Participating doctors' perspectives on the regulation of voluntary assisted dying in Victoria: a qualitative study.

OBJECTIVES: To investigate the perspectives of doctors involved with voluntary assisted dying in Victoria regarding the Voluntary Assisted Dying Act 2017 (Vic) and its operation. DESIGN, SETTING, PARTICIPANTS: Qualitative study; semi-structured interviews with 32 doctors who had participated in the voluntary assisted dying system during its first year of operation (commenced 19 June 2019). Doctors were interviewed during April-July 2020. RESULTS: Three major themes related to problems during the first year of operation of the Act were identified: the statutory prohibition of health professionals initiating discussions with their patients about voluntary assisted dying; the Department of Health and Human Services guidance requirement that all doctor-patient, doctor-pharmacist, and pharmacist-patient interactions be face-to-face; and aspects of implementation, including problems with the voluntary assisted dying online portal, obtaining documentary evidence to establish eligibility, and inadequate resourcing of the Statewide Pharmacy Service. CONCLUSIONS: Doctors reported only limited concerns about the Victorian voluntary assisted dying legislation, but have had some problems with its operation, including implications for the accessibility of voluntary assisted dying to eligible patients. While legislative change may resolve some of these concerns, most can be ameliorated by improving the processes and systems.

Rationing care by frailty during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic is disproportionately affecting older people and those with underlying comorbidities. Guidelines are needed to help clinicians make decisions regarding appropriate use of limited NHS critical care resources. In response to the pandemic, the National Institute for Health and Care Excellence published guidance that employs the Clinical Frailty Scale (CFS) in a decision-making flowchart to assist clinicians in assessing older individuals' suitability for critical care. This commentary raises some important limitations to this use of the CFS and cautions against the potential for unintended impacts. The COVID-19 pandemic has allowed the widespread implementation of the CFS with limited training or expert oversight. The CFS is primarily being used to assess older individuals' risk of adverse outcome in critical care, and to ration access to care on this basis. While some form of resource allocation strategy is necessary for emergencies, the implementation of this guideline in the absence of significant pressure on resources may reduce the likelihood of older people with frailty, who wish to be considered for critical care, being appropriately considered, and has the potential to reinforce the socio-economic gradient in health. Our incomplete understanding of this novel disease means that there is a need for research investigating the short-term predictive abilities of the CFS on critical care outcomes in COVID-19. Additionally, a review of the impact of stratifying older people by CFS score as a rationing strategy is necessary in order to assess its acceptability to older people as well as its potential for disparate impacts.

Misusing uteruses? Childrearing capacity and access to transplantable wombs.

In light of recent successful uterus transplantations, it is reasonable to expect that womb transplants will become more commonplace in the future. If this happens, important questions emerge about who should receive the donated wombs. Some arguments have been advanced that suggest that potential recipients should be screened for their anticipated childrearing capacity, as one component of a comprehensive process for determining eligibility. The main arguments provided in support of this position have to do with the presumed responsibility of the state to protect future children from harm, and with avoiding complicity for any resulting harm experienced by the child born through the transplanted uterus. The purpose of this paper is to reject this position, based on two main criticisms: (1) screening potential uterus recipients for anticipated childrearing ability, but not also screening other kinds of morally equal family builders, is unjustly discriminatory; and (2) with respect to actions performed in good faith (e.g. providing a transplantable uterus to someone for the purpose of having a child), one is not morally blameworthy for the consequences of those actions (a) that one did not intend, and (b) that were directly caused by someone else, and (c) where others are directly responsible for making sure that those consequences do not come about. These criticisms are sufficient for concluding that the state is not justified in assessing the anticipated childrearing capacity of potential uterus recipients, and this is so regardless of whether or not there is a scarcity of transplantable uteruses available.

'Inglan is a bitch': hostile NHS charging regulations contravene the ethical principles of the medical profession.

Following the recent condemnation of the National Health Service charging regulations by medical colleges and the UK Faculty of Public Health, we demonstrate that through enactment of this policy, the medical profession is betraying its core ethical principles. Through dissection of the policy using Beauchamp and Childress' framework, a disrespect for autonomy becomes evident in the operationalisation of the charging regulations, just as a disregard for confidentiality was apparent in the data sharing Memorandum of Understanding. Negative consequences of the regulations are documented to highlight their importance for clinical decision makers under the principles of beneficence and non-maleficence. Exploration of the principle of justice illuminates the core differentiation between the border-bound duties of the State and borderless duties of the clinician, exposing a fundamental tension.

ECG-based cardiac screening programs: Legal, ethical, and logistical considerations.

Screening asymptomatic people with a resting electrocardiogram (ECG) has been theorized to detect latent cardiovascular disease. However, resting ECG screening is not recommended for numerous populations, such as asymptomatic middle-aged (sedentary) people, as it is not sufficiently sensitive to detect coronary artery disease. While the issues raised in this article are largely common to all screening programs, this review focuses on 2 distinct programs: (1) screening elite athletes for conditions associated with sudden cardiac death (SCD); and (2) screening people aged ≥65 years for atrial fibrillation (AF). These 2 settings have recently gained attention for their promise and concerns regarding prevention of SCD and stroke, respectively. If screening is to be done, it must be done well. Organizations conducting screening must consider a range of legal, ethical, and logistical responsibilities that arise from the beginning to the end of the process. This includes consideration of who to screen, timing of screening, whether screening is mandatory, consent issues, and auditing systems to ensure quality control. Good infrastructure for interpretation of ECG results according to expert guidelines and follow-up testing for abnormal screening results, including a pathway to treatment, are essential. Finally, there may be significant implications for those diagnosed with cardiac disease, including insurance, employment, the ability to play sport, and mental health issues. There are several legal risks, and the best protective measures are good communication systems, thorough clinical record-keeping, careful handling of eligibility questions for those diagnosed, and reference to expert guidelines as the standard of care.

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians.

BACKGROUND: National guidelines require programmes use subjective assessments of social support when determining transplant suitability, despite limited evidence linking it to outcomes. We examined how transplant providers weigh the importance of social support for kidney transplantation compared with other factors, and variation by clinical role and personal beliefs. METHODS: The National survey of the American Society of Transplant Surgeons and the Society of Transplant Social Work in 2016. Using a discrete choice approach, respondents compared two hypothetical patient profiles and selected one for transplantation. Conditional logistic regression estimated the relative importance of each factor; results were stratified by clinical role (psychosocial vs medical/surgical providers) and beliefs (outcomes vs equity). RESULTS: Five hundred and eighy-four transplant providers completed the survey. Social support was the second most influential factor among transplant providers. Providers were most likely to choose a candidate who had social support (OR=1.68, 95% CI 1.50 to 1.86), always adhered to a medical regimen (OR=1.64, 95% CI 1.46 to 1.88), and had a 15 years life expectancy with transplant (OR=1.61, 95% CI 1.42 to 1.85). Psychosocial providers were more influenced by adherence and quality of life compared with medical/surgical providers, who were more influenced by candidates' life expectancy with transplant (p<0.05). For providers concerned with avoiding organ waste, social support was the most influential factor, while it was the least influential for clinicians concerned with fairness (p<0.05). CONCLUSIONS: Social support is highly influential in listing decisions and may exacerbate transplant disparities. Providers' beliefs and reliance on social support in determining suitability vary considerably, raising concerns about transparency and justice.

Assessing Rehabilitation Eligibility of Older Patients: An Ethical Analysis of the Impact of Bias.

Hospitalized older patients are more vulnerable to physical or cognitive functional decline. Inpatient rehabilitation programs improve significantly their functional status and may prevent their admission to nursing homes. While inpatient rehabilitation institutions have established admission criteria that can be seen as objective, the risk of bias remains and raises the question of equitable access for more vulnerable populations such as older patients. This paper reviews some established eligibility criteria for inpatient rehabilitation by examining a framework used in Montreal, Québec, Canada for assessing rehabilitation eligibility and by applying this framework to a case study. It also highlights the unique ethical challenges presented by the assessment of older patients. We conclude that in order to appropriately protect the vulnerable population of older patients in the context of priority setting and allocation of scarce resources, there is a need to establish more specific criteria that can better guide the assessment of this particular population.

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach.

BACKGROUND: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach renders research with pregnant women fair. This paper analyzes and evaluates when research with pregnant women can be considered as fair and what constitutes scientific reasons for exclusion. METHODS: Conceptual ethical and methodological analysis and evaluation of fair inclusion. RESULTS: Fair inclusion of pregnant women means (1) that pregnant women who are eligible are not excluded solely for being pregnant and (2) that the research interests of pregnant women are prioritized, meaning that they ought to receive substantially more attention. Fairness does not imply that pregnant women should be included in virtually every research project, as including only a few pregnant women in a population consisting only of women will not help to determine the effectiveness and safety of a treatment in pregnant women. Separate trials in pregnant women may be preferable once we assume, or know, that effects of interventions in pregnant women differ from the effects in other subpopulations, or when we assume, or know, that there are no differences. In the latter case, it may be preferable to conduct post-marketing studies or establish registries. If there is no conclusive evidence indicating either differences or equivalence of effects between pregnant and non-pregnant women, yet it seems unlikely that major differences or exact equivalence exist, the inclusion of pregnant women should be sufficient. Depending on the research question, this boils down to representativeness in terms of the proportion of pregnant and non-pregnant women, or to oversampling pregnant women. CONCLUSIONS: Fair inclusion of pregnant women in research implies that separate trials in pregnant women should be promoted. Inclusion of pregnant women has to be realized at the earliest phases of the research process. In addition to researchers and research ethics committees, scientific advisory councils, funders, drug regulatory agencies, pharmaceutical companies, journal editors and others have a joint responsibility to further develop the evidence base for drug use in pregnant women.

Transplant eligibility for patients with affective and psychotic disorders: a review of practices and a call for justice.

BACKGROUND: The scarcity of human organs requires the transplant community to make difficult allocation decisions. This process begins at individual medical centers, where transplant teams decide which patients to place on the transplant waiting list. Each transplant center utilizes its own listing criteria to determine if a patient is eligible for transplantation. These criteria have historically considered preexisting affective and psychotic disorders to be relative or absolute contraindications to transplantation. While attitudes within the field appear to be moving away from this practice, there is no data to confirm that eligibility criteria have changed. MAIN BODY: There are no nationwide guidelines detailing the manner in which affective and psychotic disorders should impact transplant eligibility. Individual transplant centers thus form their own transplant eligibility criteria, resulting in significant inter-institution variability. Data from the 1990s indicates that the majority of transplant programs considered certain psychiatric illnesses, such as active schizophrenia, to be absolute contraindications to transplantation. A review of literature reveals that no comprehensive data has been collected on the topic since that time. Furthermore, the limited data available about current practices suggests that psychiatric illness continues to be viewed as a contraindication to transplantation at some transplant centers. In light of this finding, we review psychiatric literature that examines the impact of affective and psychotic disorders on transplant outcomes and conclude that the presence of these disorders is not an accurate predictor of transplant success. We then discuss the requirements of justice as they relate to the creation of a just organ allocation system. CONCLUSION: We conclude that transplant eligibility criteria that exclude patients with affective and psychotic disorders on the basis of their psychiatric diagnosis alone are unjust. Just listing criteria must incorporate only those factors that have a causative effect on posttransplant morbidity and mortality. Justice also demands that we eliminate current inter-institution practice variations in favor of national transplant eligibility criteria. Given the limited data available about current practices, we call for an updated study investigating the manner in which affect and psychotic disorders impact transplant eligibility determinations.

Ethics and Medical Toxicology Research.

Optimizing care in medical toxicology necessitates designing and conducting ethical research. Nevertheless, the context of medical toxicology can make clinical research ethically challenging for a variety of reasons: medical toxicology is typified by relative rare conditions; making precise and rapid diagnoses is often fraught with uncertainty; emergent and urgent clinical exigencies make consent difficult or impossible; and some exposures are stigmatized or related to illegal activities that can compromise collecting accurate data from patients. In this paper, we examine some of the ethical issues in medical toxicology research that are especially salient in effort to promote optimal research in the field. The particular issues to be addressed are as follows: (1) rare conditions and orphan agents, (2) randomization and control arms, (3) inclusion and exclusion criteria, (4) outcome measures, (5) consent, (6) confidentiality, (7) registries, (8) oversight, and (9) transparency and reporting. Thinking about these ethical issues prospectively will help researchers and clinicians appropriately navigate them.

[Ethical aspects of clinical trials in rare diseases]. / Ethische Aspekte der klinischen Prüfung bei seltenen Erkrankungen.

It is estimated that there are about four million people suffering from rare diseases in Germany. For roughly the last 20 years, there has been an increasing interest in therapeutic research for rare diseases. Drug research is highly regulated via numerous laws, regulations and ethical conventions that do not offer any waivers for clinical trials in rare diseases. Thus the ethical assessment of the clinical trial application for a rare disease is basically the same as for a common disease. As the ethical standards of clinical research, for example regarding informed consent, are derived from constitutional rights and have been codified in the German drug law, it is no surprise that they cannot depend on the frequency of a disease. A very important aspect of the ethical assessment is the biometric quality with regard to study design, sample size estimation and statistical analysis, as methodologically poor research with humans is per se unethical. Problems with sample size estimations and pilot studies will be addressed in more detail. Pilot studies should be avoided and sample size estimations should not assume overoptimistic effect sizes and should not increase the error probability beyond 5% two-sided.

'A band of brothers'-an exploration of the range of medical ethical issues faced by British senior military clinicians on deployment to Afghanistan: a qualitative study.

AIMS: To identify and explore features of ethical issues that senior clinicians faced as deployed medical directors (DMDs) to the British Field Hospital in Afghanistan as well as to determine the ethical training requirements for future deployments. METHOD: A qualitative study in two phases conducted from November 2014 to June 2015. Phase 1 analysed 60 vignettes of cases that had generated ethical dilemmas for DMDs. Phase 2 included focus groups and an interview with 13 DMDs. FINDINGS: Phase 1 identified working with limited resources, dual conflict of meeting both clinical and military obligations and consent of children as the most prevalent ethical challenges. Themes found in Phase 2 included sharing clinical responsibilities with clinicians from other countries and not knowing team members' ways of working, in addition to the themes from Phase 1. DISCUSSION: This study has drawn together examples of scenarios to form a repository that will aid future training. Recommendations included undertaking ethics training together as a team before, during and after deployment which must include all nationalities who are assigned to the same operational tour, so that different ethical views can be explored beforehand.

Yield and Efficiency of Mental Health Screening: A Comparison of Screening Protocols at Intake to Prison.

BACKGROUND: The value of screening for mental illness has increasingly been questioned in low prevalence settings due to high false positive rates. However, since false positive rates are related to prevalence, screening may be more effective in higher prevalence settings, including correctional institutions. We compared the yield (i.e. newly detected cases) and efficiency (i.e. false positives) of five screening protocols to detect mental illness in prisons against the use of mental health history taking (the prior approach to detecting mental illness). METHODS AND FINDINGS: We estimated the accuracy of the six approaches to detect an Axis I disorder among a sample of 467 newly admitted male inmates (83.1% participation rate). Mental health history taking identified only 41.0% (95% CI 32.1, 50.6) of all inmates with mental illness. Screening protocols identified between 61.9 and 85.7% of all cases, but referred between 2 and 3 additional individuals who did not have a mental illness for every additional case detected compared to the mental health history taking approach. In low prevalence settings (i.e. 10% or less) the screening protocols would have had between 4.6 and 16.2 false positives per true positive. CONCLUSIONS: While screening may not be practical in low prevalence settings, it may be beneficial in jails and prisons where the prevalence of mental illness is higher. Further consideration of the context in which screening is being implemented, and of the impacts of policies and clinical practices on the benefits and harms of screening is needed to determine the effectiveness of screening in these settings.

When psychiatric diagnosis becomes an overworked tool.

A psychiatric diagnosis today is asked to serve many functions-clinical, research, medicolegal, delimiting insurance coverage, service planning, defining eligibility for state benefits (eg, for unemployment or disability), as well as providing rallying points for pressure groups and charities. These contexts require different notions of diagnosis to tackle the particular problem such a designation is meant to solve. In a number of instances, a 'status' definition (ie, a diagnostic label or category) is employed to tackle what is more appropriately seen as requiring a 'functional' approach (ie, how well the person is able to meet the demands of a test of performance requiring certain capabilities, aptitudes or skills). In these instances, a diagnosis may play only a subsidiary role. Some examples are discussed: the criteria for involuntary treatment; the determination of criminal responsibility; and, assessing entitlements to state benefits. I suggest that the distinction between 'status' versus 'function' has not been given sufficient weight in discussions of diagnosis. It is in the functional domain that some of the problematic relationships between clinical psychiatry and the social institutions with which it rubs shoulders are played out. A status, signified by a diagnosis, has often been encumbered with demands for which it is poorly equipped. It is a reductive way of solving problems of management, allocation or disposal for which a functional approach should be given greater weight.

Fairness, health, and access.

During the past two years, much of my work at The Hastings Center has explored the implementation of health reform in the United States and its implications for poor and vulnerable groups. These projects include a study of access to care for undocumented patients and one that examines state-level decisions about health reform, including Medicaid expansion and the creation of health insurance "marketplaces." Both raise issues central to bioethics, including fairness, justice, and the stewardship of society's resources. Our nation spent about 2.7 trillion dollars on health care in 2012, and its major public health insurance programs represent over 20 percent of the federal budget. Despite these investments, there are troubling differences in life expectancy, infant mortality, and premature death depending on factors like income, race, ethnicity, gender, and where people live.

National survey of provider opinions on controversial characteristics of liver transplant candidates.

Candidate selection for liver transplantation presents challenging ethical issues that require balancing the principles of justice and utility. The goal of this study was to assess the opinions of U.S. transplant providers regarding the ways in which controversial medical and psychosocial characteristics influence patient eligibility for liver transplantation. An online, anonymous survey about adult patient characteristics was sent to providers (hepatologists, surgeons, psychiatrists, and social workers) at all 102 active adult liver transplant centers in the United States. A majority of the providers (251/444 or 56.5%) completed the survey. The providers were queried about 8 characteristics, and the 3 that were ranked most controversial were incarceration, marijuana use, and psychiatric diagnoses. Most providers identified a patient age ≥ 80 years (62.7%), a body mass index ≥ 45 kg/m2 (56.6%), and current incarceration with a lifetime sentence (54.7%) as absolute contraindications to liver transplantation. In a multivariate analysis, the identification of absolute contraindications varied significantly with the provider type, the center volume, and the geographical region. Less than half of the providers reported that their centers had written policies regarding most of the characteristics examined. In conclusion, providers differ significantly in their opinions on controversial patient characteristics and transplant contraindications. Along with a paucity of literature data on outcomes, these provider differences may play a role in the fact that many centers do not have formal policies for selecting patients with these characteristics. Evidence-based data on the outcomes of such patients are needed to guide the formation of written policies to better standardize eligibility criteria.