Patient Perceptions of Specialist Palliative Care Intervention in Surgical Oncology Care.

INTRODUCTION: Surgical oncology patients have a high symptom burden and increased risk of morbidity. The aim of palliative care is to evaluate and treat the patient in a holistic manner focusing on the unique attributes of each patient. This goal-concordant approach could help surgical patients cope with the stress and uncertainty that often accompany serious illness and surgery, improving overall outcomes. This qualitative analysis sought to explore whether unmet specialist palliative care or end-of-life needs exist in this population. METHODS: Qualitative interviews were completed with a subset of participants in a randomized, controlled trial of a specialist palliative care intervention for patients undergoing abdominal oncologic surgery. The interview guide sought to elicit respondents' perceptions of palliative care and end-of-life needs perioperatively and postoperatively. Recurring themes were identified by two independent coders. RESULTS: Analysis of 47 interview transcripts revealed few serious concerns about end-of-life issues, however appreciation for the supportive presence offered by palliative care was present. Among participants who received specialist palliative care, many found the intervention helpful, but few were able to articulate issues that the intervention improved. CONCLUSION: These findings suggest low levels of unmet palliative care needs among this population, which is consistent with the results of the parent trial. Targeting patients with a higher symptom burden perioperatively may allow for improved symptom management and better adherence to the treatment plan postoperatively, as well as be a more focused use of specialist palliative care clinicians' efforts.

Corrigendum: Landscape of pediatric cancer treatment refusal and abandonment in the US: a qualitative study.

[This corrects the article DOI: 10.3389/fped.2022.1049661.].

Data stewardship in FTLD research: Investigator and research participant views.

INTRODUCTION: Federal policies and guidelines have expanded the return of individual results to participants and expectations for data sharing between investigators and through repositories. Here, we report investigators' and study participants' views and experiences with data stewardship practices within frontotemporal lobal degeneration (FTLD) research, which reveal unique ethical challenges. METHODS: Semi-structured interviews with (1) investigators conducting FTLD research that includes genetic data collection and/or analysis and (2) participants enrolled in a single site longitudinal FTLD study. RESULTS: Analysis of the interviews identified three meta themes: perspectives on data sharing, experiences with enrollment and participation, and data management and security as mechanisms for participant protections. DISCUSSION: This study identified a set of preliminary gaps and needs regarding data stewardship within FTLD research. The results offer initial insights on ethical challenges to data stewardship aimed at informing future guidelines and policies.

Certificates of confidentiality: privileging research data.

With the Supreme Court's decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants' data. We conclude with recommendations for stakeholders based on our analysis.

Stigma manifestations in cardiomyopathy care impact outcomes for black patients: a qualitative study.

INTRODUCTION: Inequities in clinical care may contribute to racial disparities observed in studies of heart disease morbidity and cardiogenetic testing outcomes. There is a lack of research aimed at understanding the complexity of those inequities, but stigma likely contributes. This qualitative exploratory study helps close that gap in the literature by describing intersectional stigma manifestations perceived by the Black cardiomyopathy patient population at one academic medical center. METHODS: Qualitative interviews were conducted with 14 Black cardiomyopathy patients. Interviews aimed to elicit patients' experiences with discrimination related to diagnosis, symptoms, genetic testing, knowledge of genetic results, genetic counseling, providers' actions, and providers' communication. The interview guide was informed by The Health Stigma and Discrimination Framework. Data were also collected about participant demographics, type of cardiomyopathy, age of diagnosis, documentation of relevant family history, and completion of genetic counseling and/or genetic testing. RESULTS: More than half of participants reported intersectional stigma manifestations related to their race, age, and/or weight while receiving care from cardiologists, nurse practitioners, genetic counselors, or clinical support staff. Stigma manifestations included physical roughness during patient care, withholding diagnostically-relevant information from the patient, impersonal care, coercion, and use of offensive stereotyped language by providers. These stigma manifestations impacted access to care, uptake of genetic testing, timeline to diagnosis, patient emotion, patient-provider trust, and adherence to medical recommendations. CONCLUSIONS: This study provides nuanced qualitative descriptions of stigma manifestations that affect patient and clinical outcomes in cardiology care and genetic services in one medical center in the Southeastern United States. The results of this study suggest that provider bias and stigma manifestations have an adverse effect on cardiogenetic and clinical outcomes among Black cardiomyopathy patients. Clinical interventions are suggested to assist health professionals in providing culturally-competent and respectful care. These results help inform patient-provider communication, clinical policies, and evidence-based practice in cardiology care and genetics. Continued study of this topic across more institutions and with a larger sample size is needed to confirm the generalizability of the conclusions.

Overcoming refusal of treatment in pediatric cancer without legal involvement: A descriptive case series from interviews with pediatric oncologists.

To describe strategies that pediatric oncologists utilize to persuade families to initiate or continue chemotherapy after refusing treatment, we examined transcripts from interviews of oncologists with relevant experience. We identified three cases in which the pediatric oncologists' approaches led to voluntary acceptance of recommended treatment without legal intervention. Strategies used include direct communication with alternative medicine providers, time-limited trial of alternative therapy, and praying with the family. While we cannot conclude whether these approaches could be generalized to other cases, they offer ideas for pediatric oncologists to consider when facing the decision to seek judicial involvement or discontinue persuasive efforts.

The lived experience of prostate cancer: 10-year survivor perspectives following contemporary treatment of localized prostate cancer.

PURPOSE: Studies relying on standardized instruments to measure patient-centered harms and benefits of cancer treatment may fail to capture important elements of the lived experience of cancer patients. Further, qualitative studies on the survivorship experience of men with localized prostate cancer (PCa) are limited. We sought to explore the early experience, long-term experience, and advice provided for others among long-term survivors of localized PCa. METHODS: Semi-structured qualitative interviews with a subset (n = 66) of respondents to a survey of 10-year PCa survivors who underwent active surveillance, radical prostatectomy, or radiotherapy. Topics included early and long-term experiences and advice to other men and physicians. RESULTS: Immediately after treatment, men were mostly satisfied with radiation and active surveillance due to remaining whole and avoiding surgical removal of the prostate. Meanwhile, men treated with surgery felt relieved by the removal of cancer. Some early negative perception was related to short-term anxiety, particularly among men who underwent active surveillance. Long-term experiences included accepting the trade-offs of urinary and sexual side effects with survival. Most men fared well financially, some had strengthened relationships, and many reported greater appreciation and compassion. Men provided essential advice to other men and physicians on the importance of gathering detailed information on treatments and establishing a strong relationship with physicians. CONCLUSIONS: Long-term survivors of localized PCa generally do well by accepting the long-term effects of contemporary treatments, experiencing strengthened relationships, and developing a better overall life approach. IMPLICATIONS FOR CANCER SURVIVORS: We provide useful perspectives and insights for men opting to use current-day treatments for localized PCa.

Patient Perspectives on Perioperative Supportive Care Needs Surrounding Major Abdominal Operations for Cancer.

PURPOSE: The development of supportive care interventions delivered by surgeons for their patients is a major research priority. Designing such interventions requires understanding patients' supportive care needs for major operations. This qualitative analysis aimed to determine the supportive care needs of patients undergoing major abdominal operations for cancer. METHODS: We conducted semi-structured interviews with a subset of participants in a randomized, controlled trial of a specialist palliative care intervention for patients undergoing abdominal resections for cancer (NCT03436290). Sampling was designed to balance the population by sex, age (older vs. younger than 65 years), and treatment group assignment (intervention vs. control). The interview guide was developed to elicit patient perceptions of their supportive care needs from diagnosis to the time of interview, about 1 month after their operation. Two coders used an iterative, inductive method to identify recurring themes in the interviews. RESULTS: Analysis of interview transcripts revealed five primary themes: preoperative preparation, postoperative recovery, expectation setting, coordination of care, and provider characteristics. Cutting across these themes were patients' focus on time, timeliness, and timelines, as well as their desires for information both from their surgeons and other sources. Surgeons inspired trust through the quality of their communication and their responsiveness to questions. Patients were sensitive to perceived deviations from their expectations and spoke of the need to develop patience and to expect the unexpected. CONCLUSIONS: Patients expressed several needs for supportive care that surgical teams can potentially address to improve the experience of major cancer surgery.

"Choice of law" in precision medicine research.

Large-scale precision medicine research requires massive amounts of data representing people from all walks of life; thus, in the US, it is often multistate research. Significant legal and ethical quandaries arise as a result of the patchwork of laws states have enacted that may apply to research, are not preempted by federal law, and may impose requirements or provide participant rights and protections that differ from other states. Determining which state's laws apply, and under what circumstances, is not solved by the transition to a single-IRB model and researchers cannot simply choose one state's laws to apply uniformly. At a minimum, the current process of meeting each state's requirements could be made more reliable and efficient. To fundamentally change this status quo, however, requires action at multiple levels. Federally, well-known gaps in the Genetic Information Nondiscrimination Act should be closed, and a coherent system of compensation for research injury-including non-physical injuries-should be developed. States should clarify which of their laws are intended to apply to research and work collaboratively to harmonize them. At the level of individual research projects, numerous policies and procedures could be standardized through authoritative guidelines. Examples include clarifying the scope of broad consent, understanding and upholding Certificates of Confidentiality, offering individual research results responsibly, and consistently disseminating aggregate results to participants and the public. Overall, development of a choice of law framework specific to the research context could significantly promote clarity and consistency.

Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19.

Unique challenges arise when conducting trials to evaluate therapies already in common clinical use, including difficulty enrolling patients owing to widespread open-label use of trial therapies and the need for large sample sizes to detect small but clinically meaningful treatment effects. Despite numerous successes in trials evaluating novel interventions such as vaccines, traditional explanatory trials have struggled to provide definitive answers to time-sensitive questions for acutely ill patients with COVID-19. Pragmatic trials, which can increase efficiency by allowing some or all trial procedures to be embedded into clinical care, are increasingly proposed as a means to evaluate therapies that are in common clinical use. In this Personal View, we use two concurrently conducted COVID-19 trials of hydroxychloroquine (the US ORCHID trial and the UK RECOVERY trial) to contrast the effects of explanatory and pragmatic trial designs on trial conduct, trial results, and the care of patients managed outside of clinical trials. In view of the potential advantages and disadvantages of explanatory and pragmatic trial designs, we make recommendations for their optimal use in the evaluation of therapies in the acute care setting.

Addressing choice of law challenges in multi-state precision medicine research: experts' assessment of key factors.

Precision medicine research implicates numerous state laws that may affect participants' rights and protections and are not preempted by federal law. The choice of which state's laws apply, and under what circumstances, can have significant impact on research design and oversight. But neither of the traditional approaches to choice of law issues-contractual agreement or determination by a court after a dispute arises-fit the research context well. We hosted a series of workshops with choice of law experts and research law and ethics experts to identify factors that are most crucial to account for in a future choice of law precision medicine research framework. Our workshops focused on precision medicine 'places' and choice of law factors; there was consensus that 'place where the harm occurred' was relevant and best represented by where the participant resides and/or where the research/institution is located. Our experts identified factors that need to be accounted for in a future choice of law framework. They also identified potential approaches, including a federal law or model state law as ways of achieving more uniformity of protections and a comprehensive database of laws, which merit further consideration to provide IRBs and researchers the guidance they require.

Perspectives on choice of law challenges in multistate precision medicine research.

Federal law establishes minimum standards for protecting human research participants, but many states have enacted laws that may apply to research. Precision medicine research in particular implicates state laws that govern an array of topics, including human subjects research, genetic testing, and both general and genetic privacy and discrimination. Thus, the determination of which state's laws apply, and under what circumstances, can substantially alter participant rights and protections. To shed light on this topic, we conducted interviews with experts in law, human research protections, and precision medicine research. Our goal was to better understand their experiences with choice of law issues, the effects of state law variation on research practices and stakeholder groups, and approaches to addressing such variation. Interviewees were aware of state-based variation in laws that could be applied to research. However, the extent to which they perceived such variability as problematic differed, as did their perceptions of stakeholder roles and responsibilities for addressing state law variation, and their estimations of requisite knowledge among IRBs and researchers. These divergent perspectives create an ethical and legal quandary, and further empirical and normative work is needed to fully characterize the implications of substantive differences in participant rights and protections.

Trauma Surgeons' Perceptions of Resuscitating Lethally Injured Patients for Organ Preservation.

BACKGROUND: Trauma surgeons face a challenge when deciding whether to resuscitate lethally injured patients whose organ donor status is unknown. Data suggests practice pattern variability in this setting, but little is known about why. MATERIALS AND METHODS: We conducted semi-structured interviews with trauma surgeons practicing in Level 1 or 2 trauma centers in Tennessee. Interviews focused on ethical dilemmas and resource constraints. Analysis was performed using inductive thematic analysis. RESULTS: Response rate was 73% (11/15). Four key themes emerged. All described resuscitating patients to buy time to collect more definitive clinical information and to identify family. Some acknowledged this served the secondary purpose of organ preservation. 11/11 participants felt a primacy of obligation to the patient in front of them even after it became apparent, they could not personally benefit. For 9/11 (82%), the moral obligation to consider organ preservation was secondary/balancing; 2/11 (18%) felt it was irrelevant/immoral. Resource allocation was commonly considered. All participants expressed some limitation to resources they would allocate. All participants conveyed clear moral agency in determining resuscitation extent when the goal was to save the patient's life, however this was less clear when resuscitating for organ preservation. Across themes, perceptions of a "standard practice" existed but the described practices were not consistent across interviewees. DISCUSSION: Widely ranging perceptions regarding ethical and resource considerations underlie practices resuscitating toward organ preservation. Common themes suggest a lack of consensus. Despite expressed beliefs, there is no identifiable standard of practice amongst trauma surgeons resuscitating in this setting.

Landscape of pediatric cancer treatment refusal and abandonment in the US: A qualitative study.

Objective: To describe United States (US) pediatric oncologists' experiences with treatment refusal or abandonment, exploring types and frequency of decision-making conflicts, and their impact. Study design: We conducted exploratory qualitative interviews of pediatric oncologists (n = 30) with experience caring for a pediatric patient who refused or abandoned curative treatment. Interviewees were recruited using convenience and nominated expert sampling, soliciting experiences from diverse geographic locations and institution sizes across the US. We analyzed transcripts using applied thematic analysis to identify and refine meaningful domains. Results: Many oncologists reported multiple experiences with refusal and abandonment. Most anticipated case frequency would increase due to misinformation, particularly on the internet. Interviewees described cases of treatment refusal and abandonment, but also a wider variety of cases than previously described in existing publications, including cases involving: non-adherence; negotiations for different treatments; negotiations for complementary and alternative medicine; delayed treatment initiation; and refusal of a component of recommended therapy. Cases often involved multiple stages or types of conflicts. Recurring patient/family behaviors emerged: clear opposition to treatment from the outset; hesitancy about treatment despite initiating therapy; and psychosocial circumstances becoming an obstacle to treatment completion. Oncologists revealed substantial professional and personal repercussions of these cases. Conclusion: Oncologist interviews highlight a broad range of conflicts, yielding a taxonomy of treatment refusal, non-adherence and abandonment (TRNA) that accounts for the heterogeneity of situations described. Cases' complexity and interrelatedness points to a functional model of TRNA that includes families' behaviors. This preliminary taxonomy and model warrant further research and examination to refine the model and generate strategies to prevent and mitigate TRNA.

Direct-to-consumer genetic testing: Prospective users' attitudes toward information about ancestry and biological relationships.

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals' responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such testing, taking into account use by third parties, such as potential kin and law enforcement. Participants differed widely in the perceived value of direct-to-consumer genetic tests for ancestry and kinship information for their own lives, including the desirability of contact with previously unknown relatives. Some perceived ancestry testing as mere curiosity or entertainment, while others, particularly those who had gaps in their family history, few living relatives, or who were adopted, saw greater value. Concerns about intrusion into one's life by purported kin and control of data were widespread, with many participants expressing concern about secondary uses of data that could harm users or their families. The use of direct-to-consumer genetic tests data for forensic genealogy elicited a particularly wide array of reactions, both spontaneously and in response to specific discussion prompts, mirroring the current public debate about law enforcement access to such data. The themes uncovered through our investigation warrant specific attention in the continued development of the science, policy, and practice of commercial direct-to-consumer genetic testing.

Regional ethics of surgeon resuscitation for organ transplantation after lethal injury.

BACKGROUND: Trauma patients may present with nonsurvivable injuries, which could be resuscitated for future organ transplantation. Trauma surgeons face an ethical dilemma of deciding whether, when, and how to resuscitate a patient who will not directly benefit from it. As there are no established guidelines to follow, we aimed to describe resuscitation practices for organ transplantation; we hypothesized that resuscitation practices vary regionally. METHOD: Over a 3-month period, we surveyed trauma surgeons practicing in Levels I and II trauma centers within a single state using an instrument to measure resuscitation attitudes and practices for organ preservation. Descriptive statistics were calculated for practice patterns. RESULTS: The survey response rate was 51% (31/60). Many (81%) had experience with resuscitations where the primary goal was to preserve potential for organ transplantation. Many (90%) said they encountered this dilemma at least monthly. All respondents were willing to intubate; most were willing to start vasopressors (94%) and to transfuse blood (84%) (range, 1 unit to >10 units). Of respondents, 29% would resuscitate for ≥24 hours, and 6% would perform a resuscitative thoracotomy. Respect for patients' dying process and future organ quality were the factors most frequently considered very important or important when deciding to stop or forgo resuscitation, followed closely by concerns about excessive resource use. CONCLUSION: Trauma surgeons' regional resuscitation practices vary widely for this patient population. This variation implies a lack of professional consensus regarding initiation and extent of resuscitations in this setting. These data suggest this is a common clinical challenge, which would benefit from further study to determine national variability, areas of equipoise, and features amenable to practice guidelines.