Intelligent, Autonomous Machines in Surgery.

Surgeons perform two primary tasks: operating and engaging patients and caregivers in shared decision-making. Human dexterity and decision-making are biologically limited. Intelligent, autonomous machines have the potential to augment or replace surgeons. Rather than regarding this possibility with denial, ire, or indifference, surgeons should understand and steer these technologies. Closer examination of surgical innovations and lessons learned from the automotive industry can inform this process. Innovations in minimally invasive surgery and surgical decision-making follow classic S-shaped curves with three phases: (1) introduction of a new technology, (2) achievement of a performance advantage relative to existing standards, and (3) arrival at a performance plateau, followed by replacement with an innovation featuring greater machine autonomy and less human influence. There is currently no level I evidence demonstrating improved patient outcomes using intelligent, autonomous machines for performing operations or surgical decision-making tasks. History suggests that if such evidence emerges and if the machines are cost effective, then they will augment or replace humans, initially for simple, common, rote tasks under close human supervision and later for complex tasks with minimal human supervision. This process poses ethical challenges in assigning liability for errors, matching decisions to patient values, and displacing human workers, but may allow surgeons to spend less time gathering and analyzing data and more time interacting with patients and tending to urgent, critical-and potentially more valuable-aspects of patient care. Surgeons should steer these technologies toward optimal patient care and net social benefit using the uniquely human traits of creativity, altruism, and moral deliberation.

SERIES: eHealth in primary care. Part 2: Exploring the ethical implications of its application in primary care practice.

Background: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth will affect patients' and primary care professionals' (PCPs) experiences, values, norms, and relationships.Objectives: We argue what ethical implications related to the impact of eHealth on four vital aspects of primary care could (and should) be anticipated.Discussion: (1) EHealth influences dealing with predictive and diagnostic uncertainty. Machine-learning based clinical decision support systems offer (seemingly) objective, quantified, and personalised outcomes. However, they also introduce new loci of uncertainty and subjectivity. The decision-making process becomes opaque, and algorithms can be invalid, biased, or even discriminatory. This has implications for professional responsibilities and judgments, justice, autonomy, and trust. (2) EHealth affects the roles and responsibilities of patients because it can stimulate self-management and autonomy. However, autonomy can also be compromised, e.g. in cases of persuasive technologies and eHealth can increase existing health disparities. (3) The delegation of tasks to a network of technologies and stakeholders requires attention for responsibility gaps and new responsibilities. (4) The triangulate relationship: patient-eHealth-PCP requires a reconsideration of the role of human interaction and 'humanness' in primary care as well as of shaping Shared Decision Making.Conclusion: Our analysis is an essential first step towards setting up a dedicated ethics research agenda that should be examined in parallel to the development and implementation of eHealth. The ultimate goal is to inspire the development of practice-specific ethical recommendations.

Data-driven clinical decision processes: it's time.

Changes and transformations enabled by Big Data have direct effects on Translational Medicine. At one end, superior precision is expected from a more data-intensive and individualized medicine, thus accelerating scientific discovery and innovation (in diagnosis, therapy, disease management etc.). At the other end, the scientific method needs to adapt to the increased diversity that data present, and this can be beneficial because potentially revealing greater details of how a disease manifests and progresses. Patient-focused health data provides augmented complexity too, far beyond the simple need of testing hypotheses or validating models. Clinical decision support systems (CDSS) will increasingly deal with such complexity by developing efficient high-performance algorithms and creating a next generation of inferential tools for clinical use. Additionally, new protocols for sharing digital information and effectively integrating patients data will need to be CDSS-embedded features in view of suitable data harmonization aimed at improved diagnosis, therapy assessment and prevention.

Legal and ethical issues surrounding the use of crowdsourcing among healthcare providers.

As the pace of medical discovery widens the knowledge-to-practice gap, technologies that enable peer-to-peer crowdsourcing have become increasingly common. Crowdsourcing has the potential to help medical providers collaborate to solve patient-specific problems in real time. We recently conducted the first trial of a mobile, medical crowdsourcing application among healthcare providers in a university hospital setting. In addition to acknowledging the benefits, our participants also raised concerns regarding the potential negative consequences of this emerging technology. In this commentary, we consider the legal and ethical implications of the major findings identified in our previous trial including compliance with the Health Insurance Portability and Accountability Act, patient protections, healthcare provider liability, data collection, data retention, distracted doctoring, and multi-directional anonymous posting. We believe the commentary and recommendations raised here will provide a frame of reference for individual providers, provider groups, and institutions to explore the salient legal and ethical issues before they implement these systems into their workflow.

What Should Oversight of Clinical Decision Support Systems Look Like?

A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinicians to query electronic health records (EHRs) such that responses from the EHRs could inform treatment recommendations. We argue that though using a clinical decision support system does not necessarily constitute a research activity subject to the Common Rule, it requires more ethical and regulatory oversight than activities of clinical practice are generally subjected to. In particular, we argue that the development and use of clinical decision support systems should be governed by a framework that (1) articulates appropriate conditions for their use, (2) includes processes for monitoring data quality and developing and validating algorithms, and (3) sufficiently protects patients' data.

Suspensión del soporte respiratorio en enfermos con esclerosis lateral amiotrófica / Suspension of respiratory support in patients with amyotrophic lateral sclerosis

Las decisiones médicas en pacientes con esclerosis lateral amiotrófica avanzada continúan suscitando un amplio debate. El objetivo de este trabajo es analizar las decisiones referidas al soporte respiratorio y, mediante el estudio de sus implicancias éticas, señalar un posible camino decisional para la suspensión del tratamiento. Se realizó una búsqueda bibliográfica sistemática usando Pubmed database (2010-2016) y se investigó si la ventilación no invasiva (VNI) y la ventilación mecánica (VM) producen o no un incremento en el tiempo de supervivencia y en la calidad de vida. Se incluyeron 38 artículos de revisión. A partir de los resultados obtenidos se analizaron las implicancias éticas de las decisiones de iniciar y, particularmente, de suspender las diversas posibilidades de soporte respiratorio. El tiempo de supervivencia se incrementa tanto con VNI como con VM. La calidad de vida, sobre todo según criterios fisiológicos, mejora con VNI pero es controversial con VM. La implementación de VM y su suspensión futura es un aspecto del tratamiento abierto a la discusión médica y ética. Desde una perspectiva respetuosa de la intrínseca dignidad de todo ser humano, cualquiera sea su calidad de vida y sabiendo que no hay terapias eficaces para la enfermedad de base, la decisión de retirar la VM en un paciente con enfermedad avanzada requiere: conocer la voluntad del enfermo y, sobre todo, evaluar si dicha medida de soporte respiratorio empieza a ser objetivamente desproporcionada

Decision making in advanced Amyotrophic Lateral Sclerosis (ALS) patients keeps on being a controversial issue. The aim of this work is to discuss ethical implications of withdrawing respiratory support treatment in patients with ALS. Through a bibliographic search on Pubmed database (2010-2016) we investigated whether or not the use of Non-Invasive Ventilation (NIV) and Mechanical Ventilation (MV) would increase survival and quality of life. We included 38 review articles. From these papers, results and ethical implications of initiating and mainly withdrawing respiratory support were analyzed. Survival time increased with NIV and with MV. Quality of life, above all according to physiological criteria, improved with NIV but regarding MV it remained controversial. Implementation and future withdrawal of MV seemed open to medical and ethical discussion. From a perspective of the intrinsic dignity of every human being, whatever its quality of life was, and knowing that no effective therapies for the underlying disease are available, the decision to remove MV in a patient with advanced ALS requires: knowledge of the will of the patient and, above all, evaluating whether this respiratory support measure is becoming objectively disproportionate

Developing a System for Processing Health Data of Children Using Digitalized Toys: Ethical and Privacy Concerns for the Internet of Things Paradigm.

EDUCERE (Ubiquitous Detection Ecosystem to Care and Early Stimulation for Children with Developmental Disorders) is a government funded research and development project. EDUCERE objectives are to investigate, develop, and evaluate innovative solutions for society to detect changes in psychomotor development through the natural interaction of children with toys and everyday objects, and perform stimulation and early attention activities in real environments such as home and school. In the EDUCERE project, an ethical impact assessment is carried out linked to a minors' data protection rights. Using a specific methodology, the project has achieved some promising results. These include use of a prototype of smart toys to detect development difficulties in children. In addition, privacy protection measures which take into account the security concerns of health data, have been proposed and applied. This latter security framework could be useful in other Internet of Things related projects. It consists of legal and technical measures. Special attention has been placed in the transformation of bulk data such as acceleration and jitter of toys into health data when patterns of atypical development are found. The article describes the different security profiles in which users are classified.

Towards Integrating the Principlist and Casuist Approaches to Ethical Decisions via Multi-Criterial Support.

An interactive decision support tool based on Multi-Criteria Decision Analysis (MCDA) can help health professionals integrate the principlist (principle-based) and casuist (case-based) approaches to ethical decision making in both their training and practice. MCDA can incorporate generic ethical principles as criteria; then draw on case-based reasoning as the basis for specifying, in the individual case, the available options, the ratings of each option on each criterion, and the relative weighting of the criteria. This produces a personalised, transparent and decomposable opinion on the merits of each option, as a contribution to enhanced deliberation. As proof of concept and method an exemplar aid adds veracity and confidentiality to beneficence, non-maleficence, autonomy and justice, as the criteria, with case-based reasoning supplying the necessary inputs for the decision of whether a nurse should disclose the poor prognosis of a patient to a close relative of the patient, when asked, on their first encounter.

Personalised Multi-Criterial Online Decision Support for Siblings Considering Stem Cell Donation: An Interactive Aid.

Person-centred decision support combines the best available information on the considerations that matter to the individual, with the importance the person attaches to those considerations. Nurses and other health professionals can benefit from being able to draw on this support within a clinical conversation. A case study and storyline on four siblings facing a transplant coordinator's call to donate stem cells to their brother [1] is 'translated' and used to demonstrate how an interactive multi-criteria aid can be developed for each within a conversational mode. The personalized dialogue and decision aid are accessible online for interaction. Each sibling's decision exemplifies the communication including physical and psychosocial complexities within any decision cascade from call-to-test and to donate, if compatible. A shared template can embrace the informational and ethical aspects of a decision. By interactive decision support within a clinical conversation, each stakeholder can gain a personalised opinion, as well as increased generic health decision literacy [2].

Conflict of interest in online point-of-care clinical support websites.

Point-of-care evidence-based medicine websites allow physicians to answer clinical queries using recent evidence at the bedside. Despite significant research into the function, usability and effectiveness of these programmes, little attention has been paid to their ethical issues. As many of these sites summarise the literature and provide recommendations, we sought to assess the role of conflicts of interest in two widely used websites: UpToDate and Dynamed. We recorded all conflicts of interest for six articles detailing treatment for the following conditions: erectile dysfunction, fibromyalgia, hypogonadism, psoriasis, rheumatoid arthritis and Crohn's disease. These diseases were chosen as their medical management is either controversial, or they are treated using biological drugs which are mostly available by brand name only. Thus, we hypothesised that the role of conflict of interest would be more significant in these conditions than in an illness treated with generic medications or by strict guidelines. All articles from the UpToDate articles demonstrated a conflict of interest. At times, the editor and author would have a financial relationship with a company whose drug was mentioned within the article. This is in contrast with articles on the Dynamed website, in which no author or editor had a documented conflict. We offer recommendations regarding the role of conflict of interest disclosure in these point-of-care evidence-based medicine websites.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

Need for ethics support in healthcare institutions: views of Dutch board members and ethics support staff.

OBJECTIVE: The purpose of this article is to investigate the need for ethics support in Dutch healthcare institutions in order to understand why ethics support is often not used in practice and which factors are relevant in this context. METHODS: This study had a mixed methods design integrating quantitative and qualitative research methods. Two survey questionnaires, two focus groups and 17 interviews were conducted among board members and ethics support staff in Dutch healthcare institutions. FINDINGS: Most respondents see a need for ethics support. This need is related to the complexity of contemporary healthcare, the contribution of ethics support to the core business of the organisation and to the surplus value of paying structural attention to ethical issues. The need for ethics support is, however, not unconditional. Reasons for a lacking need include: aversion of innovations, negative associations with the notion of ethics support service, and organisational factors like resources and setting. CONCLUSION: There is a conditioned need for ethics support in Dutch healthcare institutions. The promotion of ethics support in healthcare can be fostered by focusing on formats which fit the needs of (practitioners in) healthcare institutions. The emphasis should be on creating a (culture of) dialogue about the complex situations which emerge daily in contemporary healthcare practice.

Paciente conflictivo en urgencias: definición, tipología y aspectos éticos / Conflictive patients in the emergency room: Definition, classification and ethical aspects

El paciente conflictivo es aquel que suscita en el médico un problema (un conflicto) por su actitud y/o comportamiento. Los conflictos éticos en urgencias son frecuentes y muchos de ellos se producen con estos pacientes. Entre las tipologías más habituales de pacientes que generan conflictos personales con los sanitarios están los pacientes exageradamente demandantes, los que rechazan actuaciones médicas, los agresivos, los litigadores, los hiperfrecuentadores y los que acuden a urgencias sin patología urgente. Es posible que un paciente incluya varios de estos perfiles (paciente «mixto»). Ante su aparición, el abordaje debe ser en equipo y si es posible, estableciendo un proceso deliberativo. Si existen dudas y es posible, se debe consultar al comité de ética asistencial y se deben buscar los protocolos que haya al respecto, deseablemente institucionales. Tras ello, si se llega a una decisión difícil de tomar, hay que buscar el apoyo del equipo directivo del servicio e inclusive de la institución. Se debe reflejar todo este proceso en la historia clínica. La formación específica en Bioética y habilidades de comunicación puede ser de gran ayuda para minimizar y afrontar mejor los conflictos a largo plazo(AU)

A conflictive patient is one who provokes a problem (a conflict) by their attitude or behavior for the physician. Ethical conflicts in emergency care are common and many of them occur with these patients. Among the most common types of patients who generate personal conflicts with health professionals are overly demanding patients, those who refuse medical interventions, those who are aggressive, litigators, excessively-recurrent users of the heath system and those who go to the emergency room without an urgent condition. A patient may include several of these profiles (“mixed” patient). When they appear, the approach should be, if possible, by a team, establishing a deliberative process. If there is doubt and when possible, the ethics committee of the institution should be consulted, seeking the protocols, this best being institutional, on the subject. After that, if the decision is difficult, support must be sought from the emergency staff and even management. The whole process should be reflected in the clinical history. Specific education in bioethics and communication skills can be of great help to minimize and cope better with long-term conflicts(AU)

Selective resuscitation in premature twins: an ethical analysis.

Selective resuscitation refers to the practice of providing resuscitative efforts to one or some (but not all) infants born in the setting of multiple gestation. When one fetus is known to have a severe anomaly or severe growth restriction, parents are sometimes offered this option. In the setting of extreme prematurity, in the absence of an anomaly or severe growth restriction, parents are generally expected to make one unified decision for all the infants involved. The introduction of the Outcome Estimator, a tool that provides the ability to make individual outcome predictions for each fetus in a multiple gestation at borderline gestational age, based on contributing variables such as weight and gender, has led to the ethical dilemma of whether parents in this setting should also be offered the option of selective resuscitation. No convincing ethical argument for denying the parents the right to decide for each individual infant is apparent.