Bioethics and Medical Ethics Commons^™

Differences Between Government, Consortium, And Private Database Stewards Impacting The Genomic Data Market: A Survey Of U.S. Academic Genetic Researchers., Amanda K Greene, J Denard Thomas, Kaitlyn Jaffe, Luyun Chen, Kerry A Ryan, Brian J Zikmund-Fisher, J Scott Roberts, Amy L Mcguire, Katherine Hendy, Kayte Spector-Bagdady

Center for Medical Ethics and Health Policy Staff Publications

Background: Despite major shifts in U.S. federal government data sharing requirements, their impact, and relation to researcher choice of database, are underexplored. This study surveyed genetic researchers regarding trends, priorities, perceptions of quality, impact on research outcomes, and genomic data sharing and use across government, consortium, and private databases.

Methods: As part of an exploratory sequential mixed methods project, we surveyed 294 U.S.-based genomic academic researchers.

Results: Genetic researchers generally have a choice between databases, which allows them to prioritize data quality. This might explain recent trends toward the use of government and consortium databases away from private ones. Respondents …

Can I Get A Witness? The Ethical Dimensions Of Family Presence In Patient Suffering, Jennifer Blumenthal-Barby, Trevor M Bibler, Holland Kaplan, Adam Omelianchuk, Joanna Smolenski

Center for Medical Ethics and Health Policy Staff Publications

For patients who are suffering, the bedside presence of a family member can provide comfort, and many people hold that there is moral value in being present with a conscious, suffering patient. Yet what is the moral significance of the absence of family members when a patient is minimally conscious or unconscious and not aware of their absence? Clinicians are often troubled when family members and surrogate decision-makers who are able to spend a significant amount of time at an unconscious, seriously ill patient's bedside do not do so. Clinicians feel frustrated that they must bear the burden of witnessing …

Putting The L In Elsi: Legal Methods For Bioethics Research, Anya E R Prince, Benjamin Berkman, Donald Ford, Dov Fox, Christi Guerrini, Amy Koopmann, Natalie Ram, Jessica L Roberts, Kayte Spector-Bagdady, Sonia Suter

Center for Medical Ethics and Health Policy Staff Publications

Lawyers and law professors are increasingly involved in interdisciplinary scientific teams and grant research to answer ethical, legal and policy questions related to biomedical topics. Yet, the methods that lawyers use to conduct legal research and analysis are not always familiar to scientists and social scientists conducting peer review of a proposed project with legal aims or a publication reporting a legal study. To better facilitate interdisciplinary ethical, legal, and social implications collaboration, there is a need to better explain how legal research methodologies can provide robust tools to address a range of nuanced biomedical questions. This paper explores …

Toward Ethical Provenance Tracking: The Ga4gh Model Data Access Agreement (Daa), Alexander Bernier, Bartha Maria Knoppers, Jonathan Lawson, Robyn Mcdougall, Maili Raven-Adams, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Standardizing contractual clauses that govern data access enables research institutions to responsibly steward genomic and related health data while enabling its efficient downstream reuse.

Methods: We describe a document analysis study using both qualitative and comparative law analytical approaches to identify the most common categories of clauses from 29 different data access agreements used by human biomedical research consortia globally. We furthermore characterized the legal positions and standard practices for each common element of the agreement and synthesized across them to develop model clauses. A total of 3 discussion sessions were organized virtually to refine the clauses among members …

Imagining Genomics And Population Health In 2050: Anticipating Future Research, Policy, And Governance Needs, Bartha Maria Knoppers, Yann Joly, Ma Apos N H Zawati, Habiba Alsafar, Jeffrey C Barrett, Laura Blackburn, Brian Hon-Yin Chung, Martina C Cornel, Edward S Dove, David Glazer, Calvin Wai-Loon Ho, Muin J Khoury, Anna C F Lewis, Anneke Lucassen, Peter F R Mills, Colin Mitchell, Nicola Mulder, Ainsley J Newson, Anthony Ng, Paul D P Pharoah, Vasiliki Rahimzadeh, Megan C Roberts, Saskia C Sanderson, Jeffrey M Skopek, Ron Zimmern, Eric M Meslin

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Access To Digital Health Technologies: Personalized Framework And Global Perspectives, Sanjiv M Narayan, Mina K Chung, Demilade Adedinsewo, Luisa C C Brant, Leslie L Davis, David Duncker, Jennifer L Hall, Janet K Han, Carolyn S P Lam, Eldrin Lewis, Joseph Loscalzo, Manlio F Márquez, Vasiliki Rahimzadeh, Fatima Rodriguez, Prashanthan Sanders, Emma Svennberg, Kenneth Stein, Mintu Turakhia, Clyde Yancy, Antonis A Armoundas

Center for Medical Ethics and Health Policy Staff Publications

The emergence and rapid adoption of digital health technologies (DHT) present unprecedented opportunities to democratize and reduce disparities in health care by monitoring health and disease at the point of care in all patients. However, limited access to DHT is becoming a major obstacle to realizing these goals. Access to DHT is influenced not only by well-recognized social determinants of health, but also by digital determinants of health, such as digital literacy and the need for broad access to digital infrastructure, as well as commercial and economic factors. Addressing these challenges and designing unbiased systems of care are essential to …

Clinicians’ Views On A Patient Decision Aid For Deep Brain Stimulation In Parkinson’S Disease, Hillary S King, Jennifer Blumenthal-Barby, Benjamin H Levi, Sol De Jesus, Harini Sarva, Laura Y Cabrera

Center for Medical Ethics and Health Policy Staff Publications

Introduction: For people with Parkinson's disease (PD), deciding whether to pursue deep brain stimulation (DBS) has become increasingly complex. Evidence suggests current approaches to collaborative decision-making may fall short of accepted standards. Thus, a decision support intervention, such as a patient decision aid (PtDA) may be warranted. PtDAs have been shown to improve patients' knowledge, expectations, and participation in decision-making for other, similar healthcare decisions. We therefore sought to assess neurologists' awareness of, and experience using, PtDAs, and to solicit their opinions on the ideal features of a PtDA for PD patients considering DBS.

Methods: Sixteen United States-based neurology clinicians …

Organ Chips And Translational Research: Identifying And Examining New Ethical Issues, Melanie Jeske

Center for Medical Ethics and Health Policy Staff Publications

Organ chips, also known as organ-on-a-chip devices, tissue chips, or microphysiological systems, have emerged over the last decade as a promising translational technology amidst growing concern about the translational crisis between laboratory research and patient bedside. Pointing to high rates of failure between nonhuman animal models and safety and efficacy in humans, organ chips and similar new approach methods have attracted substantial public and private investment. As human-cell-based alternatives to animal models, organ chips promise more predictive, efficient, and ethical platforms for pharmaceutical and toxicity testing. Engineered cultivation systems that enable cells to assemble into tissue-like structures (e.g. kidney, brain, …

Systematic Review: Burnout In Health Care Professionals, Nicolas X. Tovar

The Journal of Purdue Undergraduate Research

No abstract provided.

A Narrative Review Of Dual Loyalty Conflicts In Custodial Settings And Implications For Community Practice, Michelle Suh, Marc David Robinson, Holland Kaplan

Center for Medical Ethics and Health Policy Staff Publications

Dual loyalty dilemmas are conflicts between health care professionals' obligations toward their patients and third-party interests. These conflicts are more common and starker in custodial settings, such as jails and prisons, military detention facilities, immigration detention centers, and involuntary psychiatric institutions. Despite encountering patients in custody, health care professionals (HCPs) in community settings have limited knowledge and training. In this narrative review, we examined dual loyalty conflicts faced by HCPs working in custodial settings and then applied the identified themes to community-based hospitals where HCPs care for patients in custody. We searched databases for original papers relating to patients in …

Survey Of U.S. Reproductive Medicine Clinicians’ Attitudes On Polygenic Embryo Screening, Rémy A Furrer, Dorit Barlevy, Aayushi Gandhi, Shai Carmi, Todd Lencz, Stacey Pereira, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

Polygenic embryo screening (PES) is used to screen embryos for their genetic likelihood of developing complex conditions and traits. We surveyed 152 U.S. reproductive endocrinology and infertility specialists (REIs) on their views of PES. While most respondents (97%) were at least slightly familiar with PES, general approval of PES was low (12%), with the majority expressing disapproval (46%) or uncertainty (42%). A majority (58%) believed risks outweigh benefits, while only 16% felt benefits outweigh risks. Most clinicians (85-77%) were very or extremely concerned about low accuracy, confusion over results, false expectations, and eugenics. Nonetheless, when asked to vote on whether …

When 'More Isn't More': The Normative And Practical Case For Improving Genetic Data Infrastructure, Sofia Labrecque, Jonathan Lawson, Bronwyn Danielle Walsh, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

A Historical Cohort Comparison After Inpatient Admission For Adolescents With Anorexia Nervosa: Feasibility Of Virtual Group Therapy, Elizabeth V Franklin, Margaret Mathias, Rachel Wolfe, Duc T Nguyen, Drusilla M Rosales, Sofia Pedroza, Albert C Hergenroeder, Constance M Wiemann

Center for Medical Ethics and Health Policy Staff Publications

Objective: Access to follow-up care after a medical admission for adolescents with anorexia nervosa (AN) is important; yet access can be delayed or unavailable. This study assessed the feasibility and acceptability of a supplemental virtual 8-week outpatient group therapy program following inpatient care. A secondary aim explored the outpatient program's impact on self-reported anxiety, disordered eating, and depression symptoms, and readmission rates.

Method: A retrospective chart review study compared 68 adolescents (aged 11-18) with AN enrolled in an 8-week group therapy program (Recovery and Prevention Program [RAPP]) to 64 adolescents who were not enrolled in RAPP (historical cohort). "RAPP completers" …

Real-World Use Of Classic And Non-Classic Psychedelics In Hispanic/Latino Adults With Obsessive-Compulsive Disorder: International Findings From The Latino Study, David S Mathai, Jill O Robinson, Kevin Wagner, Logan Neitzke-Spruill, Dayan Berrones, Jacey L Anderberg, Renee M Frederick, Vanessa Zavala Cruz, Josselyn S Muñoz, Latin American Trans-Ancestry Initiative For Ocd Genomics, Brazilian Obsessive-Compulsive Spectrum Disorder Working Group;, Carolyn I Rodriguez, Lynnette A Averill, James J Crowley, Eric A Storch, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Objective: Despite growing research on the potential mental health benefits of psychedelics, there has been limited study of these drugs in populations with obsessive-compulsive disorder (OCD) and with Hispanic and Latin American (H/L) ancestry.

Methods: Demographic and clinical assessments were conducted as part of the Latin American Trans-ancestry Initiative for OCD genomics (LATINO) Study in H/L participants with OCD living throughout the Americas. Self-reported data on the prevalence of naturalistic psychedelic use and associated outcomes on OCD symptoms were collected in a subsample of 2,639 adults. Descriptive statistics and regression analyses were used to assess psychedelic use, predictors of use, …

A Qualitative Exploration Of Child, Caregiver, And Clinician Perspectives On Mental Health In Children With Osteogenesis Imperfecta, Justin H Qian, Andrew D Wiese, Clarissa Gonzalez, Whitney S Shepherd, Hannah Cho, Gianna M Colombo, Julia M Morales, Selena Guo, Kristin M Kostick-Quenet, Dianne Nguyen, Sophie C Schneider, Kara Ayers, Members Of The Bbdc, Marie-Eve Robinson, Chaya N Murali, Brendan Lee, V Reid Sutton, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Osteogenesis imperfecta (OI) is a heritable connective disorder with clinical manifestations including bone fragility and short stature. Previous research identified psychosocial themes related to mental health among children with OI and their caregivers, such as independence, social isolation, depression, and anxiety. Several studies have also examined clinicians of individuals with OI for their perspectives on mental health among their patients. However, no known studies have compared psychosocial themes among all three participant groups concurrently. This qualitative study examined mood and anxiety, along with risk and protective factors, from perspectives of youths, parents, and clinicians. Semi-structured interviews were conducted, which were …

Eugenics And Polygenic Embryo Screening: Public, Clinician, And Patient Perceptions Of Conditions Versus Traits, Dorit Barlevy, Rémy A Furrer, Asha Kalapatapu, Abigail Martinez, Todd Lencz, Shai Carmi, Gabriel Lázaro-Muñoz, Stacey Pereira

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Polygenic embryo screening (PES) estimates an embryo's genetic chances of developing complex conditions (eg, cancer) and traits (eg, height). Stakeholders have raised concerns that PES promotes eugenic practices and ideology.

Methods: We surveyed a nationally representative sample of the US public on approval of screening embryos for 12 conditions and 12 traits and examined the association between disapproval and concern about eugenics. We also conducted semistructured interviews with US-based reproductive endocrinology and infertility specialists and patients undergoing in vitro fertilization on their perspectives toward PES.

Results: Among the US public (n = 1423), disapproval of screening embryos for traits …

The Ethics Of Clinical Ethics, Matthew Shea

Center for Medical Ethics and Health Policy Staff Publications

The concept ethics defines health care ethics as a professional practice. Yet the meaning of "ethics" is often unclear in the theory and practice of clinical ethics. Clarity on this matter is crucial for understanding the nature of clinical ethics and for debates about the professional identity and proper role of ethicists, the sort of training and skills they should possess, and whether they have ethics expertise. This article examines two different ways the ethics of clinical ethics can be understood: Real Ethics, which consists of objective moral norms grounded in moral truth; and Conventional Ethics, which consists of conventional …

Governance Of Polygenic Embryo Screening: A Qualitative Study On The Perspectives Of Clinicians And Patients, Jason Bach, Jonathan Frumovitz, Dorit Barlevy, Rémy A Furrer, Abigail Martinez, Ana Battaglino, Shai Carmi, Todd Lencz, Gabriel Lázaro-Muñoz, Stacey Pereira

Center for Medical Ethics and Health Policy Staff Publications

Objective: To investigate the perspectives of stakeholders on their attitudes toward potential regulation of polygenic embryo screening (PES), a new form of preimplantation genetic testing that is used to screen embryos for the genetic chances of developing medical conditions and nonmedical traits involving hundreds or thousands of genes.

Design: We conducted individual, semistructured interviews and analyzed transcripts using thematic analysis.

Subjects: Twenty-seven US-based reproductive endocrinology and infertility specialists and 26 patients who were currently undergoing in vitro fertilization or had within the past five years.

Main outcome measures: Repeating ideas and patterned responses were organized into themes and subthemes.

Results: …

Factors Associated With Adolescents' Self-Efficacy To Meet With Their Health Care Provider Alone, Albert C Hergenroeder, Blanca Sanchez-Fournier, Cassandra Enzler, Mary Majumder, Beth H Garland, Constance M Wiemann

Center for Medical Ethics and Health Policy Staff Publications

Adolescents with special health care needs (ASHCNs) must develop self-management skills to effectively transition into adult-based care. This requires having the self-efficacy to meet with their health care provider independent of caregivers. This study aims to identify the factors associated with self-efficacy in meeting with a provider alone among ASHCN preparing for this transition.Eighty-three English-speaking 18-year olds with renal, gastrointestinal, neurologic, or rheumatologic diseases, and their English- or Spanish-speaking caregivers were recruited at a large children's hospital, and completed a one-time assessment as the historical control group for a larger intervention study. The main outcome measure was self-efficacy to meet …

Osteogenesis Imperfecta And The Family: A Qualitative Analysis Of The Experiences Of Family And Caregivers, Gianna M Colombo, Andrew D Wiese, Amelia E Mercado, Whitney S Shepherd, Michelle Fynan, Kara Ayers, W Conor Rork, Kristin M Kostick-Quenet, Dianne Nguyen, Sophie C Schneider, Julia M Morales, Saniah I Kazimi, Hannah E Cho, Members Of The Bbdc, Chaya N Murali, Marie-Eve Robinson, Brendan Lee, V Reid Sutton, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Osteogenesis imperfecta (OI) describes a group of rare, heritable bone disorders causing bone fragility, tendency to fracture with minimal trauma, and chronic pain due to abnormal collagen synthesis. Limited research exists on the psychosocial impact of OI during childhood on caregivers and families.

Purpose: This study aimed to understand caregiver experiences, existing social support provided for families affected by OI, and the impact of OI on family life.

Method: Thirteen caregivers of individuals with OI participated in semistructured interviews. Researchers coded, abstracted, and analyzed qualitative data to develop themes on the psychosocial impact of OI on the family unit. …

Against The Phrase "Aggressive Care", Trevor M Bibler

Center for Medical Ethics and Health Policy Staff Publications

Language is the primary technology clinical ethicists use as they offer guidance about norms. Like any other piece of technology, to use the technology well requires attention, intention, skill, and knowledge. Word choice becomes a matter of professional practice. The Brief Report offers clinical ethicists several reasons for rejecting the phrase "aggressive care." Instead, ethicists should consider replacing "aggressive care" with the adjacent concept of a "recovery-focused path." The virtues of this neologism include: the opportunity to set aside the emotion of "aggression," the phrase's accuracy when capturing the intention of the patient or their representative, and an unappreciated rhetorical …

Sequencing-Based Detection Of Measles In Wastewater: Texas, January 2025, Sara Javornik Cregeen, Michael J Tisza, Blake Hanson, Marissa Cook, Anil Surathu, Rebecca Schneider, Jingjing Wu, Kirstin Short, Kaavya Domakonda, Loren Hopkins, Matthew C Ross, Joseph F Petrosino, Jennifer Deegan, Lauren B Stadler, Eric Boerwinkle, Anthony Maresso

Center for Medical Ethics and Health Policy Staff Publications

Measles is a potentially deadly viral infection spread via respiratory droplets from infected individuals. Outbreaks occur when vaccine coverage drops below the threshold of herd, or community, immunity. Using a sequencing-based approach, we report the prospective (January 7, 2025) detection of measles in nucleic acid extracts from 2 wastewater treatment plants in Houston, Texas, with a population of more than 218 000 residents. The sequencing data from 2 samples contained 53 unique reads mapping to 11 different regions of the measles virus genome with a 99.4% match to genotype B3. Importantly, no detections were observed from 821 previous samples from …

A Phase 2 Trial Of Short-Term Intravenous N-Acetylcysteine In Biliary Atresia After Kasai Portoenterostomy, Sanjiv Harpavat, Kristin A Borovsky, Michael E Scheurer, Laurel Cavallo, Franca E Erhiawarie, Sanjeev Vasudevan, Adam M Vogel, Dana Cerminara, Elizabeth M Tessier, Kalyani R Patel, Sridevi Devaraj, Benjamin L Shneider

Center for Medical Ethics and Health Policy Staff Publications

Background: For infants with biliary atresia, the only treatment that can establish bile flow and delay need for liver transplant is the Kasai portoenterostomy (KP). Unfortunately, the KP has variable success. In this study, we hypothesized that intravenous N-acetylcysteine (IV NAC) treatment following KP would improve bile flow.

Methods: This was a phase 2 study following the two-stage "minimax" trial design. Participants received IV NAC (150 mg/kg/day) for 7 days after KP, and the primary endpoint was achieving total serum bile acids (TSBA) ≤10 μmol/L within 24 weeks of KP. Secondary endpoints were clinical markers and the occurrence of sentinel …

"Holy Cow, Where Do I Sign Up?" Attitudes Of Military Veterans Toward Epigenomic Biomarker Toxic Exposure Testing, Stacey Pereira, Calvin Apodaca, Kyle Slominski, Rachele K Lipsky, Cristian Coarfa, Cheryl L Walker, Amy L Mcguire, Lea Steele, Drew A Helmer

Center for Medical Ethics and Health Policy Staff Publications

Introduction: After the Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics Promise to Address Comprehensive Toxics (PACT) Act in 2022, there has been a great interest in studying toxic exposures encountered during military service. Development of epigenomic biomarkers for exposures could facilitate understanding of exposure-related health effects, but such testing could also provide unwanted information.

Materials and methods: We explored attitudes toward epigenomic biomarker research and the potential to test for past exposures using semistructured interviews with Veterans (n = 22) who experienced potentially harmful exposures.

Results: Twenty Veterans said they would hypothetically want to receive …

Multiscale Modeling Of Drug-Induced Liver Injury From Organ To Lobule, Alon Malka-Markovitz, Stelian Camara Dit Pinto, Mohammed Cherkaoui, Steven M Levine, Sharmila Anandasabapathy, Gagan K Sood, Sadhna Dhingra, Gao Yujia, John M Vierling, Nicolas R Gallo

Center for Medical Ethics and Health Policy Staff Publications

Drug-induced liver injury poses significant challenges in drug development and in clinical care. This study builds on prior work developing a Human Liver Virtual Twin by creating a Multiscale Computational Fluid Dynamics framework that integrates patient-specific anatomical data to predict acetaminophen-induced liver injury as a demonstration of its capability. The model bridges vascular, lobular, and cellular scales to simulate dynamic blood flow, drug transport, and injury mechanisms that accurately reflect clinically observed spatial heterogeneity. Results demonstrate accurate blood flow dynamics, predictions of hepatocellular damage, and a scalable framework for studying spatial heterogeneity applicable to other hepatic pathologies. This work establishes …

Comparative Effects Of Combustible Cigarette Versus Electronic Cigarette Exposures On Kras Mutant Lung Cancer Promotion, Walter V Velasco, Maria T Grimaldo, Nastaran Karimi, Michael J Clowers, Avantika Krishna, Ranran Wu, Rahmah Ejaz, Bo Yuan, Segundo Del Aguila, Iman Bouchelkia, Javier Eduardo Moreno Barragan, Katherine E Larsen, Yasmina Rezai, Farbod Khalaj, Kyler Mitra, Carlos Reyna Rodriguez, Ricardo Millares, Angelica Baca De Anda, Susana Castro-Pando, Umesh C Karandikar, Joseph F Petrosino, Florencia Mcallister, Humam Kadara, Edwin J Ostrin, Johannes F Fahrmann, Kristi Louise Hoffman, Seyed Javad Moghaddam

Center for Medical Ethics and Health Policy Staff Publications

Despite the emerging public health concern related to the use of electronic cigarette vapors (ECV), its impact on lung cancer is poorly understood. We assessed the effect of ECV on lung tumorigenesis in a mouse model of lung adenocarcinoma. Mice were exposed to either room air, combustible cigarette smoke (CCS), or ECV 2 hours daily for 8 weeks at which lung samples were harvested and studied for different outcomes. We found that CCS, but not ECV, led to a significant increase in tumor burden. Immunophenotyping of both CCS- and ECV-exposed lungs displayed pronounced pro-tumor immunosuppressive phenotypes, characterized by significantly decreased …

Attitudes Toward Pig Islet Xenotransplantation For Type 1 Diabetes: A Scoping Review, Daniel J Hurst, Daniel Rodger, Luz A Padilla, Fernando Ovalle

Rowan-Virtua School of Osteopathic Medicine Departmental Research

BACKGROUND: Over 8 million people globally have type 1 diabetes. Islet allotransplantation offers an alternative to insulin therapy but is constrained by donor availability. Genetically modified pig islet transplantation presents a potential solution, yet understanding stakeholder attitudes is crucial before clinical adoption.

METHODS: This scoping review followed Joanna Briggs Institute methodology and PRISMA guidelines. CINAHL, EMBASE, PubMed, PsychINFO, and SCOPUS were searched for studies examining attitudes toward pig islet xenotransplantation among patients, healthcare workers, and other stakeholders.

RESULTS: From 199 sources, 16 met eligibility criteria, spanning ten countries from 2003 to 2023. The 23,780 participants included 1,535 (6.5%) patients/family members, …

Self-Collection For Cervical Cancer Screening In A Safety-Net Setting: The Prestis Randomized Clinical Trial, Jane R Montealegre, Susan G Hilsenbeck, Shaun Bulsara, Susan L Parker, Trisha L Amboree, Matthew L Anderson, Maria Daheri, Maria L Jibaja-Weiss, Kathleen M Schmeler, Ashish A Deshmukh, Elizabeth Y Chiao, Michael E Scheurer

Center for Medical Ethics and Health Policy Staff Publications

Importance: There are limited data on the effectiveness of mailed self-collection to increase cervical cancer screening (CCS) participation in underresourced health care settings.

Objective: To compare the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone reminders to increase CCS in a safety-net health system.

Design, setting, and participants: This pragmatic, parallel, single-blinded, randomized clinical trial within a publicly funded safety-net health system in Houston, Texas, compared (1) telephone reminder (TR) for clinic-based screening, (2) TR with mailed self-collection (SC), and (3) TR with mailed SC and patient navigation among a random sample of CCS-eligible patients not …

Prediction Of Methotrexate Neurotoxicity Using Clinical, Sociodemographic, And Area-Based Information In Children With Acute Lymphoblastic Leukemia, Rachel D Harris, Olga A Taylor, Maria Monica Gramatges, Amy E Hughes, Mark Zobeck, Sandi Pruitt, M Brooke Bernhardt, Ashley Chavana, Van Huynh, Kathleen Ludwig, Laura Klesse, Kenneth Heym, Timothy Griffin, Rodrigo Erana, Juan Carlos Bernini, Ashley Choi, Yuu Ohno, Melissa A Richard, Alanna C Morrison, Han Chen, Bing Yu, Philip J Lupo, Karen R Rabin, Michael E Scheurer, Austin L Brown

Center for Medical Ethics and Health Policy Staff Publications

Background: Methotrexate is a critical component of pediatric acute lymphoblastic leukemia (ALL) therapy that can result in neurotoxicity which has been associated with an increased risk of relapse. We leveraged machine learning to develop a neurotoxicity risk prediction model in a diverse cohort of children with ALL.

Methods: We included children (age 2-20 years) diagnosed with ALL (2005-2019) and treated in Texas without pre-existing neurologic disease. Clinical information was obtained by medical record review. Neurotoxicity occurring post-induction and prior to maintenance therapy was defined as neurologic episodes occurring within 21 days of methotrexate. Suspected cases were independently confirmed by 2 …

Maternal Loss Of Mouse Nlrp2 Alters The Transcriptome And Dna Methylome In Gv Oocytes And Impairs Zygotic Genome Activation In Embryos, Zahra Anvar, Michael D Jochum, Imen Chakchouk, Momal Sharif, Hannah Demond, Alvin K To, Daniel C Kraushaar, Ying-Wooi Wan, Michael C Mari, Simon Andrews, Gavin Kelsey, Ignatia B Van Den Veyver

Center for Medical Ethics and Health Policy Staff Publications

Background: NLRP2 is a subcortical maternal complex (SCMC) protein of mammalian oocytes and preimplantation embryos. SCMC proteins are encoded by maternal effect genes and play a pivotal role in the maternal-to-zygotic transition (MZT), early embryogenesis, and epigenetic (re)programming. Maternal inactivation of genes encoding SCMC proteins has been linked to infertility and subfertility in mice and humans, but the underlying molecular mechanisms for the diverse functions of SCMC proteins, and specifically the role of NLRP2, are incompletely understood.

Results: We profiled the DNA methylome of pre-ovulatory germinal-vesicle (GV) oocytes from Nlrp2-null, heterozygous (Het), and wild-type (WT) female mice and assessed the …