Publications

View details for DOI 10.1080/15265161.2024.2388752

View details for PubMedID 39283381

Abstract

Importance: Safe integration of artificial intelligence (AI) into clinical settings often requires randomized clinical trials (RCT) to compare AI efficacy with conventional care. Diabetic retinopathy (DR) screening is at the forefront of clinical AI applications, marked by the first US Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.Objective: To determine the generalizability of the 7 ethical research principles for clinical trials endorsed by the National Institute of Health (NIH), and identify ethical concerns unique to clinical trials of AI.Design, Setting, and Participants: This qualitative study included semistructured interviews conducted with 11 investigators engaged in the design and implementation of clinical trials of AI for DR screening from November 11, 2022, to February 20, 2023. The study was a collaboration with the ACCESS (AI for Children's Diabetic Eye Exams) trial, the first clinical trial of autonomous AI in pediatrics. Participant recruitment initially utilized purposeful sampling, and later expanded with snowball sampling. Study methodology for analysis combined a deductive approach to explore investigators' perspectives of the 7 ethical principles for clinical research endorsed by the NIH and an inductive approach to uncover the broader ethical considerations implementing clinical trials of AI within care delivery.Results: A total of 11 participants (mean [SD] age, 47.5 [12.0] years; 7 male [64%], 4 female [36%]; 3 Asian [27%], 8 White [73%]) were included, with diverse expertise in ethics, ophthalmology, translational medicine, biostatistics, and AI development. Key themes revealed several ethical challenges unique to clinical trials of AI. These themes included difficulties in measuring social value, establishing scientific validity, ensuring fair participant selection, evaluating risk-benefit ratios across various patient subgroups, and addressing the complexities inherent in the data use terms of informed consent.Conclusions and Relevance: This qualitative study identified practical ethical challenges that investigators need to consider and negotiate when conducting AI clinical trials, exemplified by the DR screening use-case. These considerations call for further guidance on where to focus empirical and normative ethical efforts to best support conduct clinical trials of AI and minimize unintended harm to trial participants.

View details for DOI 10.1001/jamanetworkopen.2024.32482

View details for PubMedID 39240560

View details for DOI 10.1080/15265161.2024.2377111

View details for PubMedID 39225989

Abstract

How might members of a large, multi-institutional research and resource consortium foster justice, equity, diversity, and inclusion as central to its mission, goals, governance, and culture? These four principles, often referred to as JEDI, can be aspirational-but to be operationalized, they must be supported by concrete actions, investments, and a persistent long-term commitment to the principles themselves, which often requires self-reflection and course correction. We present here the iterative design process implemented across the Clinical Genome Resource (ClinGen) that led to the development of an action plan to operationalize JEDI principles across three major domains, with specific deliverables and commitments dedicated to each. Active involvement of consortium leadership, buy-in from its members at all levels, and support from NIH program staff at pivotal stages were essential to the success of this effort. The ClinGen JEDI action plan that resulted from our process is a living document and roadmap whose target goals and deliverables will continue to evolve. Here, we offer a transparent account of how a large, multi-site biomedical research consortium achieved this, as well as the challenges and opportunities we encountered on this first step in our journey toward enacting JEDI principles in our sphere of influence. We hope that others seeking to engage in this work will gain valuable insights from our process, experience, and lessons learned.

View details for DOI 10.1016/j.ajhg.2024.12.009

View details for PubMedID 39793579

Abstract

Machine learning predictive analytics (MLPA) are utilized increasingly in health care, but can pose harms to patients, clinicians, health systems, and the public. The dynamic nature of this technology creates unique challenges to evaluating safety and efficacy and minimizing harms. In response, regulators have proposed an approach that would shift more responsibility to MLPA developers for mitigating potential harms. To be effective, this approach requires MLPA developers to recognize, accept, and act on responsibility for mitigating harms. In interviews of 40 MLPA developers of health care applications in the United States, we found that a subset of ML developers made statements reflecting moral disengagement, representing several different potential rationales that could create distance between personal accountability and harms. However, we also found a different subset of ML developers who expressed recognition of their role in creating potential hazards, the moral weight of their design decisions, and a sense of responsibility for mitigating harms. We also found evidence of moral conflict and uncertainty about responsibility for averting harms as an individual developer working in a company. These findings suggest possible facilitators and barriers to the development of ethical ML that could act through encouragement of moral engagement or discouragement of moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them.

View details for PubMedID 36541003

Abstract

Regulatory agencies need to ensure the safety and equity of AI in biomedicine, and the time to do so is now.

View details for DOI 10.1126/scitranslmed.adi0336

View details for PubMedID 37703349

Abstract

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

View details for DOI 10.1016/j.cct.2022.106703

View details for PubMedID 35176501

View details for Web of Science ID 001376888000001

View details for PubMedID 39587290

View details for DOI 10.1038/s42256-024-00926-3

View details for Web of Science ID 001363449700001

Abstract

The NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is focused on developing new tools and neurotechnologies to transform our understanding of the brain, and neuroethics is an essential component of this research effort. Coordination with other brain projects around the world will help maximize success.

View details for DOI 10.1016/j.neuron.2019.01.024

View details for PubMedID 30731065

Abstract

Genomics research enrolling undiagnosed patients can provide answers for one-third of participants and more can be diagnosed through future reanalysis. The long-term value for participants has raised questions of the "sustainability" of these studies, but the meaning, goals and best practices for sustainability remain unclear.We conducted semi-structured interviews with researchers leading studies enrolling undiagnosed patients in the United States and Canada and utilized thematic content analysis to summarize key themes.Researchers lacked consensus regarding what "sustainability" was actually intended to sustain, variably referencing study procedures, personnel, data access, and participant recontact. However, the primary driver of sustainability was widely shared as the perceived obligation to continue to search for answers for undiagnosed participants. Proposed sustainability strategies included diversifying funding sources, developing centralized data infrastructure, and building collaborations across disciplines and institutions. Researchers also emphasized the need to address ethical concerns, to integrate research with clinical care, and for leadership from research funders to guide these efforts.While genomics researchers perceived continued obligations to undiagnosed participants, they also lacked a shared understanding of the goals of sustainability and called for coordinated efforts to develop centralized infrastructure that integrated research and clinical care.

View details for DOI 10.1016/j.gim.2025.101458

View details for PubMedID 40411343

Abstract

Identifying when a child is suffering can be incredibly challenging. Understanding how the term 'suffering' is used in pediatric critical care - and specifically end of life care - is critical for clinical decision-making, communication, and goal-setting between healthcare providers and families. To gain insight into this complex question, we employed ethnographic methods to explore the underlying meanings and goals associated with the use of this term by clinicians, patients, and families in the Pediatric Intensive Care Unit (PICU).To explore how the term 'suffering' is operationalized by clinicians and families in Pediatric Intensive Care Units (PICUs) and its implications for decision-making.This study was conducted in three specialized PICUs within a large tertiary children's hospital. This exploratory qualitative study used ethnographic methods, including narrative literature review, analysis of verbatim transcripts of 30 care conferences and 50 ethnographic observations involving physicians, nurses, and families. Analyses employed an iterative, interpretive approach to identify key themes across data sources.This study identified three main themes: 1) 'Suffering' was rarely defined, 2) Discussions of patient 'suffering' included collateral impacts on providers and families, in addition to impacts on patient experience; and 3) Physicians used 'suffering' to pivot goals of care, while parents used it variably.These findings suggest that 'suffering' is often invoked in the PICU with little specificity, is used to signal provider or caregiver distress, and is used with the intention to shift goals of care in a manner not always consistent with family values or interpretations. Recognizing the implicit messages conveyed through language may support families and healthcare providers to better communicate their goals and preferences, fostering collaborative decision-making and enhancing patient outcomes in the PICU and during end-of-life care.

View details for DOI 10.1016/j.jpainsymman.2025.05.005

View details for PubMedID 40389182

Abstract

For physicians, the added responsibility of being an informal caregiver (IC, providing regular care for seriously ill loved ones) can create challenges such as increased rates of burnout that have received little attention. In this study, we explored physician mothers' informal caregiving experiences and probed their perspectives on how health systems can better support their needs.From September 14, 2021, to October 31, 2021, we distributed an online survey to a national sample of physician mothers who self-identified as ICs; survey questions examined their caregiving responsibilities and perspectives on workplace changes needed to support them.Of 23 respondents, 48% were caregivers for a child, and 74% coresided with their care recipient; 26% spent on average 40 hr per week caregiving and 44% were ICs for 5 years or more. Main caregiving responsibilities included communicating with health care providers (91%) and managing and/or attending medical appointments (70%). Three central themes emerged from open-ended questions: (a) "It's an exhausting and unrecognized burden"; (b) "Our health care system is difficult to navigate, even for physicians"; and (c) "Flexible work schedules, no penalties." Within these themes, respondents described feeling unrecognized and unsupported as ICs in their workplaces.Physician mothers who are ICs fill critical, demanding roles as health care leaders and caregivers at home. Balancing these dual roles presents significant challenges that can have adverse effects, leaving physician-mother ICs vulnerable to burnout and attrition. Targeted support strategies including flexible staffing models, expanded telehealth, and paid informal caregiving leave may improve experiences for physician ICs more generally. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

View details for DOI 10.1037/fsh0000945

View details for PubMedID 39666478

Abstract

The rise of genomic technologies has catalyzed shifts in the health care landscape through the commercialization of genome sequencing and testing services in the genomics marketplace. The development of consumer genomics into a growing array of information technologies aimed at collecting, curating, and broadly sharing personal data and biological materials reconstitutes the meaning of health and reframes patients into biocitizens. In this context, the good biocitizen is expected to assume personal responsibility for health through consumption of genomic information and acquiescence to public and private efforts at data surveillance and aggregation. These shifts raise fundamental questions about how competing interests of the public, the state, and corporate entities will be reconciled and what trade-offs are demanded for the promise of precision health.

View details for DOI 10.1002/hast.1156

View details for Web of Science ID 000543918300008

View details for PubMedID 32597530

Abstract

This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations.We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials.Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations.While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

View details for DOI 10.1038/s41436-020-0763-z

View details for PubMedID 32089547

Abstract

The Psychiatric Consultation Service at Massachusetts General Hospital sees medical and surgical inpatients with comorbid psychiatric symptoms and conditions. During their twice-weekly rounds, Dr Stern and other members of the Consultation Service discuss diagnosis and management of hospitalized patients with complex medical or surgical problems who also demonstrate psychiatric symptoms or conditions. These discussions have given rise to rounds reports that will prove useful for clinicians practicing at the interface of medicine and psychiatry.Prim Care Companion CNS Disord 2025;27(1):24f03823.Author affiliations are listed at the end of this article.

View details for DOI 10.4088/PCC.24f03823

View details for PubMedID 40048280

View details for DOI 10.1016/j.jaclp.2024.07.007

View details for PubMedID 39069171

View details for DOI 10.1080/15265161.2024.2308128

View details for PubMedID 38529987

Abstract

The study provides a comprehensive review of OpenAI's Generative Pre-trained Transformer 4 (GPT-4) technical report, with an emphasis on applications in high-risk settings like healthcare. A diverse team, including experts in artificial intelligence (AI), natural language processing, public health, law, policy, social science, healthcare research, and bioethics, analyzed the report against established peer review guidelines. The GPT-4 report shows a significant commitment to transparent AI research, particularly in creating a systems card for risk assessment and mitigation. However, it reveals limitations such as restricted access to training data, inadequate confidence and uncertainty estimations, and concerns over privacy and intellectual property rights. Key strengths identified include the considerable time and economic investment in transparent AI research and the creation of a comprehensive systems card. On the other hand, the lack of clarity in training processes and data raises concerns about encoded biases and interests in GPT-4. The report also lacks confidence and uncertainty estimations, crucial in high-risk areas like healthcare, and fails to address potential privacy and intellectual property issues. Furthermore, this study emphasizes the need for diverse, global involvement in developing and evaluating large language models (LLMs) to ensure broad societal benefits and mitigate risks. The paper presents recommendations such as improving data transparency, developing accountability frameworks, establishing confidence standards for LLM outputs in high-risk settings, and enhancing industry research review processes. It concludes that while GPT-4's report is a step towards open discussions on LLMs, more extensive interdisciplinary reviews are essential for addressing bias, harm, and risk concerns, especially in high-risk domains. The review aims to expand the understanding of LLMs in general and highlights the need for new reflection forms on how LLMs are reviewed, the data required for effective evaluation, and addressing critical issues like bias and risk.

View details for DOI 10.1371/journal.pdig.0000417

View details for PubMedID 38236824

View details for PubMedCentralID PMC10795998

Abstract

Self-referred imaging is one of the latest health care services to be marketed directly to consumers. Most aspects of these services are unregulated, and little is known about the messages in advertising used to attract potential consumers. We conducted a detailed analysis of print advertisements and informational brochures for self-referred imaging with respect to themes, content, accuracy, and emotional valence.Forty print advertisements from US newspapers around the country and 20 informational brochures were analyzed by 2 independent raters according to 7 major themes: health care technology; emotion, empowerment, and assurance; incentives; limited supporting evidence; popular appeal; statistics; and images. The Fisher exact test was used to identify significant differences in information content.Both the advertisements and the brochures emphasized health care and technology information and provided assurances of good health and incentives to self-refer. These materials also encouraged consumers to seek further information from company resources; virtually none referred to noncomplying sources of information or to the risks of having a scan. Images of people commonly portrayed European Americans. We found statistical differences between newspaper advertisements and mailed brochures for references to "prevalence of disease" (P<.001), "death" (P<.003), and "radiation" (P<.001). Statements lacking clear scientific evidence were identified in 38% of the advertisements (n = 15) and 25% of the brochures (n = 5).Direct-to-consumer marketing of self-referred imaging services, in both print advertisements and informational brochures, fails to provide prospective consumers with comprehensive balanced information vital to informed autonomous decision making. Professional guidelines and oversight for advertising and promotion of these services are needed.

View details for Web of Science ID 000225701900003

View details for PubMedID 15596630

Abstract

To examine different protocols for handling incidental findings on brain research MRIs, and provide a platform for establishing formal discussions of related ethical and policy issues.Corresponding authors identified from a database of peer-reviewed publications in 1991-2002 involving functional MRI (fMRI), alone or in combination with other imaging modalities, were invited to participate in this web-based survey. The survey asked questions regarding knowledge and handling of incidental findings, as well as characteristics of the scanning environment, training required, IRB protocol requirements, and neuroradiologist involvement.Seventy-four investigators who conduct MRI studies in the United States and abroad responded. Eighty-two percent (54/66) reported discovering incidental findings in their studies, such as arteriovenous malformations, brain tumors, and developmental abnormalities. Substantial variability was found in the procedures for handling and communicating findings to subjects, neuroradiologist involvement, personnel permitted to operate equipment, and training.Guidelines for minimum and optimum standards for detecting and communicating incidental findings on brain MRI research are needed.

View details for DOI 10.1002/jmri.20180

View details for Web of Science ID 000224762700001

View details for PubMedID 15503329

View details for PubMedCentralID PMC1506385

Abstract

Chylothorax is a potentially serious complication of lung and heart-lung transplantation. This article describes the clinical course of chylothorax in 3 heart-lung allograft recipients. We discuss management options, including dietary modifications, octreotide infusion, thoracic duct ligation and embolization, and surgical pleurodesis. In addition, we describe the novel use of aminocaproic acid to reduce lymph flow. We propose a multidisciplinary approach for the management of chylothorax that includes both medical and surgical options.

View details for Web of Science ID 000221393700018

View details for PubMedID 15135382

Abstract

Sharing human brain data can yield scientific benefits, but because of various disincentives, only a fraction of these data is currently shared. We profile three successful data-sharing experiences from the NIH BRAIN Initiative Research Opportunities in Humans (ROH) Consortium and demonstrate benefits to data producers and to users.

View details for DOI 10.1016/j.neuron.2023.09.029

View details for Web of Science ID 001135333000001

View details for PubMedID 37944519

View details for DOI 10.1080/15265161.2023.2237443

View details for Web of Science ID 001058425800017

View details for PubMedID 37647482

View details for PubMedCentralID PMC10502902

View details for DOI 10.1001/jama.2024.9450

View details for PubMedID 39141373

View details for DOI 10.1213/ANE.0000000000006061

View details for PubMedID 36806237

View details for DOI 10.1213/ANE.0000000000005947

View details for PubMedID 35709451

Abstract

Telemedicine has experienced dramatic increases in availability and use, particularly during the COVID-19 pandemic. However, it is largely unknown whether adults with intellectual and/or developmental disabilities (AIDD) can utilize telemedicine and have access to high-quality telemedicine care. Few studies have asked AIDD about their experiences with telemedicine. Existing studies have primarily focused on specialty care for IDD diagnoses, pediatric populations, or care in non-US settings.Characterize the experiences of AIDD with telemedicine using a community-based participatory research (CBPR) approach.A Community Advisory Board of AIDD and non-AIDD co-designed the study and focus group guide. Six virtual focus groups were conducted, four with AIDD and two with caregivers of AIDD (CAIDD), to solicit their experiences with and perspectives about telemedicine during the COVID-19 pandemic.Twenty-one AIDD and 13 CAIDD, recruited through community organizations and snowball sampling.Content analysis of focus group transcripts using consensus coding amongst three coders.Most AIDD in the study had participated in telemedicine. Positive experiences/benefits included (1) convenience and privacy; (2) minimizing IDD-specific in-person challenges; and (3) reducing COVID-19 risks and facilitating triage. Negative experiences and challenges included (1) IDD-specific communication challenges; (2) concerns about the need for "hands-on stuff"; and (3) challenges with technology access and abilities. Participants had mixed experiences with tele-mental healthcare. Some worried about challenges arising from a post-pandemic return to in-person care for AIDD.Participants found telemedicine beneficial, specifically in ways that mitigate existing barriers AIDD experience accessing and managing healthcare visits. While some of these benefits also exist for non-AIDD populations, they have specific potential to reduce health disparities for AIDD, even outside of a pandemic context. CBPR approaches centering AIDD voices are needed to validate and extend these results and to develop and test solutions.

View details for DOI 10.1007/s11606-025-09482-x

View details for PubMedID 40274742

View details for PubMedCentralID 7891688

View details for DOI 10.1016/j.jaad.2024.12.010

View details for PubMedID 39709079

Abstract

Visitor restriction policies to prevent the spread of COVID-19 among patients and clinicians were widespread during the pandemic, resulting in the exclusion of caregivers at key points of cancer care and treatment decision-making. The aim of this study was to explore how visitor restrictions impacted cancer treatment decision-making and care from patient and physician perspectives.Sixty-seven interviews, including 48 cancer patients and 19 cancer and palliative care physicians from four academic cancer centers in the USA between August 2020 and July 2021.Visitor restrictions that prevented caregivers from participating in clinic appointments and perioperative hospital care created challenges in cancer care that spanned three domains: practical, social, and informational. We identified eight themes that characterized challenges within the three domains across all three groups, and that these challenges had negative emotional and psychological consequences for both groups. Physicians perceived that patients' negative experiences due to lack of support through the physical presence of caregivers may have worsened patient outcomes.Our data demonstrate the tripartite structure of the therapeutic relationship in cancer care with caregivers providing critical support in the decision-making and care process to both patients and physicians. Caregiver absences led to practical, psychosocial, and informational burdens on both groups, and likely increased the risk of burnout among physicians. Our findings suggest that the quality of cancer care can be enhanced by engaging caregivers and promoting their physical presence during clinical encounters.

View details for DOI 10.1007/s00520-024-08473-8

View details for PubMedID 38622350

View details for PubMedCentralID PMC11018646