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.

Italian health professionals on the mandatory COVID-19 vaccine: An online cross-sectional survey.

Italy was the first country in Europe to make vaccination against COVID-19 mandatory for healthcare professionals by imposing restrictions in cases of non-compliance. This study investigates the opinions of the Italian healthcare professionals' categories affected by the regulation. We performed a qualitative online survey: the questionnaire comprised both close- and open-ended questions. The final dataset included n = 4,677 valid responses. Responses to closed-ended questions were analyzed with descriptive statistics. The framework method was applied for analyzing the open-ended questions. The sample spanned all health professions subject to compulsory vaccination, with a prevalence of physicians (43.8%) and nurses (26.3%). The vaccine adhesion before the introduction of the obligation was substantial. 10.4% declared not to have adhered to the vaccination proposal. Thirty-five percent of HPs who opted not to get vaccinated said they experienced consequences related to their choice. The trust in the vaccine seems slightly cracked, demonstrating overall vaccine confidence among professionals. Nonetheless, our results show that whether (or not) professionals adhere to vaccination is not a reliable indicator of consent to how it was achieved. There are criticisms about the lawfulness of the obligation. The data show a great variety of participants interpreting their roles concerning public and individual ethics. The scientific evidence motivates ethics-related decisions-the epidemic of confusing and incorrect information affected professionals. The Law triggered an increased disaffection with the health system and conflicts between professionals. Dealing with the working climate should be a commitment to assume soon.

Study protocol on advance care planning in multiple sclerosis (ConCure-SM): intervention construction and multicentre feasibility trial.

INTRODUCTION: Multiple sclerosis (MS) is the most common cause of progressive neurological disability in young adults. The use of advance care planning (ACP) for people with progressive MS (pwPMS) remains limited. The ConCure-SM project aims to assess the effectiveness of a structured ACP intervention for pwPMS. The intervention consists of a training programme on ACP for healthcare professionals caring for pwPMS, and a booklet to be used during the ACP conversation. Herein, we describe the first two project phases. METHODS: In phase 1 we translated and adapted, to the Italian legislation and MS context, the ACP booklet of the National ACP Programme for New Zealand. Acceptability, comprehensibility and usefulness of the booklet were assessed via 13 personal cognitive interviews with pwPMS and significant others (SOs), and one health professional focus group. Based on these findings, we will revise the booklet. In phase 2 we will conduct a single-arm pilot/feasibility trial with nested qualitative study. Participants will be 40 pwPMS, their SOs, health professionals from six MS and rehabilitation centres in Italy. In the 6 months following the ACP conversation, we will assess completion of an advance care plan document (primary outcome), as well as safety of the intervention. Secondary outcomes will be a range of measures to capture the full process of ACP; patient-carer congruence in treatment preferences; quality of patient-clinician communication and caregiver burden. A qualitative process evaluation will help understand the factors likely to influence future implementation and scalability of the intervention. ETHICS AND DISSEMINATION: The project is coleaded by a neurologist and a bioethicist. Phase 1 has received ethical approvals from each participating centre, while phase 2 will be submitted to the centres in May 2021. Findings from both phases will be disseminated widely through peer-reviewed publications, conferences and workshops. TRIAL REGISTRATION NUMBER: ISRCTN48527663; Pre-results.

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.

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.