Publications

View details for Web of Science ID 000542565600150

View details for Web of Science ID 000509464700132

View details for Web of Science ID 000509464700124

View details for Web of Science ID 000535430200015

View details for DOI 10.1213/ANE.0000000000004656

View details for PubMedID 31922996

View details for DOI 10.1213/ANE.0000000000004656

View details for PubMedID 31922996

Abstract

Artificial Intelligence (AI) describes systems capable of making decisions of high cognitive complexity; Autonomous AI systems in healthcare are AI systems that make clinical decisions without human oversight. Ensuring that autonomous AI provides these benefits requires evaluation of the Autonomous AI's effect on patient outcome, design, validation, data usage and accountability, from a bioethics and accountability perspective.Case study with literature review and bioethical analysis.Online library search for articles with AI and ethics as subject. Definition of terminology. Review of bioethical principles, and derivation of evaluation rules for Autonomous AI. Case study with an FDA de novo authorized Autonomous AI system.Preliminary evaluation rules derived from bioethical principles include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful FDA de novo authorization.Physicians need to become competent in understanding the limitations and risks as well as the potential benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, liability, and how its data was obtained. The Autonomous AI evaluation rules introduced here can support this process.

View details for DOI 10.1016/j.ajo.2020.02.022

View details for PubMedID 32171769

View details for DOI 10.1111/pan.13730

View details for PubMedID 31677337

View details for DOI 10.1080/15265161.2019.1687784

View details for Web of Science ID 000505296200011

View details for DOI 10.1080/15265161.2019.1687791

View details for PubMedID 31896335

Abstract

Background: In order for precision health to address health disparities, engagement of diverse racial/ethnic minority communities and the physicians that serve them is critical.Methods: A community-based participatory research approach with mixed methods was employed to gain a deeper understanding of precision health research and practice among American Indian, African American, Latino, Chinese, and Vietnamese groups and physicians that serve these communities. A survey assessed demographics and opinions of precision health, genetic testing, and precision health research. Focus groups (n=12) with each racial/ethnic minority group and physicians further explored attitudes about these topics.Results: One hundred community members (American Indian [n=17], African American [n=13], Chinese [n=17], Latino [n=27], and Vietnamese [n=26]) and 14 physicians completed the survey and participated in the focus groups. Familiarity with precision health was low among community members and high among physicians. Most groups were enthusiastic about the approach, especially if it considered influences on health in addition to genes (eg, environmental, behavioral, social factors). Significant concerns were expressed by African American and American Indian participants about precision health practice and research based on past abuses in biomedical research. In addition, physician and community members shared concerns such as security and confidentiality of genetic information, cost and affordability of genetic tests and precision medicine, discrimination and disparities, distrust of medical and research and pharmaceutical institutions, language barriers, and physician's specialty.Conclusions: Engagement of racial/ethnic minority communities and the providers who serve them is important for advancing a precision health approach to addressing health disparities.

View details for DOI 10.18865/ed.30.S1.137

View details for PubMedID 32269455

Abstract

BACKGROUND: Group-based lifestyle change programs based on the Diabetes Prevention Program (DPP) are associated with clinically significant weight loss and decreases in cardiometabolic risk factors. However, these benefits depend on successful real-world implementation. Studies have examined implementation in community settings, but less is known about integration in healthcare systems, and particularly in large, multi-site systems with the potential for extended reach.OBJECTIVE: To examine the barriers and facilitators to successful DPP implementation in a large multi-site healthcare system.DESIGN: Semi-structured interviews, based on the RE-AIM framework, were conducted in person for 30-90min each.PARTICIPANTS: Past and present DPP lifestyle coaches in the healthcare system identified using purposive sampling.APPROACH: Thematic analysis of qualitative data to identify key factors influencing the success of DPP implementation. An iterative consensus process was used to model the relationships among factors.KEY RESULTS: We conducted 33 interviews across 20 clinic sites serving 12 counties. Participants described six key factors as potential barriers or facilitators to implementation, including (1) Broader Context, including the surrounding physical and sociodemographic context; (2) Institutional Context, including finances, infrastructure, and personnel; (3) Program Provision, including curriculum, administration, cost, goals, and visibility; (4) Recruitment Process, including screening and referrals; (5) Lifestyle Coaches, including their characteristics, behaviors, and morale; and (6) Cohort, including group attrition/retention and interpersonal dynamics. These factors were both highly interconnected in their impact on implementation and widely variable across sites within the healthcare system, as illustrated in our multi-level conceptual framework.CONCLUSIONS: This study identified key factors that could serve as barriers or facilitators in the implementation of DPP in large healthcare systems, from the perspective of lifestyle coaches. With further examination, the conceptual model presented here may be used for planning and managing the implementation of group-based behavioral interventions in these settings.

View details for DOI 10.1007/s11606-020-05744-y

View details for PubMedID 32291720

Abstract

BACKGROUND: Today, approximately one in five United States adolescents age 12 to 19years is obese and just over a third are either overweight or obese. This study examines how parents and peers influence diet and physical activity behaviors of older adolescents (14-18years) with overweight or obesity to inform weight management interventions.METHODS: Adolescent participants included 14 to 18-year-olds with a Body Mass Index (BMI) greater than the 85th percentile for their age and sex who were receiving care in a large healthcare system in Northern California. Adolescents and their parents participated in separate focus groups and interviews (if not able to attend focus groups) that were held at the same time in the same location. We used qualitative thematic analysis to identify common themes discussed in the adolescent and parent focus groups as well as paired analysis of adolescent-parent dyads.RESULTS: Participants included 26 adolescents and 27 parents. Adolescent participants were 14 to 18years old. Half were female and the participants were almost evenly distributed across year in school. The majority self-identified as White (56%) and Asian (36%).Three themes were identified which included 1) parents overestimated how supportive they were compared to adolescents' perception 2) parents and adolescents had different views regarding parental influence on adolescent diet and physical activity behaviors 3) parents and adolescents held similar views on peers' influential role on lifestyle behaviors.CONCLUSION: Parents' and adolescents' differing views suggest that alignment of parent and adolescent expectations and behaviors for supporting effective weight management could be incorporated into interventions.

View details for DOI 10.1186/s12887-020-02038-4

View details for PubMedID 32220230

Abstract

OBJECTIVE: To assess whether an association exists between financial links to the indoor tanning industry and conclusions of indoor tanning literature.DESIGN: Systematic review.DATA SOURCES: PubMed, Embase, and Web of Science, up to 15 February 2019.STUDY SELECTION CRITERIA: Articles discussing indoor tanning and health were eligible for inclusion, with no article type restrictions (original research, systematic reviews, review articles, case reports, editorials, commentaries, and letters were all eligible). Basic science studies, articles describing only indoor tanning prevalence, non-English articles, and articles without full text available were excluded.RESULTS: 691 articles were included in analysis, including empiric articles (eg, original articles or systematic reviews) (357/691; 51.7%) and non-empiric articles letters (eg, commentaries, letters, or editorials) (334/691; 48.3%). Overall, 7.2% (50/691) of articles had financial links to the indoor tanning industry; 10.7% (74/691) articles favored indoor tanning, 3.9% (27/691) were neutral, and 85.4% (590/691) were critical of indoor tanning. Among the articles without industry funding, 4.4% (27/620) favored indoor tanning, 3.5% (22/620) were neutral, and 92.1% (571/620) were critical of indoor tanning. Among the articles with financial links to the indoor tanning industry, 78% (39/50) favored indoor tanning, 10% (5/50) were neutral, and 12% (6/50) were critical of indoor tanning. Support from the indoor tanning industry was significantly associated with favoring indoor tanning (risk ratio 14.3, 95% confidence interval 10.0 to 20.4).CONCLUSIONS: Although most articles in the indoor tanning literature are independent of industry funding, articles with financial links to the indoor tanning industry are more likely to favor indoor tanning. Public health practitioners and researchers need to be aware of and account for industry funding when interpreting the evidence related to indoor tanning.SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019123617.

View details for DOI 10.1136/bmj.m7

View details for PubMedID 32019742

View details for DOI 10.5888/pcd16.180221

View details for Web of Science ID 000460533200005

Abstract

Background and Rationale: ICU clinicians regularly care for patients who lack capacity, an applicable advance directive, and an available surrogate decision-maker. Although there is no consensus on terminology, we refer to these patients as "unrepresented." There is considerable controversy about how to make treatment decisions for these patients, and there is significant variability in both law and clinical practice.Purpose and Objectives: This multisociety statement provides clinicians and hospital administrators with recommendations for decision-making on behalf of unrepresented patients in the critical care setting.Methods: An interprofessional, multidisciplinary expert committee developed this policy statement by using an iterative consensus process with a diverse working group representing critical care medicine, palliative care, pediatric medicine, nursing, social work, gerontology, geriatrics, patient advocacy, bioethics, philosophy, elder law, and health law.Main Results: The committee designed its policy recommendations to promote five ethical goals: 1) to protect highly vulnerable patients, 2) to demonstrate respect for persons, 3) to provide appropriate medical care, 4) to safeguard against unacceptable discrimination, and 5) to avoid undue influence of competing obligations and conflicting interests. These recommendations also are intended to strike an appropriate balance between excessive and insufficient procedural safeguards. The committee makes the following recommendations: 1) institutions should offer advance care planning to prevent patients at high risk for becoming unrepresented from meeting this definition; 2) institutions should implement strategies to determine whether seemingly unrepresented patients are actually unrepresented, including careful capacity assessments and diligent searches for potential surrogates; 3) institutions should manage decision-making for unrepresented patients using input from a diverse interprofessional, multidisciplinary committee rather than ad hoc by treating clinicians; 4) institutions should use all available information on the patient's preferences and values to guide treatment decisions; 5) institutions should manage decision-making for unrepresented patients using a fair process that comports with procedural due process; 6) institutions should employ this fair process even when state law authorizes procedures with less oversight.Conclusions: This multisociety statement provides guidance for clinicians and hospital administrators on medical decision-making for unrepresented patients in the critical care setting.

View details for DOI 10.1164/rccm.202003-0512ST

View details for Web of Science ID 000535260100009

View details for PubMedID 32412853

View details for PubMedCentralID PMC7233335

View details for DOI 10.1177/1073110520917008

View details for PubMedID 32342787

View details for DOI 10.1080/15265161.2020.1735874

View details for PubMedID 32208071

View details for DOI 10.1016/j.jpsychores.2020.110080

View details for Web of Science ID 000543335400097

View details for DOI 10.1016/j.jpsychores.2020.110040

View details for Web of Science ID 000543335400057

View details for DOI 10.1016/j.jpsychores.2020.110062

View details for Web of Science ID 000543335400079

View details for DOI 10.1177/1073110520917008

View details for PubMedID 32342787

Abstract

Applications of facial recognition technology (FRT) in health care settings have been developed to identify and monitor patients as well as to diagnose genetic, medical, and behavioral conditions. The use of FRT in health care suggests the importance of informed consent, data input and analysis quality, effective communication about incidental findings, and potential influence on patient-clinician relationships. Privacy and data protection are thought to present challenges for the use of FRT for health applications.

View details for DOI 10.1001/amajethics.2019.180

View details for PubMedID 30794128

View details for DOI 10.1038/s41746-018-0075-8

View details for Web of Science ID 000453910600001

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

View details for DOI 10.1007/s12630-019-01472-y

View details for PubMedID 31485958

View details for DOI 10.1007/s12630-019-01376-x

View details for Web of Science ID 000480745300004

View details for PubMedID 30357277

Abstract

PURPOSE: Advances in gene therapy and precision medicine have led to a growing number of novel treatments for rare genetic diseases. Patients/families may lack access to up-to-date, accurate, and relevant information about these treatments. Social media offers one potentially important resource for these communities. Our goal was to understand how patients/families with spinal muscular atrophy (SMA)-a rare genetic condition-used social media to share, consume, and evaluate information about the novel treatment nusinersen (Spinraza) following the drug's approval.METHODS: We conducted qualitative, semistructured interviews with 20 SMA patients or parents of patients, deriving themes and subthemes through content and thematic network analysis. Participants also completed a demographic survey.RESULTS: Participants described leveraging social media to learn about nusinersen treatment, make informed treatment decisions, and advocate for/access treatment. They also described critically evaluating the trustworthiness of nusinersen-related information on social media and the privacy risks of social media use.CONCLUSION: Patients/families used social media to navigate the new and dynamic landscape of nusinersen treatment for SMA, while attempting to mitigate misinformation and privacy risks. As new treatments become available, providers and patients/families may benefit from proactively discussing social media use, so as to maximize important benefits while minimizing risks.

View details for DOI 10.1038/s41436-020-0890-6

View details for PubMedID 32601388

Abstract

EIF2AK1 and EIF2AK2 encode members of the eukaryotic translation initiation factor 2 alpha kinase (EIF2AK) family that inhibits protein synthesis in response to physiologic stress conditions. EIF2AK2 is also involved in innate immune response and the regulation of signal transduction, apoptosis, cell proliferation, and differentiation. Despite these findings, human disorders associated with deleterious variants in EIF2AK1 and EIF2AK2 have not been reported. Here, we describe the identification of nine unrelated individuals with heterozygous de novo missense variants in EIF2AK1 (1/9) or EIF2AK2 (8/9). Features seen in these nine individuals include white matter alterations (9/9), developmental delay (9/9), impaired language (9/9), cognitive impairment (8/9), ataxia (6/9), dysarthria in probands with verbal ability (6/9), hypotonia (7/9), hypertonia (6/9), and involuntary movements (3/9). Individuals with EIF2AK2 variants also exhibit neurological regression in the setting of febrile illness or infection. We use mammalian cell lines and proband-derived fibroblasts to further confirm the pathogenicity of variants in these genes and found reduced kinase activity. EIF2AKs phosphorylate eukaryotic translation initiation factor 2 subunit 1 (EIF2S1, also known as EIF2α), which then inhibits EIF2B activity. Deleterious variants in genes encoding EIF2B proteins cause childhood ataxia with central nervous system hypomyelination/vanishing white matter (CACH/VWM), a leukodystrophy characterized by neurologic regression in the setting of febrile illness and other stressors. Our findings indicate that EIF2AK2 missense variants cause a neurodevelopmental syndrome that may share phenotypic and pathogenic mechanisms with CACH/VWM.

View details for DOI 10.1016/j.ajhg.2020.02.016

View details for PubMedID 32197074

Abstract

The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies.To characterize the development of ventilator triage policies and compare policy content.Survey and mixed-methods content analysis.North American hospitals associated with members of the Association of Bioethics Program Directors.Program directors.Characteristics of institutions and policies, including triage criteria and triage committee membership.Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations.The results may not be generalizable to institutions without academic bioethics programs.Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.

View details for DOI 10.7326/M20-1738

View details for PubMedID 32330224

Abstract

Li-Fraumeni Syndrome (LFS) is characterized by risk of multiple primary malignancies in diverse sites, pediatric onset, near complete penetrance by age 70years, limited options for prevention, and substantial uncertainty regarding disease manifestation and prognosis. Forty-five families, including 117 individuals aged 13-81years, enrolled in the US National Cancer Institute's Li-Fraumeni Syndrome Study completed 66 interviews regarding their LFS experiences. An interdisciplinary team used modified grounded theory to examine family distress regarding expectations of loss and change due to likely cancer diagnoses, and the consequences of this likelihood across physical, social, and emotional domains. Disease-free periods were characterized by fearful anticipation of diagnosis or recurrence, uncertainty regarding post-treatment quality of life, and planning for shifts in family dynamics to enable caregiving. The chronicity of waiting for these changes incited dread and inhibited effective coping with the pragmatic, emotional, and existential challenges of the syndrome. Consequently, families reported high burden on roles and resources and limited guidance to prepare for, or achieve resolution with, grief. Anticipatory loss, the experience of bereavement prior to an expected change, distinguishes hereditary cancer risk from a sporadic diagnosis. Such grief is often incomplete in impact or meaning, subjected to rapid or profound change as conditions worsen, and poorly understood. In this study, losses were compounded by profound uncertainty, a chronic feature of LFS, which compromised mourning. Long-term engagement of mental health providers with bereavement training, in partnership with genetics providers, can provide invaluable educational and psychological support to families as they navigate these implacable challenges.

View details for DOI 10.1007/s10689-020-00173-6

View details for PubMedID 32222840

View details for Web of Science ID 000514591500203

Abstract

Li-Fraumeni Syndrome (LFS) is an inherited tumor predisposition syndrome with lifetime cancer risks approaching 100% and evolving risk-management strategies. This study evaluated couples' coping with LFS-related burdens.Constructivist grounded theory and anticipatory loss frameworks guided design and analysis.Twenty-six individuals enrolled in the NCI LFS Family Study completed semi-structured interviews with their partner during annual screening visits. An interdisciplinary team completed open and focused coding to identify patterns of coping and adaptation.Couples described living with ambiguous danger, a state of chronic apprehension resulting from LFS-associated uncertainties. Most couples communicated openly and alternated shouldering the burden, while others engaged in protective buffering to shield each other from distress and sustain the appearance of normalcy.Optimally, coping reduces shared psychosocial distress, yet some strategies may inadvertently increase disconnection.Mental health support is critical for both partners coping with LFS, together and separately.

View details for DOI 10.1080/07347332.2018.1543376

View details for Web of Science ID 000465227200005

View details for PubMedID 30591002