The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Expert Views on Medical Involvement in the Swiss Assisted Dying Practice: "We Want to Have Our Cake and Eat It Too"?

BACKGROUND: Most jurisdictions that allow euthanasia and assisted suicide (AS) regulate it through the medical profession. However, the extent and nature of how medicine should be involved are debated. Swiss AS practice is unusual in that it is managed by lay AS organizations that rely on a law that permits AS when done for nonselfish reasons. Physicians are not mentioned in the law but are usually called upon to prescribe the lethal medications and perform capacity evaluations. METHODS: We analyzed in-depth interviews of 23 Swiss AS experts including ethicists, lawyers, medical practitioners, and senior officials of AS organizations for their views on AS. RESULTS: Although there was agreement on some issues (e.g., need for better end-of-life care), the interviewees' preferred model for AS, and the nature of preferred medical involvement, varied, which we categorized into five types: preference for AS practice as it occurred prior to lay AS organizations; preference for the current lay model; preference for a modified lay model to increase autonomy protections while limiting medical AS normalization; preference for various types of more medicalized models of AS; and, ambivalence about any specific model of medical involvement. The rationales given for each type of model reflected varying opinions on how medicine's role would likely impact AS practice and demonstrated the experts' attitudes toward those impacts. CONCLUSION: The dynamics within the Swiss AS regime, as reflected in the varying views of Swiss AS experts, shed light on the dilemmas inherent to medical scope and involvement in AS, which may have implications for debates in other jurisdictions.

Questioning our presumptions about the presumption of capacity.

All contemporary frameworks of mental capacity stipulate that we must begin from the presumption that an adult has capacity. This presumption is crucial, as it manifests respect for autonomy and guards against prejudice and paternalism on the part of the evaluator.Given its ubiquity, we might presume that we all understand the presumption's meaning and application in the same way. Evidence demonstrates that this is not the case and that this has led to harm in vulnerable persons. There is thus strong reason to question our presumptions about the presumption of capacity.We distinguish between two main ways of understanding and applying the presumption of capacity, and advocate for the one that we argue mitigates risk of harm. Our proposed interpretation offers many advantages in that it is consonant with actual practice of capacity evaluations, precludes confused and abusive avoidance of needed evaluations, and preserves the respect for autonomy motivating the presumption in the first place.

Risk-Sensitive Assessment of Decision-Making Capacity: A Comprehensive Defense.

Should the assessment of decision-making capacity (DMC) be risk sensitive, that is, should the threshold for DMC vary with risk? The debate over this question is now nearly five decades old. To many, the idea that DMC assessments should be risk sensitive is intuitive and commonsense. To others, the idea is paternalistic or incoherent, or both; they argue that the riskiness of a given decision should increase the epistemic scrutiny in the evaluation of DMC, not increase the threshold for DMC. We respond to the critics' main concerns by providing a comprehensive account of how risk-sensitive DMC is coherent, avoids paternalism, and best fulfills the epistemic goal of DMC evaluations.

Mental capacity-why look for a paradigm shift?

Challenges to the legitimacy of mental capacity over the past 10 years have been spearheaded by the Committee on the Rights of Persons with Disabilities, the treaty body for the UN Convention on the Rights of Persons with Disabilities (CRPD). This challenge has been asserted to have produced a 'paradigm shift'. In this article, we examine why that interpretation has had such limited traction in the legal policy arena, and whether it should have traction. We also analyse whether the Committee has subtly but importantly shifted its position. We then develop an argument that the true goal, compatible with the CRPD, is the satisfactory determination of whether a person has or lacks mental capacity to make or take a relevant decision. Our article contextualises multi-disciplinary, research-informed guidelines designed as a contribution to satisfactory determination. While our article is based upon the position in England and Wales, we suggest that our conclusions are of wider application.

Epistemic injustice and the psychiatrist.

BACKGROUND: Psychiatrists depend on their patients for clinical information and are obligated to regard them as trustworthy, except in special circumstances. Nevertheless, some critics of psychiatry have argued that psychiatrists frequently perpetrate epistemic injustice against patients. Epistemic injustice is a moral wrong that involves unfairly discriminating against a person with respect to their ability to know things because of personal characteristics like gender or psychiatric diagnosis. METHODS: We review the concept of epistemic injustice and several claims that psychiatric practice is epistemically unjust. RESULTS: While acknowledging the risk of epistemic injustice in psychiatry and other medical fields, we argue that most concerns that psychiatric practice is epistemically unjust are unfounded. CONCLUSIONS: The concept of epistemic injustice does not add significantly to existing standards of good clinical practice, and that it could produce changes in practice that would be deleterious. Psychiatrists should resist calls for changes to clinical practice based on this type of criticism.

Pain research and children and adolescents with severe intellectual disability: ethical challenges and imperatives.

Children with severe intellectual disabilities encounter inequities in pain-related care, yet little pain research involves this population. A considerable issue with pain research in this population is its ethical complexity. This Viewpoint delineates the ethical challenges of pain research involving children (aged 2-12 years) and adolescents (aged 13-21 years) with severe intellectual disabilities. There are two main issues. First, some of the standard methods for assessing pain and pain sensitivity are not suitable for individuals with severe intellectual disability, who are often non-verbal and unable to understand or follow instructions. Second, children and adolescents with severe intellectual disability cannot provide informed consent or assent to participate in pain research, and their dissent is not always recognised. The existing ethical guidelines for pain research by the International Association for the Study of Pain provide helpful, but general, guidance. This Viewpoint supplements these guidelines and uses a well established framework for assessing the ethics of clinical research to highlight points relevant to designing, doing, reviewing, and evaluating research involving children and adolescents with severe intellectual disability, focusing on issues that are unaddressed in existing guidance.

Irremediability in psychiatric euthanasia: examining the objective standard.

BACKGROUND: Irremediability is a key requirement for euthanasia and assisted suicide for psychiatric disorders (psychiatric EAS). Countries like the Netherlands and Belgium ask clinicians to assess irremediability in light of the patient's diagnosis and prognosis and 'according to current medical understanding'. Clarifying the relevance of a default objective standard for irremediability when applied to psychiatric EAS is crucial for solid policymaking. Yet so far, a thorough examination of this standard is lacking. METHODS: Using treatment-resistant depression (TRD) as a test case, through a scoping review in PubMed, we analyzed the state-of-the-art evidence for whether clinicians can accurately predict individual long-term outcome and single out irremediable cases, by examining the following questions: (1) What is the definition of TRD; (2) What are group-level long-term outcomes of TRD; and (3) Can clinicians make accurate individual outcome predictions in TRD? RESULTS: A uniform definition of TRD is lacking, with over 150 existing definitions, mostly focused on psychopharmacological research. Available yet limited studies about long-term outcomes indicate that a majority of patients with long-term TRD show significant improvement over time. Finally, evidence about individual predictions in TRD using precision medicine is growing, but methodological shortcomings and varying predictive accuracies pose important challenges for its implementation in clinical practice. CONCLUSION: Our findings support the claim that, as per available evidence, clinicians cannot accurately predict long-term chances of recovery in a particular patient with TRD. This means that the objective standard for irremediability cannot be met, with implications for policy and practice of psychiatric EAS.

Spin-state crossover in photo-catalyzed nitrile dihydroboration via Mn-thiolate cooperation.

The role of S-donors in ligand-assisted catalysis using first-row metals has not been broadly investigated. Herein is described a combined experimental and computational mechanistic study of the dihydroboration of nitriles with pinacolborane (HBpin) catalyzed by the Mn(i) complex, Mn(κ3-SMeNS)(CO)3, that features thioether, imine, and thiolate donors. Mechanistic studies revealed that catalysis requires the presence of UV light to enter and remain in the catalytic cycle and evidence is presented for loss of two CO ligands. Stoichiometric reactions showed that HBpin reduces the imine N[double bond, length as m-dash]C of the ligand backbone in the absence of nitrile, forming an inactive off-cycle by-product. DFT calculations showed that the bifunctional thiolate donor, coordinative flexibility of the SMeNS ligand, and access to an open-shell intermediate are all crucuial to accessing low-energy intermediates during catalysis.

Difficult Capacity Cases-The Experience of Liaison Psychiatrists. An Interview Study Across Three Jurisdictions.

Background: Assessment of capacity for treatment and discharge decisions is common in the general hospital. Liaison psychiatrists are often asked to support the treating medical or surgical team in difficult capacity assessments. However, empirical research on identification and resolution of difficult capacity cases is limited. Some studies have identified certain patient, decisional, and interpersonal factors which cause difficulty, but no study has explored how these issues are resolved in practice. Our study therefore aimed to describe how experienced liaison psychiatrists identify and resolve difficult capacity cases in a general hospital setting. Methods: We carried out semi-structured interviews with 26 liaison psychiatrists from England, Scotland, and New Zealand, on their most difficult capacity cases. Thematic analysis was used to examine types of difficulty and how these were resolved in practice. Summaries were prepared and example quotes extracted to illustrate phenomena described. Results: We identified four types of difficulty in capacity assessment, spanning both clinical and ethical domains: 1) Difficulty determining whether the decision is the patient's own or driven by illness, 2) Difficulty in applying ethical principles, 3) Difficulty in avoiding personal bias, and 4) Procedural difficulties. The liaison psychiatrists presented as self-reflective and aware of challenges and pitfalls in hard cases. We summarized their creative strategies to resolve difficulty in assessment. Conclusion: Practitioners approaching difficult capacity cases require both clinical skills, e.g., to uncover subtle illness impairing decision-making and to consider interpersonal dynamics, and ethical skills, e.g., to negotiate the role of values and risks in capacity assessment. Education and training programmes should incorporate both aspects and could include the resolution strategies identified in our study. Practitioners, supported by health and social care systems, should work to develop self-aware and reflective capacity assessment practice.

Should Assessments of Decision-Making Capacity Be Risk-Sensitive? A Systematic Review.

Background: The concept of decision-making capacity (DMC) or competence remains controversial, despite widespread use. Risk-sensitive DMC assessment (RS-DMC)-the idea that the higher the risk involved in a decision, the greater the decisional abilities required for DMC-has been particularly controversial. We conducted a systematic, descriptive review of the arguments for and against RS-DMC to clarify the debate. Methods: We searched PubMed/MEDLINE (National Library of Medicine), PsycInfo (American Psychological Association) and Philpapers, updating our search to February 15th, 2022. We targeted peer-reviewed publications in English that argue for or against RS-DMC. Two reviewers independently screened the publications and extracted data from each eligible manuscript. Results: Of 41 eligible publications, 22 supported a risk-sensitive threshold in DMC assessment. Most arguments for RS-DMC rely on its intuitive appeal and practical merits. The arguments against RS-DMC primarily express concerns about paternalism and the seeming asymmetry between consent and refusal; critics of RS-DMC support epistemic, rather than substantive (i.e., variable threshold), risk-sensitivity; counterarguments responding to criticisms of RS-DMC address charges of paternalism and exhibit a notable variety of responses to the issue of asymmetry. Authors used a variety of frameworks regarding the definition of DMC, its elements, and its relation to decisional authority, and these frameworks were significantly associated with positions on RS-DMC. A limitation of our review is that the coding relies on judgment and interpretation. Conclusion: The review suggests that some of the debate about RS-DMC stems from differences in underlying frameworks. Most defenses of RS-DMC rely on its intuitive appeal, while most criticisms reflect concerns about paternalism or the asymmetry between consent and refusal. Defenses of RS-DMC respond to the asymmetry problem in a variety of ways. Further research is needed on the implications of underlying frameworks, the asymmetry problem, and the distinction between epistemic and substantive models of RS-DMC.

Psychiatric euthanasia, suicide and the role of gender.

The preponderance of women among persons who request and receive euthanasia and assisted suicide based on a psychiatric condition, as shown by data from The Netherlands and Belgium, is virtually unexplored. We provide a critical discussion of this gender gap, and propose that it can inform a key debate point in the controversy over the practice, namely its conflict with suicide prevention.

Resource Limitation and "Forced Irremediability" in Physician-Assisted Deaths for Nonterminal Mental and Physical Conditions: A Survey of the US Public.

BACKGROUND: Physician-assisted death (PAD) for people with nonterminal illnesses (PAD-NT) is a controversial practice legal in some countries and increasingly debated in others, including the United States. A major concern about legalization of PAD-NT is that a lack of resources may drive some with mental illnesses or physical disabilities to seek PAD. OBJECTIVE: To assess US public opinion on PAD-NT under conditions of resource limitation. METHODS: The authors surveyed 2139 US adults matched to the US population in sex, age, race/ethnicity, education, political affiliation, and income. After giving their opinions regarding terminal PAD and PAD-NT in response to traditional PAD survey questions, respondents were randomly presented one of 4 scenarios of persons with nonterminal conditions requesting PAD-NT who lacked adequate resources to maintain their quality of life. The type of resources lacking (social or health care) and medical condition (mental or physical disability) were varied. Respondents' views regarding PAD-NT for the scenario specifically and legalization generally were then reassessed. RESULTS: At baseline, 55.4% of respondents supported legalizing terminal PAD, and 36.9% supported legalizing PAD-NT. After analyzing the scenarios, 28.2% (range 18.6%-39.7%) agreed/strongly agreed with legalizing PAD-NT generally and 23.7% (15.2%-33.7%) agreed/strongly agreed with PAD-NT for the instance depicted, with mental illness scenarios receiving much lower support; respondents' comments suggest devaluation of life with physical disability versus with mental illness. Being politically liberal, not religious, and assigned physical disability scenarios were associated with greater support for PAD-NT in multivariable analyses. CONCLUSIONS: A minority of the US public supports PAD-NT in the context of inadequate resources, with much lower support for PAD-NT for mental illness than for physical disability, suggesting that PAD-NT policy debates and future research should address the issue of whether sufficient resources must be available to potential requestors of PAD-NT.