Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium.

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.

[Experience and opportunities of a Clinical ethics committee: report of the first three years of activity.] / Esperienza e opportunità di un Comitato per l'etica nella clinica: report dei primi tre anni di attività.

A Clinical ethics committee (Cec) has been implemented in an Oncology Research Institute in Northern Italy with the aim of supporting healthcare professionals in addressing ethical issues related to clinical practice. This article describes the development and the activities carried out in 3 years since Cec's implementation. Our experience may increase knowledge of the role and opportunities of Cecs in the Italian context, and provide information on useful strategies for their regulation.

The meaning of dignity in care during the COVID-19 pandemic: a qualitative study in acute and intensive care.

BACKGROUND: The pandemic Era has forced palliative care professionals to use a dignity-in-care approach in different settings from the classic ones of palliative care: acute and intensive care. We explored the meanings of dignity for patients, their family members, and clinicians who have experienced COVID-19 in the acute and intensive care setting. METHODS: A qualitative, prospective study by means of semi-structured interviews with patients hospitalized for COVID-19, family members, and clinicians who care for them. FINDINGS: Between March 2021 and October 2021, we interviewed 16 participants: five physicians, three nurses, and eight patients. None of the patients interviewed consented for family members to participate: they considered it important to protect them from bringing the painful memory back to the period of their hospitalization. Several concepts and themes arose from the interviews: humanity, reciprocity, connectedness, and relationship, as confirmed by the literature. Interestingly, both healthcare professionals and patients expressed the value of informing and being informed about clinical conditions and uncertainties to protect dignity. CONCLUSIONS: Dignity should be enhanced by all healthcare professionals, not only those in palliative care or end-of-life but also in emergency departments.

Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.

RESEARCH QUESTION AND AIM: Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC's implementation, to increase knowledge about CEC's implementation strategy. RESEARCH DESIGN: We collected quantitative data related to number and characteristics of CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC's development and implementation process. PARTICIPANTS AND RESEARCH CONTEXT: The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. ETHICAL CONSIDERATIONS: The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. FINDINGS: In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC's impact on clinical practice. CONCLUSION: Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially.

Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC).

INTRODUCTION: A Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment. METHODS AND ANALYSIS: EvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service. ETHICS AND DISSEMINATION: The protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops. TRIAL REGISTRATION NUMBER: NCT05466292.

STereotactic Arrhythmia Radioablation (STAR): the Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM.eu) and review of current patterns of STAR practice in Europe.

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.

Patient and carer involvement in the formulation of research questions: findings from the Italian guideline on palliative care in adults with glioma.

BACKGROUND: In 2017, the European Association for Neuro-Oncology (EANO) published the guideline for palliative care (PC) in adults with glioma. The Italian Society of Neurology (SIN), the Italian Association for Neuro-Oncology (AINO), and the Italian Society for Palliative Care (SICP) joined forces to update and adapt this guideline to the Italian context and aimed to involve patients and carers in the formulation of the clinical questions. METHODS: During semi-structured interviews with glioma patients and focus group meetings (FGMs) with family carers of deceased patients, participants rated the importance of a set of pre-specified intervention topics, shared their experience, and suggested additional topics. Interviews and FGMs were audio-recorded, transcribed, coded, and analyzed (framework and content analysis). RESULTS: We held 20 interviews and five FGMs (28 carers). Both parties considered the pre-specified topics as important, chiefly information/communication, psychological support, symptoms management, and rehabilitation. Patients aired the impact of focal neurological and cognitive deficits. Carers reported difficulties in dealing with patient's behavior and personality changes and appreciated the preservation of patient's functioning via rehabilitation. Both affirmed the importance of a dedicated healthcare path and patient's involvement in the decision-making process. Carers expressed the need to be educated and supported in their caregiving role. CONCLUSIONS: Interviews and FGMs were well informative and emotionally challenging. Both parties confirmed the importance of the pre-specified topics, and carers suggested one additional topic: education/support to caregivers. Our findings strengthen the importance of a comprehensive care approach and of addressing the needs of both patients and their family carers.

Health professional involvement in the formulation of research questions: findings from the Italian guideline on palliative care in adults with glioma.

BACKGROUND: In 2017, the European Association of Neuro-Oncology (EANO) published the guideline for palliative care in adults with glioma. The Italian Society of Neurology (SIN), the Italian Society for Palliative Care (SICP), and the Italian Association for Neuro-Oncology (AINO) joined forces to update the guideline, and adapt it to the Italian context. AIM: We involved patients, caregivers, and (herein presented) healthcare professionals (HPs) in the formulation of the guideline clinical questions. DESIGN AND PARTICIPANTS: Online survey of Italian HPs experienced in the care of patients with glioma. Participants rated the importance of 14 pre-specified intervention topics on a 0/10 scale and gave their free comments. RESULTS: Of 244 participants, 149 (61%) were palliative medicine (PM) HPs and 95 Neuro HPs. Their mean age was 48.9 years, 63% were women, and 48% had over 12 years of experience in the care of glioma patients. Physicians were 68%, followed by nurses (28%), psychologists (7%), therapists (3%), and social workers (2%). Most HPs rated the pre-specified topics as important (score ≥ 7) or critical (score ≥ 9), with some differences between PM and Neuro HP groups. There were 58 free comments: 46 (78%) on nine pre-specified topics, and 13 on four new topics, three of which were guideline-pertinent ("caregiver's support and education"; "family physician's training in neuro-oncology"; and "PM HPs' training in neuro-oncology"). CONCLUSIONS: Participation in the survey was high and information-rich, between-group rating differences reflecting HP background. Participants endorsed the 14 intervention topics devised by the guideline panel and identified three additional topics.

AI-based clinical decision-making systems in palliative medicine: ethical challenges.

BACKGROUND: Improving palliative care (PC) is demanding due to the increase in people with PC needs over the next few years. An early identification of PC needs is fundamental in the care approach: it provides effective patient-centred care and could improve outcomes such as patient quality of life, reduction of the overall length of hospitalisation, survival rate prolongation, the satisfaction of both the patients and caregivers and cost-effectiveness. METHODS: We reviewed literature with the objective of identifying and discussing the most important ethical challenges related to the implementation of AI-based data processing services in PC and advance care planning. RESULTS: AI-based mortality predictions can signal the need for patients to obtain access to personalised communication or palliative care consultation, but they should not be used as a unique parameter to activate early PC and initiate an ACP. A number of factors must be included in the ethical decision-making process related to initiation of ACP conversations, among which are autonomy and quality of life, the risk of worsening healthcare status, the commitment by caregivers, the patients' psychosocial and spiritual distress and their wishes to initiate EOL discussions CONCLUSIONS: Despite the integration of artificial intelligence (AI)-based services into routine healthcare practice could have a positive effect of promoting early activation of ACP by means of a timely identification of PC needs, from an ethical point of view, the provision of these automated techniques raises a number of critical issues that deserve further exploration.

Research, education, ethics consultation: evaluating a Bioethics Unit in an Oncological Research Hospital.

BACKGROUND: This study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016-2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS). METHODS: We performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU's activities and analyzed by framework analysis. RESULTS: Quantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs. CONCLUSIONS: Our findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU's ethics consultation service within the local context.

Translation and Cultural Adaptation of the <i>Go Wish Game</i>: Thinking About Personal Values to Promote Advance Care Planning.

<b><i>Background:</i></b> The Go Wish Game (GWG) is a practical tool developed to ease advance care planning (ACP) conversations regarding end-of-life (EOL) issues. The game consists of a guide and 35 cards to help persons think about their personal values and priorities in the context of care and to discuss and share those concerns with families and health care professionals (HPs). <b><i>Objectives:</i></b> To promote ACP conversations in the Italian context, we developed an Italian version of the GWG by linguistic translation and cultural adaptation. <b><i>Design:</i></b> Cross-cultural adaptation process developed by Beaton et al. <b><i>Measurements:</i></b> We started with a back-and-forth translation to guarantee linguistic appropriateness. A prefinal Italian version was developed and then qualitatively evaluated by two focus groups (FGs) to assess content validity and cultural appropriateness. Participants' suggestions were discussed by the research groups and included in the final Italian version. <b><i>Data analysis:</i></b> The FGs' transcripts were analyzed by thematic analysis. <b><i>Sample:</i></b> One FG included HPs potentially involved in ACP, the second FG involved representative from local patient associations (RLPAs) with chronic, degenerative, and potentially terminal disease. Participants were purposefully selected. The two FGs involved eight HPs and five RLPAs, respectively. <b><i>Results:</i></b> Fewer explicit statements concerning EOL choices and a broader emphasis on the role of HPs in this discussion characterized the prefinal version. Our analysis identified three themes and five subthemes: (1) <i>improving translation</i>: linguistic redefinition and practical clarification; (2) <i>how to play the GWG</i>: needs and suggestions; and (3) <i>more than a game</i>. <b><i>Conclusion:</i></b> The Italian version developed in this study presents several cultural peculiarities. The rigorous translation and cultural adaptation process applied can enrich the existing literature by spreading a practical tool for initiating ACP in other languages and cultures. Further studies are needed to evaluate this tool's effectiveness in supporting ACP and training HPs to promote the ACP process.

Advance Care Planning in Neurodegenerative Disorders: A Scoping Review.

Advance care planning (ACP) is increasingly acknowledged as a key step to enable patients to define their goals/preferences for future medical care, together with their carers and health professionals. We aimed to map the evidence on ACP in neurodegenerative disorders. We conducted a scoping review by searching PubMed (inception-December 28, 2020) in addition to trial, review, and dissertation registers. From 9367 records, we included 53 studies, mostly conducted in Europe (45%) and US-Canada (41%), within the last five years. Twenty-six percent of studies were qualitative, followed by observational (21%), reviews (19%), randomized controlled trials (RCTs, 19%), quasi-experimental (11%), and mixed-methods (4%). Two-thirds of studies addressed dementia, followed by amyotrophic lateral sclerosis (13%), and brain tumors (9%). The RCT interventions (all in dementia) consisted of educational programs, facilitated discussions, or videos for patients and/or carers. In conclusion, more research is needed to investigate barriers and facilitators of ACP uptake, as well as to develop/test interventions in almost all the neurodegenerative disorders. A common set of outcome measures targeting each discrete ACP behavior, and validated across the different diseases and cultures is also needed.

A Qualitative Study on Nudging and Palliative Care: "An Attractive but Misleading Concept".

The debate about the ethical decision-making process in the healthcare context has been enriched with a theory called "nudging", which has been defined as the framing of information that can significantly influence behaviour without restricting choice. The literature shows very limited data on the opinion and experience of palliative care healthcare professionals on the use of nudging techniques in their care setting. The aim of this study is to explore the beliefs of experienced palliative care professionals towards nudging. We performed a qualitative study using textual data collected through a focus group. It was audio-recorded, and the transcripts were subjected to a thematic analysis. It was performed within an oncological research hospital with a small and multidisciplinary group of healthcare professionals specialised in PC. Participants reported two overarching positions grounded in two main themes: (1) translating nudging in the PC setting and (2) towards a neutral space. The participants found few justifications for the use of nudging in the PC field, even if it can be very attractive and reassuring. Participants also expressed concerns about the excessive risk of developing pure paternalism.

Beyond Lockdown: The Potential Side Effects of the SARS-CoV-2 Pandemic on Public Health.

Lockdowns to contain the spread of the SARS-CoV-2 have disrupted routines and behaviors, which could lead to a worsening of lifestyle and an increase in the burden of non-communicable diseases. This study aimed to describe the changes in physical activity, diet, alcohol drinking, and cigarette smoking during lockdown. A self-administered online survey addressing adults living in a province in northern Italy was advertised through websites and social media. Citizens could access the survey in anonymity from 4 May until 15 June 2020. A total of 1826 adults completed the survey, with a worsening of physical activity (35.1%), diet (17.6%), alcohol drinking (12.5%), and cigarette smoking (7.7%) reported. In contrast, 33.5% reported an improvement in diet, 12.6% in alcohol drinking, 5.3% in physical activity and 4.1% in cigarette smoking. Female sex, young adult age, suspension of work activity, and symptoms of psychological distress were the factors associated with a greater likelihood of change, which was frequently for the worse. Lockdown had an impact on lifestyle, with some net beneficial effects on diet and mostly negative effects on physical activity. Public health measures should be implemented to avoid long-term negative effects of the lockdown, supporting individuals more prone to change for the worse.

Meanings Emerging From Dignity Therapy Among Cancer Patients.

CONTEXT: Generativity is a process whereby patients nearing the end of life invest in those they will soon leave behind. In recent years, the trajectory of cancer has changed, as new therapies have prolonged survival and patients often live with metastatic disease for several years. For these patients and for the healthcare professionals who care for them it can be useful to understand if the concept of generativity is clinically salient. OBJECTIVES: To explore the meanings emerging from two dignity therapy questions, particularly salient to generativity, amongst cancer patients in different care settings. METHODS: We conducted a multicenter, retrospective, qualitative study in 1) home palliative care (life expectancy < 3 months); 2) specialized palliative care provided by team within an oncology hospital (life expectancy > 9-12 months); and 3) oncological day hospital (potentially curable disease). We thematically analyzed the answers of two dignity therapy questions. RESULTS: Three themes and related meanings emerged from 37 dignity therapy sessions with respect to the two questions: 1) Meanings concerning the present life and illness, including the experience of suffering; 2) Thoughts and actions towards the self, including ways in which the patients have felt alive; 3) Thoughts and actions towards significant others, especially values that are based mainly on love for oneself and for others. No notable differences across stages and care settings emerged in terms of the meanings emerging from two dignity therapy questions. CONCLUSION: Conversations about generativity could inform clinicians on how to communicate about existential and meaning-based issues across different stages of illness.

[Artificial intelligence and palliative care: opportunities and limitations.] / Intelligenza artificiale e cure palliative: opportunità e limiti.

The so-called artificial intelligence tools applied to palliative care (machine learning, natural language processing) have great potential to support clinicians in improving decision-making processes and in identifying those who are at high risk of mortality or at greater risk of inappropriate treatment and/or non-positive outcomes. The improvement of prognostic abilities may help to avoid that some choices of patients with serious diseases are taken only in the last days of life, in the face of treatment options not previously discussed in an adequate and shared way. These tools can facilitate some essential aspects in the practice of palliative care, for example the activation of interviews that have as their objective the advance care planning and the definition of treatments consistent with the needs and desires of patients, especially in final stages of life. The development, also in our country, of projects for the application of artificial intelligence in palliative care requires particular attention to the possible organizational repercussions and to some ethical and relational aspects. It will be necessary to reflect on the most appropriate organizational models and on the specialized resources necessary in relation to the foreseeable increase in the number and variability of patients with early identified palliative care needs. These tools must not interfere in fundamental elements of the relationship between patient and doctor, that is the ability to communicate a poor prognosis in an individualized and ethically appropriate way.

"Teach for ethics in palliative care": a mixed-method evaluation of a medical ethics training programme.

BACKGROUND: Training in medical ethics aims to educate health care professionals in dealing with daily care ethical issues. To guarantee quality of life and spiritual and emotional support, palliative care professionals have to develop ethical and relational skills. We propose the implementation and evaluation of a specialized training programme in medical ethics dedicated to a hospital-based Palliative Care Unit. METHODS: This study is a mixed-method before-after evaluation with data triangulation. RESULTS: The results highlight that participants developed their ethical knowledge, and a deeper ethical awareness. They also felt more confident and motivated to widely apply ethical reflections and reasonings in their daily practice. CONCLUSION: The participants appreciated the innovative structure of the training, especially regarding the integration of the theoretical-interactive and practical parts. However, they recommended increasing the number of concrete occasions for ethical supervision and practical application of what they learned during the programme. The training programme also has some potential practical implications: the development of advanced ethical skills within a hospital-based PC team may improve the quality of life of the patients and their families. In addition, health care professionals with advanced ethical competencies are able to educate patients and their families towards more active participation in the decision-making process.

Health professionals learning qualitative research in their workplace: a focused ethnography.

BACKGROUND: The interest for qualitative research methodology has expanded beyond theoretical academic research on medical education, gathering interest from all healthcare professionals. Qualitative research has potentials in exploring the social, emotional, psychological aspects of care and in broadening professionals' scientific competencies. Nonetheless, qualitative research has still not been embraced within formal and academic curricula for future professionals, preventing newer generations from appreciating the value of its epistemological and methodological aspects and from using it in the development and implementation of clinical research. The purpose of this study was to comprehend the attitudes of health professionals learning and conducting qualitative studies within a practical training program developed in their workplace. METHODS: The present work consisted of a focused ethnography, including 14 professionals during their one-year attendance training on qualitative research methodology. Strategies used for collecting data included participant observations, field notes, semi-structured interviews, and a focus group. All the data were analyzed consistently with ethnographic indications. RESULTS: Analyses allowed us to evidence the educational, motivational, group-related and organizational factors influencing the attitudes and skill acquisition of healthcare professionals learning and conducting qualitative research within a practical training program developed in their workplace. Prior educational background was perceived as a sort of barrier. Nonetheless, the training boosted a change in attitude both in terms of appreciation of the research approach and trainees' emotional involvement with research participants. Doing a qualitative study in a multidisciplinary team raised in-group dynamics that hindered bringing the studies to conclusion. Trainees repeatedly lamented the difficulty in managing time to devote to research-related activities and questioned the feasibility of adopting this methodology for conducting research in their workplace. CONCLUSIONS: Continual education training on the methodological aspects and practical implications of qualitative research may foster a renewed attitude towards one's professional education, while making inter-professional relationship issues emerge. Nonetheless, broadening the perspectives of professionals on their clinical practice by means of learning qualitative methodology may have an evident quality improvement return. Strategies for future qualitative research methodology hands-on training addressed to health professionals in continuing education are proposed.

"I go into crisis when ": ethics of care and moral dilemmas in palliative care.

BACKGROUND: Recognising and knowing how to manage ethical issues and moral dilemmas can be considered an ethical skill. In this study, ethics of care is used as a theoretical framework and as a regulatory criterion in the relationship among healthcare professionals, patients with palliative care needs and family members. This study is a part of a larger project aimed at developing and implementing a training programme on "ethical communication" addressed to professionals caring for patients with palliative care needs. The aim of this study was comprehending whether and how the ethics of care informs the way healthcare professionals make sense of and handle ethical issues in palliative care. METHODS: Qualitative study employing a theoretically driven thematic analysis performed on semi-structured interviews. The research was conducted in a clinical cancer centre in northern Italy. Eligible participants were physicians and nurses from eleven hospital wards who assisted patients with chronic advanced disease daily and had previously attended a 4-h training on palliative care held by the hospital Palliative Care Unit. RESULTS: The researchers identified five themes: morality is providing global care; morality is knowing how to have a relationship with patients; morality is recognizing moral principles; moral dimension and communication; and moral dilemmas are individual conflicts. CONCLUSIONS: Ethics of care seems to emerge as a theoretical framework that includes the belief systems of healthcare professionals, especially those assisting patients with palliative care needs; moreover, it allows the values of both the patients and professionals to come to light through the relationship of care. Ethics of care is also appropriate as a framework for ethical training.

Compassionate use programs in Italy: ethical guidelines.

BACKGROUND: This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP. MAIN BODY: The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case (proposing physician and palliative physician) and with 3 components of the EC who played a major role in the EC internal discussion. CONCLUSIONS: In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient's quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the "simultaneous care" approach must be preferred. Secondly, 2) the EC's assessment must be part of the decision-making process that the care team conducts before proposing compassionate use to the patient.