Public Views on Whether the Use of Pharmaceutical Neuroenhancements Should Be Allowed.

BACKGROUND AND OBJECTIVES: Some individuals are using drugs to try to enhance cognitive and social-affective functioning and asking physicians for off-label prescriptions for neuroenhancement (e.g., stimulants). Several medical societies released guidance on prescribing neuroenhancers, some of which refer to potential societal effects of neuroenhancement (e.g., distributive justice), besides risks and benefits to users. Which institutions (e.g., medical societies, government, universities) should make decisions on allowing neuroenhancement and whether they should consider potential societal effects are unclear. We examined whether and how much support for allowing pharmaceutical neuroenhancers was influenced by the institution and potential individual and societal effects of neuroenhancers. METHODS: We conducted a discrete-choice experiment using a constructed representative sample of the US adult public. Multinomial logit models were used to analyze the data. RESULTS: Participants (n = 927) demographically resembled the US population. Risks of serious side effects (OR 0.20, CI 0.18-0.22) and a lack of benefits for users (OR 0.31, CI 0.26-0.38) had the largest negative effect on participants' support for allowing neuroenhancers. A risk of mild side effects had a moderate negative effect on participants' support for allowing neuroenhancers (OR 0.67, CI 0.62-0.74) and the prospect of more meaningful, long-lasting benefits for users a moderate positive effect (OR 1.74, CI 1.61-1.87). Positive or negative effects of neuroenhancers on the average well-being of people in society and on equality had moderate effects on participants' support for allowing neuroenhancers. For example, the odds of participants' support for allowing enhancers with a negative effect on societal well-being were around half (OR 0.45, CI 0.40-0.50) and the odds of allowing enhancers that worsen inequality were approximately 40% lower compared with enhancers without such effects (OR 0.62, CI 0.55-0.71). The odds of participants allowing neuroenhancers were slightly (10%) lower if enhancers reduced users' authenticity (OR 0.90, CI 0.84-0.97). The institution regulating neuroenhancers and neuroenhancers providing users with an unfair advantage did not affect participants' decisions. DISCUSSION: When presented with both individual and societal considerations, the public seems to support medical societies and other institutions making policy decisions about neuroenhancers based on risks and benefits for users, as well as, but to a lesser extent, effects on equality and societal well-being.

When medical assistance in dying is not a last resort option: survey of the Canadian public.

OBJECTIVES: What are the Canadian public's understanding of and views toward medical assistance in dying (MAID) in persons refusing recommended treatment or lacking access to standard treatment or resources? DESIGN/SETTING: An online survey assessed knowledge of and support for Canadian MAID law, and views about four specific scenarios in a two (medical or psychiatric) by two (treatment refusal or lack of access) design. PARTICIPANTS: A quota sample (N=2140) matched to the 2021 Canadian census by age, gender, income, education and province. MAIN OUTCOMES: Participants' level of support for MAID in general and in the four specific scenarios. RESULTS: Only 12.1% correctly answered ≥4 of 5 knowledge questions about the MAID law; only 19.2% knew terminal illness is not required and 20.2% knew treatment refusal is compatible with eligibility. 73.3% of participants expressed support for the MAID law in general, matching a nationally representative poll that used the same question. 40.4% of respondents supported MAID for mental illnesses. Support for MAID in the scenarios depicting refusal or lack of access to treatment ranged from 23.2% (lack of access in medical condition) to 32.0% (treatment refusal in medical illness). Older age, more education, higher income, lower religious attendance or being white was associated with greater support for MAID in general but was either negatively associated or not associated with support for MAID in the four refusal or lack of access scenarios. CONCLUSIONS: Most Canadians support the current MAID law but appear unaware that MAID cases they do not support are compatible with that law. The lower support for MAID in the four scenarios cuts across sociodemographics. The gap between current policy and public opinion warrants further study. For jurisdictions debating MAID, opinion surveys may need to go beyond assessing general attitudes, and target knowledge and views regarding implications of legalisation.

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.

A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial.

BACKGROUND/AIMS: It has been proposed that informed consent for randomized trials should be split into two stages, with the purported advantage of decreased information overload and patient anxiety. We compared patient understanding, anxiety and decisional quality between two-stage and traditional one-stage consent. METHODS: We approached patients at an academic cancer center for a low-stakes trial of a mind-body intervention for procedural distress during prostate biopsy. Patients were randomized to hear about the trial by either one- or two-stage consent (n = 66 vs n = 59). Patient-reported outcomes included Quality of Informed Consent (0-100); general and consent-specific anxiety and decisional conflict, burden, and regret. RESULTS: Quality of Informed Consent scores were non-significantly superior for two-stage consent, by 0.9 points (95% confidence interval = -2.3, 4.2, p = 0.6) for objective and 1.1 points (95% CI = -4.8, 7.0, p = 0.7) for subjective understanding. Differences between groups for anxiety and decisional outcomes were similarly small. In a post hoc analysis, consent-related anxiety was lower among two-stage control patients, likely because scores were measured close to the time of biopsy in the two-stage patients receiving the experimental intervention. CONCLUSION: Two-stage consent maintains patient understanding of randomized trials, with some evidence of lowered patient anxiety. Further research is warranted on two-stage consent in higher-stakes settings.

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.

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.

Quality indicators in primary elective total hip and knee arthroplasty.

PURPOSE: Total hip arthroplasty (THA) and total knee arthroplasty (TKA) represent a significant portion of healthcare spending and are high-priority for quality improvement initiatives. This study aims to develop quality indicators (QIs) in the care of primary elective THA and TKA patients. These QIs serve a number of purposes including documentation of the quality of care, objective comparisons of institutions/providers, facilitating pay-for-performance initiatives, and supporting accountability, regulation, and accreditation. METHODS: A guideline-based approach, initially described by Kötter et al., was utilized. Eight clinical practice guidelines (CPGs) were evaluated for candidate indicators (CIs). CIs with high-quality evidence and consensus statements were extracted. Eighteen additional CIs were included from previous work that evaluated quality improvement databases. Each CI and supporting evidence was submitted for independent review by an expert panel. The RAND Corporation-University of California, Los Angeles (RAND/UCLA) appropriateness methodology was utilized and items were rated based on validity, reliability, and feasibility of measurement. After two rounds of ratings and ranking, a final ranked list of QIs was obtained. RESULTS: Fifty-six CIs were identified from the literature and CPGs or proposed by the expert panel. Two rounds of voting resulted in 12 total QIs that were deemed appropriate measures of high-quality care. The final 12 QIs were ranked by order of importance: use of peri-operative tranexamic acid, infusion of prophylactic antibiotics prior to inflation of tourniquet, appropriate post-operative venous thromboembolic prophylaxis, complication rate, rate of secondary procedure, readmission rate, early mobilization, average change of pre- to one year post-operative functional status, use of multimodal analgesia, use of neuraxial anesthesia, use of peri-articular injection in TKA, and use of pre-operative PO analgesia. CONCLUSION: This study is an expert opinion based on parameters observed in modern and high-quality academic settings. Twelve QIs are proposed to assess the quality of care in the peri-operative management of primary elective THA and TKA patients.

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.