Validation Study Research Articles

P-156 Ultra-fast warming of blastocysts yields better survival rates for D5 non-PGT and similar survival rates for D5/D6 PGT blastocysts

Abstract Study question Can an ultra-fast single-step warming of vitrified blastocysts yield similar survival rates and post-warming development compared to the standard multi-step rehydration protocol? Summary answer Ultra-fast warming, shows significantly better rates of survival and post-warming development in vitro for non-PGT blastocysts and similar rates for PGT blastocysts. What is known already Excellent survival rates have been reported since the introduction of human blastocyst vitrification. Typically, most warming procedures involve three steps with decreasing concentrations of non-penetrating cryoprotectants. Recently, few studies have evaluated the effectiveness of simplifying the procedure to a single step for rehydration, while maintaining comparable survival and pregnancy rates. Adopting simpler procedures can optimize laboratory protocols, workflow, and safety, supporting further advancements in Assisted Reproduction Technologies (ART). Study design, size, duration This validation study ultra-fast warmed 246 vitrified blastocysts [129 non-PGT day5 (cryopreservation period 23/01/2017-24/04/2018 VIT-kit, Fujifilm), 57 PGT day5 (25/01/2023-31/03/2023 VIT-KitNX, Fujifilm), 60 PGTday6 (03/02/2023-22/08/2023 Vit-KitNX, Fujifilm)] and compared survival rates with 379 blastocysts [240 non-PGT day5, 97 PGT day5, 42 PGT day6] vitrified in the same time-periods and warmed for clinical application using the standard multi-step protocol. Ultra-fast warmed blastocysts were cultured for 24h in a time-lapse incubator and subjected to a viability staining. Participants/materials, setting, methods Blastocysts, originating from 111 patients that were donated to validation studies after the legal storage period(n = 129) or deemed non-transferable after PGT(n = 117), were ultra-fast warmed by immersing the straw in a 37 °C thawing solution (1M trehalose; Vit-kitwarmNX; Fujifilm) for 1 minute. Survival rates [total (≥50% intact) and fully (100% intact) ], transfer rates (2h post-warming, ≥50% intact), re-expansion time and the number of damaged cells (Live/Dead kit L-3224, Invitrogen) were analysed. Fisher’s Exact Test (p < 0.05). Main results and the role of chance Overall, the immediate post-warming survival rates (≥50% intact) were comparable between ultra-fast and multi-step warming, 98.4% vs 96.8% respectively (p = 0.3041). However, the fully intact survival rate immediately post-warming was significantly higher with ultra-fast warming (85.4% vs 76.3%; p = 0.0058) as well as the percentage of blastocysts considered transferable (96.7% vs 91.2%; p = 0.0076). Sub-group analysis demonstrated significantly better results for non-PGT blastocysts following ultra-fast warming. Higher immediate survival post-warming (100% vs 96.6%; p = 0.036) and transfer rates (100% vs 90%; p = 0.0002) were achieved. Similar results were observed for PGT blastocysts on both day 5 and day 6, with no significant differences in total, fully intact, and transfer rates observed between the two warming procedures [PGT Day5: 96.5%, 80.7%, and 93.0% vs. 97.9%(p = 0.6270), 69.1%(p = 0.1334), and 93.8%(p = 1.0000)] [PGT Day6: 96.7%, 68.3%, and 93.3% vs. 95.2%(p = 1.0000), 64.3%(p = 0.6761), and 92.8%(p = 1.0000)]. Ultra-fast warmed blastocysts showed a total re-expansion rate of 93.3% in 3.3h±2.7h on average. Viability staining demonstrated very few cells damaged. Zero cell damage was observed in 31.5% of the blastocysts, 59.0% had 1-10 cells damaged, 9.5% >10 cells damaged, and only 4 blastocysts were completely degenerated. Limitations, reasons for caution In order to limit the amount of embryos needed in this validation study, ultra-fast warming outcome parameters were compared with retrospective clinical results of blastocysts vitrified in the same time periods. Ultra-fast warming is a single-step process where precise temperature control(37 °C) of the warming medium is crucial for success. Wider implications of the findings Minimizing handling steps leads to an overall risk reduction in potential exposure to suboptimal warming conditions and operator/handling-related stress. This optimization brings huge efficiency to the busy work schedule that is characteristic for an IVF lab without dropping cryopreservation quality indicators. Trial registration number Not applicable

Psychometric properties of the modified Drug Abuse Screening Test Sinhala version (DAST-SL): evaluation of reliability and validity in Sri Lanka

BackgroundPsychoactive drug use is an important public health issue in Sri Lanka as it causes substantial health, social and economic burden to the country. Screening for substance use disorders in people who use drugs is vital in preventive health care, as it can help to identify problematic use early. Screening can aid in referring those in need, for the most appropriate treatment and care. Thus, preventing them from developing severe substance use disorders with complications. The Drug Abuse Screening Test (DAST-10) is an evidence-based tool widely used to assess the severity of psychoactive drug use. This study aimed to culturally adapt and evaluate the validity and reliability of the Drug Abuse Screening Test (DAST-10) in Sri Lanka.MethodsThe DAST-10 was culturally adapted, and the nine-item Sinhala version (DAST-SL) was validated using exploratory and confirmatory factor analysis. The validation study was conducted in the Kandy district among people who use drugs, recruited using respondent-driven sampling. Criterion validity of the questionnaire was assessed by taking the diagnosis by a psychiatrist as the gold standard. Cut-off values for the modified questionnaire were developed by constructing Receiver Operating Characteristic (ROC) curves. The reliability of the DAST-SL was assessed by measuring its internal consistency and test re-test reliability.ResultsThe validated DAST-SL demonstrated a one-factor model. A cut-off value of ≥ 2 demonstrated the presence of substance use disorder and had a sensitivity of 98.7%, specificity of 91.7%, a positive predictive value of 98.8% and a negative predictive value of 91.3%. The area under the curve of the ROC curve was 0.98. A cut-off score of ≤ 1 was considered a low level of problems associated with drug use. The DAST-SL score of 2–3 demonstrated a moderate level of problem severity, a score of 4–6 demonstrated a substantial level of problems, and a score of ≥ 7 demonstrated a severe level of drug-related problems. The questionnaire demonstrated high reliability with an internal consistency of 0.80 determined by Kuder–Richardson Formula-20 and an inter-class correlation coefficient of 0.97 for test re-test reliability.ConclusionThe DAST-SL questionnaire is a valid and reliable tool to screen for drug use problem severity in people who use drugs in Sri Lanka.

Electromagnetic analysis of the ITER wide angle viewing system components with a simplified approach

An electromagnetic (EM) analysis of the Optical Hinge (OH) and Optical Relay Unit (ORU) has been performed for the validation of their Final Designs. OH and ORU are reflective optical systems, being the starting ex-vessel components of the ITER diagnostic Wide Angle Viewing System (WAVS). These two components share a support structure, attached in turn to the Interspace Support Structure (ISS).The methodology for the realization of the EM analyses for components in fusion devices is not standardized. The choice of the method highly depends on the goals of the study, on the required accuracy of results and on the available resources. A methodology to perform the EM analysis has been developed and validated. In the EM analysis, the arising EM forces have been calculated with a finite element 3D model, and the results obtained were used for the successive structural analysis.The publication presents the methodology developed, its implementation to the OHORU components, the results obtained for the validation of their Final Designs and additional studies for the methodology validation.

Adaptation of the Social Media Addiction Scale into Azerbaijani Turkish: Validity and Reliability Study

Excessive attachment to social media, a constant desire to be online, being driven by uncontrollable motivation, and the negative impact of this situation on other significant areas of life are considered as social media addiction. In this study, the Social Media Addiction Scale Student Form (SMAS-SF), previously developed in Türkiye to determine students' levels of social media addiction, was adapted into Azerbaijani Turkish. The SMAS-SF is a five-point likert-type scale consisting of 29 items that can be grouped under four factors. The study group consisted of a total of 1,074 students aged 18-26 studying at different universities in Baku. The sample of the study was determined using the convenient sampling method, one of the non-probabilistic sampling determination types. Within the scope of the validity and reliability studies of the scale, expert opinion, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), item total correlations, lower and upper group mean differences, and internal consistency coefficient and stability analyses were performed. As a result of the analyses, it was found that the original structure of the SMAS-SF, consisting of 29 items and 4 dimensions, was confirmed, and significant evidence was provided that it can be used as a valid and reliable measurement tool to determine the level of social media addiction among university students aged 18-26. The lowest possible score that can be obtained from the scale is 29, and the highest score is 145. A high score may indicate a high level of social media addiction in students.

Identification of commensal gut microbiota signatures as predictors of clinical severity and disease progression in multiple sclerosis

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and a leading cause of neurological disability in young adults. Clinical presentation and disease course are highly heterogeneous. Typically, disease progression occurs over time and is characterized by the gradual accumulation of disability. The risk of developing MS is driven by complex interactions between genetic and environmental factors, including the gut microbiome. How the commensal gut microbiota impacts disease severity and progression over time remains unknown. In a longitudinal study, disability status and associated clinical features in 58 MS patients were tracked over 4.2 ± 0.98 years, and the baseline fecal gut microbiome was characterized via 16S amplicon sequencing. Progressor status, defined as patients with an increase in Expanded Disability Status Scale (EDSS), were correlated with features of the gut microbiome to determine candidate microbiota associated with risk of MS disease progression. We found no overt differences in microbial community diversity and overall structure between MS patients exhibiting disease progression and non-progressors. However, a total of 41 bacterial species were associated with worsening disease, including a marked depletion in Akkermansia, Lachnospiraceae, and Oscillospiraceae, with an expansion of Alloprevotella, Prevotella-9, and Rhodospirillales. Analysis of the metabolic potential of the inferred metagenome from taxa associated with progression revealed enrichment in oxidative stress-inducing aerobic respiration at the expense of microbial vitamin K2 production (linked to Akkermansia), and a depletion in SCFA metabolism (linked to Oscillospiraceae). Further, as a proof of principle, statistical modeling demonstrated that microbiota composition and clinical features were sufficient to predict disease progression. Additionally, we found that constipation, a frequent gastrointestinal comorbidity among MS patients, exhibited a divergent microbial signature compared with progressor status. These results demonstrate a proof of principle for the utility of the gut microbiome for predicting disease progression in MS in a small well-defined cohort. Further, analysis of the inferred metagenome suggested that oxidative stress, vitamin K2, and SCFAs are associated with progression, warranting future functional validation and mechanistic study.

Validation of Rome IV Criteria in Diagnosis of IBS as a Part of Functional Gastrointestinal Disorders among Children

Abstract Background There are few validation studies of existing diagnostic criteria for irritable bowel syndrome (IBS). We conducted a validation study of the Rome IV criteria in diagnosis of IBS as a part of functional gastrointestinal disorders among children (FGIDs). These revisions are expected to improve clinical care in children with FGIDs. We hypothesize that red flags may appear after the initial diagnosis leading to categorization of patients to organic illness rather than functional. Aim of the Work The aim of this study is to validate the Rome IV criteria in diagnosis of IBS as a part of functional gastrointestinal disorders among children. Patients and Methods Enrollment was targeted at children(4-16yrs) with chronic abdominal pain for 3 months or more and any patient with red flags were excluded from the study. The resulting sample included 200 patients. They were then followed up for 3 months then re-classification of the patients according to Rome 4 criteria. Comparison between the initially diagnosed patients as functional Gastrointestinal disorders with the final diagnosis after the 3 months follow in order to pick up any red flags which might appear. Results Diagnosis and follow up of patients using Rome IV is efficient in excluding organic diseases and diagnosing IBS as one of the FGIDs in children however there was interchangeable results between sub-types of IBS after the follow up of patients. None of our patients developed red flags of organic illness. Conclusion Rome criteria is helpful in diagnosing IBS and its subtypes and avoiding the need for further investigations.

Reassembling the Field-based Applicability of the Lactate Threshold for Old Age.

This study aimed to investigate the applicability of the Lactate Threshold (LT) to predict maximal oxygen uptake (˙VO2max) and demarcate the boundary between the moderate- to heavy-intensity domain (HRm-h) in old age in comparison to the most utilized methods. A cross-sectional validation study was conducted. Participants aged 61 to 77 performed a familiarization procedure, an incremental maximal exercise treadmill test (CPX) for ˙VO2max determination, the Six-minute Walk Test (6MWT), and a discontinuous incremental field test for LT determination. Lower (P<0.01) internal effort was required for LT testing (76±8%HRmax) compared to 6MWT (92±9%HRmax). The application of the 6MWT reference equations overestimated ˙VO2max by 10-23%. LTs better estimated the ˙VO2max (r ≈0.90, SEE: ≈3.0] compared to the 6MWT (r=0.68, SEE=5.5). HRm-h determined by the CPX differed (20%; P=0.001) from that obtained by LT. HRm-h stratification indicated participants fall into the very light to the vigorous intensity domains. LT testing is more submaximal than the 6MWT, and is a valuable tool to estimate the ˙VO2max in older male adults. Implementation of LT testing in physical activity programs might help improving the quality of aerobic exercise training in older men.

Measurement properties of utility-based health-related quality of life measures in cardiac rehabilitation and secondary prevention programs: a systematic review.

To identify utility-based patient-reported outcome measures (PROMs) for assessing health-related quality of life (HRQoL) in cardiac rehabilitation and secondary prevention programs (CR) and appraise existing evidence on their measurement properties. Secondly, to link their items to the International Classification of Functioning Disability and Health (ICF) and the International Consortium of Health Outcome Measures (ICHOM) domains for cardiovascular disease (CVD). Eight databases were searched. The review followed the COSMIN and JBI guidelines for measurement properties systematic reviews and PRISMA 2020 reporting guidelines. Non-experimental and observational empirical studies of patients ≥ 18years of age with CVD undergoing CR and assessed quality of life (QoL) or HRQoL using utility-based PROMs or one accompanied by health state utilities were included. Nine PROMs were identified with evidence on measurement properties for three measures: the German translations of SF-12, EQ-5D-5L, and MacNew heart disease HRQoL questionnaire. There was moderate quality evidence for responsiveness and hypothesis testing of the SF-12 and EQ-5D-5L, and high-quality evidence for responsiveness and hypothesis testing for the MacNew. All items of SF-12 and EQ-5D were linked to ICF categories, but four items of the MacNew were not classified or defined. All the PROM domains were mapped onto similar constructs from the ICHOM global sets. Three utility-based PROMs validated in CR were identified: the German versions of the EQ-5D and SF-12 and the MacNew questionnaire. These PROMs are linked to a breadth of ICF categories and all ICHOM global sets. Additional validation studies of PROMs in CR are required.

O-264 Profiling Tumor-Initiating Cells in Uterine Leiomyoma through Single-Cell Multi-omics

Abstract Study question What are the molecular and cellular features that contribute to the transformation of myometrial stem cells into tumor-initiating cells within uterine leiomyoma? Summary answer Transformative changes in differentiation and genetic processes, in a distinct subset of M/LM cells drives their progression into a tumorigenic state. What is known already Uterine leiomyomas (LM), which are benign smooth muscle-derived tumours of myometrium, impact approximately 75% of women, causing significant physical and psychological challenges and imposing substantial healthcare costs. The widespread consensus postulates a monoclonal origin for LM, implying their derivation from a dysregulated single multipotent stem cell that could give rise to tumor-initiating cells (TICs). While previous studies have shown cellular heterogeneity in both myometrium (M) and LM, the precise identity of the originating cells is unknown. Study design, size, duration Prospective, observational, and biomedical study conducted at Hospital La Fe (Valencia, Spain) for one year. Eight sample pairs of LM and M underwent single-nuclei RNAseq (snRNA-seq; n = 16) and single-cell proteomic (scP; n = 16) analyses, to generate a detailed transcriptomic and proteomic map decoupled from cell type, state, and spatial location. We further employed single-cell RNA velocity inference for differentiation trajectory [BR1] analysis of mesenchymal cells, followed by the identification of potential driver genes in LM tumorigenesis. Participants/materials, setting, methods Upon obtaining informed consent, we procured LM and M samples from eight patients aged 35-50 undergoing hysterectomies. Part of these samples were preserved in paraffin for spatial transcriptomics utilizing VISIUM (10x Genomics). The remaining tissues were dissociated into single-cell suspensions and underwent scRNA-seq and scP using Chromium Controller and Orbitrap Eclipse Tribid mass spectrometry, respectively. The analysis of the collected data was carried out using publicly accessible R/Python tools. Main results and the role of chance Analysis of snRNAseq (∼52,000 cells) revealed similar cellular compositions in M and LM, including endothelial, perivascular, smooth muscle cells (SMC), fibroblasts, and immune cells. Further trajectory analysis unveiled a subset of myometrial cells with potential as TICs, exhibiting reduced expression of hormone receptors like PGR. Analysis of these cells [BR1] suggested differentiation into two distinct cell types -fibroblasts and SMCs- with elevated hormone expression over pseudotime. Differential analysis between M and LM also showed a dysregulated transcriptomic profile in the TICs within the tumor, as evidenced by upregulation of RAD51B and HMGA2 and downregulation PGR among other genes. These genes are indicative markers, underscoring their significant roles in the tumorigenesis of LM by influencing hormone response and disrupting DNA repair mechanisms. Spatial transcriptomic analysis confirmed these findings and suggested that the distribution of TICs could be ubiquitous, since the expression of potential myometrial-stem markers, was markedly increased only on certain spots within the tissue across both LM and M. Lastly, scProt profiling (∼5,000 cells) also allowed the identification of putative TICs, which showed upregulation in LM of specific proteins involved in replication, transcription, and translation. Limitations, reasons for caution Our study sets the basis for TICs isolation in LM, yet functional validation studies need to be performed to address the clinical potential of our findings. Further studies including more patients, and addressing racial disparities will help to generalize these findings to a broader population. Wider implications of the findings Our findings indicate the presence of a particular subset of M/LM cells whose changes in differentiation path and genetic processes seem to drive the transformation of these cells into a tumorigenic state to develop LM. Targeting these markers might show promise for effectively treating these tumors. Trial registration number NCT04214457

Editorial Comment: Enhancing Radiologist Sensitivity for Incidental Pulmonary Embolism Detection With Artificial Intelligence-A Prospective Validation Study.

Editorial Comment: Enhancing Radiologist Sensitivity for Incidental Pulmonary Embolism Detection With Artificial Intelligence-A Prospective Validation Study.

P-102 Incorporation of an automated sperm counting method: a matter of time

Abstract Study question Is a fully-automated system a faster and reliable sperm counting method? Summary answer A fully-automated sperm counting system is a reliable tool that significantly reduces time spent for semen evaluation. What is known already The emergence of automated tools in our everyday life is a reality. Fully-automated systems for the evaluation of seminal samples are available for the andrology laboratories. The expected advantages of such analysers would be a higher reliability and reproducibility of results, with lower inter and intra-individual variability. Although there are few published validation studies, available data have evidenced that results obtained with these methods are, in general, consistent with those obtained with manual/conventional analysis. Moreover, automatic sperm assessment could be useful in reducing the time spent for analysis. However, no data have been published in this regard. Study design, size, duration Observational retrospective study of 220 semen samples analyzed in 2022. Every sample was analyzed using three different methodologies: manual analysis, semi-automated and fully-automated. Manual assessment was performed by senior embryologists undergoing periodical quality control evaluations and included counting with improved Neubauer chamber, motility assessment with slide with phase-contrast optics, and morphology analysis by Diff-Quick stain. The semi-automated analysis was performed by SCATM plus manual morphology assessment. The fully-automated analysis was exclusively performed by SQA-VisionTM. Participants/materials, setting, methods Male patients consulting for infertility and undergoing a spermiogram in a single centre. The sperm parameters evaluated for correlation study among methodologies were: total sperm, motile sperm and progressive sperm concentrations (106 per ml), and morphologically normal forms (%). Duration of analysis (sperm count + motility + morphology) using each method was recorded and compared. Intraclass correlation coefficient (ICC[95%CI]) was used to compare agreement between methodologies and Wilcoxon’s test was used for time (median (p25-p75)). Main results and the role of chance The observed correlation between the three methodologies was moderate (ICC=0.5-0.79) to high (ICC &amp;gt;0.8) for all parameters analysed. Concerning total sperm concentration, both fully and semi-automated systems showed a high correlation with manual assessment (ICC=0.93 (0.90-0.95) fully-automated vs manual; ICC=0.83 (0.73-0.89) semi-automated vs manual, respectively). Concerning motile sperm concentration and progressive motile sperm concentration, both fully and semi-automated systems showed a high or moderate correlation with manual assessment (ICC =0.86 (0.77-0.91) and ICC=0.87 (0.76-0.92) fully-automated vs manual; ICC=0.54 (0.27-0.70) and ICC=0.62 (0.39-0.76) semi-automated vs manual, respectively). In terms of normal forms, fully-automated showed a moderate correlation with manual assessment (ICC=0.69 (0.57-0.78)). Regarding time spent for analysis, both fully and semi-automated analysers showed to be faster than manual method (p &amp;lt; 0.001) (1343 (1199-1472) seconds faster fully-automated vs manual and 608 (429-769) seconds faster semi-automated vs manual). Comparing time spent for analysis between the fully and the semi-automated systems, fully-automated was 707 (610-784) seconds faster (p &amp;lt; 0.001) than the semi-automated. Limitations, reasons for caution Retrospective study. SCATM is a semi-automated operator-dependent system based on image analysis and its accuracy relies on the number of sperm analysed and the operators’ ability in reviewing images. SQA-VisionTM is fully-automated, based on electro-optical signal analysing millions of sperm. Therefore, conclusions may not apply to other software operators. Wider implications of the findings Fully-automated systems for sperm assessment can be reliably introduced in andrology laboratories offering a dramatic reduction in the time spent for analysis. However, such analysers may only be cost-efficient in centres with a very high activity. Trial registration number not applicable

P-335 Integrative analysis of endometriosis and adenomyosis through single-cell transcriptomics

Abstract Study question What are the shared and unique cell type -specific molecular pathways in endometriosis and adenomyosis? Summary answer Our analysis focuses on hormonal pathways and those regulating cell proliferation and apoptosis, which are crucial for the persistence of the lesions. What is known already Estrogen-driven proliferation and progesterone unresponsiveness are key mechanisms in the pathogenesis of endometriosis and adenomyosis. It has been recently observed that core pathways governing proliferation and apoptosis, such as the Wnt/beta-catenin and KRAS pathways, are involved in the etiology. The precise mechanisms of how estrogen and progesterone signaling interact with the Wnt/beta-catenin and KRAS pathways, which contribute to lesion growth maintenance, are not fully understood, but preliminary evidence suggests some level of cross-talk in both conditions. Study design, size, duration Although endometriosis and adenomyosis share similar mechanisms, they have mostly been studied in isolation. We propose a comprehensive study using an integrated approach to gain a deeper understanding of their pathophysiology. We will combine recent single-cell study data from both disorders, and examine the shared and unique cell-type-specific molecular pathways diverging from the eutopic endometrium. Participants/materials, setting, methods We will employ publicly available single-cell transcriptomic data from cases of endometriosis, adenomyosis, and controls with eutopic endometrium. Tissue sections from an extensive collection of patient samples will be examined for validation. Main results and the role of chance We will integrate single-cell transcriptomic data for endometriosis, adenomyosis, and eutopic endometrium controls. For each cell type, we will conduct comprehensive differential expression analysis between lesions and endometrium, study cell-to-cell communication among major cell types, and construct gene regulatory networks that are either shared or specific to endometriosis and adenomyosis. We will also consider GWAS lead genes and investigate their cell type-specific expression, focusing on hormonally regulated genes. Tissue sections of patient samples, apoptosis measurements, and clinical parameters including pain data will be utilized for validation. Limitations, reasons for caution The public single-cell transcriptomic data for endometriosis and adenomyosis have limitations in sample size and menstrual cycle distribution. The utilized single-cell transcriptomics data and the in-house tissue collections for validations studies are not matched. Wider implications of the findings This project aims to identify molecular pathways in endometriosis and adenomyosis, potentially revealing common disease development mechanisms and unique molecular signatures. Both endometriosis and adenomyosis are significant health issues affecting women, and their study contributes to the broader understanding of women’s health. Trial registration number not applicable

9 Early vs Late Definitive Fixation of Pelvic Ring Fractures in Polytraumatized Patients. a Systematic Review and Meta-Analysis

Abstract Aim The aim of this systematic review is to compare the short-term clinical outcomes between early (EDF) and late definitive fixation (LDF) in polytraumatized patients with pelvic ring fractures (PRF). Method The following databases: Embase, Medline and Cochrane Library were searched until June 2022. Studies comparing EDF and LDF for PRF in polytrauma patients defined as ISS &amp;gt;15 were included. The methodological quality of studies was assessed using the Newcastle Ottawa Scale. Results Out of 869 studies screened, 10 were included in the meta-analysis with a total of 2918 patients. The most common time point used to define EDF was within 24 hours of hospital admission and LDF (&amp;gt;24hr). The most common reasons for LDF were surgeon’s choice, availability of pelvic surgeon and transfer from other hospitals. Our meta-analysis revealed that EDF was associated with a reduced length of hospital stay (WMD=-3.52 days; 95% CI: [-5.43 to -1.62], p&amp;lt;0.0003) and lower incidence of ARDS (RR=0.48; 95% CI: [0.20 to 1.18], p=0.04). No significant association was found in mortality, length of ICU stays, multi-organ failure, sepsis and surgical site infection between EDF and LDF. Conclusions These findings suggest that early definitive fixation may be a safe and viable option with no increased risk of complications and mortality. However, the adequacy of resuscitation and the estimate of physiologic reserve should be balanced with the risks of operative fixation in all patients. Further prospective validation studies are warranted to test the predictive ability of the various proposed trauma care models and stratify patients for EDF.

The relationship between the dietary index based Meiji nutritional profiling system for adults and lifestyle-related diseases: a predictive validity study from the National Institute for Longevity Sciences-Longitudinal Study of Aging.

Nutritional profiling system (NPS) holds promise as a public health tool for companies to measure product healthiness and for individuals in making healthier food choices. The Meiji NPS for adults specifically targets lifestyle-related diseases prevalent among Japan's adult population, including overweight/obesity, hypertension, diabetes, and dyslipidemia. This study examined the cross-sectional association between the Meiji NPS for adults Dietary Index (MNfA-DI) and indicators of lifestyle-related diseases in a population. The study comprised 1,272 middle-aged individuals (40-64 years, 50.1% male) who participated in the seventh wave (2010-2012) of the National Institute for Longevity Sciences-Longitudinal Study of Aging project, with no missing data on three-day dietary records. The MNfA-DI was computed at the individual diet level (accounting for the whole diet) using arithmetic energy-weighted means. A higher MNfA-DI indicated a greater nutritional quality of an individual's overall diet. Lifestyle-related disease indicators included body mass index (BMI, kg/m2), body fat (%), systolic and diastolic blood pressure (mmHg), fasting plasma glucose (mg/dL), HbA1c (%), triglyceride levels (mg/dL), LDL, and HDL cholesterol levels (mg/dL). A multiple regression model was used to assess the association between the MNfA-DI and lifestyle-related disease indicators, adjusting for demographics, socioeconomic status, lifestyle factors, disease history, and energy intake as covariates, depending on the outcome. The median (interquartile range) age and MNfA-DI were 53.0 (46.0, 59.0) years and 10.1 (6.0, 14.0) points, respectively. MNfA-DI was negatively associated with body fat [partial regression coefficient (95% confidence interval) -0.04 (-0.07, -0.01)], diastolic blood pressure [-0.08 (-0.17, -0.002)], fasting plasma glucose [-0.18 (-0.33, -0.01)], and triglyceride [-1.36 (-2.16, -0.55)]. Additionally, MNfA-DI was also associated with almost indicators (except for LDL and HDL cholesterol) among participants with a BMI between 18.5 and 24.9 kg/m2. These findings suggest that the Meiji NPS for adults could be associated with a lower risk of lifestyle-related diseases. In addition, from a public health nutrition perspective, the Meiji NPS for adults may be useful to assess the food healthiness of the adult population.

Menstrual poverty scale: reliability and validity study

ABSTRACT The tendency toward poverty in the globalizing world significantly affects women. Unlike men, women have mandatory expenses every month. Especially poor women have difficulty in accessing to the hygienic products they need during the menstrual period. That is why, this study aims to develop a measurement tool that can effectively and widely assess women’s menstrual poverty. This study is a methodological study that evaluates the psychometric properties of the scale. The study included 420 women living in a middle-income province in the north of Türkiye between April – July, 2023. The data were collected using the Menstrual Poverty Scale, and the items on the scale were developed based on a review of existing literature and expert opinions (CVI = 0.85–0.95). The sample was divided into two parts. It was made exploratory factor analysis and confirmatory factor analysis. Before conducting the study, an ethics committee decision and informed consent of the women were obtained. The collected data were analyzed using the SPSS 23 and AMOS 23 programs. The EFA revealed a structure consisting of 13 items and four factors. The four factors considered were as follows; access to hygiene products, quality of life, embarrassment, and receiving information, and education about menstruation. The item factor loadings varied from 0.46 to 0.91. The Cronbach’s alpha coefficient was determined to be 0.69. The corrected item-total correlations for the scale items ranged from 0.62 to 0.84. According to the confirmatory factor analysis, the structural equation modeling results of the Menstrual Poverty Scale were found to be meaningful (p = .000; RMSEA 0.64; CMIN/Df 1.70). It is suggested to conduct validity and reliability studies in different cultures by applying the scale to women from different cultural backgrounds.

Artificial Intelligence-based Segmentation of Residual Pancreatic Cancer in Resection Specimens Following Neoadjuvant Treatment (ISGPP-2): International Improvement and Validation Study.

Neoadjuvant therapy (NAT) has become routine in patients with borderline resectable pancreatic cancer. Pathologists examine pancreatic cancer resection specimens to evaluate the effect of NAT. However, an automated scoring system to objectively quantify residual pancreatic cancer (RPC) is currently lacking. Herein, we developed and validated the first automated segmentation model using artificial intelligence techniques to objectively quantify RPC. Digitized histopathological tissue slides were included from resected pancreatic cancer specimens from 14 centers in 7 countries in Europe, North America, Australia, and Asia. Four different scanner types were used: Philips (56%), Hamamatsu (27%), 3DHistech (10%), and Leica (7%). Regions of interest were annotated and classified as cancer, non-neoplastic pancreatic ducts, and others. A U-Net model was trained to detect RPC. Validation consisted of by-scanner internal-external cross-validation. Overall, 528 unique hematoxylin and eosin (H & E) slides from 528 patients were included. In the individual Philips, Hamamatsu, 3DHistech, and Leica scanner cross-validations, mean F1 scores of 0.81 (95% CI, 0.77-0.84), 0.80 (0.78-0.83), 0.76 (0.65-0.78), and 0.71 (0.65-0.78) were achieved, respectively. In the meta-analysis of the cross-validations, the mean F1 score was 0.78 (0.71-0.84). A final model was trained on the entire data set. This ISGPP model is the first segmentation model using artificial intelligence techniques to objectively quantify RPC following NAT. The internally-externally cross-validated model in this study demonstrated robust performance in detecting RPC in specimens. The ISGPP model, now made publically available, enables automated RPC segmentation and forms the basis for objective NAT response evaluation in pancreatic cancer.

Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less.

A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm. Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018. According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements. Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.

The Social Exclusion Scale for Children (SESC): A Validity and Reliability Study in Turkish

Social exclusion is a multidimensional concept defined as being away from social resources and opportunities, being unable to participate in society, and being socially disadvantaged in society. In Türkiye, problems, such as economic disadvantages, inequalities in access to public services, migration and displacement, and lack of infrastructure make social exclusion an important risk factor for children. Therefore, adapting the Social Exclusion Scale for Children to Turkish culture and language can help identify children exposed to social exclusion, better understand the problem, develop effective interventions, and build a more inclusive society. The aim of this study was to adapt the Social Exclusion Scale for Children (SESC) to Turkish society. The data of this methodological study were collected from 380 children aged 12–17. The content validity, construct validity, and internal consistency of SESC were analyzed. The results of this study showed the validity and reliability of SESC as a measurement instrument to assess social exclusion in Turkish children aged 12–17 in the school environment. The Turkish version of SESC was found brief, practical, age-appropriate, self-reported, easily applicable, valid, and reliable measurement instrument.

Prostate cancer risk assessment and avoidance of prostate biopsies using fully automatic deep learning in prostate MRI: comparison to PI-RADS and integration with clinical data in nomograms.

Risk calculators (RCs) improve patient selection for prostate biopsy with clinical/demographic information, recently with prostate MRI using the prostate imaging reporting and data system (PI-RADS). Fully-automated deep learning (DL) analyzes MRI data independently, and has been shown to be on par with clinical radiologists, but has yet to be incorporated into RCs. The goal of this study is to re-assess the diagnostic quality of RCs, the impact of replacing PI-RADS with DL predictions, and potential performance gains by adding DL besides PI-RADS. One thousand six hundred twenty-seven consecutive examinations from 2014 to 2021 were included in this retrospective single-center study, including 517 exams withheld for RC testing. Board-certified radiologists assessed PI-RADS during clinical routine, then systematic and MRI/Ultrasound-fusion biopsies provided histopathological ground truth for significant prostate cancer (sPC). nnUNet-based DL ensembles were trained on biparametric MRI predicting the presence of sPC lesions (UNet-probability) and a PI-RADS-analogous five-point scale (UNet-Likert). Previously published RCs were validated as is; with PI-RADS substituted by UNet-Likert (UNet-Likert-substituted RC); and with both UNet-probability and PI-RADS (UNet-probability-extended RC). Together with a newly fitted RC using clinical data, PI-RADS and UNet-probability, existing RCs were compared by receiver-operating characteristics, calibration, and decision-curve analysis. Diagnostic performance remained stable for UNet-Likert-substituted RCs. DL contained complementary diagnostic information to PI-RADS. The newly-fitted RC spared 49% [252/517] of biopsies while maintaining the negative predictive value (94%), compared to PI-RADS ≥ 4 cut-off which spared 37% [190/517] (p < 0.001). Incorporating DL as an independent diagnostic marker for RCs can improve patient stratification before biopsy, as there is complementary information in DL features and clinical PI-RADS assessment. For patients with positive prostate screening results, a comprehensive diagnostic workup, including prostate MRI, DL analysis, and individual classification using nomograms can identify patients with minimal prostate cancer risk, as they benefit less from the more invasive biopsy procedure. The current MRI-based nomograms result in many negative prostate biopsies. The addition of DL to nomograms with clinical data and PI-RADS improves patient stratification before biopsy. Fully automatic DL can be substituted for PI-RADS without sacrificing the quality of nomogram predictions. Prostate nomograms show cancer detection ability comparable to previous validation studies while being suitable for the addition of DL analysis.

ASO Author Reflections: Development and Validation Study of the Prognostic Impact of Deep Learning-Determined Myxoid Stroma After Neoadjuvant Chemotherapy in Patients with Esophageal Squamous Cell Carcinoma.

ASO Author Reflections: Development and Validation Study of the Prognostic Impact of Deep Learning-Determined Myxoid Stroma After Neoadjuvant Chemotherapy in Patients with Esophageal Squamous Cell Carcinoma.