An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine.

PURPOSE: Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research. METHODS: A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months. RESULTS: A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001). CONCLUSIONS: Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Advance Directives and Code Status Information Exchange: A Consensus Proposal for a Minimum Set of Attributes.

Documentation of code status and advance directives for end-of-life (EOL) care improves care and quality of life, decreases cost of care, and increases the likelihood of an experience desired by the patient and his/her family. However, the use of advance directives and code status remains low and only a few organizations maintain code status in electronic form. Members of the American Medical Informatics Association's Ethics Committee identified a need for a patient's EOL care wishes to be documented correctly and communicated easily through the electronic health record (EHR) using a minimum data set for the storage and exchange of code status information. After conducting an environmental scan that produced multiple resources, Ethics Committee members used multiple conference calls and a shared document to arrive at consensus on the proposed minimum data set. Ethics Committee members developed a minimum required data set with links to the HL7 C_CDA Advance Directives Module. Data categories include information on the organization obtaining the code status information, the patient, any supporting documentation, and finally the desired code status information including mandatory, optional, and conditional elements. The "minimum set of attributes" to exchange advance directive / code status data described in this manuscript enables communication of patient wishes across multiple providers and health care settings. The data elements described serve as a starting point for a dialog among informatics professionals, physicians experienced in EOL care, and EHR vendors, with the goal of developing standards for incorporating this functionality into the EHR systems.

Nonstandard do-not-resuscitate orders.

PURPOSE OF REVIEW: Tattoos and medallions are examples of nonstandard do-not-resuscitate (DNR) orders that some people use to convey end-of-life wishes. These DNR orders are neither universally accepted nor understood for reasons discussed within this manuscript. RECENT FINDINGS: Studies show both providers and patients confuse the meaning and implication of DNR orders. In the United States, out-of-hospital DNR orders are legislated at the state level. Most states standardized out-of-hospital DNR orders so caregivers can immediately recognize and accept the order and act on its behalf. These out-of-hospital orders are complicated by the need to be printed on paper that does not always accompany the individual. Oregon created an online system whereby individuals recorded their end-of-life wishes that medical personnel can access with an Internet connection. This system improved communication of end-of-life wishes in patients who selected comfort care only. SUMMARY: To improve conveyance of an individual's wishes for end-of-life care, the authors discuss nationwide adoption of Oregon's online registry where a person's account could comprehensively document end-of-life wishes, be universally available in all healthcare institutions, and be searchable by common patient identifiers. Facial recognition software could identify unconscious patients who present without identification.

Health Information Technology as a Universal Donor to Bioethics Education.

Health information technology, sometimes called biomedical informatics, is the use of computers and networks in the health professions. This technology has become widespread, from electronic health records to decision support tools to patient access through personal health records. These computational and information-based tools have engendered their own ethics literature and now present an opportunity to shape the standard medical and nursing ethics curricula. It is suggested that each of four core components in the professional education of clinicians-privacy, end-of-life care, access to healthcare and valid consent, and clinician-patient communication-offers an opportunity to leverage health information technology for curricular improvement. Using informatics in ethics education freshens ethics pedagogy and increases its utility, and does so without additional demands on overburdened curricula.

Precision medicine ethics: selected issues and developments in next-generation sequencing, clinical oncology, and ethics.

PURPOSE OF REVIEW: In early 2015 the National Institutes of Health launched a new, national Precision Medicine Initiative with the primary goal of rapidly improving the prevention, diagnosis, and treatment of cancers. The first-stage emphasis on oncology presents unique opportunities for clinical oncology to influence how the ethical challenges of precision medicine are to be articulated and addressed. Thus, a review of recent developments in connection with the Initiative, in particular on core ethics issues in clinical genomics, is a useful starting point. RECENT FINDINGS: Unique ethical issues arise in precision medicine because of the enormous amounts of data generated by clinical whole-genome or whole-exome sequencing and the extent of current uncertainties with respect to data interpretations and disease associations. Among the most ethically challenging issues for clinicians are complicated informed consent processes, returning results - particularly secondary and incidental findings-and privacy and confidentiality. SUMMARY: The first tests of precision medicine ethics in practice will be in clinical oncology, providing a rare opportunity to shape the agenda and integrate practical ethics considerations. These efforts can benefit from pre-existing research ethics analyses and recommendations from clinical and translational genetics research.

Conflict of interest in online point-of-care clinical support websites.

Point-of-care evidence-based medicine websites allow physicians to answer clinical queries using recent evidence at the bedside. Despite significant research into the function, usability and effectiveness of these programmes, little attention has been paid to their ethical issues. As many of these sites summarise the literature and provide recommendations, we sought to assess the role of conflicts of interest in two widely used websites: UpToDate and Dynamed. We recorded all conflicts of interest for six articles detailing treatment for the following conditions: erectile dysfunction, fibromyalgia, hypogonadism, psoriasis, rheumatoid arthritis and Crohn's disease. These diseases were chosen as their medical management is either controversial, or they are treated using biological drugs which are mostly available by brand name only. Thus, we hypothesised that the role of conflict of interest would be more significant in these conditions than in an illness treated with generic medications or by strict guidelines. All articles from the UpToDate articles demonstrated a conflict of interest. At times, the editor and author would have a financial relationship with a company whose drug was mentioned within the article. This is in contrast with articles on the Dynamed website, in which no author or editor had a documented conflict. We offer recommendations regarding the role of conflict of interest disclosure in these point-of-care evidence-based medicine websites.

Wastewater based surveillance can be used to reduce clinical testing intensity on a university campus.

Clinical testing has been a vital part of the response to and suppression of the COVID-19 pandemic; however, testing imposes significant burdens on a population. College students had to contend with clinical testing while simultaneously dealing with health risks and the academic pressures brought on by quarantines, changes to virtual platforms, and other disruptions to daily life. The objective of this study was to analyze whether wastewater surveillance can be used to decrease the intensity of clinical testing while maintaining reliable measurements of diseases incidence on campus. Twelve months of human health and wastewater surveillance data for eight residential buildings on a university campus were analyzed to establish how SARS-CoV-2 levels in the wastewater can be used to minimize clinical testing burden on students. Wastewater SARS-CoV-2 levels were used to create multiple scenarios, each with differing levels of testing intensity, which were compared to the actual testing volumes implemented by the university. We found that scenarios in which testing intensity fluctuations matched rise and falls in SARS-CoV-2 wastewater levels had stronger correlations between SARS-CoV-2 levels and recorded clinical positives. In addition to stronger correlations, most scenarios resulted in overall fewer weekly clinical tests performed. We suggest the use of wastewater surveillance to guide COVID-19 testing as it can significantly increase the efficacy of COVID-19 surveillance while reducing the burden placed on college students during a pandemic. Future efforts should be made to integrate wastewater surveillance into clinical testing strategies implemented on college campuses.

Current ethical and social issues in epidemiology.

PURPOSE: The American College of Epidemiology held its 2021 Annual Meeting virtually, September 8-10, with a conference theme of 'From Womb to Tomb: Insights from Health Emergencies'. The American College of Epidemiology Ethics Committee hosted a symposium session in recognition of the ethical and social challenges brought to light by the coronavirus disease 2019 pandemic and on the occasion of the publication of the third edition of the classic text, Ethics and Epidemiology. The American College of Epidemiology Ethics Committee invited the book editor and contributing authors to present at the symposium session titled 'Current Ethical and Social Issues in Epidemiology.' The purpose of this paper is to further highlight the ethical challenges and presentations. METHODS: Three speakers with expertise in ethics, health law, health policy, global health, health information technology, and translational research in epidemiology and public health were selected to present on the social and ethical issues in the current landscape. Dr. S Coughlin presented on the 'Ethical and Social Issues in Epidemiology', Dr. L Beskow presented on 'Ethical Challenges in Genetic Epidemiology', and Dr. K Goodman presented on the 'Ethics of Health Informatics'. RESULTS: New digital sources of data and technologies are driving the ethical challenges and opportunities in epidemiology and public health as it relates to the three emerging topic areas identified: (1) digital epidemiology, (2) genetic epidemiology, and (3) health informatics. New complexities such as the reliance on social media to control infectious disease outbreaks and the introduction of computing advancements are requiring re-evaluation of traditional bioethical frameworks for epidemiology research and public health practice. We identified several cross-cutting ethical and social issues related to informed consent, benefits, risks and harms, and privacy and confidentiality and summarized these alongside more nuanced ethical considerations such as algorithmic bias, group harms related to data (mis)representation, risks of misinformation, return of genomic research results, maintaining data security, and data sharing. We offered an integrated synthesis of the stages of epidemiology research planning and conduct with the ethical issues that are most relevant in these emerging topic areas. CONCLUSIONS: New realities exist for epidemiology and public health as professional groups who are faced with addressing population health, and especially given the recent pandemic and the widespread use of digital tools and technologies. Many ethical issues can be understood in the context of existing ethical frameworks; however, they have yet to be clearly identified or connected with the new technical and methodological applications of digital tools and technologies currently in use for epidemiology research and public health practice. To address current ethical challenges, we offered a synthesis of traditional ethical principles in public health science alongside more nuanced ethical considerations for emerging technologies and aligned these with lifecycle stages of epidemiology research. By critically reflecting on the impact of new digital sources of data and technologies on epidemiology research and public health practice, specifically in the control of infectious outbreaks, we offered insights on cultivating these new areas of professional growth while striving to improve population health.

Selecting venues for AMIA events and conferences: guiding ethical principles.

A discussion and debate on the American Medical Informatics Association's (AMIA) Ethical, Legal, and Social Issues (ELSI) Working Group listserv in 2021 raised important issues related to a forthcoming conference in Texas. Texas had recently enacted a restrictive abortion law and restricted voting rights. Several AMIA members advocated for a boycott of the state and the scheduled conference. The discussion led the AMIA Board of Directors to request that the organization's Ethics Committee provide general guidance for principle-based venue selection. This document recommends overarching principles for the venue selection for future AMIA events and conferences. Discussions by the AMIA Board, the Ethics Committee, and the ELSI Working Group informed these recommendations, and this document on guiding principles was approved by the AMIA Board of Directors in April 2022.

Ethics Education in COVID-19: Preclinical Medical Students' Approach to Ventilator Allocation.

Introduction COVID-19 has confronted clinicians with a potential need to ration ventilators. There is little guidance for training medical students to make such decisions in future practice. How students would make ventilator triage decisions remains unknown. Methods One hundred fifty-three medical students in 18 problem-based learning groups participated in a ventilator-rationing exercise in April 2020 as part of an ethics curriculum adapted in response to the COVID-19 pandemic. Students were provided with a prompt requiring fictional patients to be prioritized for ventilators in the face of scarce resources. The authors reviewed group responses, tallied triage criteria, and identified approaches to triage decisions. Results The most common triage criteria were patient comorbidities, clinical status, age/life stage, prognosis, life expectancy, and an individual's role in pandemic response. Additional criteria included quality of life, ventilator availability, public perception, and patient need. Students approached triage decisions by developing systems for triage, appealing to empirical evidence and academic literature, making value judgments, and identifying adjuncts and alternatives to triage. Discussion With minimal input from educators, students learned key ethical principles in triage medicine, recapitulated approaches to triage described in the clinical and bioethics literature, and suggested methods for tolerating distress of complex ethical decisions. Medical education should equip students to critically consider bioethical concerns in triage and prepare for possible moral distress during public health crises.

Common topics discerned in ethics in epidemiology and public health syllabi: in-depth review.

This commentary reviews ethics in epidemiology and public health (PH) syllabi collected in 2011 and 2018. The syllabi repository was an American College of Epidemiology (ACE) Ethics Committee project to support institutions and faculty introducing, furthering or improving ethics in epidemiology and public health courses. Of 83 syllabi from 52 accredited public health schools and programs, 80 were reviewed to identify the most common ethics topics. The extracted information was categorized into eight main groups: (1) ethical/moral foundations and theories; (2) case studies in epidemiology/PH; (3) ethical issues in PH practice; (4) ethical issues in general epidemiologic/PH research; (5) ethical issues in specific research areas; (6) ethical issues in information technology; (7) ethical issues in other emerging topics in epidemiology/PH; and (8) others. The frequency of topics in each category was computed, and common topics were presented. Ethical issues absent from the syllabi were inferred. This commentary is intended to promote a dialog among those desiring to elevate epidemiology and public health ethics to an educational level commensurate with its importance.

Recommendations for the safe, effective use of adaptive CDS in the US healthcare system: an AMIA position paper.

The development and implementation of clinical decision support (CDS) that trains itself and adapts its algorithms based on new data-here referred to as Adaptive CDS-present unique challenges and considerations. Although Adaptive CDS represents an expected progression from earlier work, the activities needed to appropriately manage and support the establishment and evolution of Adaptive CDS require new, coordinated initiatives and oversight that do not currently exist. In this AMIA position paper, the authors describe current and emerging challenges to the safe use of Adaptive CDS and lay out recommendations for the effective management and monitoring of Adaptive CDS.

Ethics and informatics in the age of COVID-19: challenges and recommendations for public health organization and public policy.

The COVID-19 pandemic response in the United States has exposed significant gaps in information systems and processes that prevent timely clinical and public health decision-making. Specifically, the use of informatics to mitigate the spread of SARS-CoV-2, support COVID-19 care delivery, and accelerate knowledge discovery bring to the forefront issues of privacy, surveillance, limits of state powers, and interoperability between public health and clinical information systems. Using a consensus-building process, we critically analyze informatics-related ethical issues in light of the pandemic across 3 themes: (1) public health reporting and data sharing, (2) contact tracing and tracking, and (3) clinical scoring tools for critical care. We provide context and rationale for ethical considerations and recommendations that are actionable during the pandemic and conclude with recommendations calling for longer-term, broader change (beyond the pandemic) for public health organization and policy reform.

Assessment of Disparities Associated With a Crisis Standards of Care Resource Allocation Algorithm for Patients in 2 US Hospitals During the COVID-19 Pandemic.

Importance: Significant concern has been raised that crisis standards of care policies aimed at guiding resource allocation may be biased against people based on race/ethnicity. Objective: To evaluate whether unanticipated disparities by race or ethnicity arise from a single institution's resource allocation policy. Design, Setting, and Participants: This cohort study included adults (aged ≥18 years) who were cared for on a coronavirus disease 2019 (COVID-19) ward or in a monitored unit requiring invasive or noninvasive ventilation or high-flow nasal cannula between May 26 and July 14, 2020, at 2 academic hospitals in Miami, Florida. Exposures: Race (ie, White, Black, Asian, multiracial) and ethnicity (ie, non-Hispanic, Hispanic). Main Outcomes and Measures: The primary outcome was based on a resource allocation priority score (range, 1-8, with 1 indicating highest and 8 indicating lowest priority) that was assigned daily based on both estimated short-term (using Sequential Organ Failure Assessment score) and longer-term (using comorbidities) mortality. There were 2 coprimary outcomes: maximum and minimum score for each patient over all eligible patient-days. Standard summary statistics were used to describe the cohort, and multivariable Poisson regression was used to identify associations of race and ethnicity with each outcome. Results: The cohort consisted of 5613 patient-days of data from 1127 patients (median [interquartile range {IQR}] age, 62.7 [51.7-73.7]; 607 [53.9%] men). Of these, 711 (63.1%) were White patients, 323 (28.7%) were Black patients, 8 (0.7%) were Asian patients, and 31 (2.8%) were multiracial patients; 480 (42.6%) were non-Hispanic patients, and 611 (54.2%) were Hispanic patients. The median (IQR) maximum priority score for the cohort was 3 (1-4); the median (IQR) minimum score was 2 (1-3). After adjustment, there was no association of race with maximum priority score using White patients as the reference group (Black patients: incidence rate ratio [IRR], 1.00; 95% CI, 0.89-1.12; Asian patients: IRR, 0.95; 95% CI. 0.62-1.45; multiracial patients: IRR, 0.93; 95% CI, 0.72-1.19) or of ethnicity using non-Hispanic patients as the reference group (Hispanic patients: IRR, 0.98; 95% CI, 0.88-1.10); similarly, no association was found with minimum score for race, again with White patients as the reference group (Black patients: IRR, 1.01; 95% CI, 0.90-1.14; Asian patients: IRR, 0.96; 95% CI, 0.62-1.49; multiracial patients: IRR, 0.81; 95% CI, 0.61-1.07) or ethnicity, again with non-Hispanic patients as the reference group (Hispanic patients: IRR, 1.00; 95% CI, 0.89-1.13). Conclusions and Relevance: In this cohort study of adult patients admitted to a COVID-19 unit at 2 US hospitals, there was no association of race or ethnicity with the priority score underpinning the resource allocation policy. Despite this finding, any policy to guide altered standards of care during a crisis should be monitored to ensure equitable distribution of resources.

Ethical, legal and social issues for personal health records and applications.

Robert Wood Johnson Foundation's Project HealthDesign included funding of an ethical, legal and social issues (ELSI) team, to serve in an advisory capacity to the nine design projects. In that capacity, the authors had the opportunity to analyze the personal health record (PHR) and personal health application (PHA) implementations for recurring themes. PHRs and PHAs invert the long-standing paradigm of health care institutions as the authoritative data-holders and data-processors in the system. With PHRs and PHAs, the individual is the center of his or her own health data universe, a position that brings new benefits but also entails new responsibilities for patients and other parties in the health information infrastructure. Implications for law, policy and practice follow from this shift. This article summarizes the issues raised by the first phase of Project HealthDesign projects, categorizing them into four topics: privacy and confidentiality, data security, decision support, and HIPAA and related legal-regulatory requirements. Discussion and resolution of these issues will be critical to successful PHR/PHA implementations in the years to come.