Health Policy Commons^™

Impact Of Efavirenz On Hormone-Positive Breast Cancer Survival In Women Living With Hiv, Arthur T Johnson, Taolo Ntloedibe, Jose Euberto Mendez Reyes, Mogomotsi S Matshaba, Scott L Dryden-Peterson, Elizabeth Y Chiao

Center for Medical Ethics and Health Policy Staff Publications

Women living with HIV and breast cancer have poorer survival than HIV-negative women. Efavirenz-estrogen interactions are documented; however, the survival impact is unknown. Survival between women with estrogen-receptor positive breast cancer taking efavirenz (n = 38) and nonefavirenz regimens (n = 51) were compared. The 5-year overall-survival was 48.9% [95% confidence interval (CI) 33.0-72.2 and 51.1% (95% CI 34.0-76.8)] in the efavirenz and nonefavirenz groups, respectively suggesting efavirenz is unlikely driving poorer survival in women living with HIV and estrogen-receptor positive breast cancer.

The Impact Of Clinical Genome Sequencing In A Global Population With Suspected Rare Genetic Disease, Erin Thorpe, Taylor Williams, Chad Shaw, Evgenii Chekalin, Julia Ortega, Keisha Robinson, Jason Button, Marilyn C Jones, Miguel Del Campo, Donald Basel, Julie Mccarrier, Laura Davis Keppen, Erin Royer, Romina Foster-Bonds, Milagros M Duenas-Roque, Nora Urraca, Kerri Bosfield, Chester W Brown, Holly Lydigsen, Henry J Mroczkowski, Jewell Ward, Fabio Sirchia, Elisa Giorgio, Keith Vaux, Hildegard Peña Salguero, Aimé Lumaka, Gerrye Mubungu, Prince Makay, Mamy Ngole, Prosper Tshilobo Lukusa, Adeline Vanderver, Kayla Muirhead, Omar Sherbini, Melissa D Lah, Katelynn Anderson, Jeny Bazalar-Montoya, Richard S Rodriguez, Mario Cornejo-Olivas, Karina Milla-Neyra, Marwan Shinawi, Pilar Magoulas, Duncan Henry, Kate Gibson, Samuel Wiafe, Parul Jayakar, Daria Salyakina, Diane Masser-Frye, Arturo Serize, Jorge E Perez, Alan Taylor, Shruti Shenbagam, Ahmad Abou Tayoun, Alka Malhotra, Maren Bennett, Vani Rajan, James Avecilla, Andrew Warren, Max Arseneault, Tasha Kalista, Ali Crawford, Subramanian S Ajay, Denise L Perry, John Belmont, Ryan J Taft

Center for Medical Ethics and Health Policy Staff Publications

There is mounting evidence of the value of clinical genome sequencing (cGS) in individuals with suspected rare genetic disease (RGD), but cGS performance and impact on clinical care in a diverse population drawn from both high-income countries (HICs) and low- and middle-income countries (LMICs) has not been investigated. The iHope program, a philanthropic cGS initiative, established a network of 24 clinical sites in eight countries through which it provided cGS to individuals with signs or symptoms of an RGD and constrained access to molecular testing. A total of 1,004 individuals (median age, 6.5 years; 53.5% male) with diverse ancestral backgrounds …

Olaparib For Childhood Tumors Harboring Defects In Dna Damage Repair Genes: Arm H Of The Nci-Cog Pediatric Match Trial, Julia L Glade Bender, Kerice Pinkney, Paul M Williams, Sinchita Roy-Chowdhuri, David R Patton, Brent D Coffey, Joel M Reid, Jin Piao, Lauren Saguilig, Todd A Alonzo, Stacey L Berg, Nilsa C Ramirez, Elizabeth Fox, Brenda J Weigel, Douglas S Hawkins, Margaret M Mooney, Naoko Takebe, James V Tricoli, Katherine A Janeway, Nita L Seibel, Donald W Parsons

Center for Medical Ethics and Health Policy Staff Publications

Background: The National Cancer Institute-Children's Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) precision oncology platform trial enrolled children aged 1-21 years with treatment-refractory solid tumors and predefined actionable genetic alterations. Patients with tumors harboring alterations in DNA damage repair (DDR) genes were assigned to receive olaparib.

Methods: Tumor and blood samples were submitted for centralized molecular testing. Tumor and germline sequencing were conducted in parallel. Olaparib was given twice daily for 28-day cycles starting at a dose 30% lower than the adult recommended phase 2 dose (RP2D). The primary endpoint was the objective response.

Results: Eighteen patients matched …

Lethal Phenotypes In Mendelian Disorders, Pilar Cacheiro, Samantha Lawson, Ignatia B Van Den Veyver, Gabriel Marengo, David Zocche, Stephen A Murray, Michael Duyzend, Peter N Robinson, Damian Smedley

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Existing resources that characterize the essentiality status of genes are based on either proliferation assessment in human cell lines, viability evaluation in mouse knockouts, or constraint metrics derived from human population sequencing studies. Several repositories document phenotypic annotations for rare disorders; however, there is a lack of comprehensive reporting on lethal phenotypes.

Methods: We queried Online Mendelian Inheritance in Man for terms related to lethality and classified all Mendelian genes according to the earliest age of death recorded for the associated disorders, from prenatal death to no reports of premature death. We characterized the genes across these lethality categories, …

Post-Trial Responsibilities In Pragmatic Clinical Trials: Fulfilling The Promise Of Research To Drive Real-World Change, Stephanie R Morain, P Pearl O'Rourke, Joseph Ali, Vasiliki Rahimzadeh, Devon K Check, Hayden B Bosworth, Jeremy Sugarman

Center for Medical Ethics and Health Policy Staff Publications

While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings-or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship …

Trans-Ancestral Genetic Risk Factors For Treatment-Related Type 2 Diabetes Mellitus In Survivors Of Childhood Cancer, Cindy Im, Achal Neupane, Jessica L Baedke, Brian Lenny, Angela Delaney, Stephanie B Dixon, Eric J Chow, Sogol Mostoufi-Moab, Tianzhong Yang, Melissa A Richard, M Monica Gramatges, Philip J Lupo, Noha Sharafeldin, Smita Bhatia, Gregory T Armstrong, Melissa M Hudson, Kirsten K Ness, Leslie L Robison, Yutaka Yasui, Carmen L Wilson, Yadav Sapkota

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Type 2 diabetes mellitus (T2D) is a prevalent long-term complication of treatment in survivors of childhood cancer, with marked racial/ethnic differences in burden. In this study, we investigated trans-ancestral genetic risks for treatment-related T2D.

Patients and methods: Leveraging whole-genome sequencing data from the St Jude Lifetime Cohort (N = 3,676, 304 clinically ascertained cases), we conducted ancestry-specific genome-wide association studies among survivors of African and European genetic ancestry (AFR and EUR, respectively) followed by trans-ancestry meta-analysis. Trans-/within-ancestry replication including data from the Childhood Cancer Survivor Study (N = 5,965) was required for prioritization. Three external general population T2D polygenic …

Personal But Necessarily Predictive? Developing A Bioethics Research Agenda For Ai-Enabled Decision-Making Tools, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

The Road To Tailored Adjuvant Chemotherapy For All Four Non-Pancreatic Periampullary Cancers: An International Multimethod Cohort Study, Bas A Uijterwijk, Daniël H Lemmers, Michele Ghidini, Johanna W Wilmink, Alberto Zaniboni, Giuseppe Kito Fusai, Alessandro Zerbi, Bas Groot Koerkamp, Misha Luyer, Poya Ghorbani, Roberto Salvia, Steven White, Benedetto Ielpo, Brian K P Goh, Ugo Boggi, Geert Kazemier, Michael G House, Vasileios K Mavroeidis, Bergthor Björnsson, Michele Mazzola, Mario Serradilla, Dimitris Korkolis, Adnan Alseidi, Keith J Roberts, Zahir Soonawalla, Patrick Pessaux, William E Fisher, Sharnice Koek, Tara S Kent, Miljana Vladimirov, Louisa Bolm, Nigel Jamieson, Raffaele Dalla Valle, Jorg Kleeff, Alessandro Mazzotta, Miguel Angel Suarez Muñoz, Santiago Sánchez Cabús, Chad G Ball, Adam C Berger, Clarissa Ferarri, Marc G Besselink, Mohammed Abu Hilal, International Study Group On Non-Pancreatic Periampullary Cancer (Isgaca)

Center for Medical Ethics and Health Policy Staff Publications

Background: Despite differences in tumour behaviour and characteristics between duodenal adenocarcinoma (DAC), the intestinal (AmpIT) and pancreatobiliary (AmpPB) subtype of ampullary adenocarcinoma and distal cholangiocarcinoma (dCCA), the effect of adjuvant chemotherapy (ACT) on these cancers, as well as the optimal ACT regimen, has not been comprehensively assessed. This study aims to assess the influence of tailored ACT on DAC, dCCA, AmpIT, and AmpPB.

Patients and methods: Patients after pancreatoduodenectomy for non-pancreatic periampullary adenocarcinoma were identified and collected from 36 tertiary centres between 2010 - 2021. Per non-pancreatic periampullary tumour type, the effect of adjuvant chemotherapy and the main relevant regimens …

A Risk Is Not A Harm: Abortion Exceptions In State Laws, Trevor M Bibler, Alison Suen

Center for Medical Ethics and Health Policy Staff Publications

This letter responds to the article "Beneath the Sword of Damocles: Moral Obligations of Physicians in a Post-Dobbs Landscape," by Anne Drapkin Lyerly, Ruth R. Faden, and Michelle M. Mello, in the May-June 2024 issue of the Hastings Center Report.

Rethinking Medical Quality Training During Residency, Salih Selek

Teaching in Clinics

A brief editorial on medical quality training

2024 Uthealth & Memorial Hermann Quality Symposium Abstracts, Salih Selek

Teaching in Clinics

Every year, the UTHealth McGovern Medical School and Memorial Hermann-Texas Medical Center jointly organize a Quality Symposium, where oral and poster presentations spotlight the outstanding efforts in quality improvement initiatives ongoing at both institutions. Sixty-three teams dedicated to Quality Improvement were chosen to present their projects during the afternoon Poster Session. The abstracts included in this compilation offer a glimpse into the remarkable Quality Improvement endeavors showcased at the 2024 Quality Symposium.

A Phase 2 Clinical Trial To Evaluate The Safety, Reactogenicity, And Immunogenicity Of Different Prime-Boost Vaccination Schedules Of 2013 And 2017 A(H7n9) Inactivated Influenza Virus Vaccines Administered With And Without As03 Adjuvant In Healthy Us Adults, Christina A Rostad, Robert L Atmar, Emmanuel B Walter, Sharon Frey, Jeffery L Meier, Amy C Sherman, Lilin Lai, Rachel Tsong, Carol M Kao, Vanessa Raabe, Hana M El Sahly, Wendy A Keitel, Jennifer A Whitaker, Michael J Smith, Kenneth E Schmader, Geeta K Swamy, Getahun Abate, Patricia Winokur, Wendy Buchanan, Kaitlyn Cross, Ashley Wegel, Yongxian Xu, Inci Yildirim, Satoshi Kamidani, Nadine Rouphael, Paul C Roberts, Mark J Mulligan, Evan J Anderson

Center for Medical Ethics and Health Policy Staff Publications

Introduction: A surge of human influenza A(H7N9) cases began in 2016 in China from an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 adjuvant, prime-boost interval, and priming effects of 2013 and 2017 A(H7N9) IIVs.

Methods: Healthy adults (n = 180), ages 19-50 years, were enrolled into this partially blinded, randomized, multicenter phase 2 clinical trial. Participants were randomly assigned to 1 of 6 vaccination groups evaluating homologous versus heterologous prime-boost strategies with 2 different boost intervals (21 vs 120 days) and 2 …

Supporting Ontario Public Health Units To Address Adverse Childhood Experiences In Pandemic Recovery Planning: A Priority-Setting Exercise, Kimberly B Harding, Erica Di Ruggiero, Erick Gonzalez, Amanda Hicks, Daniel W Harrington

Faculty, Staff and Student Publications

BACKGROUND: Adverse childhood experiences (ACEs) are potentially traumatic exposures experienced during childhood, for example, neglect. There is growing evidence that the coronavirus disease 2019 (COVID-19) pandemic and related socioeconomic conditions contributed to an increased risk of ACEs. As public health programs/services are re-evaluated and restored following the state of emergency, it is important to plan using an ACEs-informed lens. The aim of this study was to identify and prioritize initiatives or activities that Public Health Ontario (PHO) could undertake to support Ontario public health units' work towards ACEs-informed pandemic recovery plans.

METHODS: The Child Health and Nutrition Research Initiative method …

Pm25, Vegetation Density, And Childhood Cancer: A Case-Control Registry-Based Study From Texas 1995–2011, Lindsay A Williams, David Haynes, Jeannette M Sample, Zhanni Lu, Ali Hossaini, Laura A Mcguinn, Thanh T Hoang, Philip J Lupo, Michael E Scheurer

Center for Medical Ethics and Health Policy Staff Publications

Background: Air pollution is positively associated with some childhood cancers, whereas greenness is inversely associated with some adult cancers. The interplay between air pollution and greenness in childhood cancer etiology is unclear. We estimated the association between early-life air pollution and greenness exposure and childhood cancer in Texas (1995 to 2011).

Methods: We included 6101 cancer cases and 109 762 controls (aged 0 to 16 years). We linked residential birth address to census tract annual average fine particulate matter < 2.5 µg/m³ (PM2.5) and Normalized Difference Vegetation Index (NDVI). We estimated odds ratios (ORs) and 95% confidence intervals (CIs) between PM2.5/NDVI interquartile range increases and cancer. We assessed statistical interaction between PM2.5 and NDVI (likelihood ratio tests).

Results: Increasing residential early-life PM2.5 exposure was associated with all childhood cancers (OR = 1.10, 95% CI = 1.06 to 1.15), …

Developing An Ethics And Policy Framework For Psychedelic Clinical Care: A Consensus Statement, Amy L Mcguire, I Glenn Cohen, Dominic Sisti, Matthew Baggott, Yuria Celidwen, Nese Devenot, Sabrina Gracias, Charles Grob, Ifetayo Harvey, Brent Kious, Mason Marks, Michael Mithoefer, Elizabeth Nielson, Dost Öngür, Alexandra Pallas, Andrew Peterson, Eduardo E Schenberg, Paul Summergrad, Brett Waters, Monnica T Williams, David B Yaden

Center for Medical Ethics and Health Policy Staff Publications

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice.

Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice.

Evidence review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 …

Why Does The Cost Of Employer-Sponsored Coverage Keep Rising?, Salpy Kanimian, Vivian Ho

Center for Medical Ethics and Health Policy Staff Publications

Over the past 25 years, the gap between the increase in health insurance costs and workers' wages has significantly expanded. This trend has led to significant concerns about healthcare affordability, with surveys revealing conflicting opinions regarding whether hospitals or health insurance companies bear the blame for escalating costs. To better understand these dynamics, we examined consumer price indices for health insurance, hospital services, and professional services from 2006 to 2023 using Bureau of Labor Statistics data. Our analysis shows that the hospital price index rose steadily between 2006 and 2023, faster than insurance premiums or professional services. To examine whether …

Contextual Factors Influencing The Association Between The Affordable Care Act’S Medicaid Expansion And Veteran Va-Medicaid Dual Enrollment, Patrick N O'Mahen, Chase S Eck, Cheng Rebecca Jiang, Laura A Petersen

Center for Medical Ethics and Health Policy Staff Publications

Objective: To evaluate changes in dual enrollment after Affordable Care Act Medicaid expansion by VA priority group, (e.g., service connection), sex, and type of state expansion.

Study setting: Our cohort was all Veterans ages 18-64 enrolled in VA and eligible for benefits due to military service-connection or low income from 2011 to 2016; the unit of analysis was person-year.

Study design: Difference-in-difference and event-study analysis. The outcome was dual VA-Medicaid enrollment for at least 1 month annually. Medicaid expansion, VA priority status, whether a state expanded by a Section 1115 waiver, and sex were independent variables. We controlled for race, …

Phase Ii Study Of Ulixertinib In Children And Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Alterations: Apec1621j Of The National Cancer Institute-Children's Oncology Group Pediatric Match Trial, Kieuhoa T Vo, Amit J Sabnis, P Mickey Williams, Sinchita Roy-Chowdhuri, David R Patton, Brent Coffey, Joel M Reid, Jin Piao, Lauren Saguilig, Todd A Alonzo, Stacey L Berg, Alok Jaju, Elizabeth Fox, Brenda J Weigel, 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 National Cancer Institute-Children's Oncology Group (NCI-COG) Pediatric MATCH trial assigns patients age 1-21 years with refractory malignancies to phase II treatment arms of molecularly targeted therapies on the basis of genetic alterations detected in their tumor. Patients with activating alterations in the mitogen-activated protein kinase pathway were treated with ulixertinib, an extracellular signal-regulated kinase (ERK)1/2 inhibitor.

Methods: As there were no previous pediatric data, ulixertinib was initially tested in a dose escalation cohort to establish the recommended phase II dose (RP2D) before proceeding to the phase II cohort. Ulixertinib was administered at 260 mg/m2/dose orally twice a day …

Latin American Trans-Ancestry Initiative For Ocd Genomics (Latino): Study Protocol, James J Crowley, Carolina Cappi, Marcos E Ochoa-Panaifo, Renee M Frederick, Minjee Kook, Andrew D Wiese, Diana Rancourt, Elizabeth G Atkinson, Paola Giusti-Rodriguez, Jacey L Anderberg, Latin American Trans‐Ancestry Initiative For Ocd Genomics, Brazilian Obsessive‐Compulsive Spectrum Disorder Working Group, Jonathan S Abramowitz, Victor R Adorno, Cinthia Aguirre, Gilberto S Alves, Gustavo S Alves, Naeshia Ancalade, Alejandro A Arellano Espinosa, Paul D Arnold, Daphne M Ayton, Izabela G Barbosa, Laura Marcela Barón Castano, Cynthia N Barrera, María Celeste Berardo, Dayan Berrones, John R Best, Tim B Bigdeli, Christie L Burton, Joseph D Buxbaum, Jennifer L Callahan, Maria Cecília B Carneiro, Sandra L Cepeda, Evelyn Chazelle, Jessica M Chire, Macarena Churruca Munoz, Pamela Claisse Quiroz, Journa Cobite, Jonathan S Comer, Daniel L Costa, Jennifer Crosbie, Victor O Cruz, Guillermo Dager, Luisa F Daza, Anabel De La Rosa-Gómez, Daniela Del Río, Fernanda Z Delage, Carolina B Dreher, Lucila Fay, Tomas Fazio, Ygor A Ferrão, Gabriela M Ferreira, Edith G Figueroa, Leonardo F Fontenelle, Diego A Forero, Daniele T H Fragoso, Bharathi S Gadad, Sheldon R Garrison, Andres González, Laura D Gonzalez, Marco A González, Polaris Gonzalez-Barrios, Wayne K Goodman, Dorothy E Grice, Jerry Guintivano, Daniel G Guttfreund, Andrew G Guzick, Matthew W Halvorsen, Joseph D Hovey, Hailiang Huang, Jonathan Irreño-Sotomonte, Reinhard Janssen-Aguilar, Matias Jensen, Alexandra Z Jimenez Reynolds, Joali Alexandra Juárez Lujambio, Nasim Khalfe, Madison A Knutsen, Caleb Lack, Nuria Lanzagorta, Monicke O Lima, Melanie O Longhurst, David A Lozada Martinez, Elba S Luna, Andrea H Marques, Molly S Martinez, Maria De Los Angeles Matos, Caitlyn E Maye, Joseph F Mcguire, Gabriela Menezes, Charlene Minaya, Tomás Miño, Sara M Mithani, Circe Montes De Oca, Alonso Morales-Rivero, Maria E Moreira-De-Oliveira, Olivia J Morris, Sandra I Muñoz, Zainab Naqqash, Ambar A Núñez Bracho, Belinda E Núñez Bracho, Maria Corina Ochoa Rojas, Luis A Olavarria Castaman, Trinidad Olivos Balmaceda, Iliana Ortega, Darpan I Patel, Ainsley K Patrick, Mariel Paz Y Mino, Jose L Perales Orellana, Bárbara Perdigão Stumpf, Tamara Peregrina, Tania Pérez Duarte, Kelly L Piacsek, Maritza Placencia, María Belén Prieto, Lucas C Quarantini, Yana Quarantini-Alvim, Renato T Ramos, Iaroslava C Ramos, Vanessa R Ramos, Kesley A Ramsey, Elise V Ray, Margaret A Richter, Bradley C Riemann, Juan C Rivas, Maria C Rosario, Camilo J Ruggero, Angel A Ruiz-Chow, Alejandra Ruiz-Velasco, Melisa N Sagarnaga, Aline S Sampaio, Leonardo C Saraiva, Russell J Schachar, Sophie C Schneider, Ethan J Schweissing, Laura D Seligman, Roseli G Shavitt, Keaton J Soileau, S Evelyn Stewart, Shaina B Storch, Emily R Strouphauer, Vissente Tapia Cuevas, Kiara R Timpano, Beatriz Treviño-De La Garza, Alexie Vallejo-Silva, Javier Vargas-Medrano, María I Vásquez, Guadalupe Vidal Martinez, Saira A Weinzimmer, Mauricio A Yanez, Gwyneth Zai, Lina M Zapata-Restrepo, Luz M Zappa, Raquel M Zepeda-Burgos, Anthony W Zoghbi, Euripedes C Miguel, Carolyn I Rodriguez, Mayra C Martinez Mallen, Pablo R Moya, Tania Borda, María Beatriz Moyano, Manuel Mattheisen, Stacey Pereira, Gabriel Lázaro-Muñoz, Karen G Martinez-Gonzalez, Michele T Pato, Humberto Nicolini, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder. Worldwide, its prevalence is ~2% and its etiology is mostly unknown. Identifying biological factors contributing to OCD will elucidate underlying mechanisms and might contribute to improved treatment outcomes. Genomic studies of OCD are beginning to reveal long-sought risk loci, but >95% of the cases currently in analysis are of homogenous European ancestry. If not addressed, this Eurocentric bias will result in OCD genomic findings being more accurate for individuals of European ancestry than other ancestries, thereby contributing to health disparities in potential future applications of genomics. In this study protocol paper, we …

Buprenorphine Use For Analgesia In Palliative Care, Leanne K Jackson, Ivy O Poon, Mary A Garcia, Syed Imam, Ursula K Braun

Center for Medical Ethics and Health Policy Staff Publications

Buprenorphine is a semi-synthetic long-acting partial µ-opioid receptor (MOR) agonist that can be used for chronic pain as a sublingual tablet, transdermal patch (Butrans®), or a buccal film (Belbuca®). Buprenorphine’s unique high receptor binding affinity and slow dissociation at the MOR allow for effective analgesia while offering less adverse effects compared to a full agonist opioid, in particular, less concern for respiratory depression and constipation. It is underused in chronic pain and palliative care due to misconceptions and stigma from its use in opioid use disorder (OUD). This case report discusses the unique pharmacology of buprenorphine, including its advantages, disadvantages, …

Addressing Or Reinforcing Injustice? Artificial Amnion And Placenta Technology, Loss-Sensitive Care And Racial Inequities In Preterm Birth, Sophie L Schott, Faith Fletcher, Alice Story, April Adams

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

A Qualitative Interview Study To Determine Barriers And Facilitators Of Implementing Automated Decision Support Tools For Genomic Data Access, Vasiliki Rahimzadeh, Jinyoung Baek, Jonathan Lawson, Edward S Dove

Center for Medical Ethics and Health Policy Staff Publications

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic …

Advancing Genomics To Improve Health Equity, Ebony B Madden, Lucia A Hindorff, Vence L Bonham, Tabia Henry Akintobi, Esteban G Burchard, Kellan E Baker, Rene L Begay, John D Carpten, Nancy J Cox, Valentina Di Francesco, Denise A Dillard, Faith E Fletcher, Stephanie M Fullerton, Nanibaa' A Garrison, Catherine M Hammack-Aviran, Vanessa Y Hiratsuka, James E K Hildreth, Carol R Horowitz, Chanita A Hughes Halbert, Michael Inouye, Amber Jackson, Latrice G Landry, Rick A Kittles, Jeff T Leek, Nita A Limdi, Nicole C Lockhart, Elizabeth O Ofili, Eliseo J Pérez-Stable, Maya Sabatello, Loren Saulsberry, Lorjetta E Schools, Jennifer L Troyer, Benjamin S Wilfond, Genevieve L Wojcik, Judy H Cho, Sandra S-J Lee, Eric D Green

Center for Medical Ethics and Health Policy Staff Publications

Health equity is the state in which everyone has fair and just opportunities to attain their highest level of health. The field of human genomics has fallen short in increasing health equity, largely because the diversity of the human population has been inadequately reflected among participants of genomics research. This lack of diversity leads to disparities that can have scientific and clinical consequences. Achieving health equity related to genomics will require greater effort in addressing inequities within the field. As part of the commitment of the National Human Genome Research Institute (NHGRI) to advancing health equity, it convened experts in …

Public Attitudes, Interests, And Concerns Regarding Polygenic Embryo Screening, Rémy A Furrer, Dorit Barlevy, Stacey Pereira, Shai Carmi, Todd Lencz, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

Importance: Polygenic embryo screening (PES) is a novel technology that estimates the likelihood of developing future conditions (eg, diabetes or depression) and traits (eg, height or cognitive ability) in human embryos, with the goal of selecting which embryos to use. Given its commercial availability and concerns raised by researchers, clinicians, bioethicists, and professional organizations, it is essential to inform key stakeholders and relevant policymakers about the public's perspectives on this technology.

Objective: To survey US adults to examine general attitudes, interests, and concerns regarding PES use.

Design, setting, and participants: For this survey study, data were collected from 1 stratified …

Patients’ And Physicians’ Beliefs And Attitudes Towards Integrating Personalized Risk Estimates Into Patient Education About Left Ventricular Assist Device Therapy, Kristin M Kostick-Quenet, Benjamin Lang, Natalie Dorfman, Jerry Estep, Mandeep R Mehra, Arvind Bhimaraj, Andrew Civitello, Ulrich Jorde, Barry Trachtenberg, Nir Uriel, Holland Kaplan, Eleanor Gilmore-Szott, Robert Volk, Mahwash Kassi, J S Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Background: Personalized risk (PR) estimates may enhance clinical decision making and risk communication by providing individualized estimates of patient outcomes. We explored stakeholder attitudes toward the utility, acceptability, usefulness and best-practices for integrating PR estimates into patient education and decision making about Left Ventricular Assist Device (LVAD).

Methods and results: As part of a 5-year multi-institutional AHRQ project, we conducted 40 interviews with stakeholders (physicians, nurse coordinators, patients, and caregivers), analyzed using Thematic Content Analysis. All stakeholder groups voiced positive views towards integrating PR in decision making. Patients, caregivers and coordinators emphasized that PR can help to better understand a …

Family Accommodation In Children And Adolescents With Misophonia, Eric A Storch, Andrew G Guzick, Johann D'Souza, Jane Clinger, Daphne Ayton, Minjee Kook, Conor Rork, Eleanor E Smith, Isabel A Draper, Nasim Khalfe, Catherine E Rast, Nicholas Murphy, Marijn Lijfijjt, Wayne K Goodman, Matti Cervin

Center for Medical Ethics and Health Policy Staff Publications

Family accommodation (e.g., reassurance, modifying routines, assisting avoidance) has not been explored among youth with misophonia but may have important clinical and intervention implications. We examined family accommodation in 102 children and adolescents with interview-confirmed misophonia and compared its frequency and content to family accommodation in 95 children and adolescents with anxiety disorders. Findings showed that family accommodation was ubiquitous in pediatric misophonia and may be even more frequent than in youth with anxiety disorders. Assisting the child, participating in misophonia-related behaviors, and modifying family routines were endorsed by more than 70% of parents of children with misophonia. Further, compared …

Parent-Led Cognitive Behavioral Teletherapy For Anxiety In Autistic Youth: A Randomized Trial Comparing Two Levels Of Therapist Support, Andrew G Guzick, Sophie C Schneider, Minjee Kook, Julia Rose Iacono, Saira A Weinzimmer, Troy Quast, Sean M Olsen, Killian Rainey Hughes, Emily Jellinek-Russo, Amanda Perozo Garcia, Abigail Candelari, Leandra N Berry, Robin P Goin-Kochel, Wayne K Goodman, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Parent-led cognitive behavioral therapy (CBT) is an efficient, promising form of therapy that may be well suited for autistic youth with anxiety disorders, though to date it has been minimally tested. In this study, 87 autistic youth (7 to 13 years old) with anxiety disorders and their parents were randomized to two forms of parent-led CBT in which parents led their child through a guided CBT workbook across 12 weeks: one with low therapist contact (four 30-minute telehealth calls), and one with standard therapist contact (ten 60-minute telehealth calls). Anxiety, functional impairment, and autism features significantly declined across therapy, without …

Ethical Concerns For Remote Computer Perception In Cardiology: New Stages For Digital Health Technologies, Artificial Intelligence, And Machine Learning, Kristin Kostick-Quenet, Jerry Estep, Jennifer S Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Patient Interest In And Clinician Reservations On Polygenic Embryo Screening: A Qualitative Study Of Stakeholder Perspectives, D Barlevy, I Cenolli, T Campbell, R Furrer, M Mukherjee, K Kostick-Quenet, S Carmi, T Lencz, G Lázaro-Muñoz, S Pereira

Center for Medical Ethics and Health Policy Staff Publications

Purpose: We explored and compared perspectives of reproductive endocrinology and infertility specialists (REIs) and in vitro fertilization (IVF) patients regarding polygenic embryo screening (PES), a new type of preimplantation screening that estimates the genetic chances of developing polygenic conditions and traits in the future.

Methods: Qualitative thematic analysis of semi-structured interviews with US-based REIs and IVF patients.

Results: Clinicians and patients often held favorable views of screening embryos for physical or psychiatric conditions, though clinicians tended to temper their positive attitudes with specific caveats. Clinicians also expressed negative views about screening embryos for traits more frequently than patients, who generally …

Direct Implantation Of Patient Brain Tumor Cells Into Matching Locations In Mouse Brains For Patient-Derived Orthotopic Xenograft Model Development, Lin Qi, Patricia Baxter, Mari Kogiso, Huiyuan Zhang, Frank K Braun, Holly Lindsay, Sibo Zhao, Sophie Xiao, Aalaa Sanad Abdallah, Milagros Suarez, Zilu Huang, Wan Yee Teo, Litian Yu, Xiumei Zhao, Zhigang Liu, Yulun Huang, Jack M Su, Tsz-Kwong Man, Ching C Lau, Laszlo Perlaky, Yuchen Du, Xiao-Nan Li

Center for Medical Ethics and Health Policy Staff Publications

Background: Despite multimodality therapies, the prognosis of patients with malignant brain tumors remains extremely poor. One of the major obstacles that hinders development of effective therapies is the limited availability of clinically relevant and biologically accurate (CRBA) mouse models.

Methods: We have developed a freehand surgical technique that allows for rapid and safe injection of fresh human brain tumor specimens directly into the matching locations (cerebrum, cerebellum, or brainstem) in the brains of SCID mice.

Results: Using this technique, we successfully developed 188 PDOX models from 408 brain tumor patient samples (both high-and low-grade) with a success rate of 72.3% …