Health Policy Commons^™

Phase Ii Study Of Vemurafenib In Children And Young Adults With Tumors Harboring Braf V600 Mutations: Nci-Cog Pediatric Match Trial (Apec1621) Arm G, Marie V Nelson, Aerang Kim, P Mickey 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, 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

Background: This is a phase II subprotocol of the NCI-COG Pediatric MATCH study evaluating vemurafenib, a selective oral inhibitor of BRAF V600 mutated kinase, in patients with relapsed or refractory solid tumors harboring BRAF V600 mutations.

Methods: Patients received vemurafenib at 550 mg/m2 (maximum 960 mg/dose) orally twice daily for 28-day cycles until progression or intolerable toxicity. The primary aim was to determine the objective response rate and secondary objectives included estimating progression-free survival and assessing the tolerability of vemurafenib.

Results: Twenty-two patients matched to the subprotocol and 4 patients (18%) enrolled. Primary reasons for non-enrollment were ineligibility due to …

Measuring Perceived Utility Of Genomic Sequencing: Development And Validation Of The Genetic Utility (Gene-U) Scale For Pediatric Diagnostic Testing, Hadley Stevens Smith, Caryn Kseniya Rubanovich, Jill Oliver Robinson, Ariel N Levchenko, Sarah A Classen, Janet Malek, Barbara Biesecker, Kyle B Brothers, Benjamin S Wilfond, Christine Rini, Sara J Knight, Amy L Mcguire, Cinnamon S Bloss

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Measuring the effects of genomic sequencing (GS) on patients and families is critical for translational research. We aimed to develop and validate an instrument to assess parents' perceived utility of pediatric diagnostic GS.

Methods: Informed by a 5-domain conceptual model, the study comprised 5 steps: (1) item writing, (2) cognitive testing, (3) pilot testing and item reduction, (4) psychometric testing, and (5) evaluation of construct validity. Parents of pediatric patients who had received results of clinically indicated GS participated in structured cognitive interviews and 2 rounds of surveys. After eliminating items based on theory and quantitative performance, we conducted …

Genomic Sequencing Research In Pediatric Cancer Care: Decision Making, Attitudes, And Perceived Utility Among Adolescents And Young Adults And Their Parents, Amanda M Gutierrez, Jill O Robinson, Hadley S Smith, Lauren R Desrosiers-Battu, Sarah R Scollon, Isabel Canfield, Rebecca L Hsu, Nicole M Schneider, D Williams Parsons, Sharon E Plon, Wendy Allen-Rhoades, Mary A Majumder, Janet Malek, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Professional guidelines recommend engaging adolescents and young adults (AYAs) in medical decision making (DM), including whether to undergo genomic sequencing (GS). We explored DM around GS and attitudes after return of GS results among a diverse group of AYAs with cancer and their parents.

Methods: We surveyed AYAs with cancer (n = 75) and their parents (n = 52) 6 months after receiving GS results through the Texas KidsCanSeq study. We analyzed AYAs' DM role in GS research enrollment and their satisfaction with that role. We compared AYAs' and parents' self-reported understanding of, attitudes toward, and perceived utility of …

Trust Criteria For Artificial Intelligence In Health: Normative And Epistemic Considerations, Kristin Kostick-Quenet, Benjamin H Lang, Jared Smith, Meghan Hurley, Jennifer Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Rapid advancements in artificial intelligence and machine learning (AI/ML) in healthcare raise pressing questions about how much users should trust AI/ML systems, particularly for high stakes clinical decision-making. Ensuring that user trust is properly calibrated to a tool's computational capacities and limitations has both practical and ethical implications, given that overtrust or undertrust can influence over-reliance or under-reliance on algorithmic tools, with significant implications for patient safety and health outcomes. It is, thus, important to better understand how variability in trust criteria across stakeholders, settings, tools and use cases may influence approaches to using AI/ML tools in real settings. As …

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 …

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 …

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.

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 …

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), …

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 …

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.

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 …

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 …

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 …

Genetic Researchers' Use Of And Interest In Research With Diverse Ancestral Groups, Kaitlyn Jaffe, Amanda K Greene, Luyun Chen, Kerry A Ryan, Chris Krenz, J Scott Roberts, Brian J Zikmund-Fisher, Amy L Mcguire, J Denard Thomas, Erica E Marsh, Kayte Spector-Bagdady

Center for Medical Ethics and Health Policy Staff Publications

Importance: Genetic researchers must have access to databases populated with data from diverse ancestral groups to ensure research is generalizable or targeted for historically excluded communities.

Objective: To determine genetic researchers' interest in doing research with diverse ancestral populations, which database stewards offer adequate samples, and additional facilitators for use of diverse ancestral data.

Design, setting, and participants: This survey study was conducted from June to December 2022 and was part of an exploratory sequential mixed-methods project in which previous qualitative results informed survey design. Eligible participants included genetic researchers who held US academic affiliations and conducted research using human …

Self-Sampling For Human Papillomavirus Testing: Acceptability In A Us Safety Net Health System, Susan L Parker, Trisha L Amboree, Shaun Bulsara, Maria Daheri, Matthew L Anderson, Susan G Hilsenbeck, Maria L Jibaja-Weiss, Mohammed Zare, Kathleen M Schmeler, Ashish A Deshmukh, Elizabeth Y Chiao, Michael E Scheurer, Jane R Montealegre

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a safety net health system.

Methods: A nested telephone survey was administered between 2021 and 2023 to a sample (n=272) of the 2,268 participants enrolled in the Prospective Evaluation of Self-Testing to Increase Screening trial. Trial participants include patients of a safety net health system aged 30-65 years who were not up to …

Case Sampling For Evaluating Hospital Postoperative Morbidity In Us Surgical Quality Improvement Programs, Vivi W Chen, Tracey Rosen, Yongquan Dong, Peter A Richardson, Jennifer R Kramer, Laura A Petersen, Nader N Massarweh

Center for Medical Ethics and Health Policy Staff Publications

Importance: US surgical quality improvement (QI) programs use data from a systematic sample of surgical cases, rather than universal review of all cases, to assess and compare risk-adjusted hospital postoperative complication rates. Given decreasing postoperative complication rates over time and the types of cases eligible for abstraction, it is unclear whether case sampling is robust for identifying hospitals with higher than expected complications.

Objective: To compare the assessment of hospital 30-day complication rates derived from sampling strategy used by some US surgical QI programs relative to universal review of all cases.

Design, setting, and participants: This US hospital-level analysis took …

Risk Factors For Childhood Brain Tumours: A Systematic Review And Meta-Analysis Of Observational Studies From 1976 To 2022, Felix M Onyije, Roya Dolatkhah, Ann Olsson, Liacine Bouaoun, Isabelle Deltour, Friederike Erdmann, Audrey Bonaventure, Michael E Scheurer, Jacqueline Clavel, Joachim Schüz

Center for Medical Ethics and Health Policy Staff Publications

BACKGROUND: Childhood brain tumours (CBTs) are the leading cause of cancer death in children under the age of 20 years globally. Though the aetiology of CBT remains poorly understood, it is thought to be multifactorial. We aimed to synthesize potential risk factors for CBT to inform primary prevention.

METHODS: We conducted a systematic review and meta-analysis of epidemiological studies indexed in the PubMed, Web of Science, and Embase databases from the start of those resources through 27 July 2023. We included data from case-control or cohort studies that reported effect estimates for each risk factor around the time of conception, …

Personalized Roadmaps For Returning Results From Digital Phenotyping, Kristin Marie Kostick-Quenet, John Herrington, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

The Million Veteran Program 1990-1991 Gulf War Era Survey: An Evaluation Of Veteran Response, Characteristics, And Representativeness Of The Gulf War Era Veteran Population, Kelly M Harrington, Rachel Quaden, Lea Steele, Drew A Helmer, Elizabeth R Hauser, Sarah T Ahmed, Mihaela Aslan, Krishnan Radhakrishnan, Jacqueline Honerlaw, Xuan-Mai T Nguyen, Sumitra Muralidhar, John Concato, Kelly Cho, J Michael Gaziano, Stacey B Whitbourne, On Behalf Of The Va Million Veteran Program

Center for Medical Ethics and Health Policy Staff Publications

To address gaps in understanding the pathophysiology of Gulf War Illness (GWI), the VA Million Veteran Program (MVP) developed and implemented a survey to MVP enrollees who served in the U.S. military during the 1990–1991 Persian Gulf War (GW). Eligible Veterans were invited via mail to complete a survey assessing health conditions as well as GW-specific deployment characteristics and exposures. We evaluated the representativeness of this GW-era cohort relative to the broader population by comparing demographic, military, and health characteristics between respondents and non-respondents, as well as with all GW-era Veterans who have used Veterans Health Administration (VHA) services and …

Newborn Screening Analytes And Structural Birth Defects Among 27,000 Newborns, Philip J Lupo, Natalie P Archer, Rachel D Harris, Lisa K Marengo, Jeremy M Schraw, Adrienne T Hoyt, Susan Tanksley, Rachel Lee, Margaret Drummond-Borg, Debra Freedenberg, Priya B Shetty, A J Agopian, Charles Shumate, Sonja A Rasmussen, Peter H Langlois, Mark A Canfield

Center for Medical Ethics and Health Policy Staff Publications

Background: Emerging evidence suggests newborn screening analytes may yield insights into the etiologies of birth defects, yet no effort has evaluated associations between a range of newborn screening analytes and birth defects.

Methods: This population-based study pooled statewide data on birth defects, birth certificates, and newborn screening analytes from Texas occurring between January 1, 2007 and December 31, 2009. Associations between a panel of thirty-six newborn screening analytes, collected by the statewide Texas Newborn Screening Program, and the presence of a birth defect, defined as at least one of 39 birth defects diagnoses recorded by the Texas Birth Defects Registry, …

Public Perspectives On Investigative Genetic Genealogy: Findings From A National Focus Group Study, Jacklyn Dahlquist, Jill O Robinson, Amira Daoud, Whitney Bash-Brooks, Amy L Mcguire, Christi J Guerrini, Stephanie M Fullerton

Center for Medical Ethics and Health Policy Staff Publications

Background: Investigative genetic genealogy (IGG) is a technique that involves uploading genotypes developed from perpetrator DNA left at a crime scene, or DNA from unidentified remains, to public genetic genealogy databases to identify genetic relatives and, through the creation of a family tree, the individual who was the source of the DNA. As policymakers demonstrate interest in regulating IGG, it is important to understand public perspectives on IGG to determine whether proposed policies are aligned with public attitudes.

Methods: We conducted eight focus groups with members of the public (N = 72), sampled from four geographically diverse US regions, …

Patient Perceptions On The Advancement Of Noninvasive Prenatal Testing For Sickle Cell Disease Among Black Women In The United States, Shameka P Thomas, Faith E Fletcher, Rachele Willard, Tiara Monet Ranson, Vence L Bonham

Center for Medical Ethics and Health Policy Staff Publications

Background: Noninvasive prenatal testing (NIPT) designed to screen for fetal genetic conditions, is increasingly being implemented as a part of routine prenatal care screening in the United States (US). However, these advances in reproductive genetic technology necessitate empirical research on the ethical and social implications of NIPT among populations underrepresented in genetic research, particularly Black women with sickle cell disease (SCD).

Methods: Forty (N = 40) semi-structured interviews were conducted virtually with Black women in the US (19 participants with SCD; 21 participants without SCD) from June 2021 to January 2022. We employed a qualitative approach to examine the …

A Novel Tailed Primer Nucleic Acid Test For Detection Of Hpv 16, 18 And 45 Dna At The Point Of Care, Megan M Chang, Ariel Ma, Emilie Newsham Novak, Maria Barra, Kathryn A Kundrod, Jane Richards Montealegre, Michael E Scheurer, Philip E Castle, Kathleen Schmeler, Rebecca Richards-Kortum

Center for Medical Ethics and Health Policy Staff Publications

Cervical cancer is a leading cause of death for women in low-resource settings despite being preventable through human papillomavirus (HPV) vaccination, early detection, and treatment of precancerous lesions. The World Health Organization recommends high-risk HPV (hrHPV) as the preferred cervical cancer screening strategy, which is difficult to implement in low-resource settings due to high costs, reliance on centralized laboratory infrastructure, and long sample-to-answer times. To help meet the need for rapid, low-cost, and decentralized cervical cancer screening, we developed tailed primer isothermal amplification and lateral flow detection assays for HPV16, HPV18, and HPV45 DNA. We translated these assays into a …

Comparison Of Hospital Online Price And Telephone Price For Shoppable Services, Merina Thomas, James Flaherty, Jiefei Wang, Morgan Henderson, Vivian Ho, Mark Cuban, Peter Cram

Center for Medical Ethics and Health Policy Staff Publications

Importance: US hospitals are required to publicly post their prices for specified shoppable services online. However, the extent to which a hospital's prices posted online correlate with the prices they give to a telephone caller is unknown.

Objective: To compare hospitals' online cash prices for vaginal childbirth and brain magnetic resonance imaging (MRI) with prices offered to secret shopper callers requesting price estimates by telephone.

Design, setting, and participants: This cross-sectional study included cash online prices from each hospital's website for vaginal childbirth and brain MRI collected from representative US hospitals between August and October 2022. Thereafter, again between August …