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The integration of patient-reported outcomes and experiences through PROMs and PREMs tools represents a significant evolution in the quality of care and clinical practice. This article reviews the state of the art and the application experiences of these tools, focusing on their impact on the management of cardiovascular diseases. The use of PROMs and PREMs allows for a more comprehensive assessment of patient well-being by integrating with traditional clinical indicators. An increasing number of studies suggests that the systematic collection of these data can help physicians in better identifying individual patient's needs, improving doctor-patient communication, and personalizing therapies. In aggregate form, these data can be used to improve the quality of services. This article explores the main international experiences, starting from the activities carried out in this field by the European Society of Cardiology, the challenges in implementing such tools, and the prospects for a more widespread adoption in daily clinical practice. It emphasizes the activities carried out in Italy by the Fondazione Toscana Gabriele Monasterio and the Management and Healthcare Laboratory of the Scuola Superiore Sant'Anna of Pisa, highlighting the importance of validated tools, appropriate technologies, and a cultural change to promote patient-centered care.

Providing timely and satisficing End-of-Life care (EOLC) is a priority for healthcare systems since aging population and chronic diseases are boosting the global demand for care at end-of-life (EOL). In OECD countries the access to EOLC is insufficient. In Italy, the average rate of cancer patients assisted by the palliative care (PC) network at EOL was 28% in 2021, with high variability in the country. Among the Italian regions offering the best coverages, Tuscany has a rate of about 40%, but intraregional variation is marked as well. The study aims to explore the delivery of EOLC to adult cancer patients in public facilities in the Tuscany region through survey data collection among professionals. Two online surveys were delivered to Directors of community-based PC Functional-Units (FUs) and Directors of hospital-based medical-oncology units. All FU Directors responded to the survey (n = 14), and a response rate of 96% was achieved from hospital-unit Directors (n = 27). The results highlight the availability of numerous dedicated services, but reveal heterogeneity among and within organisations, including variations in the professionals involved, pathways, and tools adopted. Care continuity is supported by institutionalized collaboration between hospital and community settings, but hindered by fragmented care processes and heterogeneous transition pathways. Late referral to PC is perceived as a major constraint to EOLC. Developing structured pathways for patient transition to end-stage PC is crucial, and practices/processes should be uniformly implemented to ensure equity. Multi-professional care should be facilitated through tailored supporting tools. Both hospital-unit and FU Directors suggest developing shared pathways between organisations/professionals (82% and 80% respectively) and digital information sharing (61% and 80% respectively). Hospital and community-based professionals have similar perceptions about the concerns and challenges to EOLC provision in the region, but community-based professionals are more sensitive to the importance of improving communication on PC to the public and early discussing EOLC with caregivers. This finding suggests the need of enhancing hospital personnel's awareness about these issues. Professional training and the capacity to assess patients' needs and preferences should be improved. The identified needs can inform future research and interventions to improve the quality and outcomes of EOLC for cancer patients., (© 2024. The Author(s).)

Objective: To investigate end-of-life (EoL) care for heart failure (HF) in Tuscany (Italy) from healthcare professionals' perspective and identify areas for intervention., Methods: All the directors of Cardiology units (n = 29) and palliative care (PC) units (n = 14) in Tuscany were surveyed on the practices of EoL care., Results: Forty-five percent of cardiologists reported that their hospital had some EoL care services for HF patients. However, 75% did not have a multidisciplinary team providing EoL care for HF patients. Sixty-four percent stated that <25% of patients who might benefit from PC did receive it, and 18% stated that no patient received PC. For most of PC specialists, HF patients accounted for <25% of their patients. PC specialists believed that patients with cancer diseases were much more likely to receive PC than HF patients at EoL, and 36% judged that almost no HF patients were timely referred to hospice care. The majority of PC specialists reported that almost no HF patient prepared advance healthcare directives, as opposite to 57% for cancer patients, suggesting poor understanding or acceptance of their terminal condition., Conclusions: The management of HF patients in the EoL stage in Tuscany is often suboptimal. EoL care should be implemented to ensure an adequate quality of life to these patients., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Transthyretin cardiac amyloidosis (ATTR-CA) has a deep impact on the quality of life (QoL), yet no specific patient-reported outcome measures (PROMs) for ATTR-CA exist., Methods: The ITALY study involved 5 Italian referral centres (Pisa, Pavia, Ferrara, Florence, Messina) enrolling consecutive outpatients with ATTR-CA., Results: Two 30-item questionnaires were created for wild-type (wt) and variant (v) ATTR-CA. Scores ranged from 100 (best condition) to 0 (worst condition). Out of 140 patients enrolled (77% with ATTRwt-CA), 115 repeated the re-evaluation at 6 months. At baseline, only 30% of patients needed help to fill out the questionnaires. Among baseline variables, all KCCQ and SF-36 domains were univariate predictors of ITALY scores in ATTRwt-CA patients, with the KCCQ Symptom Summary score (beta coefficient 0.759), Social Limitations (0.781), and Overall summary score (0.786) being the strongest predictors. The SF-36 Emotional well-being score (0.608), the KCCQ Overall summary score (0.656), and the SF-36 Energy/fatigue score (0.669) were the strongest univariate predictors of ITALY scores in ATTRv-CA. Similar results were found at 6 months., Conclusions: The ITALY questionnaires are the first specific PROMs for ATTRwt- and ATTRv-CA. Questionnaire completion is feasible. ITALY scores display close relationships with non-ATTR-specific measures of QoL.

The decline in children's vaccination coverage and the resurgence of preventable infectious diseases draw attention to parents' vaccine hesitancy. Our study introduces two validated tools to independently assess vaccine hesitancy and health literacy among parents with school-age children. We developed a Vaccine Confidence Index (VCI) from 10 Likert items, exploring their relationships through exploratory and confirmatory factor analyses. We modified the IMETER (Italian medical term recognition test) to measure health literacy. We assessed the internal consistency of the modified IMETER and the 10 Likert items using Cronbach's alpha test (α) and McDonald's omega total coefficient (ω) with good results (ω = 0.92, α = 0.90; ω = 0.87, α = 0.82 respectively). We used these tools within a questionnaire conducted on 743 parents recruited from pediatric clinic waiting rooms in Italy, collecting demographic data, information sources on vaccines and vaccine-preventable diseases knowledge. The VCI resulting from factor analyses consisted of six items on a ten-point Likert scale, reflecting the ratio of positive to negative items. The survey revealed significant variations in the VCI according to individual features such as education, use of social networks, or Health institutions as sources of information. Multivariate logistic regression identified an association between vaccine intention and the VCI. Health literacy was functional for 91.2% of participants, but knowledge about vaccine-preventable diseases was generally low. The VCI showed no significant association with health literacy and vaccine-preventable diseases knowledge. The VCI and the modified IMETER effectively assess vaccination attitude and health literacy, offering valuable public health tools for tailoring vaccination campaigns to hesitant population subgroups.

In Europe, National Immunisation Technical Advisory Groups (NITAGs) were established in most countries to promote evidence-informed decision-making in introducing new or improved vaccines or changing recommendations for existing ones. Still, the role, activities and outcomes of NITAGs have not been optimally implemented across Europe. Within the European Joint Action on Vaccination (EU-JAV), we conducted a survey to collect information on decision-making process including the main criteria for the introduction of new vaccines or changes to recommendations on their use. Between December 2021 and January 2022, 13 of the 28 European countries invited participated in an online survey. The criteria ranked as most relevant were disease burden and availability of financial resources. Only one country specified that the NITAG recommendations were binding for the government or the health authority. Vaccinations more often reported for introduction or recommendation changes were those against herpes zoster, influenza, human papillomavirus infection, pneumococcal and meningococcal disease. The planned changes will mainly address children and adolescents (2-18 years) and adults (≥ 45-65 years). Our findings show potential overlaps in the activities of NITAGs between countries; and therefore, collaboration between NITAGs may lead to optimisation of the workload and better use of resources.

Sepsis is a life-threatening condition characterized by uncontrolled systemic inflammation and coagulation, leading to multiorgan failure. Therapeutic options to prevent sepsis-associated immunopathology remain scarce. Here, we established a mouse model of long-lasting disease tolerance during severe sepsis, manifested by diminished immunothrombosis and organ damage in spite of a high pathogen burden. We found that both neutrophils and B cells emerged as key regulators of tissue integrity. Enduring changes in the transcriptional profile of neutrophils include upregulated Cxcr4 expression in protected, tolerant hosts. Neutrophil Cxcr4 upregulation required the presence of B cells, suggesting that B cells promoted disease tolerance by improving tissue damage control via the suppression of neutrophils' tissue-damaging properties. Finally, therapeutic administration of a Cxcr4 agonist successfully promoted tissue damage control and prevented liver damage during sepsis. Our findings highlight the importance of a critical B-cell/neutrophil interaction during sepsis and establish neutrophil Cxcr4 activation as a potential means to promote disease tolerance during sepsis., Competing Interests: RG, BM, GO, MW, AG, FQ, AF, KL, AH, AK, AA, IM, FO, FO, JB, IL, CB, SK No competing interests declared, LB is affiliated with Polypharma Biologics. The author has no financial interests to declare, (© 2022, Gawish et al.)

Higher education institutions (HEIs) worldwide have been deeply affected by the Coronavirus Disease 2019 (COVID-19) pandemic and subsequent lockdown measures. HEIs are environments at high risk of COVID-19 diffusion, due to the high number of people sharing the same environment, and complex to protect, because of the multiple functions present (e.g. teaching rooms, research facilities, dormitories). Protection of HEIs is therefore a serious, but apparently neglect, public health issue. Italy was the first country to be heavily hit in Europe by COVID-19. Italian HEIs had to quickly respond to the emergency with multifaceted interventions to protect all the people on campus while guaranteeing the continuity of research and teaching activities. The purpose of this viewpoint is to propose and discuss a list of priority actions for the protection of HEIs, based on international guidelines and the experience of a small size Italian Public University and Research campus.

Rationale: Lung transplantation is the ultimate treatment option for patients with end-stage respiratory diseases but bears the highest mortality rate among all solid organ transplantations due to chronic lung allograft dysfunction (CLAD). The mechanisms leading to CLAD remain elusive due to an insufficient understanding of the complex post-transplant adaptation processes., Objectives: To better understand these lung adaptation processes after transplantation and to investigate their association with future changes in allograft function., Methods: We performed an exploratory cohort study of bronchoalveolar lavage samples from 78 lung recipients and donors. We analysed the alveolar microbiome using 16S rRNA sequencing, the cellular composition using flow cytometry, as well as metabolome and lipidome profiling., Measurements and Main Results: We established distinct temporal dynamics for each of the analysed data sets. Comparing matched donor and recipient samples, we revealed that recipient-specific as well as environmental factors, rather than the donor microbiome, shape the long-term lung microbiome. We further discovered that the abundance of certain bacterial strains correlated with underlying lung diseases even after transplantation. A decline in forced expiratory volume during the first second (FEV 1 ) is a major characteristic of lung allograft dysfunction in transplant recipients. By using a machine learning approach, we could accurately predict future changes in FEV 1 from our multi-omics data, whereby microbial profiles showed a particularly high predictive power., Conclusion: Bronchoalveolar microbiome, cellular composition, metabolome and lipidome show specific temporal dynamics after lung transplantation. The lung microbiome can predict future changes in lung function with high precision., Competing Interests: Conflict of interest: M.L. Watzenböck has nothing to disclose. Conflict of interest: A.-D. Gorki has nothing to disclose. Conflict of interest: F. Quattrone has nothing to disclose. Conflict of interest: R. Gawish has nothing to disclose. Conflict of interest: S. Schwarz has nothing to disclose. Conflict of interest: C. Lambers has nothing to disclose. Conflict of interest: P. Jaksch has nothing to disclose. Conflict of interest: K. Lakovits has nothing to disclose. Conflict of interest: S. Zahalka has nothing to disclose. Conflict of interest: N. Rahimi has nothing to disclose. Conflict of interest: P. Starkl has nothing to disclose. Conflict of interest: D. Symmank has nothing to disclose. Conflict of interest: T. Artner has nothing to disclose. Conflict of interest: C. Pattaroni has nothing to disclose. Conflict of interest: N. Fortelny has nothing to disclose. Conflict of interest: K. Klavins has nothing to disclose. Conflict of interest: F. Frommlet has nothing to disclose. Conflict of interest: B.J. Marsland has nothing to disclose. Conflict of interest: K. Hoetzenecker has nothing to disclose. Conflict of interest: S. Widder reports grants from Austrian Science Fund (Elise Richter V585-B31), during the conduct of the study. Conflict of interest: S. Knapp reports grants from FWF, during the conduct of the study., (Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.)

Background: Amyloid transthyretin (ATTR) amyloidosis is caused by the systemic deposition of transthyretin molecules, either normal (wild-type ATTR, ATTRwt) or mutated (variant ATTR, ATTRv). ATTR amyloidosis is a disease with a severe impact on patients' quality of life (QoL). Nonetheless, limited attention has been paid to QoL so far, and no specific tools for QoL assessment in ATTR amyloidosis currently exist. QoL can be evaluated through patient-reported outcome measures (PROMs), which are completed by patients, or through scales, which are compiled by clinicians. The scales investigate QoL either directly or indirectly, i.e., by assessing the degree of functional impairment and limitations imposed by the disease., Design: Search for the measures of QoL evaluated in phase 2 and phase 3 clinical trials on ATTR amyloidosis., Results: Clinical trials on ATTR amyloidosis have used measures of general health status, such as the Short Form 36 Health Survey (SF-36), or tools developed in other disease settings such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) or adaptations of other scales such as the modified Neuropathy Impairment Score +7 (mNIS+7)., Conclusions: Scales or PROMs for ATTR amyloidosis would be useful to better characterize newly diagnosed patients and to assess disease progression and response to treatment. The ongoing ITALY (Impact of Transthyretin Amyloidosis on Life qualitY) study aims to develop and validate 2 PROMs encompassing the whole phenotypic spectrum of ATTRwt and ATTRv amyloidosis, that might be helpful for patient management and may serve as surrogate endpoints for clinical trials., (© 2021 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting.)

Our online randomized controlled trial on 6230 healthcare workers (HCWs) tests the impact that three nudges - social norms, reminding the impact on beneficiaries, and defaults - have on the intention to vaccinate against seasonal influenza across job families. Willingness to get a flu shot was higher among subjects invited to imagine themselves working at the local health authority (LHA) with the greatest immunization coverage within their region relative to their counterparts prompted to imagine working at the LHA with the lowest coverage. Reminding the impact of flu vaccination on beneficiaries had different effects across job families, with physicians caring more benefits for themselves, nurses about patients' benefits, and technicians about family and friends. Default responses anchoring toward a high rather than a low vaccination intention increased the willingness to immunize among all HCW except physicians. Targeted nudges can be considered in developing interventions to promote influenza vaccination among HCWs., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Lipocalin 2 (LCN2) is a secreted glycoprotein with roles in multiple biological processes. It contributes to host defense by interference with bacterial iron uptake and exerts immunomodulatory functions in various diseases. Here, we aimed to characterize the function of LCN2 in lung macrophages and dendritic cells (DCs) using Lcn2-/- mice. Transcriptome analysis revealed strong LCN2-related effects in CD103+ DCs during homeostasis, with differential regulation of antigen processing and presentation and antiviral immunity pathways. We next validated the relevance of LCN2 in a mouse model of influenza infection, wherein LCN2 protected from excessive weight loss and improved survival. LCN2-deficiency was associated with enlarged mediastinal lymph nodes and increased lung T cell numbers, indicating a dysregulated immune response to influenza infection. Depletion of CD8+ T cells equalized weight loss between WT and Lcn2-/- mice, proving that LCN2 protects from excessive disease morbidity by dampening CD8+ T cell responses. In vivo T cell chimerism and in vitro T cell proliferation assays indicated that improved antigen processing by CD103+ DCs, rather than T cell intrinsic effects of LCN2, contribute to the exacerbated T cell response. Considering the antibacterial potential of LCN2 and that commensal microbes can modulate antiviral immune responses, we speculated that LCN2 might cause the observed influenza phenotype via the microbiome. Comparing the lung and gut microbiome of WT and Lcn2-/- mice by 16S rRNA gene sequencing, we observed profound effects of LCN2 on gut microbial composition. Interestingly, antibiotic treatment or co-housing of WT and Lcn2-/- mice prior to influenza infection equalized lung CD8+ T cell counts, suggesting that the LCN2-related effects are mediated by the microbiome. In summary, our results highlight a novel regulatory function of LCN2 in the modulation of antiviral immunity., Competing Interests: The authors have declared that no competing interests exist.

This article explores why governments do not respond to public compliance problems in a timely manner with appropriate instruments, and the consequences of their failure to do so. Utilising a case study of Italian vaccination policy, the article considers counterfactuals and the challenges of governing health policy in an age of disinformation. It counterposes two methods of governing vaccination compliance: discipline , which uses public institutions to inculcate the population with favourable attitudes and practices, and modulation , which uses access to public institutions as a form of control. The Italian government ineffectively employed discipline for a number of years. Epistemological and organisational constraints stymied its efforts to tackle a significant childhood vaccination compliance problem. With a loss of control over the information environment, vaccinations were not served well by exogenous crises, the sensationalism of the news cycle and online misinformation. Hampered by austerity, lack of capacity and epistemic shortcomings, the Italian government did not protect the public legitimacy of the vaccination programme. Instead of employing communications to reassure a hesitant population, they focused on systemic and delivery issues, until it was too late to do anything except make vaccinations mandatory (using modulation). The apparent short-term success of this measure in generating population compliance does not foreclose the need for ongoing governance of vaccine confidence through effective discipline. This is evident for the COVID-19 vaccination campaign, with many Italians still indicating that they would not accept a vaccine despite the devastation that the disease has wrought throughout their country., Competing Interests: Conflict of interestThe lead author is a recipient of an Australia Research Council Discovery Early Career Researcher Award from the Australian Government, grant number DE190100158. The funder has had no involvement in any of the academic content of this work. She has previously received speaker’s fees from Merck, conference and registration fees from GSK and consulted for the Government of Western Australia. She also previously received an unrestricted research grant from Sanofi. The other authors have no conflict to report., (© The Author(s) 2021.)