Open Access. Powered by Scholars. Published by Universities.®

Statistics and Probability Commons™

Open Access. Powered by Scholars. Published by Universities.®

Humans

Discipline
Institution
Publication Year
Publication

Articles 1 - 30 of 146

Full-Text Articles in Statistics and Probability

Feasibility And Acceptability Of Automated Texts To Offer, Screen, And Enroll Patients In A Cancer Clinical Trial Financial Reimbursement Program: Mixed Methods Study, Ashley E Santaniello, Hena Patel, Sarah Milinski, Mohan Balachandran, Vivian Nguyen, E. Paul Wileyto, Robert H. Vonderheide, Dana Dornsife, Robert G. Johnson, Carmen E. Guerra Jul 2026

Feasibility And Acceptability Of Automated Texts To Offer, Screen, And Enroll Patients In A Cancer Clinical Trial Financial Reimbursement Program: Mixed Methods Study, Ashley E Santaniello, Hena Patel, Sarah Milinski, Mohan Balachandran, Vivian Nguyen, E. Paul Wileyto, Robert H. Vonderheide, Dana Dornsife, Robert G. Johnson, Carmen E. Guerra

Student Papers, Posters & Projects

BACKGROUND: Out-of-pocket (OOP) costs pose a significant barrier to participating in cancer clinical trials (CCTs). Financial reimbursement programs (FRPs) that reduce the burden of OOP costs can support participation in CCTs if the information is readily available to participants at the time of enrollment. Prior studies have shown the importance and impact of FRPs, but despite improvements, significant barriers still remain.

OBJECTIVE: This study was designed to explore the feasibility and acceptability of automated texts designed to offer, screen, and enroll CCT participants in an FRP for OOP travel and lodging-related clinical trial costs.

METHODS: This study used a mixed …


Multi-Level Variable Selection Using A Bart-Enhanced Mixed-Effects Framework, Keming Zhang, Yaoyao Li, Jungang Zou, Sijian Wang, Bernadette A. Fausto, Liangyuan Hu May 2026

Multi-Level Variable Selection Using A Bart-Enhanced Mixed-Effects Framework, Keming Zhang, Yaoyao Li, Jungang Zou, Sijian Wang, Bernadette A. Fausto, Liangyuan Hu

College of Health Professions Faculty Papers

Selecting important individual- and cluster-level predictors has become increasingly critical in healthcare research, where data often exhibit hierarchical structures due to collection from multiple clusters. Mixed-effects models, which account for within-cluster correlation and between-cluster heterogeneity, are a natural approach for multilevel variable selection. However, currently available variable selection methods for multilevel data are predominantly based on mixed-effects models that impose restrictive parametric assumptions, potentially limiting their utility when the underlying relationships are nonlinear or involve interactions. While nonparametric methods have shown promise for variable selection in non-clustered data, they have been much less studied in the multilevel setting. Moreover, nonparametric …


Novel R Shiny Tool For Survival Analysis With Time-Varying Covariate In Oncology Studies: Overcoming Biases And Enhancing Collaboration, Yimei Li, Yang Qiao, Fei Gao, Jordan Gauthier, Qiang Ed Zhang, Jenna Voutsinas, Wendy Leisenring, Ted Gooley, Corinne Summers, Alexandre Hirayama, Cameron Turtle, Rebecca Gardner, Jarcy Zee, Qian Vicky Wu Jan 2026

Novel R Shiny Tool For Survival Analysis With Time-Varying Covariate In Oncology Studies: Overcoming Biases And Enhancing Collaboration, Yimei Li, Yang Qiao, Fei Gao, Jordan Gauthier, Qiang Ed Zhang, Jenna Voutsinas, Wendy Leisenring, Ted Gooley, Corinne Summers, Alexandre Hirayama, Cameron Turtle, Rebecca Gardner, Jarcy Zee, Qian Vicky Wu

Wills Eye Hospital Papers

PURPOSE: Our study is motivated by evaluating the role of hematopoietic cell transplantation (HCT) after chimeric antigen receptor T-cell (CAR-T) therapy for ALL, a debated topic. Because patients may receive HCT at different times after CAR-T infusion or never, HCT post-CAR-T should be considered as a time-varying covariate (TVC).

METHODS: Standard Cox models and Kaplan-Meier (KM) curves (naïve method) assume that TVC status is known and fixed at baseline, which can yield biased estimates. Landmark analysis is a popular alternative but depends on a chosen landmark time. Time-dependent (TD) Cox model is better suited for TVC although visualizing survival curves …


A Phase 1, First-In-Human, Dose Escalation Study Of Jnj-80038114, A Psmaxcd3 Bispecific Antibody, In Participants With Metastatic Castration-Resistant Prostate Cancer, Andrew Hudson, Anuradha Jayaram, Benjamin Garmezy, Nicholas Zorko, Kevin Zarrabi, Ligi Mathews, Brent Rupnow, Mengjie Li, Debopriya Ghosh, Karen Urtishak, Peter Francis, Sherry Wang, Edward Attiyeh, Johann De Bono Jan 2026

A Phase 1, First-In-Human, Dose Escalation Study Of Jnj-80038114, A Psmaxcd3 Bispecific Antibody, In Participants With Metastatic Castration-Resistant Prostate Cancer, Andrew Hudson, Anuradha Jayaram, Benjamin Garmezy, Nicholas Zorko, Kevin Zarrabi, Ligi Mathews, Brent Rupnow, Mengjie Li, Debopriya Ghosh, Karen Urtishak, Peter Francis, Sherry Wang, Edward Attiyeh, Johann De Bono

Department of Medical Oncology Faculty Papers

PURPOSE: Prostate-specific membrane antigen (PSMA) has been identified as a therapeutic target for metastatic castration-resistant prostate cancer (mCRPC). The recent success of radioligands targeting PSMA spurred development of new PSMA-targeting agents including immunotherapy. JNJ-80038114 is a bispecific antibody that binds PSMA on tumor cells and CD3 on T cells to induce anti-tumor activity.

METHODS: This was a phase 1, open-label, multicenter study of JNJ-80038114 in participants with mCRPC and ≥ 1 prior systemic therapy. JNJ-80038114 was administered subcutaneously every 3 weeks (Q3W), starting at 0.1 mg. The primary endpoint was safety. Secondary endpoints included pharmacokinetics (PK), immunogenicity, and prostate-specific antigen …


First-Generation Medical School Applicants: A Quantitative Study Designed To Identify Areas Of Educational Support, Bethsabe Romero, Amanda K. Burbage Jan 2026

First-Generation Medical School Applicants: A Quantitative Study Designed To Identify Areas Of Educational Support, Bethsabe Romero, Amanda K. Burbage

EVMS School of Health Professions Faculty Publications

First-generation (First Gen) students are unique medical school applicants. Due to their lived experience, they approach patient care by prioritizing trust, comfort and understanding. They have proven ability to overcome obstacles and were found to be more resilient than their continuing generation (Cont Gen) peers. Despite these notable attributes, they face unique challenges in gaining medical school acceptance. There are very few quantitative studies examining this student subpopulation, and our study identifies characteristics of first-generation medical school applicants while highlighting areas of needed support. This cross-sectional study used deidentified Application and Matriculating Student Questionnaire survey data that was obtained from …


An Association Test For Ordinal Outcomes In Clustered Data With Informative Cluster Size, Hasika K. Wickrama Senevirathne, Sandipan Dutta Jan 2026

An Association Test For Ordinal Outcomes In Clustered Data With Informative Cluster Size, Hasika K. Wickrama Senevirathne, Sandipan Dutta

Mathematics & Statistics Faculty Publications

In cluster-correlated data, the number of observations in a cluster can be associated with the outcome from that cluster. This phenomenon is known as informative cluster size which can occur in cluster-randomized clinical trial data. Several studies have found that ignoring the issue of informative cluster size can produce biased results in the analysis of clustered data. Most of the existing methods for addressing informative cluster size are suited to continuous outcomes. However, ordinal outcomes and covariates are often encountered in clustered data obtained from large clinical studies. The existing methods for ordinal association testing in clustered data can produce …


An Ensemble Classifier For Ordinal Outcomes In High-Dimensional Genomics Data, Heranga K. Rathnasekara, Sinjini Sikdar Jan 2026

An Ensemble Classifier For Ordinal Outcomes In High-Dimensional Genomics Data, Heranga K. Rathnasekara, Sinjini Sikdar

Mathematics & Statistics Faculty Publications

Analysis of genomics data for predicting disease outcomes is a fast-growing field in medical research. There often exist categorical, specifically, ordinal outcomes that need to be predicted based on genomic profiles. This has led to recent development of some high-dimensional ordinal classification methods that can address the large dimensionality of the genomic covariate set. These high-dimensional ordinal models tend to vary widely in their performance depending on the data they are applied to and the evaluation criteria used. In this article, we outline an ensemble ordinal classifier that integrates different ordinal modeling approaches through bootstrap-based model evaluation, multi-metric performance assessment, …


Differential Impact Of Admission Type And Clinical Complexity On Diabetes Hospitalization Costs Among African American And Hispanic Patients In Southeastern Virginia, Ismail El Moudden, Asra Amidi, Reem Sharaf-Alddin, Michael C. Bittner, Qi Zhang Jan 2026

Differential Impact Of Admission Type And Clinical Complexity On Diabetes Hospitalization Costs Among African American And Hispanic Patients In Southeastern Virginia, Ismail El Moudden, Asra Amidi, Reem Sharaf-Alddin, Michael C. Bittner, Qi Zhang

Department of Obstetrics & Gynecology Faculty Publications

Background

Diabetes mellitus (DM) imposes substantial healthcare costs with documented disparities among African Americans and Hispanic patients. To inform care delivery and resource allocation, this study identified hospitalization cost predictors among African American and Hispanic patients with diabetes in Southeastern Virginia.

Methods

We analyzed 6,011 hospital discharges from the Virginia Health Information database (2016-2020) for adults aged 18-85 with diabetes. Discharges were classified by Medicare Severity Diagnosis-Related Groups: DM with complications/comorbidities (DCC, n = 3,328), DM with major complications/comorbidities (DMCC, n = 1,518), and DM without major complications/comorbidities (DWO, n = 1,165). Because cost distributions were right-skewed (skewness 3.5-8.24), we …


Short-Term Preeclampsia Prediction: Cutoff Variations For Sflt-1/Plgf In U.S. Patients With Or Without Hypertensive Disorders, Yaxin Li, Kristen Cagino, Jim Yee, Caroline Andy, Dajana Borova, Ayush Shah, Isla Racine, Tracy Grossman, Zhen Zhao Dec 2025

Short-Term Preeclampsia Prediction: Cutoff Variations For Sflt-1/Plgf In U.S. Patients With Or Without Hypertensive Disorders, Yaxin Li, Kristen Cagino, Jim Yee, Caroline Andy, Dajana Borova, Ayush Shah, Isla Racine, Tracy Grossman, Zhen Zhao

Student Papers, Posters & Projects

BACKGROUND: Preeclampsia (PE) is a complex disorder with significant maternal and fetal risks. The soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) ratio shows promise as a diagnostic tool, but its adoption in the U.S. remains limited due to the lack of accessible testing platforms, U.S.-based studies, and evidence-based implementation guidelines.

PATIENTS/MATERIALS AND METHODS: We conducted a cohort study to evaluate the sFlt-1/PlGF ratio for predicting PE within two weeks among pregnant individuals ≥18 years, ≥20 weeks gestation. Serum samples were obtained from routine prenatal visits or triage evaluations. sFlt-1/PlGF ratios were measured using Roche Elecsys assays, and …


Analysis Of Errors In The Management Of Cutaneous Disorders, Robert J. Pariser, Sarah Alnaif Jan 2025

Analysis Of Errors In The Management Of Cutaneous Disorders, Robert J. Pariser, Sarah Alnaif

Department Dermatology Faculty Publications

In this study, we prospectively and retrospectively evaluated the occurrence of errors in the management of cutaneous disorders from patient visits and medical records in a single dermatology practice in southeast Virginia over a 3-year period (June 2020-July 2023). Providers should be able to improve diagnostic accuracy by utilizing established rapid bedside diagnostic techniques.


An 11-Year (2012-2022) Review Of Journal Of Athletic Training Publication Study Designs And Sample Sizes, Zachary K. Winkelmann, Samantha E. Scarneo-Miller, Emily C. Smith, Ryan M. Argetsinger, Lindsey E. Eberman Jan 2025

An 11-Year (2012-2022) Review Of Journal Of Athletic Training Publication Study Designs And Sample Sizes, Zachary K. Winkelmann, Samantha E. Scarneo-Miller, Emily C. Smith, Ryan M. Argetsinger, Lindsey E. Eberman

Rehabilitation Sciences Faculty Publications

Background

Research findings must be representative by creating a sample of individuals, ensuring the results can be generalized and applicable to a larger population, which has historically been guided by a power analysis. However, the varied research design methods require a unique approach to sampling and a formula for recruitment and size. Therefore, the purpose of this study was to analyze historical data from published manuscripts in the Journal of Athletic Training (JAT) relative to study design and sample sizes. A secondary purpose was to further explore metrics for survey-based research.

Methods

This descriptive analysis explored 1267 publications in each …


Group Antenatal Care Positively Transforms The Care Experience: Results Of An Effectiveness Trial In Malawi, Crystal L. Patil, Kathleen F. Noor, Esnath Kapito, Li C. Liu, Xiaohan Mei, Elizabeth Chodzaza, Genesis Chorwe-Sungani, Ursula Kafuulafula, Elizabeth T. Abrams, Allissa Desloge, Ashley Gresh, Rohan D. Jeremiah, Dhruvi R. Patel, Anne Batchelder, Heidy Wang, Jocelyn Faydenko, Sharon S. Rising, Ellen Chirwa Jan 2025

Group Antenatal Care Positively Transforms The Care Experience: Results Of An Effectiveness Trial In Malawi, Crystal L. Patil, Kathleen F. Noor, Esnath Kapito, Li C. Liu, Xiaohan Mei, Elizabeth Chodzaza, Genesis Chorwe-Sungani, Ursula Kafuulafula, Elizabeth T. Abrams, Allissa Desloge, Ashley Gresh, Rohan D. Jeremiah, Dhruvi R. Patel, Anne Batchelder, Heidy Wang, Jocelyn Faydenko, Sharon S. Rising, Ellen Chirwa

Department of Medicine Faculty Publications

Background

We developed and tested a Centering-based group antenatal (ANC) model in Malawi, integrating health promotion for HIV prevention and mental health. We present effectiveness data and examine congruence with only the Group ANC theory of change model, which identifies key processes as supportive relationships, empowered partners in learning and care, and meaningful services, leading to better ANC experiences and outcomes.

Methods

We conducted a hybrid effectiveness-implementation trial at seven clinics in Blantyre District, Malawi, comparing outcomes for 1887 pregnant women randomly assigned to Group ANC or Individual ANC. Group effects on outcomes were summarized and evaluated using t-tests, Mann-Whitney, …


Surgical Delay-Associated Mortality Risk Varies By Subtype In Loco-Regional Breast Cancer Patients In Seer-Medicare, Macall Leslie Salewon, Rashmi Pathak, William Dooley, Ronald Squires, Hallgeir Rui, Inna Chervoneva, Takemi Tanaka Dec 2024

Surgical Delay-Associated Mortality Risk Varies By Subtype In Loco-Regional Breast Cancer Patients In Seer-Medicare, Macall Leslie Salewon, Rashmi Pathak, William Dooley, Ronald Squires, Hallgeir Rui, Inna Chervoneva, Takemi Tanaka

Department of Pharmacology, Physiology, and Cancer Biology Faculty Papers

Substantial evidence supports that delay of surgery after breast cancer diagnosis is associated with increased mortality risk, leading to the introduction of a new Commission on Cancer quality measure for receipt of surgery within 60 days of diagnosis for non-neoadjuvant patients. Breast cancer subtype is a critical prognostic factor and determines treatment options; however, it remains unknown whether surgical delay-associated breast cancer-specific mortality (BCSM) risk differs by subtype. This retrospective cohort study aimed to assess whether the impact of delayed surgery on survival varies by subtype (hormone [HR] + /HER2 -, HR -/HER2 -, and HER2 +) in patients with …


A Latent Class Assessment Of Healthcare Access Factors And Disparities In Breast Cancer Care Timeliness, Matthew Dunn, Didong Li, Marc Emerson, Caroline Thompson, Hazel Nichols, Sarah Van Alsten, Mya Roberson, Stephanie Wheeler, Lisa Carey, Terry Hyslop, Jennifer Elston Lafata, Melissa Troester Dec 2024

A Latent Class Assessment Of Healthcare Access Factors And Disparities In Breast Cancer Care Timeliness, Matthew Dunn, Didong Li, Marc Emerson, Caroline Thompson, Hazel Nichols, Sarah Van Alsten, Mya Roberson, Stephanie Wheeler, Lisa Carey, Terry Hyslop, Jennifer Elston Lafata, Melissa Troester

Kimmel Cancer Center Faculty Papers

BACKGROUND: Delays in breast cancer diagnosis and treatment lead to worse survival and quality of life. Racial disparities in care timeliness have been reported, but few studies have examined access at multiple points along the care continuum (diagnosis, treatment initiation, treatment duration, and genomic testing).

METHODS AND FINDINGS: The Carolina Breast Cancer Study (CBCS) Phase 3 is a population-based, case-only cohort (n = 2,998, 50% black) of patients with invasive breast cancer diagnoses (2008 to 2013). We used latent class analysis (LCA) to group participants based on patterns of factors within 3 separate domains: socioeconomic status ("SES"), "care barriers," and …


Using Causal Diagrams Within The Grading Of Recommendations, Assessment, Development And Evaluation Framework To Evaluate Confounding Adjustment In Observational Studies, Kevin Mcintyre, Karina N Tassiopoulos, Curtis Jeffrey, Saverio Stranges, Janet Martin Nov 2024

Using Causal Diagrams Within The Grading Of Recommendations, Assessment, Development And Evaluation Framework To Evaluate Confounding Adjustment In Observational Studies, Kevin Mcintyre, Karina N Tassiopoulos, Curtis Jeffrey, Saverio Stranges, Janet Martin

Epidemiology and Biostatistics Publications

BACKGROUND AND OBJECTIVES: The current Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system instructs appraisers to evaluate whether individual observational studies have sufficiently adjusted for confounding. However, it does not provide an explicit, transparent, or reproducible method for doing so. This article explores how implementing causal graphs into the GRADE framework can help appraisers and end-users of GRADE products to evaluate the adequacy of confounding control from observational studies.

METHODS: Using modern epidemiological theory, we propose a system for incorporating causal diagrams into the GRADE process to assess confounding control.

RESULTS: Integrating causal graphs into the GRADE framework enables …


Communities That Heal Intervention And Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial, Bridget Freisthler, Rouba A. Chahine, Jennifer Villani, Redonna Chandler, Daniel J. Feaster, Svetla Slavova, Jolene Defiore-Hyrmer, Alexander Y. Walley, Sarah Kosakowski, Arnie Aldridge, Carolina Barbosa, Sabana Bhatta, Candace Brancato, Carly Bridden, Mia Christopher, Tom Clarke, James David, Lauren D'Costa, Irene Ewing, Soledad Fernandez, Erin Gibson, Louisa Gilbert, Megan E. Hall, Sarah Hargrove, Timothy Hunt, Elizabeth N. Kinnard, Lauren Larochelle, Aaron Macoubray, Shawn R. Nigam, Edward V. Nunes, Carrie B. Oser, Sharon Pagnano, Peter J. Rock, Pamela Salsberry, Aimee Shadwick, Thomas J. Stopka, Sylvia Tan, Jessica L. Taylor, Philip M. Westgate, Elwin Wu, Gary A. Zarkin, Sharon L. Walsh, Nabila El-Bassel, T. John Winhusen, Jeffrey H. Samet, Emmanuel A. Oga Oct 2024

Communities That Heal Intervention And Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial, Bridget Freisthler, Rouba A. Chahine, Jennifer Villani, Redonna Chandler, Daniel J. Feaster, Svetla Slavova, Jolene Defiore-Hyrmer, Alexander Y. Walley, Sarah Kosakowski, Arnie Aldridge, Carolina Barbosa, Sabana Bhatta, Candace Brancato, Carly Bridden, Mia Christopher, Tom Clarke, James David, Lauren D'Costa, Irene Ewing, Soledad Fernandez, Erin Gibson, Louisa Gilbert, Megan E. Hall, Sarah Hargrove, Timothy Hunt, Elizabeth N. Kinnard, Lauren Larochelle, Aaron Macoubray, Shawn R. Nigam, Edward V. Nunes, Carrie B. Oser, Sharon Pagnano, Peter J. Rock, Pamela Salsberry, Aimee Shadwick, Thomas J. Stopka, Sylvia Tan, Jessica L. Taylor, Philip M. Westgate, Elwin Wu, Gary A. Zarkin, Sharon L. Walsh, Nabila El-Bassel, T. John Winhusen, Jeffrey H. Samet, Emmanuel A. Oga

Biostatistics Faculty Publications

IMPORTANCE: The HEALing Communities Study (HCS) evaluated the effectiveness of the Communities That HEAL (CTH) intervention in preventing fatal overdoses amidst the US opioid epidemic.

OBJECTIVE: To evaluate the impact of the CTH intervention on total drug overdose deaths and overdose deaths involving combinations of opioids with psychostimulants or benzodiazepines.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was a parallel-arm, multisite, community-randomized, open, and waitlisted controlled comparison trial of communities in 4 US states between 2020 and 2023. Eligible communities were those reporting high opioid overdose fatality rates in Kentucky, Massachusetts, New York, and Ohio. Covariate constrained randomization stratified …


Perioperative Mortality In Low-, Middle-, And High-Income Countries: Protocol For A Multi-Level Meta-Regression Analysis, Kevin Mcintyre, Yun-Hee Choi, Ava John-Baptiste, Daniel J Lizotte, Eunice Y S Chan, Jessica Moodie, Saverio Stranges, Janet Martin Jan 2024

Perioperative Mortality In Low-, Middle-, And High-Income Countries: Protocol For A Multi-Level Meta-Regression Analysis, Kevin Mcintyre, Yun-Hee Choi, Ava John-Baptiste, Daniel J Lizotte, Eunice Y S Chan, Jessica Moodie, Saverio Stranges, Janet Martin

Epidemiology and Biostatistics Publications

BACKGROUND: Surgery is an indispensable component of a functional healthcare system. To date there is limited information regarding how many people die during the perioperative period globally. This study describes a protocol for a systematic review and multilevel meta-regression to evaluate time trends regarding the odds of perioperative mortality among adults undergoing a bellwether surgical procedure while accounting for higher order clustering at the national level.

METHODS: Published studies reporting the number of perioperative deaths from bellwether surgical procedures among adults will be identified from MEDLINE, Embase, Cochrane CENTRAL, LILACS and Global Index Medicus. The primary outcome will be the …


Models Of Shared Care For The Management Of Psychotic Disorder After First Diagnosis In Ontario., Joshua C. Wiener, Rebecca Rodrigues, Jennifer N S Reid, Kelly K. Anderson Dec 2023

Models Of Shared Care For The Management Of Psychotic Disorder After First Diagnosis In Ontario., Joshua C. Wiener, Rebecca Rodrigues, Jennifer N S Reid, Kelly K. Anderson

Epidemiology and Biostatistics Publications

OBJECTIVE: To describe the provision of care for young people following first diagnosis of psychotic disorder.

DESIGN: Retrospective cohort study using health administrative data.

SETTING: Ontario.

PARTICIPANTS: People aged 14 to 35 years with a first diagnosis of nonaffective psychotic disorder in Ontario between 2005 and 2015 (N=39,449).

MAIN OUTCOME MEASURES: Models of care, defined by psychosis-related service contacts with primary care physicians and psychiatrists during the 2 years after first diagnosis of psychotic disorder.

RESULTS: During the 2-year follow-up period, 29% of the cohort received only primary care, 30% received only psychiatric care, and 32% received both primary and …


Repurposing The Fda-Approved Anthelmintic Pyrvinium Pamoate For Pancreatic Cancer Treatment: Study Protocol For A Phase I Clinical Trial In Early-Stage Pancreatic Ductal Adenocarcinoma, Francesca M. Ponzini, Christopher W. Schultz, Benjamin E. Leiby, Shawnna Cannaday, T. Yeo, James Posey, Wilbur B. Bowne, Charles Yeo, Jonathan R. Brody, Harish Lavu, Avinoam Nevler Oct 2023

Repurposing The Fda-Approved Anthelmintic Pyrvinium Pamoate For Pancreatic Cancer Treatment: Study Protocol For A Phase I Clinical Trial In Early-Stage Pancreatic Ductal Adenocarcinoma, Francesca M. Ponzini, Christopher W. Schultz, Benjamin E. Leiby, Shawnna Cannaday, T. Yeo, James Posey, Wilbur B. Bowne, Charles Yeo, Jonathan R. Brody, Harish Lavu, Avinoam Nevler

Department of Surgery Faculty Papers

BACKGROUND: Recent reports of the utilisation of pyrvinium pamoate (PP), an FDA-approved anti-helminth, have shown that it inhibits pancreatic ductal adenocarcinoma (PDAC) cell growth and proliferation in-vitro and in-vivo in preclinical models. Here, we report about an ongoing phase I open-label, single-arm, dose escalation clinical trial to determine the safety and tolerability of PP in PDAC surgical candidates.

METHODS AND ANALYSIS: In a 3+3 dose design, PP is initiated 3 days prior to surgery. The first three patients will be treated with the initial dose of PP at 5 mg/kg orally for 3 days prior to surgery. Dose doubling will …


Differences In Clinical Presentation At First Hospitalization And The Impact On Involuntary Admissions Among First-Generation Migrant Groups With Non-Affective Psychotic Disorders., Kelly K Anderson, Rebecca Rodrigues Sep 2023

Differences In Clinical Presentation At First Hospitalization And The Impact On Involuntary Admissions Among First-Generation Migrant Groups With Non-Affective Psychotic Disorders., Kelly K Anderson, Rebecca Rodrigues

Epidemiology and Biostatistics Publications

BACKGROUND: Some migrant and ethnic minority groups have a higher risk of coercive pathways to care; however, it is unclear whether differences in clinical presentation contribute to this risk. We sought to assess: (i) whether there were differences in clinician-rated symptoms and behaviours across first-generation immigrant and refugee groups at the first psychiatric hospitalization after psychosis diagnosis, and (ii) whether these differences accounted for disparities in involuntary admission.

METHODS: Using population-based health administrative data from Ontario, Canada, we constructed a sample (2009-2013) of incident cases of non-affective psychotic disorder followed for two years to identify first psychiatric hospitalization. We compared …


Sickle Cell Disease Treatment With Arginine Therapy (Start): Study Protocol For A Phase 3 Randomized Controlled Trial., Chris A Rees, David C. Brousseau, Daniel M Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E Chumpitazi, Gladstone Airewele, Todd Chang, Christopher Denton, Angela Ellison, Alexis Thompson, Fahd Ahmad, Nitya Bakshi, Keli D Coleman, Sara Leibovich, Deborah Leake, Dunia Hatabah, Hagar Wilkinson, Michelle Robinson, T Charles Casper, Elliott Vichinsky, Claudia R Morris Aug 2023

Sickle Cell Disease Treatment With Arginine Therapy (Start): Study Protocol For A Phase 3 Randomized Controlled Trial., Chris A Rees, David C. Brousseau, Daniel M Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E Chumpitazi, Gladstone Airewele, Todd Chang, Christopher Denton, Angela Ellison, Alexis Thompson, Fahd Ahmad, Nitya Bakshi, Keli D Coleman, Sara Leibovich, Deborah Leake, Dunia Hatabah, Hagar Wilkinson, Michelle Robinson, T Charles Casper, Elliott Vichinsky, Claudia R Morris

Department of Pediatrics Faculty Papers

BACKGROUND: Despite substantial illness burden and healthcare utilization conferred by pain from vaso-occlusive episodes (VOE) in children with sickle cell disease (SCD), disease-modifying therapies to effectively treat SCD-VOE are lacking. The aim of the Sickle Cell Disease Treatment with Arginine Therapy (STArT) Trial is to provide definitive evidence regarding the efficacy of intravenous arginine as a treatment for acute SCD-VOE among children, adolescents, and young adults.

METHODS: STArT is a double-blind, placebo-controlled, randomized, phase 3, multicenter trial of intravenous arginine therapy in 360 children, adolescents, and young adults who present with SCD-VOE. The STArT Trial is being conducted at 10 …


Sex Differences In The Clinical Presentation Of Early Psychosis In A Primary Care Setting, Brooke Carter, Rebecca Rodrigues, Jennifer Reid, Suzanne Archie, Amanda L Terry, Lena Palaniyappan, Arlene G Macdougall, Aristotle Voineskos, Saadia Hameed Jan, Liisa Jaakkimainen, Branson Chen, Neo Sawh, Kelly K. Anderson Jun 2023

Sex Differences In The Clinical Presentation Of Early Psychosis In A Primary Care Setting, Brooke Carter, Rebecca Rodrigues, Jennifer Reid, Suzanne Archie, Amanda L Terry, Lena Palaniyappan, Arlene G Macdougall, Aristotle Voineskos, Saadia Hameed Jan, Liisa Jaakkimainen, Branson Chen, Neo Sawh, Kelly K. Anderson

Epidemiology and Biostatistics Publications

Primary care is an important part of the help-seeking pathway for young people experiencing early psychosis, but sex differences in clinical presentation in these settings are unexplored. We aimed to identify sex differences in clinical presentation to primary care services in the 1-year period prior to a first diagnosis of psychotic disorder. We identified first-onset cases of non-affective psychotic disorder over a 10-year period (2005-2015) using health administrative data linked with electronic medical records (EMRs) from primary care (n = 465). Detailed information on encounters in the year prior to first diagnosis was abstracted, including psychiatric symptoms, other relevant behaviours, …


Patient And Physician Factors Associated With First Diagnosis Of Non-Affective Psychotic Disorder In Primary Care, Joshua C. Wiener, Rebecca Rodrigues, Jennifer N S Reid, Suzanne Archie, Richard G Booth, Chiachen Cheng, Saadia Hameed Jan, Paul Kurdyak, Arlene G Macdougall, Lena Palaniyappan, Bridget L Ryan, Kelly K. Anderson Mar 2023

Patient And Physician Factors Associated With First Diagnosis Of Non-Affective Psychotic Disorder In Primary Care, Joshua C. Wiener, Rebecca Rodrigues, Jennifer N S Reid, Suzanne Archie, Richard G Booth, Chiachen Cheng, Saadia Hameed Jan, Paul Kurdyak, Arlene G Macdougall, Lena Palaniyappan, Bridget L Ryan, Kelly K. Anderson

Epidemiology and Biostatistics Publications

Primary care physicians play a central role in pathways to care for first-episode psychosis, and their increased involvement in early detection could improve service-related outcomes. The aim of this study was to estimate the proportion of psychosis first diagnosed in primary care, and identify associated patient and physician factors. We used linked health administrative data to construct a retrospective cohort of people aged 14-35 years with a first diagnosis of non-affective psychosis in Ontario, Canada between 2005-2015. We restricted the sample to patients with help-seeking contacts for mental health reasons in primary care in the six months prior to first …


Evaluating The Feasibility And Potential Impacts Of A Recovery-Oriented Psychosocial Rehabilitation Toolkit In A Health Care Setting In Kenya: A Mixed-Methods Study, Regina Casey, Joshua C. Wiener, Terry Krupa, Rosemary Lysaght, Marlene Janzen Le Ber, Ruth Ruhara, Elizabeth Price, Romaisa Pervez, Sean Kidd, Victoria Mutiso, David M Ndetei, Arlene G Macdougall Mar 2023

Evaluating The Feasibility And Potential Impacts Of A Recovery-Oriented Psychosocial Rehabilitation Toolkit In A Health Care Setting In Kenya: A Mixed-Methods Study, Regina Casey, Joshua C. Wiener, Terry Krupa, Rosemary Lysaght, Marlene Janzen Le Ber, Ruth Ruhara, Elizabeth Price, Romaisa Pervez, Sean Kidd, Victoria Mutiso, David M Ndetei, Arlene G Macdougall

Epidemiology and Biostatistics Publications

OBJECTIVES: This pilot study evaluated the feasibility and potential impacts of delivering the Psychosocial Rehabilitation (PSR) Toolkit for people with serious mental illness within a health care setting in Kenya.

METHOD: This study used a convergent mixed-methods design. Participants were people with serious mental illness (n = 23), each with an accompanying family member, who were outpatients of a hospital or satellite clinic in semirural Kenya. The intervention consisted of 14 weekly group sessions of PSR cofacilitated by health care professionals and peers with mental illness. Quantitative data were collected from patients and family members using validated outcome measures before …


Cancer Incidence And Stage At Diagnosis Among People With Psychotic Disorders: Systematic Review And Meta-Analysis., Jared C Wootten, Joshua C Wiener, Phillip S Blanchette, Kelly K. Anderson Oct 2022

Cancer Incidence And Stage At Diagnosis Among People With Psychotic Disorders: Systematic Review And Meta-Analysis., Jared C Wootten, Joshua C Wiener, Phillip S Blanchette, Kelly K. Anderson

Epidemiology and Biostatistics Publications

Research regarding the incidence of cancer among people with psychotic disorders relative to the general population is equivocal, although the evidence suggests that they have more advanced stage cancer at diagnosis. We conducted a systematic review and meta-analysis to examine the incidence and stage at diagnosis of cancer among people with, relative to those without, psychotic disorders. We searched the MEDLINE, EMBASE, PsycINFO, and CINAHL databases. Articles were included if they reported the incidence and/or stage at diagnosis of cancer in people with psychotic disorders. Random effects meta-analyses were used to determine risk of cancer and odds of advanced stage …


Cancer Incidence And Stage At Diagnosis Among People With Recent-Onset Psychotic Disorders: A Retrospective Cohort Study Using Health Administrative Data From Ontario, Canada., Jared C Wootten, Lucie Richard, Phillip S Blanchette, Joshua C. Wiener, Kelly K. Anderson Sep 2022

Cancer Incidence And Stage At Diagnosis Among People With Recent-Onset Psychotic Disorders: A Retrospective Cohort Study Using Health Administrative Data From Ontario, Canada., Jared C Wootten, Lucie Richard, Phillip S Blanchette, Joshua C. Wiener, Kelly K. Anderson

Epidemiology and Biostatistics Publications

OBJECTIVE: Prior evidence on the relative risk of cancer among people with psychotic disorders is equivocal. The objective of this study was to compare incidence and stage at diagnosis of cancer for people with psychotic disorders relative to the general population.

METHOD: We constructed a retrospective cohort of people with a first diagnosis of non-affective psychotic disorder and a comparison group from the general population using linked health administrative databases in Ontario, Canada. The cohort was followed for incident diagnoses of cancer over a 25-year period. We used Poisson and logistic regression models to compare cancer incidence and stage at …


Sex And Gender Differences In Symptoms Of Early Psychosis: A Systematic Review And Meta-Analysis, Brooke Carter, Jared Wootten, Suzanne Archie, Amanda L Terry, Kelly K. Anderson Aug 2022

Sex And Gender Differences In Symptoms Of Early Psychosis: A Systematic Review And Meta-Analysis, Brooke Carter, Jared Wootten, Suzanne Archie, Amanda L Terry, Kelly K. Anderson

Epidemiology and Biostatistics Publications

First-episode psychosis (FEP) can be quite variable in clinical presentation, and both sex and gender may account for some of this variability. Prior literature on sex or gender differences in symptoms of psychosis have been inconclusive, and a comprehensive summary of evidence on the early course of illness is lacking. The objective of this study was to conduct a systematic review and meta-analysis of the literature to summarize prior evidence on the sex and gender differences in the symptoms of early psychosis. We conducted an electronic database search (MEDLINE, Scopus, PsycINFO, and CINAHL) from 1990 to present to identify quantitative …


The Prevalence And Impact Of Adolescent Hospitalization To Adult Psychiatric Units., Samantha Mcrae, Jordan Edwards, Kathy N Speechley, Javeed Sukhera, Guangyong Zou, Kelly K. Anderson Jul 2022

The Prevalence And Impact Of Adolescent Hospitalization To Adult Psychiatric Units., Samantha Mcrae, Jordan Edwards, Kathy N Speechley, Javeed Sukhera, Guangyong Zou, Kelly K. Anderson

Epidemiology and Biostatistics Publications

BACKGROUND: With increasing psychiatric hospitalizations among adolescents and constrained hospital resources, there are times when youth are hospitalized in adult inpatient psychiatry units. Evidence on the prevalence of this practice and associated impacts is lacking.

AIMS: We sought to explore the prevalence, determinants, and outcomes related to the hospitalization of adolescents aged 12-17 years on adult inpatient psychiatry units in Ontario.

METHODS: Using health administrative data, we constructed a cohort of adolescents with an inpatient psychiatric admission in Ontario (2007-2011). We classified adolescents as having an admission to an adult psychiatry unit or to other inpatient units. Multivariable regression models …


Ovarian Cancer Epidemiology, Healthcare Access And Disparities (Orchid): Methodology For A Population-Based Study Of Black, Hispanic And White Patients With Ovarian Cancer, Tomi Akinyemiju, April Deveaux, Lauren Wilson, Anjali Gupta, Ashwini Joshi, Malcolm Bevel, Chioma Omeogu, Onyinye Ohamadike, Bin Huang, Maria Pisu, Margaret Liang, Molly Mcfatrich, Erin Daniell, Laura Jane Fish, Kevin Ward, Maria Schymura, Andrew Berchuck, Arnold L. Potosky Oct 2021

Ovarian Cancer Epidemiology, Healthcare Access And Disparities (Orchid): Methodology For A Population-Based Study Of Black, Hispanic And White Patients With Ovarian Cancer, Tomi Akinyemiju, April Deveaux, Lauren Wilson, Anjali Gupta, Ashwini Joshi, Malcolm Bevel, Chioma Omeogu, Onyinye Ohamadike, Bin Huang, Maria Pisu, Margaret Liang, Molly Mcfatrich, Erin Daniell, Laura Jane Fish, Kevin Ward, Maria Schymura, Andrew Berchuck, Arnold L. Potosky

Biostatistics Faculty Publications

INTRODUCTION: Less than 40% of patients with ovarian cancer (OC) in the USA receive stage-appropriate guideline-adherent surgery and chemotherapy. Black patients with cancer report greater depression, pain and fatigue than white patients. Lack of access to healthcare likely contributes to low treatment rates and racial differences in outcomes. The Ovarian Cancer Epidemiology, Healthcare Access and Disparities study aims to characterise healthcare access (HCA) across five specific dimensions-Availability, Affordability, Accessibility, Accommodation and Acceptability-among black, Hispanic and white patients with OC, evaluate the impact of HCA on quality of treatment, supportive care and survival, and explore biological mechanisms that may contribute to …


Covid-19 And The Impact On Rural And Black Church Congregants: Results Of The C-M-C Project, Lovoria B. Williams, Anita F. Fernander, Tofial Azam, Maria L. Gomez, Junghee Kang, Cassidy L. Moody, Hannah Bowman, Nancy E. Schoenberg Jul 2021

Covid-19 And The Impact On Rural And Black Church Congregants: Results Of The C-M-C Project, Lovoria B. Williams, Anita F. Fernander, Tofial Azam, Maria L. Gomez, Junghee Kang, Cassidy L. Moody, Hannah Bowman, Nancy E. Schoenberg

Nursing Faculty Publications

The COVID-19 pandemic has had devastating effects on Black and rural populations with a mortality rate among Blacks three times that of Whites and both rural and Black populations experiencing limited access to COVID-19 resources. The primary purpose of this study was to explore the health, financial, and psychological impact of COVID-19 among rural White Appalachian and Black nonrural central Kentucky church congregants. Secondarily we sought to examine the association between sociodemographics and behaviors, attitudes, and beliefs regarding COVID-19 and intent to vaccinate. We used a cross sectional survey design developed with the constructs of the Health Belief and Theory …