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Background: Shared decision-making (SDM) plays a crucial role in breast cancer care by empowering patients and reducing decision regret. Patient decision aids (PtDAs) are valuable tools for facilitating SDM, now available in digital and artificial intelligence (AI)-powered formats to offer increasingly personalized contents. The ongoing CINDERELLA clinical trial (ClinicalTrials.gov: NCT05196269) evaluates an innovative AI cloud-based approach using a web platform and a mobile application (CINDERELLA APProach) versus the conventional approach to support SDM in breast cancer patients undergoing locoregional treatment. This protocol outlines a trial-based multidimensional evaluation, encompassing economic, financial, implementability, and environmental considerations associated with the CINDERELLA APProach., Methods: A within-trial cost-consequence and cost-utility analysis from a societal perspective will be performed using patient-level data on outcomes and resource use. The latter will be valued in monetary terms using country-specific unit costs or patient valuations. A budget impact analysis will be performed over 1 and 5 years from the budget holder perspectives. The CINDERELLA APProach implementability will be assessed through an evaluation of its usability, acceptability, organizational impact, and overall feasibility. The environmental impact will be quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data for the evaluation will be gathered from patient questionnaires, interviews with patients and managers, focus groups with healthcare professionals, and app electronic data., Discussion: A thorough understanding of the broad consequences of the CINDERELLA APProach may foster its successful translation into real-world settings, hopefully benefiting breast cancer patients and clinical practice., (© 2024. The Author(s).)

Background: the peer-review process, which is the foundation of modern scientific production, represents one of its essential elements. However, despite numerous benefits, it presents several critical issues., Objectives: to collect the opinions of a group of researchers from the epidemiological scientific community on peer-review processes., Design: cross-sectional study using a questionnaire evaluation., Setting and Participants: a 29-question survey was administered to 516 healthcare professionals through the SurveyMonkey platform. The questions focused on the individual characteristics of the respondents and their perceived satisfaction with some characteristics of the review process as well as their propensity of changing some aspects of it. In addition, three open-ended questions were included, allowing respondents to provide comments on the role that reviewers and the review process should play. Descriptive statistics were produced in terms of absolute frequencies and percentages for the information collected through the questionnaire. Secondly, a multiple logistic regression analysis was conducted to assess the willingness to change certain aspects of peer review, adjusting for covariates such as age, sex, being the author of at least one scientific work, being a reviewer of at least one scientific work, and belonging to a specific discipline. The results are expressed as odds ratios (ORs) and their 95% confidence intervals (95%CI). Text analysis and representation using word cloud were also used for an open-ended question., Main Outcomes Measures: level of satisfaction regarding some characteristics of the peer-review process., Results: a total of 516 participants completed the questionnaire. Specifically, 87.2% (N. 450) of the participants were the authors of at least one scientific publication, 78.7% were first authors at least once (N. 406), and 71.5% acted as reviewers within the peer-review process (N. 369). The results obtained from the multiple logistic regression models did not highlight any significant differences in terms of propensity to change for age and sex categories, except for a lower propensity of the under 35 age group towards unmasking, defined as the presence of reviewers and editorial boards names on the publish article (OR <35 years vs 45-54 years: 0.51; 95%CI 0.29-0.89) and a higher propensity for post-formatting proposals, defined as the possibility of formatting the article following journal guidelines after the acceptance, among those under 45 (OR <35 years vs 45-54 years: 1.73; 95%CI 0.90-3.31; OR 35-44 years vs 45-54 years: 2.02; 95%CI 1.10-3.72). Finally, approximately 50% of respondents found it appropriate to receive credits for the revision work performed, while approximately 30% found it appropriate to receive a discount on publication fees for the same journal in which they acted as reviewers., Conclusions: the peer-review process is considered essential, but imperfect, by the professionals who participated in the questionnaire, thus providing a clear picture of the value that peer-review adds rigorously to each scientific work and the need to continue constructive dialogue on this topic within the scientific community.

Background: During the last decade, planning concentration policies have been applied in healthcare systems. Among them, attention has been given to guiding patients towards high-volume hospitals that perform better, acccording to the volume-outcome association. This paper analyses which factors drive patients to choose big or small hospitals (with respect to the international standards of volumes of activity)., Methods: We examined colon cancer surgeries performed in Piedmont (Italy) between 2004 and 2018. We categorised the patient choice of the hospital as big/small, and we used this outcome as main dependent variable of descriptive statistics, tests and logistic regression models. As independent variables, we included (i) patient characteristics, (ii) characteristics of the closest big hospital (which should be perceived as the most immediate to be chosen), and (iii) territorial characteristics (i.e., characteristics of the set of hospitals among which the patient can choose). We also considered interactions among variables to examine which factors influence all or a subset of patients., Results: Our results confirm that patient personal characteristics (such as age) and hospital characteristics (such as distance) play a primary role in the patient decision process. The findings seem to support the importance of closing small hospitals when they are close to big hospitals, although differences emerge between rural and urban areas. Other interesting insights are provided by examining the interactions between factors, e.g., patients affected by comorbidities are more responsive to hospital quality even though they are distant., Conclusions: Reorganising healthcare services to concentrate them in high-volume hospitals emerged as a crucial issue more than forty years ago. Evidence suggests that concentration strategies guarantee better clinical performance. However, in healthcare systems in which patients are free to choose where to be treated, understanding patients' behaviour and what drives them towards the most effective choice is of paramount importance. Our study builds on previous research that has already analysed factors influencing patients' choices, and takes a step further to enlighten which factors drive patients to choose between a small or a big hospital (in terms of volume). The results could be used by decision makers to design the best concentration strategy., (© 2023. The Author(s).)

Background: The risk of proximal femoral fractures increases with aging, causing significant morbidity, disability, mortality and socioeconomic pressure. The aims of the present work are (1) to investigate the epidemiology and incidence of these fractures among the elderly in the Region of Lombardy; (2) to identify the factors influencing survival; (3) to identify the factors influencing hospitalization and post-operative costs., Methods: The Region of Lombardy provided anonymized datasets on hospitalized patients with a femoral neck fracture between 2011 and 2016, and anonymized datasets on extra-hospital treatments to track the patient history between 2008 and 2019. Statistical evaluations included descriptive statistics, survival analysis, Cox regression and multiple linear models., Results: 71,920 older adults suffered a femoral fracture in Lombardy between 2011 and 2016. 76.3% of patients were females and the median age was 84. The raw incidence of fractures was stable from year 2011 to year 2016, while the age-adjusted incidence diminished. Pertrochanteric fractures were more spread than transcervical fractures. In patients treated with surgery, receiving treatment within 48 h reduced the hazard of death within the next 24 months. Combined surgical procedures led to increased hazard in comparison with arthroplasty alone, while no differences were observed between different arthroplasties and reduction or fixation. In patients treated conservatively, age and male gender were associated with higher hazard of death. All patients considered, the type of surgery was the main factor determining primary hospitalization costs. A higher number of surgeries performed by the index hospital in the previous year was associated with financial savings. The early intervention significantly correlated with minor costs., Conclusions: The number of proximal femoral fractures is increasing even if the age-adjusted incidence is decreasing. This is possibly due to prevention policies focused on the oldest cohort of the population. Two policies proved to be significantly beneficial in clinical and financial terms: the centralization of patients in high-volume hospitals and a time limit of 48 h from fracture to surgery., Trial Registration: Non applicable., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: The beginning of the Covid-19 pandemic has forced many hospital departments worldwide to implement telehealth strategies for the first time. Telehealth represents the opportunity to increase value for all stakeholders, including patients and healthcare staff, but its success constitutes a challenge for all of them and particularly patients play a crucial role for their needed adherence. This study focuses on the experience of the Rheumatology Unit of Niguarda Hospital in Milan (Italy), where telehealth projects have been implemented for more than a decade with structured design and organized processes. The case study is paradigmatic because patients have experimented personalized mixes of telehealth channels, including e-mails and phone calls, Patient Reported Outcomes questionnaires, and home delivery of drugs. Given all these peculiarities, we decided to deepen patients' perspective through three main aspects related to the adoption of telehealth: (i) the benefits perceived, (ii) the willingness to enrol in future projects, (iii) the preference on the service-mix between remote contacts and in-person visits. Most importantly, we investigated differences in the three areas among all patients based on the mix of telehealth channels experienced., Methods: We conducted a survey from November 2021 to January 2022, enrolling consecutively patients attending the Rheumatology Unit of Niguarda Hospital in Milan (Italy). Our survey comprised an introductory set of questions related to personal, social, clinical and ICT skills information, followed by the central part on telehealth. All the answers were analysed with descriptive statistics and regression models., Results: A complete response was given by 400 patients: 283 (71%) were female, 237 (59%) were 40-64 years old, 213 (53%) of them declared to work, and the disease most represented was Rheumatoid Arthritis (144 patients, 36%). Descriptive statistics and regression results revealed that (i) non-users imagined wide-ranging benefits compared to users; (ii) other things being equal, having had a more intense experience of telehealth increased the odds of accepting to participate to future projects by 3.1 times (95% C.I. 1.04-9.25), compared to non-users; (iii) the more telehealth was experienced, the higher the willingness to substitute in-person with online contacts., Conclusions: Our study contributes to enlighten the crucial role played by the telehealth experience in determining patients' preferences., (© 2023. The Author(s).)

Introduction: Epidemiology is increasingly involved on a wide variety of topics and to engage different professionals and disciplines in an increasingly active way. A fundamental role is played by young researchers active in Italian epidemiology who create opportunities for meeting and discussion, in the name of multidisciplinarity and integration of different skills., Objective: The aim of this paper is to provide a detailed description of the topics most frequently studied in epidemiology by young people and to highlight any changes in these topics in the pre- and post-Covid-19 workplaces., Methods: All abstracts submitted in the years 2019 and 2022 by young participants in the Maccacaro Prize, an annual award aimed at Italian association of epidemiology (Aie) conference addressed to people under 35 years of age, were considered. In addition to the comparison of the topics, a comparison of the related work structures and their geographical location was carried out by grouping the research centres into three Italian geographical regions: north, centre and south/islands., Results: Between 2019 and 2022, the number of abstracts participating in the Maccacaro Prize increased. The interest in topics related to infectious diseases, vaccines, and pharmaco-epidemiology has sharply increased, while in environmental and maternal and child epidemiology it has moderately increased. Social epidemiology, health promotion and prevention, as well as clinical and evaluative epidemiology, have experienced a decrease in interest. Finally, after analysing the geographical distribution of reference centres, it was discovered that certain regions, such as Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany and Latium, have a strong and consistent presence of young people in the field of epidemiology. Conversely, there is a small number of young professionals working in this field in other Italian regions, especially in Southern regions., Conclusions: The pandemic has changed our personal and working habits, but it has also played a fundamental role in making epidemiology known. The increase in young people joining an association such as the Aie is a clear sign of the growing interest in this discipline.

The increasing presence of documented and undocumented migrants increases the commitment of the Italian National Health Service to their health needs, following its founding principle of equity. In particular, chronic diseases, such as diabetes, represent a crucial area where patients' health is affected by their adherence to care pathways, for which the recent literature has reported alarming low levels. In the case of migrants, obstacles to adherence, such as language or organizational barriers, could be overcome thanks also to charitable organizations providing healthcare services. In this study, we aimed to compare the adherence among documented and undocumented migrants who received healthcare services in Milan, Italy, either from the National Health Service (NHS) or from a charitable organization. We identified a cohort of newly taken into care diabetic patients composed of two groups: (i) documented migrants that attend the NHS; and (ii) undocumented migrants that attend a charity. Information was tracked by merging two datasets: the regional healthcare information system of Lombardy, and a unique dataset that collects data on specialistic visits and pharmaceutical prescriptions for all people visiting one of the most prominent charitable organizations in Italy. The annual diabetologist visit was used as the measure of adherence. The probability of being adherent was compared among the two groups by using a multivariate log-binomial regression model, considering a set of personal characteristics that may impact health behaviors. The cohort comprised 6429 subjects. The percentage of adherence was 52% among the documented migrants, and 74% among the undocumented. Regression results confirmed this pattern: undocumented patients have an increased probability of being adherent by 1.19 times (95% CI: 1.12 to 1.26) compared to documented ones. Our study revealed the potentiality of charitable organizations in guaranteeing continuity of care to undocumented migrants. We argue that this mechanism would benefit from central coordination by the government.

Based on the principle of health equity, the Italian National Health Service is known worldwide for being a universalistic system that guarantees healthcare services for all its population, among which there are undocumented migrants. A commitment for their health needs is further motivated by their lower utilisation rates of healthcare services, which becomes even more crucial when considering chronic conditions such as diabetes that require adherence and continuity of care. However, the need for more official data has resulted in little research documenting these healthcare usage patterns. For this reason, our objective has been to deepen, from the Italian NHS perspective, the quantity, costs, type, preventability and organisation of healthcare services directed to undocumented migrants. We used official healthcare data from the Lombardy Region, which enable the identification of people receiving the STP code (undocumented migrants) and of people with foreign citizenship (documented migrants). After quantifying the average annual amount and expenditure for healthcare services grouped by Italian citizens, documented migrants and undocumented migrants for all clinical conditions (quantity and costs), we performed three primary investigations where we enlightened differences between the three mentioned groups focusing on the diagnosis of diabetes: (i) mapping the types of healthcare services used and their characteristics (type); (ii) quantifying the impact of preventable hospital admissions (preventability); (iii) examining the healthcare patterns linking pharmaceutical prescriptions with hospital accesses (organisation). Our results reveal significant differences among the three groups, such as more urgent hospital admissions, more preventable complications, and a higher recurrence in terms of access and costs to hospital services rather than pharmaceutical prescriptions for undocumented migrants. These findings can represent the leverage to raise awareness toward the emerging challenges of the migrant health burden.

Planning problems in healthcare systems have received greater attention in the last decade, especially because of the concerns recently raised about the scattering of surgical interventions among a wide number of different facilities that can undermine the quality of the outcome due to the volume-outcome association. In this paper, an approach to plan the amount of surgical interventions that a facility has to perform to assure a low adjusted mortality rate is proposed. The approach explicitly takes into account the existing interaction among patients' choices and decision makers' planning decisions. The first objective of the proposed approach is to find a solution able to reach quality in health outcomes and patients' adherence. The second objective is to investigate the difference among solutions that are identified as optimal by either only one of the actors' perspective, i.e., decision makers and patients, or by considering both the perspectives simultaneously. Following these objectives, the proposed approach is applied to a case study on Italian colon cancer interventions performed in 2014. Results confirm a variation in the hospital planned volumes when considering patients' behaviour together with the policy maker plan, especially due to personal preferences and lack of information about hospital quality., (© 2021. The Author(s).)

Background and Aim: Evidence on determinants of prices for orphan medicines is scarce and not available for Italy. The aim of this paper is to provide an evidence on variables affecting the annual treatment cost of orphan drugs in Italy, testing the hypothesis of a negative correlation with the dimension of the target population and a positive correlation with the added therapeutic value of the drug and the quality of the evidence of pivotal studies., Methods: Drugs with a European orphan designation reimbursed in Italy in the last 6 years (2014-2019) were considered. Univariate, cluster analysis and multiple regression models were used to investigate the correlation between the annual treatment cost and, as explanatory variables, the dimension of the target population, the existence of Randomized Clinical Trials as a proxy of the quality of the pivotal studies, the added therapeutic value., Results: In the univariate analysis prevalence and added therapeutic value, as expected, have a negative and positive correlation with cost respectively. The correlation with RCT is not significant. In the multivariate model, coefficients for prevalence and added value are confirmed but for the latter are not significant anymore. We also found, through an interaction analysis, that the existence of an RCT has a positive impact on annual treatment cost when the target population is very small., Conclusions: Our results suggest that value arguments and sustainability (dimension of the target population and its impact on budget impact) issues are considered for orphan drugs pricing: the role played by sustainability is systematically supported by our results. A more transparent and reproducible price negotiation process for orphan drugs is needed in Italy. This paper has contributed to highlight the implicit drivers of this process., (© 2021. The Author(s).)