Publications

View details for DOI 10.1016/j.accpm.2022.101125

View details for PubMedID 35803575

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

View details for DOI 10.1111/pan.13730

View details for PubMedID 31677337

Abstract

Data sharing must be accompanied by responsibility sharing.

View details for DOI 10.1126/science.abq6851

View details for PubMedID 36227983

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

View details for DOI 10.1146/annurev-criminol-011518-024433

View details for Web of Science ID 000456392800020

View details for DOI 10.1523/JNEUROSCI.2077-18.2018

View details for PubMedID 30541767

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

View details for PubMedID 29691509

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

View details for PubMedID 35902745

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

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

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

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

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

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

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

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

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

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

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

View details for DOI 10.1080/15265161.2022.2075051

View details for PubMedID 35737496

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