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Objective: The aim of this paper was to evaluate the quality of life of adult patients with onco-hematological disease treated with hematopoietic stem cell transplantation up to two years post-transplantation. Method: A quantitative, observational, longitudinal, and analytical study was conducted with 121 participants diagnosed with onco-hematological cancer who underwent hematopoietic stem cell transplantation between October 2017 and September 2019, with a 2-year post-transplantation follow-up, of whom only 39 completed the study. The Functional Assessment of Cancer Therapy—Bone Marrow Transplantation (FACT-BMT) questionnaire and its subscales, Functional Assessment of Cancer Therapy—General (FACT-BMT) and Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI), developed by the Functional Assessment of Chronic Illness Therapy (FACIT) and validated for Spain, were used to assess quality of life. Result: The average age for hematopoietic stem cell transplantation was 54 years, with a majority of male participants. The evaluation of quality of life showed a decrease at the time of hospital discharge, followed by a progressive improvement up to one year after the transplantation. There was a significant difference in the quality of life questionnaire scores between both sexes during all stages of the research, with higher scores in male participants. The length of hospital stay significantly affected patients' physical and functional well-being, and marital status was related to differences in the perception of quality of life. Conclusions: Despite the initial decrease in quality of life for patients undergoing hematopoietic stem cell transplantation, levels of quality of life similar to baseline are regained one year after the transplantation. Sociodemographic variables are related to how these patients perceive their quality of life. However, further studies with a larger sample size are needed for more precise results. [ABSTRACT FROM AUTHOR]

The definition of Early Cholecystectomy (EC) is still debatable. This paper aims to find whether the timing of EC affects outcomes. The article reports a multicentric prospective observational study including patients with acute calculous cholecystitis (ACC) who had cholecystectomy within ten days from the onset of symptoms. Kruskall-Wallis test, Fisher's Exact test, and Spearman rank correlation were used for statistical analysis. The patients were divided into three groups depending on the timing of the operation: 0–3 days, 4–7 days, or 8–10 days from the onset of symptoms. 1117 patients were studied over a year. The time from the onset of symptoms to EC did not affect the post-operative complications and mortality, the conversion, and the reintervention rate. The time represented a significant risk factor for intraoperative complications (0–3 days, 2.8%; 4–7 days, 5.6%; 8–10 days, 7.9%; p = 0.01) and subtotal cholecystectomies (0–3 days, 2.7%; 4–7 days, 5.6%; 8–10 days, 10.9%; p < 0.001). ACC is an evolutive inflammatory process and, as the days go by, the local and systemic inflammation increases, making surgery more complex and difficult with a higher risk of intraoperative complications. We recommend performing EC for ACC as soon as possible, within the first ten days of the onset of symptoms. [ABSTRACT FROM AUTHOR]

Simple Summary: Measurable residual disease monitoring is an important prognostic tool in haematological malignancies commonly performed by two modalities: flow cytometry and molecular methods. In this paper, we studied consecutive adult participants requiring flow cytometric measurable residual disease monitoring. This is one of the largest prospective Australian studies to date, providing a unique insight into the Australian context. We described five distinctive patterns associated with disease relapse and survival and also investigated correlation with molecular methods. Our results provide additional evidence that the correlation between molecular and flow cytometric methods is moderate in B-lymphoblastic leukaemia and poor in acute myeloid leukaemia. There was a strong association between flow cytometry results and relapse in acute myeloid leukaemia but less so for B-lymphoblastic leukaemia. Our novel data indicate that the pattern of change in measurable residual disease over time was associated with the risk of relapse, particularly in acute myeloid leukaemia and highlight the divergent ways measurable residual disease testing can be employed across different leukaemias. Measurable residual disease (MRD) detected by flow cytometry (FC) is well established in paediatric B- lymphoblastic leukaemia (B-ALL) and adult chronic lymphocytic leukaemia (CLL), but its utility in adult B-ALL and adult acute myeloid leukaemia (AML) is less clear. In this prospective MRD study, one of the largest in Australia to date, we examined consecutive bone marrow aspirates from adult participants with B-ALL (n = 47) and AML (n = 87) sent for FC-MRD testing at a quaternary referral hospital in Sydney. FC-MRD results were correlated to corresponding Mol-MRD testing where available and clinical outcomes at three-month intervals over 1 year. B-ALL showed a moderate positive correlation (rs = 0.401, p < 0.001), while there was no correlation between FC-MRD and Mol-MRD for AML (rs = 0.13, p = 0.237). Five FC-MRD patterns were identified which had significant associations with relapse (X2(4) = 31.17(4), p > 0.001) and survival (X2(4) = 13.67, p = 0.008) in AML, but not in B-ALL. The three-month MRD results were also strongly associated with survival in AML, while the association in B-ALL was less evident. There was a moderate correlation between FC-MRD and Mol-MRD in B-ALL but not AML. The association of FC-MRD with relapse and survival was stronger in AML than in B-ALL. Overall, these findings suggest divergent utilities of FC-MRD in AML and B-ALL. [ABSTRACT FROM AUTHOR]

Simple Summary: Recently, nivolumab, pembrolizumab, both immune-checkpoint inhibitors (ICIs) and the combination of dabrafenib plus trametinib (D + T) were registered as adjuvant melanoma treatments, to prevent recurrence. The aim of this paper was to retrospectively review the benefits and risks of these treatments in clinical practice, by extracting data from electronic health records with a text-mining tool. In a population of 122 patients, 55 used nivolumab, 48 used pembrolizumab and 20 used D + T, and we found that the ICIs were better tolerated than D + T. However, the frequent adverse events of D + T are reversible and include pyrexia and fatigue. ICIs show immune-related chronic adverse events, and chronic thyroid-related adverse events occurred frequently. The efficacy results, including the recurrence-free survival, are promising; however, the follow-up was too short for conclusions. This study furthermore showed that the application of text-mining is a valuable method to collect data for the evaluation of adjuvant melanoma treatments. Introduction: Nivolumab (N), pembrolizumab (P), and dabrafenib plus trametinib (D + T) have been registered as adjuvant treatments for resected stage III and IV melanoma since 2018. Electronic health records (EHRs) are a real-world data source that can be used to review treatments in clinical practice. In this study, we applied EHR text-mining software to evaluate the real-world tolerability, safety, and efficacy of adjuvant melanoma treatments. Methods: Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 at the Leiden University Medical Center, the Netherlands, were included. CTcue text-mining software (v3.1.0, CTcue B.V., Amsterdam, The Netherlands) was used to construct rule-based queries and perform context analysis for patient inclusion and data collection from structured and unstructured EHR data. Results: In total, 122 patients were included: 54 patients treated with nivolumab, 48 with pembrolizumab, and 20 with D + T. Significantly more patients discontinued treatment due to toxicity on D + T (N: 16%, P: 6%, D + T: 40%), and X2 (6, n = 122) = 14.6 and p = 0.024. Immune checkpoint inhibitors (ICIs) mainly showed immune-related treatment-limiting adverse events (AEs), and chronic thyroid-related AE occurred frequently (hyperthyroidism: N: 15%, P: 13%, hypothyroidism: N: 20%, P: 19%). Treatment-limiting toxicity from D + T was primarily a combination of reversible AEs, including pyrexia and fatigue. The 1-year recurrence-free survival was 70.3% after nivolumab, 72.4% after pembrolizumab, and 83.0% after D + T. Conclusions: Text-mining EHR is a valuable method to collect real-world data to evaluate adjuvant melanoma treatments. ICIs were better tolerated than D + T, in line with RCT results. For BRAF+ patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D + T against the risk of long-term immune-related AEs. [ABSTRACT FROM AUTHOR]

Individuals' gender development is influenced by the characteristics of personal and contextual environments. However, the role of sibling contexts in shaping gender norms has rarely been studied among Chinese youth at early adolescence as most of them were the only child. The aim of this paper is to compare perceived gender norms among adolescents aged 10–14 with different sibling configurations, to help inform and tailor guidance for sexual and reproductive health education in the future. We used the Global Early Adolescent Study baseline data collected from Shanghai, China. The sample for analysis was 1615 students. We used univariate analysis and multivariate ordinal logistic regression to compare perceived gender-stereotyped traits and gender role attitudes, stratified by age and sex. The results showed that sibling context was more influential for boys than girls at early adolescence in their gender socialization process. Among boys those who were with mixed-sex siblings scored higher on gender-stereotyped traits (ORonly-childvs. mixed-sex siblings = 0.67, 95% CI: 0.48–0.94, p = 0.019; ORsame-sex siblingsvs. mixed-sex siblings = 0.59, 95% CI: 0.37–0.96, p = 0.033). Younger early adolescents aged 10–12 who were the only child or who had mixed-sex siblings perceived more traditional gender role attitudes than those living with same-sex siblings (ORonly-childvs. same-sex siblings = 1.71, 95% CI: 1.06–2.75, p = 0.028; ORmixed-sex siblingsvs. same-sex siblings = 1.74, 95% CI: 1.03–2.94, p = 0.037). Comprehensive sexuality education with gender and power components being well addressed, both in and out of the family, is needed to provide extra gender-inclusive and gender-egalitarian environments for youth. [ABSTRACT FROM AUTHOR]

This study explores patterns of alcohol drinking within a representative New Zealand sample (2887 participants (1464 female, 1423 male)). Alcohol use and drinking patterns across the population are described. Multivariable logistic regressions document associations between alcohol use and drinking patterns and the likelihood of experiencing different health outcomes. Alcohol use, early drinking initiation, frequent drinking, and heavy episodic drinking (HED) are prevalent in New Zealand and vary in relation to gender, age, and socioeconomic characteristics. Those who reported alcohol-related problems were more likely to report poor mental health (AOR: 2.21; 95% CI: 1.42–3.46) and disability (AOR: 1.79, 95% CI: 1.06–3.00), and less likely to experience positive mental health (AOR: 0.28, 95% CI: 0.18–0.42). Those who reported HED were also less likely to experience good general health (AOR: 0.61, 95% CI: 0.47–0.81) and positive mental health (AOR: 0.67, 95% CI: 0.53–0.84). Younger age cohorts were more likely to engage in early drinking, and those who initiated regular drinking before age 18 were more likely to report HED and alcohol-related problems. Findings indicate that problem drinking and HED are not only associated with poor physical health, but also reduce the likelihood of individuals experiencing positive mental health. This provides information to enable public health practitioners to target alcohol prevention strategies at the entire population of drinkers. [ABSTRACT FROM AUTHOR]

Simple Summary: Alterations in the SMARCB1/INI1 expression pattern have been detected in many tumors, including chordomas. We studied a large group of patients with conventional spinal chordomas, and the aims were to assess the differences in the immunohistochemical expression of SMARCB1/INI1 and the underlying alterations in the SMARCB1 gene and to investigate the correlation between clinicopathological features and patient survival. Partial SMARCB1/INI1 loss was identified in several patients, and this pattern correlated with mobile spine location and inadequate surgical margins. Moreover, mobile spine tumor location and inadequate surgical margins negatively impacted disease-free survival. The complete loss of SMARCB1/INI1 is currently ongoing as a target for molecular therapy; therefore, the partial loss of SMARCB1/INI1 in tumors could also have therapeutic implications. The partial loss of SMARCB1/INI1 expression has recently been reported in skull base conventional chordomas, with possible therapeutic implications. We retrospectively analyzed 89 patients with conventional spinal chordomas to investigate the differences in the immunohistochemical expression of SMARCB1/INI1 and the underlying genetic alterations in the SMARCB1 gene. Moreover, we assessed the correlation of clinicopathological features (age, gender, tumor size, tumor location, surgical margins, Ki67 labelling index, SMARCB1/INI1 pattern, previous surgery, previous treatment, type of surgery, and the Charlson Comorbidity Index) with patient survival. Our cohort included 51 males and 38 females, with a median age at diagnosis of 61 years. The median tumor size at presentation was 5.9 cm. The 5-year overall survival (OS) and 5-year disease-free survival (DFS) rates were 90.8% and 54.9%, respectively. Partial SMARCB1/INI1 loss was identified in 37 (41.6%) patients with conventional spinal chordomas (27 mosaic and 10 clonal). The most frequent genetic alteration detected was the monoallelic deletion of a portion of the long arm of chromosome 22, which includes the SMARCB1 gene. Partial loss of SMARCB1/INI1 was correlated with cervical–thoracic–lumbar tumor location (p = 0.033) and inadequate surgical margins (p = 0.007), possibly due to the high degree of tumor invasiveness in this site. Among all the considered clinicopathological features related to patient survival, only tumor location in the sacrococcygeal region and adequate surgical margins positively impacted DFS. In conclusion, partial SMARCB1/INI1 loss, mostly due to 22q deletion, was detected in a significant number of patients with conventional spinal chordomas and was correlated with mobile spine location and inadequate surgical margins. [ABSTRACT FROM AUTHOR]

Simple Summary: This nationwide cohort study evaluated the incidence and severity of immune-related adverse events (irAEs) in melanoma patients receiving adjuvant versus advanced anti-PD-1 therapy. A total of 1465 advanced melanoma patients and 908 adjuvant-treated patients were included. Patients in the adjuvant group were younger, had superior ECOG performance status, and had fewer comorbidities compared to those in the advanced group. No significant difference was observed in the incidence of grade III-IV irAEs between the two groups. However, higher ECOG status (>1) and the presence of any comorbidities were independently associated with an increased risk of irAE development across both treatment settings. Although adjuvant therapy was not linked to a heightened risk of severe irAEs compared to advanced therapy, it was more frequently discontinued due to toxicity in the adjuvant group. These findings provide critical insights for informing patient consultations regarding adjuvant anti-PD-1 treatment. Introduction: The difference in incidence and severity of anti-PD-1 therapy-related adverse events (irAEs) between adjuvant and advanced treated melanoma patients remains unclear, as no head-to-head studies have compared these groups. Methods: This multi-center cohort study analyzed melanoma patients treated with anti-PD-1 in adjuvant or advanced settings between 2015 and 2021. Comorbidities and ECOG performance status were assessed before treatment, and grade III-IV irAEs were monitored during treatment. Univariate and multivariate regression analyses were conducted to identify factors associated with irAE development. Results: A total of 1465 advanced melanoma patients and 908 resected melanoma patients received anti-PD-1 therapy. Adjuvant-treated patients were younger, with a median age of 63 years compared to 69 years in the advanced group (p < 0.01), and had a better ECOG performance status (p < 0.01). Comorbidities were seen more frequently in advanced melanoma patients than in those receiving adjuvant treatment, 76% versus 68% (p < 0.01). Grade III-IV irAEs occurred in 214 (15%) advanced treated patients and in 119 (13%) adjuvant-treated patients. Multivariate analysis showed an increased risk of severe irAE development with the presence of any comorbidity (adjusted OR 1.22, 95% CI 1.02–1.44) and ECOG status greater than 1 (adjusted OR 2.00, 95% CI 1.20–3.32). Adjuvant therapy was not associated with an increased risk of irAE development compared to advanced treatment (adjusted OR 0.95, 95% CI 0.74–1.21) after correcting for comorbidities and ECOG performance score. Anti-PD-1 therapy was halted due to toxicity (any grade irAE) more often in the adjuvant setting than in the advanced setting, 20% versus 15% (p < 0.01). Conclusions: Higher ECOG performance status and presence of any comorbidity were independently associated with an increased risk of Grade III-IV irAE in adjuvant and advanced treated melanoma patients. Patients treated in the adjuvant setting did not have an increased risk of developing severe irAEs compared to advanced melanoma patients. These findings are of clinical significance in consulting patients for adjuvant anti-PD-1 treatment. [ABSTRACT FROM AUTHOR]

Background: Premature children with retinopathy of prematurity (ROP) have been reported to an have increased risk of visual and neurocognitive impairments, yet little is known about whether vision could affect specific neurocognition. This study aimed to clarify the correlations between neurocognition and vision in premature children. Materials and Methods: This is a nonrandomized, cross-sectional, observational study in a pediatric cohort with five groups: (1) full-term (n = 25), (2) prematurity without ROP (n = 154), (3) prematurity with ROP but without treatment (n = 39), (4) prematurity with ROP and with bevacizumab (IVB) treatment (n = 62), and (5) prematurity with ROP and with laser/laser + IVB treatment (n = 20). Neurocognitive function was evaluated by the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) around the age of 4 years. Visual acuity (VA) and refractive errors were tested. Correlations between WPPSI parameters and visual outcomes were analyzed across five groups. Results: Among the 300 recruited children (mean age = 4.02 + 0.97 years, male = 56.3%), 297 were assessed by WPPSI-IV and 142 were assessed by vision tests. The Full-Scale Intelligence Quotient (FSIQ) index was worse in the premature groups. After adjusting for covariates, seven items, including FSIQ-Index (p = 0.047), fluid-reasoning index (p = 0.004), FR-percentile ranking (p = 0.008), object assembly (p = 0.034), picture concept (p = 0.034), zoo locations (p = 0.014) and bug search (p = 0.020), showed significant differences between groups. The better the best corrected VA (BCVA), the higher the scores on Verbal Comprehension Index (VCI), VCI-PR, and the subtest of information. Conclusions: Specific cognitive dysfunctions are related to the BCVA in this large cohort. Subtest performance profiles in WPPSI can be affected by prematurity, ROP treatment, and different ROP treatment. FSIQ is generally lower in premature children and even lower in children with ROP. [ABSTRACT FROM AUTHOR]

Background: Significant improvement in neonatal care has enabled increasing survival of preterm infants. Metabolic bone disease of prematurity is often overlooked due to other comorbidities of preterm birth. The best approach is screening and prevention of the disease in high-risk infants such as preterm infants. Aim: We followed up the clinical, radiological, and serum biochemical markers of metabolic bone disease in extremely preterm infants (<28 weeks of gestation). The clinical applicability and validation of C-terminal telopeptide of type I collagen (CTX-I) as a novel bone turnover marker were assessed. Standard and novel biochemical bone turnover markers and quantitative ultrasound were compared. Method: Patients' data were collected from medical records. Assessments of calcium, phosphate, alkaline phosphatase, bone-alkaline phosphatase, CTX-I, and quantitative ultrasound were prospectively performed twice in 42 extremely preterm infants at postmenstrual ages of 30–32 weeks and 36–40 weeks. Bone mineral density was measured by quantitative ultrasound. Conclusion: Phosphate, alkaline phosphatase, bone alkaline phosphatase, calcium, or ionized calcium are not related to gestational age, but bone mineral density, measured by quantitative ultrasound, is related. There is no correlation between standard and novel biochemical markers and quantitative ultrasound for the identification of metabolic bone disease. [ABSTRACT FROM AUTHOR]

Background: In Germany, more than 40% of infants are born to immigrant parents. Increased survival rates of very preterm (below 32 weeks gestation at birth; VP) infants have not resulted in equally improved life chances and quality of life. More information on perinatal variations in outcomes according to social inequalities, migration background, and language barriers is needed. We tested whether mothers' immigrant status and language barriers are associated with perinatal health and short-term neonatal outcomes. Methods: The data are from the national multi-centre German Neonatal Network (GNN) cohort, including VP births from 2009 onwards. In total, 3606 (n = 1738 female) children were assessed, and 919 (n = 449 female) of these children had immigrant backgrounds. Immigrant status was operationalised as a binary variable based on the children's mothers' countries of birth (born in Germany vs. foreign-born). Self-reported home language (L1) was used to calculate the average linguistic distance to German as one continuous variable. Results: Mixed-effects models showed that two out of fourteen effects of interest survived the adjustment for known confounders and accounting for the nestedness of data within birth hospitals. Linguistic distance from mothers' L1s to German was independently associated with diagnoses of preeclampsia (OR = 1.01, 95% CI = [1.00, 1.01]). Infants of foreign-born mothers had higher odds for amniotic infection syndrome (AIS; OR = 1.45 [1.13, 1.86]) than infants of German mothers. Conclusions: Our findings from this large multi-centre longitudinal cohort of VP-born children indicate that maternal immigrant status and language barriers have limited impact on perinatal health and severe neonatal outcomes. This suggests that, regardless of background or language skills, there may be few inequalities in the perinatal health of pregnant women and their newborn preterm infants. [ABSTRACT FROM AUTHOR]

Simple Summary: In this work, we evaluated the need for frequent laboratory assessments in patients with metastatic renal cell carcinoma treated with nivolumab and nivolumab+ipilimumab during the TITAN-RCC clinical trial. We analysed how often reached criteria for dose delay or permanent discontinuation of therapy would have been missed if the frequency of laboratory testing had been reduced, in order to avoid over-sampling patients and to optimise clinical workflow and staffing. Our study showed that if the frequency of laboratory tests had been reduced, reached dose delay criteria would hardly have been missed. This would have affected up to 1% (2/207) of patients. An exception was dose delay due to the elevation of lipase blood levels which would have been missed in up to 7% (15/207) of patients. However, these patients presented with symptoms and would have been identified based thereupon. Discontinuation criteria would have only been overlooked for lipase (2% [4/207] of patients) and amylase (0.5% [1/207] of patients). Again, these patients would have been identified, since only symptomatic patients would have needed to discontinue treatment due to amylase or lipase laboratory values. In conclusion, in asymptomatic patients in our setting, laboratory analyses do not seem to be necessary before every treatment application. In clinical trials, laboratory values are assessed with high frequency. This can be stressful for patients, resource intensive, and difficult to implement, for example in office-based settings. In the prospective, multicentre phase 2 TITAN-RCC trial (NCT02917772), we investigated how many relevant changes in laboratory values would have been missed if laboratory values had been assessed less frequently. Patients with metastatic renal cell carcinoma (n = 207) received a response-based approach with nivolumab and nivolumab+ipilimumab boosts for non-response. We simulated that laboratory values were obtained before every second dose instead of every dose of the study drug(s). We assessed elevated leukocyte counts, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatinine, amylase, lipase, and thyroid-stimulating hormone. Dose delay and discontinuation criteria were defined according to the study protocol. With the reduced frequency of laboratory analyses, dose delay criteria were rarely missed: in a maximum of <0.1% (3/4382) of assessments (1% [2/207] of patients) during nivolumab monotherapy and in a maximum of 0.2% (1/465) of assessments (1% [1/132] of patients) during nivolumab+ipilimumab boosts. An exception was lipase-related dose delay which would have been missed in 0.6% (25/4204) of assessments (7% [15/207] of patients) during nivolumab monotherapy and in 0.8% (4/480) of assessments (3% [4/134] of patients) during nivolumab+ipilimumab boosts, but would have required the presence of symptoms. Discontinuation criteria would have only been missed for amylase (<0.1% [1/3965] of assessments [0.5% (1/207) of patients] during nivolumab monotherapy, none during nivolumab+ipilimumab boosts) and lipase (0.1% [5/4204] of assessments [2% (4/207) of patients] during nivolumab monotherapy; 0.2% [1/480] of assessments [0.7% (1/134) of patients] during nivolumab+ipilimumab boosts). However, only symptomatic patients would have had to discontinue treatment due to amylase or lipase laboratory values. In conclusion, a reduced frequency of laboratory testing appears to be acceptable in asymptomatic patients with metastatic renal cell carcinoma treated with nivolumab or nivolumab+ipilimumab. [ABSTRACT FROM AUTHOR]

Simple Summary: This multicenter study (n = 1133, inclusion criteria: 3.5 cm maximum tumor size and preoperative indication for a boost) provides detailed data on acute and long-term toxicities in breast cancer patients undergoing breast-conserving surgery combined with an anticipated intraoperative boost with low-energy X-rays followed by whole breast irradiation. Toxicity assessments, based on LENT SOMA criteria, were performed annually up to 10 years of follow-up. IORT boost was completed in 90% and EBRT in 97% of cases. No grade 3 or 4 acute toxicities were observed, with mild acute side effects reported in a small proportion of patients. Chronic toxicities were seen in 16.2% of patients with teleangiectasia, 14.3% with grade ≥ 2 fibrosis, 3.4% with grade ≥ 2 pain, and 1.1% with hyperpigmentation. The results show that the therapy is safe and feasible in terms of toxicity and confirms intraoperative boost as a standard method of boost application in a large prospective cohort. In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1–120, 20.4% dropped out), with a median age of 61 years (range 30–90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation. [ABSTRACT FROM AUTHOR]

Simple Summary: Newly diagnosed type 2 diabetes mellitus is associated with a higher risk of cancer, possibly in young individuals with diabetes. While the incidence of cancer is mildly decreasing in the background population, it does not decrease in patients with type 2 diabetes. In non-diabetic persons, certain types of cancer also occur in young age, while the 60–69-year-old group dominates for cancer cases in patients with type 2 diabetes. The majority of the new cancer cases is recognized within 6 months after the diagnosis of diabetes. This may call for increased cancer surveillance in patients with newly diagnosed type 2 diabetes mellitus. (1) Background: Patients with type 2 diabetes mellitus (T2DM) are at higher risk of cancer but how these two diseases associate is still debated. The goal of this study was the assessment of the overall incidence of cancer among patients with newly diagnosed T2DM in Hungary. (2) Methods: A nationwide, retrospective, longitudinal study was performed using a Hungarian database. After exclusion of cases of age < 18 years, with gestational diabetes, with polycystic ovary syndrome, and with type 1 and prevalent type 2 diabetes mellitus, the incident T2DM (approx. 50,000 cases yearly) and for comparison, the diabetes-free Hungarian adult population (approx. 7,000,000 cases yearly) was included in the study. The primary endpoints were the overall and site-specific incidence and annual percentage change of the incidence of cancer in both populations. (3) Results: The overall incidence of cancer in patients amounted to 29.4/1000 and 6.6/1000 with or without T2DM, respectively, and the OR (95%CI) of cancer of the T2DM group was 4.32 (4.14–4.53), p < 0.0001. The risk of having cancer was age dependent. The incidence of cancer was declining in the non-diabetic but was unchanged in the T2DM population. The average lag time of diagnosing cancer after the detection of T2DM was 3.86 months. (4) Conclusions: Incident T2DM is associated with a significantly higher overall risk of incident cancer, with a reverse correlation of age. Newly registered T2DM patients were suggested to be screened for cancer within 6 months. [ABSTRACT FROM AUTHOR]

Simple Summary: Transoral Robotic Surgery (TORS) is increasingly used for various conditions, yet its success and failure remain underexplored. In this multicenter study, we assessed 220 TORS interventions across 211 patients. Success criteria differed by condition, including tumor identification for CUP, resection margins for malignancies, and symptom improvement for benign cases like OSA and chronic lingual tonsillitis. Predictors of success varied, with factors such as patient comorbidity, tumor characteristics, and demographics playing roles. Conversely, failure predictors encompassed postoperative complications and pain, linked to patient health and demographics. These insights into TORS outcomes may aid in patient selection and counseling across different conditions, informing clinical practice and enhancing patient care. Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and chronic lingual tonsillitis. However, the success and failure of TORS have not been analyzed to date. In this retrospective observational multicenter cohort study, we evaluated patients treated with TORS using the da Vinci surgical system. Success criteria were defined as identification of the primary tumor for CUP, >2 mm resection margin for malignant conditions, and improvement on respiratory polygraphy and tonsillitis complaints for benign conditions. A total of 220 interventions in 211 patients were included. We identified predictors of success, such as low comorbidity status ACE-27, positive P16 status, and lower age for CUP, and female gender and OSA severity for benign conditions. For other malignancies, no predictors for success were found. Predictors of failure based on postoperative complications included high comorbidity scores (ASA) and anticoagulant use, and for postoperative pain, younger age and female gender were identified. This study provides valuable insights into the outcomes and predictors of success and failure in TORS procedures across various conditions and may also help in patient selection and counseling. [ABSTRACT FROM AUTHOR]

According to the Theory of Change, the resilience of the family unit plays a crucial role in shaping the developmental trajectory of children. Families exhibiting higher levels of family resilience are typically characterized by transparent and effective communication, optimistic outlooks on adversity, adept problem-solving skills, strong spiritual beliefs, and effective management of social and financial resources. While existing research has indicated that parental and familial characteristics can predict diverse outcomes for children, investigations concerning the association between family resilience and children's subjective well-being remains limited. Therefore, this study aims to examine whether different dimensions of family resilience can predict changes in children's subjective well-being, tested one year later. The sample includes 762 child-mother-father triads (intact families). Children aged 9–13 years (48% boys, age = 11.04, SD = 1.16) assessed their life satisfaction, positive and negative affect in two study waves, while mothers and fathers assessed family resilience in the first wave. A dyadic data common fate model was employed to create latent variables representing family resilience. Three latent variables were: family problem-solving, family spirituality, and utilization of social and economic resources. Findings from the structural equation model indicated a positive association between higher levels of family problem-solving and increased children's life satisfaction, alongside a negative relationship between higher family spirituality and negative affect. Parental assessments of social and economic resources utilization were not uniquely related to children's life satisfaction, positive, or negative affect. [ABSTRACT FROM AUTHOR]

Previous research has highlighted the positive impact of greater health-related quality of life (Hr-QoL) and subjective well-being (SWB) on chronic diseases' severity and progression. There is a paucity of studies investigating the long-term trajectories of these variables among hypertensive patients. The present study aims to investigate the relationships between psychological variables (Type A and D personality, locus of control—LoC, self-esteem, and trait anxiety) with SWB and Hr-QoL in patients with hypertension and comorbid metabolic syndrome. A total of 185 volunteer patients (130 males, 70.3%; mean age 54 ± 10.93) were enrolled. Patients filled out measures of Hr-QoL and SWB, LoC, and self-esteem at three time points—Type A and D behaviors and anxiety measures only at baseline. Analyses were run through two-level hierarchical mixed models with repeated measures (Level 1) nested within participants (Level 2), controlling for sociodemographic and clinical confounders. Neither Hr-QoL nor SWB changed over time. Patients with greater self-esteem and internal LoC (and lower external LoC) increased their SWB and Hr-QoL up to 1-year follow-up. A greater Type A behavior and trait anxiety at baseline predicted a longitudinal increase in most of the dependent variables. Results suggest that it could be useful to tailor interventions targeting specific variables to increase Hr-QoL and SWB among hypertensive patients. [ABSTRACT FROM AUTHOR]

This study assessed differences in interprofessional collaboration, perception of nonbeneficial care, and staff well-being between critical care and palliative care teams. In six German hospitals, a staff survey was conducted between December 2013 and March 2015 among nurses and physicians in intensive and palliative care units. To allow comparability between unit types, a matching was performed for demographic characteristics of staff. N = 313 critical care and 79 palliative care staff participated, of which 72 each were successfully matched. Critical care nurses perceived the poorest overall quality of collaboration compared with critical care physicians and palliative care physicians and nurses. They also reported less inclusive leadership from attendings and head nurses, and the least collaboration on care decisions with physicians. They were most likely to perceive nonbeneficial care, and they reported the lowest levels of job satisfaction and the highest intention to leave the job. In partial correlations, aspects of high-quality collaboration were associated with less perceived nonbeneficial care and higher staff well-being for both critical care and palliative care staff. Our findings indicate that critical care teams could improve collaboration and enhance well-being, particularly among nurses, by adopting principles of collaborative work culture as established in palliative care. [ABSTRACT FROM AUTHOR]

Simple Summary: Outcomes for high-risk myeloma patients are still poor, despite many advances in treatment. In addition, scarce data exist on double maintenance in transplant-eligible high-risk newly diagnosed multiple myeloma (NDMM) patients. We present the results of a prospective study on 120 transplant-eligible NDMM patients with prolonged cytogenetic risk-based all-oral maintenance with lenalidomide + ixazomib (IR) for high-risk patients and lenalidomide (R) alone for non-high-risk patients after ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation. We found that high-risk cytogenetics had no impact on the proportion of patients achieving sustained undetectable minimal residual disease or on the rate of progression-free survival with IR maintenance. Our data suggest that prolonged use of all-oral double maintenance with IR with reasonable adverse effects would be a potential option for high-risk myeloma patients. Scarce data exist on double maintenance in transplant-eligible high-risk (HR) newly diagnosed multiple myeloma (NDMM) patients. This prospective phase 2 study enrolled 120 transplant-eligible NDMM patients. The treatment consisted of four cycles of ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation and cytogenetic risk-based maintenance therapy with lenalidomide + ixazomib (IR) for HR patients and lenalidomide (R) alone for NHR patients. The main endpoint of the study was undetectable minimal residual disease (MRD) with sensitivity of <10−5 by flow cytometry at any time, and other endpoints were progression-free survival (PFS) and overall survival (OS). We present the preplanned analysis after the last patient has been two years on maintenance. At any time during protocol treatment, 28% (34/120) had MRD < 10−5 at least once. At two years on maintenance, 66% of the patients in the HR group and 76% in the NHR group were progression-free (p = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10−5. Altogether 95% of the patients with sustained MRD <10−5, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (p < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Local therapies (LTs) are suggested by most experts and guidelines for the treatment of advanced ACC. However, there are only a few published studies on LTs, and there are no clear recommendations regarding which patients benefit from which treatments. Therefore, this multicentre cohort study aimed to investigate the outcomes and factors associated with LTs (n = 132) when used as a therapeutic approach in 66 patients with metastatic ACC. These patients were treated with local thermal ablation (LTA, n = 84) therapies, transarterial (chemo)embolisation (TA(C)E, n = 40), and transarterial radioembolisation (TARE, n = 8). In 21% of the treated tumoural lesions, complete remission was achieved. Time to progression of the treated lesion was particularly long in patients treated with LTA (median not yet reached), whereas it was only 8.3 months after TA(C)E and 8.2 months after TARE. Thus, this study provides clear evidence that LTs can be quite efficient in a subgroup of patients with advanced ACC. International guidelines recommend local therapies (LTs) such as local thermal ablation (LTA; radiofrequency, microwave, cryoablation), transarterial (chemo)embolisation (TA(C)E), and transarterial radioembolisation (TARE) as therapeutic options for advanced adrenocortical carcinoma (ACC). However, the evidence for these recommendations is scarce. We retrospectively analysed patients receiving LTs for advanced ACC. Time to progression of the treated lesion (tTTP) was the primary endpoint. The secondary endpoints were best objective response, overall progression-free survival, overall survival, adverse events, and the establishment of predictive factors by multivariate Cox analyses. A total of 132 tumoural lesions in 66 patients were treated with LTA (n = 84), TA(C)E (n = 40), and TARE (n = 8). Complete response was achieved in 27 lesions (20.5%; all of them achieved by LTA), partial response in 27 (20.5%), and stable disease in 38 (28.8%). For the LTA group, the median tTTP was not reached, whereas it was reached 8.3 months after TA(C)E and 8.2 months after TARE (p < 0.001). The median time interval from primary diagnosis to LT was >47 months. Fewer than four prior therapies and mitotane plasma levels of >14 mg/L positively influenced the tTTP. In summary, this is one of the largest studies on LTs in advanced ACC, and it demonstrates a very high local disease control rate. Thus, it clearly supports the guideline recommendations for LTs in these patients. [ABSTRACT FROM AUTHOR]

In response to the diverse health challenges faced by today's youth and their extensive time spent in schools, we conducted a school health awareness campaign aimed at prioritizing well-being and academic performance. This analytical longitudinal study, spanning 27 schools in Lebanon, aimed to assess the impact of the awareness campaign on the health knowledge and practices of 5-, 8-, and 11-year-old students throughout pre- and post-intervention testing focused on general health and healthy habits, employing 11, 14, and 15 questions tailored to 5, 8, and 11 year olds, respectively. The questions covered various aspects, including sleep, personal and dental hygiene, nutrition, physical activity, addiction, security measures, and bullying. Out of the 7100 students who participated, 16.11% (1144 students) were evaluated before and after the campaign. The results indicated a significant increase in health awareness post-intervention across all age groups. For instance, in 5-year-olds, limited awareness decreased from 91.6% to 36.38%, while adequate awareness rose from 8.03% to 62.3%. Improvement varied across health knowledge topics, with security-related questions showing the highest enhancement. Factors such as governorate, normal-weight status, and close supervision influenced improvement. However, no significant correlations were found with school type, size, gender, age, nationality, parental factors, or comorbidities. The study concludes that the school health awareness campaign successfully heightened children's health awareness, advocating for the integration of regular health promotions into the standard educational curriculum. [ABSTRACT FROM AUTHOR]

Simple Summary: Anxiety, depression and fear of cancer progression are common psychological challenges faced by women with ovarian cancer. It can affect a person's well-being, treatment compliance and quality of life. In this study, we assessed how often and how severe these concerns are 12 months after surgical treatment and if there is any association with surgical, patient and tumour factors. A total of 141 patients with advanced ovarian cancer who did not have disease progression at 12 months post-surgery completed two questionnaires. We found that a significant proportion of patients undergoing surgery for ovarian cancer experience anxiety, depression and fear of progression. It was not possible to identify a group of patients who are more affected by anxiety, depression or fear of progression. It is essential for healthcare providers to be attentive to the emotional needs of all ovarian cancer patients and provide appropriate support to help them cope with these psychological concerns effectively. Patients with ovarian cancer (OC) often experience anxiety, depression and fear of progression (FOP); however, it is unclear whether surgical complexity has a role to play. We investigated the prevalence of anxiety, depression and FOP at 12 months post-cytoreductive surgery and investigated associations with surgical complexity, patient (age, ethnicity, performance status, BMI) and tumour (stage, disease load) factors. One hundred and forty-one patients with FIGO Stage III–IV OC, who did not have disease progression at 12 months post-surgery, completed the Hospital Anxiety and Depression Scale and FOP short-form questionnaire. Patients underwent surgery with low (40.4%), intermediate (31.2%) and high (28.4%) surgical complexity scores. At 12 months post-surgery, 99 of 141 (70%) patients with advanced OC undergoing surgery experienced clinically significant anxiety, 21 of 141 (14.9%) patients experienced moderate to severe depression and 37 of 140 (26.4%) experienced dysfunctional FOP. No associations were identified between the three different surgical complexity groups with regards to anxiety, depression or FOP scores. Unsurprisingly, given the natural history of the disease, most patients with OC suffer from anxiety, depression and fear of progression after completion of first-line cancer treatment. Surgical complexity at the time of surgery is not associated with a deleterious impact on anxiety, depression or FOP for patients with OC. Patients with OC experience a profound mental health impact and should be offered mental health support throughout their cancer journey. [ABSTRACT FROM AUTHOR]

Early positive bonding between parents and babies promotes the development of parenting skills and parents' sensitivity to their infant's needs. Positive bonding has been suggested to decrease the risk of maltreatment. There is less research into the differences between primiparae's and their spouses' bonding with their baby and changes in the parent-to-infant bonding during the first year of the baby's life. The aim of this study was to describe bonding with one's baby and related differences and changes within first-time parents. The data were collected from nine maternal health clinics in 2019–2021 in one city in Finland. The Mother-to-Infant Bonding Scale (MIBS) and the Edinburgh Postnatal Depression Scale (EPDS) were used. The data were collected during pregnancy (T1) and when the baby was aged 1–2 months (T2) and 6–8 months (T3). The questionnaire was completed separately by the primiparae (n = 81 at T1) and their spouses (n = 79 at T1). The findings demonstrated that both parents had positive feelings for their baby. The primiparae's and their spouses' MIBS scores were relatively low at T2 and T3. The change between time points or the difference in the parents' bonding was not statistically significant when examining MIBS total scores. The present study identified a positive weak-to-moderate correlation between the MIBS and EPDS. This association was highlighted in the group of primiparae. The results of this study can be used to develop maternity and child health clinic services, and to promote parents' equal growth in parenthood. [ABSTRACT FROM AUTHOR]

Simple Summary: To assess the percentage of early breast cancer (EBC) patients treated with neoadjuvant systemic therapy (NAT) in Italy, criteria of patient selection and types of therapies delivered, 1276 stage I-II-III patients were enrolled and evaluated in the multicenter prospective observational BRIDE study in 2018–2021. NAT was administered to 13.9% of EBC patients. In multivariate analysis, menopausal status, cT, cN, grade, HER2-positive and Triple Negative (TN) subgroups were significantly associated with the decision to administer NAT. According to phenotypic subgroup, NAT was administered to 53.2% of HER2+/HR-negative (pathologic complete response—pCR-74.2%), 27.9% of HER2+/HR+ (pCR 52.3%), 7.1% of HER2-negative/HR+ (pCR 17.2%) and 30.3% of TN (pCR 37.9%) patients. Phenotypic subgroup influenced the type of NAT delivered. Today, the use of NAT in EBC should be always considered, especially in HER2+ and TN, because of the association between pCR and better survival of patients and the current availability of effective therapies for patients with residual disease. To evaluate the rate of early breast cancer (EBC) patients treated with neoadjuvant systemic therapy (NAT) in Italy, criteria of patient selection and types of therapies delivered, an analysis of 1276 patients with stage I-II-III was conducted out of 1633 patients enrolled in the multicenter prospective observational BRIDE study. A total of 177 patients (13.9%) were treated with NAT and 1099 (85.9%) with surgery; in multivariate analysis, menopausal status, cT, cN, grade, HER2-positive and Triple negative (TN) subgroups were significantly associated with the decision to administer NAT. The type of NAT delivered was influenced by EBC subtype. NAT was administered to 53.2% of HER2+/HR-negative, 27.9% of HER2+/HR+, 7.1% of HER2-negative/HR+ and 30.3% of TN EBC patients. The pCR rates were similar to the ones reported in the literature: 74.2% in HER2+/HR-negative, 52.3% in HER2+/HR+, 17.2% in HER2-negative/HR+ and 37.9% in TN. In clinical practice, patient and tumor characteristics influenced oncologists in the decision to administer NAT in EBC and in the choice of the type of systemic therapy, according to ESMO and AIOM Guidelines. Currently, it is recommended always to evaluate the use of NAT in EBC, mainly in HER2+ and TN patients, considering that pCR is associated with significantly better survival of the patient and that effective therapies are now available for residual disease. [ABSTRACT FROM AUTHOR]

Introduction: The COVID-19 pandemic has had a considerable impact on the psychological and psychopathological status of the population and health care workers in terms of insomnia, anxiety, depression, and post-traumatic stress disorder. The primary aim of this study was to describe and evaluate the impact of the pandemic on insomnia levels of a cohort of Italian nurses, particularly those involved in the care of COVID-19 patients. The secondary aim was to identify the interaction between insomnia and hardiness, anxiety, and sleep disturbances. Materials and Methods: A descriptive–exploratory study was conducted using an online survey during the first wave of the COVID-19 pandemic (March to July 2020). The questionnaire consisted of multiple-choice, open-ended, closed, and semi-closed questions. The psychometric tools administered were the Dispositional Resilience Scale (DRS-15), the State–Trait Anxiety Inventory (STAI-Y), and the Insomnia Severity Index (ISI). Results: a cohort of 1167 nurses fully completed the questionnaire (86.2% of total respondents). The insomnia scale survey showed an increase in post-pandemic scores compared to those before the pandemic, implying that insomnia levels increased after the first pandemic wave. Insomnia scores were directly correlated with anxiety levels (r = 0.571; p ≤ 0.05) and inversely correlated with hardiness levels (r = −0.324; p < 0.001). Multivariate analysis revealed the following protective factors: not having worked in COVID-19 wards, high levels of hardiness (commitment), and the presence of high pre-pandemic insomnia disorder. The main risk factor for insomnia reported in the analysis was a high anxiety score. Discussion and Conclusion: Anxiety represented the main risk factor for insomnia severity in our sample, while hardiness was confirmed as a protective factor. Thus, it is necessary to design further studies to identify additional risk factors for poor sleep quality and to develop educational courses and strategies aimed at enhancing rest and sleep quality, especially for frontline nurses. [ABSTRACT FROM AUTHOR]

Simple Summary: Genetic profiling of plasma cell-free DNA (cfDNA) from liquid biopsies (LiqBio) is a possible alternative to genetic profiling of tissue biopsies to diagnose B-cell lymphoma (BCL), and a complementary tool of PET/CT to determine measurable residual disease (MRD). The aim of our study was to confirm the utility of LiqBio for diagnosis and surveillance of BCL. We confirmed the correlation between somatic mutations in paired LiqBio and tissue biopsies at diagnosis in a population of 78 patients; furthermore, we identified additional mutations in LiqBio at diagnosis from patients with no available tissue samples or no mutations detected in tissue samples. As a surveillance tool for MRD detection, LiqBio combined with PET/CT showed to be a valuable method, improving the PET/CT specificity. Purpose: To assess the potential value of LiqBio as a complementary tool for diagnosis and surveillance of BCL. Methods: This prospective multi-center study included 78 patients (25 follicular lymphomas (FL) and 53 large B-cell lymphomas (LBCL)). We performed next-generation sequencing (NGS) of cfDNA LiqBio and paired gDNA tissue biopsies at diagnosis and compared the mutational statuses. Also, through NGS of LiqBio, we identified MRD biomarkers and compared this novel LiqBio–MRD method with PET/CT in detecting MRD at follow-up. Results: We identified mutations in 71% of LiqBio and 95% of tissue biopsies, and found a correlation between variant allele frequency of somatic mutations. Additionally, we identified mutations in 73% of LiqBio from patients with no available tissue samples or no mutations in them. Regarding the utility of LiqBio–MRD as a dynamic monitoring tool, when compared with the PET/CT method, a lower sensitivity was observed for LiqBio–MRD at 92.3% (vs. 100% for PET/CT), but a higher specificity of 91.3% (vs. 86.9% for PET/CT). Conclusion: Genetic profiling of tumor cfDNA in plasma LiqBio is a complementary tool for BCL diagnosis and MRD surveillance. [ABSTRACT FROM AUTHOR]

Simple Summary: Opioid switching is the practice of substituting one opioid for another to improve pain relief or reduce adverse effects. This study aimed to examine pain and adverse event outcomes in people with advanced cancer pain, comparing those who undergo opioid switching with a control group, using multidimensional pain and standardized adverse event recording to add toward the limited data on this common practice. We found that compared to the control group, opioid switching reduced pain (worst, average, now) (p < 0.05), uncontrolled breakthrough pain (a 3-fold reduction, p = 0.008), and psychological distress (48% to 16%, p < 0.005). This study demonstrates that opioid switching is effective at reducing pain, adverse effects, and psychological distress to satisfactory levels of symptom control within 1 week in a population with advanced cancer pain. The use of multidimensional tools and standardized reporting further adds to the quality of evidence supporting opioid switching practice. Opioid switching is a common practice of substituting one opioid for another to improve analgesia or adverse effects; however, it has limited evidence. This study aimed to examine the effectiveness of opioid switching in advanced cancer. This multi-center prospective cohort study recruited patients assessed to switch opioids (opioid switch group) or to continue ongoing opioid treatment (control group). Clinical data (demographics, opioids) and validated instruments (pain and adverse effects) were collected over two timepoints seven days apart. Descriptive analyses were utilized. Non-parametric tests were used to determine differences. Fifty-four participants were recruited (23 control group, 31 switch group). At the follow-up, opioid switching reduced pain (worst, average, and now) (p < 0.05), uncontrolled breakthrough pain (3-fold reduction, p = 0.008), and psychological distress (48% to 16%, p < 0.005). The switch group had a ≥25% reduction in the reported frequency of seven moderate-to-severe adverse effects (score ≥ 4), compared to a reduction in only one adverse effect in the control group. The control group experienced no significant pain differences at the follow-up. Opioid switching is effective at reducing pain, adverse effects, and psychological distress in a population with advanced cancer pain, to levels of satisfactory symptom control in most patients within 1 week. [ABSTRACT FROM AUTHOR]

Simple Summary: The evaluation of RAS mutations from plasma circulating tumour DNA (ctDNA) has emerged as an efficient approach to guide therapeutic decisions in the treatment of metastatic colorectal cancer (mCRC). However, disagreements about the RAS mutational status in tests using liquid and tumour tissue biopsies can lead to misinterpretation of the tumour genotype and compromise effective therapy. We used digital droplet PCR (ddPCR) technology and logistic regression models to decipher the clinicopathological profiles that commonly influence the levels and detection of plasmatic RAS mutations and are associated with discordant assays. The absence of liver metastases and the resection of the primary tumour were associated with reduced ctDNA levels and low percentages of positive agreement between tissue and ctDNA tests, predominantly when the mCRC originated in the right colon and rectum. Thus, ctDNA assays reporting undetected RAS mutations in these patients should be taken prudently, and further investigations should be considered before any decision about treatment. We aimed to identify common mCRC profiles associated with a discordant mutational status of RAS between the standard of care (SoC) tumour tissue tests and ctDNA tests to understand ctDNA detection and improve treatment responses. This was a multicentre, retrospective and prospective study. A total of 366 Spanish mCRC patients were independently recruited. BEAMing ddPCR technology was employed to detect ctDNA RAS mutations, and logistic regression analyses were performed to investigate clinicopathological factors associated with discordance. The highest concordance ratios were observed in profiles with multiple metastatic sites when the liver was present (89.7%; 95% CI 84.8–93.2), profiles with synchronous disease without primary tumour resection (90.2%; 95% CI 83.6–94.3) and profiles with mCRC originating in the left colon (91.3%; 95% CI 85.0–95.0). Metachronous disease originating in the right colon (OR = 6.1; 95% CI 1.7–26.5; p-value = 0.006) or rectum (OR = 5.0; 95% CI 1.5–17.8; p-value = 0.009) showed the highest probability of discrepancies. Primary tumour resection and a higher frequency of single metastases in the peritoneum or lungs in these patients were associated with reduced plasmatic mutation allele fractions (MAFs) and an increased probability of showing false-negative genotypes. Additional testing of patients with mCRC originating in the right colon or rectum with a single non-mutated ctDNA test is advised before the choice of therapy. [ABSTRACT FROM AUTHOR]

For decades, scholars have studied leader–member exchange (LMX) relationships to understand and explain the effects of leadership on follower attitudes and performance outcomes within work settings. One available instrument to measure these aspects is the LMX-7 scale. This measurement has been widely used in empirical studies, but its psychometric properties have been poorly explored. The aim of this study was to test the psychometric characteristics (content, structural and construct validity, and reliability) of the Italian version of the LMX-7 scale and to support its cultural adaptation. We used a cross-sectional multi-center design. The forward–backward translation process was used to develop the Italian version of the scale. The scale was administered through an online survey to 837 nurses and nurse managers working in different settings. The factorial structure was tested using both exploratory and confirmatory factor analyses (EFA and CFA), and reliability was evaluated using Cronbach's alpha. For the construct validity, we used hypothesis testing and differentiation by known groups. The Italian version of the LMX-7 scale presented one dimension. All the psychometric tests performed confirmed its validity and suggested its usefulness for future research. [ABSTRACT FROM AUTHOR]

Simple Summary: As a direct consequence of the COVID-19 pandemic, cancer screening programs, management of chronic disease and cancer treatments were either cancelled or delayed. 164 patients with hepatocellular cancer (HCC) were evaluated to understand the impact of the first lockdown on treatment delays, and 1-year survival. We observed that 70% of patients were not treated within 31 days, with the median time to treatment being 49 days. This was particularly true of those with early-stage disease undergoing surgical or interventional radiology treatment. However, we noted that delay to treatment had no impact on mortality at 1-year. Given the diversity of the patients included in the study, we investigated possible factors influencing treatment delay, such as age, ethnicity, and geographical location. None of these factors were found to be associated with treatment delays. Future studies with longer follow-up are needed to assess whether delay to treatment had a negative impact on patients' survival. Our study allows a better understanding of treatment delays and short-term impact on survival during severe health services disruptions. Findings from this study highlight the need for better prioritisation of HCC treatment services particularly for the management of early-stage disease during any future pandemic lockdown. Introduction: The COVID-19 pandemic has caused severe disruption of healthcare services worldwide and interrupted patients' access to essential services. During the first lockdown, many healthcare services were shut to all but emergencies. In this study, we aimed to determine the immediate and long-term indirect impact of COVID-19 health services utilisation on hepatocellular cancer (HCC) outcomes. Methods: A prospective cohort study was conducted from 1 March 2020 until 30 June 2020, correlating to the first wave of the COVID-19 pandemic. Patients were enrolled from tertiary hospitals in the UK and Germany with dedicated HCC management services. All patients with current or past HCC who were discussed at a multidisciplinary meeting (MDM) were identified. Any delay to treatment (DTT) and the effect on survival at one year were reported. Results: The median time to receipt of therapy following MDM discussion was 49 days. Patients with Barcelona Clinic Liver Cancer (BCLC) stages-A/B disease were more likely to experience DTT. Significant delays across all treatments for HCC were observed, but delay was most marked for those undergoing curative therapies. Even though severe delays were observed in curative HCC treatments, this did not translate into reduced survival in patients. Conclusion: Interruption of routine healthcare services because of the COVID-19 pandemic caused severe delays in HCC treatment. However, DTT did not translate to reduced survival. Longer follow is important given the delay in therapy in those receiving curative therapy. [ABSTRACT FROM AUTHOR]

Introduction: Video-based automatic motion analysis has been employed to identify infant motor development delays. To overcome the limitations of lab-recorded images and training datasets, this study aimed to develop an artificial intelligence (AI) model using videos taken by mobile phone to assess infants' motor skills. Methods: A total of 270 videos of 41 high-risk infants were taken by parents using a mobile device. Based on the Pull to Sit (PTS) levels from the Hammersmith Motor Evaluation, we set motor skills assessments. The videos included 84 level 0, 106 level 1, and 80 level 3 recordings. We used whole-body pose estimation and three-dimensional transformation with a fuzzy-based approach to develop an AI model. The model was trained with two types of vectors: whole-body skeleton and key points with domain knowledge. Results: The average accuracies of the whole-body skeleton and key point models for level 0 were 77.667% and 88.062%, respectively. The Area Under the ROC curve (AUC) of the whole-body skeleton and key point models for level 3 were 96.049% and 94.333% respectively. Conclusions: An AI model with minimal environmental restrictions can provide a family-centered developmental delay screen and enable the remote monitoring of infants requiring intervention. [ABSTRACT FROM AUTHOR]

Background: Obstructive sleep apnea can have a negative impact on children's and adolescents' neurocognitive abilities and hinder their academic and adaptive progress in academic, social, and/or behavioral dimensions. In this retrospective cross-sectional study, we investigated the influence of body weight conditions and allergy status on long-term mental health, cognitive development, and quality of life in children and adolescents who snored. Methods: The study sample included 47 subjects (age range 4.1 to 15.3 years) who exhibited high levels of snoring and underwent home-based polysomnography between 2015 and 2019. Follow-up assessments (3 years on average between baseline and follow-up) entailed phone interviews with the subject's parents/caregivers who completed three validated questionnaires investigating sleep, quality of life, and parental ratings. Results: We found a correlation between age at diagnosis and being retrospectively overweight and high levels of snoring. In addition to a higher risk of developing emotional symptoms (8.2% increase in retrospective overweight status for each unit increase in the emotional score at follow-up) and oppositional behavior (9% increase in retrospective overweight status for each unit of oppositional T points at follow-up), we also noted reduced long-term social symptoms (11% decrease in retrospective overweight status for each unit increase in the social score at follow-up) and cognitive symptoms (10.6% decrease in retrospective overweight status for each unit increase in the cognitive score at follow-up), as well as a 6.1% increase in retrospective allergy status for each unit increase in academic performance at follow-up. Conclusions: Snoring can have negative impacts on mental health and cognitive development in the long term. Early detection and intervention for neuropsychological disorders is important in children and adolescents who score high on snoring. In the long term, the effects of snoring on neuropsychological disorders may vary based on previous body weight and allergy status. [ABSTRACT FROM AUTHOR]

Simple Summary: Cancer of the nasal vestibule is thought to be rare. Multiple staging systems exist for the staging of these tumors, which can lead to variability and, therefore, the poor reliability of data. This retrospective study aimed to evaluate these staging systems. One hundred and forty-eight patients with carcinoma of the nasal vestibule were included and re-staged per the available staging systems. Stage distribution varied widely between the four evaluated staging systems. The classification per Bussu et al. had the most balanced allocation of patients amongst the stages. The widespread adoption of a single system and the introduction of a designated topography code for this disease could lead to greater uniformity in data reporting and an improved understanding of the incidence and disease outcome. Further analysis of survival data is needed to assess which classification system is the best suited for nasal vestibule carcinoma. Squamous cell carcinoma of the nasal vestibule is reported to account for less than one percent of all head and neck malignancies. It lacks a designated WHO ICD-O topography code, and multiple systems are available for the staging of this disease, which results in unwanted variability and the subsequent poor reliability of data. The aim of this study was to evaluate the currently available staging systems for cancer of the nasal vestibule, including the recently introduced classification by Bussu et al., which built on Wang's original concept but with clearer anatomical cutoffs. Different staging systems for cancer of the nasal vestibule (UICC nasal cavity, UICC skin cancer of the head and neck, Wang and Bussu et al.) were evaluated via a retrospective analysis of 148 patients. The staging system, per Bussu et al., had the most balanced allocation of patients among the stages. When using the Wang classification as a reference, stage migration occurred less frequently with the Bussu classification. The widespread adoption of a single staging system, as well as the introduction of a designated topography code for cancer of the nasal vestibule, could lead to more uniformity in data reporting and improve an understanding of the incidence and disease outcome. The newly proposed carcinoma of the nasal vestibule classification by Bussu et al. has the potential to improve the staging and allocation among stages. Further analysis of survival data is needed to assess which classification system is best suited for nasal vestibule carcinoma. [ABSTRACT FROM AUTHOR]

Background: Patients with anorectal malformation (ARM) need long-term follow-up, in order to evaluate fecal continence; the main predictors of longer-term success are the type of ARM, associated anomalies and sacral integrity. Three-Dimensional High Resolution Anorectal Manometry (3D-HRAM) gives detailed information on pressure on the anal complex profile. Our objective was to analyze anal sphincter activity in ARM patients with 3D-HRAM establishing the correlation between manometric and clinical data. Methods: Forty ARM patients were submitted to 3D-HRAM: manometric, anatomical and clinical scores were correlated with each other and with the bowel management response (BM). Results: A positive correlation between all scores and types of ARM was found: in high ARM and in patients with spinal anomalies (regardless to ARM type) lower scores were reported and even after BM they did not achieve good continence. Conclusions: 3D-HRAM gives detailed data on the functional activity of the anal sphincter complex. Our study revealed a correlation between manometric parameters and clinical outcomes, confirming spinal malformations and ARM type as the most important prognostic risk factors for a bad outcome. Specific sphincteric defects can also be explored with manometry, allowing for tailored bowel management strategies. [ABSTRACT FROM AUTHOR]

Simple Summary: Both palliative care and telemedicine are emerging disciplines that were combined in the present study to transfer expertise between inpatient tertiary and primary care hospitals. In this context, our study focuses solely on the effects of telemedicine from the physicians' perspective, so consultations were also permitted without direct patient involvement or reference. We were able to demonstrate that due to this lower threshold linkage, unnecessary referrals and transfers can be avoided while maintaining high satisfaction among the conducting physicians. Moreover, it facilitates the short-term incorporation of further specialized medical disciplines and intercollegiate collaboration. However, there are still numerous technical issues at present. But overall, telemedicine offers great advantages in palliative care, which ought to be exploited in the future. (1) Background: As the number of people receiving specialized palliative care (PC) continues to rise, there is a need to ensure the transfer of this expertise from university-based PC departments to primary care hospitals without such in-house access. The present study examines the potential of telemedicine to bridge these gaps. (2) Methods: This is a prospective multi-center feasibility trial. All physicians were appropriately pre-equipped and instructed to conduct telemedical consultations (TCs), which took place within fixed meetings or on-call appointments either related or unrelated to individual patients (allowing TCs also for educational and knowledge exchange purposes). (3) Results: An inquiry for participation was submitted to 11 hospitals, with 5 external hospitals actively cooperating. In the first study section, a total of 57 patient cases were included within 95 patient-related TCs during 80 meetings. Other university disciplines were involved in 21 meetings (26.2%). Therapy adjustments resulted following 25 of 71 affected TCs (35.2%). In 20 cases (21.1%), an on-site consultation at the university hospital was avoided, and in 12 cases (12.6%), a transfer was avoided. Overall, TCs were considered helpful in resolving issues for 97.9% of the cases (n = 93). Yet, technical problems arose in about one-third of all meetings for at least one physician (36.2%; n = 29). Besides, in the second study section, we also conducted 43 meetings between physicians for education and knowledge exchange only. (4) Conclusions: Telemedicine has the potential to transfer university expertise to external hospitals through simple means. It improves collaboration among physicians, may prevent unnecessary transfers or outpatient presentations, and is thus likely to lower costs. [ABSTRACT FROM AUTHOR]

Objective: To identify physicians' views on the barriers to measuring cervical length for preventing preterm deliveries. Materials and methods: This prospective, descriptive implementation study had three phases. In Phase I, 20 physicians were interviewed. Phase II comprised questionnaire development and data validation. The questionnaire was distributed to 120 Phase III participants. Results and discussion: All 120 participants responded. In 44 cases, the physicians received support from their local Maternal and Child Health Boards for preterm-birth-prevention programs; the other 76 physicians did not. The doctors tended to believe that cervical length screening plays no role in preventing preterm births (4/44 (9.1%) and 24/76 (31.6%); OR, 4.615; 95% CI, 1.482–14.373; p = 0.005). They were unsure about the correct measurement procedures (13/44 (29.5%) and 37/76 (48.7%); OR, 2.262; 95% CI, 1.028–4.977; p = 0.040). A lack of cost-free drug support (progesterone) for women with short cervices was identified as a barrier to preventing preterm births (30/44 (68.2%) and 32/76 (42.1%); OR, 0.339; 95% CI, 0.155–0.741; p = 0.006). Conclusions: Many physicians are unconvinced that measuring cervical length prevents premature births, and are unsure about the correct measurement procedures. There is a lack of government funding for hormone-usage programs. [ABSTRACT FROM AUTHOR]

(1) Background: Falls are a significant health problem among older adults, and can result in severe injuries, disability, and even death. In Spain, the prevalence of falls is lower if the person lives in the community than if they are institutionalized. Research has shown that exercise is an effective strategy for reducing the risk of falls among older adults. The objective of this study was to study the influence of a multicomponent exercise intervention on falls in people between 65 and 80 years of age despite the presence of diseases and drug use that are risk factors for falls; (2) Methods: This is a quasi-experimental study that focuses on people aged 65–80 who attended 21 primary healthcare centres. Target: Inclusion criteria were people between 65 and 80 years of age, living in the community with independent ambulation, and who were served by the healthcare centre of their region. Variables analysed: The number and characteristics of falls, sociodemographic, drug use, and previous diseases; (3) Results: The drugs associated with falls are benzodiazepines (OR 2.58), vasodilators (OR = 2.51), and psychotropics (OR = 1.61). For one of the years, a relationship was found between the consumption of antidepressants and falls (OR = 1.83). The associated diseases were mental and behavioural (OR = 2.53); (4) Discussion: The intervention has been related to the reduction in falls in people who consumed benzodiazepines, vasodilators, and psychotropics and in people with mental disorders; (5) Conclusion: This research concludes the importance of the implementation of the Otago Exercise Programme in the prevention of falls in the elderly. [ABSTRACT FROM AUTHOR]

Simple Summary: Despite advances in treatment generated by clinical trials in metastatic breast cancer (MBC), their impact on routine daily practice and the reflection of the outcome within the community remains unclear. This study evaluates time-related differences in treatment patterns and outcome in a real-world patient population with MBC over a ten-year timeframe. Except for the HER2+ subgroup, which showed a significant survival benefit with the incorporation of novel agents, we failed to identify significant variations in outcomes for the remaining subgroups. A consistent feature we observed was the challenge in treating TNBC, which had the worst prognosis in both time-related cohorts. Elucidation of biologic characteristics to identify novel treatment options remains an unmet need to improve outcomes in TNBC. The favorable survival attained with routine endocrine agents in the luminal A subgroup suggests that barriers in access to CDK inhibitors may not have a negative impact on the outcome in subgroups of hormone receptor-positive patients, constituting an appealing strategy for communities with limited resources. This multicenter registry study aims to analyze time-related changes in the treatment patterns and outcome of patients with metastatic breast cancer (MBC) over a ten-year period. Correlations between demographic, prognostic variables and survival outcomes were carried out in database aggregates consisting of cohorts based on disease presentation (recurrent vs. de novo) and the diagnosis date of MBC (Cohort I: patient diagnosed between January 2010 and December 2014; and Cohort II: between January 2015 and December 2019). Out of 1382 patients analyzed, 52.3% patients had recurrent disease, with an increased frequency over time (47.9% in Cohort I vs. 56.1% in Cohort II, p < 0.001). In recurrent patients, 38.4% (n = 277) relapsed within two years from initial diagnosis, among which triple-negative BC (TNBC) was the most frequent (51.7%). Median overall survival (OS) was 51.0 (48.0–55.0) months for all patients, which was similar across both cohorts. HER2+ subtype had the highest OS among subgroups (HER2+ vs. HR+ vs. TNBC; 57 vs. 52 vs. 27 months, p < 0.001), and the dnMBC group showed a better outcome than recMBC (53 vs. 47 months, p = 0.013). Despite the lack of CDK inhibitors, luminal A patients receiving endocrine therapy had a favorable outcome (70 months), constituting an appealing approach with limited resources. The only survival improvement during the timeframe was observed in HER2+ dnMBC patients (3-year OS Cohort I: 62% vs. Cohort II: 84.7%, p = 0.009). The incorporation of targeted agents within standard treatment has improved the outcome in HER2+ MBC patients over time. Nevertheless, despite advances in early diagnosis and treatment, the prognosis of patients with TNBC remains poor, highlighting the need for more effective treatment options. [ABSTRACT FROM AUTHOR]

Background and Objectives: obstructed defecation syndrome (ODS) is a common but underestimated condition that may affect the outcomes after hemorrhoidectomy. Therefore, the aim of this study was to determine the prevalence of obstructed defecation syndrome (ODS) among patients who underwent hemorrhoidectomy and to assess the correlation between preoperative constipation score and postoperative patients' satisfaction. Materials and Methods: This prospective study included adult patients who underwent hemorrhoidectomy for 3rd and 4th-grade hemorrhoidal diseases. All participant patients underwent an assessment of functional OD severity by the Agachan–Wexner Constipation Scoring System. All patients were subjected to conventional hemorrhoidectomy. At 6 months postoperatively, patients were assessed again for their constipation score and postoperative patients' satisfaction. Results: The study included 120 patients (62 males and 58 females) with a mean age of 38.7 ± 12.1 years. About one-quarter of patients (24.2%) had obstructed defecation (constipation score ≥12). ODS (constipation score ≥12) was found to be significantly more among older patients, female patients, especially those with multiple pregnancies and multiple labors, and those with perineal descent. The postoperative constipation score (5.6 ± 3.3 mean ± SD) showed significant improvement (p = 0.001) compared to (9.3 ± 3.9 mean ± SD) preoperatively. Postoperative patients' satisfaction (mean 12.3 ± 3.0) at 6 months had a negative correlation with preoperative total constipation score (r = −0.035, p = 0.702). Conclusions: The prevalence of obstructed defecation among patients with hemorrhoids was higher than reported among the general population. High preoperative constipation scores had a negative correlation with postoperative patients' satisfaction. Routine preoperative measurement of ODS can allow the detection of this particular group of patients who require a more physical and psychological evaluation, in addition to special preoperative counseling. [ABSTRACT FROM AUTHOR]

Simple Summary: The transurethral resection of bladder tumors followed by intravesical Bacillus Calmette-Guerin (BCG) instillations represents the standard treatment for high-risk and selected intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients. We hypothesized that intravesical BCG might be protective against symptomatic SARS-CoV-2 infection, especially in those patients who experienced systemic adverse events during BCG treatment. We tested our hypothesis in a large multicenter cohort of NMIBC patients treated with adjuvant intravesical BCG in the year preceding the first and second waves of the SARS-CoV-2 pandemic at two tertiary urological centers in Northern Italy. We aim to evaluate the potential protective role of intravesical Bacillus Calmette-Guerin (BCG) against SARS-CoV-2 in patients with non-muscle invasive bladder cancer (NMIBC). Patients treated with intravesical adjuvant therapy for NMIBC between January 2018 and December 2019 at two Italian referral centers were divided into two groups based on the received intravesical treatment regimen (BCG vs. chemotherapy). The study's primary endpoint was evaluating SARS-CoV-2 disease incidence and severity among patients treated with intravesical BCG compared to the control group. The study's secondary endpoint was the evaluation of SARS-CoV-2 infection (estimated with serology testing) in the study groups. Overall, 340 patients treated with BCG and 166 treated with intravesical chemotherapy were included in the study. Among patients treated with BCG, 165 (49%) experienced BCG-related adverse events, and serious adverse events occurred in 33 (10%) patients. Receiving BCG or experiencing systemic BCG-related adverse events were not associated with symptomatic proven SARS-CoV-2 infection (p = 0.9) nor with a positive serology test (p = 0.5). The main limitations are related to the retrospective nature of the study. In this multicenter observational trial, a protective role of intravesical BCG against SARS-CoV-2 could not be demonstrated. These results may be used for decision-making regarding ongoing and future trials. [ABSTRACT FROM AUTHOR]

Robotic gait training has the potential to improve secondary health conditions for people with severe neurological impairment. The purpose of this study was to describe who is using the Trexo robotic gait trainer, how much training is achieved in the home and community, and what impacts are observed after the initial month of use. In this prospective observational single-cohort study, parent-reported questionnaires were collected pre- and post-training. Of the 70 participants, the median age was 7 years (range 2 to 24), 83% had CP, and 95% did not walk for mobility. Users trained 2–5 times/week. After the initial month, families reported a significant reduction in sleep disturbance (p = 0.0066). Changes in bowel function, positive affect, and physical activity were not statistically significant. These findings suggest that families with children who have significant mobility impairments can use a robotic gait trainer frequently in a community setting and that sleep significantly improves within the first month of use. This intervention holds promise as a novel strategy to impact multi-modal impairments for this population. Future work should include an experimental study design over a longer training period to begin to understand the relationship between training volume and its full potential. [ABSTRACT FROM AUTHOR]

Simple Summary: Radiation therapy (RT) is one of the corner stones of the local treatment of breast cancer (BC). Toxicity factors related to RT and their consequences are poorly known because of limited DICOM data and limited analyses on contouring, dose distribution and the RT technique. This manuscript describes the methodology used and provides the first characterization of the study population and RT data in CANTO-RT (CANcer TOxicities RadioTherapy). To our knowledge, our study is the largest available multicenter prospective multicenter cohort of early breast cancer with full DICOM RT data (files (CT, RT Structure, RT Dose, RT Plan)). This study answers to a concern about toxicity factors related to radiotherapy and their consequences and aims to identify predictors of development and the persistence of long-term toxicities in breast cancer patients. Further long-term projects (heart, lung, skin, fatigue) and follow up is ongoing. This article describes the methodology used and provides a characterization of the study population in CANTO-RT (CANcer TOxicities RadioTherapy). CANTO (NCT01993498) is a prospective clinical cohort study including patients with stage I-III BC from 26 French cancer centers. Patients matching all CANTO inclusion and exclusion criteria who received RT in one of the 10 top recruiting CANTO centers were selected. Individual full DICOM RT files were collected, pseudo-anonymized, structured and analyzed on the CANTO-RT/UNITRAD web platform. CANTO-RT included 3875 BC patients with a median follow-up of 64 months. Among the 3797 patients with unilateral RT, 3065 (80.4%) had breast-conserving surgery, and 2712 (71.5%) had sentinel node surgery. Tumor bed boost was delivered in 2658 patients (68.5%) and lymph node RT in 1356 patients (35%), including internal mammary chain in 844 patients (21.8%). Most patients (3691 (95.3%)) were treated with 3D conformal RT. Target volumes, organs at risk contours and dose/volume histograms were extracted after quality-control procedures. CANTO-RT is one of the largest early BC prospective cohorts with full individual clinical, biological, imaging and DICOM RT data available. It is a valuable resource for the identification and validation of clinical and dosimetric predictive factors of RT and multimodal treatment-related toxicities. [ABSTRACT FROM AUTHOR]

(1) Background: Trampoline fractures (proximal tibia fracture with positive anterior tilt) are increasing. This study represents the first attempt to determine the extent of remodeling in these fractures after conservative treatment (2) Methods: This Swiss prospective multicenter study included children aged 2 to 5 years with a trampoline fracture who were radiologically examined on the day of the accident and after one year. In addition, the anterior tilt angle was compared between the injured and unaffected tibia. Remodeling was defined as complete (final anterior tilt angle ≤ 0°), incomplete (smaller but still >0°), or no remodeling. (3) Results: The mean extent of remodeling was −3.5° (95% CI: −4.29°, −2.66°, p < 0.001). Among the 89 children included in the study, 26 (29.2%) showed complete, 63 (70.8%) incomplete, and 17 patients (19.1%) no remodeling. Comparison of the anterior tilt angles between the fractured and healthy tibia showed that the anterior tilt angle on the fractured leg was, on average larger by 2.82° (95% CI: 2.01°, 3.63°; p < 0.001). (4) Conclusions: Although the anterior tilt angle decreased during the study period, the majority of patients showed incomplete remodeling. In contrast, children with radiological examinations >1 year after the trauma showed advanced remodeling, suggesting that one year is too short to observe complete remodeling. [ABSTRACT FROM AUTHOR]

Simple Summary: Determining the most sensitive imaging technique to evaluate neuroendocrine tumors spread may have an impact on therapeutic management. The aim of this multicentric study was to prospectively assess 68Ga-DOTANOC PET/CT sensitivity compared to the combination of multiphasic CT, somatostatin receptor scintigraphy and MRI to evaluate whether this imaging modality results in therapeutic modifications. We confirm in a homogenous population of 105 grade 1 or 2 gastroenteropancreatic neuroendocrine tumors the higher sensitivity of 68Ga-DOTANOC PET/CT in per-patient and per-region analysis, as well as in the detection of primary tumor and small lesions such as peritoneal carcinomatosis and bone lesions leading to an impact on therapeutic management of almost half of the patients. The aim of this multicentric study was to prospectively compare 68Ga-DOTANOC PET/CT versus somatostatin receptor scintigraphy (SRS) with SPECT/CT, combined with multiphasic CT scan and MRI in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET). Patients with histologically proven grade 1 or 2 GEP-NET with suspicion of recurrence or progression, or with typical aspects of GEP-NET on morphological imaging, were explored with conventional imaging (CI): SRS with SPECT/CT, multiphasic CT scan and/or liver MRI followed by 68Ga-DOTANOC PET/CT. The gold standard was based on histology and imaging follow-up. The data of 105 patients (45 woman and 60 men; median age) were analyzed. 68Ga-DOTANOC PET/CT sensitivity was significantly higher than CI sensitivity in per-patient (98.9% vs. 88.6%, p = 0.016) and per-region (97.6% vs. 75.6%, p < 0.001) analyses, in the detection of the primary (97.9% vs. 78.7%; p = 0.016), peritoneal carcinomatosis (95% vs. 30%, p < 0.001), and bone metastases (100% vs. 33.3%, p = 0.041). 68Ga-DOTANOC PET/CT had an impact on the therapeutic management of 41.9% (44/105) patients compared to decisions based on CI explorations. Our data confirm the superiority of 68Ga-DOTANOC PET/CT over CI in the detection of peritoneal carcinomatosis and bone metastasis, as well as its strong therapeutic impact on the management of patients with grade 1-2 GEP-NETs. [ABSTRACT FROM AUTHOR]

Simple Summary: Both postoperative complications and perioperative blood transfusions have been separately related to worse prognosis after gastrectomy for patients with gastric cancer. This multicenter cohort study aims to evaluate their synergic effect on inflammatory activation and prognosis. Patients were classified into four groups based on their perioperative course: one, no blood transfusion and no infectious complication; two, blood transfusion; three, infectious complication; four, both transfusion and infectious complication. The analysis shows that perioperative blood transfusion and infectious complications have a synergic effect creating a pro-inflammatory activation that favors tumor recurrence. These findings reinforce the need of promoting restrictive policies of transfusion for patients undergoing gastrectomies implementing patients blood management programs. Background: The aim of this study was to evaluate the impact of perioperative blood transfusion and infectious complications on postoperative changes of inflammatory markers, as well as on disease-free survival (DFS) in patients undergoing curative gastric cancer resection. Methods: Multicenter cohort study in all patients undergoing gastric cancer resection with curative intent. Patients were classified into four groups based on their perioperative course: one, no blood transfusion and no infectious complication; two, blood transfusion; three, infectious complication; four, both transfusion and infectious complication. Neutrophil-to-lymphocyte ratio (NLR) was determined at diagnosis, immediately before surgery, and 10 days after surgery. A multivariate Cox regression model was used to analyze the relationship of perioperative group and dynamic changes of NLR with disease-free survival. Results: 282 patients were included, 181 in group one, 23 in group two, 55 in group three, and 23 in group four. Postoperative NLR changes showed progressive increase in the four groups. Univariate analysis showed that NLR change > 2.6 had a significant association with DFS (HR 1.55; 95% CI 1.06–2.26; p = 0.025), which was maintained in multivariate analysis (HR 1.67; 95% CI 1.14–2.46; p = 0.009). Perioperative classification was an independent predictor of DFS, with a progressive difference from group one: group two, HR 0.80 (95% CI: 0.40–1.61; p = 0.540); group three, HR 1.42 (95% CI: 0.88–2.30; p = 0.148), group four, HR 2.85 (95% CI: 1.64–4.95; p = 0.046). Conclusions: Combination of perioperative blood transfusion and infectious complications following gastric cancer surgery was related to greater NLR increase and poorer DFS. These findings suggest that perioperative blood transfusion and infectious complications may have a synergic effect creating a pro-inflammatory activation that favors tumor recurrence. [ABSTRACT FROM AUTHOR]

Simple Summary: The superior vena cava (SVC)'s involvement in non-small-cell lung cancer (NSCLC) has been considered a technical and oncological contraindication for surgery. In recent decades, different studies have demonstrated that surgery should not be contraindicated per se, but in highly selected cases and specialized centers, it could be curative with acceptable risks. Nevertheless, the tangential resection of the SVC or patch reconstruction have different surgical risks from prosthetic replacement. Moreover, the percentage of SVC involvement may influence the prognoses of these selected patients. Our intention was to investigate the relation between the rate of SVC involvement and surgical and oncological outcomes. The conclusions of our retrospective study may improve the management of patients with T4 NSCLC and SVC invasion. Background: Surgery for non-small-cell lung cancers (NSCLCs) invading the superior vena cava (SVC) is rarely performed due to surgical complexities and reported poor prognoses. Different methods have been described to reconstruct the SVC, such as direct suture, patch use or prosthesis, according to its circumferential involvement. The aim of our study was to analyze the short- and long-term results of different types of SVC resection and reconstruction for T4 NSCLCs. Methods: Between January 2000 and December 2019, 80 patients received an anatomical lung resection with SVC surgery in this multicenter retrospective study. The partial resection and direct suture or patch reconstruction group included 64 patients, while the complete resection and prosthesis reconstruction group included 16 patients. The primary endpoints were as follows: long-term survival and disease-free survival. The secondary endpoints were as follows: perioperative complications and 30- and 90-day mortality. Unpaired t-tests or Mann–Whitney U tests for non-parametric variables were applied to discrete or continuous data, and the chi-square test was applied to dichotomous or categorical data. Survival rates were calculated using the Kaplan–Meier method and compared using the log-rank test. Results: No differences were found between the two groups in terms of general characteristics and surgical, oncological and survival outcomes. In particular, there were no differences in terms of early (50.0% vs. 68.8%, p = 0.178) and late complication frequency (12.5% vs. 12.5%, p = 1.000), 30- and 90-day mortality, R status, recurrence, overall survival (33.89 ± 40.35 vs. 35.70 ± 51.43 months, p = 0.432) and disease-free survival (27.56 ± 40.36 vs. 31.28 ± 53.08 months, p = 0.668). The multivariate analysis demonstrated that age was the only independent predictive factor for overall survival. Conclusions: According to our results, SVC resection has good oncological and survival outcomes, regardless of the proportion of circumferential involvement and the type of reconstruction. [ABSTRACT FROM AUTHOR]

Simple Summary: Recurrence of stage II (pT3-T4 pN0) colorectal cancer (CRC) occurs in about 15% of patients and it is often due to undetected lymph node (LN) metastases with conventional pathology haematoxylin and eosin (H&E) LN analysis. Despite more sensitive molecular methods of LN staging having proved to have prognostic value in stage II CRC, we aimed at determining whether the pN stage could be better assessed with LN cytology smears. We analysed 3936 LNs from 217 CRC surgical resections, using three methods, H&E, cytology smears, and the One Step Nucleic Acid Amplification (OSNA) molecular assay. We compared the pN stages obtained from both H&E and cytology, as well as with the OSNA results. We concluded that LN analysis with cytology smears not only enables performing the pN stage, but detects more LN metastases than H&E, with a similar detection rate to molecular methods. Cytology LN analysis would allow a better patient therapeutic management. Stage II colorectal cancer (CRC) recurrence remains a clinical problem. Some of these patients are true stage III CRC with a pN0 pathology stage. This large prospective multicentre cohort study aimed at evaluating the diagnostic ability of lymph node (LN) cytology smears to perform the pN stage and compare it with the conventional haematoxylin and eosin (H&E) pathology pN stage. Additionally, we used the One-Step Nucleic Acid Amplification (OSNA), a high-sensitive molecular method of LN staging. A total of 3936 fresh LNs from 217 CRC surgical specimens were examined by three methods, H&E, LN cytology smears, and OSNA. H&E detected 29% of patients with positive LNs, cytology smears 35%, and OSNA 33.2% (p < 0.0001). H&E and cytology concordantly classified 92.2% of tumours, and 88.5% between OSNA and H&E. Cytology had 96.8% sensitivity and 90.3% specificity to discriminate positive/negative patients compared to H&E (p = 0.004), and 87.3% sensitivity and 89% specificity when compared to OSNA (p = 0.56). Patients with positive LNs detected by any of the three methods had significantly worse disease-free and overall survival. We conclude that pN stage accuracy for detecting positive LNs is superior with LN cytological smears than with conventional H&E, which would enable a better pN stage and management of early-stage CRC patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Individuals with neurofibromatosis type 1 (NF1) are vulnerable to socioemotional difficulties. However, we know little about how socioemotional functioning changes across childhood and adolescence and what factors predict the change. The current longitudinal study aims to address this gap by examining how demographic and NF1-disease related factors predict development of socioemotional functioning in a sample of children and adolescents with NF1 and PNs. We found substantial within-group variabilities in socioemotional development with developmental patterns varying across socioemotional domains, reporters of socioemotional functioning, age at baseline, parental education, race/ethnicity, number of NF1-related complications, and visibility of tumors. These findings indicate the need for individualized patient care and interventions that consider each child's unique background and needs. The results also suggest the need for more longitudinal research to further understand how various factors affect socioemotional development in children with NF1 to better inform intervention development and practices. Individuals with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs) have a higher risk for socioemotional problems. The current study aims to identify the socioemotional developmental pattern and its predictors across childhood and adolescence in individuals with NF1 and PNs. Participants included 88 children with NF1 and PNs (aged 6–18 years old, M = 12.05, SD = 3.62, 57% male) in a natural history study. Neuropsychological assessments were administered three times over six years. There are large variabilities in socioemotional development in the study participants. Developmental patterns varied across socioemotional domains, respondent type (parent-report [PR] vs. child-report [CR]), demographic factors, and NF1 disease-related factors. For instance, lower parental education was associated with a greater decline in internalizing problems (PR) but a greater increase in school disconnectedness (CR) over time. Non-White (vs. White) children were more likely to experience increased adaptive skills (PR) but decreased personal adjustment (CR). Children with more visible tumors experienced a greater decrease in school disconnectedness (CR). Children with more NF1 complications experienced a greater decrease in externalizing problems (PR). These findings indicate the necessity of using multi-informants and investigating subdomains of socioemotional functions. They also highlight the importance of developing individualized approaches to patient care and interventions. [ABSTRACT FROM AUTHOR]

Simple Summary: The bone scan (BS) is widely used in follow-up to detect bone metastasis (BM) in breast cancer (BC) patients presenting bone-related symptoms after surgery. However, it remains controversial whether asymptomatic BS (intensive postoperative BS) screening could be translated into a survival benefit. Therefore, we conducted this multicenter real-world study to understand the prognostic impact of intensive postoperative BS screening among 1059 Chinese patients with BM during the years 2005–2013. This study showed that intensive postoperative BS screening was an independent prognostic factor and prolonged the survival in patients with BC with BM. The prognostic value of intensive BS screening was consistently favorable for survival in patients at clinical high-risk. These findings suggested that intensive BS screening was important for improving survival, and should be recommended for postoperative surveillance, especially for patients with a high risk of recurrence and metastasis. The prognostic value of intensive postoperative bone scan (BS) screening, which is performed in asymptomatic patients with breast cancer (BC) after surgery, remained unclear. Patients diagnosed with BC with bone metastasis (BM) from five medical centers in China during the years 2005–2013 were retrospectively collected. Propensity score matching (PSM) was performed to balance the baseline characteristics. The survival outcomes were overall survival (OS) and overall survival after BM (OSABM). Among 1059 eligible patients, 304 underwent intensive postoperative BS while 755 did not. During a median follow-up of 6.67 years (95%CI 6.45, 7.21), intensive postoperative BS prolonged the median OS by 1.63 years (Log-Rank p = 0.006) and OSABM by 0.66 years (Log-Rank p = 0.002). Intensive postoperative BS was an independent prognostic factor for both OS (adjusted HR 0.77, 95%CI 0.64, 0.93, adjusted p = 0.006) and OSABM (adjusted HR 0.71, 95%CI 0.60, 0.86, adjusted p < 0.001). The prognostic value of intensive postoperative BS was consistently favorable for OS among clinical high-risk patients, including those with ages younger than 50, stage II, histology grade G3 and ER-Her2- subtype. This multicenter real-world study showed that intensive postoperative BS screening improved survival for BC patients with BM and should probably be recommended for postoperative surveillance, especially for patients at clinical high-risk. [ABSTRACT FROM AUTHOR]

Current data support an increase in the prevalence of high blood pressure (HBP) in pediatric patients with sleep-disordered breathing (SDB). Adeno-tonsillectomy has been shown to be an effective treatment for most patients. Our objective was to determine the prevalence of HBP in pediatric patients with SDB and the impact of adeno-tonsillectomy with a multicenter, longitudinal, and prospective study that included 286 children referred for suspected SDB. The diagnosis of SDB was established by polysomnography (PSG) and the diagnosis of HBP by 24-h ambulatory blood pressure monitoring (ABPM). In patients without SDB and SDB without treatment indication, these tests were repeated six months after the baseline visit. For patients with medical treatment for SDB, the tests were repeated six months after the treatment initiation. Finally, in patients with surgery indication, ABPM was performed just before surgical treatment and ABPM and PSG six months after the intervention. The study contributes to elucidating the association between SDB and HBP in pediatric patients. Moreover, it contributes to determining if intervention with adeno-tonsillectomy is associated with BP reduction. The results have direct implications for the management of SDB, providing essential information on treatment indications for existing clinical guidelines. NCT03696654. [ABSTRACT FROM AUTHOR]