[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.

User appraisal of a booklet for advance care planning in multiple sclerosis: a multicenter, qualitative Italian study.

OBJECTIVES: Implementation of advance care planning (ACP) in people with progressive multiple sclerosis (PwPMS) is limited. We aimed to involve users (PwPMS, significant others, and healthcare professionals involved in PwPMS care) in the evaluation and refinement of a booklet to be used during the ACP conversations. METHODS: This qualitative study consisted of cognitive interviews with PwPMS and significant others and a focus group with healthcare professionals from three Italian centers. We analyzed the interviews using the framework method and the focus group using thematic analysis. RESULTS: We interviewed 10 PwPMS (3 women; median age 54 years; median Expanded Disability Status Scale score 6.0) and three significant others (2 women; 2 spouses and one daughter). The analysis yielded three themes: booklet comprehensibility and clarity, content acceptability and emotional impact, and suggestions for improvement. Twelve healthcare professionals (7 neurologists, 3 psychologists, one nurse, and one physiotherapist) participated in the focus group, whose analysis identified two themes: booklet's content importance and clarity and challenges to ACP implementation. Based on analysis results, we revised the booklet (text, layout, and pictures) and held a second-round interviews with two PwPMS and one significant other. The interviewees agreed on the revisions but reaffirmed their difficulty in dealing with the topic and the need for a physician when using the booklet. CONCLUSIONS: Appraisal of the booklet was instrumental in improving its acceptability and understandability before using it in the ConCure-SM feasibility trial. Furthermore, our data reveal a lack of familiarity with ACP practice in the Italian context.

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.

Italian cross-cultural adaptation of the Quality of Communication questionnaire and the 4-item advance care planning engagement questionnaire.

BACKGROUND: Advance care planning (ACP) is influenced by several factors (e.g., patient's readiness to engage, clinician's skills, and the cultural environment). Availability of reliable and valid self-reported measures of the ACP domains is crucial, including cross-cultural equivalence. AIM: To culturally adapt into Italian the 19-item Quality of Communication (QOC) and the 4-item ACP Engagement (4-item ACP-E) questionnaires. METHODS: We translated and culturally adapted the two questionnaires and produced a significant other (SO) version of the QOC (QOC-SO). Each questionnaire was field tested via cognitive interviews with users: nine patients (QOC, 4-item ACP-E) and three SOs (QOC-SO) enrolled at three palliative care services. RESULTS: We made minor changes to 5/19 QOC items, to improve clarity and internal consistency; we changed the response option 'didn't do' into 'not applicable'. Finally, we slightly revised the QOC to adapt it to the paper/electronic format. QOC debriefing revealed that the section on end of life was emotionally challenging for both patients and SOs. We simplified the 4-item ACP-E layout, added a sentence in the introduction, and revised the wording of one item, to improve coherence with the Italian ACP legislation. ACP-E debriefing did not reveal any major issue. CONCLUSIONS: Results were satisfactory in terms of semantic, conceptual and normative equivalence of both questionnaires. Acceptability was satisfactory for the 4-item ACP-E, while findings of the QOC cognitive debriefing informed a major amendment of a pilot trial protocol on ACP in multiple sclerosis (ConCure-SM): use of the interviewer version only, in an adaptive form. Psychometric testing of both questionnaires on a large, independent sample will follow.

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.

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.

Among equity and dignity: an argument-based review of European ethical guidelines under COVID-19.

BACKGROUND: Under COVID-19 pandemic, many organizations developed guidelines to deal with the ethical aspects of resources allocation. This study describes the results of an argument-based review of ethical guidelines developed at the European level. It aims to increase knowledge and awareness about the moral relevance of the outbreak, especially as regards the balance of equity and dignity in clinical practice and patient's care. METHOD: According to the argument-based review framework, we started our research from the following two questions: what are the ethical principles adopted by the ethical guidelines produced at the beginning of the COVID-19 outbreak related to resource allocation? And what are the practical consequences in terms of 'priority' of access, access criteria, management of the decision-making process and patient care? RESULTS: Twenty-two ethical guidelines met our inclusion criteria and the results of our analysis are organized into 4 ethical concepts and related arguments: the equity principle and emerging ethical theories; triage criteria; respecting patient's dignity, and decision making and quality of care. CONCLUSION: Further studies can investigate the practical consequences of the application of the guidelines described, in terms of quality of care and health care professionals' moral distress.

'Too late or too soon': The ethics of advance care planning in dementia setting.

Advance care planning (ACP) is considered a pivotal aid in the decision-making process, especially for many people living with dementia, who inevitably will lose the capacity to make decisions at the end of life. In Italy, ACP has been recently regulated by law 219/2017, leading to the investigation of how physicians deal with ACP in dementia. In order to comprehend the perception of physicians who provide care for patients with dementia regarding ACP and to describe their difficulties and needs, this study presents the results of a qualitative research study performed within a local health authority in northern Italy. Data were collected by semi-structured interviews with 11 physicians dealing with patients with dementia and were analysed using interpretative phenomenological analysis. Four superordinate themes were identified, describing both the difficulties and challenges perceived by physicians in performing shared ACP in their daily activities. This study demonstrates that physicians experience troubles synchronizing the time of shared ACP with the more rapid development of dementia. Results also suggest that further training about communication on ACP is urgently required to ease the implementation of shared ACP. A broader involvement of institutions and other professionals is also important in spreading ACP among healthcare institutions.

"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.

The necessity of ethical support for health care professionals in Intensive Care: Role and competencies of the Clinical Ethics Committee / La necesidad de apoyo ético para los profesionales de la salud en Medicina Intensiva: papel y competencias del Comité de Ética Asistencial / La necessitat de suport ètic per a professionals de la salut en Medicina Intensiva: paper I competències del Comitè d'Ètica Assistencial

Promoting measures that aim to mitigate discrepancies in the decision-making process, ensuring adequate training of physicians in the ethical aspect of care, and incrementing the wellbeing of patients and their families are becoming the principal objectives for high-quality care, especially in the Intensive Medicine Unit (ICU). In this paper, we're going to deal with the implementation of a specific ethics support for the ICU health care professionals, and considering the advanced Spanish experience on this matter, it deals with the current potentialities and limits of CEC's role to improve the quality of health care assistance

Promover medidas que tengan como objetivo mitigar las discrepancias en el proceso de toma de decisiones, garantizar la capacitación adecuada de los médicos en el aspecto ético de la atención e incrementar el bienestar de los pacientes y sus familias se están convirtiendo en los objetivos principales para una atención de alta calidad, especialmente en Medicina Intensiva. En este artículo abordaremos la implementación de un apoyo ético específico para los profesionales de la salud de la UCI. Teniendo en cuenta la amplia experiencia española en este tema, nos centraremos en el potencial y los límites actuales del rol del CEA para mejorar la calidad de asistencia sanitaria

Promoure mesures que tinguin com a objectiu mitigar els discrepàncies en el procés de presa de decisions, garantir la capacitació adequada dels metges respecte a l'aspecte ètic de l'atenció I incrementar el benestar dels pacients I els seves families s'estan convertint en els objectius principals per a una atenció de qualitat, especialment a Medicina Intensiva. En aquest article abordarem la implementació d'un soport ètic específic per a professionals de la salut de l'UCI. Tenint en compte l'àmplia experiència espanyola en aquest tema, ens centrarem en el potencial I els límits actuals del rol del CEA per a millorar la qualitat de l'assistència sanitària

Clinical ethics consultation among Italian ethics committee: A mixed method study.

OBJECTIVE: The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings. METHODS: The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants. RESULTS: Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents. CONCLUSION: To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.