Bioethics and Medical Ethics Commons^™

Circulating Trophoblast Numbers As A Potential Marker For Pregnancy Complications, Brielle Crovetti, Mohamad Ali Maktabi, Hadi Erfani, Tachjaree Panchalee, Qun Wang, Liesbeth Vossaert, Ignatia Van Den Veyver

Center for Medical Ethics and Health Policy Staff Publications

Objective: To explore the potential of circulating trophoblasts (TBs) as a non-invasive tool to assess placental health and predict obstetric complications.

Methods: We retrospectively reviewed maternal characteristics and pregnancy outcomes of 369 women who enrolled in our original cell-based NIPT (cbNIPT) study. The number of circulating TBs recovered from the maternal blood samples was recorded and expressed as fetal cell concentration (FCC). We evaluated if FCC can be used to predict pregnancy outcomes such as hypertensive disorders of pregnancy (HDP), fetal growth restriction, placental abruption, preterm labor, and pregnancy loss.

Results: Receiver operating characteristic (ROC) analysis was performed to find …

De Novo Heterozygous Variants In Slc30a7 Are A Candidate Cause For Joubert Syndrome, Monica Penon-Portmann, Mohammad K Eldomery, Lorraine Potocki, Dana Marafi, Jennifer E Posey, Zeynep Coban-Akdemir, Tamar Harel, Christopher M Grochowski, Hailey Loucks, Walter Patrick Devine, Jessica Van Ziffle, Dan Doherty, James R Lupski, Joseph T Shieh

Center for Medical Ethics and Health Policy Staff Publications

Joubert syndrome (JS), a well-established ciliopathy, is characterized by the distinctive molar tooth sign on brain MRI, ataxia, and neurodevelopmental features. Other manifestations can include polydactyly, accessory frenula, renal, or liver disease. Here, we report individuals meeting criteria for JS with de novo heterozygous variants in SLC30A7 (Chr1p21.2). The first individual is a female with history of unilateral postaxial polydactyly, classic molar tooth sign on MRI, macrocephaly, ataxia, ocular motor apraxia, neurodevelopmental delay, and precocious puberty. Exome sequencing detected a de novo heterozygous missense variant in SLC30A7: NM_133496.5: c.407 T > C, (p.Val136Ala). The second individual had bilateral postaxial polydactyly, molar …

Stepped Care Versus Standard Care For Children After Trauma: A Randomized Non-Inferiority Clinical Trial, Alison Salloum, Yuanyuan Lu, Henian Chen, Troy Quast, Judith A Cohen, Michael S Scheeringa, Kristen Salomon, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Objective: Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based therapist-led treatment for children after trauma. Parents often experience barriers to treatment engagement, including cost. Stepped care TF-CBT (SC-TF-CBT) was developed as an alternative delivery system. Step One is a parent-led therapist-assisted treatment. Step Two provides therapist-led TF-CBT for children who did not benefit from Step One and require more intensive treatment. This study compared SC-TF-CBT to standard TF-CBT in a community-based non-inferiority trial.

Method: A total of 183 children (aged 4-12 years) experiencing posttraumatic stress symptoms (PTSS) and their caregivers were randomly assigned to SC-TF-CBT or standard TF-CBT within 6 community …

Sexual Health Assessment Is Vital To Whole Health Models Of Care, Alex Uzdavines, Drew A Helmer, Juliette F Spelman, Kristin M Mattocks, Amanda M Johnson, John F Chardos, Kristine E Lynch, Michael R Kauth

Center for Medical Ethics and Health Policy Staff Publications

Sexual health is the state of well-being regarding sexuality. Sexual health is highly valued and associated with overall health. Overall health and well-being are more than the absence of disease or dysfunction. Health care systems adopting whole health models of care need to incorporate a holistic assessment of sexual health. This includes assessing patients' sexual orientation and gender identity (SOGI). If health systems, including but not limited to the Veterans Health Administration (VHA), incorporate sexual health into whole health they could enhance preventive care, promote healthy sexual functioning, and optimize overall health and well-being. Assessing sexual health can give providers …

Integrated Dna Copy Number And Expression Profiling Identifies Igf1r As A Prognostic Biomarker In Pediatric Osteosarcoma, Aaron M Taylor, Jiayi M Sun, Alexander Yu, Horatiu Voicu, Jianhe Shen, Donald A Barkauskas, Timothy J Triche, Julie M Gastier-Foster, Tsz-Kwong Man, Ching C Lau

Center for Medical Ethics and Health Policy Staff Publications

Osteosarcoma is a primary malignant bone tumor arising from bone-forming mesenchymal cells in children and adolescents. Despite efforts to understand the biology of the disease and identify novel therapeutics, the survival of osteosarcoma patients remains dismal. We have concurrently profiled the copy number and gene expression of 226 osteosarcoma samples as part of the Strategic Partnering to Evaluate Cancer Signatures (SPECS) initiative. Our results demonstrate the heterogeneous landscape of osteosarcoma in younger populations by showing the presence of genome-wide copy number abnormalities occurring both recurrently among samples and in a high frequency. Insulin growth factor receptor 1 (IGF1R) is a …

Therapeutic Targeting Of Macrophage Plasticity Remodels The Tumor-Immune Microenvironment, Hee-Jin Jang, Hyun-Sung Lee, Wendong Yu, Maheshwari Ramineni, Cynthia Y Truong, Daniela Ramos, Taylor Splawn, Jong Min Choi, Sung Yun Jung, Ju-Seog Lee, Daniel Y Wang, Joel M Sederstrom, Massimo Pietropaolo, Farrah Kheradmand, Christopher I Amos, Thomas M Wheeler, R Taylor Ripley, Bryan M Burt

Center for Medical Ethics and Health Policy Staff Publications

Although the majority of patients with advanced lung adenocarcinoma (LUAD) are eligible to receive immune checkpoint blockade, approximately 80% of these tumors are resistant to this therapeutic approach. Insights at the single-cell level into mechanisms that drive LUAD tumorigenesis and the relationship of LUAD histologic heterogeneity to response to immune checkpoint blockade could help identify biomarkers and potential combinational approaches to improve immunotherapy efficacy. Here we used a genetically engineered mouse model that replicates the development of human LUAD through a spectrum of pre-invasive to invasive adenocarcinoma histologic subtypes. A systems onco-immunology approach of integrating the analytical power and unique, …

An Updated Assessment Of 43,110 Patients Enrolled In The Childhood Cancer Research Network: A Children’S Oncology Group Report, Austin L Brown, Pagna Sok, Michael E Scheurer, Karen R Rabin, Erin L Marcotte, Douglas S Hawkins, Logan G Spector, Philip J Lupo

Center for Medical Ethics and Health Policy Staff Publications

Background: The Childhood Cancer Research Network (CCRN) was established by the Children's Oncology Group (COG) as a resource for epidemiologic studies of childhood cancer. The objective of this study was to evaluate the representativeness of CCRN and identify factors associated with enrollment.

Method: The number of US childhood patients with cancer diagnosed < 20 years of age enrolled in CCRN (2008-2015) was compared to expected counts, calculated from Surveillance, Epidemiology, and End Results incidence rates and US Census population estimates. Observed-to-expected ratios and corresponding 95% confidence intervals (CI) were estimated across sex, race, diagnosis age, calendar year, and cancer diagnosis groups. Multivariable linear regression models were generated to evaluate the association between open COG phase 3 therapeutic trials and CCRN enrollment rates.

Result: The 43,110 cases enrolled in CCRN represented 36% of the expected childhood cancers diagnosed from 2008 to 2015 (N = 120,118). CCRN enrollment ratios [95% CI] were highest among males (0.38 [95% CI, 0.37-0.38]), non-Hispanics (0.35 [95% CI, 0.35-0.36]), and those diagnosed from 1 to 4 years …

Phase Ii Study Of Selumetinib In Children And Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Genetic Alterations: Arm E Of The Nci-Cog Pediatric Match Trial, Olive S Eckstein, Carl E Allen, P Mickey Williams, Sinchita Roy-Chowdhuri, David R Patton, Brent Coffey, Joel M Reid, Jin Piao, Lauren Saguilig, Todd A Alonzo, Stacey L Berg, Nilsa C Ramirez, Alok Jaju, Joyce Mhlanga, Elizabeth Fox, Douglas S Hawkins, Margaret M Mooney, Naoko Takebe, James V Tricoli, Katherine A Janeway, Nita L Seibel, D Williams Parsons

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The NCI-COG Pediatric MATCH trial assigns patients age 1-21 years with relapsed or refractory solid tumors, lymphomas, and histiocytic disorders to phase II studies of molecularly targeted therapies on the basis of detection of predefined genetic alterations. Patients with tumors harboring mutations or fusions driving activation of the mitogen-activated protein kinase (MAPK) pathway were treated with the MEK inhibitor selumetinib.

Methods: Patients received selumetinib twice daily for 28-day cycles until disease progression or intolerable toxicity. The primary end point was objective response rate; secondary end points included progression-free survival and tolerability of selumetinib.

Results: Twenty patients (median age: 14 …

Actionable Tumor Alterations And Treatment Protocol Enrollment Of Pediatric And Young Adult Patients With Refractory Cancers In The National Cancer Institute-Children's Oncology Group Pediatric Match Trial, D Williams Parsons, Katherine A Janeway, David R Patton, Cynthia L Winter, Brent Coffey, P Mickey Williams, Sinchita Roy-Chowdhuri, Gregory J Tsongalis, Mark Routbort, Nilsa C Ramirez, Lauren Saguilig, Jin Piao, Todd A Alonzo, Stacey L Berg, Elizabeth Fox, Douglas S Hawkins, Jeffrey S Abrams, Margaret Mooney, Naoko Takebe, James V Tricoli, Nita L Seibel, Nci-Cog Pediatric Match Team

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The National Cancer Institute-Children's Oncology Group Pediatric MATCH trial aimed to facilitate evaluation of molecular-targeted therapies in biomarker-selected cohorts of childhood and young adult patients with cancer by screening tumors for actionable alterations.

Patients and methods: Tumors from patients age 1-21 years with refractory solid tumors, lymphomas, or histiocytic disorders were subjected to cancer gene panel sequencing and limited immunohistochemistry to identify actionable alterations for assignment to phase II treatment arms. The rates of treatment arm assignment and enrollment were compared between clinical and demographic groups.

Results: Testing was completed for 94.7% of tumors submitted. Actionable alterations were detected …

Assessing Smoking Status And Risk Of Sars-Cov-2 Infection: A Machine Learning Approach Among Veterans, Alice B S Nono Djotsa, Drew A Helmer, Catherine Park, Kristine E Lynch, Amir Sharafkhaneh, Aanand D Naik, Javad Razjouyan, Christopher I Amos

Center for Medical Ethics and Health Policy Staff Publications

The role of smoking in the risk of SARS-CoV-2 infection is unclear. We used a retrospective cohort design to study data from veterans' Electronic Medical Record to assess the impact of smoking on the risk of SARS-CoV-2 infection. Veterans tested for the SARS-CoV-2 virus from 02/01/2020 to 02/28/2021 were classified as: Never Smokers (NS), Former Smokers (FS), and Current Smokers (CS). We report the adjusted odds ratios (aOR) for potential confounders obtained from a cascade machine learning algorithm. We found a 19.6% positivity rate among 1,176,306 veterans tested for SARS-CoV-2 infection. The positivity proportion among NS (22.0%) was higher compared …

Is A Video Worth A Thousand Words?, Laura Kolbe, Ryan H Nelson, Joelle Robertson-Preidler, Olivia Schuman, Inmaculada De Melo-Martín

Faculty and Staff Publications

Bodily imagery elicits strong affective responses and is highly salient, potentially altering viewers' decision making. When clinicians engage surrogates in video calls showing the patient's body, several competing ethical issues must be considered. On the one hand, surrogates may require visual information to make informed decisions, and video technology closes crucial information gaps. On the other, video technology puts an increased amount of control in the hands of clinicians over how the patient's condition is perceived. This article explores some situations that can result in manipulation due to the affective impact of bodily images and the potential for selectivity and …

A Novel, De Novo Intronic Variant In Pogz Causes White-Sutton Syndrome, Ashanta Merriweather, David R Murdock, Jill A Rosenfeld, Hongzheng Dai, Shamika Ketkar, Lisa Emrick, Sarah Nicholas, Richard A Lewis, Undiagnosed Diseases Network, Carlos A Bacino, Daryl A Scott, Brendan Lee, Vernon Reid Sutton, Lorraine Potocki, Lindsay C Burrage

Center for Medical Ethics and Health Policy Staff Publications

White-Sutton syndrome (WHSUS), which is caused by heterozygous pathogenic variants in POGZ, is characterized by a spectrum of intellectual disabilities and global developmental delay with or without features of autism spectrum disorder. Additional features may include hypotonia, behavioral abnormalities, ophthalmic abnormalities, hearing loss, sleep apnea, microcephaly, dysmorphic facial features, and rarely, congenital diaphragmatic hernia (CDH). We present a 6-year-old female with features of WHSUS, including CDH, but with nondiagnostic clinical trio exome sequencing. Exome sequencing reanalysis revealed a heterozygous, de novo, intronic variant in POGZ (NM_015100.3:c.2546-20T>A). RNA sequencing revealed that this intronic variant leads to skipping of exon 18. …

Provider Perceptions Of Telehealth And In-Person Exposure And Response Prevention For Obsessive-Compulsive Disorder, Andrew D Wiese, Kendall N Drummond, Madeleine N Fuselier, Jessica C Sheu, Gary Liu, Andrew G Guzick, Wayne K Goodman, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Until recently, psychotherapies, including exposure and response prevention (ERP) for obsessive-compulsive disorder (OCD), have primarily been delivered in-person. The COVID-19 pandemic required OCD providers delivering ERP to quickly transition to telehealth services. While evidence supports telehealth ERP delivery, limited research has examined OCD provider perceptions about patient characteristics that are most appropriate for this modality, as well as provider abilities to identify and address factors interfering with effective telehealth ERP. In the present study, OCD therapists (N = 113) rated the feasibility of delivering telehealth ERP relative to in-person for different (1) patient age-groups, (2) levels of OCD severity, and …

A Validation Framework For Somatic Copy Number Detection In Targeted Sequencing Panels, Raghu Chandramohan, Jacquelyn Reuther, Ilavarasi Gandhi, Horatiu Voicu, Karla R Alvarez, Sharon E Plon, Dolores H Lopez-Terrada, Kevin E Fisher, D Williams Parsons, Angshumoy Roy

Center for Medical Ethics and Health Policy Staff Publications

Somatic copy number alterations (SCNAs) in tumors are clinically significant diagnostic, prognostic, and predictive biomarkers. SCNA detection from targeted next-generation sequencing panels is increasingly common in clinical practice; however, detailed descriptions of optimization and validation of SCNA pipelines for small targeted panels are limited. This study describes the validation and implementation of a tumor-only SCNA pipeline using CNVkit, augmented with custom modules and optimized for clinical implementation by testing reference materials and clinical tumor samples with different classes of copy number variation (CNV; amplification, single copy loss, and biallelic loss). Using wet-bench and in silico methods, various parameters impacting CNV …

The Role Of An Inpatient Hospice And Palliative Clinical Pharmacist In The Interdisciplinary Team, Jetavia Jones Moody, Ivy O Poon, Ursula K Braun

Center for Medical Ethics and Health Policy Staff Publications

Palliative care is a specialized health care service for individuals with serious illness at any stage and can be provided in any setting. Current national consensus developed by palliative care experts recommends the inclusion of pharmacists in an interdisciplinary team (IDT) to provide quality palliative care. However, national registry data report that less than 10% of inpatient palliative teams in the U.S. have a clinical pharmacist. Clinical pharmacists have an impactful role in palliative patients' quality of life by optimizing symptom management, deprescribing, and providing education to the palliative care team as well as patients and their families. In this …

Breast Cancer Diagnosis And Treatment During The Covid-19 Pandemic In A Nationwide, Insured Population, Jennifer L Caswell-Jin, Maryam N Shafaee, Lan Xiao, Mina Liu, Esther M John, Melissa L Bondy, Allison W Kurian

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The early months of the COVID-19 pandemic led to reduced cancer screenings and delayed cancer surgeries. We used insurance claims data to understand how breast cancer incidence and treatment after diagnosis changed nationwide over the course of the pandemic.

Methods: Using the Optum Research Database from January 2017 to March 2021, including approximately 19 million US adults with commercial health insurance, we identified new breast cancer diagnoses and first treatment after diagnosis. We compared breast cancer incidence and proportion of newly diagnosed patients receiving pre-operative systemic therapy pre-COVID, in the first 2 months of the COVID pandemic and in …

Investigation Of Urinary Metabolomics In A Phase I Hookworm Vaccine Trial In Gabon, Madeleine Eunice Betouke Ongwe, Yoanne D Mouwenda, Koen A Stam, Peter G Kremsner, Bertrand Lell, David Diemert, Jeff Bethony, Maria E Bottazzi, Peter J Hotez, Remko V Leeuwen, Martin P Grobusch, Ayola A Adegnika, Oleg A Mayboroda, Maria Yazdanbakhsh

Center for Medical Ethics and Health Policy Staff Publications

Metabolomics provides a powerful tool to study physiological changes in response to various perturbations such as vaccination. We explored whether metabolomic changes could be seen after vaccination in a phase I trial where Gabonese adults living either in rural or semi-urban areas received the subunit hookworm vaccine candidates (Na-GST-1 and Na-APR-1 (M74) adjuvanted with Alhydrogel plus GLA-AF (n = 24) or the hepatitis B vaccine (n = 8) as control. Urine samples were collected and assayed using targeted 1H NMR spectroscopy. At baseline, a set of metabolites significantly distinguished rural from semi-urban individuals. The pre- and post-vaccination comparisons indicated significant …

Fast Cbt For Pediatric Ocd: A Multiple-Baseline Controlled Pilot Trial Of Parent Training In Exposure And Response Prevention Delivered, Lara J Farrell, Natalja A Nabinger De Diaz, Sharna Mathieu, Matthew L Mckenzie, Taka Miyamoto, Caroline L Donovan, Allison M Waters, Sonja March, Nicole Bothma, Rianca Kroon, Gabrielle Simcock, Robert S Ware, Robert R Selles, Eric A Storch, Thomas Ollendick

Center for Medical Ethics and Health Policy Staff Publications

Objective: The current study utilized a single case series, non-concurrent multiple baseline design to examine the efficacy of training parents via telehealth videoconferencing in exposure and response prevention (ERP) for home delivery of the treatment for their children and adolescents with obsessive compulsive disorder (OCD).

Method: There were nine participants aged 8 to 14 years who had received a primary diagnosis of OCD. The design involved a series of AB replications, whereby following pre-treatment assessments participants were randomly assigned to either a 2-week (n = 4) or 3-week (n = 5) baseline condition with weekly monitoring of their …

Features Of Burnout Amongst Pathologists: A Reassessment, Michael B Cohen, Marisa Saint Martin, David J Gross, Kristen Johnson, Stanley J Robboy, Thomas M Wheeler, Rebecca L Johnson, W Stephen Black-Schaffer

Faculty, Staff and Students Publications

There has been little rigorous assessment of burnout among pathologists and pathology trainees. Given this relative dearth of relevant literature on pathologist burnout, this report aims to raise awareness of the issue among those working in and around this specialty. Our results are based on a survey given in conjunction with the American Board of Pathology's (ABPath) biennial Continuing Certification (CC) reporting of activities required of diplomates to maintain certification. The survey was voluntary, open to all diplomates participating in CC, and conducted over two consecutive years (2019 and 2020), with alternate years comprising different sets of diplomates. The data …

Creation Of A Global Vaccine Risk Index, Tasmiah Nuzhath, Peter J Hotez, Ashish Damania, P Shuling Liu, Brian Colwell

Center for Medical Ethics and Health Policy Staff Publications

The World Health Organization has identified vaccine hesitancy as one of its top ten global health threats for 2019. Efforts are underway to define the factors responsible for reductions in vaccine confidence. However, as global measles cases accelerated beginning in 2018, it became evident that additional factors were promoting measles re-emergence, including war, political and socio-economic collapse, shifting poverty, and vulnerability to weather events and climate change. Accordingly, we propose a Global Vaccine Risk Index (VRI) to consider these variables as a more comprehensive means to identify vulnerable nations where we might expect measles and other vaccine-preventable diseases to emerge …

Creating A Collaborative Trauma-Informed Interdisciplinary Citywide Victim Services Model Focused On Health Care For Survivors Of Human Trafficking, Juhi Jain, Mackenzie Bennett, Mark D Bailey, Daniel Liaou, Sheri-Ann O Kaltiso, Jordan Greenbaum, Kimberly Williams, Mollie R Gordon, Melissa I M Torres, Phuong T Nguyen, John H Coverdale, Victor Williams, Cayla Hari, Samantha Rodriguez, Temilola Salami, Jonell E Potter

Center for Medical Ethics and Health Policy Staff Publications

Although human trafficking is recognized as a public health issue, research on the health effects of human trafficking and best intervention practices is limited. We describe 2 citywide collaborative victim services models, the THRIVE (Trafficking, Healthcare, Resources, and Interdisciplinary Victim Services and Education) Clinic at the University of Miami and Jackson Health System in Miami, Florida, and the Greater Houston Area Pathways for Advocacy-based, Trauma-Informed Healthcare (PATH) Collaborative at Baylor College of Medicine, CommonSpirit Health, and San Jose Clinic in Houston, Texas, funded in part by the Office for Victims of Crime, which focus on trauma-informed health care delivery for …

A Mixed-Methods Protocol To Develop And Validate A Stewardship Maturity Matrix For Human Genomic Data In The Cloud, Vasiliki Rahimzadeh, Ge Peng, Mildred Cho

Center for Medical Ethics and Health Policy Staff Publications

This article describes a mixed-methods protocol to develop and test the implementation of a stewardship maturity matrix (SMM) for repositories which govern access to human genomic data in the cloud. It is anticipated that the cloud will host most human genomic and related health datasets generated as part of publicly funded research in the coming years. However, repository managers lack practical tools for identifying what stewardship outcomes matter most to key stakeholders as well as how to track progress on their stewardship goals over time. In this article we describe a protocol that combines Delphi survey methods with SMM modeling …

Post-Trial Access In Implanted Neural Device Research: Device Maintenance, Abandonment, And Cost, Gabriel Lázaro-Muñoz, Michelle T Pham, Katrina A Muñoz, Kristin Kostick-Quenet, Clarissa E Sanchez, Laura Torgerson, Jill Robinson, Stacey Pereira, Simon Outram, Barbara A Koenig, Philip A Starr, Aysegul Gunduz, Kelly D Foote, Michael S Okun, Wayne Goodman, Amy L Mcguire, Peter Zuk

Center for Medical Ethics and Health Policy Staff Publications

Background: Clinical trial participants who benefit from experimental neural devices for the treatment of debilitating and otherwise treatment-resistant conditions are generally not ensured continued access to effective therapy or maintenance of devices at the conclusion of trials.

Objective/hypothesis: Post-trial obligations have been extensively examined in the context of drug trials, but there has been little empirical examination of stakeholder perspectives regarding these obligations in the rapidly growing field of neural device research.

Methods: This study examined the perspectives of 44 stakeholders (i.e., 23 researchers and 21 patient-participants) involved in implantable neural device trials.

Results: Researchers were concerned about current post-trial …

Going Beyond The Data: Using Testimonies To Humanize Pedagogy On Black Health, Keisha S Ray

Faculty and Staff Publications

When health professions learners' primary pedagogical experience of Black people and how they become patients is through statistics, it becomes very easy for learners to think of Black people as data points rather than as individuals whose health is often at the mercy of racist institutions. When the human dimension of Black people's health is ignored, specifically the ways that poor health affects individual wellbeing, one of the barriers to proper health for Black patients is how to be seen and considered as a part of a larger problem of systemic racism and institutional injustices as well as individuals whose …

Strong Constraints From Cosine-100 On The Dama Dark Matter Results Using The Same Sodium Iodide Target, Govinda Adhikari, Estella B De Souza, Nelson Carlin, Jae Jin Choi, Seonho Choi, Mitra Djamal, Anthony C Ezeribe, Luis E França, Chang Hyon Ha, In Sik Hahn, Eunju Jeon, Jay Hyun Jo, Han Wool Joo, Woon Gu Kang, Matthew Kauer, Hyounggyu Kim, Hongjoo Kim, Kyungwon Kim, Sunghyun Kim, Sun Kee Kim, Won Kyung Kim, Yeongduk Kim, Yong-Hamb Kim, Young Ju Ko, Eun Kyung Lee, Hyunseok Lee, Hyun Su Lee, Hye Young Lee, In Soo Lee, Jaison Lee, Jooyoung Lee, Moo Hyun Lee, Seo Hyun Lee, Seung Mok Lee, Douglas Leonard, Bruno B Manzato, Reina H Maruyama, Robert J Neal, Stephen L Olsen, Byung Ju Park, Hyang Kyu Park, Hyeonseo Park, Kangsoon Park, Ricardo L C Pitta, Hafizh Prihtiadi, Sejin Ra, Carsten Rott, Keon Ah Shin, Andrew Scarff, Neil J C Spooner, William G Thompson, Liang Yang, Gyun Ho Yu

Faculty and Staff Publications

We present new constraints on dark matter interactions using 1.7 years of COSINE-100 data. The COSINE-100 experiment, consisting of 106 kg of tallium-doped sodium iodide [NaI(Tl)] target material, is aimed to test DAMA’s claim of dark matter observation using the same NaI(Tl) detectors. Improved event selection requirements, a more precise understanding of the detector background, and the use of a larger dataset considerably enhance the COSINE-100 sensitivity for dark matter detection. No signal consistent with the dark matter interaction is identified and rules out model-dependent dark matter interpretations of the DAMA signals in the specific context of standard halo model …

Beneficial Effects Of The 30-Minute Door-To-Needle Time Standard For Alteplase Administration, Suja S Rajan, Marquita Decker-Palmer, Jessica Wise, Thanh Dao, Cindy Salem, Sean I Savitz

Faculty and Staff Publications

Objective: The American Heart Association recently raised the bar on the timely treatment of acute ischemic stroke (AIS) with intravenous alteplase. Our study looks at the effectiveness of this new standard, by examining the effect of varying door-to-needle times of alteplase initiation on the clinical, quality of care, and efficiency of care outcomes.

Methods: This retrospective case-control study examined 752 AIS patients treated with intravenous alteplase in a large academic health system during 2015-2018, and compared their outcomes after treatment within 30, 45, and 60 min of arrival. The outcomes compared were: (1) clinical - discharge and 90-day modified Rankin …

Genetic Testing In Pregnancies With Ultrasound Anomalies: Exploration Of Factors That Influence Uptake, Lukas D. Kruidenier

Dissertations and Theses (Open Access)

Prenatal genetic diagnostic and screening tests have been rapidly evolving over the past decade with the introduction and expansion of cell free DNA screening (cfDNA) and the use of chromosomal microarray (CMA) as a first-line test for evaluation of fetal anomalies. Understanding patient motivations for or against expanded genetic testing options is paramount, therefore this study aimed to ascertain the patient perspective. Ninety-nine patients with an ultrasound anomaly participated in an anonymous, cross-sectional, research survey assessing coping strategies, factors influencing the genetic testing decision, and demographic variables. After multivariable analysis, the desire for directive counseling regarding testing was correlated with …

Safety And Immunogenicity Of The Oral, Inactivated, Enterotoxigenic Escherichia Coli Vaccine Etvax In Bangladeshi Children And Infants: A Double-Blind, Randomised, Placebo-Controlled Phase 1/2 Trial, Firdausi Qadri, Marjahan Akhtar, Taufiqur R Bhuiyan, Mohiul I Chowdhury, Tasnuva Ahmed, Tanzeem A Rafique, Arifuzzaman Khan, Sadia I A Rahman, Farhana Khanam, Anna Lundgren, Gudrun Wiklund, Joanna Kaim, Madeleine Löfstrand, Nils Carlin, A Louis Bourgeois, Nicole Maier, Alan Fix, Thomas Wierzba, Richard I Walker, Ann-Mari Svennerholm

Faculty and Staff Publications

Background: Enterotoxigenic Escherichia coli causes diarrhoea, leading to substantial mortality and morbidity in children, but no specific vaccine exists. This trial tested an oral, inactivated, enterotoxigenic E coli vaccine (ETVAX), which has been previously shown to be safe and highly immuongenic in Swedish and Bangladeshi adults. We tested the safety and immunogenicity of ETVAX, consisting of four E coli strains overexpressing the most prevalent colonisation factors (CFA/I, CS3, CS5, and CS6) and a toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT) as an adjuvant, in Bangladeshi children.

Methods: We did a randomised, double-blind, placebo-controlled, dose-escalation, age-descending, phase …

Is Whole-Exome Sequencing An Ethically Disruptive Technology? Perspectives Of Pediatric Oncologists And Parents Of Pediatric Patients With Solid Tumors, Laurence B Mccullough, Melody J Slashinski, Amy L Mcguire, Richard L Street, Christine M Eng, Richard A Gibbs, D William Parsons, Sharon E Plon

Faculty, Staff and Students Publications

BACKGROUND: It has been anticipated that physician and parents will be ill prepared or unprepared for the clinical introduction of genome sequencing, making it ethically disruptive.

PROCEDURE: As a part of the Baylor Advancing Sequencing in Childhood Cancer Care study, we conducted semistructured interviews with 16 pediatric oncologists and 40 parents of pediatric patients with cancer prior to the return of sequencing results. We elicited expectations and attitudes concerning the impact of sequencing on clinical decision making, clinical utility, and treatment expectations from both groups. Using accepted methods of qualitative research to analyze interview transcripts, we completed a thematic analysis …

Attitudes Of Parents At Risk Of Inheriting Li-Fraumeni Syndrome To Wards Predictive Genetic Testing In Their Minor-Aged Children., Leslie A. Newman

Dissertations and Theses (Open Access)

Li-Fraumeni Syndrome (LFS) is a hereditary cancer syndrome which predisposes individuals to cancer beginning in childhood. These risks are spread across a lifetime, from early childhood to adulthood. Mutations in the p53 tumor suppressor gene are known to cause the majority of cases of LFS. The risk for early onset cancer in individuals with Li-Fraumeni Syndrome is high. Studies have shown that individuals with LFS have a 90% lifetime cancer risk. Children under 18 have up to a 15% chance of cancer development. Effectiveness of cancer screening and management in individuals with Li-Fraumeni Syndrome is unclear. Screening for LFS-associated cancers …