AJOB Empirical Bioethics最新文献

Introduction: Deep brain stimulation (DBS) is approved under a humanitarian device exemption to manage treatment-resistant obsessive-compulsive disorder (TR-OCD) in adults. It is possible that DBS may be trialed or used clinically off-label in children and adolescents with TR-OCD in the future. DBS is already used to manage treatment-resistant childhood dystonia. Evidence suggests it is a safe and effective intervention for certain types of dystonia. Important questions remain unanswered about the use of DBS in children and adolescents with TR-OCD, including whether mental health clinicians would refer pediatric patients for DBS, and who would be a good candidate for DBS.

Objectives: To explore mental health clinicians' views on what clinical and psychosocial factors they would consider when determining which children with OCD would be good DBS candidates.

Materials and methods: In depth, semi-structured interviews were conducted with n = 25 mental health clinicians who treat pediatric patients with OCD. The interviews were transcribed, coded, and analyzed using thematic content analysis. Three questions focused on key, clinical, and psychosocial factors for assessing candidacy were analyzed to explore respondent views on candidacy factors. Our analysis details nine overarching themes expressed by clinicians, namely the patient's previous OCD treatment, OCD severity, motivation to commit to treatment, presence of comorbid conditions, family environment, education on DBS, quality of life, accessibility to treatment, and patient age and maturity.

Conclusions: Clinicians generally saw considering DBS treatment in youth as a last resort and only for very specific cases. DBS referral was predominantly viewed as acceptable for children with severe TR-OCD who have undertaken intensive, appropriate treatment without success, whose OCD has significantly reduced their quality of life, and who exhibit strong motivation to continue treatment given the right environment. Appropriate safeguards, eligibility criteria, and procedures should be discussed and identified before DBS for childhood TR-OCD becomes practice.

Background: Some have hypothesized that talk about suffering can be used by clinicians to motivate difficult decisions, especially to argue for reducing treatment at the end of life. We examined how talk about suffering is related to decision-making for critically ill patients, by evaluating transcripts of conversations between clinicians and patients' families.

Methods: We conducted a secondary qualitative content analysis of audio-recorded family meetings from a multicenter trial conducted in the adult intensive care units of five hospitals from 2012-2017 to look at how the term "suffering" and its variants were used. A coding guide was developed by consensus-oriented discussion by four members of the research team. Two coders independently evaluated each transcript. We followed an inductive approach to data analysis in reviewing transcripts; findings were iteratively discussed among study authors until consensus on key themes was reached.

Results: Of 146 available transcripts, 34 (23%) contained the word "suffer" or "suffering" at least once, with 58 distinct uses. Clinicians contributed 62% of first uses. Among uses describing the suffering of persons, 57% (n = 24) were related to a decision, but only 42% (n = 10) of decision-relevant uses accompanied a proposal to limit treatment, and only half of treatment-limiting uses (n = 5) were initiated by clinicians. The target terms had a variety of implicit meanings, including poor prognosis, reduced functioning, pain, discomfort, low quality of life, and emotional distress. Suffering was frequently attributed to persons who were unconscious.

Conclusions: Our results did not support the claim that the term "suffering" and its variants are used primarily by clinicians to justify limiting treatment, and the terms were not commonly used in our sample when decisions were requested. Still, when these terms were used, they were often used in a decision-relevant fashion.

To succeed, an accreditation process for clinical ethics fellowship programs (CEFPs) would need support from CEFP directors. To assess CEFP directors' opinions, we surveyed all 36 CEFP directors in the United States and Canada, achieving a 100% response rate. We found that support for accreditation is strong, with 30.6% strongly supportive, 44.4% supportive, 22.2% neutral, 2.8% opposed, and 0% strongly opposed. Most directors (77.8%) would be likely to apply for accreditation within the next five years regardless of the availability of government funding; even more (86.1%) would apply if government funding became available for accredited programs. Most directors thought that lack of a national accreditation process (75.0%), lack of agreed-upon standards (90.0%), and lack of funding for CEFPs (91.7%) were at least moderate problems for the field. When directors were asked what they thought was the greatest challenge or barrier to developing an accreditation process, many mentioned the diversity of programs and the challenge of achieving consensus on accreditation standards. Directors offered a variety of suggestions for how to overcome or manage challenges or barriers, including collecting data on existing programs, mirroring standards established for other health professions, and setting clear expectations on the need for compromise. When directors were asked how they expected that accreditation and government funding would affect their own programs, the field of clinical ethics, and patient care, directors mostly had very positive expectations; no director expected negative effects in any of these areas. Overall, this study provides evidence that developing an accreditation process for CEFPs would be both possible and desirable. Our findings have immediate practical implications for the field and will inform efforts that are already underway to establish an accreditation process for CEFPs.

Background: Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU).

Methods: We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach.

Results: Clinicians' greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study's approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access.

Conclusions: The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the "gatekeeping" typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen.

Background: Potential clinical interventions to mitigate or eliminate symptoms of Down syndrome (DS) continue to be an active area of pre-clinical and clinical research. However, views of members of the DS community have yet to be fully explored.

Methods: We conducted a survey with parents/caregivers of people with DS (n = 532) to explore interest in potential therapeutic approaches during fetal development or childhood that may improve neurocognition and modulate the DS phenotype. We qualitatively analyzed open-ended responses.

Results: Some respondents rejected the development of therapies for DS categorically as being fundamentally ableist and promoting the erasure of diverse individuals. Many reflected tensions between the desire to improve quality of life and an aversion to erasure of a child's personality.

Conclusion: Findings suggest that views on identity, personality, and disability may influence the acceptance of new interventions, especially if they are thought to mitigate positive attributes of the phenotype or negatively influence social acceptance of people with DS.

Background: Rare diseases are generally poorly understood from scientific and medical standpoints due, to their complexity and low prevalence. As a result, individuals living with rare diseases struggle to obtain timely diagnoses and suitable care. These clinical difficulties add to the physical and psychological impacts of living with chronic and often severe medical conditions. From the standpoint of pragmatist ethics, the morally problematic situations that adults living with rare diseases experience matter crucially. However, there is little known about these experiences.

Methods: A survey study was conducted with 121 adults living with rare diseases in Québec, Canada, to identify morally problematic situations encountered in the healthcare system and everyday life as part of a participatory action research project. Morally problematic situations elicited internal tensions and constraints to agency.

Results: Adults living with rare diseases experienced morally problematic situations of stigmatization, disbelief, and sometimes abuse in the healthcare system. These situations were compounded by diagnostic delays, inadequate care, and suboptimal follow-up, and led some individuals to opt-out of medical care. In their personal lives, these individuals sometimes found themselves in situations of physical and financial dependency. They often also had to give up professional occupations, academic training, or life projects.

Conclusions: Adults living with rare diseases experience important morally problematic situations navigating the healthcare system and their everyday lives, some of which could be alleviated through interventions developed through future participatory action research.

Background: There are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering.

Methods: Semi-structured qualitative interviews were conducted during 2021-2022, as part of a larger study. This analysis includes a broad question about how participants view ethics as related to their work, with follow up probes about the topics they consider most important. Interviews were transcribed, inductively coded by two researchers to consensus, and analyzed thematically.

Results: Twenty-four scientists participated in the study. Interviewees hold positions as professors, principal investigators, and senior staff researchers in universities or research institutes in the United States and Europe. Among those scientists who reported reflecting on ethical considerations in their work, many equated ethics with research ethics topics (e.g., safety, replicability), or with regulation and guidelines. Participants expressed the view that ethical issues are primarily relevant for clinical trials of bioengineered products, or for those working with animal or human subjects. Scientists described their research as "too early" or "not examining anything living" with regard to ethical reflection. Finally, many felt that ethics is seen as territory for experts and therefore beyond scientists' competencies.

Conclusions: Molecular systems engineering scientists currently focus on regulatory aspects as the framework for their ethical analyses. They describe using a framework to define when life arises, as a means to determine when further ethical engagement is warranted. Further research is needed to investigate how scientists relate to the ethics of their scientific work, and build consensus around concepts of life, autonomous behavior, and physiological relevance of bioengineered systems.

Background: Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For patients on LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians use them and if OTAs themselves modify clinician prescribing practices.

Objective: To determine how clinicians use OTAs and the potential impacts of OTAs on opioid prescribing.

Design: We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT, and two who did not.

Participants: 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive, convenience sampling.

Approach: Discussions were recorded, transcribed, and analyzed for themes using reflexive thematic analysis by a multidisciplinary team.

Key results: Our analysis identified three main themes: (1) OTAs did not influence clinicians' decisions whether to use LTOT generally but did shape clinical decision-making for individual patients; (2) clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful; (3) there is a potential misalignment between the intended purposes of OTAs and their implementation.

Conclusion: This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact the clinicians' decisions about whether to use LTOT generally, they do sometimes influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs' purposes, which shows the need for more clarity about how OTAs could be used to promote shared decision-making, joint accountability, informed consent, and patient education.

Importance: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.

Objective: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type.

Design and setting and participants: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).

Main outcome measures: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.

Results: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.

Conclusions and relevance: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Artificial intelligence (AI) has garnered tremendous attention in health care, and many hope that AI can enhance our health system's ability to care for people with chronic and degenerative conditions, including Parkinson's Disease (PD). This paper reports the themes and lessons derived from a qualitative study with people living with PD, family caregivers, and health care providers regarding the ethical dimensions of using AI to monitor, assess, and predict PD symptoms and progression. Thematic analysis identified ethical concerns at four intersecting levels: personal, interpersonal, professional/institutional, and societal levels. Reflecting on potential benefits of predictive algorithms that can continuously collect and process longitudinal data, participants expressed a desire for more timely, ongoing, and accurate information that could enhance management of day-to-day fluctuations and facilitate clinical and personal care as their disease progresses. Nonetheless, they voiced concerns about intersecting ethical questions around evolving illness identities, familial and professional care relationships, privacy, and data ownership/governance. The multi-layer analysis provides a helpful way to understand the ethics of using AI in monitoring and managing PD and other chronic/degenerative conditions.