The First- and Second-Order Ethical Reasons Approach: The Case of Human Challenge Trials.

At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth.

Clinical decision-making process and distributive justice: The mediating role of economic analysis. Empirical evidence from Italy.

Background: The COVID-19 pandemic has not only tested the resilience of public health systems but also underscored the criticality of allocative choices on health resources. These choices, however, are not confined to health emergencies but are integral to public health decisions, which inherently grapple with limited resources. In this context, physicians play a pivotal role as the architects of clinical actions in various scenarios.

Does Body Memory Exist? A Review of Models, Approaches and Recent Findings Useful for Neurorehabilitation.

Over the past twenty years, scientific research on body representations has grown significantly, with Body Memory (BM) emerging as a prominent area of interest in neurorehabilitation. Compared to other body representations, BM stands out as one of the most obscure due to the multifaceted nature of the concept of "memory" itself, which includes various aspects (such as implicit vs. explicit, conscious vs.

Cognitive and non-cognitive factors affecting decision-making about deceased organ donation in Italy: a systematic review.

Introduction: Decision-making about organ donation (OD) is influenced by interrelated cognitive and non-cognitive factors. The identification of these factors in the general population and among healthcare professionals (HCP) in Italy are key ethical and scientific requirements to inform targeted communication and policy-making interventions, and to promote decision-making processes that are truly informed.

Evidence Acquisition: A systematic review of articles published between January 1, 1999, and January 31, 2024 was performed by searching four databases using these terms: "organ donation" AND (attitude OR opinion OR knowledge OR awareness OR intention OR beliefs OR norms OR perception) AND (Italy OR Italian).

An Overview of the Bodily Awareness Representation and Interoception: Insights and Progress in the Field of Neurorehabilitation Research.

In the last two decades, the scientific literature on so-called body representations has been increasing, and the notion of body awareness (BA) is particularly interesting for neurorehabilitation. In this article, we present results derived from recent studies on this representation, considering the different definitions and explicative models proposed as well as the empirical settings used to test it, providing an extensive overview of these issues. This article discusses the challenge of understanding how we integrate the sensory experiences of proprioception (knowing where our body is in space) and interoception (sensing internal bodily sensations, like hunger of thirst) with our perception of self.

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study.

Background: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE).

Methods: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023.

An Overview of the Body Schema and Body Image: Theoretical Models, Methodological Settings and Pitfalls for Rehabilitation of Persons with Neurological Disorders.

Given the widespread debate on the definition of the terms "Body Schema" and "Body Image", this article presents a broad overview of the studies that have investigated the nature of these types of body representations, especially focusing on the innovative information about these two representations that could be useful for the rehabilitation of patients with different neurological disorders with motor deficits (especially those affecting the upper limbs). In particular, we analyzed (i) the different definitions and explicative models proposed, (ii) the empirical settings used to test them and (iii) the clinical and rehabilitative implications derived from the application of interventions on specific case reports. The growing number of neurological diseases with motor impairment in the general population has required the development of new rehabilitation techniques and a new phenomenological paradigm placing body schema as fundamental and intrinsic parts for action in space.

The need for clinical ethics consultation: a monocentric observational survey study in the intensive care unit (Consul.E.T.I. study).

Background: The current organizational structure of the Italian healthcare system does not include the institutionalization of clinical ethics services. To describe the need for structured clinical ethics consultation services for ICU staff members in the intensive care unit (ICU), a monocentric observational survey study was performed utilizing a paper-based questionnaire.

Results: A total of 73 healthcare professionals (HCPs) responded out of a team of 84 people (87%).

A New Treatment Option in Incomplete Partition Type III: The Varese Bone-Air Stimulation (B.A.S.).

The incomplete partition type III is a severe cochlear malformation present in X-linked deafness. It is a rare, non-syndromic cause of severe to profound mixed hearing loss, often progressive. The complete absence of bony modiolus and the wide communication between the cochlea and the internal auditory canal make cochlear implantation challenging, with still no consensus on the management of these patients.

Public perceptions and expectations: Disentangling the hope and hype of organoid research.

Organoid technologies are rapidly advancing and hold great potential and hope for disease modeling and clinical translational research. Still, they raise a number of complex, ethical questions regarding their current and future use. Patient and public involvement is important in building public trust and helping to secure responsible conduct and valued innovations; nevertheless, research into patient and public perspectives on organoid technologies remains scarce.

The Circle Method: A Novel Approach to Clinical Ethics Consultation.

AbstractDifferent methods are available in clinical ethics consultation. In our experience as ethics consultants, certain individual methods have proven insufficient, and so we use a combination of methods. Based on these considerations, we first critically analyze the pros and cons of two well-known methods in the working field of clinical ethics, namely Beauchamp and Childress's four-principle approach and Jonsen, Siegler, and Winslade's four-box method.

A rare case of sudden death due to endomyocardial fibrosis in Italy: A differential diagnosis with other causes of restrictive cardiomyopathy.

A 45-years-old Indonesian woman was admitted to the hospital with nausea, vomiting, abdominal pain and tachyarrhythmia. Atrial fibrillation was found at ECG, blood tests showed mild hepatic function alterations. Radiological exams showed bilateral pleural effusions, ascites, hepatomegaly.

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion.

Background: Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite "hostile" anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this "inconsistency" between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the "best interest" of the patient can be set.

From COVID-19 Pandemic to Patient Safety: A New "Spring" for Telemedicine or a Boomerang Effect?

During the Covid-19 health emergency, telemedicine was an essential asset through which health systems strengthened their response during the critical phase of the pandemic. According to the post-pandemic economic reform plans of many countries, telemedicine will not be limited to a tool for responding to an emergency condition but it will become a structural resource that will contribute to the reorganization of Healthcare Systems and enable the transfer of part of health care from the hospital to the home-based care. However, scientific evidences have shown that health care delivered through telemedicine can be burdened by numerous ethical and legal issues.

Liver transplantation from active COVID-19 donors: Is it ethically justifiable?

The debate on the opportunity to use organs from donors testing positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in recipients with naïve resolved or active COVID-19 is ongoing. We aim to present the ethical analyses underlying the decision to perform liver transplantation (LT) in selected patients with resolved or active COVID-19 in Italy. We used Jonsen, Siegler, and Winslade's Four-Boxes casuistic method, addressing the four topics considered as constitutive of the essential structure of single clinical cases for their ethical analysis (medical indications, patient preferences, quality of life, and contextual features) to enable decision-making on a case-by-case basis.

How to continue COVID-19 vaccine clinical trials? The ethics of vaccine research in a time of pandemic.

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants.

The 3-T Model of Informed Consent for Nonstandard Risk Donors: A Proposal for Transplant Clinical Practice.

Background: The risk of disease transmission from nonstandard risk donors (NSRDs) is low, and outcomes are similar or better relative to transplants performed with standard criteria donors. However, NSRDs have posed new ethical challenges to the informed consent (IC) process. Based on the shared decision-making model, coinciding with the 3 main timings of the IC process ([1] pretransplant assessments and waiting list registration, [2] time on the waiting list, and [3] time of the organ offer), we put forward a model (3-T Model) to summarize the knowledge on IC for NSRDs and to deliver conceptual and practical support to transplant providers on this emergent issue.

The fate of stillborns. Perceptions from a historical, anthropological and bioethical reasoning.

Issues of disposal of fetal remains and related parental distress do not concern only the present. This contribution aims at offering a glimpse of what grieving management concerning perinatal death must have been in ancient times. The discussion of the topic of death and treatment of perinatal remains is based on historical, anthropological, and bioethical reasoning, in a dialogue that contributes to the current debate on fetal personhood.

Analyzing the paradigmatic cases of two persons with a disorder of consciousness: reflections on the legal and ethical perspectives.

Background: Media have increasingly reported on the difficulties associated with end-of-life decision-making in patients with Disorders of Consciousness (DOC), contextualizing such dilemma in detailed accounts of the patient's life. Two of the first stories debated in the scientific community were those related to the cases of two women, one American, the other Italian, who captured attention of millions of people in the first years of this third millennium.

Methods: Much has been written about the challenges of surrogate decision-making for patients in DOC, but less has been written comparing these challenges across legal systems and cultures.

Five autopsy reports of rib fractures in the mental hospital of Reggio Emilia (1874-5): pathogenesis proposal in defence of the 'non-restraint' system.

At the end of the nineteenth century, recurrent cases of rib fractures were recorded in psychiatric asylums, opening a long chapter of discussions about the application of the 'non-restraint' system. Here we present a brief discussion of an article written by Enrico Morselli about five cases of rib fractures in the mental asylum of Reggio Emilia, in 1874-5. Morselli, a supporter of the ideas of 'non-restraint', suggested a common pathological cause.

Theoretical Models of Consciousness: A Scoping Review.

The amount of knowledge on human consciousness has created a multitude of viewpoints and it is difficult to compare and synthesize all the recent scientific perspectives. Indeed, there are many definitions of consciousness and multiple approaches to study the neural correlates of consciousness (NCC). Therefore, the main aim of this article is to collect data on the various theories of consciousness published between 2007-2017 and to synthesize them to provide a general overview of this topic.

Analyzing the Loss and the Recovery of Consciousness: Functional Connectivity Patterns and Changes in Heart Rate Variability During Propofol-Induced Anesthesia.

The analysis of the central and the autonomic nervous systems (CNS, ANS) activities during general anesthesia (GA) provides fundamental information for the study of neural processes that support alterations of the consciousness level. In the present pilot study, we analyzed EEG signals and the heart rate (HR) variability (HRV) in a sample of 11 patients undergoing spinal surgery to investigate their CNS and ANS activities during GA obtained with propofol administration. Data were analyzed during different stages of GA: baseline, the first period of anesthetic induction, the period before the loss of consciousness, the first period after propofol discontinuation, and the period before the recovery of consciousness (ROC).