions.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Social determinants of health (SDOH) are the conditions in which people are born, grow, work, and live. Although evidence suggests that SDOH influence a range of health outcomes, health systems lack the infrastructure to access and act upon this information. The purpose of this manuscript is to explain the methodology that a health system used to: 1) identify and integrate publicly available SDOH data into the health systems’ Data Warehouse, 2) integrate a HIPAA compliant geocoding software (via DeGAUSS), and 3) visualize data to inform SDOH projects (via Tableau). First, authors engaged key stakeholders across the health system to convey the implications of SDOH data for our patient population and identify variables of interest. As a result, fourteen publicly available data sets, accounting for >30,800 variables representing national, state, county, and census tract information over 2016–2019, were cleaned and integrated into our Data Warehouse. To pilot the data visualization, we created county and census tract level maps for our service areas and plotted common SDOH metrics (e.g., income, education, insurance status, etc.). This practical, methodological integration of SDOH data at a large health system demonstrated feasibility. Ultimately, we will repeat this process system wide to further understand the risk burden in our patient population and improve our prediction models – allowing us to become better partners with our community.
{"title":"Integration of Social Determinants of Health Data into the Largest, Not-for-Profit Health System in South Florida","authors":"Lourdes M. Rojas, Gregory L. Vincent, D. Parris","doi":"10.6339/22-jds1063","DOIUrl":"https://doi.org/10.6339/22-jds1063","url":null,"abstract":"Social determinants of health (SDOH) are the conditions in which people are born, grow, work, and live. Although evidence suggests that SDOH influence a range of health outcomes, health systems lack the infrastructure to access and act upon this information. The purpose of this manuscript is to explain the methodology that a health system used to: 1) identify and integrate publicly available SDOH data into the health systems’ Data Warehouse, 2) integrate a HIPAA compliant geocoding software (via DeGAUSS), and 3) visualize data to inform SDOH projects (via Tableau). First, authors engaged key stakeholders across the health system to convey the implications of SDOH data for our patient population and identify variables of interest. As a result, fourteen publicly available data sets, accounting for >30,800 variables representing national, state, county, and census tract information over 2016–2019, were cleaned and integrated into our Data Warehouse. To pilot the data visualization, we created county and census tract level maps for our service areas and plotted common SDOH metrics (e.g., income, education, insurance status, etc.). This practical, methodological integration of SDOH data at a large health system demonstrated feasibility. Ultimately, we will repeat this process system wide to further understand the risk burden in our patient population and improve our prediction models – allowing us to become better partners with our community.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical risk prediction models are commonly developed in a post-hoc and passive fashion, capitalizing on convenient data from completed clinical trials or retrospective cohorts. Impacts of the models often end at their publication rather than with the patients. The field of clinical risk prediction is rapidly improving in a progressively more transparent data science era. Based on collective experience over the past decade by the Prostate Biopsy Collaborative Group (PBCG), this paper proposes the following four data science-driven strategies for improving clinical risk prediction to the benefit of clinical practice and research. The first proposed strategy is to actively design prospective data collection, monitoring, analysis and validation of risk tools following the same standards as for clinical trials in order to elevate the quality of training data. The second suggestion is to make risk tools and model formulas available online. User-friendly risk tools will bring quantitative information to patients and their clinicians for improved knowledge-based decision-making. As past experience testifies, online tools expedite independent validation, providing helpful information as to whether the tools are generalizable to new populations. The third proposal is to dynamically update and localize risk tools to adapt to changing demographic and clinical landscapes. The fourth strategy is to accommodate systematic missing data patterns across cohorts in order to maximize the statistical power in model training, as well as to accommodate missing information on the end-user side too, in order to maximize utility for the public.
{"title":"Active Data Science for Improving Clinical Risk Prediction","authors":"D. Ankerst, Matthias Neumair","doi":"10.6339/22-jds1078","DOIUrl":"https://doi.org/10.6339/22-jds1078","url":null,"abstract":"Clinical risk prediction models are commonly developed in a post-hoc and passive fashion, capitalizing on convenient data from completed clinical trials or retrospective cohorts. Impacts of the models often end at their publication rather than with the patients. The field of clinical risk prediction is rapidly improving in a progressively more transparent data science era. Based on collective experience over the past decade by the Prostate Biopsy Collaborative Group (PBCG), this paper proposes the following four data science-driven strategies for improving clinical risk prediction to the benefit of clinical practice and research. The first proposed strategy is to actively design prospective data collection, monitoring, analysis and validation of risk tools following the same standards as for clinical trials in order to elevate the quality of training data. The second suggestion is to make risk tools and model formulas available online. User-friendly risk tools will bring quantitative information to patients and their clinicians for improved knowledge-based decision-making. As past experience testifies, online tools expedite independent validation, providing helpful information as to whether the tools are generalizable to new populations. The third proposal is to dynamically update and localize risk tools to adapt to changing demographic and clinical landscapes. The fourth strategy is to accommodate systematic missing data patterns across cohorts in order to maximize the statistical power in model training, as well as to accommodate missing information on the end-user side too, in order to maximize utility for the public.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daeyoung Lim, Ming-Hui Chen, N. Ravishanker, Mark Bolduc, Brian McKeon, Stanley Nolan
The complexity of energy infrastructure at large institutions increasingly calls for data-driven monitoring of energy usage. This article presents a hybrid monitoring algorithm for detecting consumption surges using statistical hypothesis testing, leveraging the posterior distribution and its information about uncertainty to introduce randomness in the parameter estimates, while retaining the frequentist testing framework. This hybrid approach is designed to be asymptotically equivalent to the Neyman-Pearson test. We show via extensive simulation studies that the hybrid approach enjoys control over type-1 error rate even with finite sample sizes whereas the naive plug-in method tends to exceed the specified level, resulting in overpowered tests. The proposed method is applied to the natural gas usage data at the University of Connecticut.
{"title":"A Hybrid Monitoring Procedure for Detecting Abnormality with Application to Energy Consumption Data","authors":"Daeyoung Lim, Ming-Hui Chen, N. Ravishanker, Mark Bolduc, Brian McKeon, Stanley Nolan","doi":"10.6339/22-jds1039","DOIUrl":"https://doi.org/10.6339/22-jds1039","url":null,"abstract":"The complexity of energy infrastructure at large institutions increasingly calls for data-driven monitoring of energy usage. This article presents a hybrid monitoring algorithm for detecting consumption surges using statistical hypothesis testing, leveraging the posterior distribution and its information about uncertainty to introduce randomness in the parameter estimates, while retaining the frequentist testing framework. This hybrid approach is designed to be asymptotically equivalent to the Neyman-Pearson test. We show via extensive simulation studies that the hybrid approach enjoys control over type-1 error rate even with finite sample sizes whereas the naive plug-in method tends to exceed the specified level, resulting in overpowered tests. The proposed method is applied to the natural gas usage data at the University of Connecticut.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Many undergraduate students who matriculated in Science, Technology, Engineering and Mathematics (STEM) degree programs drop out or switch their major. Previous studies indicate that performance of students in prerequisite courses is important for attrition of students in STEM. This study analyzed demographic information, ACT/SAT score, and performance of students in freshman year courses to develop machine learning models predicting their success in earning a bachelor’s degree in biology. The predictive model based on Random Forest (RF) and Extreme Gradient Boosting (XGBoost) showed a better performance in terms of AUC (Area Under the Curve) with more balanced sensitivity and specificity than Logistic Regression (LR), K-Nearest Neighbor (KNN), and Neural Network (NN) models. An explainable machine learning approach called break-down was employed to identify important freshman year courses that could have a larger impact on student success at the biology degree program and student levels. More important courses identified at the program level can help program coordinators to prioritize their effort in addressing student attrition while more important courses identified at the student level can help academic advisors to provide more personalized, data-driven guidance to students.
{"title":"Identifying Prerequisite Courses in Undergraduate Biology Using Machine Learning","authors":"Youngjin Lee","doi":"10.6339/22-jds1068","DOIUrl":"https://doi.org/10.6339/22-jds1068","url":null,"abstract":"Many undergraduate students who matriculated in Science, Technology, Engineering and Mathematics (STEM) degree programs drop out or switch their major. Previous studies indicate that performance of students in prerequisite courses is important for attrition of students in STEM. This study analyzed demographic information, ACT/SAT score, and performance of students in freshman year courses to develop machine learning models predicting their success in earning a bachelor’s degree in biology. The predictive model based on Random Forest (RF) and Extreme Gradient Boosting (XGBoost) showed a better performance in terms of AUC (Area Under the Curve) with more balanced sensitivity and specificity than Logistic Regression (LR), K-Nearest Neighbor (KNN), and Neural Network (NN) models. An explainable machine learning approach called break-down was employed to identify important freshman year courses that could have a larger impact on student success at the biology degree program and student levels. More important courses identified at the program level can help program coordinators to prioritize their effort in addressing student attrition while more important courses identified at the student level can help academic advisors to provide more personalized, data-driven guidance to students.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"491 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
How do statistical regression results compare to intuitive, visually fitted results? Fitting lines by eye through a set of points has been explored since the 20th century. Common methods of fitting trends by eye involve maneuvering a string, black thread, or ruler until the fit is suitable, then drawing the line through the set of points. In 2015, the New York Times introduced an interactive feature, called ‘You Draw It,’ where readers are asked to input their own assumptions about various metrics and compare how these assumptions relate to reality. This research is intended to implement ‘You Draw It’, adapted from the New York Times, as a way to measure the patterns we see in data. In this paper, we describe the adaptation of an old tool for graphical testing and evaluation, eye-fitting, for use in modern web-applications suitable for testing statistical graphics. We present an empirical evaluation of this testing method for linear regression, and briefly discuss an extension of this method to non-linear applications.
{"title":"‘You Draw It’: Implementation of Visually Fitted Trends with r2d3","authors":"Emily A. Robinson, Réka Howard, Susan Vanderplas","doi":"10.6339/22-jds1083","DOIUrl":"https://doi.org/10.6339/22-jds1083","url":null,"abstract":"How do statistical regression results compare to intuitive, visually fitted results? Fitting lines by eye through a set of points has been explored since the 20th century. Common methods of fitting trends by eye involve maneuvering a string, black thread, or ruler until the fit is suitable, then drawing the line through the set of points. In 2015, the New York Times introduced an interactive feature, called ‘You Draw It,’ where readers are asked to input their own assumptions about various metrics and compare how these assumptions relate to reality. This research is intended to implement ‘You Draw It’, adapted from the New York Times, as a way to measure the patterns we see in data. In this paper, we describe the adaptation of an old tool for graphical testing and evaluation, eye-fitting, for use in modern web-applications suitable for testing statistical graphics. We present an empirical evaluation of this testing method for linear regression, and briefly discuss an extension of this method to non-linear applications.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiabu Ye, Binbing Yu, H. Mann, A. Sabin, Z. Szíjgyártó, David Wright, P. Mukhopadhyay, C. Massacesi, S. Ghiorghiu, R. Iacona
We assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on the statistical analysis of time-to-event outcomes in late-phase oncology trials. Using a simulated case study that mimics a Phase III ongoing trial during the pandemic, we evaluated the impact of COVID-19-related deaths, time off-treatment and missed clinical visits due to the pandemic, on overall survival and/or progression-free survival in terms of test size (also referred to as Type 1 error rate or alpha level), power, and hazard ratio (HR) estimates. We found that COVID-19-related deaths would impact both size and power, and lead to biased HR estimates; the impact would be more severe if there was an imbalance in COVID-19-related deaths between the study arms. Approaches censoring COVID-19-related deaths may mitigate the impact on power and HR estimation, especially if study data cut-off was extended to recover censoring-related event loss. The impact of COVID-19-related time off-treatment would be modest for power, and moderate for size and HR estimation. Different rules of censoring cancer progression times result in a slight difference in the power for the analysis of progression-free survival. The simulations provided valuable information for determining whether clinical-trial modifications should be required for ongoing trials during the COVID-19 pandemic.
{"title":"Addressing the Impact of the COVID-19 Pandemic on Survival Outcomes in Randomized Phase III Oncology Trials","authors":"Jiabu Ye, Binbing Yu, H. Mann, A. Sabin, Z. Szíjgyártó, David Wright, P. Mukhopadhyay, C. Massacesi, S. Ghiorghiu, R. Iacona","doi":"10.6339/22-jds1079","DOIUrl":"https://doi.org/10.6339/22-jds1079","url":null,"abstract":"We assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on the statistical analysis of time-to-event outcomes in late-phase oncology trials. Using a simulated case study that mimics a Phase III ongoing trial during the pandemic, we evaluated the impact of COVID-19-related deaths, time off-treatment and missed clinical visits due to the pandemic, on overall survival and/or progression-free survival in terms of test size (also referred to as Type 1 error rate or alpha level), power, and hazard ratio (HR) estimates. We found that COVID-19-related deaths would impact both size and power, and lead to biased HR estimates; the impact would be more severe if there was an imbalance in COVID-19-related deaths between the study arms. Approaches censoring COVID-19-related deaths may mitigate the impact on power and HR estimation, especially if study data cut-off was extended to recover censoring-related event loss. The impact of COVID-19-related time off-treatment would be modest for power, and moderate for size and HR estimation. Different rules of censoring cancer progression times result in a slight difference in the power for the analysis of progression-free survival. The simulations provided valuable information for determining whether clinical-trial modifications should be required for ongoing trials during the COVID-19 pandemic.","PeriodicalId":73699,"journal":{"name":"Journal of data science : JDS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71320957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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