Addressing sex-based disparities in solid organ transplantation in the United States - a conference report.

Solid organ transplantation provides the best treatment for end-stage organ failure, but significant sex-based disparities in transplant access exist. On June 25, 2021, a virtual multidisciplinary conference was convened to address sex-based disparities in transplantation. Common themes contributing to sex-based disparities were noted across kidney, liver, heart, and lung transplantation, specifically the existence of barriers to referral and wait listing for women, the pitfalls of using serum creatinine, the issue of donor/recipient size mismatch, approaches to frailty and a higher prevalence of allosensitization among women. In addition, actionable solutions to improve access to transplantation were identified, including alterations to the current allocation system, surgical interventions on donor organs, and the incorporation of objective frailty metrics into the evaluation process. Key knowledge gaps and high-priority areas for future investigation were also discussed.

Disparities in Unilateral Do Not Resuscitate Order Use During the COVID-19 Pandemic.

OBJECTIVES: A unilateral do-not-resuscitate (UDNR) order is a do-not-resuscitate order placed using clinician judgment which does not require consent from a patient or surrogate. This study assessed how UDNR orders were used during the COVID-19 pandemic. DESIGN: We analyzed a retrospective cross-sectional study of UDNR use at two academic medical centers between April 2020 and April 2021. SETTING: Two academic medical centers in the Chicago metropolitan area. PATIENTS: Patients admitted to an ICU between April 2020 and April 2021 who received vasopressor or inotropic medications to select for patients with high severity of illness. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The 1,473 patients meeting inclusion criteria were 53% male, median age 64 (interquartile range, 54-73), and 38% died during admission or were discharged to hospice. Clinicians placed do not resuscitate orders for 41% of patients ( n = 604/1,473) and UDNR orders for 3% of patients ( n = 51/1,473). The absolute rate of UDNR orders was higher for patients who were primary Spanish speaking (10% Spanish vs 3% English; p ≤ 0.0001), were Hispanic or Latinx (7% Hispanic/Latinx vs 3% Black vs 2% White; p = 0.003), positive for COVID-19 (9% vs 3%; p ≤ 0.0001), or were intubated (5% vs 1%; p = 0.001). In the base multivariable logistic regression model including age, race/ethnicity, primary language spoken, and hospital location, Black race (adjusted odds ratio [aOR], 2.5; 95% CI, 1.3-4.9) and primary Spanish language (aOR, 4.4; 95% CI, 2.1-9.4) had higher odds of UDNR. After adjusting the base model for severity of illness, primary Spanish language remained associated with higher odds of UDNR order (aOR, 2.8; 95% CI, 1.7-4.7). CONCLUSIONS: In this multihospital study, UDNR orders were used more often for primary Spanish-speaking patients during the COVID-19 pandemic, which may be related to communication barriers Spanish-speaking patients and families experience. Further study is needed to assess UDNR use across hospitals and enact interventions to improve potential disparities.

Ethics of Extracorporeal Membrane Oxygenation under Conventional and Crisis Standards of Care.

Extracorporeal membrane oxygenation (ECMO) is a form of life support for cardiac and/or pulmonary failure with unique ethical challenges compared to other forms of life support. Ethical challenges with ECMO exist when conventional standards of care apply, and are exacerbated during periods of absolute ECMO scarcity when "crisis standards of care" are instituted. When conventional standards of care apply, we propose that it is ethically permissible to withhold placing patients on ECMO for reasons of technical futility or when patients have terminal, short-term prognoses that are untreatable by ECMO. Under crisis standards of care, it is ethically permissible to broaden exclusionary criteria to also withhold ECMO from patients who have a low likelihood of recovery, to maximize the overall number of lives saved. Unilateral withdrawal of ECMO against a patient's preferences is unethical under conventional standards of care, but is ethical under crisis standards of care to increase access to ECMO to others in society. ECMO should only be rationed when true scarcity exists, and allocation protocols should be transparent to the public. When rationing must occur under crisis standards of care, it is imperative that oversight bodies assess for inequities in the allocation of ECMO and make frequent changes to improve any inequities.

Patient-provider communications about pharmacogenomic results increase patient recall of medication changes.

Effective doctor-patient communication is critical for disease management, especially when considering genetic information. We studied patient-provider communications after implementing a point-of-care pharmacogenomic results delivery system to understand whether pharmacogenomic results are discussed and whether medication recall is impacted. Outpatients undergoing preemptive pharmacogenomic testing (cases), non-genotyped controls, and study providers were surveyed from October 2012-May 2017. Patient responses were compared between visits where pharmacogenomic results guided prescribing versus visits where pharmacogenomics did not guide prescribing. Provider knowledge of pharmacogenomics, before and during study participation, was also analyzed. Both providers and case patients frequently reported discussions of genetic results after visits where pharmacogenomic information guided prescribing. Importantly, medication changes from visits where pharmacogenomics influenced prescribing were more often recalled than non-pharmacogenomic guided medication changes (OR = 3.3 [1.6-6.7], p = 0.001). Case patients who had separate visits where pharmacogenomics did and did not, respectively, influence prescribing more often remembered medication changes from visits where genomic-based guidance was used (OR = 3.4 [1.2-9.3], p = 0.02). Providers also displayed dramatic increases in personal genomic understanding through program participation (94% felt at least somewhat informed about pharmacogenomics post-participation, compared to 61% at baseline, p = 0.04). Using genomic information during prescribing increases patient-provider communications, patient medication recall, and provider understanding of genomics, important ancillary benefits to clinical use of pharmacogenomics.

Practical allocation system for the distribution of specialised care during cellular therapy access scarcity.

Novel cellular therapy techniques promise to cure many haematology patients refractory to other treatment modalities. These therapies are intensive and require referral to and care from specialised providers. In the USA, this pool of providers is not expanding at a rate necessary to meet expected demand; therefore, access scarcity appears forthcoming and is likely to be widespread. To maintain fair access to these scarce and curative therapies, we must prospectively create a just and practical system to distribute care. In this article, we first review previously implemented medical product and personnel allocation systems, examining their applicability to cellular therapy provider shortages to demonstrate that this problem requires a novel approach. We then present an innovative system for allocating cellular therapy access, which accounts for the constraints of distribution during real-world oncology practice by using a combination of the following principles: (1) maximising life-years per personnel time, (2) youngest and robust first, (3) sickest first, (4) first come/first served and (5) instrumental value. We conclude with justifications for the incorporation of these principles and the omission of others, discuss how access can be distributed using this combination, consider cost and review fundamental factors necessary for the practical implementation and maintenance of this system.

Clinical Medical Ethics: Its History and Contributions to American Medicine.

In 1972, I created the new field of clinical medical ethics (CME) in the Department of Medicine at the University of Chicago. In my view, CME is an intrinsic part of medicine and is not a branch of bioethics or philosophical ethics or legal ethics. The relationship of patients with medically trained and licensed clinicians is at the very heart of CME. CME must be practiced and applied not by nonclinical bioethicists, but rather by licensed clinicians in their routine, daily encounters with inpatients and outpatients. CME must be practiced and applied by licensed clinicians in their routine, daily encounters with inpatients and outpatients. CME addresses many clinical issues such as truth-telling, informed consent, confidentiality, surrogate decision making, and end-of-life care, while also encouraging personal, humane, and compassionate interactions between experienced clinicians and patients. The goals of CME are to improve patient care and outcomes by helping physicians and other health professionals identify and respond to clinical-ethical challenges that arise in the ordinary care of patients. As Edmund Pellegrino, Peter A. Singer, and I wrote in the first issue of The Journal of Clinical Ethics, 30 years ago: "The central goal of CME is to improve the quality of patient care by identifying, analyzing, and contributing to the resolution of ethical problems that arise in the routine practice of clinical medicine." Similar to cardiology and oncology consultations, ethics consultations are a small component of a much larger field, and the process of consultations is certainly not at the core of cardiology or oncology or CME. In this article, I intend to discuss the origins of the field of CME, its goals and methods, the relationship between the broad field of CME and the much narrower practice of ethics consultation, the contributions of the MacLean Center at the University of Chicago in developing the field of CME, and, finally, how CME has improved the practice of medicine in the United States.

The ASBH Approach to Certify Clinical Ethics Consultants Is Both Premature and Inadequate.

In November 2018 the American Society for Bioethics and Humanities (ASBH) administered the first Healthcare Ethics Consultant Certification examination to 138 candidates, 136 of whom (98.5 percent) passed and were "certified" as "healthcare ethics consultants." I believe this certification process is both premature and inadequate. Certification for ethics consultants is premature because, as Kornfeld and Prager state repeatedly in their article in this issue of The Journal of Clinical Ethics, "The Clinician as Clinical Ethics Consultant: An Empirical Method of Study," there is a lack of "empirical data on the nature of the problems that prompt ethics consultation requests and on the functions required to address them." These authors proceed to provide a model for the kind of empirical data collection that is needed. Even more relevant, the ASBH model that certifies clinical ethics consultants is inadequate. First, it is inappropriate for a nonclinical organization such as the ASBH to claim the right to certify a clinical process, ethics consultation, involving patients and health professionals. Second, the current certification process requires only a written examination in contrast to the two-step quality attestation process proposed in 2013 by Eric Kodish, MD, and 11 other senior members of the ASBH, including its then president. Third and most importantly, the eligibility criteria for being certified to work on hospital units and to make clinical recommendations for patients and families are minimal and insufficient. The only stated requirements are a bachelor's degree and 400 hours of healthcare ethics consulting experience. By contrast, practicing physicians and nurses train for many years to gain clinical experience that enables them to apply clinical ethical standards in the care and management of all inpatients and outpatients, not just the small percent for whom an ethics consultation is requested.

Physician-Assisted Suicide: Why Neutrality by Organized Medicine Is Neither Neutral Nor Appropriate.

It has been proposed that medical organizations adopt neutrality with respect to physician-assisted suicide (PAS), given that the practice is legal in some jurisdictions and that membership is divided. We review developments in end-of-life care and the role of medical organizations with respect to the legalization of PAS since the 1990s. We argue that moving from opposition to neutrality is not ethically neutral, but a substantive shift from prohibited to optional. We argue that medical organizations already oppose many practices that are legal in many jurisdictions, and that unanimity among membership has not been required for any other clinical or ethical policy positions. Moreover, on an issue so central to the meaning of medical professionalism, it seems important for organized medicine to take a stand. We subsequently review the arguments in favor of PAS (arguments from autonomy and mercy, and against the distinction between killing and allowing to die (K/ATD)) and the arguments against legalization (the limits of autonomy, effects on the patient-physician relationship, the meaning of healing, the validity of the K/ATD distinction, the social nature of suicide, the availability of alternatives, the propensity for incremental extension, and the meaning of control). We conclude that organized medicine should continue its opposition to PAS.

Medical ethics education in China: Lessons from three schools.

BACKGROUND: Ethics teaching is a relatively new area of medical education in China, with ethics curricula at different levels of development. This study examined ethics education at three medical schools in China to understand their curricular content, teaching and learning methods, forms of assessments, changes over time, and what changes are needed for further improvement. METHODS: We used student and faculty surveys to obtain information about the ethics courses' content, teaching methods, and revisions over time. The surveys also included five realistic cases and asked participants whether each would be appropriate to use for discussion in ethics courses. Students rated the cases on a scale and gave written comments. Finally, participants were asked to indicate how much they would agree with the statement that medical professionalism is about putting the interests of patients and society above one's own. RESULTS: There were both similarities and differences among these schools with regard to course topics, teaching and assessment methods, and course faculty compositions, suggesting their courses are at different levels of development. Areas of improvement for the schools' courses were identified based on this study's findings and available literature. A model of the evolution of medical ethics education in China was proposed to guide reform in medical ethics instruction in China. Analysis identified characteristics of appropriate cases and participants' attitudes toward the ideal of professionalism. DISCUSSION: We conclude that the development of medical ethics education in China is promising while much improvement is needed. In addition, ethics education is not confined to the walls of medical schools; the society at large can have significant influence on the formation of students' professional values.

A Justifiable Asymmetry.

It is a clinician's cliché that a physician only challenges a patient's capacity to make a treatment decision if that decision is not what the physician wants. Agreement is proof of decisional capacity; disagreement is proof or at least evidence of capacity's absence. It is assumed that this asymmetry cannot be justified, that the asymmetry must be a form of physicians' paternalism. Instead what is at issue when patient and physician disagree are usually two laudable impulses. The first is physicians' commitment to patients' well-being: physicians have a professional obligation as well as, ideally, a personal commitment to take care of patients--to do their best to bring about a positive medical outcome. The second impulse is common to much of human life, namely, the urge to find and to understand the source of our disagreements with one another. In this article we argue that, jointly, these impulses justify the asymmetry with regard to examining patients' capacity.

Recommendations for management of patients with neuroendocrine liver metastases.

Many management strategies exist for neuroendocrine liver metastases. These strategies range from surgery to ablation with various interventional radiology procedures, and include both regional and systemic therapy with diverse biological, cytotoxic, or targeted agents. A paucity of biological, molecular, and genomic information and an absence of data from rigorous trials limit the validity of many publications detailing management. This Review represents the views from an international conference, for which 15 expert working groups prepared evidence-based assessments addressing specific questions, and from which an independent jury derived final recommendations. The aim of the conference was to review the existing approaches to neuroendocrine liver metastases, assess the evidence on which management decisions were based, develop internationally acceptable recommendations for clinical practice (when evidence was available), and make recommendations for clinical and research endeavours. This report represents the final clinical statements and proposals for future research.

Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago "1,200 Patients Project".

Pharmacogenomic testing is viewed as an integral part of precision medicine. To achieve this, we originated The 1,200 Patients Project which offers broad, preemptive pharmacogenomic testing to patients at our institution. We analyzed enrollment, genotype, and encounter-level data from the first year of implementation to assess utility of providing pharmacogenomic results. Results were delivered via a genomic prescribing system (GPS) in the form of traffic lights: green (favorable), yellow (caution), and red (high risk). Additional supporting information was provided as a virtual pharmacogenomic consult, including citation to relevant publications. Currently, 812 patients have participated, representing 90% of those approached; 608 have been successfully genotyped across a custom array. A total of 268 clinic encounters have occurred at which results were accessible via the GPS. At 86% of visits, physicians accessed the GPS, receiving 367 result signals for medications patients were taking: 57% green lights, 41% yellow lights, and 1.4% red lights. Physician click frequencies to obtain clinical details about alerts varied according to color severity (100% of red were clicked, 72% yellow, 20% green). For 85% of visits, clinical pharmacogenomic information was available for at least one drug the patient was taking, suggesting relevance of the delivered information. We successfully implemented an individualized health care model of preemptive pharmacogenomic testing, delivering results along with pharmacogenomic decision support. Patient interest was robust, physician adoption of information was high, and results were routinely utilized. Ongoing examination of a larger number of clinic encounters and inclusion of more physicians and patients is warranted.

Ethical issues in surgical innovation.

Innovation is responsible for most advances in the field of surgery. Innovative approaches to solving clinical problems have significantly decreased morbidity and mortality for many surgical procedures, and have led to improved patient outcomes. While innovation is motivated by the surgeon's expectation that the new approach will be beneficial to patients, not all innovations are successful or result in improved patient care. The ethical dilemma of surgical innovation lies in the uncertainty of whether a particular innovation will prove to be a "good thing." This uncertainty creates challenges for surgeons, patients, and the healthcare system. By its very nature, innovation introduces a potential risk to patient safety, a risk that may not be fully known, and it simultaneously fosters an optimism bias. These factors increase the complexity of informed consent and shared decision making for the surgeon and the patient. Innovative procedures and their associated technology raise issues of cost and resource distribution in the contemporary, financially conscious, healthcare environment. Surgeons and institutions must identify and address conflicts of interest created by the development and application of an innovation, always preserving the best interest of the patient above the academic or financial rewards of success. Potential strategies to address the challenges inherent in surgical innovation include collecting and reporting objective outcomes data, enhancing the informed consent process, and adhering to the principles of disclosure and professionalism. As surgeons, we must encourage creativity and innovation while maintaining our ethical awareness and responsibility to patients.

History and evolution of surgical ethics: John Gregory to the twenty-first century.

As surgery grew to become a respected medical profession in the eighteenth century, medical ethics emerged as a response to the growing need to protect patients and maintain the public's trust in physicians. The early influences of John Gregory and Thomas Percival were instrumental in the formulation of patient-centered medical ethics. In the late nineteenth century, the modern surgical advances of anesthesia and antisepsis created the need for a discipline of ethics specific to surgery in order to confront new and evolving ethical issues. One of the founding initiatives of the American College of Surgeons in 1913 was to eliminate unethical practices such as fee-splitting and itinerant surgery. As surgery continued to advance in the era of solid organ transplantation and minimally invasive surgery in the latter half of the twentieth century, surgical innovation and conflict of interest have emerged as important ethical issues moving forward into the twenty-first century. Surgical ethics has evolved into a distinct branch of medical ethics, and the core of surgical ethics is the surgeon-patient relationship and the surgeon's responsibility to advance and protect the well-being of the patient.

International Travel for Organ Transplantation: Provider and Patient Perspectives.

Background: Organ allocation in the United States to non-US citizen, non-US residents who travel for transplant (NC/NRTx) is controversial. Current policies may not be informed by stakeholder opinions, as limited data exist assessing the knowledge or opinions of providers or patients on this issue. Methods: A cross-sectional, hospital-based pilot survey was distributed to providers and patients from December 2019 to June 2020 at a single large urban transplant institute. Providers were members of the departments of surgery and medicine and included both transplant and nontransplant providers. Surveys included 10 questions on eligibility, prioritization, and limitations for deceased donor transplantation and 12 demographic questions. Results: A total of 209 providers responded (61% women, median age 40) and 119 patients responded (62% women, median age 54). Awareness of eligibility for transplantation of US citizens, non-US citizens residing in the United States (NC/R), and NC/NRTx was high in both groups, though providers and patients lacked awareness of the eligibility of nonlegal NC/R (those who live in the United States who are not citizens and are not legal residents) to donate and receive organs. Overall, 79.3% of patients stated that NC/NRTx should be eligible for transplant in the United States compared with only 60.7% of providers (P = 0.001). Providers were more likely than patients to prioritize transplant to legal NC/NR over NC/NRTx (58.2% versus 35.1%, P < 000.1) and reported that families should be able to limit donations to NC/NRTx (34.9% versus 23.2%, P = 0.03). Conclusions: Surveyed patients and providers generally support transplant in non-US citizens; however, the strength of support varied considerably based on the legal status of the patient and the occupation of those surveyed. Larger studies are necessary to develop data-informed policy.