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.

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.

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.

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.

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.

Stigma, biomarkers, and algorithmic bias: recommendations for precision behavioral health with artificial intelligence.

Effective implementation of artificial intelligence in behavioral healthcare delivery depends on overcoming challenges that are pronounced in this domain. Self and social stigma contribute to under-reported symptoms, and under-coding worsens ascertainment. Health disparities contribute to algorithmic bias. Lack of reliable biological and clinical markers hinders model development, and model explainability challenges impede trust among users. In this perspective, we describe these challenges and discuss design and implementation recommendations to overcome them in intelligent systems for behavioral and mental health.

Ethical surgical triage of patients with head and neck cancer during the COVID-19 pandemic.

BACKGROUND: Coronavirus has serially overtaken our metropolitan hospitals. At peak, patients with acute respiratory distress syndrome may outnumber mechanical ventilators. In our Miami Hospital System, COVID-19 cases have multiplied for 4 weeks and elective surgery has been suspended. METHODS: An Otolaryngologic Triage Committee was created to appropriately allocate resources to patients. Hospital ethicists provided support. Our tumor conference screened patients for nonsurgical options. Patients were tested twice for coronavirus before performing urgent contaminated operations. N95 masks and protective equipment were conserved when possible. Patients with low-grade cancers were advised to delay surgery, and other difficult decisions were made. RESULTS: Hundreds of surgeries were canceled. Sixty-five cases screened over 3 weeks are tabulated. Physicians and patients expressed discomfort regarding perceived deviations from standards, but risk of COVID-19 exposure tempered these discussions. CONCLUSIONS: We describe the use of actively managed surgical triage to fairly balance our patient's health with public health concerns.

Ethics in Health Informatics.

Contemporary bioethics was fledged and is sustained by challenges posed by new technologies. These technologies have affected many lives. Yet health informatics affects more lives than any of them. The challenges include the development and the appropriate uses and users of machine learning software, the balancing of privacy rights against the needs of public health and clinical practice in a time of Big Data analytics, whether and how to use this technology, and the role of ethics and standards in health policy. Historical antecedents in statistics and evidence-based practice foreshadow some of the difficulties now faced, but the scope and scale of these challenges requires that ethics, too, be brought to scale in parallel, especially given the size of contemporary data sets and the processing power of new computers. Fortunately, applied ethics affords a variety of tools to help identify and rank applicable values, support best practices, and contribute to standards. The bioethics community can in partnership with the informatics community arrive at policies that promote the health sciences while reaffirming the many and varied rights that patients expect will be honored.

Commercial Interests in Continuing Medical Education: Where Do Electronic Health Record Vendors Fit?

The Accreditation Council for Continuing Medical Education (ACCME) will not accredit an organization that it defines as a commercial interest, that is an entity that produces, markets, resells, or distributes health care goods or services consumed by, or used on, patients. Thus, commercial interests are not eligible to be accredited organizations offering continuing medical education (CME) credit to physicians. This decision is based on the concern that commercial interests may use CME events to market their products or services to physicians, who then might inappropriately prescribe or administer those products or services to patients. Studies have shown that CME events supported by pharmaceutical companies, for example, have influenced physicians' prescribing behaviors.Currently, however, the ACCME does not recognize electronic health record (EHR) vendors, which are part of a multi-billion-dollar business, as commercial interests, and it accredits them to provide or directly influence CME events. Like pharmaceutical company-sponsored CME events, EHR vendor activities, which inherently only focus on use of the sponsoring vendor's EHR system despite its potential intrinsic limitations, can lead to physician reciprocity. Such events also may inappropriately influence EHR system purchases, upgrades, and implementation decisions. These actions can negatively influence patient safety and care. Thus, the authors of this Perspective call on the ACCME to recognize EHR vendors as commercial interests and remove them from the list of accredited CME providers.

Expanding ethics curriculum resources: American College of Epidemiology's syllabus collection project.

This commentary provides an update on the evolution of the American College of Epidemiology's online and open-source collection of ethics syllabi in epidemiology and public health. Begun in 2011, the syllabus-collection project anticipated the Council on Education for Public Health's accreditation requirement calling for "the development of ethical practice" and identifying a need to "demonstrate our commitment to ethical dealings." The Ethics Committee of the American College of Epidemiology continued the project in 2018 seeking to acquire as many syllabi as possible for the repository; all 180 Council on Education for Public Health-accredited schools and programs were contacted and asked to share syllabi that addressed ethical and related issues. The overarching goal was to support institutions that have not yet introduced ethics into public health and epidemiology curricula. In total, 45 new syllabi were collected in 2018 and collated with the 38 acquired in 2011; 83 syllabi have been compiled from 52 accredited entities. Having a readily available on-line resource to support institutions and faculty seeking to introduce or improve the presentation of ethics in public health and epidemiology curricula is believed to be an important contribution to public health science and pedagogy.

Understanding of and Barriers to Electronic Health Record Patient Portal Access in a Culturally Diverse Pediatric Population.

BACKGROUND: Electronic health records (EHRs) have become a standard in the health care setting. In an effort to improve health literacy, foster doctor-patient communication, and ease the transition from adolescent to adult care, our institution created a policy that allows patients aged between 13 and 17 years to have EHR portal access. A literature review revealed predictable differences in portal registration among different ethnicities and socioeconomic statuses. Consequently, a cross-sectional survey was developed to investigate barriers to EHR portal access in a sample of culturally diverse adolescents. OBJECTIVE: The aim of this study was to assess for barriers to EHR portal access in a culturally diverse adolescent population. METHODS: A 42-item anonymous survey was completed by 97 adolescents aged between 13 and 18 years, attending general pediatrics clinics. The results were analyzed using descriptive statistics and t tests. RESULTS: The average participant age was 15.5 (SD 1.5) years with 60% (58/97) male and 40% (39/97) female. Participants were 44% (43/97) black, 41% (40/97) Hispanic, 9% (9/97) Caucasian, 3% (3/97) Asian, and 2% (2/97) others. There were statistically significant differences in perceptions of confidentiality in age (13 to 15 years vs 16 to 18 years; P=.001) and insurance status (government vs private; P=.012) but not in gender, ethnicity, or parental education level. Younger adolescents with governmental insurance were more confident in the level of confidentiality with their physician. A total of 94% of participants had heard of the term EHR, but only 55% were familiar with its function. Furthermore, 77% of patients primarily accessed the internet through phones, and 50% of participants knew that patients aged under 18 years could obtain care for mental health, substance abuse, sexual health, and pregnancy. CONCLUSIONS: This research has identified gaps in EHR technology with regard to the pediatric patient population. The results of our survey show that adolescents may have misconceptions regarding the doctor-patient relationship, their ability to obtain care, and the modalities present in an EHR. As technology progresses, it is essential to have a deeper understanding of adolescents' perceptions of confidentiality, technology, and available resources to design an EHR system that encourages patient education and communication while limiting barriers to care.

Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.

OBJECTIVE: In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). MATERIALS AND METHODS: A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. RESULTS: Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. CONCLUSIONS: A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).