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.

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.

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.

Should Foreigners Get Costly Lifesaving Treatments in the United States?

Many foreign parents bring their children to the United States for medical treatments that are unavailable in their own country. Often, however, parents cannot afford expensive treatments. Doctors and hospitals then face a dilemma. Is it ethically permissible to consider the patient's citizenship and ability to pay? In this Ethics Rounds, we present a case in which a child from another country needs an expensive treatment. His parents cannot afford the treatment. He has come to a public hospital in the United States. We present responses from experts in pediatrics, bioethics, and health policy.

Prospective Study of Nonbeneficial Care in Neurocritical Care Unit.

OBJECTIVE: We sought to determine whether a set of simple criteria can identify patients in the neuroscience intensive care unit (NICU) at high risk of poor outcome and delivery of nonbeneficial care early in the course of their illness. Secondarily, factors affecting limitation of care protocols were assessed. METHODS: We prospectively identified patients who were admitted to the NICU with partial loss of brainstem reflexes persisting for >24 hours due to an intrinsic lesion of the brain (trauma, stroke, hemorrhage, etc.). RESULTS: The study included 102 patients. Seventy-two of them died after a mean of 16 days (median: 8 days), and 23 remained comatose, locked-in, or in a vegetative state. Four were conscious and following commands, while 3 were minimally conscious, episodically obeying simple commands. Three out of 4 conscious patients were young males with traumatic brain injuries. Patients who remained full code spent a mean of 22.2 days in the NICU, compared with 10.4 for those who had withdrawal of care (P = 0.022) and 11.9 for patients who received a do-not-resuscitate order (P = 0.045). Time to death did not differ significantly between the groups. Overall, institution of various limitations of care protocols correlated positively with older age (odds ratio [OR] = 1.07, P = 0.0008), being treated on the neurology service (OR = 4.4, P = 0.043), and having health insurance (OR = 5.4, P = 0.03). CONCLUSIONS: We identified simple criteria that can be used to identify patients in the NICU setting for whom continued aggressive care is likely nonbeneficial. Our analysis revealed demographic, social, and economic factors correlating with proxies' willingness to consider limitation of care.

Beyond the Genetic Information Nondiscrimination Act: ethical and economic implications of the exclusion of disability, long-term care and life insurance.

The Genetic Information Nondiscrimination Act (GINA) was intended to protect individuals in the USA from discrimination based on their genetic data, but does not apply to life, long-term care or disability insurance. Patient advocates and ethicists have argued that GINA does not go far enough. Others express concerns for the viability of insurance companies if millions of potential customers know more than professional actuaries. Here we discuss the exclusion of certain insurance types from GINA. We explore the ethical and economic implications of this distinction, and potential paths forward. We suggest that because long-term care and disability insurance can be essential for well-being, there is no good reason to place them in a class with life insurance and therefore beyond GINA's reach.

Comparative outcome studies of clinical decision support software: limitations to the practice of evidence-based system acquisition.

Clinical decision support systems (CDSSs) assist clinicians with patient diagnosis and treatment. However, inadequate attention has been paid to the process of selecting and buying systems. The diversity of CDSSs, coupled with research obstacles, marketplace limitations, and legal impediments, has thwarted comparative outcome studies and reduced the availability of reliable information and advice for purchasers. We review these limitations and recommend several comparative studies, which were conducted in phases; studies conducted in phases and focused on limited outcomes of safety, efficacy, and implementation in varied clinical settings. Additionally, we recommend the increased availability of guidance tools to assist purchasers with evidence-based purchases. Transparency is necessary in purchasers' reporting of system defects and vendors' disclosure of marketing conflicts of interest to support methodologically sound studies. Taken together, these measures can foster the evolution of evidence-based tools that, in turn, will enable and empower system purchasers to make wise choices and improve the care of patients.

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.

Sorrell v. IMS Health: issues and opportunities for informaticians.

In 2011, the US Supreme Court decided Sorrell v. IMS Health, Inc., a case that addressed the mining of large aggregated databases and the sale of prescriber data for marketing prescription drugs. The court struck down a Vermont law that required data mining companies to obtain permission from individual providers before selling prescription records that included identifiable physician prescription information to pharmaceutical companies for drug marketing. The decision was based on constitutional free speech protections rather than data sharing considerations. Sorrell illustrates challenges at the intersection of biomedical informatics, public health, constitutional liberties, and ethics. As states, courts, regulatory agencies, and federal bodies respond to Sorrell, informaticians' expertise can contribute to more informed, ethical, and appropriate policies.

Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force.

The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others' efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety.

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.

Ethics, evidence, and public policy.

The growth of evidence-based medicine (EBM) raises a number of ethical issues that have too often been overlooked. These include issues that arise when clinicians make judgments under uncertainty, new challenges for the clinician-patient relationship, new duties for institutional review boards, issues in physician autonomy and reimbursement, and challenges for disclosure and informed consent. Ethics and EBM must be addressed by policy makers and integrated into medical education.

UME-21 and teaching ethics: a step in the right direction.

BACKGROUND AND OBJECTIVES: Ethics education for medical students has included a number of relatively vague descriptions of appropriate curricular objectives, but medical schools struggle with the general teaching of ethics, as well as with presenting the ethical dilemmas posed by managed care. This paper proposes some standards and uses them to analyze the general and managed care ethics content of the Undergraduate Medical Education for the 21st Century (UME-21) curricula. METHODS: We analyzed progress and final reports from each school to define their learning objectives, content, teaching methods, and evaluation strategies in ethics. Each was evaluated using principles of adult learning and Rest's Four Component Model of Moral Development. Good examples of curricular elements from participating schools are described. RESULTS: Ethics curricula varied widely among the schools. Goals and objectives were often stated in generalities. Teaching methods were diverse and innovative, and several new combinations of learning activities were created to highlight ethics topics. Content represented managed care and non-managed care topics in varying proportions. Student surveys of attitudes toward managed care and opinions of the ethics programs were the most commonly used as evaluation tools. Some schools were able to develop more direct means of evaluating student learning. The Four Component Model was not fully addressed in the programs developed by the participating schools. CONCLUSIONS: We make recommendations about the objectives, teaching methods, content, and evaluation methods of an ideal medical school curriculum in ethics.

Overseeing research on therapeutic cloning: a private ethics board responds to its critics.

Advanced Cell Technology's Ethics Advisory Board has been called window dressing for a corporate marketing plan. But the scientists and managers have paid attention, and the lawyers have gone along.