Clinical ethics consultation services: public-facing information on NCI-designated cancer center websites.

Clinical ethics consultation services (CECS) can be particularly complex in oncology, and widespread misconceptions exist about their nature. As a result, visibility and accessibility of information regarding CECS is critical. We investigated the availability and content of information regarding CECS on websites of NCI-designated comprehensive cancer centers and cancer centers (CCs). Each website was reviewed for information on CECS and reviewed for benchmarks partially derived from the American Society of Bioethics and Humanities recommendations for CECS. Our analysis revealed that of 70 NCI-designated center websites, 38 had information on CECS, and 17 were found directly on these sites. When CECS information was available, most websites provided a mission statement (71%) and an explanation of what constitutes an ethics consult (74%). Few provided a description of the consult process (45%) or service membership (39%). Our findings reveal a significant gap in CECS visibility on the websites of NCI-designated CCs.

Establishing and Defining an Approach to Climate Conscious Clinical Medical Ethics.

An anthropocentric scope for clinical medical ethics (CME) has largely separated this area of bioethics from environmental concerns. In this article, we first identify and reconcile the ethical issues imposed on CME by climate change including the dispersion of related causes and effects, the transdisciplinary and transhuman nature of climate change, and the historic divorce of CME from the environment. We then establish how several moral theories undergirding modern CME, such as virtue ethics, feminist ethics, and several theories of justice, promote both a flourishing of human medical practice and the environment. We conclude by defining an expanded the scope of CME as inclusive of not only patients, families, physicians, and other health professionals but other humans, non-humans, and their shared environment. We then apply this scope and theory to a widely used framework for applying CME, the Four Topics model, to construct a climate conscious approach to CME.

Shifting from Equality toward Equity: Addressing Disparities in Research Participation for Clinical Cancer Research.

AbstractThere is societal consensus that cancer clinical trial participation is unjust because some sociodemographic groups have been systematically underrepresented. Despite this, neither a definition nor an ethical explication for the justice norm of equity has been clearly articulated in this setting, leading to confusion over its application and goals. Herein we define equity as acknowledging sociodemographic circumstances and apportioning resource and opportunity allocation to eliminate disparities in outcomes, and we explore the issues and tensions this norm generates through practical examples. We assess how equality-based enrollment structures in clinical cancer research have perpetuated historical disparities and what equity-based alternatives are necessary to achieve representativeness and an expansive conception of participatory justice in clinical cancer research. This framework addresses the breadth from normative to applied by defining the justice norm of equity and translating it into practical strategies for addressing participation disparities in clinical cancer research.

Everyday Clinical Ethics: Essential Skills and Educational Case Scenarios.

Bioethics conjures images of dramatic healthcare challenges, yet everyday clinical ethics issues unfold regularly. Without sufficient ethical awareness and a relevant working skillset, clinicians can feel ill-equipped to respond to the ethical dimensions of everyday care. Bioethicists were interviewed to identify the essential skills associated with everyday clinical ethics and to identify educational case scenarios to illustrate everyday clinical ethics. Individual, semi-structured interviews were conducted with a convenience sample of bioethicists. Bioethicists were asked: (1) What are the essential skills required for everyday clinical ethics? And (2) What are potential educational case scenarios to illustrate and teach everyday clinical ethics? Participant interviews were analyzed using qualitative content analysis. Twenty-five (25) bioethicists completed interviews (64% female; mean 14.76 years bioethics experience; 80% white). Five categories of general skills and three categories of ethics-specific skills essential for everyday clinical ethics were identified. General skills included: (1) Awareness of Core Values and Self-Reflective Capacity; (2) Perspective-Taking and Empathic Presence; (3) Communication and Relational Skills; (4) Cultural Humility and Respect; and (5) Organizational Understanding and Know-How. Ethics-specific skills included: (1) Ethical Awareness; (2) Ethical Knowledge and Literacy; and (3) Ethical Analysis and Interaction. Collectively, these skills comprise a Toolbox of Everyday Clinical Ethics Skills. Educational case scenarios were identified to promote everyday ethics. Bioethicists identified skills essential to everyday clinical ethics. Educational case scenarios were identified for the purpose of promoting proficiency in this domain. Future research could explore the impact of integrating educational case scenarios on clinicians' ethical competencies.

Parents' and adolescents' perspectives and understanding of information about childhood cancer precision medicine.

BACKGROUND: Precision medicine is projected to become integral to childhood cancer care. As such, it is essential to support families to understand what precision medicine entails. METHODS: A total of 182 parents and 23 adolescent patients participating in Precision Medicine for Children with Cancer (PRISM), an Australian precision medicine clinical trial for high-risk childhood cancer, completed questionnaires after study enrollment (time 0 [T0]). Of the parents, 108 completed a questionnaire and 45 completed an interview following return of precision medicine results (time 1 [T1]). We analyzed the mixed-methods data comprising measures exploring families' perceptions and understanding of PRISM's participant information sheet and consent form (PISCF), and factors associated with understanding. RESULTS: Most parents were satisfied with the PISCF, rating it as at least "somewhat" clearly presented (n = 160/175; 91%) and informative (n = 158/175; 90%). Many suggested improvements including the use of clearer language and a more visually engaging format. Parents' actual understanding of precision medicine was low on average, but scores improved between T0 and T1 (55.8/100-60.0/100; p = .012). Parents from culturally and/or linguistically diverse backgrounds (n = 42/177; 25%) had lower actual understanding scores than those from a Western/European background whose first language was English (p = .010). There was little correlation between parents' perceived and actual understanding scores (p = .794; Pearson correlation -0.020; 95% CI, -0.169 to 0.116). Most adolescent patients read the PISCF either "briefly" or "not at all" (70%) and had a perceived understanding score of 63.6/100 on average. CONCLUSIONS: Our study revealed gaps in families' understanding of childhood cancer precision medicine. We highlighted areas for potential intervention such as through targeted information resources. PLAIN LANGUAGE SUMMARY: Precision medicine is projected to become part of the standard of care for children with cancer. Precision medicine aims to give the right treatment to the right patient and involves several complex techniques, many of which may be challenging to understand. Our study analyzed questionnaire and interview data from parents and adolescent patients enrolled in an Australian precision medicine trial. Findings revealed gaps in families' understanding of childhood cancer precision medicine. Drawing on parents' suggestions and the literature, we make brief recommendations about improving information provision to families, such as through targeted information resources.

Hopes, concerns, satisfaction and regret in a precision medicine trial for childhood cancer: a mixed-methods study of parent and patient perspectives.

BACKGROUND: Paediatric precision oncology aims to match therapeutic agents to driver gene targets. We investigated whether parents and patients regret participation in precision medicine trials, particularly when their hopes are unfulfilled. METHODS: Parents and adolescent patients completed questionnaires at trial enrolment (T0) and after receiving results (T1). Parents opted-in to an interview at T1. Bereaved parents completed a questionnaire 6-months post-bereavement (T1B). We analysed quantitative data with R and qualitative data thematically with NVivo, before integrating all data for interpretation. RESULTS: 182 parents and 23 patients completed T0; 108/182 parents and 8/23 patients completed T1; 27/98 bereaved parents completed T1B; and 45/108 parents were interviewed. At enrolment, participants held concurrent hopes that precision medicine would benefit future children and their child. Participants expressed concern regarding wait-times for receipt of results. Most participants found the trial beneficial and not burdensome, including bereaved parents. Participants reported high trial satisfaction (median scores: parents: 93/100; patients: 80/100). Participants expressed few regrets (parent median scores: parents: 10/100; bereaved parents: 15/100; patient regret: 2/8 expressed minimal regret). CONCLUSIONS: Even when trial outcomes did not match their hopes, parents and patients rarely regretted participating in a childhood cancer precision medicine trial. These data are critical for integrating participants' views into future precision medicine delivery.

The role of ethicists in pediatric hematology/oncology: Current status and future needs.

As pediatric hematology/oncology (PHO) becomes more complex and sub-subspecialized, dedicated PHO ethicists have emerged as sub-subspecialists focused on addressing ethical issues encountered in clinical and research practices. PHO physicians and other clinicians with advanced training in bioethics contribute to the field through ethics research, education, and ethics consultation services. Furthermore, there exists a newer generation of PHO trainees interested in bioethics. This review details the experiences of current PHO ethicists, providing a blueprint for future educational, research and service activities to strengthen the trajectory of the burgeoning sub-subspecialty of PHO ethics. Creating an American Society of Pediatric Hematology/Oncology (ASPHO) ethics Special Interest Group, enhancing clinical ethics education for pediatric hematologists/oncologists (PHOs), developing multi-institutional research collaborations, and increasing attention to ethical issues germane to nonmalignant hematology will serve the interests of the entire field of PHO, enhancing the care of PHO patients and careers of PHOs.

Clinical ethics consultation documentation in the era of open notes.

BACKGROUND: In 2021, federal rules from the 21st Century Cures Act mandated most clinical notes be made available in real-time, online, and free of charge to patients, a practice often referred to as "open notes." This legislation was passed to support medical information transparency and reinforce trust in the clinician-patient relationship; however, it created additional complexities in that relationship and raises questions of what should be included in notes intended to be read by both clinicians and patients. MAIN BODY: Even prior to open notes, how an ethics consultant should document a clinical ethics consultation was widely debated as there can be competing interests, differing moral values, and disagreement about pertinent medical information in any given encounter. Patients can now access documentation of these discussions through online portals which broach sensitive topics related to end-of-life care, autonomy, religious/cultural conflict, veracity, confidentiality, and many others. Clinical ethics consultation notes must be ethically robust, accurate, and helpful for healthcare workers and ethics committee members, but now also sensitive to the needs of patients and family members who can read them in real-time. CONCLUSION: We explore implications of open notes for ethics consultation, review clinical ethics consultation documentation styles, and offer recommendations for documentation in this new era.

Could Behavioral Economics Mitigate Shortcomings in Shared Decision-Making?

While shared decision-making (SDM) is generally considered to be the standard in current clinical practice, strict application of SDM can result in adverse outcomes in certain contexts. This article examines two illustrative cases-antibiotic over-prescription and decision-making at or near the end of life-to highlight how strictly applied SDM can result in suboptimal outcomes. The article continues to describe how strategies from libertarian paternalism, particularly default setting, framing, and nudging, can be valuable tools in supplementing strict applications of SDM, resulting in improved outcomes and patient care on both individual and societal levels.

Ethical Challenges in Pediatric Oncology Care and Clinical Trials.

The care of pediatric cancer patients is a vast departure from cancer care of adults. While the available treatment modalities-chemotherapy, radiation, and surgery-are the same, the diseases, care-delivery, and outcomes differ greatly. And just as 'children are not just little adults,' pediatric bioethics occupies a distinct place within the broader field of bioethics. In this chapter, we will begin with an introduction to fundamental principles and frameworks for understanding ethical issues in pediatrics, highlighting the triadic nature of medical decision-making between a physician, the child-patient, and the child's parent as the surrogate decision-maker. We will then delve into further details of how these principles and frameworks shape the care of children with cancer, examining specific ethical challenges commonly encountered by pediatric oncologists. We will traverse this landscape by examining issues involving (a) informed consent; (b) research involving children; (c) end of life; (d) genetic and genomic testing; and (e) professionalism. We also examine ethical challenges in clinical research, in children and more broadly. While not an exhaustive exploration of the myriad ethical issues one might encounter in pediatric cancer medicine and clinical trials, this chapter provides readers with a foundation for further reading.

Socioeconomic disparities in survival after high-risk neuroblastoma treatment with modern therapy.

BACKGROUND: Modern therapeutic advances in high-risk neuroblastoma have improved overall survival (OS), but it is unclear whether these survival gains have been equitable. This study examined the relationship between socioeconomic status (SES) and overall survival (OS) in children with high-risk neuroblastoma and whether SES-associated disparities have changed over time. PROCEDURE: In this population-based cohort study, children <18 years diagnosed with high-risk neuroblastoma (diagnosis at age ≥12 months with metastatic disease) from 1991 to 2015 were identified through the National Cancer Institute's Surveillance, Epidemiology, and End Results database. Associations of county-level SES variables and OS were tested with univariate Cox proportional hazards regression. For a subcohort diagnosed after 2007, insurance status was examined as an individual-level SES variable. Multivariable regression analyses with treatment era and interaction terms were performed when SES variables reached near-significance (p ≤ .1) in univariate and bivariate modeling with treatment era. RESULTS: Among 1217 children, 2-year OS improved from 53.0 ± 3.4% in 1991-1998 to 76.9 ± 2.9% in 2011-2015 (p < .001). In univariate analyses, children in high-poverty counties (hazard ratio [HR] = 1.74, 95% confidence interval [CI] = 1.17-2.60, p = .007), and those with Medicaid (HR = 1.40, 95% CI = 1.05-1.86, p = .02) experienced an increased hazard of death. No interactions between treatment era and SES variables were statistically significant in multivariable analyses, indicating that differences in the OS between SES groups did not change over time. CONCLUSIONS: Survival disparities among children with high-risk neuroblastoma have not widened over time, suggesting equitable access to and benefit from therapeutic advances. However, children of low SES experience persistently inferior survival. Interventions to narrow this disparity are paramount.

How should we approach parental refusals of opioids on behalf of children in the perioperative setting? A practical approach based on ethical theory.

In the midst of the current opioid epidemic, we have encountered more parents who are concerned about the use of opioids in the perioperative setting. Some parents have completely refused the use of opioids on behalf of their children. How should we approach this treatment refusal? This article describes ethical theory related to the refusal of treatment by parents on behalf of their children, and when it is justified to override parental decisions. We propose a decision-making framework that focuses on improving communication and considering alternatives. Assessment of harm to the child from avoiding opioids, as well as potential harms from overriding parental autonomy must be undertaken prior to considering overriding parents.

Ethical considerations in genomic testing for hematologic disorders.

As our technological capacities improve, genomic testing is increasingly integrating into patient care. The field of clinical hematology is no exception. Genomic testing carries great promise, but several ethical issues must be considered whenever such testing is performed. This review addresses these ethical considerations, including issues surrounding informed consent and the uncertainty of the results of genomic testing; the challenge of incidental findings; and possible inequities in access to and benefit from such testing. Genomic testing is likely to transform the practice of both benign and malignant hematology, but clinicians must carefully consider these core ethical issues in order to make the most of this exciting and evolving technology.

Intended and unintended consequences: Ethics, communication, and prognostic disclosure in pediatric oncology.

BACKGROUND: The majority of patients desire all available prognostic information, but some physicians hesitate to discuss prognosis. The objective of the current study was to examine outcomes of prognostic disclosure among the parents of children with cancer. METHODS: The authors surveyed 353 parents of children with newly diagnosed cancer at 2 tertiary cancer centers, and each child's oncologist. Using multivariable logistic regression, the authors assessed associations between parental report of elements of prognosis discussions with the oncologist (quality of information/communication and prognostic disclosure) and potential consequences of these discussions (trust, hope, peace of mind, prognostic understanding, depression, and anxiety). Analyses were stratified by oncologist-reported prognosis. RESULTS: Prognostic disclosure was not found to be associated with increased parental anxiety, depression, or decreased hope. Among the parents of children with less favorable prognoses (<75% chance of cure), the receipt of high-quality information from the oncologist was associated with greater peace of mind (odds ratio [OR], 5.23; 95% confidence interval [95% CI], 1.81-15.16) and communication-related hope (OR, 2.54; 95% CI, 1.00-6.40). High-quality oncologist communication style was associated with greater trust in the physician (OR, 2.45; 95% CI, 1.09-5.48) and hope (OR, 3.01; 95% CI, 1.26-7.19). Accurate prognostic understanding was less common among the parents of children with less favorable prognoses (OR, 0.39; 95% CI, 0.17-0.88). Receipt of high-quality information, high-quality communication, and prognostic disclosure were not found to be significantly associated with more accurate prognostic understanding. CONCLUSIONS: The results of the current study demonstrate no evidence that disclosure is associated with anxiety, depression, or decreased hope. Communication processes may increase peace of mind, trust, and hope. It remains unclear how best to enhance prognostic understanding. Cancer 2018;124:1232-41. © 2017 American Cancer Society.

Pediatric Oncology Provider Views on Performing a Biopsy of Solid Tumors in Children with Relapsed or Refractory Disease for the Purpose of Genomic Profiling.

BACKGROUND: Patients with relapsed and refractory solid tumors have a poor prognosis. Recent advances in genomic technology have made it feasible to screen tumors for actionable mutations, with the anticipation that this may provide benefit to patients. METHODS: Pediatric oncologists were emailed an anonymous 34-question survey assessing their willingness to offer a rebiopsy to patients with relapsed disease for the purpose of tumor genomic profiling. They were presented with two scenarios evaluating morbidity and invasiveness of the procedures using the clinical examples of medulloblastoma and Ewing sarcoma. RESULTS: A total of 195 pediatric oncologists responded to the questionnaire. Morbidity and invasiveness of the procedure demonstrated significant differences in provider willingness to refer their patients for rebiopsy. The pretest probability was a major variable influencing provider willingness to offer a rebiopsy. Respondents were more likely to offer a rebiopsy if the likelihood was high that the results would have an impact on clinical management than if the biopsy was for histologic confirmation alone (mean 89 vs. 56 %; p = 0.017). Compared with the rate of a rebiopsy for histologic confirmation, significantly fewer providers were willing to offer a rebiopsy if they were led to believe the likelihood of finding an actionable mutation was low (mean 45 vs. 56 %; p = 0.021). CONCLUSION: The scenario showed that the pretest probability of finding an actionable mutation was influential in determining provider willingness to offer a rebiopsy for the purpose of tumor genomic profiling. Further research is warranted to evaluate the benefit of tumor genomic profiling in terms of patient outcomes.

Patient/parent perspectives on genomic tumor profiling of pediatric solid tumors: The Individualized Cancer Therapy (iCat) experience.

BACKGROUND: Genomic tumor profiling (GTP) plays an important role in the care of many adult cancer patients. Its role in pediatric oncology is still evolving, with only a subset of patients currently expected to receive clinically significant results. Little is known about perspectives of pediatric oncology patients/parents on GTP. PROCEDURE: We surveyed individuals who previously underwent GTP through the iCat (Individualized Cancer Therapy) pilot study of molecular profiling in children with relapsed, refractory, and high-risk solid tumors at four pediatric cancer centers. Following return of profiling results, a cross-sectional survey was offered to the patient, if he or she was 18 years or older at enrollment, or parent, if he or she was under 18 years of age. Forty-five surveys (85% response) were completed. RESULTS: Eighty-nine percent (39/44) of respondents reported hoping participation would help find cures for future patients, while 59% (26/44) hoped it would increase their/their child's chance of cure. Most had few concerns about GTP, but 12% (5/43) worried they would learn their/their child's cancer was less treatable or more aggressive than previously thought. Sixty-four percent (29/45) reported feeling their participation had helped others and 44% (20/45) felt they had helped themselves/their own child, despite only one substudy subject receiving targeted therapy matched to GTP findings. Fifty-four percent (21/39) wished to receive all available profiling data, including findings unrelated to cancer and of unclear significance. CONCLUSIONS: Participants in pediatric GTP research perceive benefits of GTP to themselves and others, but expectations of personal benefits of GTP may exceed actual positive impact. These issues warrant consideration during consent discussions about GTP research participation.