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.

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.

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.

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.

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.

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.

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.

'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.

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.

"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.

[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.

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.

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.

A qualitative study with Italian patients exploring the spiritual dimension during a chronic disease.

BACKGROUND: Spirituality is a vast dimension influenced by cultural and personal differences. Little is known about the spirituality of patients suffering from a chronic disease in Italy from palliative care hospital settings. AIM: To investigate patients' perspectives about their spirituality during their illness. METHOD: The research question was: 'How does living with chronic disease inform/shape the spiritual dimension of patients?'. To address it, we conducted a qualitative interview study with thematic analysis. RESULTS: We enrolled 21 participants among patients suffering from rheumatic, haematologic, neurodegenerative and respiratory chronic diseases. Participants generally had great difficulty answering the questions researchers posed and often could not define 'spirituality'. We found different topics grouped under four main themes: definition of spirituality, internal dialogue, expression of spirituality in everyday life and take stock. Religion is not reported as an answer to spiritual suffering, even in a country that is felt religious-driven like Italy. DISCUSSION: Patients are generally not cognizant of this dimension even living with a chronic disease; consequently, they cannot express spiritual needs because they can't recognise them. Health professionals should identify this dimension and its characteristics to recognise potential spiritual suffering.

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.