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Abstract Suicide is a significant leading cause of death among young people, particularly those struggling with mental disorders. The present study utilised data from 230 young people (aged 16–18 years) undergoing a transitional care process from Child and Adolescent Mental Health Services to Adult Mental Health Services within the MILESTONE European project (2014–2019), a longitudinal cluster randomised controlled trial. The objectives of this study were to monitor temporal patterns of general health and social functioning over two years, to detect sex differences, and to identify factors associated with Suicidal Thoughts and Behaviours (STB) at the first and last time points. The results demonstrate a decrease in STB over the two-year follow-up period among all participants. Females exhibited a higher prevalence of STB across all time points, whereas males only exhibited STB at the nine-month follow-up. The most influential factors associated with STB were previous suicide attempts and mood disorders at baseline, and mood disorders and relational problems at the end of follow-up. These findings emphasise the importance of monitoring STB and informing young people undergoing a transitional care period about its key risk factors. Moreover, sex differences in STB suggest the need for different preventive strategies for males and females.

Introduction: The immune system mediates important effects on bone metabolism, but little has been done to understand immunotherapy’s role in this interaction. This study aims to describe and identify risk factors for the occurrence and/or exacerbation of vertebral fractures (vertebral fracture progression) during immune checkpoint inhibitors (ICIs). Methods: We conducted an observational, retrospective, monocentric study. We collected data on melanoma and NSCLC patients, treated with first-line ICIs at the Medical Oncology Department ASST Spedali Civili of Brescia, between January 2015 and November 2021, and with a median follow-up of 20.1 (6–36) months. We collected data on patients, diseases, immune-related adverse events, and cortico-steroid therapy initiated on concomitant ICIs. Results: We identified 135 patients, 65 (48.2 %) with locally advanced/metastatic melanoma and 70 (51.8 %) with locally advanced/metastatic non-small cell lung cancer (NSCLC). Twenty-one (15.6 %) patients already had an asymptomatic vertebral fracture at baseline before starting ICIs in monotherapy. A total of ten patients, or 7.4 %, had a vertebra fracture progression defined as a new vertebral fracture or a worsening of a previous fracture. There was a strong relation between the steroid therapy and irAEs with vertebra fracture progression [OR (95 % CI) 8.1 (3.7–17.8) p-value

Purpose: The impact of dietary counseling on body composition in early breast cancer patients (EBC) treated with aromatase inhibitors (AIs) is uncertain. The aim of this study was to assess the effects of a diet counseling program on weight, BMI, total and regional body composition in patients treated with AIs. Methods: This observational study involved 194 EBC patients, of which 97 attended a 6-month personalized counseling program, based on Mediterranean diet principles (cohort A) and 97 did not (cohort B). Dual-energy X-ray absorptiometry (DXA) scan was used to measure the total and regional fat and lean body mass, before (baseline) and after at least 18 months of AI-therapy. Results: Weight and BMI increased significantly, on the average, in cohort B, but not in cohort A. In the cohorts A and B, fat mass increased by 10 % and 7.7 % respectively, while lean mass decreased by 3.3 % and 2.6 % from before to after AI therapy, without statistically significant differences between them using the Mann-Whitney test. The changes in body composition were greater in premenopausal than in postmenopausal women at cancer diagnosis. The proportion of patients with sarcopenia, obesity and sarcopenic obesity increased from before to after AI therapy, similarly in both cohorts. Conclusions: Patients treated with AIs reported an increase in fat mass and a decrease in lean mass, and consequently an increase in sarcopenia and obesity, regardless of the participation in a dietary counseling program. A combined dietary counseling and physical exercise program may be necessary for preventing these unfavourable changes in these patients.

Abstract This study evaluated the relationship between negative symptoms, daily time use (productive/non-productive activities, PA/NPA), and negative emotions in schizophrenia-spectrum disorders (SSDs): 618 individuals with SSDs (311 residential care patients [RCPs], 307 outpatients) were surveyed about socio-demographic, clinical (BPRS, BNSS) and daily time use (paper-and-pencil Time Use Survey completed twice/week) characteristics. Among them 57 RCPs and 46 outpatients, matched to 112 healthy controls, also underwent ecological monitoring of emotions (8 times/day for a week) through Experience Sampling Method (ESM). RCPs spent significantly less time in PA than outpatients. Patients with more negative symptomatology spent more time in NPA and less in PA compared to patients with milder symptoms. Higher time spent in NPA was associated with negative emotions (p

Objectives To estimate the incidence and prevalence of SLE in Italy, and to describe the demographic and clinical characteristics of patients with newly diagnosed SLE.Methods A retrospective cohort study was conducted using The Health Improvement Network general practice database in Italy, encompassing data from 634 753 people. SLE cases were identified over the period 2017–2022, employing three alternative definitions to provide a more detailed understanding of SLE characteristics. Incidence rates were expressed as cases per 100 000 person-years and prevalence as cases per 100 000 people. Demographic and clinical characteristics of incident SLE cases were also studied.Results From 2017 to 2022, a total of 191 incident and 1385 prevalent cases were identified under our first definition. In 2022, the incidence rate was 6.51 cases (95% CI 6.29 to 6.74) per 100 000 person-years, and the prevalence 60.57 (95% CI 59.89 to 61.25) per 100 000 people, being the prevalence five times higher in women compared with men. Both estimates have trended upwards since 2017. A geographical variation across the country was also seen. The demographic and clinical characteristics of incident SLE cases were described, while the potential associations of SLE incidence with some pre-existing conditions were observed, such as chronic kidney disease, chronic hepatic disease, rheumatoid arthritis and Sjogren’s syndrome.Conclusions The results of this nationwide study, the first conducted in Italy, showed that the incidence of SLE has increased in Italy in recent years. Age, sex, and area of residence strongly correlate with the epidemiology of this condition.

Background: Among its extragonadal effects, follicle-stimulating hormone (FSH) has an impact on body composition and bone metabolism. Since androgen deprivation therapy (ADT) has a profound impact on circulating FSH concentrations, this hormone could potentially be implicated in the changes of fat body mass (FBM), lean body mass (LBM), and bone fragility induced by ADT. The objective of this study is to correlate FSH serum levels with body composition parameters, bone mineral density (BMD), and bone turnover markers at baseline conditions and after 12 months of ADT. Methods: Twenty-nine consecutive non-metastatic prostate cancer (PC) patients were enrolled from 2017 to 2019 in a phase IV study. All patients underwent administration of the luteinizing hormone-releasing hormone antagonist degarelix. FBM, LBM, and BMD were evaluated by dual-energy x-ray absorptiometry at baseline and after 12 months of ADT. FSH, alkaline phosphatase, and C-terminal telopeptide of type I collagen were assessed at baseline and after 6 and 12 months. For outcome measurements and statistical analysis, t-test or sign test and Pearson or Spearman tests for continuous variables were used when indicated. Results: At baseline conditions, a weak, non-significant, direct relationship was found between FSH serum levels and FBM at arms (r = 0.36) and legs (r = 0.33). Conversely, a stronger correlation was observed between FSH and total FBM (r = 0.52, p = 0.006), fat mass at arms (r = 0.54, p = 0.004), and fat mass at trunk (r = 0.45, p = 0.018) assessed after 12 months. On the other hand, an inverse relationship between serum FSH and appendicular lean mass index/FBM ratio was observed (r = −0.64, p = 0.001). This is an ancillary study of a prospective trial and this is the main limitation. Conclusions: FSH serum levels after ADT could have an impact on body composition, in particular on FBM. Therefore, FSH could be a promising marker to monitor the risk of sarcopenic obesity and to guide the clinicians in the tailored evaluation of body composition in PC patients undergoing ADT. Funding: This research was partially funded by Ferring Pharmaceuticals. The funder had no role in design and conduct of the study, collection, management, analysis, and interpretation of the data and in preparation, review, or approval of the manuscript. Clinical trial number: clinicalTrials.gov NCT03202381, EudraCT Number 2016-004210-10.

Abstract Objective The standard method of generating disorder‐specific disability scores has lay raters make rankings between pairs of disorders based on brief disorder vignettes. This method introduces bias due to differential rater knowledge of disorders and inability to disentangle the disability due to disorders from the disability due to comorbidities. Methods We propose an alternative, data‐driven, method of generating disorder‐specific disability scores that assesses disorders in a sample of individuals either from population medical registry data or population survey self‐reports and uses Generalized Random Forests (GRF) to predict global (rather than disorder‐specific) disability assessed by clinician ratings or by survey respondent self‐reports. This method also provides a principled basis for studying patterns and predictors of heterogeneity in disorder‐specific disability. We illustrate this method by analyzing data for 16 disorders assessed in the World Mental Health Surveys (n = 53,645). Results Adjustments for comorbidity decreased estimates of disorder‐specific disability substantially. Estimates were generally somewhat higher with GRF than conventional multivariable regression models. Heterogeneity was nonsignificant. Conclusions The results show clearly that the proposed approach is practical, and that adjustment is needed for comorbidities to obtain accurate estimates of disorder‐specific disability. Expansion to a wider range of disorders would likely find more evidence for heterogeneity.

Abstract Background Evaluating emotional experiences in the life of people with Schizophrenia Spectrum Disorder (SSD) is fundamental for developing interventions aimed at promoting well‐being in specific times and contexts. However, little is known about emotional variability in this population. In DiAPAson project, we evaluated between‐ and within‐person differences in emotional intensity, variability, and instability between people with SSD and healthy controls, and the association with psychiatric severity and levels of functioning. Methods 102 individuals diagnosed with SSD (57 residential patients, 46 outpatients) and 112 healthy controls were thoroughly evaluated. Daily emotions were prospectively assessed with Experience Sampling Method eight times a day for a week. Statistical analyses included ANOVA, correlations, and generalized linear models. Results Participants with SSD, and especially residential patients, had a higher intensity of negative emotions when compared to controls. Moreover, all people with SSD reported a greater between‐person‐variability of both positive and negative emotions and greater intra‐variability of negative emotions than healthy controls. In addition, the emotion variability in people with SSD does not follow a linear or quadratic trend but is more “chaotic” if compared to controls. Conclusions Adequate assessments of positive and negative emotional experiences and their time course in people with SSD can assist mental health professionals with well‐being assessment, implementing targeted interventions through the identification of patterns, triggers, and potential predictors of emotional states.

The COVID-19 pandemic has underscored the critical role of observational studies in evaluating the effectiveness of public health strategies. However, although many studies have explored the true impact of vaccination on preventive behavior, their results may be skewed by potential biases and confounding variables. This study examines the application of covariate adjustment and propensity score (PS) estimation, particularly through inverse probability treatment weighting (IPTW), to assess their performance in reducing bias in a framework featuring ordinal outcomes and cumulative logistic regression models, as commonly used in observational studies related to social sciences and psychology. Before applying these methods to the case study, we conducted a simulation study that accounted for the presence or absence of model misspecification in an observational scenario with ordinal outcomes, binary treatment, and a continuous confounder. Our findings demonstrate the effectiveness of combining covariate adjustment with PS methods in reducing bias and improving causal inference. These methods were subsequently applied to an Italian observational study on COVID-19 vaccine hesitancy conducted during the initial phase of the vaccination campaign (April-May 2021). Our analysis revealed that vaccination status had a limited short-term impact on the adoption of preventive measures. This study highlights the importance of employing appropriate adjustment techniques in observational research, particularly when evaluating complex behavioral outcomes. The results support the combined use of covariate adjustment and PS methods to enhance the reliability of findings, ultimately contributing to more informed public health decision-making.

Introduction: Whether adjuvant therapy with aromatase inhibitors (AIs) causes sleep disturbances or not in postmenopausal women with early breast cancer (EBC) is still a controversial issue. Methods: Between March 2014 and November 2017, validated questionnaires for assessing insomnia, anxiety, depression, quality of life (QoL) and restless legs syndrome (RLS) were administered to 160 EBC patients at baseline and after 3, 6, 12, and 24 months of AI therapy. Results: AI therapy significantly decreased the patients’ QoL, but did not influence insomnia, anxiety or depression. However, it significantly increased the frequency and severity of RLS. Patients with RLS at baseline (19%) or who developed RLS during AI therapy (26.3%) reported statistically lower quality of sleep, higher anxiety and depression, and worse QoL compared to patients who never reported RLS (54.7%). Conclusion: Although AI therapy does not affect sleep quality, it may increase RLS frequency. The presence of RLS could identify a group of EBC patients who may benefit from psychological support.

PurposeThe Cancer Genome Atlas Research Network identified Epstein-Barr-Virus (EBV)-positive gastric cancer as a distinct molecular subtype. The prevalence is 8-9% and the histological examination shows pronounced lymphocytic infiltration, elevated levels of IFN-γ and consequently overexpression of PD-L1. The role of plasma EBV DNA load as a prognostic factor in patients with this cancer subtype is still to be defined.Methods and analysisThe present multicenter prospective observational study “EBV PRESAGE”, involving German and Italian cancer centers, aims to evaluate the prognostic role of plasma EBV DNA in EBV-related gastric cancer (GC). The objective is to study the association between plasma EBV DNA load at different consecutive time points and the patient’s prognosis. Every patient with a new diagnosis of gastric cancer (including gastroesophageal junction adenocarcinoma) will be screened for Epstein-Barr encoded small Region (EBER) on tissue biopsies using in situ hybridization (ISH). If EBER ISH is positive, blood analysis for plasma EBV DNA will be conducted. The plasma EBV quantitative analysis will be centralized, and extraction, detection, and quantification of EBV DNA in plasma samples will be performed using real-time PCR.DiscussionWe hypothesized that plasma EBV DNA represents a non-invasive tool for monitoring EBV-related GC and might be valuable as a prognostic marker.

Background Schizophrenia spectrum disorders (SSD) compromise psychosocial functioning, including daily time use, emotional expression and physical activity (PA).Objective We performed a cohort study aimed at investigating: (1) the differences in PA, daily activities and emotions between patients with SSD and healthy controls (HC); (2) the strength of the association between these variables and clinical features among patients with SSD.Methods Ninety-nine patients with SSD (53 residential patients, 46 outpatients) and 111 matched HC were assessed for several clinical variables, and levels of functioning by means of standardised clinical measures. Self-reported daily activities and emotions were assessed with a smartphone application for ecological momentary assessment (EMA), and PA levels were assessed with a wearable accelerometer for 7 consecutive days.FindingsPatients with SSD, especially those living in residential facilities, spent more time being sedentary, and self-reported more sedentary and self-care activities, experiencing higher levels of negative emotions compared with HC. Moreover, higher functioning levels among patients were associated with more time spent in moderate-to-vigorous activity.Conclusions Sedentary behaviour and negative emotions are particularly critical among patients with SSD and are associated with more impaired clinical outcomes.Clinical implications Mobile-EMA and wearable sensors are useful for monitoring the daily life of patients with SSD and the level of PA. This population needs to be targeted with specific rehabilitative programmes aimed at improving their commitment to structured daily activities.

Abstract Background Recovery and human rights promotion for people with Schizophrenia Spectrum Disorders (SSDs) is fundamental to provide good care in Residential Facilities (RFs). However, there is a concern about rehabilitation ethos in RFs. This study aimed to investigate the care quality of Italian RFs, the quality of life (QoL) and care experience of residents with SSD. Methods Fourty-eight RFs were assessed using a quality assessment tool (QuIRC-SA) and 161 residents with SSD were enrolled. Seventeen RFs provided high intensity rehabilitation (SRP1), 15 medium intensity (SRP2), and 16 medium-low level support (SRP3). Staff-rated tools measured psychiatric symptoms and psychosocial functioning; user-rated tools assessed QoL and satisfaction with services. RFs comparisons were made using ANOVA and Chi-squared. Results Over two-thirds patients (41.5 y.o., SD 9.7) were male. Seventy-six were recruited from SRP1 services, 48 from SRP2, and 27 from SRP3. The lowest QuIRC-SA scoring was Recovery Based Practice (45.8%), and the highest was promotion of Human Rights (58.4%). SRP2 had the lowest QuIRC-SA ratings and SRP3 the highest. Residents had similar psychopathology (p = 0.140) and functioning (p = 0.537). SRP3 residents were more employed (18.9%) than SRP1 (7.9%) or SRP2 (2.2%) ones, and had less severe negative symptoms (p = 0.016) and better QoL (p = 0.020) than SRP2 residents. There were no differences in the RF therapeutic milieu and their satisfaction with care. Conclusions Residents of the lowest supported RFs in Italy had less severe negative symptoms, better QoL and more employment than others. The lowest ratings for Recovery Based Practice across all RFs suggest more work is needed to improve recovery.

Abstract COVID-19 pandemic had a negative impact on the mental health and well-being (WB) of citizens. This cross-sectional study included 4 waves of data collection aimed at identifying profiles of individuals with different levels of WB. The study included a representative stratified sample of 10,013 respondents in Italy. The WHO 5-item well-being scale (WHO-5) was used for the assessment of WB. Different supervised machine learning approaches (multinomial logistic regression, partial least-square discriminant analysis—PLS-DA—, classification tree—CT—) were applied to identify individual characteristics with different WB scores, first in waves 1–2 and, subsequently, in waves 3 and 4. Forty-one percent of participants reported “Good WB”, 30% “Poor WB”, and 28% “Depression”. Findings carried out using multinomial logistic regression show that Resilience was the most important variable able for discriminating the WB across all waves. Through the PLS-DA, Increased Unhealthy Behaviours proved to be the more important feature in the first two waves, while Financial Situation gained most relevance in the last two. COVID-19 Perceived Risk was relevant, but less than the other variables, across all waves. Interestingly, using the CT we were able to establish a cut-off for Resilience (equal to 4.5) that discriminated good WB with a probability of 65% in wave 4. Concluding, we found that COVID-19 had negative implications for WB. Governments should support evidence-based strategies considering factors that influence WB (i.e., Resilience, Perceived Risk, Healthy Behaviours, and Financial Situation).

Background: The “zipper model of empathy” has been proposed for psychopathy. It postulates that empathic behavior may fail to arise due to impaired facial emotion recognition. In this study, we examined if the model may be of relevance for schizophrenia. Methods: In a sample of participants with schizophrenia and a history of severe interpersonal violence, associations between measures of social cognition (emotion recognition, theory of mind) and aspects of psychopathy (lack of empathy, lack of remorse) were investigated. A non-violent sample experiencing schizophrenia served as a control group. Results: Correlation analyses revealed a specific and statistically significant association between facial emotion recognition and lack of empathy in the violent sample. Follow-up analyses identified that neutral emotions were of particular importance. Logistic regression analyses confirmed that impairments in facial emotion recognition predicted levels of empathy in the violent sample experiencing schizophrenia. Conclusions: Our results suggest that the “zipper model of empathy” may be relevant for schizophrenia. The findings further point to the potential benefit of including social cognitive training in the treatment of persons with schizophrenia and a history of interpersonal aggression.

BackgroundThe Experience Sampling Method (ESM) is a valid method of remotely recording activities and mood, but the predictors of adherence to ESM in patients with Schizophrenia Spectrum Disorder (SSD) are not known. Studies on adherence are significant as they highlight the strengths and weaknesses of ESM-based study designs and allow the development of recommendations and practical guidelines for implementing future studies or treatment plans. ObjectiveThe aim of this study was to compare the adherence to ESM in patients with SSD and unaffected control individuals, investigate their patterns, and report the predictors of adherence. MethodsIn total, 131 patients with SSD (74 in residential facilities and 57 outpatients) and 115 unaffected control individuals were recruited at 10 different centers in Italy as part of the DiAPAson project. Demographic information, symptom severity, disability level, and level of function were recorded for the clinical sample. Participants were evaluated for daily time use and mood through a smartphone-based ESM 8 times a day for 7 consecutive days. Adherence was measured by the response rate to ESM notifications. Results were analyzed using the chi-square test, ANOVA, Kruskal-Wallis test, and Friedman test, and a logistic regression model. ResultsThe overall adherence rate in this study was 50% for residents, 59% for outpatients, and 78% for unaffected control individuals. Indeed, patients with SSD had a lower rate of adherence to ESM than the unaffected control group (P≤.001), independent of time slot, day of monitoring, or day of the week. No differences in adherence rates between weekdays and weekends were found among the 3 groups. The adherence rate was the lowest in the late evening time slot (8 PM to 12 AM) and days 6-7 of the study for both patients with SSD and unaffected control individuals. The adherence rate among patients with SSD was not predicted by sociodemographic characteristics, cognitive function, or other clinical features. A higher adherence rate (ie, ≥70%) among patients with SSD was predicted by higher collaboration skills (odds ratio [OR] 2.952; P=.046) and self-esteem (OR 3.394; P=.03), and lower positive symptom severity (OR 0.835; P=.04). ConclusionsAdherence to ESM prompts for both patients with SSD and unaffected control individuals decreased during late evening and after 6 days of monitoring. Higher self-esteem and collaboration skills predicted higher adherence to ESM among patients with SSD, while higher positive symptom scores predicted lower adherence rates. This study provides important information to guide protocols for future studies using ESM. Future clinical or research studies should set ESM monitoring to waking hours, limit the number of days of monitoring, select patients with more collaborative skills and avoid those with marked positive symptoms, provide intensive training sessions, and improve participants’ self-confidence with technologies. International Registered Report Identifier (IRRID)RR2-10.1186/s12888-020-02588-y

Background: Bone mineral density (BMD) lacks sensitivity in individual fracture risk assessment in early breast cancer (EBC) patients treated with aromatase inhibitors (AIs). New dual-energy X-ray absorptiometry (DXA) based risk factors are needed. Methods: Trabecular bone score (TBS), bone strain index (BSI) and DXA parameters of bone geometry were evaluated in postmenopausal women diagnosed with EBC. The aim was to explore their association with morphometric vertebral fractures (VFs). Subjects were categorized in 3 groups in order to evaluate the impact of AIs and denosumab on bone geometry: AI-naive, AI-treated minus (AIDen-) or plus (AIDen+) denosumab. Results: A total of 610 EBC patients entered the study: 305 were AI-naive, 187 AIDen-, and 118 AIDen+. In the AI-naive group, the presence of VFs was associated with lower total hip BMD and T-score and higher femoral BSI. As regards as bone geometry parameters, AI-naive fractured patients reported a significant increase in femoral narrow neck (NN) endocortical width, femoral NN subperiosteal width, intertrochanteric buckling ratio (BR), intertrochanteric endocortical width, femoral shaft (FS) BR and endocortical width, as compared to non-fractured patients. Intertrochanteric BR and intertrochanteric cortical thickness significantly increased in the presence of VFs in AIDen- patients, not in AIDen+ ones. An increase in cross-sectional area and cross-sectional moment of inertia, both intertrochanteric and at FS, significantly correlated with VFs only in AIDen+. No association with VFs was found for either lumbar BSI or TBS in all groups. Conclusions: Bone geometry parameters are variably associated with VFs in EBC patients, either AI-naive or AI treated in combination with denosumab. These data suggest a tailored choice of fracture risk parameters in the 3 subgroups of EBC patients.

Abstract Aims Care needs represent an essential paradigm in planning residential facility (RF) interventions. However, possible disagreements between users and staff are critical issues in service delivery. The Experience Sampling Method (ESM) tracks experiences in the real world and real time. This study aimed to evaluate the care needs of patients with schizophrenia spectrum disorder (SSD) in RFs and its association with daily activities and mood monitored using the ESM. Methods As part of the DIAPASON project, 313 residents with SSD were recruited from 99 Italian RFs. Sociodemographic and clinical characteristics were recorded. Care needs, the severity of symptomatology and negative symptoms were assessed. Fifty-six residents were also assessed for 7 consecutive days using the mobile ESM. Descriptive, agreement, predictor and moderator analyses were conducted. Results The staff rated a higher number of total and met needs than service users (p < 0.001). Only a slight agreement between users and staff on unmet needs was found in self-care (k = 0.106) and information (k = 0.100) needs, while a moderate agreement was found in accommodation (k = 0.484), food (k = 0.406), childcare (k = 0.530), physical health (k = 0.470), telephone (k = 0.458) and transport (k = 0.425) needs. Older age (−0.15; p < 0.01), longer SSD diagnosis (−0.16; p < 0.01), higher collaboration (−0.16; p < 0.01) and lower symptomatology (−0.16; p < 0.01) decreased the number of unmet needs, while being a female (0.27; p < 0.05) and a shorter length of stay in an RF (0.54; p < 0.001) increased the number of unmet needs. A higher number of unmet needs was associated with a lower amount of time spent in leisure activities or reporting a positive mood: on the contrary, more unmet needs were associated with a greater amount of time spent in religious or non-productive activities. The associations between unmet needs rated by staff and users and momentary mood as assessed using the ESM were not moderated by the severity of symptomatology. Conclusions Although care needs are fundamental in planning residential activities aimed at recovery-oriented rehabilitation, RF interventions did not fully meet users' needs, and some disagreements on unmet needs between users and staff were reported. Further efforts are necessary to overcome Italian RF limits in delivering rehabilitative interventions defined by real users' needs to facilitate users' productivity and progress towards personal recovery.

BackgroundParathyroid carcinoma (PC) is an extremely rare malignant tumor with an incidence of about 6 new cases per 10 million inhabitants per year. While several papers have been published on treatments and outcomes of PC patients with loco-regional disease, little is known about the prognosis, treatment strategies, and prognostic factors of patients with distant metastasis.Materials and methodsWe performed a systematic review and a pooled analysis of histopathologically confirmed PC cases published in literature using the following keywords: “metastasis–metastatic–secondary nodes” AND “parathyroid carcinoma”. Original case reports and case series reporting metastatic parathyroid carcinoma were included. Data from 58 articles were extracted in a piloted form by five reviewers on a shared database.ResultsSeventy-nine patients with metastatic PC were identified between 1898 and 2018. Ten (13%) patients had synchronous metastases, while metachronous metastases occurred in 43 (54%) patients. The remaining 26 patients developed metastatic disease concomitantly to local recurrence. Primary hyperparathyroidism guided the diagnosis of metastatic recurrence in 58 (73%) patients. Surgery was the main primary approach adopted, as it was performed in 43 (54%) patients. Twenty (25%) patients underwent systemic antineoplastic therapy, consisting of chemotherapy, immunotherapy, tyrosine kinase inhibitors, and hexestrol therapy. Bone resorption inhibitors had a limited efficacy in the long-term control of hypercalcemia. After a median follow-up of 37.5 months, 43 (55%) patients died, 22 (51%) due to the consequences of uncontrolled PHPT. The median overall survival was 36 months (range: 1–252). Surgery was associated with a better OS (HR 0.48, 95% CI 0.26–0.88), whereas bone metastases represented a negative prognostic factor (HR 2.7, 95% CI 1.4–5.2).ConclusionMetastatic PC has a relatively poor prognosis. The main goals of treatment are to counteract tumor growth and control hypercalcemia. Surgery of metastases is the best approach to achieve rapid control of PHPT and longer survival. Target therapies and immunotherapy deserve to be extensively tested in metastatic PC and strategies to better control hypercalcemia should be implemented.

Abstract Change in eating habits in early breast cancer (EBC) patients during chemotherapy has been poorly studied in the literature. The primary aim of this study was to prospectively evaluate food preferences and weight change in EBC patients before and after adjuvant chemotherapy. From April 2014 to June 2018, 205 EBC patients underwent a dietary assessment according to the following timeline: baseline evaluation (one week before starting chemotherapy, T0); first follow-up (approximately 2–3 months after starting chemotherapy, T1); final follow-up (one week after chemotherapy end, T2). A statistically significant reduction of the following foods was reported after the start of chemotherapy: pasta or rice, bread, breadsticks/crackers, red meat, fat and lean salami, fresh and aged cheese, milk, yogurt, added sugar, soft drinks, alcoholic beverages (wine, beer, and schnapps), and condiments (oil and butter). Conversely, fruit consumption consistently increased. As a result of these changes, a Healthy Eating Index (HEI) specifically developed for this study and suggestive of a balanced diet, significantly increased. Body weight did not increase, despite reduction in physical activity. This prospective study shows that EBC patients tend to adopt “healthier dietary patterns” during adjuvant chemotherapy, leading to a non-change in weight, despite reduction in physical activity.

BackgroundThe hesitancy in taking the COVID-19 vaccine is a global challenge. The need to identify predictors of COVID-19 vaccine reluctance is critical. Our objectives were to evaluate sociodemographic, psychological, and behavioral factors, as well as attitudes and beliefs that influence COVID-19 vaccination hesitancy in the general population of Italy.MethodsA total of 2,015 people were assessed in two waves (March, April and May, 2021). Participants were divided into three groups: (1) individuals who accepted the vaccination (“accepters”); (2) individuals who refused the vaccination (“rejecters”); and (3) individuals who were uncertain about their attitudes toward the vaccination (“fence sitters”). Group comparisons were performed using ANOVA, the Kruskal-Wallis test and chi-square tests. The strength of the association between the groups and the participants' characteristics was analyzed using a series of multinomial logistic regression models with bootstrap internal validation (one for each factor).ResultsThe “fence sitters” group, when compared to the others, included individuals of younger age, lower educational level, and worsening economic situation in the previous 3 months. After controlling for sociodemographic factors, the following features emerged as the main risk factors for being “fence sitters” (compared with vaccine “accepters”): reporting lower levels of protective behaviors, trust in institutions and informational sources, frequency of use of informational sources, agreement with restrictions and higher conspirative mentality. Higher levels of COVID-19 perceived risk, trust in institutions and informational sources, frequency of use of informational sources, agreement with restrictions and protective behaviors were associated with a higher likelihood of becoming “fence sitters” rather than vaccine “rejecters.”ConclusionsThe “fence sitters” profile revealed by this study is intriguing and should be the focus of public programmes aimed at improving adherence to the COVID-19 vaccination campaign.

BackgroundOvarian strumal carcinoid is a rare tumor in which thyroid (struma) and carcinoid components coexist. The disease is generally considered to be a borderline malignancy, however, cases with metastatic disease have been described. No data in the literature are available to guide diagnosis and therapy.MethodsWe performed a pooled analysis and a systematic review of histopathological-confirmed strumal carcinoid cases published in the literature using the following keywords: “strumal carcinoid of the ovary”, “strumal carcinoid case report”. A case of strumal carcinoid tumor diagnosed and followed-up at the Medical Oncology Unit of Spedali Civili (Brescia, Italy) was also described and included.ResultsSixty-six eligible publications were identified, providing data from one hundred and seventeen patients, plus a case diagnosed at our institution. At presentation, among the eighty-eight patients with symptomatic disease, 37% of patients suffered from abdominal distention and 49% from pain due to a growing abdominal tumor mass, 37% from constipation (peptide YY was analyzed in only nine of them, resulting above the physiologic range). Surgery was the primary therapy in 99% of the patients. Three patients had metastatic disease at diagnosis and five patients underwent recurrence after radical surgery. Histology at disease recurrence concerned the thyroid component in two patients, the carcinoid component in two patients, both histologies in one patient. Median disease-free survival and overall survival in this series were not attained.ConclusionStrumal carcinoid of the ovary generally presents a benign behavior and surgery is curative in most cases. However, a small group of patients with this disease can undergo disease recurrence due to both the thyroid and the neuroendocrine (carcinoid) components. A follow-up in radically operated patients is therefore needed, particularly in those with a voluminous disease at diagnosis.

ObjectiveTo evaluate the efficacy of clinical triage of oncological patients for safe continuation of cancer therapy implemented during the first SARS-CoV-2 outbreak.MethodsBetween 25 February and 21 April 2020, patients attending the Medical Oncology Unit, Spedali Civili Hospital, Brescia (Italy) for cancer therapy underwent triage to identify those with no signs and symptoms suspicious for SARS-CoV-2 infection in which antineoplastic treatment could be continued as scheduled. Triage questions investigated common symptoms (e.g., fever, cough, dyspnea, anosmia, dysgeusia, headache, nasal congestion, conjunctival congestion, sore throat, diarrhea, nausea and vomiting); body temperature and pulse oximetry were also recorded. All patients were followed-up for overt SARS-CoV-2 through to 18th May 2020.ResultsOverall, 1180 patients (median age 65 years) underwent triage during the study period. The most frequent primary malignances were breast (32%), gastrointestinal (18%), and lung (16.5%) cancer. Thirty-one (2.5%) presented with clinically evident SARS-CoV-2 infection and tested positive on nasopharyngeal swab testing and/or radiological imaging. Triage identified 69 (6%) grey zone patients with symptoms suspicious for SARS-CoV-2; 5 (7.2%) subsequently developed symptomatic disease. Neither the symptomatic nor the grey zone patients received their scheduled treatment; instead, they were referred for hospitalization or home quarantine.ConclusionTriage of oncological patients at our Unit provided for safe continuation of scheduled cancer treatment in 91.5% of patients during the initial SARS-CoV-2 outbreak.