Search

Purpose: To give an overview of the multicenter Prostate Cancer Outcomes (PCO) study, involving paper-based and web-based collection of patient-reported outcome measures (PROM) in patients undergoing local treatment for prostate cancer in certified centers in Germany. The PCO study is part of the larger Movember-funded TrueNTH Global Registry. The article reports on the study's design and provides a brief progress report after the first 2 years of data collection. Methods: Prostate cancer centers (PCCs) certified according to German Cancer Society requirements were invited to participate in collecting patient-reported information on symptoms and function before and at least once (at 12 months) after treatment. The data were matched with disease and treatment information. This report describes progress in patient inclusion, response rate, and variations between centers relative to online/paper use, and also data quality, including recruitment variations relative to treatment in the first participating PCCs. Results: PCC participation increased over time; 44 centers had transferred data for 3094 patients at the time of this report. Patient recruitment varied widely across centers. Recruitment was highest among patients undergoing radical prostatectomy. The completeness of the data was good, except for comorbidity information. Conclusions: The PCO study benefits from a quality improvement system first established over 10 years ago, requiring collection and harmonization of a predefined clinical dataset across centers. Nevertheless, establishing a PROM routine requires substantial effort on the part of providers and constant monitoring in order to achieve high-quality data. The findings reported here may be useful for guiding implementation in similar initiatives. [ABSTRACT FROM AUTHOR]

Background: Previous studies have demonstrated that the trauma population has needs for rehabilitation services that are best provided in a continuous and coordinated way. The discharge destination after acute care is the second step to ensuring quality of care. There is a lack of knowledge regarding the factors associated with the discharge destination for the overall trauma population. This paper aims to identify sociodemographic, geographical, and injury-related factors associated with discharge destination following acute care at trauma centers for patients with moderate-to-severe traumatic injuries. Methods: A multicenter, population-based, prospective study was conducted with patients of all ages with traumatic injury [New Injury Severity Score (NISS) > 9] admitted within 72 h after the injury to regional trauma centers in southeastern and northern Norway over a 1-year period (2020). Results: In total, 601 patients were included; a majority (76%) sustained severe injuries, and 22% were discharged directly to specialized rehabilitation. Children were primarily discharged home, and most of the patients ≥ 65 years to their local hospital. Depending on the centrality of their residence [Norwegian Centrality Index (NCI) 1–6, where 1 is most central], we found that patients residing in NCI 3–4 and 5–6 areas sustained more severe injuries than patients residing in NCI 1–2 areas. An increase in the NISS, number of injuries, or a spinal injury with an Abbreviated Injury Scale (AIS) ≥ 3 was associated with discharge to local hospitals and specialized rehabilitation than to home. Patients with an AIS ≥ 3 head injury (RRR 6.1, 95% Confidence interval 2.80–13.38) were significantly more likely to be discharged to specialized rehabilitation than patients with a less severe head injury. Age < 18 years was negatively associated with discharge to a local hospital, while NCI 3–4, preinjury comorbidity, and increased severity of injuries in the lower extremities were positively associated. Conclusions: Two-thirds of the patients sustained severe traumatic injury, and 22% were discharged directly to specialized rehabilitation. Age, centrality of the residence, preinjury comorbidity, injury severity, length of hospital stay, and the number and specific types of injuries were factors that had the greatest influence on discharge destination. [ABSTRACT FROM AUTHOR]

Objectives: Despite the obstacles of limited education and employment opportunities—and the stress associated with immigration and pregnancy—Mexican immigrant women have low rates of preterm birth (PTB) compared to the US national average for all races and ethnicities. Stressors during pregnancy, and stressors associated with acculturation, may accelerate cellular aging manifested by shortened telomere length (TL) in pregnant women. Our objectives were to: (1) determine whether women with PTBs had shorter telomere lengths compared to women who had full term births; (2) assess the association of acculturation with TL and PTB. Methods: This prospective pilot study collected data from 100 self-identified Mexican-origin pregnant women. Survey data included self-administered sociodemographic and acculturation measures and was collected from participants via paper and pen, while biologic data was collected via a single blood draw during a regularly scheduled prenatal visit between 26 and 36 weeks gestation. PTB data was collected from the participant's medical record after delivery. Results: TL was significantly associated with PTB; the median TL of the women with PTB was less than the median TL for the full sample (p = 0.02). Based on regression analysis for PTB vs acculturation, we found no significant associations between acculturation and PTB or TL. Conclusions for Practice: This study provides important evidence of the association between shortened maternal TL and adverse birth outcomes. By linking social, clinical and biologic data, we can enhance our understanding of social determinants that may affect racial and ethnic disparities in preterm birth. [ABSTRACT FROM AUTHOR]

Deep learning for computer vision can be leveraged for interpreting surgical scenes and providing surgeons with real-time guidance to avoid complications. However, neither generalizability nor scalability of computer-vision-based surgical guidance systems have been demonstrated, especially to geographic locations that lack hardware and infrastructure necessary for real-time inference. We propose a new equipment-agnostic framework for real-time use in operating suites. Using laparoscopic cholecystectomy and semantic segmentation models for predicting safe/dangerous ("Go"/"No-Go") zones of dissection as an example use case, this study aimed to develop and test the performance of a novel data pipeline linked to a web-platform that enables real-time deployment from any edge device. To test this infrastructure and demonstrate its scalability and generalizability, lightweight U-Net and SegFormer models were trained on annotated frames from a large and diverse multicenter dataset from 136 institutions, and then tested on a separate prospectively collected dataset. A web-platform was created to enable real-time inference on any surgical video stream, and performance was tested on and optimized for a range of network speeds. The U-Net and SegFormer models respectively achieved mean Dice scores of 57% and 60%, precision 45% and 53%, and recall 82% and 75% for predicting the Go zone, and mean Dice scores of 76% and 76%, precision 68% and 68%, and recall 92% and 92% for predicting the No-Go zone. After optimization of the client-server interaction over the network, we deliver a prediction stream of at least 60 fps and with a maximum round-trip delay of 70 ms for speeds above 8 Mbps. Clinical deployment of machine learning models for surgical guidance is feasible and cost-effective using a generalizable, scalable and equipment-agnostic framework that lacks dependency on hardware with high computing performance or ultra-fast internet connection speed. [ABSTRACT FROM AUTHOR]

Background: Given the significance of motor competence (MC) for healthy development and as a cornerstone for lifelong physical activity (PA), it is crucial to understand the manifold factors that are associated with MC. Thus, the aim of the present study was to investigate correlates of children's MC and their fundamental movement skills (FMS) within their daily life from a comprehensive biopsychosocial-ecological perspective. Methods: This is a cross-sectional sub-study of the 'Physical Literacy for Communities (PL4C)' WAVES cohort study conducted in the West Vancouver School District, Canada. Motor competence was assessed using the PLAYfun tool including overall MC score and five FMS category scores, namely, running, locomotor skills, upper and lower body control and balance skills. By means of structural equation modeling (SEM), direct associationswith MC and with the specific FMS categories addressing physical activity behavior, self-perceived physical literacy, parenting, and school ground design were investigated. Results: A total of 355 children with a mean age of 7.5 years and 111.1 min of MVPA per day participated. The group comprised 51% boys and 47% girls from 14 elementary schools. Most children were at an emerging MC-level (71%), while those at a competent MC-level exhibited significantly more daily minutes of MVPA (123 versus 109, p = 0.001). Additionally, they played outdoors more frequently and engaged in more instructor-led PA. The results revealed that logistical support from parents had not only a direct positive association with overall MC, both for girls and boys, but also with most of the FMS categories. However, the correlates of MC varied between genders and showed different patterns across the five FMS categories. While time spent in sports or coach-/instructor-led physical activities had a significant SEM generated direct effect only for boys' MC and for locomotor, upper body object control and balance, the aesthetic design of the school grounds was only associated with girls' MC and those same three FMS categories. Multivariate SEM could explain 26% of variance for girls' MC and 30% for boys'. Conclusions: This exploratory baseline assessment revealed parental logistical support as an important correlate of MC, irrespective of gender. There were distinct gender patterns across biopsychosocial-ecological correlates influencing MC and FMS. Despite the heterogeneity of the results, our findings indicate a potential role of school ground design in supporting the development of children's MC, especially for girls. Key Points: • The influence of biopsychosocial-ecological correlates on motor competence (MC) varied based on gender and the specific fundamental movement skill (FMS) categories. • While parental logistical support demonstrated a positive direct association with both genders' MC and most of the FMS categories, coach-led physical activities appeared to enhance only boys'. • The positive direct association of outdoor play on boys' MC and of school ground aesthetics on girls' MC might suggest the role of the physical environment in MC development. [ABSTRACT FROM AUTHOR]

Emergency medical services (EMSs) face critical situations that require patient risk classification based on analytical and vital signs. We aimed to establish clustering-derived phenotypes based on prehospital analytical and vital signs that allow risk stratification. This was a prospective, multicenter, EMS-delivered, ambulance-based cohort study considering six advanced life support units, 38 basic life support units, and four tertiary hospitals in Spain. Adults with unselected acute diseases managed by the EMS and evacuated with discharge priority to emergency departments were considered between January 1, 2020, and June 30, 2023. Prehospital point-of-care testing and on-scene vital signs were used for the unsupervised machine learning method (clustering) to determine the phenotypes. Then phenotypes were compared with the primary outcome (cumulative mortality (all-cause) at 2, 7, and 30 days). A total of 7909 patients were included. The median (IQR) age was 64 (51–80) years, 41% were women, and 26% were living in rural areas. Three clusters were identified: alpha 16.2% (1281 patients), beta 28.8% (2279), and gamma 55% (4349). The mortality rates for alpha, beta and gamma at 2 days were 18.6%, 4.1%, and 0.8%, respectively; at 7 days, were 24.7%, 6.2%, and 1.7%; and at 30 days, were 33%, 10.2%, and 3.2%, respectively. Based on standard vital signs and blood test biomarkers in the prehospital scenario, three clusters were identified: alpha (high-risk), beta and gamma (medium- and low-risk, respectively). This permits the EMS system to quickly identify patients who are potentially compromised and to proactively implement the necessary interventions. [ABSTRACT FROM AUTHOR]

Sleep is essential to life. Accurate measurement and classification of sleep/wake and sleep stages is important in clinical studies for sleep disorder diagnoses and in the interpretation of data from consumer devices for monitoring physical and mental well-being. Existing non-polysomnography sleep classification techniques mainly rely on heuristic methods developed in relatively small cohorts. Thus, we aimed to establish the accuracy of wrist-worn accelerometers for sleep stage classification and subsequently describe the association between sleep duration and efficiency (proportion of total time asleep when in bed) with mortality outcomes. We developed a self-supervised deep neural network for sleep stage classification using concurrent laboratory-based polysomnography and accelerometry. After exclusion, 1113 participant nights of data were used for training. The difference between polysomnography and the model classifications on the external validation was 48.2 min (95% limits of agreement (LoA): −50.3 to 146.8 min) for total sleep duration, −17.1 min for REM duration (95% LoA: −56.7 to 91.0 min) and 31.1 min (95% LoA: −67.3 to 129.5 min) for NREM duration. The sleep classifier was deployed in the UK Biobank with ~100,000 participants to study the association of sleep duration and sleep efficiency with all-cause mortality. Among 66,262 UK Biobank participants, 1644 mortality events were observed. Short sleepers (<6 h) had a higher risk of mortality compared to participants with normal sleep duration 6–7.9 h, regardless of whether they had low sleep efficiency (Hazard ratios (HRs): 1.36; 95% confidence intervals (CIs): 1.18 to 1.58) or high sleep efficiency (HRs: 1.29; 95% CIs: 1.04–1.61). Deep-learning-based sleep classification using accelerometers has a fair to moderate agreement with polysomnography. Our findings suggest that having short overnight sleep confers mortality risk irrespective of sleep continuity. [ABSTRACT FROM AUTHOR]

Background: Evidence for the management of pregnant women with acute hypoxaemic respiratory failure (AHRF) is currently lacking. The likelihood of avoiding intubation and the risks of continuing the pregnancy under invasive ventilation remain undetermined. We report the management and outcome of pregnant women with pneumonia related to SARS-CoV-2 admitted to the ICU of tertiary maternity hospitals of the Paris area. Methods: We studied a retrospective cohort of pregnant women admitted to 15 ICUs with AHRF related to SARS-CoV-2 defined by the need for O2 ≥ 6 L/min, high-flow nasal oxygen (HFNO), non-invasive or invasive ventilation. Trajectories were assessed to determine the need for intubation and the possibility of continuing the pregnancy on invasive ventilation. Results: One hundred and seven pregnant women, 34 (IQR: 30–38) years old, at a gestational age of 27 (IQR: 25–30) weeks were included. Obesity was present in 37/107. Intubation was required in 47/107 (44%). Intubation rate according to respiratory support was 14/19 (74%) for standard O2, 17/36 (47%) for non-invasive ventilation and 16/52 (31%) for HFNO. Factors significantly associated with intubation were pulmonary co-infection: adjusted OR: 3.38 (95% CI 1.31–9.21), HFNO: 0.11 (0.02–0.41) and non-invasive ventilation: 0.20 (0.04–0.80). Forty-six (43%) women were delivered during ICU stay, 39/46 (85%) for maternal pulmonary worsening, 41/46 (89%) at a preterm stage. Fourteen non-intubated women were delivered under regional anaesthesia; 9/14 ultimately required emergency intubation. Four different trajectories were identified: 19 women were delivered within 2 days after ICU admission while not intubated (12 required prolonged intubation), 23 women were delivered within 2 days after intubation, in 11 intubated women pregnancy was continued allowing delivery after ICU discharge in 8/11, 54 women were never intubated (53 were delivered after discharge). Timing of delivery after intubation was mainly dictated by gestational age. One maternal death and one foetal death were recorded. Conclusion: In pregnant women with AHRF related to SARS-CoV-2, HFNO and non-invasive mechanical ventilation were associated with a reduced rate of intubation, while pulmonary co-infection was associated with an increased rate. Pregnancy was continued on invasive mechanical ventilation in one-third of intubated women. Study registration retrospectively registered in ClinicalTrials (NCT05193526). [ABSTRACT FROM AUTHOR]

Background: Social isolation and loneliness are associated with living with a chronic condition particularly where stigma is a factor. Our study aimed to examine the lived experience of adolescents living with HIV in relation to isolation because of their diagnosis and consequences of disclosure. Giddens' structuration theory was used as an analytic framework to identify the potential mechanisms underlying adolescents living with HIV's experiences. Method: Longitudinal in-depth interviews were conducted with 20 adolescents living with HIV aged 15–24 years with each participant taking part in three interviews (total 60) between September 2020 and October 2021. Thematic analysis was performed using Braun and Clarke's steps for coding and analysing qualitative data and informed by the structuration theory framework. Results: The findings indicated that adolescents living with HIV have agency and make conscious choices about sharing their status. However, these choices are influenced by their experiences in their community. The discrimination and negative judgements they often experience prevent them from disclosing their status. Stigma, discrimination, and psychological distress contribute to the isolation that adolescents and young adults living with HIV experience. The limited disclosure itself can lead to them becoming isolated and lonely. Conclusion: The negative experiences which adolescents living with HIV face can have an impact not only on their psychological wellbeing but also on their decision to disclose and seek support. These experiences may lead to social isolation and loneliness, an unintended consequence of their action in protecting themselves from the conditions created by the structures/environment in which they live. [ABSTRACT FROM AUTHOR]

6–11-year-old children provide a critical window for physical activity (PA) interventions. The Virtual Fitness Buddy ecosystem is a precision health PA intervention for children integrating mixed reality technology to connect people and devices. A cluster randomized, controlled trial was conducted across 19 afterschool sites over two 6-month cohorts to test its efficacy in increasing PA and decreasing sedentary behavior. In the treatment group, a custom virtual dog via a mixed reality kiosk helped children set PA goals while sharing progress with parents to receive feedback and support. Children in the control group set PA goals using a computer without support from the virtual dog or parents. 303 children had 8+ hours of PA data on at least one day of each of the 3 intervention time intervals. Conversion of sedentary time was primarily to light-intensity PA and was strongest for children with low baseline moderate-to-vigorous PA than children above 45 min of baseline moderate-to-vigorous PA. Findings suggest that the VFB ecosystem can promote sustainable PA in children and may be rapidly diffused for widespread public health impact. [ABSTRACT FROM AUTHOR]

Background: There is an epidemic of firearm injuries in the United States since the mid-2000s. Thus, we sought to examine whether hospitalization from firearm injuries have increased over time, and to examine temporal changes in patient demographics, firearm injury intent, and injury severity. Methods: This was a multicenter, retrospective, observational cohort study of patients hospitalized with a traumatic injury to six US level I trauma centers between 1/1/2016 and 6/30/2022. ICD-10-CM cause codes were used to identify and describe firearm injuries. Temporal trends were compared for demographics (age, sex, race, insured status), intent (assault, unintentional, self-harm, legal intervention, and undetermined), and severity (death, ICU admission, severe injury (injury severity score ≥ 16), receipt of blood transfusion, mechanical ventilation, and hospital and ICU LOS (days). Temporal trends were examined over 13 six-month intervals (H1, January–June; H2, July–December) using joinpoint regression and reported as semi-annual percent change (SPC); significance was p < 0.05. Results: Firearm injuries accounted for 2.6% (1908 of 72,474) of trauma hospitalizations. The rate of firearm injuries initially declined from 2016-H1 to 2018-H2 (SPC = − 4.0%, p = 0.002), followed by increased rates from 2018-H2 to 2020-H1 (SPC = 9.0%, p = 0.005), before stabilizing from 2020-H1 to 2022-H1 (0.5%, p = 0.73). NH black patients had the greatest hospitalization rate from firearm injuries (14.0%) and were the only group to demonstrate a temporal increase (SPC = 6.3%, p < 0.001). The proportion of uninsured patients increased (SPC = 2.3%, p = 0.02) but there were no temporal changes by age or sex. ICU admission rates declined (SPC = − 2.2%, p < 0.001), but ICU LOS increased (SPC = 2.8%, p = 0.04). There were no significant changes over time in rates of death (SPC = 0.3%), severe injury (SPC = 1.6%), blood transfusion (SPC = 0.6%), and mechanical ventilation (SPC = 0.6%). When examined by intent, self-harm injuries declined over time (SPC = − 4.1%, p < 0.001), assaults declined through 2019-H2 (SPC = − 5.6%, p = 0.01) before increasing through 2022-H1 (SPC = 6.5%, p = 0.01), while undetermined injuries increased through 2019-H1 (SPC = 24.1%, p = 0.01) then stabilized (SPC = − 4.5%, p = 0.39); there were no temporal changes in unintentional injuries or legal intervention. Conclusions: Hospitalizations from firearm injuries are increasing following a period of declines, driven by increases among NH Black patients. Trauma systems need to consider these changing trends to best address the needs of the injured population. [ABSTRACT FROM AUTHOR]

Through technological innovations, patient cohorts can be examined from multiple views with high-dimensional, multiscale biomedical data to classify clinical phenotypes and predict outcomes. Here, we aim to present our approach for analyzing multimodal data using unsupervised and supervised sparse linear methods in a COVID-19 patient cohort. This prospective cohort study of 149 adult patients was conducted in a tertiary care academic center. First, we used sparse canonical correlation analysis (CCA) to identify and quantify relationships across different data modalities, including viral genome sequencing, imaging, clinical data, and laboratory results. Then, we used cooperative learning to predict the clinical outcome of COVID-19 patients: Intensive care unit admission. We show that serum biomarkers representing severe disease and acute phase response correlate with original and wavelet radiomics features in the LLL frequency channel (cor(Xu1, Zv1) = 0.596, p value < 0.001). Among radiomics features, histogram-based first-order features reporting the skewness, kurtosis, and uniformity have the lowest negative, whereas entropy-related features have the highest positive coefficients. Moreover, unsupervised analysis of clinical data and laboratory results gives insights into distinct clinical phenotypes. Leveraging the availability of global viral genome databases, we demonstrate that the Word2Vec natural language processing model can be used for viral genome encoding. It not only separates major SARS-CoV-2 variants but also allows the preservation of phylogenetic relationships among them. Our quadruple model using Word2Vec encoding achieves better prediction results in the supervised task. The model yields area under the curve (AUC) and accuracy values of 0.87 and 0.77, respectively. Our study illustrates that sparse CCA analysis and cooperative learning are powerful techniques for handling high-dimensional, multimodal data to investigate multivariate associations in unsupervised and supervised tasks. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the design and cohort characteristics of the Social Spectrum Study: a clinical cohort study that used a two-phase sampling design to identify children at risk for ASD. After screening 1281 children aged 2.5-10 years who had been consecutively referred to one of six mental health services in the Netherlands, children who screened positive for ASD (n = 428) and a random selection of screen negatives (n = 240) were invited to participate in diagnostic assessments and questionnaires regarding the child, family and society. A 1-year follow-up was also conducted. Results from this study may contribute to knowledge of the identification and characterization of children with ASD, family processes, and the impact of ASD on the family and society. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Patient-Reported Outcomes is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Remote monitoring of cognition holds the promise to facilitate case-finding in clinical care and the individual detection of cognitive impairment in clinical and research settings. In the context of Alzheimer's disease, this is particularly relevant for patients who seek medical advice due to memory problems. Here, we develop a remote digital memory composite (RDMC) score from an unsupervised remote cognitive assessment battery focused on episodic memory and long-term recall and assess its construct validity, retest reliability, and diagnostic accuracy when predicting MCI-grade impairment in a memory clinic sample and healthy controls. A total of 199 participants were recruited from three cohorts and included as healthy controls (n = 97), individuals with subjective cognitive decline (n = 59), or patients with mild cognitive impairment (n = 43). Participants performed cognitive assessments in a fully remote and unsupervised setting via a smartphone app. The derived RDMC score is significantly correlated with the PACC5 score across participants and demonstrates good retest reliability. Diagnostic accuracy for discriminating memory impairment from no impairment is high (cross-validated AUC = 0.83, 95% CI [0.66, 0.99]) with a sensitivity of 0.82 and a specificity of 0.72. Thus, unsupervised remote cognitive assessments implemented in the neotiv digital platform show good discrimination between cognitively impaired and unimpaired individuals, further demonstrating that it is feasible to complement the neuropsychological assessment of episodic memory with unsupervised and remote assessments on mobile devices. This contributes to recent efforts to implement remote assessment of episodic memory for case-finding and monitoring in large research studies and clinical care. [ABSTRACT FROM AUTHOR]

Purpose: Scholarship on the social and structural determinants of intimate partner violence (IPV) rarely differentiates between Johnson's types in examining pathways to violent outcomes. This study applies Bronfenbrenner's model to consider the etiology of Johnson's types at multiple social-ecological levels. Method: To test the hypothesis that pathways from local social and structural conditions to IPV differ by type of IPV, I reanalyzed longitudinal data from a recent study that explored the role of factors at multiple social-ecological levels on physical IPV in a highly vulnerable sample: 1,112 different-sex couples in which the male partner had recently returned from prison. Results: In fitted structural equation models, local social and structural conditions predict both situational couple violence (SCV) and coercive controlling violence (CCV). However, the influence of local conditions on each type of IPV occurs via different proximal factors. Local conditions predict SCV via hopelessness and predict CCV via post-traumatic stress and dysfunctional conflict. Conclusions: These exploratory findings indicate that local social and structural conditions could promote both SCV and CCV, but via different proximal processes. They suggest that IPV research has much to gain from integrating the distinct theoretical and methodological contributions of scholarship on Johnson's typology and ongoing inquiry into the broader social ecology of IPV. [ABSTRACT FROM AUTHOR]

Background: Pulmonary involvement is still regarded as a common cause of morbidity in Polymyositis/Dermatomyositis. Interstitial lung disease can result in potentially fatal consequences such as ventilatory failure, secondary pulmonary arterial hypertension, or cor pulmonale. Early diagnosis of interstitial lung disease is hence a top priority in Polymyositis/Dermatomyositis patients. Krebs von den Lungen-6 is a transmembrane mucoprotein that has recently been identified as a promising marker for interstitial lung disease diagnosis and progression. As a result, it is regarded as a powerful predictor of interstitial lung disease severity. Thirty polymyositis/dermatomyocitis patients were enrolled in this study. Thirty age and sex matched healthy individuals were selected as control group. Cutaneous Dermatomyositis Disease Area Severity index(CDASI) was used for evaluation of skin severity, KL6 was measured using Elisa kit, High-resolution computed tomography, pulmonary function tests were made. Results: Sixteen female and 14 male patients had a mean age of 41.64–8.02 and amedian of the disease duration of 4 years. Fifteen patients (50%) had normal readings on High-resolution computed tomography of the chest HRCT chest, while the other half had significant HRCT chest findings. KL-6 concentrations were seen to be higher in Polymyositis/Dermatomyositis patients mainly those with ILD (mean ± SD 38.66 ± 22.98), compared to the control group (Mean ± S 589.04 ± 409) and in patients without ILD (Mean ± SD 86.70 ± 8.99), (p < 0.001). KL-6 serum concentrations were shown to have a significant connection with the HRCT score (r = 0.803, P < 0.001). Forced vital capacity (FVC%) (r = − 0.910, P < 0.001), forced expiratory volume in 1 s (FEV1%) (r = − 0.767, P < 0.001), and FEV1/FVC% (r = − 0.228, P = 0.112) were all inversely related to KL-6 concentrations. Conclusion: Individuals with PM and DM with concomitant ILD have increased KL-6 serum concentrations in comparison to myositis individuals without ILD, denoting its potential role in diagnosis and follow up of PM/DM with ILD. Further studies are needed to discuss the role of KL6 in large sample of the patient's population, and its correlation with other organ affection rather than ILD. Also to clarify the potentiality of adding the KL6 biomarker to the guidelines of treat to target for Rheumatic diseases with lung affection and to see the effect of treatment on KL6 serum level. [ABSTRACT FROM AUTHOR]

Vocational identity develops through the complex and dynamic interactions of the subdimensions of identity. A four-wave longitudinal study was conducted to investigate how each subdimension (in-breadth exploration, in-depth exploration, commitment-making, identification with commitment, career flexibility, career self-doubt) of each of the three processes of vocational identity (exploration, commitment, reconsideration) interacts across time during the emerging adulthood. The participants were full-time college students in South Korea—248 at T1, 194 at T2, 159 at T3, and 115 at T4. They rated the Vocational Identity Status Assessment four times at 6-month intervals. The results of the autoregressive cross-lagged path analysis indicated that an increase in in-breadth exploration led to a decrease in career self-doubt, which subsequently led to an increase in the subdimensions of commitment. These findings suggest a specific short-term interaction pattern for the relationship between the subdimensions of vocational identity, known only as a complex interaction. Implications, limitations, and directions for future studies are also discussed. [ABSTRACT FROM AUTHOR]

Purpose: Aspirin has been suggested to reduce the risk of cancer. However, previous studies have been inconsistent regarding the relationship between aspirin use and the risk of occurrence of prostate cancer (PCa). The purpose of this study was to assess the effect of aspirin on clinical outcomes in patients with PCa in a meta-analysis and to explore the possible dose-response relationship. Methods: A systematic literature search was conducted in 10 electronic databases and 4 registries. The combined relative risks (RRs) were calculated using a random-effects model with 95% confidence interval (CIs) to assess the effect of aspirin on the risk of PCa. Relevant subgroup analyses and sensitivity analyses were performed. Results: The across studies results show that aspirin use associated with lower incidence of PCa (RR: 0.96, 95% CI: 0.95–0.98), and reduced mortality (RR: 0.88, 95% CI: 0.82–0.95). The results of the subgroup analysis indicated that both cohort and population studies in the Americas showed a reduction in PCa incidence and mortality with aspirin use. A linear correlation was observed between dosage/duration of aspirin use and its protective effect. Additionally, post-diagnosis aspirin use was associated with decreased risk of PCa mortality. Conclusions: This meta-analysis revealed an independent correlation between the use of aspirin and reductions in both the incidence and mortality rates of PCa. However, randomized controlled trials did not find any association between aspirin use and PCa. Furthermore, the impact of aspirin on PCa occurrence was found to be dependent on both dosage and duration. [ABSTRACT FROM AUTHOR]

Introduction: Older patients are frequently re-admitted to the hospital after attending the emergency department (ED). We investigated whether direct admission to the hospital was associated with a lower risk of readmission at 30 days compared to admission via the ED, in patients aged ≥ 75 years. Methods: Retrospective multicenter cohort study from 01/01/2018 to 31/12/2019, including patients aged ≥ 75 years from two hospitals. Patients admitted directly were matched 1:1 with patients admitted via the ED for center, age category, sex, major diagnosis category, type of stay (medical/surgical), and severity. We compared readmission at 30 days (primary outcome) and length of stay (secondary outcome) between groups. Results: A total of 1486 matched patients with an available outcome measure were included for analysis. We observed no significant difference in 30-day readmission rate between those admitted directly (102/778, 13.1%) and those admitted via the ED (87/708, 12.3%, p = 0.63). There was a significant difference in length of stay between both groups: median 5 days [Q1–Q3: 2–8] vs 6 days [2–11] for direct and ED admissions, respectively (effect size: 0.11, p < 0.001). By multivariate analysis, only moderate to severe denutrition was associated with the risk of readmission at 30 days (Odds Ratio 2.133, 95% Confidence Interval 1.309–3.475). Conclusion: The mode of entry to the hospital of patients aged 75 years and older was not associated with the risk of readmission at 30 days. However, those admitted directly had a significantly shorter length of stay than those admitted via the ED. [ABSTRACT FROM AUTHOR]

Background: Young adult (YA) cancer survivors experience clinically significant distress and have limited access to psychosocial support. Given growing evidence for unique adaptive benefits of positive emotion in the context of health-related and other life stress, we developed an eHealth positive emotion skills intervention for post-treatment survivors called EMPOWER (Enhancing Management of Psychological Outcomes With Emotion Regulation) and evaluated feasibility and proof of concept for reducing distress and enhancing well-being. Method: In this single-arm pilot feasibility trial, post-treatment YA cancer survivors (ages 18–39) participated in the EMPOWER intervention which included 8 skills (e.g., gratitude, mindfulness, acts of kindness). Participants completed surveys at baseline (pre-intervention), 8 weeks (post-intervention), and 12 weeks (1-month follow-up). Primary outcomes included feasibility (assessed by participation percentage) and acceptability (would recommend EMPOWER skills to a friend). Secondary outcomes included psychological well-being (mental health, positive affect, life satisfaction, meaning/purpose, general self-efficacy) and distress (depression, anxiety, anger). Results: We assessed 220 YAs for eligibility; 77% declined. Of those screened, 44 (88%) were eligible and consented, 33 began the intervention, and 26 (79%) completed the intervention. Overall retention was 61% at 12 weeks. Average acceptability ratings were high (8.8/10). Participants (M = 30.8 years, SD = 6.6) were 77% women, 18% racial/ethnic minorities, and 34% breast cancer survivors. At 12 weeks, EMPOWER was associated with improved mental health, positive affect, life satisfaction, meaning/purpose, and general self-efficacy (ps <.05, ds =.45 to.63) and decreased anger (p <.05, d = − 0.41). Conclusion: EMPOWER demonstrated evidence of feasibility and acceptability as well as proof of concept for enhancing well-being and reducing distress. Self-guided, eHealth interventions show promise for addressing YA cancer survivors' needs and warrant additional research to optimize survivorship care. Trial Registration: ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154 [ABSTRACT FROM AUTHOR]

Summary: In this multi-institutional retrospective cohort study, we compared the long-term risk of osteonecrosis of the jaw following the use of denosumab vs. bisphosphonates in osteoporotic patients. After 2-year use, the likelihood of osteonecrosis of the jaw is lower with denosumab compared to bisphosphonates, and the difference increases with time. Purpose: To compare the long-term risk of osteonecrosis of the jaw (ONJ) between osteoporotic patients treated with bisphosphonates (BPs) and denosumab. Methods: This multi-institutional retrospective cohort study included patients aged > 40 years with osteoporosis between January 2010 and December 2018. Patients who met the eligibility criteria were divided into BPs and denosumab groups by propensity score matching (PSM). The risk of ONJ of denosumab vs. BPs was estimated using a Cox proportional hazards model and was described by the cumulative incidence rate using the Kaplan–Meier method. Results: A total of 84,102 patients with osteoporosis were enrolled, among whom, 8962 were eligible for inclusion based on their first-line drug use (denosumab, n = 3,823; BPs, n = 5,139). Following PCM matching (1:1), the BPs and denosumab groups included 3665 patients each. The incidence density of ONJ in the denosumab and BPs matching groups was 1.47 vs. 2.49 events (per 1000 person-years), respectively. The hazard ratio of ONJ in the denosumab vs. BPs group was estimated as 0.581 (95% confidence interval: 0.33–1.04, p = 0.07). The cumulative incidence rates of ONJ in both groups were similar for the first and second years of drug use (p = 0.062), but significantly different from the third year onwards (p = 0.022). The severity of ONJ was not significantly different between the two groups. Conclusion: In osteoporotic patients, after 2 years of use, the likelihood of ONJ being induced by denosumab is lower than that of BPs, and the difference increases with time. [ABSTRACT FROM AUTHOR]

Background: Sodium (Na) balance is unexplored in dialyzed children. We assessed a simplified sodium balance (sNaB) and its correlates in pediatric patients receiving maintenance dialysis. Methods: Patients < 18 years old on hemodialysis (HD) or peritoneal dialysis (PD) in six European Pediatric Dialysis Working Group centers were recruited. sNaB was calculated from enteral Na, obtained by a 3-day diet diary, Na intake from medications, and 24-h urinary Na (uNa). Primary outcomes were systolic blood pressure and diastolic blood pressure standard deviation scores (SBP and DBP SDS), obtained by 24-h ambulatory blood pressure monitoring or office BP according to age, and interdialytic weight gain (IDWG). Results: Forty-one patients (31 HD), with a median age of 13.3 (IQR 5.2) years, were enrolled. Twelve patients (29.3%) received Na-containing drugs, accounting for 0.6 (0.7) mEq/kg/day. Median total Na intake was 1.5 (1.1) mEq/kg/day, corresponding to 60.6% of the maximum recommended daily intake for healthy children. Median uNa and sNaB were 0.6 (1.8) mEq/kg/day and 0.9 (1.7) mEq/kg/day, respectively. The strongest independent predictor of sNaB in the cohort was urine output. In patients receiving HD, sNaB correlated with IDWG, pre-HD DBP, and first-hour refill index, a volume index based on blood volume monitoring. sNaB was the strongest predictor of IDWG in multiple regression analysis (β = 0.63; p = 0.005). Neither SBP SDS nor DBP SDS correlated with sNaB. Conclusions: Na intake is higher than uNa in children on dialysis, and medications may be an important source of Na. sNaB is best predicted by urine output in the population, and it is a significant independent predictor of IDWG in children on HD. [ABSTRACT FROM AUTHOR]

Purpose: Dietary intake may have pronounced effects on circulating biomarker concentrations. Therefore, the aim was to provide a descriptive overview of serum metabolite concentrations in relation to time since last meal, focusing on amino acids, lipids, one-carbon metabolites, and biomarkers of vitamin status. Methods: We used baseline data from the observational community-based Hordaland Health Study, including 2960 participants aged 46–49 years and 2874 participants aged 70–74 years. A single blood draw was taken from each participant, and time since last meal varied. Estimated marginal geometric mean metabolite concentrations were plotted as a function of time since last meal, up to 7 h, adjusted for age, sex, and BMI. Results: We observed a common pattern for nearly all amino acids and one-carbon metabolites with highest concentrations during the first 3 h after dietary intake. Homocysteine and cysteine were lowest the 1st hour after a meal, while no patterns were observed for glutamate and glutamic acid. The concentrations of phylloquinone and triglycerides were highest 1 h after dietary intake. Thiamine and thiamine monophosphate concentrations were highest, while flavin mononucleotide concentrations were lowest within the first 2 h after a meal. No clear patterns emerged for the other fat-soluble vitamins, blood lipids, or B-vitamin biomarkers. Conclusion: Our findings suggest that distinguishing between "fasting" and "non-fasting" blood samples may be inadequate, and a more granular approach is warranted. This may have implications for how to account for dietary intake when blood sampling in both clinical and research settings. [ABSTRACT FROM AUTHOR]

Background: Although acute headache following COVID-19 vaccination is widely acknowledged, the long-term progression of these headaches remains poorly understood. Our objective was to identify various phenotypes of prolonged or worsened headaches associated with COVID-19 vaccination and document any changes in these phenotypes over an extended period. Additionally, we aimed to document the diverse headache presentations among patients with pre-existing primary headaches. Methods: A multinational, prospective observational study was conducted to investigate prolonged or worsened headaches associated with COVID-19 vaccination. Questionnaires assessing COVID-19 vaccination-related headaches at three time points (initial visit, 3rd month follow-up, and 6th month follow-up) were developed for the study. Headache specialists/clinicians evaluated patients using these questionnaires in a prospective manner. Repeated K-means cluster analysis was performed to identify patient profiles with prolonged or worsened headaches related to COVID-19 vaccination. Results: Among the 174 patients included in the study, there was a female-to-male ratio of 128 (73.6%) to 46 (26.4%). The mean age of the patient group was 45.2 ± 13.3 years, and 107 patients (61.5%) had a pre-existing history of primary headaches. Through the analysis, two major clusters were identified based on headache characteristics at each visit. During the first visit (n = 174), Cluster 1 primarily comprised patients with a history of primary headaches, frontal localization of pain, throbbing pain type, more severe headaches accompanied by symptoms such as nausea, phonophobia, photophobia, and osmophobia, and worsened by physical activity. In contrast, Cluster 2 consisted of patients with longer headache durations (over one month) and a stabbing/pressing quality of pain. Patients in Cluster 1 had a higher prevalence of migraine as the pre-existing primary headache disorder compared to Cluster 2 (90.48% vs. 68.18%, respectively; p = 0.005). Conclusion: The identification of two distinct phenotypes of prolonged or worsened headaches related to COVID-19 vaccination can provide valuable clinical insights. Having an awareness of the potential worsening of headaches following COVID-19 vaccination, particularly in patients with a primary headache disorder such as migraine, can help clinicians and headache experts anticipate and adjust their treatment strategies accordingly. This knowledge can aid in preplanning treatment modifications and optimize patient care. [ABSTRACT FROM AUTHOR]

Ileocolic intussusception is one of the common acute abdomens in children and is first diagnosed urgently using ultrasound. Manual diagnosis requires extensive experience and skill, and identifying surgical indications in assessing the disease severity is more challenging. We aimed to develop a real-time lesion visualization deep-learning pipeline to solve this problem. This multicenter retrospective-prospective study used 14,085 images in 8736 consecutive patients (median age, eight months) with ileocolic intussusception who underwent ultrasound at six hospitals to train, validate, and test the deep-learning pipeline. Subsequently, the algorithm was validated in an internal image test set and an external video dataset. Furthermore, the performances of junior, intermediate, senior, and junior sonographers with AI-assistance were prospectively compared in 242 volunteers using the DeLong test. This tool recognized 1,086 images with three ileocolic intussusception signs with an average of the area under the receiver operating characteristic curve (average-AUC) of 0.972. It diagnosed 184 patients with no intussusception, nonsurgical intussusception, and surgical intussusception in 184 ultrasound videos with an average-AUC of 0.956. In the prospective pilot study using 242 volunteers, junior sonographers' performances were significantly improved with AI-assistance (average-AUC: 0.966 vs. 0.857, P < 0.001; median scanning-time: 9.46 min vs. 3.66 min, P < 0.001), which were comparable to those of senior sonographers (average-AUC: 0.966 vs. 0.973, P = 0.600). Thus, here, we report that the deep-learning pipeline that guides lesions in real-time and is interpretable during ultrasound scanning could assist sonographers in improving the accuracy and efficiency of diagnosing intussusception and identifying surgical indications. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the prevalence of sarcopenia according to the old and new Asian Working Group on Sarcopenia (AWGS) operational criteria and explore the effects of sarcopenia on adverse outcomes in older adults with type 2 diabetes (T2D). Methods: A total of 386 patients with T2D aged ≥ 60 years were recruited in retrospective cohort study. Sarcopenia was assessed with different versions of the AWGS consensus, including the AWGS2014, AWGS2019H (muscle mass adjusted for height), and AWGS2019B (muscle mass adjusted for body mass index). The median follow-up period was 47 months. The composite primary endpoint was the first occurrence of cardiovascular disease (CVD), fragility fracture, and all-cause mortality and the secondary outcomes included the three separate components of the primary outcome. Results: In this study, the prevalence of sarcopenia under different criteria was significantly different, with AWGS2019H having the highest prevalence of 31.3%. The agreement among sarcopenia criteria was unsatisfactory. By Cox regression analysis, all three AWGS definitions of sarcopenia were associated with the composite outcome of all-cause mortality, fracture and CVD (hazard ratio [HR], 2.69 vs. HR, 2.63; vs. HR, 2.23; model 3). Further exploratory analysis, sarcopenia defined by the AWGS2019H criteria was an independent risk factor for death, incident CVD, and fractures. While AWGS2014 criteria was an increased risk factor of death and CVD. The AWGS2019B criteria were only associated with incident fractures. Conclusion: All three AWGS definitions of sarcopenia were associated the composite primary endpoint. Additionally, the AWGS2019H criteria may be a better independent risk factor for negative health outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Overweight and obesity have increased in people living with HIV (PLH). Our study evaluated weight, body-mass-index (BMI), and waist-to-hip ratio (WHR) change over 5 years of follow-up in PLH compared to the general population. Methods: HIV-positive participants in the HIV Heart Aging (HIVH) study were matched 1:2 by age and sex with HIV-negative controls of the population-based Heinz Nixdorf Recall (HNR) study. Both studies were recruited in the German Ruhr area. The association between HIV and weight, BMI, and WHR changes was examined using linear regression. Regression models were adjusted for parameters potentially affecting weight gain. Results: The matched HIVH and HNR participants (N = 585 and N = 1170, respectively; 14.7% females) had a mean age of 55 years at baseline. Despite the lower baseline weight (− 6 kg, 95% CI − 7.46 to − 4.59), the linear regression showed greater absolute and relative weight and BMI increases after 5 years in HIVH compared to HNR. Adjusting the linear regression models for smoking amplified that HIVH had a higher absolute and relative weight difference of 0.7 kg or ~ 1% compared to HNR after 5 years (95% Cl 0.1 to 1.3 and 0.2 to 1.6, respectively). Adjusting for HDL, LDL, systolic blood pressure, and diabetes mellitus did not affect the results. Conclusions: PLH had lower weight than the general population at baseline and after 5 years, but experienced greater increases in body weight after 5 years. WHR change after 5 years was lower in PLH compared to the general population, despite a higher WHR at baseline. [ABSTRACT FROM AUTHOR]

Large-scale screening for the risk of coronary heart disease (CHD) is crucial for its prevention and management. Physical examination data has the advantages of wide coverage, large capacity, and easy collection. Therefore, here we report a gender-specific cascading system for risk assessment of CHD based on physical examination data. The dataset consists of 39,538 CHD patients and 640,465 healthy individuals from the Luzhou Health Commission in Sichuan, China. Fifty physical examination characteristics were considered, and after feature screening, ten risk factors were identified. To facilitate large-scale CHD risk screening, a CHD risk model was developed using a fully connected network (FCN). For males, the model achieves AUCs of 0.8671 and 0.8659, respectively on the independent test set and the external validation set. For females, the AUCs of the model are 0.8991 and 0.9006, respectively on the independent test set and the external validation set. Furthermore, to enhance the convenience and flexibility of the model in clinical and real-life scenarios, we established a CHD risk scorecard base on logistic regression (LR). The results show that, for both males and females, the AUCs of the scorecard on the independent test set and the external verification set are only slightly lower (<0.05) than those of the corresponding prediction model, indicating that the scorecard construction does not result in a significant loss of information. To promote CHD personal lifestyle management, an online CHD risk assessment system has been established, which can be freely accessed at http://lin-group.cn/server/CHD/index.html. [ABSTRACT FROM AUTHOR]

Aim: The study aimed to determine trends in the prevalence of underweight, overweight, obesity and their putative risk factors in different cohorts from a representative population of adolescents in Central Italy. Subject and methods: After random sampling, five cohorts of adolescents attending public high schools – aged 14 to 18 years – were evaluated from 2005 to 2018 (n: 25,174). Collected information included self-reported body mass index (BMI), descriptors of family environment, eating behaviour, physical activity, screen use, bullying victimisation, sexual behaviour (age at first intercourse, number of partners) and perceived psychological distress. For these data, between-cohort prevalence differences were used to esteem prevalence variations across time. In the 2018 cohort, the association between these factors and body weight was evaluated through multinomial regressions with sex-specific crude relative risk ratios for different BMI categories. Results: An increased prevalence of overweight was observed for both boys and girls. The study outlined a transition towards higher parental education and unemployment, reduced soft drinks consumption and higher psychological distress. Sex-specific changes were observed for physical and sexual activity, and a rising percentage of girls reported being bullied and distressing family relationships. Parental education and employment, together with physical activity, confirmed to be protective factors against pathological weight. The latter clustered with reduced soft drinks consumption, bullying victimisation, early sexual activity, worse family relationships and higher distress. Conclusion: An increased prevalence of both overweight and underweight was observed across time. Economic factors associated with unemployment and changes in behavioural patterns may have contributed to this trend. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to investigate whether total knee arthroplasty (TKA) patients who consulted an occupational medicine specialist (OMS) within 3 months after surgery, return to work (RTW) earlier than patients who did not consult an OMS. Methods: A multi-center prospective cohort study was performed among working TKA patients, aged 18 to 65 years and intending to RTW. Time to RTW was analyzed using Kaplan Meier and Mann Whitney U (MWU), and multiple linear regression analysis was used to adjust for effect modification and confounding. Results: One hundred and eighty-two (182) patients were included with a median age of 59 years [IQR 54–62], including 95 women (52%). Patients who consulted an OMS were less often self-employed but did not differ on other patient and work-related characteristics. TKA patients who consulted an OMS returned to work later than those who did not (median 78 versus 62 days, MWU p < 0.01). The effect of consulting an OMS on time to RTW was modified by patients' expectations in linear regression analysis (p = 0.05). A median decrease in time of 24 days was found in TKA patients with preoperative high expectations not consulting an OMS (p = 0.03), not in patients with low expectations. Conclusions: Consulting an OMS within 3 months after surgery did not result in a decrease in time to RTW in TKA patients. TKA patients with high expectations did RTW earlier without consulting an OMS. Intervention studies on how OMSs can positively influence a timely RTW, incorporating patients' preoperative expectations, are needed. [ABSTRACT FROM AUTHOR]

Background: Rates of aggressive offending among Justice-Involved Young Women (JIYW) have increased over the past few decades. Yet, there is little discourse, research, or intervention to address it among young women. Aims/hypotheses: This study hypothesized that a higher capacity for self-restraint measured on the Weinberger Adjustment Inventory (WAI) scale among 14-18-year-old JIYW would moderate the relationship between the exposure to violence and serious aggressive offending. Methods: The pathways to desistance project, a multi-site, longitudinal study, included a sample of JIYW aged 14–18 years old (n = 184). The baseline data were analyzed using linear multiple regression. Results: After controlling for two variables, race and neighborhood conditions, the overall model was significant (F = 8.31 (df = 7,176), p =.001). The predictor variables (exposure to violence and self-restraint) explained 25% of the outcome variable (level of aggressive offending). The moderation result was significant such that higher self-restraint weakens the relationship between exposure to violence and aggressive offending (B = − 0.01, t (176) = -2.39, p =.018). Conclusions/implications: This study highlights the need to disrupt the trauma- to- prison pipeline by enhancing positive social skills in a trauma-responsive manner, which could mitigate the effect of exposure to violence among JIYW. [ABSTRACT FROM AUTHOR]

Given emerging adulthood is a period of increased independence, it is unclear how much contact emerging adults have with their parents, how this communication occurs, and how frequency of communication differs across sociodemographic characteristics. The main aim of this study was to examine communication patterns and modalities between emerging adults and their parents. Data are from an 8-year longitudinal, population-based study of socio-economically and racially/ethnically diverse adolescents followed into emerging adulthood (n = 1539; mean age = 22.1; 53.1% female). Latent profile analysis results supported a 5-class model, in which classes were characterized by patterns of frequency of communication with parents across different modalities. The most common communication modality included medium levels of engagement (i.e., few times/week), with both parents, and was in-person or via the phone (i.e., calls, text messages, email). Results differed by race/ethnicity. Findings from this exploratory study may be useful for supporting positive communication patterns between emerging adults and their parents and may inform what intervention delivery format (e.g., phone, social media-based, in-person) may be more effective for certain parent/emerging adult subgroups engaging in family-based interventions. Highlights: Emerging adults and their parents were communicating regularly, several times per week. Preferred communication modality was phone (i.e., texting, emailing, calling). The most common pattern of communication was medium engagement with both parents. Emerging adults who also had high connectedness with their mothers reported the most frequent communication. [ABSTRACT FROM AUTHOR]

Summary: This study aimed to describe the real-world efficacy and safety of the combination therapy of atezolizumab and bevacizumab (Atezo/Bev) for unresectable hepatocellular carcinoma (HCC). This retrospective analysis of a multicenter registry cohort included 268 patients treated with Atezo/Bev. The incidence of adverse events (AE) and its impact on overall survival (OS) and progression-free survival (PFS) were analyzed. Of the 268 patients, 230 (85.8%) experienced AE. The median OS and PFS in the whole cohort were 462 and 239 days, respectively. The OS and PFS were not different in terms of AE, but they were significantly shorter in patients with increased bilirubin level and those with increased aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Regarding increased bilirubin level, the hazard ratios (HRs) were 2.61 (95% confidence interval [CI]: 1.04–6.58, P = 0.042) and 2.85 (95% CI: 1.37–5.93, P = 0.005) for OS and PFS, respectively. Regarding increased AST or ALT, the HRs were 6.68 (95% CI: 3.22–13.84, P < 0.001) and 3.54 (95% CI: 1.83–6.86, P < 0.001) for OS and PFS, respectively. Contrarily, the OS was significantly longer in patients with proteinuria (HR: 0.46 [95% CI: 0.23–0.92], P = 0.027). Multivariate analysis confirmed that proteinuria (HR: 0.53 [95% CI: 0.25–0.98], P = 0.044) and increased AST or ALT (HR: 6.679 [95% CI: 3.223–13.84], P = 0.003) were independent risk factors for a shorter OS. Furthermore, analysis limited to cases who completed at least 4 cycles confirmed that increased AST or ALT and proteinuria were negative and positive factors for OS, respectively. In the real-world setting, increased AST or ALT and bilirubin level during Atezo/Bev treatment were found to have a negative impact on PFS and OS, whereas proteinuria had a positive impact on OS. [ABSTRACT FROM AUTHOR]

Introduction: Low birth weight (LBW), biological vulnerability that includes preterm birth (PTB) and small for gestational age (SGA), is associated with reduced maternal sensitivity ("making accurate inferences about an infant's physical and emotional needs and responding appropriately") and impaired infant cognitive development. However, research does not examine if preterm birth, SGA, or both drive these associations. This study separated these measures of biological vulnerability to examine associations of LBW, PTB, and SGA with maternal sensitivity and infant cognitive development (controlling for maternal depression, breastfeeding, and demographic covariates). Methods: The sample included 6900 9-month-old infants from the Early Childhood Longitudinal Study-Birth Cohort and used birth certificate data, maternal interviews, assessments of maternal sensitivity and infant cognitive development. Multiple linear regressions examined LBW, PTB, and SGA associations with concurrent measures of maternal sensitivity and infant cognition. Results: Of the biological vulnerabilities, preterm birth had the strongest negative association with maternal sensitivity (F1,6450 = 29.48 versus 15.33 and 5.51, ps <.001) and infant cognitive development (F1,6450) = 390.65 versus 248.02 and 14.43, ps <.001). In the final regression model, preterm birth and maternal sensitivity were uniquely associated with infant cognitive development (R2 =.05, p <.001), after controlling for maternal depression, breastfeeding, and demographics. Conclusion: In this nationally representative infant sample infants, PTB had a stronger negative association with both maternal sensitivity and infant cognitive development in comparison to SGA or LBW. The LBW designation combines infants born preterm with SGA infants, potentially minimizing differences in developmental outcomes of PTB and SGA infants. [ABSTRACT FROM AUTHOR]

Background: To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM: ≥ 15 days/month), and multiple preventive treatment failures. Methods: This is a prospective, cohort, real-life study at 28 headache centers on consecutive patients affected by HFEM or CM with multiple preventive treatment failures who were prescribed subcutaneous fremanezumab (225 mg monthly/675 mg quarterly) for ≥ 24 weeks. Primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM at weeks 21–24 compared to baseline. Secondary endpoints encompassed changes in monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS, HIT-6 and MIDAS scores at the same time interval. Changes in MMDs/MHDs, monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS and HIT-6 scores at week 4 were also monitored. Results: Four hundred ten patients who had received ≥ 1 dose of fremanezumab were considered for safety analysis while 148 patients treated for ≥ 24 weeks were included in the efficacy analysis. At weeks 21–24, fremanezumab significantly (p < 0.001) reduced MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM compared to baseline. The proportions of ≥ 50%, ≥ 75% and 100% responders at weeks 21-24were 75.0%, 30.8%, 9.6% (HFEM), and 72.9, 44.8 and 1% (CM). A significant (p < 0.001) decrease in MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM was already present at week 4. The proportions of ≥ 50%, ≥ 75%, and 100% responders at week 4 were 67.6%, 32.4%, 11.8% (HFEM) and 67.3%, 40%, 1.8% (CM). CM remitted to episodic migraine and medication overuse to no-medication overuse in 83.3 and 75% of patients at week 24, and in 80 and 72.4% at week 4. Adverse events were rare (2.4%), mild and transient. No patient discontinued treatment for any reason. Conclusions: Fremanezumab is characterized by an early and sustained efficacy in HFEM and CM patients with multiple preventive treatment failures in real-life, revealing an optimal safety and tolerability profile. [ABSTRACT FROM AUTHOR]

Background: A faecal or urinary ostomy may be lifesaving. However, it involves significant bodily change, and the adjustment process to life with an ostomy includes a broad spectre of physical and psychosocial challenges. Thus, new interventions are needed to improve adaptation to living with an ostomy. This study aimed to examine experiences and outcomes using a new clinical feedback system with patient-reported outcome measures in ostomy care. Methods: In this longitudinal explorative study, 69 ostomy patients were followed by a stoma care nurse in an outpatient clinic, using a clinical feedback system postoperatively at 3, 6 and 12 months. The patients responded electronically to the questionnaires before each consultation. The Generic Short Patient Experiences Questionnaire was used to measure patient experiences and satisfaction with follow-up. The Ostomy Adjustment Scale (OAS) measured adjustment to life with an ostomy, and the Short Form-36 (SF-36) assessed the patient's health-related quality of life. Longitudinal regression models with time as an explanatory (categorical) variable were used to analyse changes. The STROBE guideline was applied. Results: The patients were satisfied with their follow-up (96%). Especially, they felt they received sufficient and individualised information, were involved in treatment decisions, and benefited from the consultations. The OAS subscale scores for 'daily activities', 'knowledge and skills' and 'health' improved over time (all p < 0.05), as did the physical and mental component summary scores of the SF-36 (all p < 0.05). Effect sizes of changes were small (0.20–0.40). Sexuality was the most challenging factor reported. Conclusions: The clinical feedback system could be helpful because outpatient follow-ups for ostomy patients may be more tailored when clinicians use clinical feedback systems. However, further development and testing are needed. Plain English summary: Studies show that patients struggle with adjustment to the ostomy in a broad spectre of physical and psychosocial factors, and stoma care nurse follow-up is necessary. Mapping each patient's most important challenges during a short outpatient follow-up consultation may be difficult. Thus, missing information on individual factors affecting adjustment and quality of life can result in underreported problems and unclear communication between patients and stoma care nurse. The study aimed to explore patient satisfaction and experiences using digital questionnaires before each consultation in stoma care nurse ostomy follow-up and to study adjustment to ostomy and health-related quality of life in routine follow-up 3,6 and 12 months after ostomy surgery. The study results showed that the patients were satisfied with their follow-up using questionnaires before consultations (96%). Especially, they felt they received sufficient and individualised information, were involved in treatment decisions, and benefited from the consultations. Especially the life areas "daily activities", having "knowledge and skills", "health", and the patient's health-related quality of life improved during the first year after the operation. Thus, patient reported outcomes/clinical feedbacksystem is a promising method for follow-up of ostomy patients because it may promote better discussions during the consultation and tailor the patient's adjustment trajectory more precisely than without such a system. [ABSTRACT FROM AUTHOR]

Purpose: The aim was to study the associations between dietary intake of fatty acids in childhood and the risk of islet autoimmunity and type 1 diabetes (T1D). Methods: The prospective Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study included children with genetic susceptibility to T1D born between 1996 and 2004. Participants were followed up every 3 to 12 months up to 6 years for diet, islet autoantibodies, and T1D. Dietary intake of several fatty acids at the age of 3 months to 6 years was assessed 1–8 times per participant with a 3-day food record. Joint models adjusted for energy intake, sex, HLA genotype and familial diabetes were used to investigate the associations of longitudinal intake of fatty acids and the development of islet autoimmunity and T1D. Results: During the 6-year follow-up, 247 (4.4%) children of 5626 developed islet autoimmunity and 94 (1.7%) children of 5674 developed T1D. Higher intake of monounsaturated fatty acids (HR 0.63; 95% CI 0.47, 0.82), arachidonic acid (0.69; 0.50, 0.94), total n-3 fatty acids (0.64; 0.48, 0.84), and long-chain n-3 fatty acids (0.14; 0.04, 0.43), was associated with a decreased risk of islet autoimmunity with and without energy adjustment. Higher intake of total fat (0.73; 0.53, 0.98), and saturated fatty acids (0.55; 0.33, 0.90) was associated with a decreased risk of T1D only when energy adjusted. Conclusion: Intake of several fatty acids was associated with a decreased risk of islet autoimmunity or T1D among high-risk children. Our findings support the idea that dietary factors, including n-3 fatty acids, may play a role in the disease process of T1D. [ABSTRACT FROM AUTHOR]

Purpose: This multicenter observational study was done to evaluate risk factors related to the development of BSI in patients admitted to ICU for COVID-19. Methods: All patients with COVID-19 admitted in two COVID-19 dedicated ICUs in two different hospital between 02–2020 and 02–2021 were recruited. Result: 537 patients were included of whom 265 (49.3%) experienced at least one BSI. Patients who developed bacteremia had a higher SOFA score [10 (8–12) vs 9 (7–10), p < 0.001], had been intubated more frequently [95.8% vs 75%, p < 0.001] and for a median longer time [16 days (9–25) vs 8 days (5–14), p < 0.001]. Patients with BSI had a median longer ICU stay [18 days (12–31.5) vs 9 days (5–15), p < 0.001] and higher mortality [54% vs 42.3%, p < 0.001] than those who did not develop it. Development of BSI resulted in a higher SOFA score [aHR 1.08 (95% CI 1.03–1.12)] and a higher Charlson score [csAHR 1.15 (95% CI 1.05–1.25)]. Conclusion: A high SOFA score and a high Charlson score resulted associated with BSI's development. Conversely, immunosuppressive therapy like steroids and tocilizumab, has no role in increasing the risk of bacteremia. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to determine the prevalence of congenital anomalies of the kidney and urinary tract (CAKUT) in the neonatal intensive care unit (NICU) and to evaluate risk factors associated with worse outcomes. We hypothesized that infants with CAKUT with extra-renal manifestations have higher mortality. Methods: This is a cohort study of all inborn infants who were diagnosed with any form of CAKUT discharged from NICUs managed by the Pediatrix Medical Group from 1997 to 2018. Logistic and linear regression models were used to analyze risk factors associated with in-hospital mortality. Results: The prevalence of CAKUT was 1.5% among infants hospitalized in 419 NICUs. Among the 13,383 infants with CAKUT analyzed, median gestational age was 35 (interquartile range [IQR] 31–38) weeks and median birth weight was 2.34 (IQR 1.54–3.08) kg. Overall in-hospital mortality for infants with CAKUT was 6.8%. Oligohydramnios (adjusted odds ratio [aOR] 4.5, 95% confidence interval [CI] 2.2–9.1, p < 0.001), extra-renal anomalies (aOR 2.5, 95% CI 2.0–3.1, p < 0.001), peak SCr (aOR 1.02, 95% CI 1.01–1.03, p < 0.001) and exposure to nephrotoxic medications (aOR 1.4, 95% CI 1.1–1.7, p = 0.01) were associated with increased mortality, while a history of urological surgery or intervention was associated with lower mortality (aOR 0.6, 95% CI 0.4–0.7, p < 0.001). Conclusions: Infants hospitalized in the NICU who have CAKUT and the independent risk factors for mortality (e.g., oligohydramnios and presence of extra-renal anomalies) require close monitoring, minimizing of exposure to nephrotoxic drugs, and timely urological surgery or intervention. A higher resolution version of the Graphical abstract is available as Supplementary information [ABSTRACT FROM AUTHOR]

How well a surgery is performed impacts a patient's outcomes; however, objective quantification of performance remains an unsolved challenge. Deconstructing a procedure into discrete instrument-tissue "gestures" is a emerging way to understand surgery. To establish this paradigm in a procedure where performance is the most important factor for patient outcomes, we identify 34,323 individual gestures performed in 80 nerve-sparing robot-assisted radical prostatectomies from two international medical centers. Gestures are classified into nine distinct dissection gestures (e.g., hot cut) and four supporting gestures (e.g., retraction). Our primary outcome is to identify factors impacting a patient's 1-year erectile function (EF) recovery after radical prostatectomy. We find that less use of hot cut and more use of peel/push are statistically associated with better chance of 1-year EF recovery. Our results also show interactions between surgeon experience and gesture types—similar gesture selection resulted in different EF recovery rates dependent on surgeon experience. To further validate this framework, two teams independently constructe distinct machine learning models using gesture sequences vs. traditional clinical features to predict 1-year EF. In both models, gesture sequences are able to better predict 1-year EF (Team 1: AUC 0.77, 95% CI 0.73–0.81; Team 2: AUC 0.68, 95% CI 0.66–0.70) than traditional clinical features (Team 1: AUC 0.69, 95% CI 0.65–0.73; Team 2: AUC 0.65, 95% CI 0.62–0.68). Our results suggest that gestures provide a granular method to objectively indicate surgical performance and outcomes. Application of this methodology to other surgeries may lead to discoveries on methods to improve surgery. [ABSTRACT FROM AUTHOR]

Summary: Alpha-fetoprotein (AFP) response (relative decline in AFP) is associated with imaging response evaluated by response evaluation criteria in solid tumors ver1.1 (RECIST) and survival in treatment for hepatocellular carcinoma (HCC). However, the optimal threshold of AFP response is still unknown, especially in atezolizumab and bevacizumab (Atez/Bev) treatment. In this prospective multicenter study, we aimed to investigate an optimal threshold of AFP response in Atez/Bev treatment. Out of 284 patients with unresectable HCC who were treated with Atez/Bev, 91 patients with AFP ≥ 10 ng/ml were enrolled in the multicenter study. We investigated the relationship between various AFP response thresholds (relative decline ≥ 20%, ≥ 50%, and ≥ 75%) and treatment response and progression-free survival (PFS). An AFP relative decrease of ≥ 50% was associated with an overall response rate (ORR) with an odds ratio (95% confidence interval [CI]) of 5.7 (1.9–17). Disease control rate (DCR) was associated with an AFP relative decrease of ≥ 20%, with a 100% positive predictive value and a 52.0% sensitivity. AFP relative decreases of ≥ 50% and ≥ 20% were significantly associated with PFS with a hazard ratio (HR) of 5.60 (95% CI: 1.6–19, p = 0.006) and a HR of 4.44 (95% CI: 1.9–10, p < 0.001), respectively. AFP response of ≥ 50% and ≥ 20% were related to ORR and DCR, respectively, and both of these responses were also associated with PFS. AFP can be used as a real-time monitor during Atez/Bev treatment and is helpful for treatment optimization. [ABSTRACT FROM AUTHOR]

Background and objectives: The identification of predictors of response to antiCGRP mAbs could favor tailored therapies and personalized treatment plans. This study is aimed at investigating predictors of ≥ 50%, ≥ 75% and 100% response at 24 weeks in patients with high-frequency episodic (HFEM: 8–14 days/month) or chronic migraine (CM). Methods: This is a large, multicenter, cohort, real-life study. We considered all consecutive adult patients affected by HFEM or CM who were prescribed antiCGRP mAbs for ≥ 24 weeks in 20 headache centers. Patients were interviewed face-to-face using a shared semi-structured questionnaire carefully exploring socio-demographic and clinical characteristics. Patients received subcutaneous erenumab (70 mg or140 mg, monthly), galcanezumab (120 mg monthly, following a 240 mg loading dose), or fremanezumab (225 mg, monthly or 675 mg, quarterly) according to drug market availability, physician's choice, or patient's preference. The primary endpoint of the study was the assessment of ≥ 50% response predictors at 24 weeks. Secondary endpoints included ≥ 75% and 100% response predictors at 24 weeks. Results: Eight hundred sixty-four migraine patients had been treated with antiCGRP mAbs for ≥ 24 weeks (erenumab: 639 pts; galcanezumab: 173 pts; fremanezumab: 55 pts). The ≥50% response (primary endpoint) in HFEM was positively associated with unilateral pain (UP) + unilateral cranial autonomic symptoms (UAs) (OR:4.23, 95%CI:1.57–11.4; p = 0.004), while in CM was positively associated with UAs (OR:1.49, 95%CI:1.05–2.11; p = 0.026), UP + UAs (OR:1.90, 95%CI:1.15–3.16; p = 0.012), UP + allodynia (OR:1.71, 95%CI:1.04–2.83; p = 0.034), and negatively associated with obesity (OR:0.21, 95%CI:0.07–0.64; p = 0.006). The 75% response (secondary endpoint) was positively associated with UP + UAs in HFEM (OR:3.44, 95%CI:1.42–8.31; p = 0.006) and with UP + UAs (OR:1.78, 95%CI:1.14–2.80; p = 0.012) and UP + allodynia (OR:1.92, 95%CI:1.22–3.06; p = 0.005) in CM. No predictor of 100% response emerged in patients with HFEM or CM. Conclusions: A critical evaluation of headache characteristics indicating peripheral or central sensitization may help in predicting responsiveness to antiCGRP mAbs in HFEM and CM. A more precise pain profiling may represent a steppingstone for a mechanism-based approach and personalized treatment of migraine with compounds targeting specific molecular mechanisms. [ABSTRACT FROM AUTHOR]

Background: Urinary tract infection (UTI) is one of the most common bacterial infections in childhood and is associated with long-term complications. We aimed to assess the effect of adjuvant dexamethasone treatment on reducing kidney scarring after acute pyelonephritis (APN) in children. Methods: Multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial (RCT) where children from 1 month to 14 years of age with proven APN were randomly assigned to receive a 3-day course of either an intravenous corticosteroid (dexamethasone 0.30 mg per kg/day) twice daily or placebo. The late technetium 99 m-dimercaptosuric acid scintigraphy (> 6 months after acute episode) was performed to assess kidney scar persistence. Kidney scarring risk factors (vesicoureteral reflux, kidney congenital anomalies, or urinary tract dilatation) were also assessed. Results: Ninety-one participants completed the follow-up and were finally included (dexamethasone n = 49 and placebo n = 42). Both groups had similar baseline characteristics. Twenty participants showed persistent kidney scarring after > 6 months of follow-up without differences in incidence between groups (22% and 21% in the dexamethasone and placebo groups, p = 0.907). Renal damage severity in the early DMSA (β = 0.648, p = 0.023) and procalcitonin values (β = 0.065 p = 0.027) significantly modulated scar development. Vesicoureteral reflux grade showed a trend towards significance (β = 0.545, p = 0.054), but dexamethasone treatment showed no effect. Conclusion: Dexamethasone showed no effect on reducing the risk of scar formation in children with APN. Hence, there is no evidence for an adjuvant corticosteroid treatment recommendation in children with APN. However, the study was limited by not achieving the predicted sample size and the expected scar formation. Trial registration: Clinicaltrials.gov, NCT02034851. Registered in January 14, 2014. "A higher resolution version of the Graphical abstract is available as Supplementary information." [ABSTRACT FROM AUTHOR]

Purpose: The SARS-CoV-2 pandemic severely disrupted society and the health care system. In addition to epidemiological changes, little is known about the pandemic's effects on the trauma care chain. Therefore, in addition to epidemiology and aetiology, this study aims to describe the impact of the SARS-CoV-2 pandemic on prehospital times, resource use and outcome. Methods: A multicentre observational cohort study based on the Dutch Nationwide Trauma Registry was performed. Characteristics, resource usage, and outcomes of trauma patients treated at all trauma-receiving hospitals during the first (W1, March 12 through May 11) and second waves (W2, May 12 through September 23), as well as the interbellum period in between (INT, September 23 through December 31), were compared with those treated from the same periods in 2018 and 2019. Results: The trauma caseload was reduced by 20% during the W1 period and 11% during the W2 period. The median length of stay was significantly shortened for hip fracture and major trauma patients (ISS ≥ 16). A 33% and 66% increase in the prevalence of minor self-harm-related injuries was recorded during the W1 and W2 periods, respectively, and a 36% increase in violence-related injuries was recorded during the INT. Mortality was significantly higher in the W1 (2.9% vs. 2.2%) and W2 (3.2% vs. 2.7%) periods. Conclusion: The imposed restrictions in response to the SARS-CoV-2 pandemic led to diminished numbers of acute trauma admissions in the Netherlands. The long-lasting pressing demand for resources, including ICU services, has negatively affected trauma care. Further caution is warranted regarding the increased incidence of injuries related to violence and self-harm. [ABSTRACT FROM AUTHOR]

Background: There is an increased use of Patient-Reported Outcome Measures (PROMs) in children and adolescents. The aim of this study was to compare the feasibility, concurrent validity and known-group validity of the EQ-5D-Y-3L (Y-3L), EQ-5D-Y-5L (Y-5L) and PedsQL self-report PROMs. Methods: Five hundred and fifty children and adolescents, aged 8–15-years, with acute and chronic health conditions and a general population sample were recruited from schools and hospitals in Cape Town South Africa. All respondents self-completed the Y-5L, PedsQL, Self-Rated Health Question and Y-3L. Feasibility of the measures was determined by comparing the number of missing responses. Convergent validity was assessed by Spearman's and Intra-class correlations on the corresponding items and summary scores respectively. Known-groups validity across health conditions was assessed across the summary scores of the measures with analysis of variance (ANOVA). Results: The Y-3L and Y-5L had a total of 1% and 3.5% missing responses compared to 19% on the PedsQL. Similar items on the PedsQL and Y-3L/Y-5L showed high correlations (> 0.5) and related items showed moderate correlations (0.3). PedsQL total score was moderately and significantly associated with Y-3L and Y-5L level sum and VAS scores. The Y-3L and Y-5L level sum and VAS scores showed significant differences between known health groups whereas the PedsQL only showed differences between those with acute and chronic illness. Conclusion: The results of this study show that the Y-3L and Y-5L showed comparable psychometric validity to the PedsQL. When considering the choice between the PedsQL, Y-5L and Y-3L these study results indicate that the EQ-5D-Y instruments (Y-3L and Y-5L) are recommended for studies assessing known-group validity or where missing data should be minimised. The PedsQL generic measure may be preferable in future studies including the general population where a ceiling effect is anticipated. When considering the choice between the Y-5L and the Y-3L there was no systematic difference in the validity between these instruments or between the Y-3L or Y-5L and the PedsQL. Thus, the selection of EQ-5D-Y measures to include in future studies should be guided by the characteristics of the population to be tested. [ABSTRACT FROM AUTHOR]

Autism spectrum disorder (ASD) can be reliably diagnosed at 18 months, yet significant diagnostic delays persist in the United States. This double-blinded, multi-site, prospective, active comparator cohort study tested the accuracy of an artificial intelligence-based Software as a Medical Device designed to aid primary care healthcare providers (HCPs) in diagnosing ASD. The Device combines behavioral features from three distinct inputs (a caregiver questionnaire, analysis of two short home videos, and an HCP questionnaire) in a gradient boosted decision tree machine learning algorithm to produce either an ASD positive, ASD negative, or indeterminate output. This study compared Device outputs to diagnostic agreement by two or more independent specialists in a cohort of 18–72-month-olds with developmental delay concerns (425 study completers, 36% female, 29% ASD prevalence). Device output PPV for all study completers was 80.8% (95% confidence intervals (CI), 70.3%–88.8%) and NPV was 98.3% (90.6%–100%). For the 31.8% of participants who received a determinate output (ASD positive or negative) Device sensitivity was 98.4% (91.6%–100%) and specificity was 78.9% (67.6%–87.7%). The Device's indeterminate output acts as a risk control measure when inputs are insufficiently granular to make a determinate recommendation with confidence. If this risk control measure were removed, the sensitivity for all study completers would fall to 51.6% (63/122) (95% CI 42.4%, 60.8%), and specificity would fall to 18.5% (56/303) (95% CI 14.3%, 23.3%). Among participants for whom the Device abstained from providing a result, specialists identified that 91% had one or more complex neurodevelopmental disorders. No significant differences in Device performance were found across participants' sex, race/ethnicity, income, or education level. For nearly a third of this primary care sample, the Device enabled timely diagnostic evaluation with a high degree of accuracy. The Device shows promise to significantly increase the number of children able to be diagnosed with ASD in a primary care setting, potentially facilitating earlier intervention and more efficient use of specialist resources. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the characteristics of sarcopenic dysphagia (SD) and the prognosis of swallowing function in convalescent rehabilitation hospital patients; and to investigate the association between malnutrition severity and SD. Design: A prospective, multi-center, cohort study. Setting: We extracted registry data from the Japanese Sarcopenic Dysphagia Database, focusing on patients admitted to convalescent rehabilitation hospitals. Participants: A total of 207 participants were recruited and stratified according to the presence or absence of SD. Next, the participants were divided into groups based on nutrition status using the Global Leadership Initiative on Malnutrition criteria normal nutrition, moderate malnutrition, and severe malnutrition. We also compared the outcomes between patients with SD (SD group) and those without SD (no-SD group) according to malnutrition status. Measurements: The Food Intake LEVEL Scale (FILS) score was the outcome measure. Higher scores on the FILS indicate better swallowing function. We compared the patient characteristics between the SD and non-SD groups among all patients and then according to the severity of malnutrition. Results: A total of 207 patients were recruited. 11 were diagnosed with normal nutrition, 72 with moderate malnutrition, and 124 with severe malnutrition. There were 128 participants with SD and 79 participants without SD; the prevalence of SD was 61.8%. Hip fracture was the most common disease among the SD patients (34.4%). The median time to the end of follow-up was 73.5 days for the SD group and 84.0 days for the no-SD group. There was no significant difference in the FILS score between the SD and no-SD groups, but the increase in the FILS score was significantly lower in the SD group than the no-SD group among patients with severe malnutrition after adjusting for confounding factors (age, sex, FILS at admission, BMI, cognitive functional independence measure, and care level before onset) (β = −0.206, p = 0.011, 95% confidence interval = −0.723, −0.098). Conclusion: Orthopedic diseases are the most common type of disease among SD patients in convalescent rehabilitation hospitals. Swallowing dysfunction was particularly severe in malnourished patients with SD. This result suggests the importance of the definition of SD for malnourished patients. We should practice nutritional management as soon as possible in severely malnourished patients diagnosed with SD. [ABSTRACT FROM AUTHOR]

Background: Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8–14 days/month) or CM. Methods: This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9–12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥ 50%, ≥ 75% and 100% responder rates at the same time intervals. Results: Sixty-seventh number migraine patients had received ≥ 1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p < 0.05), MHDs (-9.4, p < 0.001), MAI (-5.7, p < 0.05; -11.1, p < 0.001), NRS (-3.1, p < 0.001; -2.5, p < 0.001), and MIDAS scores (-58.3, p < 0.05; -43.7; p < 0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p < 0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥ 50%, ≥ 75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR = 0.91; 95% CI 0.85–0.98, p = 0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason. Conclusions: Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor. [ABSTRACT FROM AUTHOR]

Introduction: The burden of MDRO in health systems is a global issue, and a growing problem. We conducted a European multicenter cohort study to assess the incidence, impact and risk factors for multidrug-resistant organisms in patients with major trauma. We conducted this study because the predictive factors and effects of MDRO in severely injured patients are not yet described. Our hypothesis is that positive detection of MDRO in severely injured patients is associated with a less favorable outcome. Methods: Retrospective study of four level-1 trauma centers including all patients after major trauma with an injury severity score (ISS) ≥ 9 admitted to an intensive care unit (ICU) between 2013 and 2017. Outcome was measured using the Glasgow outcome scale (GOS). Results: Of 4131 included patients, 95 (2.3%) had a positive screening for MDRO. Risk factors for MDRO were male gender (OR 1.73 [95% CI 1.04–2.89]), ISS (OR 1.01 [95% CI 1.00–1.03]), PRBC's given (OR 1.73 [95% CI 1.09–2.78]), ICU stay > 48 h (OR 4.01 [95% CI 2.06–7.81]) and mechanical ventilation (OR 1.85 [95% CI 1.01–3.38]). A positive MDRO infection correlates with worse outcome. MDRO positive cases GOS: good recovery = 0.6%, moderate disability = 2.1%, severe disability = 5.6%, vegetative state = 5.7% (p < 0.001). Conclusions: MDRO in severely injured patients are rare but associated with a worse outcome at hospital discharge. We identified potential risk factors for MDRO in severely injured patients. Based on our results, we recommend a standardized screening procedure for major trauma patients. [ABSTRACT FROM AUTHOR]