With the introduction of artificial intelligence (AI) to healthcare, there is also a need for professional guidance to support its use. New (2022) reports from National Health Service AI Lab & Health Education England focus on healthcare workers’ understanding and confidence in AI clinical decision support systems (AI-CDDSs), and are concerned with developing trust in, and the trustworthiness of these systems. While they offer guidance to aid developers and purchasers of such systems, they offer little specific guidance for the clinical (...) users who will be required to use them in patient care.This paper argues that clinical, professional and reputational safety will be risked if this deficit of professional guidance for clinical users of AI-CDDSs is not redressed. We argue it is not enough to develop training for clinical users without first establishing professional guidance regarding the rights and expectations of clinical users.We conclude with a call to action for clinical regulators: to unite to draft guidance for users of AI-CDDS that helps manage clinical, professional and reputational risks. We further suggest that this exercise offers an opportunity to address fundamental issues in the use of AI-CDDSs; regarding, for example, the fair burden of responsibility for outcomes. (shrink)

BackgroundIn the early stages of the COVID-19 pandemic, many health systems, including those in the UK, developed triage guidelines to manage severe shortages of ventilators. At present, there is an insufficient understanding of how the public views these guidelines, and little evidence on which features of a patient the public believe should and should not be considered in ventilator triage.MethodsTwo surveys were conducted with representative UK samples. In the first survey, 525 participants were asked in an open-ended format to provide (...) features they thought should and should not be considered in allocating ventilators for COVID-19 patients when not enough ventilators are available. In the second survey, 505 participants were presented with 30 features identified from the first study, and were asked if these features should count in favour of a patient with the feature getting a ventilator, count against the patient, or neither. Statistical tests were conducted to determine if a feature was generally considered by participants as morally relevant and whether its mean was non-neutral.ResultsIn Survey 1, the features of a patient most frequently cited as being morally relevant to determining who would receive access to ventilators were age, general health, prospect of recovery, having dependents, and the severity of COVID symptoms. The features most frequently cited as being morally irrelevant to determining who would receive access to ventilators are race, gender, economic status, religion, social status, age, sexual orientation, and career. In Survey 2, the top three features that participants thought should count in favour of receiving a ventilator were pregnancy, having a chance of dying soon, and having waited for a long time. The top three features that participants thought should count against a patient receiving a ventilator were having committed violent crimes in the past, having unnecessarily engaged in activities with a high risk of COVID-19 infection, and a low chance of survival.ConclusionsThe public generally agreed with existing UK guidelines that allocate ventilators according to medical benefits and that aim to avoid discrimination based on demographic features such as race and gender. However, many participants expressed potentially non-utilitarian concerns, such as inclining to deprioritise ventilator allocation to those who had a criminal history or who contracted the virus by needlessly engaging in high-risk activities. (shrink)

Tragic choices arise during the COVID-19 pandemic when the limited resources made available in acute medical settings cannot be accessed by all patients who need them. In these circumstances, healthcare rationing is unavoidable. It is important in any healthcare rationing process that the interests of the community are recognised, and that decision-making upholds these interests through a fair and consistent process of decision-making. Responding to recent calls to safeguard individuals’ legal rights in decision-making in intensive care, and for new authoritative (...) national guidance for decision-making, this paper seeks to clarify what consistency and fairness demand in healthcare rationing during the COVID-19 pandemic, from both a legal and ethical standpoint. The paper begins with a brief review of UK law concerning healthcare resource allocation, considering how community interests and individual rights have been marshalled in judicial deliberation about the use of limited health resources within the National Health Service. It is then argued that an important distinction needs to be drawn between procedural and outcome consistency, and that a procedurally consistent decision-making process ought to be favoured. Congruent with the position that UK courts have adopted for resource allocation decision-making in the NHS more generally, specific requirements for a procedural framework and substantive triage criteria to be applied within that framework during the COVID-19 pandemic are considered in detail. (shrink)

The late Robert Veatch, one of the United States’ founders of bioethics, never tired of reminding us that the paradigm-shifting contribution that bioethics made to patient care was to liberate patients out of the hands of doctors, who were traditionally seen to know best, even when they decidedly did not know best. It seems to us that with the advent of COVID-19, health policy has come full-circle on this. COVID-19 gave rise to a large number of purportedly “ethical” guidance documents (...) aiming to assist health care providers and practitioners with responding to the ethical challenges that might arise in their response to the pandemic. Ethics has two primary functions: provide clear action guidance, and provide clear action justification. The documents in question arguably reflect the ultimate policy triumph of bioethical “principlism”, and, perhaps surprisingly, as a corollary, the ultimate triumph of “doctor-knows-best”. (shrink)

BackgroundDuring the arrival of the COVID-19 pandemic, various professional ethical guidance was issued to (and for) health and social care professionals in England and Wales. Guidance can help to inform and support such professionals and their patients, clients and service users, but a plethora of guidance risked information overload, confusion, and inconsistency. MethodsDuring the early months of the pandemic, we undertook a rapid review, asking: what are the principles adopted by professional ethical guidance in England and Wales for dealing with (...) COVID-19? We undertook thematic content analysis of the 29 documents that met our inclusion criteria.ResultsThe 29 documents captured 13 overlapping principles: respect, fairness, minimising harm, reciprocity, proportionality, flexibility, working together, inclusiveness, communication, transparency, reasonableness, responsibility, and accountability.ConclusionsWe intend this attempt to collate and outline the prominent principles to be helpful, particularly, for healthcare practice during the COVID-19 pandemic and, hopefully, for future pandemic planning. We also offer some reflections on the guidance and the principles therein. After describing the principles, we reflect on some of the similarities and differences in the guidance, and the challenges associated not only with the specific guidance reviewed, but also with the nature and import of “professional ethical guidance”. (shrink)

BackgroundAs the COVID-19 pandemic develops, healthcare professionals are looking for support with, and guidance to inform, the difficult decisions they face. In the absence of an authoritative national steer in England, professional bodies and local organisations have been developing and disseminating their own ethical guidance. Questions inevitably arise, some of which are particularly pressing during the pandemic, as events are unfolding quickly and the field is becoming crowded. My central question here is: which professional ethical guidance should the professional follow?Main (...) bodyAdopting a working definition of “professional ethical guidance”, I offer three domains for a healthcare professional to consider, and some associated questions to ask, when determining whether – in relation to any guidance document – they should “bin it or pin it”. First, the professional should consider the source of the guidance: is the issuing body authoritative or, if not, at least sufficiently influential that its guidance should be followed? Second, the professional should consider the applicability of the guidance, ascertaining whether the guidance is available and, if so, whether it is pertinent. Pertinence has various dimensions, including whether the guidance applies to this professional, this patient and/or this setting, whether it is up-to-date, and whether the guidance addresses the situation the professional is facing. Third, the professional should consider the methodology and methods by which the guidance was produced. Although the substantive quality of the guidance is important, so too are the methods by which it was produced. Here, the professional should ask whether the guidance is sufficiently inclusive – in terms of who has prepared it and who contributed to its development – and whether it was rigorously developed, and thus utilised appropriate processes, principles and evidence.ConclusionAsking and answering such questions may be challenging, particularly during a pandemic. Furthermore, guidance will not do all the work: professionals will still need to exercise their judgment in deciding what is best in the individual case, whether or not this concerns COVID-19. But such judgments can and should be informed by guidance, and hopefully these preliminary observations will provide some useful pointers for time-pressed professionals. (shrink)

Background Non-adherence to medication is associated with increased risk of relapse in patients with bipolar disorder. Objectives To validate patient-evaluated adherence to medication measured via smartphones against validated adherence questionnaire; and investigate characteristics for adherence to medication measured via smartphones. Methods Patients with BD evaluated adherence to medication daily for 6–9 months via smartphones. The Medication Adherence Rating Scale and the Rogers’ Empowerment questionnaires were filled out. The 17-item Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Functional (...) Assessment Short Test were clinically rated. Data were collected multiple times per patient. The present study represents exploratory pooled reanalyses of data collected as part of two randomised controlled trials. Findings During the study 90.50% of the days were evaluated as ‘medication taken’, 6.91% as ‘medication taken with changes’ and 2.59% as ‘medication not taken’. Adherence to medication measured via smartphones was valid compared with the MARS. Younger age and longer illness duration were significant predictors for non-adherence to medication. Decreased affective symptoms measured with smartphone-based patient-reported mood and clinical ratings as well as decreased empowerment were associated with non-adherence. Conclusions Smartphone-based monitoring of adherence to medication was valid compared with validated adherence questionnaire. Younger age and longer illness duration were predictors for non-adherence. Increased empowerment was associated with adherence. Clinical implications Using smartphones for empowerment of adherence using patient-reported measures may be helpful in everyday clinical settings. Trial registration number NCT01446406 and NCT02221336. (shrink)

Healthcare practitioners have access to a range of ethical guidance. However, the normative role of this guidance in ethical decision-making is underexplored. This paper considers two ways that healthcare practitioners could approach ethics guidance. We first outline the idea of deference to ethics guidance, showing how an attitude of deference raises three key problems: moral value; moral understanding; and moral error. Drawing on philosophical literature, we then advocate an alternative framing of ethics guidance as a form of moral testimony by (...) colleagues and suggest that a more promising attitude to ethics guidance is to approach it in the spirit of ‘critical engagement’ rather than deference. (shrink)

We report here an emerging dispute in Italy concerning triage criteria for critically ill covid-19 patients, and how best to support doctors having to make difficult decisions in a context of insufficient life saving resources. The dispute we present is particularly significant as it juxtaposes two opposite views of who should make triage decisions, and how doctors should best be supported. There are both empirical and normative questions at stake here. The empirical questions pertain to the available level of evidence (...) that healthcare professionals would rather not be left alone with their ‘clinical judgments’ to make triage decisions, and to the accounts of distributive justice that doctors and healthcare professionals rely on, when making triage decisions. The normative questions pertain to how this empirical evidence should inform guidelines on how prioritisation decisions are made in a context of emergency, and who gets to have the authority to do so. This debate goes beyond the discussion of the care of critically ill patients with COVID-19 and has broader implications beyond the national context for the discussion of how to relieve moral distress in contexts of imbalances between healthcare resources and clinical needs of a population. (shrink)

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each (...) guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources. (shrink)

The COVID-19 pandemic has coincided with the proliferation of ethical guidance documents to assist public health authorities, health care providers, practitioners and staff with responding to ethical challenges posed by the pandemic. Like ethical guidelines relating to infectious disease that have preceded them, what unites many COVID-19 guidance documents is their dependency on an under-developed approach to bioethical principlism, a normative framework that attempts to guide actions based on a list of prima facie, unranked ethical principles. By situating them in (...) relation to the key philosophical debates concerning bioethical principlism, we aim to explore the limits and limitations of pandemic ethical guidance documents as, specifically, ethics documents – documents that fulfil the functions of ethics as a fundamentally normative discipline. This means not only determining whether such ethical guidance documents can, in principle, provide adequate action guidance and action justification, but also, more importantly where pandemics are concerned, determining whether they support consistent decision making and transparent processes of justification. Having highlighted the problems with merely furnishing ethical guidelines with substantive ethical content in terms of principles and values, we argue that organizations that develop these documents should, instead, focus on the procedural dimensions of action guidance and action justification, which extend to questions regarding the make-up of the committees, panels and groups that develop such guidelines, the public transparency of justifications for specific pandemic-related advice or interventions and the development of explicit procedures for transparent and consistent decision making. (shrink)