"It's all about delivery": researchers and health professionals' views on the moral challenges of accessing neurobiological information in the context of psychosis.

BACKGROUND: The convergence of neuroscience, genomics, and data science holds promise to unveil the neurobiology of psychosis and to produce new ways of preventing, diagnosing, and treating psychotic illness. Yet, moral challenges arise in neurobiological research and in the clinical translation of research findings. This article investigates the views of relevant actors in mental health on the moral challenges of accessing neurobiological information in the context of psychosis. METHODS: Semi-structured individual interviews with two groups: researchers employed in the National Health Service (NHS) or a university in England (n = 14), and mental health professionals employed in NHS mental health services (n = 14). This article compares results in the two groups (total n = 28). RESULTS: This article presents findings around three conceptual areas: (1) research ethics as mostly unproblematic, (2) psychosis, neurobiological information, and mental health care, and (3) identity, relationships, and the future. These areas are drawn from the themes and topics that emerged in the interviews across the two groups of participants. Researchers and health professionals provided similar accounts of the moral challenges of accessing-which includes acquisition, communication, and use of-neurobiological information in the context of psychosis. Acquiring neurobiological information was perceived as mostly unproblematic, provided ethical safeguards are put in place. Conversely, participants argued that substantive moral challenges arise from how neurobiological information is delivered-that is, communicated and used-in research and in clinical care. Neurobiological information was seen as a powerful tool in the process through which individuals define their identity and establish personal and clinical goals. The pervasiveness of this narrative tool may influence researchers and health professionals' perception of ethical principles and moral obligations. CONCLUSIONS: This study suggests that the moral challenges that arise from accessing neurobiological information in the context of psychosis go beyond traditional research and clinical ethics concerns. Reflecting on how accessing neurobiological information can influence individual self-narratives will be vital to ensure the ethical translation of neuroscience and genomics into mental health. TRIAL REGISTRATION: The study did not involve a health care intervention on human participants. It was retrospectively registered on 11 July 2018, registration number: researchregistry4255.

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.

Commentary: On action guidance and good practice in early intervention for psychosis: a response to Bortolotti & Jefferson (2018).

In this response to Bortolotti and Jefferson (2018), we discuss the action-guidance problem of moral attributes and the risk of superiority illusion in early intervention for psychosis. First, we suggest that guidance documents are not devoid of behavioural recommendations and goals for service provision, though these are not linked to the ethical dimensions of good practice embedded in the documents. Second, we acknowledge the risk of superiority illusion; we suggest that this risk may be reduced if the ethical and clinical goals of early intervention are presented as interrelated and measurable.

What constitutes 'good practice' in early intervention for psychosis? Analysis of clinical guidelines.

BACKGROUND: Early Intervention in Psychosis (EIP) services have been implemented with the dual aims of preventing harmful outcomes associated with early-onset psychosis and improving prognosis. However, concerns have been raised regarding the ethical implications of involving young people in EIP services. One way to ensure high ethical standards and promote good practice in EIP delivery is through governance of clinical practice. This study aimed to investigate the normative dimensions of good practice in EIP through examination of clinical guideline documents published in England over the past 15 years. METHODS: A total of 14 clinical guidelines and relevant policy documents for EIP were retrieved and analysed using a mixed inductive and deductive thematic approach. Themes were derived from the data itself, whereas the development of broader categories was performed through a constant comparison with the scientific literature describing ethical issues in EIP. RESULTS: Ethical touchpoints of good practice in EIP included both procedural and substantive factors, which were seen to be interdependent and mutually constitutive. These ethical touchpoints were largely implicit in the documents analysed. Procedural requirements of EIP service delivery consisted of norms and rules pertaining to EIP service structure, adherence to codes of ethics, inclusivity, patient and family centredness and appropriate treatment provision. Substantive factors consisted of moral attributes that should be cultivated by healthcare professionals working in EIP: competency, empathy, sensitivity and trustworthiness. CONCLUSIONS: We argue that, to ensure good practice in EIP, procedural and substantive ethical expectations embedded in EIP guideline documents should be made explicit in EIP service and care delivery. We suggest that the procedural and substantive factors highlighted in this paper contribute useful dimensions for the eventual evaluation of good practice in EIP services across England.

Anticipating hopes, fears and expectations towards COVID-19 vaccines: A qualitative interview study in seven European countries.

Vaccine uptake is essential to managing the ongoing COVID-19 pandemic, and vaccine hesitancy is a persistent concern. At the same time, both decision-makers and the general population have high hopes for COVID-19 vaccination. Drawing from qualitative interview data collected in October 2020 as part of the pan-European SolPan study, this study explores early and anticipatory expectations, hopes and fears regarding COVID-19 vaccination across seven European countries. We find that stances towards COVID-19 vaccines were shaped by personal lived experiences, but participants also aligned personal and communal interests in their considerations. Trust, particularly in expert institutions, was an important prerequisite for vaccine acceptance, but participants also expressed doubts about the rapid vaccine development process. Our findings emphasise the need to move beyond the study of factors driving vaccine hesitancy, and instead to focus on how people personally perceive vaccination in their particular social and political context.

"We're Not Moving Forward": Carers' Demand for Novel Research and Effective Interventions for Psychotic Disorders.

The lack of access to effective interventions for psychotic disorders places a considerable burden on informal caregivers. At the same time, the convergence of clinical neurosciences and next-generation genomics has the potential to transform psychiatric care. This article presents findings from a qualitative study. I conducted focus groups with carers of a person suffering from psychosis. I investigated how carers conceptualise the ethical issues arising from novel neurobiological approaches to psychosis. On the one hand, carers pictured a narrative of hope. They strongly demanded novel research and effective interventions that might help their ill relative to recover and lead a flourishing life. On the other hand, carers were frustrated at their present situation and feared that technological innovation might produce more harm than benefits. I argue that carers' moral outlook can be best understood by referring to an ethics of care. This study suggests that investigating carers' perspectives on sensitive ethical issues is vital to ensure that the needs of those who suffer from psychosis are appropriately met.

The risks of risk. Regulating the use of machine learning for psychosis prediction.

Recent advances in Machine Learning (ML) have the potential to revolutionise psychosis prediction and psychiatric assessment. This article has two objectives. First, it clarifies which aspects of English Law are relevant in order to regulate the use of ML in clinical research on psychosis prediction. It is argued that its lawful implementation will depend upon the legal requirements regarding the balance between potential harms and benefits, particularly with reference to: (i) any additional risks introduced by the use of ML for data analysis and outcome prediction; and (ii) the inclusion of vulnerable research populations such as minors or incapacitated adults. Second, this article investigates how clinical prediction via ML might affect the practice of risk assessment under mental health legislation, with reference to English Law. It is argued that there is a potential for virtuous applications of clinical prediction in psychiatry. However, reaffirming the distinction between psychosis risk and risk of harm is paramount. Establishing psychosis risk and assessing a person's risk of harm are discrete practices, and so should remain when using artificial intelligence for psychiatric assessment. Evaluating whether clinical prediction via ML might benefit individuals with psychosis will depend on which risk we try to assess and on what we try to predict, whether this is psychosis transition, a psychotic relapse, self-harm and suicidality, or harm to others.

Care pathways models and clinical outcomes in Disorders of consciousness.

OBJECTIVE: Patients with Disorders of consciousness, are persons with extremely low functioning levels and represent a challenge for health care systems due to their high needs of facilitating environmental factors. Despite a common Italian health care pathway for these patients, no studies have analyzed information on how each region have implemented it in its welfare system correlating data with patients' clinical outcomes. MATERIALS AND METHODS: A multicenter observational pilot study was realized. Clinicians collected data on the care pathways of patients with Disorder of consciousness by asking 90 patients' caregivers to complete an ad hoc questionnaire through a structured phone interview. Questionnaire consisted of three sections: sociodemographic data, description of the care pathway done by the patient, and caregiver evaluation of health services and information received. RESULTS: Seventy-three patients were analyzed. Length of hospital stay was different across the health care models and it was associated with improvement in clinical diagnosis. In long-term care units, the diagnosis at admission and the number of caregivers available for each patient (median value = 3) showed an indirect relationship with worsening probability in clinical outcome. Caregivers reported that communication with professionals (42%) and the answer to the need of information were the most critical points in the acute phase, whereas presence of Non-Governmental Organizations (25%) and availability of psychologists for caregivers (21%) were often missing during long-term care. The 65% of caregivers reported they did not know the UN Convention on the Rights of Persons with Disabilities. CONCLUSION: This study highlights relevant differences in analyzed models, despite a recommended national pathway of care. Future public health considerations and actions are needed to guarantee equity and standardization of the care process in all European countries.