Palliative and End-of-Life Care¶

Chapter 13 | Harrison's 22e

KEY CLINICAL POINTS¶

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RAW CONTENT¶

[PAGE 74] PART The Profession Medicine help to mitigate tensions. Before starting clinical research, investigators utilize the strengths of each. The impact of AI on clinician workflow should complete training in the ethics of clinical research, which is and satisfaction, as well as patient outcomes, needs to be assessed. widely available. Physicians also should be critical consumers of clini- Physicians should stay informed of emerging evidence about such cal research results and keep up with research advances that change technologies and the ethical challenges that accompany their use and standards of practice. always keep their patients’ best interests and informed preferences at Forms of research that generate knowledge useful for improving the forefront. health might pose concerns about informed consent, privacy and con- GLOBAL CONSIDERATIONS fidentiality, and psychosocial risk without physical risks. Research with routinely collected clinical data available in electronic health records, I INTERNATIONAL RESEARCH leftover clinical specimens, data from mobile devices, administra- Clinical research is often conducted across multiple sites and across tive data, and combinations could encompass traditional discovery national borders. Societal, legal, and cultural norms and perspectives research as well as quality improvement, comparative effectiveness about research may vary, and there are many ethical challenges. research, and learning health care systems. Physician-investigators involved in international research should be EMERGING TECHNOLOGIES familiar with federal regulations, applicable international regulatory and good clinical practice guidelines, as well as national and local laws Scientific advances in genome sequencing, gene editing (e.g., with where research is taking place. Partnering with local researchers and CRISPR-Cas9), machine learning, artificial intelligence, brain–computer communities is essential not only to demonstrate respect but also to interfaces, cell-based therapies, and other technologies offer great facilitate successful clinical research. promise for research and clinical care with the ultimate goal of improv- ing the prediction, prevention, and treatment of disease. Groundbreak- I INTERNATIONAL CLINICAL EXPERIENCES ing innovations that have strong scientific plausibility still need to be Providing patient care in international settings can be a humanitarian evaluated in rigorous clinical studies for efficacy and safety. service and/or broaden clinical experience. Such arrangements, how- Physicians should keep up to date on the status of novel and often ever, raise ethical challenges—for example, as a result of differences in complex technologies as research evolves, data emerge, and technolo- beliefs about health and illness, expectations regarding health care and gies are incorporated into clinical practice. They can help their patients physicians’ roles, standards of clinical practice, resource limitations, understand research findings and the evidence for clinical use, correct and cultural norms regarding disclosure and other issues. Visiting any misunderstandings, facilitate shared decision-making, and advo- physicians and trainees should receive training and mentoring about cate for fair access to such therapies. Furthermore, physicians should cultural and clinical practices in the host community, respect local cus- engage in professional and public discussion related to allocation of toms and values, collaborate closely with local professionals and staff, resources and fair access to expensive new therapies and emerging and recognize their own limits. technologies and their impact on overall health care affordability. CONCLUSION Certain cell-based therapies, such as peripheral blood stem cell transplantation (Chap. 119) and chimeric antigen receptor (CAR)-T Ethical issues are common in clinical medicine and occur in circum- cell therapy (Chap. 78), are approved for use in several serious hema- stances that may be foreseeable, novel, or unexpected. Physicians tologic disorders. Somatic cell gene therapies have been approved as address these ethical issues by being prepared, informed, and reflective, safe and effective for clinical use in β thalassemia, hemophilia A, sickle and using appropriate available resources. cell disease, and some rare pediatric-onset diseases. Numerous other I FURTHER READING gene therapy applications are under review by regulatory agencies. The Beauchamp T, Childress J: Principles of Biomedical Ethics, 8th ed. approved therapies have a very high cost, which often limits access. New York, Oxford University Press, 2019. Germline gene editing in blastocysts or embryos raises many ethical Berwick D: Salve Lucrum: The existential threat of greed in US health questions and is not permitted in the United States and many other care. JAMA 329:629, 2023. countries. Harris L: Divisions, new and old: Conscience and religious freedom at Some patients may request cell-based, gene, or other complex, HHS. N Engl J Med 378:1369, 2018. highly technical, and expensive therapies for unproven indications. Yet, Hightower M et al: Is medicine ready for AI: Intention to treat epi- claims of cures through unproven stem cell or gene-based “therapies” sode 6. N Engl J Med 388:e49, 2023. pose significant health and financial risks to patients without evidence National Academy of Medicine. Action Collaborative on Clinician of benefit. Physicians should help patients distinguish approved thera- Wellbeing and Resilience. https://nam.edu/initiatives/clinician-resilience- pies from unproven claims and refer interested patients to well-designed and-well-being/. clinical trials. Artificial intelligence (AI) using computers to carry out tasks typi- cally done by humans, and machine learning (ML), a type of AI that automatically learns and improves its performance without explicit programming, are increasingly used in clinical practice. AI clinical algorithms are used to make diagnoses using images from radiology studies, retinal scans, pathology slides, or skin photographs; to search for potential diagnoses associated with a genomic sequence; and to 13 Palliative and predict outcomes for patients, such as surgical complications, hospital End-of-Life Care readmissions, or not coming to scheduled appointments. Physicians should use these predictive algorithms when they are confident that they are clinically meaningful, are unbiased, and do not lead to worse Ezekiel J. Emanuel, John W. Urwin patient outcomes. Generative AI, large language models (LLMs), or chatbots (Chap. 501) promise to help reduce burdensome adminis- trative tasks that contribute to health care worker burnout, such as EPIDEMIOLOGY drafting clinical notes and summaries for patients and writing letters to obtain authorization or appeal denials of insurance coverage. Although I CAUSES OF DEATH rapidly evolving in sophistication, LLMs can sometimes “hallucinate” In 2019, before the COVID-19 pandemic, 2,854,838 individuals died and provide false information. Physicians should be confident that the in the United States (Table 13-1). Approximately 74% of these deaths LLM or bots they use are providing medically accurate information occurred in those aged ≥ 65 years. The epidemiology of death has and advice. Collaboration between AI developers and clinicians can changed significantly since 1900 and even since 1980. In 1900, heart [PAGE 75] Palliative and End-of-Life Care CHAPTER TABLE 13-1 Ten Leading Causes of Death in the United States and Britain UNITED STATES (2019) ENGLAND AND WALES (2019) NUMBER OF DEATHS, NUMBER OF DEATHS, NUMBER OF DEATHS, ALL NUMBER OF DEATHS, CAUSE OF DEATH ALL AGES (%) PEOPLE ≥ 65 YEARS OF AGE AGES (%) PEOPLE ≥ 65 YEARS OF AGE All deaths 2,854,838 2,117,332 530,841 449,047 Heart diseasea 659,041 (23.1) 531,583 (25.1) 87,095 (16.4) 74,967 (16.7) Malignant neoplasms 599,601 (21.0) 435,462 (20.6) 147,419 (27.8) 118,982 (26.5)