Bioethics and Medical Ethics Commons^™

Pretesting Discrete-Choice Experiments: A Guide For Researchers, Nicola B Campoamor, Christi J Guerrini, Whitney Bash Brooks, John F P Bridges, Norah L Crossnohere

Center for Medical Ethics and Health Policy Staff Publications

Discrete-choice experiments (DCEs) are a frequently used method to explore the preferences of patients and other decision-makers in health. Pretesting is an essential stage in the design of a high-quality choice experiment and involves engaging with representatives of the target population to improve the readability, presentation, and structure of the preference instrument. The goal of pretesting in DCEs is to improve the validity, reliability, and relevance of the survey, while decreasing sources of bias, burden, and error associated with preference elicitation, data collection, and interpretation of the data. Despite its value to inform DCE design, pretesting lacks documented good practices …

Evidence Review And Considerations For Use Of First Line Genome Sequencing To Diagnose Rare Genetic Disorders, Kristen M Wigby, Deanna Brockman, Gregory Costain, Caitlin Hale, Stacie L Taylor, John Belmont, David Bick, David Dimmock, Susan Fernbach, John Greally, Vaidehi Jobanputra, Shashikant Kulkarni, Elizabeth Spiteri, Ryan J Taft

Center for Medical Ethics and Health Policy Staff Publications

Early use of genome sequencing (GS) in the diagnostic odyssey can reduce suffering and improve care, but questions remain about which patient populations are most amenable to GS as a first-line diagnostic test. To address this, the Medical Genome Initiative conducted a literature review to identify appropriate clinical indications for GS. Studies published from January 2011 to August 2022 that reported on the diagnostic yield (DY) or clinical utility of GS were included. An exploratory meta-analysis using a random effects model evaluated DY based on cohort size and diagnosed cases per cohort. Seventy-one studies met inclusion criteria, comprising over 13,000 …

Panorama Of Human Embryo-Derived Cells In Biomedicine And Progress In Their Research And Regulation, Jianchao Gao, Yaojin Peng, Wei Wei, Shuang Lu, Chenyan Gao

Bulletin of Chinese Academy of Sciences (Chinese Version)

Since the establishment of the first human diploid cell line derived from aborted fetal tissue in the 1960s, human embryoderived cells have been widely used in biomedical field and significantly contributes to improving human health. In recent years, human pluripotent stem cells, including human embryonic stem cells (hESCs), have shown great therapeutic potential in regenerative medicine, and thus received great attention from governments and the public. However, due to various factors such as history, culture, religious beliefs, ethics and morality, research and application involving human embryo-derived cells have been controversial worldwide. This study explores the history and progress of human …

A Review Of Olanzapine In The Treatment Of Cancer Anorexia-Cachexia Syndrome, Ivy O Poon, Veronica Ajewole, Ursula K Braun

Center for Medical Ethics and Health Policy Staff Publications

Background: Cancer anorexia-cachexia syndrome (CAS) is a multifactorial condition that is highly prevalent in advanced cancer patients and associated with significant reduction in functional performance, reduction in quality of life, and increased mortality. Currently, no medications are approved for this indication. Recently, the American Society of Clinical Oncology (ASCO) released a rapid recommendation suggesting that low-dose olanzapine once daily may be used to treat cancer cachexia. Many questions still exist on how to use olanzapine for this indication in clinical practice. The objective of this review is to identify existing knowledge on the use of olanzapine for CAS.

Methods: A …

Birds, Bats And Minds. Tales Of A Revolutionary Scientist: Donald R. Griffin. Volume Three, Carolyn A. Ristau

eBooks

In this three-volume biography, we revisit the life and accomplishments of the revolutionary scientist, Donald R. Griffin. He encountered a lifetime of initial hostile resistance to his ideas and studies; now they are largely accepted. He and a colleague discovered the phenomenon of echolocation used by bats to navigate and capture insects, proposed that birds navigate guided by such cues as the sun and stars, and suggested that animals are likely aware, thinking and feeling beings. Forty interviews with his colleagues and friends help us understand the young emerging scientist and the mature researcher. We learn about his and others’ …

Gene-Specific Acmg/Amp Classification Criteria For Germline Apc Variants: Recommendations From The Clingen Insight Hereditary Colorectal Cancer/Polyposis Variant Curation Expert Panel\, Isabel Spier, Xiaoyu Yin, Marcy Richardson, Marta Pineda, Andreas Laner, Deborah Ritter, Julie Boyle, Pilar Mur, Thomas V O Hansen, Xuemei Shi, Khalid Mahmood, John-Paul Plazzer, Elisabet Ognedal, Margareta Nordling, Susan M Farrington, Gou Yamamoto, Stéphanie Baert-Desurmont, Alexandra Martins, Ester Borras, Carli Tops, Erica Webb, Victoria Beshay, Maurizio Genuardi, Tina Pesaran, Gabriel Capellá, Sean V Tavtigian, Andrew Latchford, Ian M Frayling, Sharon E Plon, Marc Greenblatt, Finlay A Macrae, Stefan Aretz, Insight-Clingen Hereditary Colon Cancer/Polyposis Variant Curation Expert Panel

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The Hereditary Colorectal Cancer/Polyposis Variant Curation Expert Panel (VCEP) was established by the International Society for Gastrointestinal Hereditary Tumours and the Clinical Genome Resource, who set out to develop recommendations for the interpretation of germline APC variants underlying Familial Adenomatous Polyposis, the most frequent hereditary polyposis syndrome.

Methods: Through a rigorous process of database analysis, literature review, and expert elicitation, the APC VCEP derived gene-specific modifications to the ACMG/AMP (American College of Medical Genetics and Genomics and Association for Molecular Pathology) variant classification guidelines and validated such criteria through the pilot classification of 58 variants.

Results: The APC-specific criteria …

Veterans Health Administration Enrollees’ Choice Of Care Setting Relates To The Expansion Of Care Options: Evidence From Screening Colonoscopies Before And After The Mission Act, Chase S Eck, Cheng Jiang, Laura A Petersen

Center for Medical Ethics and Health Policy Staff Publications

Objective: To estimate whether those enrolled in the Veterans Health Administration (VHA) were less likely to use VHA-delivered colorectal cancer screening colonoscopies after the MISSION Act.

Data sources and study setting: Secondary data were collected on VHA-enrolled Veterans from FY2017-FY2021.

Study design: This retrospective cross-sectional study measured the volume and share of screening colonoscopies that were VHA-delivered over time and by drive time eligibility-defined as living more than 60 min away from the nearest VHA specialty-care clinic. We used a multivariable logistic regression to adjust for patient and facility factors.

Data extraction: Data were extracted for VHA enrollees (n = …

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.

Determinants Of Referral Network Size For Screening Colonoscopies In The Veterans Health Administration After The Implementation Of The Mission Act, Chase S Eck, Vivian Ho, Cheng Jiang, Laura A Petersen

Center for Medical Ethics and Health Policy Staff Publications

Objective: To measure key characteristics of the Veterans Health Administration's (VHA) Community Care (CC) referral network for screening colonoscopy and identify market and institutional factors associated with network size.

Data sources: VHA electronic health records, CC claim data, and National Plan and Provider Enumeration System.

Study design: In this retrospective cross-sectional study, we measure the size of the VHA's CC referral networks over time and by VHA parent facility (n = 137). We used a multivariable linear regression to identify factors associated with network size at the market-year level. Network size was measured as the number of physicians who performed …

Should Secondary Pharmacogenomic Variants Be Actively Screened And Reported When Diagnostic Genome-Wide Sequencing Is Performed In A Child?, Jan M Friedman, Yvonne Bombard, Bruce Carleton, Amalia M Issa, Bartha Knoppers, Sharon E Plon, Vasiliki Rahimzadeh, Mary V Relling, Marc S Williams, Clara Van Karnebeek, Danya Vears, Martina C Cornel

Center for Medical Ethics and Health Policy Staff Publications

This white paper was prepared by the Global Alliance for Genomics and Health Regulatory and Ethics Work Stream's Pediatric Task Team to review and provide perspective with respect to ethical, legal, and social issues regarding the return of secondary pharmacogenomic variants in children who have a serious disease or developmental disorder and are undergoing exome or genome sequencing to identify a genetic cause of their condition. We discuss actively searching for and reporting pharmacogenetic/genomic variants in pediatric patients, different methods of returning secondary pharmacogenomic findings to the patient/parents and/or treating clinicians, maintaining these data in the patient's health record over …

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, …

Utility Of A Low-Cost 3-D Printed Microscope For Evaluating Esophageal Biopsies, Daniel G Rosen, Evandro Sobroza De Mello, Sadhna Dhingra, Sanford M Dawsey, Joe Knapper, Richard Bowman, Sharmila Anandasabapathy

Center for Medical Ethics and Health Policy Staff Publications

In this manuscript we assessed the utility of a low-cost 3D printed microscope to evaluate esophageal biopsies. We conducted a comparative analysis between the traditional microscope and our 3-D printed microscope, utilizing a set of esophageal biopsy samples obtained from patients undergoing screening endoscopy. Two pathologists independently examined 30 esophageal biopsies by light microscopy and digital images obtained using a low-cost 3D printed microscope (Observer 1 and 2). The glass slide consensus diagnosis was compared to the findings of 2 additional pathologist who independently just reviewed the digital images (Observer 3 and 4). The intra-observer agreement was substantial to almost …

Personalized Trial Ethics And Institutional Review Board Submissions, Joyce P Samuel, Susan H Wootton

Faculty, Staff and Student Publications

The ethical and regulatory oversight of any clinical activity related to human subjects is commonly determined based on its categorization as either clinical practice or research. Prominent bioethicists have criticized the traditional distinctions used to delineate these categories, calling them counterproductive and outmoded, and arguing that learning and clinical practice should be deliberately and appropriately integrated. Personalized trials represent a clinical activity with characteristics that overlap both categories, making ethical and regulatory oversight requirements less straightforward. When the primary intent of the personalized trial is to assist in the conduct of individualized patient care with an emphasis on protecting the …

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 …

Ethical Considerations For Integrating Multimodal Computer Perception And Neurotechnology, Meghan E Hurley, Anika Sonig, John Herrington, Eric A Storch, Gabriel Lázaro-Muñoz, Jennifer Blumenthal-Barby, Kristin Kostick-Quenet

Center for Medical Ethics and Health Policy Staff Publications

Background: Artificial intelligence (AI)-based computer perception technologies (e.g., digital phenotyping and affective computing) promise to transform clinical approaches to personalized care in psychiatry and beyond by offering more objective measures of emotional states and behavior, enabling precision treatment, diagnosis, and symptom monitoring. At the same time, passive and continuous nature by which they often collect data from patients in non-clinical settings raises ethical issues related to privacy and self-determination. Little is known about how such concerns may be exacerbated by the integration of neural data, as parallel advances in computer perception, AI, and neurotechnology enable new insights into subjective states. …

Law Enforcement Use Of Genetic Genealogy Databases In Criminal Investigations: Nomenclature, Definition And Scope, Oliver M Tuazon, Ray A Wickenheiser, Ricky Ansell, Christi J Guerrini, Gerrit-Jan Zwenne, Bart Custers

Center for Medical Ethics and Health Policy Staff Publications

Although law enforcement use of commercial genetic genealogy databases has gained prominence since the arrest of the Golden State Killer in 2018, and it has been used in hundreds of cases in the United States and more recently in Europe and Australia, it does not have a standard nomenclature and scope. We analyzed the more common terms currently being used and propose a common nomenclature: investigative forensic genetic genealogy (iFGG). We define iFGG as the use by law enforcement of genetic genealogy combined with traditional genealogy to generate suspect investigational leads from forensic samples in criminal investigations. We describe iFGG …

Insights From Social Media Into Public Perspectives On Investigative Genetic Genealogy, Sara Huston, Diana Madden, Andrea Villanes, Nathan Reed, Whitney Bash Brooks, Christopher Healey, Christi Guerrini

Center for Medical Ethics and Health Policy Staff Publications

Social media sites like X (formerly Twitter) increasingly serve as spaces for the public to discuss controversial topics. Social media can spark extreme viewpoints and spread biased or inaccurate information while simultaneously allowing for debate around policy-relevant topics. The arrest of Joseph J. DeAngelo in April 2018 ignited a barrage of social media conversations on how DNA and genetic genealogy led to the suspect. These conversations continued over the following years as policies changed and as the use of the approach expanded. We examined social media coverage of investigative genetic genealogy (IGG) to characterize the volume and temporal patterns in …

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, …

A Use Case Of Chatgpt: Summary Of An Expert Panel Discussion On Electronic Health Records And Implementation Science, Seppo T Rinne, Julian Brunner, Timothy P Hogan, Jacqueline M Ferguson, Drew A Helmer, Sylvia J Hysong, Grace Mckee, Amanda Midboe, Megan E Shepherd-Banigan, A Rani Elwy

Center for Medical Ethics and Health Policy Staff Publications

Objective: Artificial intelligence (AI) is revolutionizing healthcare, but less is known about how it may facilitate methodological innovations in research settings. In this manuscript, we describe a novel use of AI in summarizing and reporting qualitative data generated from an expert panel discussion about the role of electronic health records (EHRs) in implementation science.

Materials and methods: 15 implementation scientists participated in an hour-long expert panel discussion addressing how EHRs can support implementation strategies, measure implementation outcomes, and influence implementation science. Notes from the discussion were synthesized by ChatGPT (a large language model-LLM) to generate a manuscript summarizing the discussion, …

Interrogating The Value Of Return Of Results For Diverse Populations: Perspectives From Precision Medicine Researchers, Caitlin E Mcmahon, Nicole Foti, Melanie Jeske, William R Britton, Stephanie M Fullerton, Janet K Shim, Sandra Soo-Jin Lee

Center for Medical Ethics and Health Policy Staff Publications

Background: Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the "duty to report" from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.

Methods: Semi-structured interviews with a …

Bridging The Gap: Transforming Primary Care Through The Artificial Intelligence And Machine Learning For Primary Care (Aim-Pc) Curriculum, Winston Liaw, Brian Hischier, Cornelius A James, Ioannis Kakadiaris, Jacqueline K Kueper, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Variability In Perceptions Of Complementary Health Approaches Among Graduate Student Trainees, Delaney C. Bilodeau

Theses and Dissertations

Complementary Health Approaches (CHAs) encompass a diverse range of practices which are often used both independently and alongside conventional medical treatments. Understanding how graduate students training in different fields perceive CHAs is important because these professional trainees will go on to occupy roles as healthcare practitioners, researchers, policy makers, and consumers. This study used sequential rank agreement methods (Ekstrøm, Gerds, & Jensen, 2019) to investigate variations in perceptions of CHAs in a sample of graduate students (N = 416) from 140 possible training programs. Ratings of CHA familiarity, perceptions of CHA legitimacy, and willingness to recommend CHAs were compared …

Animal Personality And Sentience As Distinct Concepts, Mark Briffa

Animal Sentience

Owens et al (2024) discuss how knowledge of both animal personality and sentience in target populations can be leveraged to enhance wildlife conservation programmes. In this commentary I expand on the distinction between these two concepts. Behavioural differences should be considered broadly across conservation programmes, not just those involving species deemed sentient.

How Should Focus Be Shifted From Individual Preference To Collective Wisdom For Patients At The End Of Life With Antimicrobial-Resistant Infections?, Jeannie P. Cimiotti, Kimberly Adams Tufts, Lucia D. Wocial, Elizabeth Peter

Ellmer School of Nursing Faculty Publications

Despite growth in numbers of organizational antimicrobial stewardship programs, antimicrobial resistance continues to escalate. Interprofessional education and collaboration are needed to make these programs appropriately responsive to the ethically and clinically complex needs of patients at the end of life whose care plans still require antimicrobial management.

The Determinants Of Nonprofit Hospital Ceo Compensation, Derek Jenkins, Marah N Short, Vivian Ho

Center for Medical Ethics and Health Policy Staff Publications

Hospital CEO salaries have grown quickly over the past two decades. We investigate correlates of rising nonprofit hospital CEO pay between 2012 and 2019 by merging compensation data from Candid's IRS 990 forms with hospital data from the National Academy for State Health Policy Hospital Cost Tool. Almost half of the measured increase in CEO compensation (44.5%) accrued to a "base case" CEO, who was leading a non-teaching hospital system or independent hospital with fewer than 100 beds that earned 0 profits and provided no charity care. Another 28.5% of the measured salary increase resulted from changes in the generosity …

Study Protocol For Measuring Stigmatization In Persistent Tic Disorders: Development And Validation Of The Tourette Discrimination-Stigmatization Scale, Jaclyn M Martindale, Victor M Ringheanu, Kelly A Pring, Sandra Norona, Kimberly Wiseman, Roy E Strowd, Leah Chapman, Joseph Rigdon, Stephen R Rapp, Eric A Storch, Edward Ip, Jonathan W Mink

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Persistent Tic Disorders such as Tourette Syndrome are common neurodevelopmental disorders that are highly stigmatized. Many individuals with Persistent Tic Disorders experience peer rejection, loneliness, and self-stigma. Experiencing stigmatization during childhood can influence the persistence of moderate-to-severe tics later in life. Additionally, these factors have been associated with increased suicidal ideation, suicide attempts, and psychiatric symptom severity. There is a need for interventions to reduce stigma and stigmatization in Persistent Tic Disorders. Before developing cost-effective interventions to mitigate stigma's profound downstream health impacts, a reliable measure of stigmatization must be created. The overarching goal of this research is to …

"A Double-Edged Sword": A Brief History Of Genomic Data Governance And Genetic Researcher Perspectives On Data Sharing, Kayte Spector-Bagdady, Kerry A Ryan, Amy L Mcguire, Chris D Krenz, M Grace Trinidad, Kaitlyn Jaffe, Amanda Greene, J Denard Thomas, Madison Kent, Stephanie Morain, David Wilborn, J Scott Roberts

Center for Medical Ethics and Health Policy Staff Publications

As the federal government continues to expand upon and improve its data sharing policies over the past 20 years, complex challenges remain. Our interviews with U.S. academic genetic researchers (n=23) found that the burden, translation, industry limitations, and consent structure of data sharing remain major governance challenges.

Choosing Your “Healthiest” Embryo After Dobbs: Polygenic Screening And Distinctive Challenges For Truth In Advertising And Informed Consent, Dov Fox, Sonia Suter, Meghna Mukherjee, Stacey Pereira, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

Polygenic embryo screening ("PES") analyzes embryos for hundreds or thousands of genomic loci to generate risk scores that estimate genetic susceptibility to conditions and traits compared to the general population. The technology is commercially marketed directly to consumers. Companies focus mostly on medical conditions, sometimes in ways that oversell its advantages and efficacy, encouraging fertility patients to "choose your healthiest embryo" and "protect your future child from genetic risks." The advertising of PES trades on norms of children's health and good parenting and reinforces those normative ideals. While it is easy to assume PES will be constrained in practice by …

Development Of A Multi-Level/Multi-Modal Intervention For Health Care Transition Preparation, Beth H Garland, Mary Majumder, Constance M Wiemann, Blanca Sanchez-Fournier, Jordyn Babla, Albert C Hergenroeder

Center for Medical Ethics and Health Policy Staff Publications

Aims: Health care transition (HCT) to adult care and young adult disease self-management is a multi-step process involving three major stakeholders - the adolescent, the caregiver, and the provider. Preparation gaps exist within each of these stakeholder groups. This paper presents the development of the Intervention to Promote Autonomy and Competence in Transition-aged Youth (IPACT), a multi-level (adolescent, caregiver, provider), multi-modal (interactive skill building sessions, educational materials, videos) intervention to address gaps in all three stakeholder groups simultaneously and help support achieving the three core elements of HCT planning.

Methods: Eight processes were utilized to develop the IPACT intervention, including …

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 …