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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]

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

Background Value-based healthcare (VBHC) is a conceptual framework to improve the value of healthcare by health, care-process and economic outcomes. Benchmarking should provide useful information to identify best practices and therefore a good instrument to improve quality across healthcare organizations. This paper aims to provide a proof-of-concept of the feasibility of an international VBHC benchmarking in breast cancer, with the ultimate aim of being used to share best practices with a data-driven approach among healthcare organizations from different health systems. Methods In the VOICE community—a European healthcare centre cluster intending to address VBHC from theory to practice—information on patient-reported, clinical-related, care-process-related and economic-related outcomes were collected. Patient archetypes were identified using clustering techniques and an indicator set following a modified Delphi was defined. Benchmarking was performed using regression models controlling for patient archetypes and socio-demographic characteristics. Results Six hundred and ninety patients from six healthcare centres were included. A set of 50 health, care-process and economic indicators was distilled for benchmarking. Statistically significant differences across sites have been found in most health outcomes, half of the care-process indicators, and all economic indicators, allowing for identifying the best and worst performers. Conclusions To the best of our knowledge, this is the first international experience providing evidence to be used with VBHC benchmarking intention. Differences in indicators across healthcare centres should be used to identify best practices and improve healthcare quality following further research. Applied methods might help to move forward with VBHC benchmarking in other medical conditions. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to provide a preliminary evaluation of treatment outcomes, retention and client satisfaction following a 12-week combined cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) group treatment for cannabis use disorder (CUD) delivered in an outpatient setting. Implementation of the program is also described. Methods: A retrospective observational cohort study was conducted using data collected from medical records and self-report assessments. Participants were treatment-seeking cannabis users at the Centre for Addiction and Mental Health, Toronto. Cannabis use, cannabis-related problems, craving, withdrawal symptoms, self-efficacy for remaining abstinent, depression and anxiety were assessed pre- and post-treatment. Treatment retention was calculated by inspecting clinic attendance records, and client satisfaction was evaluated using an anonymous feedback survey. Potential predictors of treatment outcomes and retention were investigated in exploratory analyses. Results: Cannabis use was lower and days of abstinence higher post-treatment (vs pre-treatment). Post-treatment improvements in cannabis-related problems, craving, withdrawal symptoms, self-efficacy and mood were also observed. Completion of group treatment (⩾75% of sessions attended) was 57% and moderate levels of treatment satisfaction were reported. Conclusions: This study provides preliminary evidence that a 12-week combined CBT and MET treatment for cannabis use disorder delivered in a novel group setting improves cannabis use outcomes. Potential predictors of reduced cannabis use and retention were identified. Future controlled studies are warranted, and strategies for increasing retention should be explored. [ABSTRACT FROM AUTHOR]

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

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

INTRODUCTION Heated tobacco products (HTPs) are promoted as less harmful than cigarettes; nonetheless, whether HTPs help smokers quit is uncertain. METHODS Data from 4067 Mexican adult smokers surveyed longitudinally every four months (November 2019-March 2021) were analyzed. Mixed-effects multinomial models regressed HTP use frequency (no use=reference; monthly; weekly; and daily use) on sociodemographics and tobacco/nicotine-related variables. Among participants who completed at least two surveys (n=2900) over four months, the duration of their longest smoking quit attempt (SQA) between surveys (SQAs: <30 days; >30 days; no SQA=reference) was regressed on HTP use frequency, and changes in the number of cigarettes smoked per day were regressed on HTP initiation between surveys, adjusting for covariates. RESULTS Consistent predictors of all HTP use frequencies (monthly, weekly, or daily vs no use) were daily smoking >5 cigarettes (ARRR=1.69 [95% CI: 1.12-2.55], 1.88 [95% CI: 1.26-2.81] and 6.46 [95% CI: 3.33-12.52], respectively); e-cigarette use (ARRR =5.68 [95% CI: 3.38-9.53], 6.54 [95% CI: 4.06-10.55] and 2.59 [95% CI: 1.26-5.30]); lower HTP risk perceptions (ARRR=2.12 [95% CI: 1.50-30.00], 2.25 [95% CI: 1.63-3.10] and 2.00 [95% CI: 1.25-3.22]); exposure to HTP information inside (ARRR=2.13 [95% CI: 1.44-3.15], 2.13 [95% CI: 1.49-3.05] and 3.72 [95% CI: 2.28-6.09]) and outside stores (ARRR=2.36 [95% CI: 1.56-3.57], 2.32 [95% CI: 1.65-3.25] and 2.44 [95% CI: 1.41-4.24]) where tobacco is sold; having family (ARRR=2.46 [95% CI: 1.54-3.91], 2.90 [95% CI: 1.93-4.37] and 2.96 [95% CI: 1.52-5.77]) and friends (ARRR=5.78 [95% CI: 3.60-9.30], 4.98 [95% CI: 3.22-7.72] and 6.61 [95% CI: 2.91-15.01]) who use HTPs. HTP use frequency was not associated with quit attempts, except for monthly HTP use predicting SQAs lasting ≥30 days (ARRR=2.12 [95% CI: 1.17-3.85]). Initiation of HTP use was not associated with changes in smoking frequency. Limiting analysis to those who intend to quit smoking also yielded null results. CONCLUSIONS Among Mexican adult smokers, frequency of HTP use was mostly not associated with either cessation behaviors or changes in cigarette consumption, suggesting that HTPs have limited to no effectiveness for smoking cessation. [ABSTRACT FROM AUTHOR]

INTRODUCTION India has unique tobacco-free film and TV rules designed to prevent tobacco uptake. In this study, we examined the potential influence of exposure to smoking imagery in regionally famous films, on susceptibility to smoke in teenagers enrolled in schools in a district in Southern India. METHODS A longitudinal survey of students, in grades 6 to 8 at baseline in 2017 and grades 7 to 9 one year later in 2018, ascertained prospective incident susceptibility to smoking during the study period in relation to baseline exposure to 27 locally popular films with actual or implied smoking imagery. RESULTS We analyzed linked data from 33676 participants, and 3973 (11.8%) of the adolescents reported incident susceptibility. There was a significant increase in susceptibility to smoking with increasing exposure at baseline to smoking imagery in films on univariable analysis, highest tertile of exposure relative to no exposure (OR=1.4; 95% CI: 1.0 -2.1, ptrend<0.001), and this trend remained significant (p=0.022) after mutual adjustment for recognized confounders, highest vs no exposure (AOR=1.3; 95% CI: 0.9-1.8). We found no statistically significant association between exposure to tobacco-free film rules and change in susceptibility. CONCLUSIONS Prospectively, watching films featuring smoking imagery increases adolescents' vulnerability to smoking. Further research revealed no difference in susceptibility change between youth who saw partially compliant films and those who watched non-compliant films. Our findings, thus, underscore the need to incorporate comprehensive approaches to prevent the inclusion of smoking imagery in films. [ABSTRACT FROM AUTHOR]

Background: Critical incident reporting and analysis is one of the key components of patient safety in anesthesiology. The aim of this study was to determine the frequency and characteristics of critical incidents during anesthesia, main causes and factors involved, influence on patient outcomes, prevalence of incident reporting and further analysis. Methods: A multicenter prospective audit was conducted at the clinical departments of the Bogomolets National Medical University during the period from 1 to 2021 to 1 December 2021. 13 hospitals from different Ukrainian regions took part in the study. Anesthesiologists voluntarily submitted critical incident reports into a Google form as they occurred during the working shifts, reporting the details of the incident, and the incident registration routine in their hospital. The study design was approved by the Bogomolets National Medical University (NMU) ethics committee, protocol #148, 07.09.2021. Results: The incidence of critical incidents was 9.35 cases per 1000 anesthetic procedures. Most common incidents were related to the respiratory system: difficult airway (26.8%), reintubation (6.4%), oxygen desaturation (13.8%); cardiovascular system: hypotension (14.9%), tachycardia (6.4%), bradycardia (11.7%), hypertension (5.3%), collapse (3.2%); massive hemorrhage (17%). Factors associated with critical incidents were elective surgery (OR 4.8 [3.1–7.5]), age from 45 to 75 years (OR 1.67 [1.1–2.5]), ASA II (OR 38 [13–106]}, III (OR 34 [12–98]) or IV (3.7 [1.2–11]) compared to ASA I; regional anesthesia (OR 0.67 95 CI 0.5–0.9) or general anesthesia (GA) and regional anesthesia combination (OR 0.55 95 CI 0.3–0.9] decreased the risk of incidents compared to GA alone. Procedural sedation was associated with increased risk of a critical incident, compared to GA (OR 0.55 95 CI 0.3–0.9). The incidents occurred most commonly during the maintenance phase (75/113, 40%, OR compared to extubation phase 20 95 CI 8–48) or the induction phases of anesthesia (70/118, 37%, OR compared to extubation phase 18 95 CI 7–43). Among common reasons that could lead to the incident, the physicians have identified: individual patient features (47%), surgical tactics (18%), anesthesia technique (16%) and human factor (12%). The most frequent failings contributing to the incident occurrence were: insufficient preoperative assessment (44%), incorrect interpretation of the patients' state (33%), faulty manipulation technique (14%), miscommunication with a surgical team (13%) and delay in emergency care (10%). Furthermore, 48% of cases, as judged by participating physicians, were preventable and the consequences of another 18% could be minimized. The consequences of the incidents were insignificant in over a half of the cases, but in 24.5% have led to prolonged hospital stay, in 16% patients required an urgent transfer to the ICU and 3% of patients died during their hospital stay. The majority of the critical incidents (84%) were reported through the hospital reporting system, using mostly paper forms (65%), oral reports (15%) and an electronic database (4%). Conclusion: Critical incidents during anesthesia occur rather often, mainly during the induction or maintenance phases of anesthesia, and could lead to prolonged hospital stay, unplanned transfer to the ICU or death. Reporting and further analysis of the incident are crucial, so we should continue to develop the web-based reporting systems on both local and national levels. Study registration: NCT05435287, clinicaltrials.gov, 23/6/2022. [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]

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

Background: Several medications have been applied to Alzheimer's dementia patients (AD) but their efficacies have been insufficient. The efficacy and safety of 4 weeks of repetitive transcranial magnetic stimulation (rTMS) in Japanese AD were evaluated in this exploratory clinical trial. Methods: Forty-two patients, aged 60-93 years (average, 76.4 years), who were taking medication (> 6 months) and had Mini-Mental State Examination (MMSE) scores ≤ 25 and Clinical Dementia Rating Scale scores (CDR-J) of 1 or 2, were enrolled in this single-center, prospective, randomized, three-arm study [i.e., 120% resting motor threshold (120% RMT), 90% RMT for the bilateral dorsolateral prefrontal cortex, and Sham]. Alzheimer's Disease Assessment Scale-Japanese Cognitive (ADAS-J cog), Montreal Cognitive Assessment (MoCA-J), Clinical Global Impression of Change (CGIC), Neuropsychiatric inventory (NPI), and EuroQOL 5 Dimensions 5-Level (EQ-5D-5L) were administered. The primary endpoint was the mean change from baseline in the MMSE score (week 4). An active rTMS session involved applying 15 trains bilaterally (40 pulses/train at 10 Hz; intertrain interval, 26 s). Participants received ≥ 8 interventions within the first 2 weeks and at least one intervention weekly in the 3rd and 4th weeks. Full Analysis set (FAS) included 40 patients [120% RMT (n = 15), 90% RMT (n = 13), and Sham (n = 12)]. Results: In the FAS, MMSE, ADAS-J cog, MoCA-J, CDR-J, CGIC, NPI, and EQ-5D-5L scores between the three groups were not significantly different. Two patients were erroneously switched between the 120% RMT and 90% RMT groups, therefore, "as treated" patients were mainly analyzed. Post hoc analysis revealed significant treatment efficacy in participants with MMSE scores ≥ 15, favoring the 120% RMT group over the Sham group. Responder analysis revealed 41.7% of the 120% RMT group had a ≥ 3-point improvement in the ADAS-J cog versus 0% in the Sham group (Fisher's exact test, p = 0.045). The MoCA-J showed the same tendency but was not significant. Efficacy disappeared in week 20, based on the ADAS-cog and MoCA-J. No intervention-related serious adverse events occurred. Conclusion: This paper is the first report of using rTMS in Japanese AD patients. The treatment seems safe and moderate-mild stage AD should be target population of pivotal clinical trial with 120% RMT rTMS. [ABSTRACT FROM AUTHOR]

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

Background: This paper is a follow‐up study continuing the COVISTRESS network previous research regarding health‐related determinants. Objective: The aim was to identify the main consequences of COVID‐19 lockdown on Body MassIndex and Perceived Fragility, related to Physical Activity (PA), for different categories of populations, worldwide. Design: The study design included an online survey, during the first wave of COVID‐19 lockdown, across different world regions. Setting and participants: The research was carried out on 10 121 participants from 67 countries. The recruitment of participants was achieved using snowball sampling techniques via social networks, with no exclusion criteria other than social media access. Main outcome measures: Body MassIndex, Physical Activity, Perceived Fragility and risk of getting infected items were analysed. SPSS software, v20, was used. Significance was set at P <.05. Results: Body MassIndex significantly increased during lockdown. For youth and young adults (18‐35 years), PA decreased by 31.25%, for adults (36‐65 years) by 26.05% and for the elderly (over 65 years) by 30.27%. There was a high level of Perceived Fragility and risk of getting infected for female participants and the elderly. Correlations between BMI, Perceived Fragility and PA were identified. Discussion and Conclusions: The research results extend and confirm evidence that the elderly are more likely to be at risk, by experiencing weight gain, physical inactivity and enhanced Perceived Fragility. As a consequence, populations need to counteract the constraints imposed by the lockdown by being physically active. [ABSTRACT FROM AUTHOR]

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INTRODUCTION The SMART Quit Clinic Program (FAHSAI Clinic) has been implemented in Thailand since 2010; however, it remains unclear whether the benefits gained from this program justify its costs. We assessed its cost-effectiveness compared to usual care in a population of Thai smokers with cardiovascular disease (CVD) from a societal perspective. METHODS We conducted a cost-utility analysis using a Markov model to simulate lifetime costs and quality-adjusted life years (QALYs) of Thai smokers aged ≥35 years receiving smoking cessation services offered from FAHSAI Clinic or usual care over a horizon of 50 years. The model used a 6-month continuous abstinence rate from a multicenter prospective study of 24 FAHSAI Clinics. A series of sensitivity analyses including probabilistic sensitivity analysis were conducted to assess robustness of study findings. Cost data are presented in US$ for 2020. RESULTS The FAHSAI Clinic was dominant as it was less costly ($9537.92 vs $10964.19) and more effective (6.06 vs 5.96 QALYs) compared with usual care over the 50-year time horizon. Changes in risks of stroke and coronary heart disease among males had the largest impact on the cost-effectiveness findings. The probability that FAHSAI Clinic was cost-effective was 99.8% at a willingness-to- pay threshold of $5120. CONCLUSIONS The FAHSAI Clinic smoking cessation program was clinically superior and cost-saving compared to usual care for Thai patients with CVD in all scenarios. A budget impact analysis is needed to estimate the financial impact of adopting this program within the Thai healthcare system. [ABSTRACT FROM AUTHOR]

Background: Treatment retention is a major factor contributing to favourable outcome in the treatment of substance misuse, but the literature remains very limited. Despite evidence of the association of personality with drug use experimentation and relapse, surprisingly little is known about its role in the treatment process. Clients' personality functioning as measured by malleable and context sensitive characteristic adaptations in treatment are of concern. Aims: This study examines whether, and to what extent, personality functioning contributes to or hinders treatment completion. This paper examined the extent to which service users' characteristic adaptations may be potential determinants of treatment completion. Methodology: A longitudinal multi-site design was utilised, examining the therapy process in a naturalistic setting in five inpatient treatment units. The study examined whether service users' characteristic adaptations (SIPP-118) predict completion, while controlling psychosocial, motivational and treatment engagement indicators involving n = 340 participants from 5 inpatient centres. Multivariate regression analyses were applied to examine the predictive role of characteristic adaptations on treatment completion. Results: Findings indicated that certain dysfunctional characteristic adaptations emerged as strong predictors of treatment completion. Dysfunctional levels on Self-control and Social concordance were significant predictors of drop out from treatment. Individuals with low capacity to tolerate, use and control one's own emotions and impulses were almost three times more likely to drop-out compared to those without [OR] = 2.73, Wald = 6.09, P =.014, 95% CI [1.2, 6.0]. Individuals with dysfunctional levels on the ability to value someone's identity, withhold aggressive impulses towards others and work together with others were 2.21 more times more likely to complete treatment [OR] = 2.21, Wald = 4.12, P =.042, 95% CI [1.0, 4.7]. The analysis at the facet level provided additional insight. Individuals with higher adaptive levels on Effortful Control were 46% more times likely to complete treatment than the group [OR] = 4.67, Wald = 10.231, P =.001, 95% CI [1.81, 12.04], 47% more likely on Aggression regulation [OR] = 4.76, Wald = 16.68, P <.001, 95% CI [2.1, 10.3], and 26% more likely on Stable self-image [OR] = 2.62, Wald = 6.75, P <.009, 95% CI [0.9, 3.0]. Conclusions: These findings extend our knowledge of the predictive role of characteristic adaptations in treatment completion and highlight the clinical utility of capturing these individual differences early on. Delineating the role of characteristic adaptations in treatment may provide the basis for enhancing treatment effectiveness through individualized interventions that are scientifically driven and may open new avenues for the scientific enquiry of personality and treatment. [ABSTRACT FROM AUTHOR]

Background The World Health Organization has raised concerns that vaccinated people may reduce physical and social distancing more than necessary. With imperfect vaccine protection and the lifting of mobility restrictions, understanding how human mobility responded to vaccination and its potential consequence is critical. We estimated vaccination-induced mobility (VM) and examined whether it attenuates the effect of COVID-19 vac-cination on controlling case growth. Methods We collected a longitudinal data set of 107 countries between 15 February 2020 and 6 February 2022 from Google COVID-19 Community Mobility Reports, the Oxford COVID-19 Government Response Tracker, Our World in Data, and World Development Indicators. We measured mobility in four categories of location: retail and recreational places, transit stations, grocery stores and pharmacies, and workplaces. We applied panel data models to address unobserved country characteristics and used Gelbach decomposition to evaluate the extent to which VM has offset vaccination effectiveness. Results Across locations, a 10-percentage-point (pp) increase in vaccine coverage was associated with a 1.4-4.3 pp increase in mobility (P < 0.001). VM was greater in lower-income coun-tries (up to 7.9 pps; 95% confidence interval (CI) = 5.3 to 10.5, P < 0.001) and in earlier stages of vaccine rollouts (up to 19.2 pps; 95% CI = 15.1 to 23.2%, P < 0.001). VM decreased the ef-fectiveness of vaccines in controlling case growth by 33.4% in retail and recreation places (P < 0.001), 26.4% in transit sta-tions (P < 0.001), and 15.4% in grocery stores and pharmacies (P = 0.002). Conclusions VM provides support for the Peltzman effect; it attenuates but does not completely counter vaccine effectiveness. Our study findings suggest strategies for mitigating the unintended consequences of VM, including reducing short-term mobility responses after vaccination, prioritizing mobility in grocery-type places and workplaces, and accelerating rollouts at earlier stages of vaccination, especially in lower-income countries. [ABSTRACT FROM AUTHOR]

Background Although maternal age might affect pregnancy outcomes, it remains unclear whether this relationship is linear or curvilinear and if it differs between nulliparous and multiparous women. We aimed to characterize the relationship between maternal age and risks of pregnancy outcomes in a diverse sample of Chinese singleton pregnant women and to evaluate whether the relationship varied by parity. Methods We based this prospective multicenter cohort study on data from 18 495 singleton pregnant women who participated in the University Hospital Advanced Age Pregnant Cohort Study, conducted in eight Chinese public hospitals from 2016 to 2021. We used restricted cubic splines to model nonlinear relationships between maternal age continuum and adverse outcomes, and performed multivariable log-binomial regression to estimate the adjusted relative risk (RR) and 95% confidence interval (CI). Results Among 18 495 singleton pregnant women (mean age 35.7, standard deviation (SD) = 4.2 years), maternal age was not related to postpartum hemorrhage or small for gestational age, but showed a positive, nonlinear relationship to gestational diabetes mellitus, hypertensive disorders of pregnancy, preeclampsia, placenta accreta spectrum, placenta previa, cesarean delivery, preterm birth, large for gestational age, macrosomia, and fetal congenital anomaly, with inflection points around 35.6-40.4 years. Compared to women younger than 35 years, older women had higher risks of adverse pregnancy outcomes, except for postpartum hemorrhage and small for gestational age. The risks of placenta accreta spectrum, placenta previa, large for gestational age, and macrosomia were highest for women aged 40-44 years, and risks of gestational diabetes mellitus, hypertensive disorders of pregnancy, preeclampsia, cesarean delivery, preterm birth and congenital anomaly were highest for those aged ≥45 years. Most risks were more pronounced in nulliparous than multiparous women (P for interaction <0.02). Conclusions Delayed childbirth was related to increased risks of adverse pregnancy outcomes, especially for nulliparous women. Appropriate childbearing age, generally before 35 years, is recommended for optimising pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Background Advanced maternal age is becoming an increasingly common issue worldwide, presenting substantial health risks to pregnant women. However, dose-response associations of maternal age with a comprehensive range of pregnancy complications and their multimorbidity remain unclear. Methods We conducted a retrospective cohort study using data from China's National Maternal Near Miss Surveillance System for 2017-2018, including 18 hospitals in southern China. We included 135 274 pregnant women aged 15-54 years with a singleton birth. We used multivariable logistic regression and restricted cubic spline to examine dose-response associations between maternal age and various pregnancy complications, as well as multimorbidity. We employed the Apriori algorithm to mine the association rules among pregnancy complications and identify frequent multimorbidity patterns. Results We found three distinct patterns of associations between maternal age and specific pregnancy complications. In relation to increasing maternal age, gestational diabetes mellitus, preeclampsia, and gestational hypertension showed nonlinear increasing trends for both nulliparas and multiparas, as did multimorbidity in nulliparas. Conversely, we observed linear increasing trends for placental previa in both nulliparas and multiparas, placental abruption in nulliparas, and multimorbidity in multiparas. Infection and severe anaemia had an approximate J-shaped curve among nulliparas, while postpartum haemorrhage exhibited a similar curve in both nulliparas and multiparas. Advanced maternal age was linked to an elevated risk of multimorbidity during pregnancy or postpartum period, exhibiting more complicated patterns. The most common multimorbidity patterns in this age group were "preeclampsia + gestational diabetes mellitus", "gestational hypertension+ gestational diabetes mellitus", "infection+ gestational diabetes mellitus", and "placental previa+gestational diabetes mellitus". Conclusions Maternal age was associated with pregnancy complications and multimorbidity in three broad dose-response manners, including approximate J-shaped curves, as well as nonlinear and linear increasing trends, depending on the specific outcome and parity, which may suggest different underlying biological mechanisms. Women with advanced maternal age had a higher risk and more complicated patterns of multimorbidity during pregnancy or postpartum, suggesting that this group should be targeted for more intensive health care. [ABSTRACT FROM AUTHOR]

Background We aimed to estimate latent foetal growth conditions and explore their determinants among maternal characteristics and ultrasound biometric parameters. We additionally investigated the influence of foetal growth conditions on perinatal variables. Methods We used data from live-born singletons in the Maternal and Child Health and Nutrition in Acre, Brazil (MINA-Brazil Study) population-based birth cohort. Maternal and perinatal characteristics were assessed in medical records from the maternity hospital and interviews with participants from July 2015 to June 2016. A sub-sample went through ultrasound examinations during the antenatal period, with assessment of foetal head and abdominal circumferences, and femur length. We estimated latent foetal growth conditions with a structural equation modelling framework, informed by the child's birth weight z-scores (BWZ) and birth length z-scores (BLZ) according to gestational age. Odds ratios and 95% confidence intervals (CIs) for the occurrence of perinatal events were estimated according to linear predictions of the latent variable. Results We included 1253 participants. Latent foetal growth conditions explained 88.3% of BWZ and 53.7% of BLZ variation. Maternal elevated blood pressure, primiparity, smoking, malaria, and insufficient gestational weight gain negatively impacted foetal growth conditions. In the subsample (n=499), ultrasound biometric parameters assessed at 28 weeks were positively associated with the latent variable, with the largest contribution from foetal abdominal circumference. Each standardised unit of predicted foetal growth conditions halved the chance for preterm birth (95% CI=0.26, 0.74) and longer hospital stay (>3 days) (95% CI=0.28, 0.88). Conversely, BWZ and BLZ were not independently associated with these perinatal variables in separate logistic regression models. Conclusions Latent foetal growth conditions jointly encompassing weight gain and linear growth during gestation were negatively influenced by a scenario of dual burden of maternal morbidities, with perinatal implications. [ABSTRACT FROM AUTHOR]

Background Many low- and middle-income countries (LMICs) prioritise minimising maternal, neonatal, and infant mortality. To improve maternal and child health, various evidence-based interventions have been introduced. Quality of care is pertinent while strengthening service utilisations. Achieving optimal-quality care is often marred with difficulties, such as inadequate skills and knowledge of health workers, poor fidelity to protocols, and poor user acceptance. Angola is a LMIC facing these problems. This study aimed to demonstrate the influence of health facilities' quality of care at antenatal care (ANC) on subsequent maternal, newborn and child health (MNCH) service utilisation in Angolan pregnant women. Methods Population-based cohort data from the Maternal and Child Health Handbook (MCH-HB) effectiveness study were analysed. The original study was conducted among women who became pregnant between March and April 2019 in Benguela Province, Angola. Socioeconomic and MNCH service utilisation indicators were collected through interviewer-administered structured questionnaires. The indicator of quality of care was a composite measure that assessed the implementation of the MCH-HB based on the RE-AIM framework, mostly consisted of common factors related to delivery and management of MNCH services. A multivariate logistic regression analysis was performed between quality of care, socioeconomic factors, and service utilisation indicators among the intervention group participants who had at least one ANC visit. Results Of the 3351 pregnant women who visited ANC at least once, 2911 without missing values among explanatory or dependent variables were included in the analysis. Among them, 2032 (69.8%) were exposed to optimal-quality ANC, and 2058 (70.7%), 1573 (54.0%), and 941 (32.3%) achieved ANC target, facility delivery, and vaccination target for six-month-old infants, respectively. Exposure to suboptimal-quality care at ANC was associated with lower odds for facility delivery (adjusted odds ratio (AOR)=0.60, 95% CI=0.49-0.73) and the achievement of the vaccination target (AOR=0.43, 95% CI=0.33-0.55). A low socioeconomic status was inversely associated with health service utilisation indicators. Conclusions Health facilities' quality of care influences subsequent MNCH service utilisation. Therefore, simultaneous efforts to improve quality of care and the mobilisation of pregnant women and communities are essential for enhancing maternal and child health. [ABSTRACT FROM AUTHOR]

Background Published guidelines on decision-making and resuscitation of extremely preterm infants primarily focus on high-income countries. For rapidly industrializing ones like China, there is a lack of population-based data for informing prenatal management and practice guidelines. Methods The Sino-northern Neonatal Network conducted a prospective multi-centre cohort study between 1 January 2018 and 31 December 2021. Infants with a gestational age (GA) between 22 (postnatal age in days = 0) and 28 (postnatal age in days = 6) admitted to 40 tertiary NICUs in northern China were included and evaluated for death or severe neurological injury before discharge. Results For all extremely preterm infants (n = 5838), the proportion of admission to the neonatal was 4.1% at 22-24 weeks, 27.2% at 25-26 weeks, and 75.2% at 27 and 28 weeks. Among 2228 infants admitted to the NICU, 216 (11.1%) were still elected for withdrawal of care (WIC) due to non-medical factors. Survival rates without severe neurological injury were 6.7% for infants at 22-23 weeks, 28.0% at 24 weeks, 56.7% at 24 weeks, 61.7% at 25 weeks, 79.9% at 26 weeks, and 84.5% at 27 and 28 weeks. Compared with traditional criterion at 28 weeks, the relative risk for death or severe neurological injury were 1.53 (95% confidence interval (CI) = 1.26-1.86) at 27 weeks, 2.32 (95% CI = 1.73-3.11) at 26 weeks, 3.62 (95% CI = 2.43-5.40) at 25 weeks, and 8.91 (95% CI = 4.69-16.96) at 24 weeks. The NICUs with higher proportion of WIC also had a higher rate of death or severe neurological injury after maximal intensive care (MIC). Conclusions Compared to the traditional threshold of 28 weeks, more infants received MIC after 25 weeks, leading to significant increases in survival rates without severe neurological injury. Therefore, the resuscitation threshold should be gradually adjusted from 28 to 25 weeks based on reliable capacity. [ABSTRACT FROM AUTHOR]

Children with a significant cognitive and motor developmental delay (SDD) are vulnerable for the development of (future) behavioral and mental health problems. To support children within this target group, knowledge on their social-emotional development is necessary. Therefore, in this paper, an explorative assessment of the changes in the social-emotional functioning of children with SDD over a two-year period was done. Yearly semi-structured interviews with one or more primary caregiver(s) of 25 children were conducted and analyzed on 13 domains of social-emotional functioning, according to an adapted version of the Scale for Emotional Development - Revised (SED-R). This study showed a lot of variation in individual and group patterns of change across the two-year period. Charting the social-emotional development in this target group is challenging and requires further in-depth analysis of individual trajectories as well as more fine-grained and long-term data collection. [ABSTRACT FROM AUTHOR]

Study Objective: The present study is aimed at providing an assessment of the changes in burnout, job strain, isostrain, sleepiness, and fatigue levels over time and identifying factors associated with these symptoms among healthcare workers in French emergency departments (EDs). Method: We conducted a prospective, multicenter study in four EDs and an emergency medical service. Participants completed questionnaires at inclusion and at 90 days to assess burnout, job strain, isostrain, sleepiness, and fatigue. Results: A total of 211 respondents (43.5%) completed the questionnaires at inclusion. At the beginning of the study, 84 (40.8%) participants presented symptoms of burnout, 86 (43.2%) had symptoms of job strain, and 58 (29.4%) of isostrain. Forty‐two (20.1%) healthcare workers presented symptoms of sleepiness, and 8 (3.8%) had symptoms of fatigue. We found that symptoms of burnout were more frequent for healthcare workers with a previous psychiatric history (55.3% vs. 39.1%, p = 0.02) and were lower among participants who had at least one dependent child (33.1% vs. 48.3%, p = 0.013). Symptoms of job strain were higher among administrative staff compared to physicians (55.6% vs. 28.7%, p = 0.01) and among healthcare workers with managerial responsibilities compared to those without (45.6% vs. 28.8%, p = 0.015). Symptoms of isostrain were higher among administrative staff (42.3%) compared to paramedics (34.1%) and physicians (19.8%, p = 0.026). Conclusion: We identified that potential factors associated with the emergence of symptoms of burnout and job strain are suggested, underlining several areas of improvement for the prevention against mental health disorders in the specific population of ED healthcare workers. Trial Registration: ClinicalTrials.gov identifier: NCT04383886. [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]

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

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

Aim: To explore the correlations between examination tolerance and anxiety, knowledge needs and examination cooperation in sedation‐free gastroscopy examinees. Design: Cross‐sectional survey using convenience sampling. Methods: A total of 170 healthy adults who underwent sedation‐free gastroenteroscopy were asked to complete a visual analogue scale (VAS) to rate their examination tolerance, the state anxiety questionnaire (S‐AI), a newly designed knowledge needs questionnaire and a cooperation questionnaire. Results: The VAS score was 4.47 ± 1.96, the state anxiety score was 39.46 ± 9.81, the total score for knowledge needs was 44.89 ± 11.02, and the average cooperation score was 2.47 ± 0.38. The VAS score during the examination positively correlated with the pretest state anxiety score and pretest knowledge needs score and negatively correlated with the examination cooperation score. The results of multiple linear regression analysis showed that after undergoing the examination for the first time, anxiety, body position and swallowing control were the main factors influencing the examination tolerance of sedation‐free gastroscopy examinees. Patient or Public Contribution: We would like to thank the staff and patients of the participating hospital for their assistance and cooperation in performing the current study. [ABSTRACT FROM AUTHOR]

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

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

Background: Longitudinal cohort studies gather large amounts of data over time, often without direct benefit to participants. A positive experience may encourage retention in the study, and participants may benefit in unanticipated ways. Objective: To explore first‐time mothers' experiences of taking part in a longitudinal cohort study and completing self‐administered surveys during pregnancy and at 3, 6, 9 and 12 months' postpartum. Design: Content analysis of comments written by participants in the Maternal health And Maternal Morbidity in Ireland study's five self‐completion surveys, a multisite cohort study exploring women's health and health problems during and after pregnancy. This paper focuses on what women wrote about taking part in the research. Ethical approval was granted by the site hospitals and university. Setting and participants: A total of 2174 women were recruited from two maternity hospitals in Ireland between 2012 and 2015. Findings: A total of 1000 comments were made in the five surveys. Antenatally, barriers related to surveys being long and questions being intimate. Postpartum, barriers related to being busy with life as first‐time mothers. Benefits gained included gaining access to information, taking time to reflect, stopping to think and being prompted to seek help. Survey questions alone were described as valuable sources of information. Discussion and conclusions: Findings suggest that survey research can "give back" to women by being a source of information and a trigger to seek professional help, even while asking sensitive questions. Understanding this can help researchers construct surveys to maximize benefits, real and potential, for participants. [ABSTRACT FROM AUTHOR]

Background: Recognition of homogeneous subgroups of patients can usefully improve prediction of their outcomes and the targeting of treatment. There are a number of research approaches that have been used to recognise homogeneity in such subgroups and to test their implications. One approach is to use statistical clustering techniques, such as Cluster Analysis or Latent Class Analysis, to detect latent relationships between patient characteristics. Influential patient characteristics can come from diverse domains of health, such as pain, activity limitation, physical impairment, social role participation, psychological factors, biomarkers and imaging. However, such ‘whole person' research may result in data-driven subgroups that are complex, difficult to interpret and challenging to recognise clinically. This paper describes a novel approach to applying statistical clustering techniques that may improve the clinical interpretability of derived subgroups and reduce sample size requirements. Methods: This approach involves clustering in two sequential stages. The first stage involves clustering within health domains and therefore requires creating as many clustering models as there are health domains in the available data. This first stage produces scoring patterns within each domain. The second stage involves clustering using the scoring patterns from each health domain (from the first stage) to identify subgroups across all domains. We illustrate this using chest pain data from the baseline presentation of 580 patients. Results: The new two-stage clustering resulted in two subgroups that approximated the classic textbook descriptions of musculoskeletal chest pain and atypical angina chest pain. The traditional single-stage clustering resulted in five clusters that were also clinically recognisable but displayed less distinct differences. Conclusions: In this paper, a new approach to using clustering techniques to identify clinically useful subgroups of patients is suggested. Research designs, statistical methods and outcome metrics suitable for performing that testing are also described. This approach has potential benefits but requires broad testing, in multiple patient samples, to determine its clinical value. The usefulness of the approach is likely to be context-specific, depending on the characteristics of the available data and the research question being asked of it. [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]

Background: To elucidate the treatment and surgery outcomes with or without perioperative therapies in Japanese patients with clinical stage III non‐small cell lung cancer (NSCLC) in real‐world settings. Methods: We performed subset analyses of the SOLUTION study, a multicenter, noninterventional, observational study of Japanese patients diagnosed with clinical stage III NSCLC, for those who started first‐line treatment (surgery±perioperative therapy) between January 2013 and December 2014 (study registration: UMIN000031385). Follow‐up data were obtained using medical records from diagnosis to March 1, 2018. Results: Of 149 eligible patients, 67 underwent surgery alone (median age 71 years) and 82 underwent surgery+perioperative therapy (median age 63 years). Lung resection was performed in 137 patients and the others underwent exploratory thoracotomy or other procedures. Perioperative therapies included adjuvant therapy only (n = 41), neoadjuvant therapy only (n = 24), and neoadjuvant+adjuvant therapy (n = 17). The median overall survival (OS) and 3‐year OS rate were 29.3 months and 44.0%, respectively, in patients who underwent surgery alone, and not reached and 61.1%, respectively, in patients who underwent surgery+perioperative therapy. The 3‐year progression‐free survival (PFS) and disease‐free survival (DFS) rates were 42.4% and 47.1%, respectively, in patients who underwent surgery+perioperative therapy and 28.5% and 28.9%, respectively, in patients who underwent surgery alone. In multivariable Cox regression, perioperative therapy was associated with improved OS (hazard ratio [95% confidence interval] 0.49 [0.29–0.81]), PFS (0.62 [0.39–0.96]), and DFS (0.62 [0.39–0.97]) versus surgery alone. Conclusions: Our study suggested that perioperative therapy may be associated with better survival among patients undergoing surgical treatment of clinical stage III NSCLC. [ABSTRACT FROM AUTHOR]

Objectives: Individuals who die by suicide often consult their general practitioners (GPs) in their final weeks of life. The aim of this study was to gain a deeper knowledge of the clinical characteristics and GP assessments and treatments among individuals who consulted their GPs during the month preceding suicide. Further, we compared these features in those with and without contact with psychiatric services (PC and NPC, respectively) during the two years that preceded the suicide. Design: A nationwide retrospective explorative study investigating medical records. Setting: Primary care in Sweden. Participants: Individuals who died by suicide in Sweden in 2015 with a GP visit within 30 days of death. Results: The study cohort corresponds to one fifth (n = 238) of all suicides that occurred in Sweden in 2015 (n = 1179), representing all those with available primary care records showing contact with a GP during the final 30 days of life (NPC: n = 125; PC: n = 113). The mean age was 58 years ± 19. Patients in the NPC group were older (NPC: 63 years ± 19 vs. PC: 53 years ± 18, p < 0.0001) and presented psychiatric symptoms less often (NPC: 50% vs. PC: 67%, p < 0.006). Somatic symptoms were as common as psychiatric symptoms for the whole sample, being present in more than half of individuals. Suicide risk was noted in only 6% of all individuals. Referral to psychiatric services occurred in 14%, less commonly for the NPC group (NPC: 6% vs. PC: 22%, p < 0.001). Cardiovascular or respiratory symptoms were noted in 19%, more often in the NPC group (NPC: 30% vs. PC: 6%, p < 0.001), as were diagnoses involving the circulatory system (all 10%, NPC:14% vs. PC: 5%, p < 0.020). Conclusion: A high level of somatic symptoms was observed in primary care patients both with and without psychiatric contact, and this might have influenced GPs' management decisions. Psychiatric symptoms were noted in two thirds of those with psychiatric contact but only half of those without. While GPs noted psychiatric symptoms in over half of all individuals included in the study, they seldom noted suicide risk. These findings highlight the need for increased attention to psychiatric symptoms and suicide risk assessment, particularly among middle-aged and older individuals presenting with somatic symptoms. Strengths and limitations of this study: The National Cause of Death Register has excellent coverage of suicide deaths and access to medical records was very good. The medical record review provided detailed information regarding primary care utilization before death by suicide. Because of the lack of statistical power, due to the limited number of persons with GP contact during the last month of life, we chose not to correct for multiple comparisons. Our study approach did not capture the reasons behind GPs' documentation of elevated suicide risk. No systematic inter-rater reliability (IRR) testing was made, however, reviewers received training and continuous support from the research group. [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: Uterine sarcomas (US) represent a rare and heterogeneous spectrum of tumors characterized by diverse clinical behaviors and tumor responses. This study aims to assess patient and tumor characteristics and oncologic outcomes. Method: This historical cohort study encompassed all patients with histologically confirmed diagnoses of the US who were referred to two oncology centers affiliated with Mashhad University of Medical Sciences (Iran) between March 2011 and April 2020. Data analyses were conducted using STATA version 14.02. Survival estimation was carried out utilizing the Kaplan-Meier method. The significance level was established at 0.05. Results: A total of 33 patients were included in this study, comprising 23 with US and 10 with carcinosarcoma (CS). The mean age was 49.3 years for CS and 62.4 years for US (P = 0.0001). Nearly all patients were overweight, with a mean body mass index of 27.1 (confidence interval: 25.6-28.7). The majority of patients were diagnosed at an early stage. The Federation of Gynecology and Obstetrics (FIGO) stage, patient's anemia, and surgical resection were identified as significant prognostic factors. The median overall survival was 50.88 ± 5.7 months. The survival rates at 2, 3, and 5 years were 75%, 56%, and 41%, respectively. No significant difference was observed between CS and US regarding overall and disease-free survival. Conclusion: Despite the typical early-stage diagnosis for US patients, the 5-year survival rate remains low. This study underscores the pivotal role of FIGO stage, tumor size, and surgical resection as vital prognostic factors for survival. [ABSTRACT FROM AUTHOR]

This study aimed to improve the predictive accuracy of the Braden assessment for pressure injury risk in skilled nursing facilities (SNFs) by incorporating real‐world data and training a survival model. A comprehensive analysis of 126 384 SNF stays and 62 253 in‐house pressure injuries was conducted using a large calibrated wound database. This study employed a time‐varying Cox Proportional Hazards model, focusing on variations in Braden scores, demographic data and the history of pressure injuries. Feature selection was executed through a forward‐backward process to identify significant predictive factors. The study found that sensory and moisture Braden subscores were minimally contributive and were consequently discarded. The most significant predictors of increased pressure injury risk were identified as a recent (within 21 days) decrease in Braden score, low subscores in nutrition, friction and activity, and a history of pressure injuries. The model demonstrated a 10.4% increase in predictive accuracy compared with traditional Braden scores, indicating a significant improvement. The study suggests that disaggregating Braden scores and incorporating detailed wound histories and demographic data can substantially enhance the accuracy of pressure injury risk assessments in SNFs. This approach aligns with the evolving trend towards more personalized and detailed patient care. These findings propose a new direction in pressure injury risk assessment, potentially leading to more effective and individualized care strategies in SNFs. The study highlights the value of large‐scale data in wound care, suggesting its potential to enhance quantitative approaches for pressure injury risk assessment and supporting more accurate, data‐driven clinical decision‐making. [ABSTRACT FROM AUTHOR]

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

Background According to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, both immunohistochemical HER2 (3+) and HER2 (2+)/in situ hybridization (ISH) amplified [HER2 (2+)/ISH+] breast cancers (BCs) fall under the HER2-positive BC category. However, there is a lack of studies exploring the difference of neoadjuvant therapeutic response between patients with HER2 (3+) and HER2 (2+)/ISH+ early BC. We aimed to evaluate the neoadjuvant therapeutic response, long-term outcome, and intrinsic subtype heterogeneity between HER2 (3+) and HER2 (2+)/ISH+ BC. Methods We examined 2 distinct cohorts. Cohort 1 (C1) encompassed 2648 patients with HER2-positive early BC diagnoses, and they received neoadjuvant therapy (NT) and surgery between January 1, 2009 and December 31, 2022, from the Shanghai Jiao Tong University Breast Cancer Data Base. Cohort 2 (C2) comprised 135 patients with early-stage HER2-positive BC who underwent NT and surgery at Henan Cancer Hospital from January 1, 2021, to December 31, 2022. These patients had available genomic and transcriptomic data at their disposal. C1 and C2 were further categorized into 2 patient cohorts as follows: (1) patients with IHC HER2 (3+) early BC [HER2 (3+) group], (2) patients with HER2 (2+)/ISH+ early BC [HER2 (2+)/ISH+ group]. Among those excluded from the analysis were patients < 18 years or >80 years of age. Clinicopathological parameters, long-term outcomes, and intrinsic subtypes were analyzed. Results In the C1 population, 83.7% had HER2 (3+) BC, while 16.3% had HER2 (2+)/ISH+ BC. Patients with HER2 (3+) had a significantly higher pathological complete response (PCR) rate (38.9%) than patients with HER2 (2+)/ISH+ (18.1%; P  < .001), but the disease-free survival (DFS) was comparable after a median follow-up of 29 months (P  = .556). The addition of trastuzumab or trastuzumab plus pertuzumab to neoadjuvant chemotherapy (NAC) improved PCR rates and DFS in HER2 (3+) BC but not in HER2 (2+)/ISH+ BC. In the C2 population, 97.75% HER2 (3+) and 52.17% HER2 (2+)/ISH+ were HER2 enriched (HER2E) subtype (P  < .001). HER2E showed increased PCR rates compared to non-HER2E (P  = .004). Conclusions Compared to HER2 (3+) BC, the limited effectiveness of neoadjuvant trastuzumab and pertuzumab therapy for HER2 (2+)/ISH+ BC is due to subtype heterogeneity. Reassessment of targeted therapy efficacy in patients with HER2 (2+)/ISH+ BC is essential. [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: In Germany, more than 40% of infants are born to immigrant parents. Increased survival rates of very preterm (below 32 weeks gestation at birth; VP) infants have not resulted in equally improved life chances and quality of life. More information on perinatal variations in outcomes according to social inequalities, migration background, and language barriers is needed. We tested whether mothers' immigrant status and language barriers are associated with perinatal health and short-term neonatal outcomes. Methods: The data are from the national multi-centre German Neonatal Network (GNN) cohort, including VP births from 2009 onwards. In total, 3606 (n = 1738 female) children were assessed, and 919 (n = 449 female) of these children had immigrant backgrounds. Immigrant status was operationalised as a binary variable based on the children's mothers' countries of birth (born in Germany vs. foreign-born). Self-reported home language (L1) was used to calculate the average linguistic distance to German as one continuous variable. Results: Mixed-effects models showed that two out of fourteen effects of interest survived the adjustment for known confounders and accounting for the nestedness of data within birth hospitals. Linguistic distance from mothers' L1s to German was independently associated with diagnoses of preeclampsia (OR = 1.01, 95% CI = [1.00, 1.01]). Infants of foreign-born mothers had higher odds for amniotic infection syndrome (AIS; OR = 1.45 [1.13, 1.86]) than infants of German mothers. Conclusions: Our findings from this large multi-centre longitudinal cohort of VP-born children indicate that maternal immigrant status and language barriers have limited impact on perinatal health and severe neonatal outcomes. This suggests that, regardless of background or language skills, there may be few inequalities in the perinatal health of pregnant women and their newborn preterm infants. [ABSTRACT FROM AUTHOR]

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

Introduction: The optimal strategy for differentiated thyroid cancer (DTC) patients treated with radioiodine (RAI) following thyroidectomy remains controversial. Multi-centre clinical studies are essential to identify strategies to improve patient outcomes while minimising treatment-induced toxicity. Materials and Methods: The INSPIRE clinical trial (ClinicalTrials.gov Identifier: NCT04391244) aims to investigate patient-specific dosimetry for DTC patients and to determine the range of absorbed doses delivered to target and nontarget tissues and their relationship with treatment outcome and toxicity. Results: We report here initial results of the first 30 patients enrolled onto the INSPIRE trial. A large range of absorbed doses are observed for both thyroid remnants and salivary glands, with median values of 4.8 Gy (Range 0.2 - 242 Gy) and 0.3 Gy (Range 0.1 to 1.7 Gy), respectively. Discussion: The preliminary study results are encouraging and could help to improve our understanding of absorbed doses to thyroid remnants and normal organs following RAI therapy. Such knowledge could potentially enable patientspecific treatment planning with improved clinical outcomes and quality-of-life of patients. [ABSTRACT FROM AUTHOR]

Background: The management of inappropriate medication use in older patients suffering from multimorbidity and polymedication is a major healthcare challenge. In a primary care setting, a medication review is an effective tool through which a pharmacist can collaborate with a practitioner to detect inappropriate drug use. Aim: This project described the implementation of a systematic process for the management of potentially inappropriate medication use among Lebanese older adults. Its aim was to involve pharmacists in geriatric care and to suggest treatment optimization through the analysis of prescriptions using explicit and implicit criteria. Method: This study evaluated the medications of patients over 65 years taking a minimum of five chronic medications a day in different regions of Lebanon. Descriptive statistics for all the included variables using mean and standard deviation (Mean (SD)) for continuous variables and frequency and percentage (n, (%)) for multinomial variables were then performed. Results: A total of 850 patients (50.7% women, 28.6% frail, 75.7 (8.01) mean age (SD)) were included in this study. The mean number of drugs per prescription was 7.10 (2.45). Roughly 88% of patients (n = 748) had at least one potentially inappropriate drug prescription: 66.4% and 64.4% of the patients had at least 1 drug with an unfavorable benefit-to-risk ratio according to Beers and EU(7)-PIM respectively. Nearly 50.4% of patients took at least one medication with no indication. The pharmacists recommended discontinuing medication for 76.5% of the cases of drug related problems. 26.6% of the overall proposed interventions were implemented. Discussion: The rate of potentially inappropriate drug prescribing (PIDP) (88%) was higher than the rates previously reported in Europe, US, and Canada. It was also higher than studies conducted in Lebanon where it varied from 22.4 to 80% depending on the explicit criteria used, the settings, and the medical conditions of the patients. We used both implicit and explicit criteria with five different lists to improve the detection of all types of inappropriate medication use since Lebanon obtains drugs from many different sources. Another potential source for variation is the lack of a standardized process for the assessment of outpatient medication use in the elderly. Conclusion: The prevalence PIDP detected in the sample was higher than the percentages reported in previous literature. Systematic review of prescriptions has the capacity to identify and resolve pharmaceutical care issues thus improving geriatric care. [ABSTRACT FROM AUTHOR]

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

Background: Sarcopenia is associated with increased morbidity and mortality. The systemic immune-inflammation index (SII) has been correlated to a variety of disorders. The present study conducted a systematic review and meta-analysis to investigate the relationship between SII and sarcopenia. Methods: A literature search was performed in Web of Science, PubMed, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Database, and VIP Chinese Science and Technology Database, from inception to March 2024. Then, the literature quality was assessed. After the heterogeneity test, a random effects or fixed effects model was applied to establish the forest plot, and investigate the relationship between SII and sarcopenia. Then, the sensitivity analysis and publication bias were examined. Results: Nine articles, which included 18,634 adults, were analyzed. Sarcopenic adults had higher SII levels, when compared to non-sarcopenic adults (standardized mean difference [SMD] = 0.66, 95% confidence interval [CI] = 0.22 − 0.19, p = 0.003). The high SII level was associated to the increased risk of sarcopenia (odds ratio = 1.52, 95% CI = 1.09–2.13, p = 0.01). In addition, the subgroup analysis revealed that the SII levels were higher in the sarcopenic group, when compared to the non-sarcopenic group, in elderly adults, as well as in adults with or without gastrointestinal disorders. The analysis was robust with a low risk of publication bias. Conclusions: SII is closely associated to sarcopenia. Sarcopenic adults had elevated SII levels. The high SII level increased the risk of sarcopenia. Large scale multi-center prospective studies are required to validate these study findings. [ABSTRACT FROM AUTHOR]

Introduction: Chronic non-cancer pain (CNCP) is a lifelong condition with radical consequences, calling for management involving patients' families. Interventions based on the family systems nursing framework by Wright and Leahey have proved beneficial in other populations but require investigation in a CNCP population. This trial assumed that family nursing conversations (FNCs) based on the family systems nursing framework would increase patients' and family members' self-efficacy concerning CNCP management. Objective: To investigate whether an intervention with FNCs as an add-on to the usual multidisciplinary treatment of CNCP would have an effect on patients' and family members' self-efficacy. Additionally, to investigate any impact on family function, health-related quality of life, anxiety, and depression. Methods: The trial applied a prospective non-blinded quasi-experimental design with two comparable groups of patients and family members: a historical control group (HCG) and an intervention group (IG). The intervention was executed by nurses employed at a multidisciplinary pain center in the Capital Region of Denmark. HCG data were collected before the nurses' intervention training. The primary outcome was self-efficacy. Secondary outcomes were family function, health-related quality of life, anxiety, and depression. Results: In total, 58 patients and 85 family members were included. The primary outcome, self-efficacy, detected no statistically significant between-group differences in mean change for patients, p =.990, or family members, p =.765. A statistically significant effect in favor of the IG was found in between-group differences in mean change in patients' behavioral family function, p =.034, and anxiety, p =.031. No statistically significant between-group differences were detected in family members' secondary outcomes. Conclusion: The intervention had no effect on patients' or family members' self-efficacy but a positive effect on patients' behavioral family function and anxiety. The intervention was deeply affected by the COVID-19 pandemic. Hence, any results should be interpreted with caution. [ABSTRACT FROM AUTHOR]