Publications

SCBE faculty and fellows publish often in leading journals. SCBE is also home to the editorial office of the American Journal of Bioethics (AJOB).

 

Member, Stanford Cancer Institute

Publications

  • A Tale of Two Pandemics: Cancer Coping and Care Delivery During the COVID-19 Pandemic Aslakson, R., Siden, R., Verano, M., Holdsworth, L., Braun, N., Tabor, H., Wong, B., Colborn, K., Smith, S., Lira, I., Hallahan, C., Nudotor, R., Siddiqi, A., Harris, E., Days-Yancey, K., Nasso, S., Rickerson, E., Fahy, B., Waterman, B., Johnston, F., Smith, T., Schapira, L. ELSEVIER SCIENCE INC. 2022: 1082-1083
  • An Evidence-Informed Cancer Care Communication Tool to Support Patients, Family, and Cancer and Palliative Care Clinicians During the COVID-19 Pandemic Siden, R., Holdsworth, L., Wong, B., Verano, M., Tabor, H., Aslakson, R. ELSEVIER SCIENCE INC. 2022: 1075
  • "Like Not Having an Arm": Perspectives of Patients, Caregivers, and Practitioners on the Impact of Visitor Restrictions on Cancer Care During the COVID-19 Pandemic Holdsworth, L., Siden, R., Wong, B., Verano, M., Tabor, H., Aslakson, R. ELSEVIER SCIENCE INC. 2022: 1085
Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine

Publications

  • Loss of access to legal abortion in America: history, implications, and action items for anesthesiologists. Anaesthesia, critical care & pain medicine Landau, R., Burgart, A. M., Sutton, C. D. 2022: 101125

    View details for DOI 10.1016/j.accpm.2022.101125

    View details for PubMedID 35803575

  • Parents Demand and Teenager Refuses Epidural Anesthesia. Pediatrics Berkowitz, I., Burgart, A., Truog, R. D., Mancuso, T. J., Char, D., Lantos, J. D. 2020

    Abstract

    A 15-year-old girl is scheduled to undergo an upper lobectomy to debulk metastatic Ewing sarcoma. The anesthesiologist recommended placement of a thoracic epidural catheter to provide postoperative analgesia. The patient did not want a needle to be placed near her spine. She was terrified that the procedure would be painful and that it might paralyze her. Although the anesthesiologist reassured her that sedation and local anesthesia would make the procedure comfortable, she remained vehemently opposed to the epidural procedure. The parents spoke privately to the anesthesiologist and asked for placement of the epidural after she was asleep. They firmly believed that this would provide optimal postoperative analgesia and thus would be in her best interest. Experts discuss the pros and cons of siding with the patient or parents.

    View details for DOI 10.1542/peds.2019-3295

    View details for PubMedID 32398328

  • The opioid crisis should lead pediatric anesthesiologists to a broader vision of opioid stewardship. Paediatric anaesthesia Burgart, A. M., Char, D. 2019; 29 (11): 1078–80

    View details for DOI 10.1111/pan.13730

    View details for PubMedID 31677337

Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric)

Publications

  • Bereaved Caregiver Perspectives on the End of Life in Pediatric Patients With Ventricular Assist Devices. Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies Bui, C. M., Schneider, L. M., Brown, M. R., Char, D. S., McIlvennan, C. K., Hollander, S. A. 2022

    Abstract

    OBJECTIVES: Ventricular assist devices (VADs) are increasingly used in pediatric heart failure as bridges to heart transplantation, although 25% will die with VADs. Family experiences in this population are not well-described. The objective is to understand bereaved families' perspectives on VAD and end-of-life decision-making.DESIGN: Semistructured interviews with bereaved caregivers of pediatric VAD patients.SETTING: Tertiary children's hospital.PATIENTS: Families of six pediatric VAD patients who died from 2014 to 2020.INTERVENTIONS: Not available.MEASUREMENTS AND MAIN RESULTS: Applying a grounded theory framework, interviews were coded by two independent readers using qualitative software. Themes were discussed in iterative multidisciplinary meetings. Participants were interviewed at a median 2.4 years after their child died. Three major themes emerged: 1) "lack of regret" for VAD implantation despite the outcome; 2) "caregiver-child accord" (via patient's verbal assent or physical cues) at implantation and end-of-life was important in family decision-making; and 3) development of a "local surrogate family" (medical team and peer families) provided powerful support.CONCLUSIONS: Bereaved families' perspectives provide insight into quality decision-making for major interventions and end-of-life care in pediatric patients with chronic illness who face decisions regarding technology dependence.

    View details for DOI 10.1097/PCC.0000000000003089

    View details for PubMedID 36194025

  • Could, Should Families Watch Their Loved One's Surgeries and, If So, When? Anesthesia and analgesia Quinonez, Z. A., Pyke-Grimm, K. A., Char, D. 2022; 135 (4): 704-707

    View details for DOI 10.1213/ANE.0000000000005801

    View details for PubMedID 36108184

  • Could, Should Families Watch Their Loved One's Surgeries and, If So, When? ANESTHESIA AND ANALGESIA Quinonez, Z. A., Pyke-Grimm, K. A., Char, D. 2022; 135 (4): 704-707
Professor (Research) of Pediatrics (Center for Biomedical Ethics) and of Medicine (Primary Care and Population Health)

Publications

  • Latinx attitudes, barriers, and experiences with genetic counseling and testing: A systematic review. Journal of genetic counseling Dron, H. A., Bucio, D., Young, J. L., Tabor, H. K., Cho, M. K. 2022

    Abstract

    As genetics is increasingly used across clinical settings, there is a need to understand the impact and experiences of diverse patients. This review systematically examined research literature on Latinx experiences with genetic counseling and genetic testing (GC/GT) in the United States, synthesizing key themes and knowledge gaps pertaining to both patient experience and hypothetical scenarios. Findings were based on a systematic search, inclusion, and thematic analysis of 81 empirical peer-reviewed articles published from January 1990 to July 2019 pertaining to Latinx populations and GC/GT. Studies most commonly addressed Latinas' perspectives on GC/GT in prenatal settings or for hereditary breast and ovarian cancer (HBOC). Costs, referrals, and communication were significant barriers to accessing genetic services for many Latinx patients, particularly those with low English proficiency (LEP). Studies highlighted difficulties accessing and communicating in healthcare settings, and how medical context and prior experience with healthcare workers and institutions influenced GC/GT decision-making. Providers' implicit biases about Latinx patients negatively impacted their care and impeded communication. Despite low awareness of cancer GT, Latinx patients often reported interest in learning more about GC/GT or unmet needs for GT discussion and provider involvement. This systematic review identified areas where providers can take action to improve Latinx experiences with GC/GT. Clinicians should elicit and respond to patient preferences about shared decision-making. For patients with low numeracy or LEP, providers should consider tailored educational and communication techniques. Most studies focused on HBOC and prenatal testing, and Latinx patients are heterogeneous, leaving many research questions about Latinx experience with GT/GC in other clinical areas.

    View details for DOI 10.1002/jgc4.1632

    View details for PubMedID 36301246

  • Data sharing and community-engaged research. Science (New York, N.Y.) Sabatello, M., Martschenko, D. O., Cho, M. K., Brothers, K. B. 2022; 378 (6616): 141-143

    Abstract

    Data sharing must be accompanied by responsibility sharing.

    View details for DOI 10.1126/science.abq6851

    View details for PubMedID 36227983

  • Three decades of ethical, legal, and social implications research: Looking back to chart a path forward. Cell genomics Dolan, D. D., Lee, S. S., Cho, M. K. 2022; 2 (7)

    Abstract

    More than thirty years ago in the United States, the National Center for Human Genome Research (NCHGR) at the National Institutes of Health (NIH) and its partner in the Human Genome Project (HGP), the Department of Energy (DOE), called for proposals from social scientists, ethicists, lawyers, and others to explore the ethical, legal, and social implications (ELSI) of mapping and sequencing the human genome. Today, nearly twenty years after the completion of the HGP, the ELSI Research Program of the National Human Genome Research Institute (NHGRI) continues this support. It has fostered the growth of ELSI research into a global field of study, uniquely positioned at the nexus of many academic disciplines and in proximity to basic and applied scientific research. We examine the formation of the first ELSI program and consider whether science policy in the public interest can exist within the confines of a set-aside from the NHGRI budget.

    View details for DOI 10.1016/j.xgen.2022.100150

    View details for PubMedID 35935917

Postdoctoral Scholar, Biomedical Ethics
Deane F. and Kate Edelman Johnson Professor of Law and, Professor, by courtesy, of Genetics

Publications

  • Neuroscience and the Criminal Justice System ANNUAL REVIEW OF CRIMINOLOGY, VOL 2 Greely, H. T., Farahany, N. A., Petersilia, J., Sampson, R. J. 2019; 2: 451–71
  • Neuroethics Guiding Principles for the NIH BRAIN Initiative. The Journal of neuroscience : the official journal of the Society for Neuroscience Greely, H. T., Grady, C., Ramos, K. M., Chiong, W., Eberwine, J., Farahany, N. A., Johnson, L. S., Hyman, B. T., Hyman, S. E., Rommelfanger, K. S., Serrano, E. E. 2018; 38 (50): 10586–88

    View details for DOI 10.1523/JNEUROSCI.2077-18.2018

    View details for PubMedID 30541767

  • The ethics of experimenting with human brain tissue. Nature Farahany, N. A., Greely, H. T., Hyman, S. n., Koch, C. n., Grady, C. n., Pașca, S. P., Sestan, N. n., Arlotta, P. n., Bernat, J. L., Ting, J. n., Lunshof, J. E., Iyer, E. P., Hyun, I. n., Capestany, B. H., Church, G. M., Huang, H. n., Song, H. n. 2018; 556 (7702): 429–32

    View details for DOI 10.1038/d41586-018-04813-x

    View details for PubMedID 29691509

Sr Research Scholar, School of Medicine - Biomedical Ethics

Publications

  • Beyond "Ensuring Understanding": Toward a Patient-Partnered Neuroethics of Brain Device Research. AJOB neuroscience Halley, M. C., Dixon-Salazar, T., Wexler, A. 2022; 13 (4): 241-244

    View details for DOI 10.1080/21507740.2022.2126550

    View details for PubMedID 36272165

  • Supporting undiagnosed participants when clinical genomics studies end. Nature genetics Halley, M. C., Ashley, E. A., Tabor, H. K. 2022

    View details for DOI 10.1038/s41588-022-01150-8

    View details for PubMedID 35902745

  • Impact of Sexual Harassment and Social Support on Burnout in Physician Mothers. Journal of women's health (2002) Linos, E., Lasky-Fink, J., Halley, M., Sarkar, U., Mangurian, C., Sabry, H., Linos, E., Jagsi, R. 2022

    Abstract

    Background: Burnout affects >50% of physicians, especially women. This study aimed to examine how negative workplace interactions can predict burnout, and whether positive social interactions can mitigate risk. Materials and Methods: In a study of 1627 physician mothers who responded to a survey by the Physician Moms Group, an online Facebook group, we first examined the association between workplace sexual harassment and burnout. In an embedded experiment, we then measured the causal impact of priming perceived social support and connectedness on the three dimensions of employee burnout. Results: Two-thirds of respondents reported having experienced sexual harassment in the past year. Sexual harassment by patients was associated with 0.27 points higher emotional exhaustion, one dimension of burnout (95% confidence interval [CI] 0.12-0.41), equivalent to the predicted impact of an additional 22 weekly work hours on emotional exhaustion. Sexual harassment by patients was also associated with 0.40 points higher patient depersonalization, another dimension of burnout (95% CI 0.27-0.53). Sexual harassment by colleagues was associated with 0.16 points higher emotional exhaustion (95% CI 0.02-0.30), but not other dimensions of burnout. We found no significant relationship between experiences of sexual harassment and levels of personal accomplishment (the third dimension of burnout) among this sample. Priming physician mothers to reflect on their connectedness with other physician mothers significantly increased their sense of personal accomplishment. The priming intervention did not yield a significant effect on emotional exhaustion or depersonalization. Conclusions: Negative and positive social interactions each affect different dimensions of burnout. Sexual harassment-a pervasive type of negative social interaction-strongly predicts emotional exhaustion and depersonalization. Reflecting on social connectedness-a type of positive social interaction-can improve one's sense of personal accomplishment with an effect similar in magnitude to more intensive in-person interventions, suggesting that social connectedness through online groups merits further consideration as a tool to mitigate burnout.

    View details for DOI 10.1089/jwh.2021.0487

    View details for PubMedID 35730998

Clinical Associate Professor, Medicine - Primary Care and Population Health

Publications

  • "No Escalation of Treatment" Designations: A Multi-Institutional Exploratory Qualitative Study. Chest Batten, J. N., Blythe, J. A., Wieten, S. E., Dzeng, E., Kruse, K. E., Cotler, M. P., Porter-Williamson, K., Kayser, J. B., Harman, S. M., Magnus, D. 2022

    Abstract

    BACKGROUND: No Escalation of Treatment (NoET) designations are used in intensive care units internationally to limit treatment for critically ill patients. However, they are the subject of debate in the literature and have not been qualitatively studied.QUESTION: How do physicians understand and perceive NoET designations, especially with regards to their utility and associated challenges? What mechanisms do hospitals provide to facilitate the use of NoET designations?STUDY DESIGN AND METHODS: Qualitative study at seven United States hospitals, employing semi-structured interviews with thirty physicians and review of relevant institutional records (e.g., hospital policies, screenshots of ordering menus in the electronic health record).RESULTS: At all hospitals, participants reported the use of NoET designations, which were understood to mean that providers should withhold new or higher-intensity interventions ("escalations") but not withdraw ongoing interventions. Three hospitals provided a specific mechanism for designating a patient as NoET (e.g., a DNR/Do-Not-Escalate code status order); at the remaining hospitals, a variety of informal methods (e.g., verbal handoffs) were used. We identified five functions of NoET designations: (1) Defining an intermediate point of treatment limitation, (2) Helping physicians navigate pre-arrest clinical decompensations, (3) Helping surrogate decision makers transition toward comfort care, (4) Preventing patient harm from invasive measures, and (5) Conserving critical care resources. Across hospitals, participants reported implementation challenges related to the ambiguity in meaning of NoET designations.INTERPRETATION: Despite ongoing debate, NoET designations are used in a varied sample of hospitals and are perceived as having multiple functions, suggesting they may fulfill an important need in the care of critically ill patients, especially at the end of life. The use of NoET designations can be improved through the implementation of a formal mechanism that encourages consistency across providers and clarifies the meaning of "escalation" for each patient.

    View details for DOI 10.1016/j.chest.2022.08.2211

    View details for PubMedID 36007596

  • Top Ten Tips Palliative Care Clinicians Should Know About Their Work's Intersection with Clinical Ethics. Journal of palliative medicine Weaver, M. S., Boss, R. D., Christopher, M. J., Gray, T. F., Harman, S., Madrigal, V. N., Michelson, K. N., Paquette, E. T., Pentz, R. D., Scarlet, S., Ulrich, C. M., Walter, J. K. 2021

    Abstract

    Palliative care (PC) subspecialists and clinical ethics consultants often engage in parallel work, as both function primarily as interprofessional consultancy services called upon in complex clinical scenarios and challenging circumstances. Both practices utilize active listening, goals-based communication, conflict mediation or mitigation, and values explorations as care modalities. In this set of tips created by an interprofessional team of ethicists, intensivists, a surgeon, an attorney, and pediatric and adult PC nurses and physicians, we aim to describe some paradigmatic clinical challenges for which partnership may improve collaborative, comprehensive care.

    View details for DOI 10.1089/jpm.2021.0521

    View details for PubMedID 34807737

  • "Relax City Homecare team; protocols are ready for you" - A Quality Improvement Project Conducted on Behalf of the City Homecare Unit Team at the Trivandrum Institute of Palliative Sciences. Indian journal of palliative care Sunilkumar, M. M., Thampi, A., Lekshmi, S., Harman, S. M., Vallath, N. 2021; 27 (2): 204-210

    Abstract

    The city homecare unit (CHU) of the Trivandrum Institute of Palliative Sciences was dissatisfied with the quality of care provided to their patient population.This study aims to improve the average satisfaction score of CHU during their daily homecare services.The improvement project for the CHU activities was conducted with a prospective plan-do-study-act design, with stepwise application of improvement tools.The A3 quality improvement (QI) methodology, which uses tools for (i) analysing contributors (process mapping, cause-effect diagram); (ii) to derive key drivers (Pareto chart) and (iii) for measuring impact of interventions and sustainability (annotated run chart) was applied. The project was conducted as a mentored activity of the PC-PAICE program. The team's weekly average satisfaction score was recorded prospectively as the outcome parameter, with 0 representing total dissatisfaction and 10 representing total satisfaction. Accuracy of triaging and appropriateness of registration process were the process parameters selected. These were recorded as run charts across the project period of 9 months.The cause-effect tool and the impact effort tool were used to analyse the mapped CHU processes. Even though we identified 22 contributors to the problem, eight of them were found to be significant. Key drivers were determined based on these eight and applied to the CHU processes. Over the project period, the satisfaction scores of the CHU improved significantly from 5.82 to 7.6 that is, satisfaction levels were high on most days. The triaging and registration goals were achieved. The team also built its own capacity for QI.The application of the A3 methodology simplified and streamlined efforts and achieved the quality goal for the CHU team.

    View details for DOI 10.25259/IJPC_408_20

    View details for PubMedID 34511785

    View details for PubMedCentralID PMC8428877

Sr Research Scholar, Pediatrics - Center for Biomedical Ethics

Publications

  • Excavating the Personal Genome: The Good Biocitizen in the Age of Precision Health HASTINGS CENTER REPORT Lee, S. 2020; 50: S54–S61

    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

  • Obligations of the "Gift": Reciprocity and Responsibility in Precision Medicine. The American journal of bioethics : AJOB Lee, S. S. 2020: 1–15

    Abstract

    Precision medicine relies on data and biospecimens from participants who willingly offer their personal information on the promise that this act will ultimately result in knowledge that will improve human health. Drawing on anthropological framings of the "gift," this paper contextualizes participation in precision medicine as inextricable from social relationships and their ongoing ethical obligations. Going beyond altruism, reframing biospecimen and data collection in terms of socially regulated gift-giving recovers questions of responsibility and care. As opposed to conceiving participation in terms of donations that elide clinical labor critical to precision medicine, the gift metaphor underscores ethical commitments to reciprocity and responsibility. This demands confronting inequities in precision medicine, such as systemic bias and lack of affordability and access. A focus on justice in precision medicine that recognizes the sociality of the gift is a critical frontier for bioethics.

    View details for DOI 10.1080/15265161.2020.1851813

    View details for PubMedID 33325811

  • Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol's evolution. Genetics in medicine : official journal of the American College of Medical Genetics Kraft, S. A., McMullen, C. n., Lindberg, N. M., Bui, D. n., Shipman, K. n., Anderson, K. n., Joseph, G. n., Duenas, D. M., Porter, K. M., Kauffman, T. L., Koomas, A. n., Ransom, C. L., Jackson, P. n., Goddard, K. A., Wilfond, B. S., Lee, S. S. 2020

    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

Thomas A. Raffin Professor of Medicine and Biomedical Ethics and Professor (Teaching) of Medicine (Primary Care and Population Health)

Publications

  • Revise the UDDA to Align the Law with Practice through Neuro-Respiratory Criteria. Neurology Omelianchuk, A., Bernat, J., Caplan, A., Greer, D., Lazaridis, C., Lewis, A., Pope, T., Ross, L. F., Magnus, D. 1800

    Abstract

    Although the Uniform Determination of Death Act (UDDA) has served as a model statute for 40 years, there is a growing recognition that the law must be updated. One issue being considered by the Uniform Law Commission's Drafting Committee to revise the UDDA is whether the text "all functions of the entire brain, including the brainstem" should be changed. Some argue that the absence of diabetes insipidus indicates that some brain functioning continues in many individuals who otherwise meet the "accepted medical standards" like the American Academy of Neurology's. The concern is that the legal criteria and the medical standards used to determine death by neurological criteria are not aligned. We argue for the revision of the UDDA to more accurately specify legal criteria which align with the medical standards: brain injury leading to permanent loss of a) the capacity for consciousness, b) the ability to breathe spontaneously, and c) brainstem reflexes. We term these criteria "neuro-respiratory criteria" and show that they are well-supported in the literature for physiological and social reasons justifying their use in the law.

    View details for DOI 10.1212/WNL.0000000000200024

    View details for PubMedID 35078943

  • Variation in the design of Do Not Resuscitate orders and other code status options: a multi-institutional qualitative study. BMJ quality & safety Batten, J. N., Blythe, J. A., Wieten, S., Cotler, M. P., Kayser, J. B., Porter-Williamson, K., Harman, S., Dzeng, E., Magnus, D. 2020

    Abstract

    BACKGROUND: US hospitals typically provide a set of code status options that includes Full Code and Do Not Resuscitate (DNR) but often includes additional options. Although US hospitals differ in the design of code status options, this variation and its impacts have not been empirically studied.DESIGN AND METHODS: Multi-institutional qualitative study at 7 US hospitals selected for variability in geographical location, type of institution and design of code status options. We triangulated across three data sources (policy documents, code status ordering menus and in-depth physician interviews) to characterise the code status options available at each hospital. Using inductive qualitative methods, we investigated design differences in hospital code status options and the perceived impacts of these differences.RESULTS: The code status options at each hospital varied widely with regard to the number of code status options, the names and definitions of code status options, and the formatting and capabilities of code status ordering menus. DNR orders were named and defined differently at each hospital studied. We identified five key design characteristics that impact the function of a code status order. Each hospital's code status options were unique with respect to these characteristics, indicating that code status plays differing roles in each hospital. Physician participants perceived that the design of code status options shapes communication and decision-making practices about resuscitation and life-sustaining treatments, especially at the end of life. We identified four potential mechanisms through which this may occur: framing conversations, prompting decisions, shaping inferences and creating categories.CONCLUSIONS: There are substantive differences in the design of hospital code status options that may contribute to known variability in end-of-life care and treatment intensity among US hospitals. Our framework can be used to design hospital code status options or evaluate their function.

    View details for DOI 10.1136/bmjqs-2020-011222

    View details for PubMedID 33082165

  • "I don't want to be Henrietta Lacks": diverse patient perspectives on donating biospecimens for precision medicine research. Genetics in medicine : official journal of the American College of Medical Genetics Lee, S. S., Cho, M. K., Kraft, S. A., Varsava, N., Gillespie, K., Ormond, K. E., Wilfond, B. S., Magnus, D. 2018

    Abstract

    PURPOSE: To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections.METHODS: We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research.RESULTS: Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data.CONCLUSION: Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.

    View details for PubMedID 29887604

John and Terry Levin Family Professor of Medicine and Professor, by courtesy, of Emergency Medicine and of Medicine

Publications

  • Psychosocial assessment of transplant candidates: Inter-rater reliability and concurrent validity of the Japanese version of the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT). Journal of the Academy of Consultation-Liaison Psychiatry Satoko, I., Oshibuchi, H., Tsutsui, J., Kobayashi, S., Takano, K., Sugawara, H., Kamba, R., Akaho, R., Ishida, H., Maldonado, J., Nishimura, K. 2021

    Abstract

    BACKGROUND: The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) is a comprehensive instrument developed to provide a standardized, objective, and evidence-based psychosocial evaluation of the main pre-transplant psychosocial risk factors that may influence transplant outcomes.OBJECTIVE: Since established assessment procedures or standardized tools designed to perform pre-solid organ transplant psychosocial evaluation are currently unavailable in Japan, the present study aimed to develop and preliminarily validate the Japanese version of the SIPAT.METHODS: First, the Japanese version of the SIPAT was developed using standard forward-back-translation procedures. Then, the Japanese versions of the SIPAT and the Japanese version of Psychosocial Assessment of Candidates for Transplant (PACT) were retrospectively and blindly applied to 107 transplant cases by 4 independent raters.RESULTS: The interrater reliability of the scores obtained with the Japanese version of the SIPAT was excellent (Pearson's correlation coefficient = 0.86). The concurrent validity of the SIPAT to the PACT for each examiner was substantial (Spearman's rank correlation coefficient = -0.66).CONCLUSION: These findings suggest that the Japanese version of the SIPAT is a promising and reliable instrument. Further research is required to test the predictive validity of the Japanese version of the SIPAT.

    View details for DOI 10.1016/j.jaclp.2021.10.004

    View details for PubMedID 34863909

  • Research Needs for Inpatient Management of Severe Alcohol Withdrawal Syndrome An Official American Thoracic Society Research Statement AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE Steel, T. L., Afshar, M., Edwards, S., Jolley, S. E., Timko, C., Clark, B. J., Douglas, I. S., Dzierba, A. L., Gershengorn, H. B., Gilpin, N. W., Godwin, D. W., Hough, C. L., Maldonado, J. R., Mehta, A. B., Nelson, L. S., Patel, M. B., Rastegar, D. A., Stollings, J. L., Tabakoff, B., Tate, J. A., Wong, A., Burnham, E. L., Amer Thoracic Soc Assembly Critica, Assembly Behav Sci Hlth Serv Res, Assembly Nursing 2021; 204 (7): E61-E87

    Abstract

    Background: Severe alcohol withdrawal syndrome (SAWS) is highly morbid, costly, and common among hospitalized patients, yet minimal evidence exists to guide inpatient management. Research needs in this field are broad, spanning the translational science spectrum. Goals: This research statement aims to describe what is known about SAWS, identify knowledge gaps, and offer recommendations for research in each domain of the Institute of Medicine T0-T4 continuum to advance the care of hospitalized patients who experience SAWS. Methods: Clinicians and researchers with unique and complementary expertise in basic, clinical, and implementation research related to unhealthy alcohol consumption and alcohol withdrawal were invited to participate in a workshop at the American Thoracic Society 2019 International Conference. The committee was subdivided into four groups on the basis of interest and expertise: T0-T1 (basic science research with translation to humans), T2 (research translating to patients), T3 (research translating to clinical practice), and T4 (research translating to communities). A medical librarian conducted a pragmatic literature search to facilitate this work, and committee members reviewed and supplemented the resulting evidence, identifying key knowledge gaps. Results: The committee identified several investigative opportunities to advance the care of patients with SAWS in each domain of the translational science spectrum. Major themes included 1) the need to investigate non-γ-aminobutyric acid pathways for alcohol withdrawal syndrome treatment; 2) harnessing retrospective and electronic health record data to identify risk factors and create objective severity scoring systems, particularly for acutely ill patients with SAWS; 3) the need for more robust comparative-effectiveness data to identify optimal SAWS treatment strategies; and 4) recommendations to accelerate implementation of effective treatments into practice. Conclusions: The dearth of evidence supporting management decisions for hospitalized patients with SAWS, many of whom require critical care, represents both a call to action and an opportunity for the American Thoracic Society and larger scientific communities to improve care for a vulnerable patient population. This report highlights basic, clinical, and implementation research that diverse experts agree will have the greatest impact on improving care for hospitalized patients with SAWS.

    View details for DOI 10.1164/rccm.202108-1845ST

    View details for Web of Science ID 000705466800002

    View details for PubMedID 34609257

    View details for PubMedCentralID PMC8528516

  • The Use of Physostigmine in the Diagnosis and Treatment of Anticholinergic Toxicity After Olanzapine Overdose: Literature Review and Case Report JOURNAL OF THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY Serrano, W., Maldonado, J. 2021; 62 (4): 285-297
Assistant Professor (Research) of Pediatrics (Biomedical Ethics)

Publications

  • Dimensions of Research-Participant Interaction: Engagement is Not a Replacement for Consent. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Shearer, E., Martinez, N., Magnus, D. 2020; 48 (1): 183–84

    View details for DOI 10.1177/1073110520917008

    View details for PubMedID 32342787

  • What Are Important Ethical Implications of Using Facial Recognition Technology in Health Care? AMA journal of ethics Martinez-Martin, N. 2019; 21 (2): E180–187

    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

  • Data mining for health: staking out the ethical territory of digital phenotyping NPJ DIGITAL MEDICINE Martinez-Martin, N., Insel, T. R., Dagum, P., Greely, H. T., Cho, M. K. 2018; 1
Assistant Professor (Research) of Pediatrics (Stanford Center for Biomedical Ethics)

Publications

Clinical Professor, Genetics

Publications

  • Defining the Critical Components of Informed Consent for Genetic Testing. Journal of personalized medicine Ormond, K. E., Borensztein, M. J., Hallquist, M. L., Buchanan, A. H., Faucett, W. A., Peay, H. L., Smith, M. E., Tricou, E. P., Uhlmann, W. R., Wain, K. E., Coughlin, C. R., On Behalf Of The Clinical Genome CADRe Workgroup 1800; 11 (12)

    Abstract

    PURPOSE: Informed consent for genetic testing has historically been acquired during pretest genetic counseling, without specific guidance defining which core concepts are required.METHODS: The Clinical Genome Resource (ClinGen) Consent and Disclosure Recommendations Workgroup (CADRe) used an expert consensus process to identify the core concepts essential to consent for clinical genetic testing. A literature review identified 77 concepts that are included in informed consent for genetic tests. Twenty-five experts (9 medical geneticists, 8 genetic counselors, and 9 bioethicists) completed two rounds of surveys ranking concepts' importance to informed consent.RESULTS: The most highly ranked concepts included: (1) genetic testing is voluntary; (2) why is the test recommended and what does it test for?; (3) what results will be returned and to whom?; (4) are there other types of potential results, and what choices exist?; (5) how will the prognosis and management be impacted by results?; (6) what is the potential family impact?; (7) what are the test limitations and next steps?; and (8) potential risk of genetic discrimination and legal protections.CONCLUSION: Defining the core concepts necessary for informed consent for genetic testing provides a foundation for quality patient care across a variety of healthcare providers and clinical indications.

    View details for DOI 10.3390/jpm11121304

    View details for PubMedID 34945775

  • Application of a framework to guide genetic testing communication across clinical indications. Genome medicine Hallquist, M. L., Tricou, E. P., Ormond, K. E., Savatt, J. M., Coughlin, C. R., Faucett, W. A., Hercher, L., Levy, H. P., O'Daniel, J. M., Peay, H. L., Stosic, M., Smith, M., Uhlmann, W. R., Wand, H., Wain, K. E., Buchanan, A. H. 2021; 13 (1): 71

    Abstract

    BACKGROUND: Genetic information is increasingly relevant across healthcare. Traditional genetic counseling (GC) may limit access to genetic information and may be more information and support than some individuals need. We report on the application and clinical implications of a framework to consistently integrate genetics expertise where it is most useful to patients.METHODS: The Clinical Genome Resource's (ClinGen) Consent and Disclosure Recommendations (CADRe) workgroup designed rubrics to guide pre- and post-genetic test communication. Using a standard set of testing indications, pre- and post-test rubrics were applied to 40 genetic conditions or testing modalities with diverse features, including variability in levels of penetrance, clinical actionability, and evidence supporting a gene-disease relationship. Final communication recommendations were reached by group consensus.RESULTS: Communication recommendations were determined for 478 unique condition-indication or testing-indication pairs. For half of the conditions and indications (238/478), targeted discussions (moderate communication depth) were the recommended starting communication level for pre- and post-test conversations. Traditional GC was recommended pre-test for adult-onset neurodegenerative conditions for individuals with no personal history and post-test for most conditions when genetic testing revealed a molecular diagnosis as these situations are likely higher in complexity and uncertainty. A brief communication approach was recommended for more straightforward conditions and indications (e.g., familial hypercholesterolemia; familial variant testing).CONCLUSIONS: The CADRe recommendations provide guidance for clinicians in determining the depth of pre- and post-test communication, strategically aligning the anticipated needs of patients with the starting communication approach. Shorter targeted discussions or brief communications are suggested for many tests and indications. Longer traditional GC consultations would be reserved for patients with more complex and uncertain situations where detailed information, education, and psychological support can be most beneficial. Future studies of the CADRe communication framework will be essential for determining if CADRe-informed care supports quality patient experience while improving access to genetic information across healthcare.

    View details for DOI 10.1186/s13073-021-00887-x

    View details for PubMedID 33926532

  • Improving reporting standards for polygenic scores in risk prediction studies. Nature Wand, H., Lambert, S. A., Tamburro, C., Iacocca, M. A., O'Sullivan, J. W., Sillari, C., Kullo, I. J., Rowley, R., Dron, J. S., Brockman, D., Venner, E., McCarthy, M. I., Antoniou, A. C., Easton, D. F., Hegele, R. A., Khera, A. V., Chatterjee, N., Kooperberg, C., Edwards, K., Vlessis, K., Kinnear, K., Danesh, J. N., Parkinson, H., Ramos, E. M., Roberts, M. C., Ormond, K. E., Khoury, M. J., Janssens, A. C., Goddard, K. A., Kraft, P., MacArthur, J. A., Inouye, M., Wojcik, G. L. 2021; 591 (7849): 211–19

    Abstract

    Polygenic risk scores (PRSs), which often aggregate results from genome-wide association studies, can bridge the gap between initial discovery efforts and clinical applications for the estimation of disease risk using genetics. However, there is notable heterogeneity in the application and reporting of these risk scores, which hinders the translation of PRSs into clinical care. Here, in a collaboration between the Clinical Genome Resource (ClinGen) Complex Disease Working Group and the Polygenic Score (PGS) Catalog, we present the Polygenic Risk Score Reporting Standards (PRS-RS), in which we update the Genetic Risk Prediction Studies (GRIPS) Statement to reflect the present state of the field. Drawing on the input of experts in epidemiology, statistics, disease-specific applications, implementation and policy, this comprehensive reporting framework defines the minimal information that is needed to interpret and evaluate PRSs, especially with respect to downstream clinical applications. Items span detailed descriptions of study populations, statistical methods for the development and validation of PRSs and considerations for the potential limitations of these scores. In addition, we emphasize the need for data availability and transparency, and we encourage researchers to deposit and share PRSs through the PGS Catalog to facilitate reproducibility and comparative benchmarking. By providing these criteria in a structured format that builds on existing standards and ontologies, the use of this framework in publishing PRSs will facilitate translation into clinical care and progress towards defining best practice.

    View details for DOI 10.1038/s41586-021-03243-6

    View details for PubMedID 33692554

The Colleen and Robert Haas Professor in Medicine and Biomedical Ethics, Emeritus

Publications

  • Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging ARCHIVES OF INTERNAL MEDICINE Illes, J., Kann, D., Karetsky, K., Letourneau, P., Raffin, T. A., Schraedley-Desmond, P., Koenig, B. A., Atlas, S. W. 2004; 164 (22): 2415-2419

    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

  • Discovery and disclosure of incidental findings in neuroimaging research 33rd Annual Meeting of the Society-for-Neuroscience Illes, J., Kirschen, M. P., Karetsky, K., Kelly, M., Saha, A., Desmond, J. E., Raffin, T. A., Glover, G. H., Atlas, S. W. JOHN WILEY & SONS INC. 2004: 743–47

    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

  • Chylothorax after heart/lung transplantation JOURNAL OF HEART AND LUNG TRANSPLANTATION Ziedalski, T. M., Raffin, T. A., Sze, D. Y., Mitchell, J. D., Robbins, R. C., Theodore, J., Faul, J. L. 2004; 23 (5): 627-631

    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

Member, Maternal & Child Health Research Institute (MCHRI)

Publications

  • Automating Justice: An Ethical Responsibility of Computational Bioethics. The American journal of bioethics : AJOB Rahimzadeh, V., Lawson, J., Baek, J., Dove, E. S. 2022; 22 (7): 30-33

    View details for DOI 10.1080/15265161.2022.2075051

    View details for PubMedID 35737496

  • Regulatory Angels and Technology Demons? Making Sense of Evolving Realities in Health Data Privacy for the Digital Age. The American journal of bioethics : AJOB Rahimzadeh, V. 2022; 22 (7): 68-70

    View details for DOI 10.1080/15265161.2022.2075981

    View details for PubMedID 35737504

  • Leveraging Algorithms to Improve Decision-Making Workflows for Genomic Data Access and Management. Biopreservation and biobanking Rahimzadeh, V., Lawson, J., Rushton, G., Dove, E. S. 2022

    Abstract

    Studies on the ethics of automating clinical or research decision making using artificial intelligence and other algorithmic tools abound. Less attention has been paid, however, to the scope for, and ethics of, automating decision making within regulatory apparatuses governing the access, use, and exchange of data involving humans for research. In this article, we map how the binary logic flows and real-time capabilities of automated decision support (ADS) systems may be leveraged to accelerate one rate-limiting step in scientific discovery: data access management. We contend that improved auditability, consistency, and efficiency of the data access request process using ADS systems have the potential to yield fairer outcomes in requests for data largely sourced from biospecimens and biobanked samples. This procedural justice rationale reinforces a broader set of participant and data subject rights that data access committees (DACs) indirectly protect. DACs protect the rights of citizens to benefit from science by bringing researchers closer to the data they need to advance that science. DACs also protect the informational dignities of individuals and communities by ensuring the data being accessed are used in ways consistent with participant values. We discuss the development of the Global Alliance for Genomics and Health Data Use Ontology standard as a test case of ADS for genomic data access management specifically, and we synthesize relevant ethical, legal, and social challenges to its implementation in practice. We conclude with an agenda of future research needed to thoughtfully advance strategies for computational governance that endeavor to instill public trust in, and maximize the scientific value of, health-related human data across data types, environments, and user communities.

    View details for DOI 10.1089/bio.2022.0042

    View details for PubMedID 35772014

This profile is not available
Professor of Anesthesiology, Perioperative and Pain Medicine, Emerita

Publications

  • Being Sick With an Englishwoman. Anesthesia and analgesia Shafer, A. 2022; 135 (1): 217-218

    View details for DOI 10.1213/ANE.0000000000005947

    View details for PubMedID 35709451

  • Chromatic Scale. JAMA Shafer, A. 2022; 327 (23): 2359

    View details for DOI 10.1001/jama.2022.5383

    View details for PubMedID 35727275

  • Poetry and Medicine. Anesthesiology clinics Shafer, A. 2022; 40 (2): 359-372

    Abstract

    Poetry and medicine are related in multiple ways, including historical interests in healing, defined broadly, through words. More contemporary scholarship explores how poems, which include insights into the human condition, can enlarge our understanding of health, illness, mortality, and health care, including issues of diversity. Anesthesiology and poetry have particular affinities due to their structures, timeframes, and rhythms. Patients, physicians, and health care workers can benefit in terms of well-being by access to reading, reflecting on, and writing poetry.

    View details for DOI 10.1016/j.anclin.2022.01.009

    View details for PubMedID 35659407

Associate Professor of Medicine (General Medical Disciplines) and, by courtesy, of Epidemiology and Population Health

Publications

  • A Tale of Two Pandemics: Cancer Coping and Care Delivery During the COVID-19 Pandemic Aslakson, R., Siden, R., Verano, M., Holdsworth, L., Braun, N., Tabor, H., Wong, B., Colborn, K., Smith, S., Lira, I., Hallahan, C., Nudotor, R., Siddiqi, A., Harris, E., Days-Yancey, K., Nasso, S., Rickerson, E., Fahy, B., Waterman, B., Johnston, F., Smith, T., Schapira, L. ELSEVIER SCIENCE INC. 2022: 1082-1083
  • An Evidence-Informed Cancer Care Communication Tool to Support Patients, Family, and Cancer and Palliative Care Clinicians During the COVID-19 Pandemic Siden, R., Holdsworth, L., Wong, B., Verano, M., Tabor, H., Aslakson, R. ELSEVIER SCIENCE INC. 2022: 1075
  • "Like Not Having an Arm": Perspectives of Patients, Caregivers, and Practitioners on the Impact of Visitor Restrictions on Cancer Care During the COVID-19 Pandemic Holdsworth, L., Siden, R., Wong, B., Verano, M., Tabor, H., Aslakson, R. ELSEVIER SCIENCE INC. 2022: 1085
This profile is not available