How should artificial intelligence be used in Australian health care? Recommendations from a citizens' jury.

OBJECTIVE: To support a diverse sample of Australians to make recommendations about the use of artificial intelligence (AI) technology in health care. STUDY DESIGN: Citizens' jury, deliberating the question: "Under which circumstances, if any, should artificial intelligence be used in Australian health systems to detect or diagnose disease?" SETTING, PARTICIPANTS: Thirty Australian adults recruited by Sortition Foundation using random invitation and stratified selection to reflect population proportions by gender, age, ancestry, highest level of education, and residential location (state/territory; urban, regional, rural). The jury process took 18 days (16 March - 2 April 2023): fifteen days online and three days face-to-face in Sydney, where the jurors, both in small groups and together, were informed about and discussed the question, and developed recommendations with reasons. Jurors received extensive information: a printed handbook, online documents, and recorded presentations by four expert speakers. Jurors asked questions and received answers from the experts during the online period of the process, and during the first day of the face-to-face meeting. MAIN OUTCOME MEASURES: Jury recommendations, with reasons. RESULTS: The jurors recommended an overarching, independently governed charter and framework for health care AI. The other nine recommendation categories concerned balancing benefits and harms; fairness and bias; patients' rights and choices; clinical governance and training; technical governance and standards; data governance and use; open source software; AI evaluation and assessment; and education and communication. CONCLUSIONS: The deliberative process supported a nationally representative sample of citizens to construct recommendations about how AI in health care should be developed, used, and governed. Recommendations derived using such methods could guide clinicians, policy makers, AI researchers and developers, and health service users to develop approaches that ensure trustworthy and responsible use of this technology.

Understanding Wheelchair Use in Older Adults From the National Health and Aging Trends Study.

OBJECTIVE: To identify the trends of wheelchair use and physical characteristics among older people who used wheelchairs relative to those who did not. DESIGN: Cohort and survey. SETTING: General community. PARTICIPANTS: 7026 participants (N=7026) were selected from the 2011 cohort of the National Health and Aging Trends Study (NHATS), which is made up of Medicare beneficiaries over the age of 65. Repeated observations among participants in the 2011 cohort were analyzed in the 4 following rounds: 2013 (N=4454), 2015 (N=3327), 2017 (N=2623), and 2019 (N=2091). Participants were divided into 2 groups: those who used and did not use wheelchairs. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: Physical characteristics, including pain, strength limitation, balance problems, mobility disability, as well as the frequency of going outside. RESULTS: The number of older adults who use wheelchairs had increased significantly from 4.7 per 100 people in 2011 to 7.1 in 2019 (P<.001). The logistic regression analysis indicated that participants who reported less frequently going out were at least 4.27 times more likely to be wheelchair users than non-wheelchair users (P<.01). Participants who reported health and physical problems were at least 2.48 times more likely to be wheelchair users than non-wheelchair users from 2011 to 2017 (P<.0001). Balance or coordination problems increased (24%-38%) significantly among non-wheelchair users from 2011 to 2019 (all P<.05). CONCLUSIONS: Current wheelchair users reported more physical difficulties and were much less likely to go outside. This lower outdoor mobility could be due to physical difficulties or potential barriers in physical and socio-cultural environments. In addition, older adults who do not use wheelchairs showed increasing physical problems over time (including balance or coordination problems). Clinicians should consider older wheelchair users' health and physical limitations when prescribing wheelchairs.

Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

Immersive participatory design of assistive robots to support older adults.

Assistive robots have the potential to support independence, enhance safety, and lower healthcare costs for older adults, as well as alleviate the demands of their care partners. However, ensuring that these robots will effectively and reliably address end-user needs in the long term requires user-specific design factors to be considered during the robot development process. To identify these design factors, we embedded Stretch, a mobile manipulator created by Hello Robot Inc., in the home of an older adult with motor impairments and his care partner for four weeks to support them with everyday activities. An occupational therapist and a robotics engineer lived with them during this period, employing an immersive participatory design approach to co-design and customise the robot with them. We highlight the benefits of this immersive participatory design experience and provide insights into robot design that can be applied broadly to other assistive technologies.

Practical, epistemic and normative implications of algorithmic bias in healthcare artificial intelligence: a qualitative study of multidisciplinary expert perspectives.

BACKGROUND: There is a growing concern about artificial intelligence (AI) applications in healthcare that can disadvantage already under-represented and marginalised groups (eg, based on gender or race). OBJECTIVES: Our objectives are to canvas the range of strategies stakeholders endorse in attempting to mitigate algorithmic bias, and to consider the ethical question of responsibility for algorithmic bias. METHODOLOGY: The study involves in-depth, semistructured interviews with healthcare workers, screening programme managers, consumer health representatives, regulators, data scientists and developers. RESULTS: Findings reveal considerable divergent views on three key issues. First, views on whether bias is a problem in healthcare AI varied, with most participants agreeing bias is a problem (which we call the bias-critical view), a small number believing the opposite (the bias-denial view), and some arguing that the benefits of AI outweigh any harms or wrongs arising from the bias problem (the bias-apologist view). Second, there was a disagreement on the strategies to mitigate bias, and who is responsible for such strategies. Finally, there were divergent views on whether to include or exclude sociocultural identifiers (eg, race, ethnicity or gender-diverse identities) in the development of AI as a way to mitigate bias. CONCLUSION/SIGNIFICANCE: Based on the views of participants, we set out responses that stakeholders might pursue, including greater interdisciplinary collaboration, tailored stakeholder engagement activities, empirical studies to understand algorithmic bias and strategies to modify dominant approaches in AI development such as the use of participatory methods, and increased diversity and inclusion in research teams and research participant recruitment and selection.

Scientists' Views on the Ethics, Promises and Practices of Synthetic Biology: A Qualitative Study of Australian Scientific Practice.

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, we conducted an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant's views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field.

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

OBJECTIVE: The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations. SUMMARY BACKGROUND DATA: Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and risks pose challenges for regulation. High-profile implantable device failures have fuelled concerns about the level of clinical evidence needed for market approval. Calls for more rigorous evaluation lack clarity about what kind of evaluation is appropriate, and are commonly interpreted as meaning more randomized controlled trials (RCTs). These are valuable where devices are genuinely new and claim to offer measurable therapeutic benefits. Where this is not the case, RCTs may be inappropriate and wasteful. METHODS: Starting with a set of ethical principles and basic precepts of clinical epidemiology, we developed a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable. RESULTS: The algorithm clearly defines a group of devices where an RCT is deemed necessary, and the associated framework indicates that an IDEAL 2b study should be the default clinical evaluation method where it is not. CONCLUSIONS: The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.

Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives.

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Maximizing the Benefits of Participatory Design for Human-Robot Interaction Research With Older Adults.

OBJECTIVE: We reviewed human-robot interaction (HRI) participatory design (PD) research with older adults. The goal was to identify methods used, determine their value for design of robots with older adults, and provide guidance for best practices. BACKGROUND: Assistive robots may promote aging-in-place and quality of life for older adults. However, the robots must be designed to meet older adults' specific needs and preferences. PD and other user-centered methods may be used to engage older adults in the robot development process to accommodate their needs and preferences and to assure usability of emergent assistive robots. METHOD: This targeted review of HRI PD studies with older adults draws on a detailed review of 26 articles. Our assessment focused on the HRI methods and their utility for use with older adults who have a range of needs and capabilities. RESULTS: Our review highlighted the importance of using mixed methods and including multiple stakeholders throughout the design process. These approaches can encourage mutual learning (to improve design by developers and to increase acceptance by users). We identified key phases used in HRI PD workshops (e.g., initial interview phase, series of focus groups phase, and presentation phase). These approaches can provide inspiration for future efforts. CONCLUSION: HRI PD strategies can support designers in developing assistive robots that meet older adults' needs, capabilities, and preferences to promote acceptance. More HRI research is needed to understand potential implications for aging-in-place. PD methods provide a promising approach.

Ethical Guidance for Hard Decisions: A Critical Review of Early International COVID-19 ICU Triage Guidelines.

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.

Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial.

OBJECTIVE: This three-armed randomized controlled feasibility trial tested the acceptability and acute effects of aerobic exercise and technology-guided mindfulness training (relative to standalone interventions) on cancer-related fatigue among breast cancer survivors (BCS). METHODS: BCS recruited from Central Illinois completed pre- and post-testing using established measures and were randomized to one of three groups (combined aerobic exercise with guided-mindfulness relaxation, aerobic exercise only, and relaxation only), conducted in three 90 min sessions over the course of 7 days in a fitness room and research office on a university campus. RESULTS: We enrolled 40 BCS (Mage = 57.33 ± 8.75), MBMI = 27.38 ± 5.27, Mfatigue = 4.56 ± 1.81 as measured by the Piper Fatigue Scale. More favorable post-intervention evaluations were reported by the combined group, compared to aerobic exercise or relaxation only (p < 0.05). Reductions in fatigue favoring the combined group (p = 0.05) showed a modest effect size (Cohen's d = 0.91) compared to aerobic exercise only. CONCLUSIONS: These findings provide preliminary evidence for the feasibility of combining evidence-based techniques to address fatigue among BCS. The combined approach, incorporating mobile health technology, presents an efficacious and well-received design. If replicated in longer trials, the approach could provide a promising opportunity to deliver broad-reaching interventions for improved outcomes in BCS. Preregistered-ClinicalTrials NCT03702712.

Overdiagnosis: one concept, three perspectives, and a model.

Defining, estimating, communicating about, and dealing with overdiagnosis is challenging. One reason for this is because overdiagnosis is a complex phenomenon. In this article we try to show that the complexity can be analysed and addressed in terms of three perspectives, i.e., that of the person, the professional, and the population. Individuals are informed about overdiagnosis based on population-based estimates. These estimates depend on professionals' conceptions and models of disease and diagnostic criteria. These conceptions in turn depend on individuals' experience of suffering, and on population level outcomes from diagnostics and treatment. As the personal, professional, and populational perspectives are not easy to reconcile, we must address them explicitly and facilitate interaction. Population-based estimates of overdiagnosis must be more directly informed by personal need for information. So must disease definitions and diagnostic criteria. Only then can individuals be appropriately informed about overdiagnosis.

Evaluation of artificial intelligence clinical applications: Detailed case analyses show value of healthcare ethics approach in identifying patient care issues.

This paper is one of the first to analyse the ethical implications of specific healthcare artificial intelligence (AI) applications, and the first to provide a detailed analysis of AI-based systems for clinical decision support. AI is increasingly being deployed across multiple domains. In response, a plethora of ethical guidelines and principles for general AI use have been published, with some convergence about which ethical concepts are relevant to this new technology. However, few of these frameworks are healthcare-specific, and there has been limited examination of actual AI applications in healthcare. Our ethical evaluation identifies context- and case-specific healthcare ethical issues for two applications, and investigates the extent to which the general ethical principles for AI-assisted healthcare expressed in existing frameworks capture what is most ethically relevant from the perspective of healthcare ethics. We provide a detailed description and analysis of two AI-based systems for clinical decision support (Painchek® and IDx-DR). Our results identify ethical challenges associated with potentially deceptive promissory claims, lack of patient and public involvement in healthcare AI development and deployment, and lack of attention to the impact of AIs on healthcare relationships. Our analysis also highlights the close connection between evaluation and technical development and reporting. Critical appraisal frameworks for healthcare AIs should include explicit ethical evaluation with benchmarks. However, each application will require scrutiny across the AI life-cycle to identify ethical issues specific to healthcare. This level of analysis requires more attention to detail than is suggested by current ethical guidance or frameworks.

A Framework for Design of Conversational Agents to Support Health Self-Care for Older Adults.

OBJECTIVE: We examined the potential of conversational agents (CAs) to support older adults' self-care related to chronic illness in light of lessons learned from decades of pedagogical agent research, which investigates the impact and efficacy of CAs for a wide range of learners. BACKGROUND: The role of CAs in education (i.e., pedagogical agents) has been long studied, but their potential for supporting self-care has received less attention, especially for older adults. METHODS: We reviewed work on pedagogical agents and considered how it informs the design of CAs for older adults. We propose a framework for designing CAs to support older adult self-care, which organizes a review of work in this area and integration with the pedagogical agent literature. RESULTS: Our review of the pedagogical agent literature revealed an evolution from teaching machines to interactive, social systems that influence student motivational as well as learning outcomes. To integrate this review with work on CAs and self-care, we developed a framework that specifies how self-care goals evolve with stages of an illness, communication goals that support self-care at each stage, patient needs, and requirements for CAs to support these needs. The review identified an agenda for future research on CA functions and features that help older adults accept need for self-care, establish self-care, and sustain self-care over time. CONCLUSIONS: Integrating insights from the pedagogical agent literature with research on developing CAs for self-care defines an agenda for developing and evaluating CAs to help older adults manage illness.

Modeling Task Scheduling Decisions of Emergency Department Physicians.

OBJECTIVE: This study evaluated task-scheduling decisions in the context of emergency departments by comparing patterns of emergency physicians' task-scheduling models across levels of experience. BACKGROUND: Task attributes (priority, difficulty, salience, and engagement) influence task-scheduling decisions. However, it is unclear how attributes interact to affect decisions, especially in complex contexts. An existing model of task scheduling, strategic task overload management-no priority (STOM-NP), found that an equal weighting of attributes can predict task-scheduling behavior. Alternatively, mathematical modeling estimated that priority alone could make similar predictions as STOM-NP in a parsimonious manner. Experience level may also influence scheduling decisions. METHOD: An experimental design methodology shortened a judgment analysis approach to compare a priori task-scheduling decision strategies. Emergency physicians with two levels of experience rank-ordered 10 sets of 3 tasks varying on 4 task attributes in this complex environment. RESULTS: Bayesian statistics were used to identify best-fit decision strategies. STOM-NP and priority-only provided the best model fits. STOM-NP fit the lower-experienced physicians best, whereas priority-only-using only one cue-fit the higher-experienced physicians best. CONCLUSION: Models of decision strategies for task-scheduling decisions were extended to complex environments. Experts' level of experience influenced task-scheduling decisions, where the scheduling decisions of more-experienced experts was consistent with a more frugal decision process. Findings have implications for training and evaluation. APPLICATION: We assessed models of cues that influence task-scheduling decisions, including a parsimonious model for task priority only. We provided a sample approach for shortening methods for understanding decisions.

Revisiting the equity debate in COVID-19: ICU is no panacea.

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit (ICU) resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the pandemic context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning.

Against the use and publication of contemporary unethical research: the case of Chinese transplant research.

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He's gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing-as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of 'non-use' of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.

No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations.

OBJECTIVE: To update, clarify, and extend IDEAL concepts and recommendations. BACKGROUND: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. METHODS: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions-Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a "Pre-IDEAL" stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. CONCLUSIONS: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Bioethics and activism: A natural fit?

Bioethics is a practically oriented discipline that developed to address pressing ethical issues arising from developments in the life sciences. Given this inherent practical bent, some form of advocacy or activism seems inherent to the nature of bioethics. However, there are potential tensions between being a bioethics activist, and academic ideals. In academic bioethics, scholarship involves reflection, rigour and the embrace of complexity and uncertainty. These values of scholarship seem to be in tension with being an activist, which requires pragmatism, simplicity, certainty and, above all, action. In this paper I explore this apparent dichotomy, using the case example of my own involvement in international efforts to end forced organ harvesting from prisoners of conscience in China. I conclude that these tensions can be managed and that academic bioethics requires a willingness to be activist.

Supporting trust in home healthcare providers: insights into the care recipients' perspective.

Successful care in home health for older adults is heavily dependent on the relationships between care recipients and care providers. A key component of that relationship is trust. To investigate trust in this context, we explored what older care recipients perceive as supporting trust in home care providers. Participants discussed three main categories that support trust in a care provider: professional skills (e.g., safety), personal traits (e.g., honesty), and communication (e.g., content). Insights from the care recipients' perspective are utilized to provide training recommendations for developing trust. For example, care providers should complete tasks in the care recipients' preferred manner.