Chiara Crico

Background: Clinical Ethics Committees (CECs) are services for supporting healthcare professionals (HPs) in dealing with ethical issues in clinical practice. The CEC of the Local Health Authority (LHA) of Reggio Emilia was implemented in 2020 in the context of a research project ( EVACEC ) aimed at identifying how a CEC can be successfully normalized within a healthcare organization. This mixed-methods article describes the CEC’s dissemination, use and integration among HPs, with a focus on the experiences of those who required ethics consultation. Methods: Quantitative data on dissemination, knowledge, and use of CEC were gathered through an online survey sent to all HPs of the LHA and were analyzed by descriptive statistics. Qualitative data were collected by semi-structured interviews with those HPs who submitted an ethics consultation request and were analyzed by thematic analysis. Results: Two hundred seventy-three HPs completed the survey, with 80.6% reporting to have faced at least one ethical issue in their clinical practice. 57.7% were aware of the service, with heterogeneous levels of knowledge about the CEC functions, composition, and target users; barriers to access were also identified. Among them, only 23.4% had actually utilized it and 85.7% of this subsample found it useful. From June 2022 to October 2022, 5 HPs who submitted a request to the CEC were interviewed. Thematic analysis revealed four themes: (i) a sense of loneliness in the decision-making process: seeking ethical support; (ii) valued features of the CEC: a source of mutual and expert support; (iii) how ethics consultation supports medical decision-making; (iv) trust, visibility, and access: key features to normalization. Conclusions: Our findings show that when accessed, CEC offered support by providing multidisciplinary perspectives and fostering deliberation in morally complex situations. However, the limited awareness and use of the CEC among those HPs most exposed to ethical issues suggests that further institutional efforts (i.e. integrating ethics training into routine clinical practice and establishing clearer referral pathways), are required to improve its dissemination and ethical sensitivity among HPs. Further research is needed to assess the long-term impact of these implementation strategies to identify best practices for CEC normalization. Trial registration: The protocol has been registered on ClinicalTrail.gov (registration n. NCT05466292).

Background and Aims: Stereotactic arrhythmia radioablation (STAR) is increasingly used for refractory ventricular tachycardia (VT), yet prospective multicentre outcome data remain limited. Here, the planned interim analysis of the prospective Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) registry is reported. Methods: STOPSTORM is a European prospective, international, multicentre registry of patients treated with STAR. The primary efficacy endpoint was the change in sustained VT episode burden comparing the 6 months before versus the 6 months after STAR. The primary safety endpoint was the occurrence of serious adverse events (SAEs) adjudicated as possibly or probably treatment-related. Overall survival was assessed using time-to-event methods. Results: Across 28 centres, 193 patients were included (mean age 68±9 years; 88% male; 53% non-ischaemic cardiomyopathy). Median follow-up was 19 months. Among 107 evaluable patients with ≥6-month follow-up, the median VT episode burden was reduced by 80% after STAR. Among patients surviving ≥6 months, 72% were free from implantable cardioverter-defibrillator (ICD) shock. In the full cohort, 12 SAEs were adjudicated as possibly or probably treatment-related, including pericardial effusion, coronary events, and early post-treatment ventricular arrhythmia. Overall survival probability was 77% at 12 months. Conclusions: In the largest prospective multicentre cohort reported to date, STAR was associated with a substantial reduction in VT burden and ICD shocks, with a low frequency of possibly or probably treatment-related SAEs.

Background: Ventricular tachycardia (VT) is a life-threatening condition, and standard treatments are not suitable for many affected patients. Stereotactic arrhythmia radioablation (STAR) has emerged as a promising experimental last-resort treatment for patients with refractory VT, but it lacks clinical standardization. To address this issue, the STOPSTORM.eu consortium aims to collect data on patients treated with STAR via the development of a multicentric patient registry. The Ethics & Regulations Working Group (ERG) provides support addressing ethical and regulatory challenges. Methods: The ERG conducted a survey to assess how prospective data on STAR are collected at the partner centres and to explore potential ethical concerns. Responses were analysed to evaluate clinical trial approval processes, adherence to STOPSTORM guidelines, and emerging ethical issues. Results: Among the 28 partners, there were 13 interventional clinical trials—ongoing or concluded—across seven countries; centres without ongoing trials enrolled patients under compassionate use. Most trials were single arm, with few exceptions (a randomized trial and dose escalation studies). Most ethics committees approved STAR trials without major objections, but regulatory inconsistencies were observed, resulting in approval denial or delay. Ethical concerns included potential therapeutic misconception among patients, autonomy issues due to the vulnerability of VT patients, and inequities in access to STAR. The heterogeneity in trial designs, endpoints, and follow-up strategies among participating centres posed challenges for data standardization, but using a registry to collect data from multiple local clinical trials offers an innovative approach to overcoming logistical and financial barriers in research on rare diseases. Conclusion: Multicentric non-pharmaceutical trials on STAR may present ethical, regulatory, and organizational challenges. The open registry model facilitates large-scale data collection and supports future protocol standardization. However, greater intercentre collaboration and regulatory harmonization are needed to optimize STAR’s integration into clinical practice while upholding ethical standards in patient care and research.

Introduction: The Clinical Ethics Committee (CEC) of the Local Health Authority (LHA) of Reggio Emilia, Italy, is a multi-professional service established in 2020 to support healthcare professionals (HPs) in dealing with ethical issues in clinical practice. We evaluated the integration of the CEC into routine practice, 24 months after its implementation. Methods: We conducted semi-structured interviews with CEC members and LHA stakeholders involved in the service implementation. The interview scripts were outlined and transcript analysis was carried out following the four concepts of Normalization Process Theory (NPT): coherence, cognitive participation, collective action, reflexive monitoring. Results: Between June 2022 and January 2023, 15 participants were interviewed (12 CEC members and 3 LHA directors). All participants consider the service an important opportunity for HPs to be supported in complex situations (coherence). The CEC’s President, a bioethicist working at the LHA, played a key role ensuring the CEC’s participation and activation (cognitive participation). The main barriers to the CEC implementation were: financial sustainability, CEC members’ lack of training, absence of in-person relationships (collective action). Overall, participants reported a positive experience with the CEC, however recommended several modifications (reflexive monitoring). Conclusions: We identified key components to support the normalization of CECs and enable their activation within a clinical setting. An active and sustainable CEC must be visible, accessible, understood and trusted, clear in purpose, sufficiently integrated into the life of the organisation, adequately resourced, appropriately constituted and competent, accountable and independent. These findings can inform the development of practical strategies for CECs implementation and of appropriate outcomes for further evaluation.

This preliminary ethical appraisal from the STOPSTORM.eu consortium is meant to raise critical points that clinicians administering stereotactic arrhythmia radioablation should consider to meet the highest standards in medical ethics and thus promote quality of life of patients recruited for radiotherapy treatments at a stage in which they experience a significant degree of vulnerability.

Background: Clinical Ethics Support Services (CESS) have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders’ expectations about a potential CESS to be implemented within the Institution. Methods: The study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders’ professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory. Results: Twenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases. Conclusions: The interviewees showed a limited degree of ‘ethical awareness’: despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients.

Clinical Ethics Committees (CECs), as distinct from Research Ethics Committees, were originally established with the aim of supporting healthcare professionals in managing controversial clinical ethical issues. However, it is still unclear whether they manage to accomplish this task and what is their impact on clinical practice. This systematic review aims to collect available assessments of CECs’ performance as reported in literature, in order to evaluate CECs’ effectiveness. We retrieved all literature published up to November 2019 in six databases (PubMed, Ovid MEDLINE, Scopus, Philosopher’s Index, Embase and Web of Science), following PRISMA guidelines. We included only articles specifically addressing CECs and providing any form of CECs performance assessment. Twenty-nine articles were included. Ethics consultation was the most evaluated of CECs’ functions. We did not find standardized tools for measuring CECs’ efficacy, but 33% of studies considered “user satisfaction” as an indicator, with 94% of them reporting an average positive perception of CECs’ impact. Changes in patient treatment and a decrease of moral distress in health personnel were reported as additional outcomes of ethics consultation. The highly diverse ways by which CECs carry out their activities make CECs’ evaluation difficult. The adoption of shared criteria would be desirable to provide a reliable answer to the question about their effectiveness. Nonetheless, in general both users and providers consider CECs as helpful, relevant to their work, able to improve the quality of care. Their main function is ethics consultation, while less attention seems to be devoted to bioethics education and policy formation.