Validation Study Research Articles

P064 SYSTEMATIC REVIEW OF PROPORTION OF FEMALES AND MALES RECRUITED IN BLOOD PRESSURE DEVICE VALIDATION STUDIES AND RELATIONSHIP WITH MEASUREMENT ACCURACY

Background and Objective: New to market automatic blood pressure (BP) devices should undergo clinical validation according to a scientifically recognised protocol to ensure accurate measurements. Some recent research suggests a reduced accuracy of automated cuff BP in females compared to males. Females have been underrepresented in many areas of clinical research, but it is unknown whether this is common among BP device validation studies and if it is a contributory factor to reduced accuracy in females. The aim of this study was to determine the proportion of females compared to males recruited to validation studies and whether there is any relationship with the accuracy of automated BP measurement. Methods: A systematic review of BP device validation studies published between 1987 and 2023 was conducted. Studies that tested automated, upper-arm devices compared to auscultatory BP in a general population, including children, were included. Descriptive statistics were used to determine the proportion of females and males recruited and weighted meta-regression analyses were used to assess the relationship between sex and measurement accuracy. Results: Out of 322 eligible validation studies, the proportion of females and males recruited was reported in 287 (89.1%) studies. Only six (2.1%) studies included <30% females or males, which is the current minimum requirement of international standards. An average of 50.8% females were recruited to validation studies, and this was consistent across different validation protocols and year of study publication. There was no relationship between sex and measurement accuracy (p>0.05), except for a negligible tendency of automated devices to overestimate manual measurements of diastolic BP among studies with a greater proportion of females (R2=0.017, p=0.027). Conclusion: Females are not underrepresented in BP device validation studies. There was no meaningful relationship between the proportion of females recruited and measurement accuracy. These findings indicate current protocols are adequate to ensure representation of females and males in validation studies.

O32 AVAILABILITY OF PROPERLY VALIDATED BLOOD PRESSURE MEASURING DEVICES FOR PREGNANT WOMEN: STRIDE BP SYSTEMATIC REVIEW

Background and Objective: Validated automated upper-arm cuff blood pressure (BP) measuring devices are currently recommended for BP measurement. However, a validated BP device in the general population may be inaccurate in pregnant women. Thus, separate validation studies are required in pregnant women with normal BP, hypertension, and preeclampsia. This study assessed the published evidence on BP devices in pregnancy. Methods: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed searches to identify validation studies of automated cuff BP monitors. Validation studies in pregnancy conducted using an established protocol, including the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), ANSI/AAMI/ISO 2013/2009, ESH-IP 2010/2002, AAMI 2002/1992/1987, and BHS 1993/1990, were identified. Results: Of 569 validation studies included in the STRIDE BP database, 63 (35 devices) were identified including pregnant women. Among them, STRIDE BP rejected 45 studies, of which 25 were reported as “device pass” in the published validation paper. Among the studies rejected by STRIDE BP but published as “pass”, the main reasons for rejection were violations in the BP measurement protocol (44%), inadequate reference device or cuffs for reference and test device (36%), no data in women with hypertension and/or preeclampsia (36%), single observer for reference BP measurement (28%), and inappropriate data analysis (20%). Eventually 18 studies in pregnant women (28.6%) fulfilled the protocol requirements, and 16 devices (8 of them available on the market) can be recommended for clinical use in pregnancy. When additional ‘equivalent’ devices were considered (devices lacking validation studies but with differences from validated devices not affecting the BP measurement accuracy), 37 devices were found to be accurate in pregnancy, with 27 of them available on the market (Table). Conclusions: This analysis showed a shortage of properly validated BP devices for pregnant women available in the market, with published validation often having major methodological issues. There is an urgent need to develop and properly validate more BP devices in pregnancy. TABLE. Validated devices for office, home, and ambulatory BP measurement in pregnant women.

P077 IS THERE A DIFFERENCE IN THE ACCURACY OF AUTOMATED BLOOD PRESSURE DEVICES DESIGNED FOR HOME OR IN-CLINIC USE? A SYSTEMATIC REVIEW AND META-ANALYSIS OF VALIDATION STUDIES

Background and Objective: Advances in technology mean that accurate BP measurements can be automatically performed, allowing widescale use of BP measurement at home. Despite these advances, some health professionals and patients question the accuracy of devices that are designated for use at home compared to in-clinic BP devices. This study sought to determine if there were differences in the accuracy of home BP devices compared with in-clinic BP devices. Methods: A systematic review of BP measurement validation studies of automated, upper-arm devices in adults published between 1987-2023. Intended primary use of each device was extracted from the published validation study. A random effects meta-analysis was performed to estimate pooled mean BP differences across validation studies for home BP and in-clinic BP devices, compared to manual BP. Results: There were 210 home device, and 77 in-clinic device validation studies that met inclusion criteria. In comparison to manual systolic BP, the mean difference for home device systolic BP was 0.11 mmHg (95% CI: 0.09, 0.13), and the mean difference for in-clinic device systolic BP was 0.18 mmHg (95% CI: 0.16, 0.21). There was no significant difference in the accuracy of home vs. in-clinic systolic BP (p=0.88). In comparison to manual diastolic BP, the mean difference for home device diastolic BP was 0.15 mmHg (95% CI: 0.13, 0.17), and the mean difference for in-clinic device diastolic BP was -0.93 mmHg (95% CI: -0.96, -0.90). There was a small difference in the accuracy of home vs. in-clinic device diastolic BP (1.08 mmHg, 95%CI: 0.44, 1.72; p<0.01). Conclusion: There were no meaningful differences in accuracy between home BP devices and in-clinic BP devices, showing that any validated device will yield accurate BP results if used according to standardized measurement principles.

O30 AVAILABILITY OF PROPERLY VALIDATED AUTOMATED BLOOD PRESSURE MEASURING DEVICES FOR CHILDREN: STRIDE BP SYSTEMATIC REVIEW

Background and Objective: Properly validated automated upper-arm cuff blood pressure (BP) measuring devices are currently recommended for office, home, and ambulatory BP measurement. However, the validation of BP devices in children presents additional challenges, necessitating separate studies. This study assessed the evidence on accurate automated BP devices in children. Methods: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed searches to identify validation studies of automated cuff BP monitors. Validation studies including children (3-12 years) conducted using an established protocol, including the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), ANSI/AAMI/ISO 2013/2009, ESH-IP 2010/2002, AAMI 2002/1992/1987, and BHS 1993/1990, were identified from the STRIDE BP database. Results: Of 569 validation studies included in the STRIDE BP database, 47 (33 devices) were identified including children. Among them, STRIDE BP rejected 29 studies of which 18 were reported as “device pass” in the published paper. Among studies rejected by STRIDE BP but published as “pass”, main reasons for rejection were violations in the BP measurement procedure (sequence, number, repeats) (50%), inadequate reference device or cuffs for reference and test device (16.6%), inadequate sample size (22.2%), and single observer for reference BP (22.2%). Eventually 18 studies in children (38.3%) fulfilled all the validation protocol requirements, and 16 devices (10 available on the market) met the validation requirements and can be recommended for use in children. When additional ‘equivalent’ devices were considered (devices lacking validation studies but with differences from validated devices not affecting the measurement accuracy), 21 devices were found to be accurate, with 13 of them available on the market (Table). Conclusions: This analysis highlight a serious shortage of properly validated BP devices for children available in the market, with published validation studies often having major methodological issues. There is an urgent call to manufacturers and investigators to develop and properly validate more BP devices for children. TABLE. Validated devices for office, home, and ambulatory BP measurement in children.

Validation studies and multi-omics analysis of Zhx2 as a candidate quantitative trait gene underlying brain oxycodone metabolite (oxymorphone) levels and behavior.

Sensitivity to the subjective reinforcing properties of opioids has a genetic component and can predict addiction liability of opioid compounds. We previously identified Zhx2 as a candidate gene underlying increased brain concentration of the oxycodone ( OXY ) metabolite oxymorphone ( OMOR ) in BALB/cJ ( J ) versus BALB/cByJ ( By ) females that could increase OXY state-dependent reward. A large structural intronic variant is associated with a robust reduction of Zhx2 expression in J mice, which we hypothesized enhances OMOR levels and OXY addiction-like behaviors. We tested this hypothesis by restoring the Zhx2 loss-of-function in Js ( MVKO ) and modeling the loss-of-function variant through knocking out the Zhx2 coding exon ( E3KO ) in Bys and assessing brain OXY metabolite levels and behavior. Consistent with our hypothesis, Zhx2 E3KO females showed an increase in brain OMOR levels and OXY-induced locomotor activity. However, contrary to our hypothesis, state-dependent expression of OXY-CPP was decreased in E3KO females and increased in E3KO males. We also overexpressed Zhx2 in the livers and brains of Js and observed Zhx2 overexpression in select brain regions that was associated with reduced OXY state-dependent learning. Integrative transcriptomic and proteomic analysis of E3KO mice identified astrocyte function, cell adhesion, extracellular matrix properties, and endothelial cell functions as pathways influencing brain OXY metabolite concentration and behavior. These results support Zhx2 as a quantitative trait gene underlying brain OMOR concentration that is associated with changes in OXY behavior and implicate potential quantitative trait mechanisms that together inform our overall understanding of Zhx2 in brain function.

Analytical Validation of an Early Detection Pancreatic Cancer Test Using 5-Hydroxymethylation Signatures

Early detection of pancreatic cancer has been shown to improve patient survival rates. However, effective early detection tools to detect pancreatic cancer do not currently exist. The Avantect Pancreatic Cancer Test, leveraging the 5-hydroxymethylation [5-hydroxymethylcytosine (5hmC)] signatures in cell-free DNA, was developed and analytically validated to address this unmet need. We report a comprehensive analytical validation study encompassing precision, sample stability, limit of detection, interfering substance studies, and a comparison with an alternative method. The assay performance on an independent case-control patient cohort was previously reported with a sensitivity for early-stage (stage I/II) pancreatic cancer of 68.3% (95% CI, 51.9%-81.9%) and an overall specificity of 96.9% (95% CI, 96.1%-97.7%). Precision studies showed a cancer classification of 100% concordance in biological replicates. The sample stability studies revealed stable assay performance for up to 7 days after blood collection. The limit of detection studies revealed equal results between early- and late-stage cancer samples, emphasizing strong early-stage performance characteristics. Comparisons of concordance of the Avantect assay with the enzymatic methyl sequencing (EM-Seq) method, which measures both methylation (5-methylcytosine) and 5hmC, were >95% for all samples tested. The Avantect Pancreatic Cancer Test showed strong analytical validation in multiple validation studies required for laboratory-developed test accreditation. The comparison of 5hmC versus EM-Seq further validated the 5hmC approach as a robust and reproducible assay.

Conditional generative adversarial network-assisted system for radiation-free evaluation of scoliosis using a single smartphone photograph: a model development and validation study

Adolescent idiopathic scoliosis (AIS) is the most common spinal disorder in children, characterized by insidious onset and rapid progression, which can lead to severe consequences if not detected in a timely manner. Currently, the diagnosis of AIS primarily relies on X-ray imaging. However, due to limitations in healthcare access and concerns over radiation exposure, this diagnostic method cannot be widely adopted. Therefore, we have developed and validated a screening system using deep learning technology, capable of generating virtual X-ray images (VXI) from two-dimensional Red Green Blue (2D-RGB) images captured by a smartphone or camera to assist spine surgeons in the rapid, accurate, and non-invasive assessment of AIS. We included 2397 patients with AIS and 48 potential patients with AIS who visited four medical institutions in mainland China from June 11th 2014 to November 28th 2023. Participants data included standing full-spine X-ray images captured by radiology technicians and 2D-RGB images taken by spine surgeons using a camera. We developed a deep learning model based on conditional generative adversarial networks (cGAN) called Swin-pix2pix to generate VXI on retrospective training (n=1842) and validation (n=100) dataset, then validated the performance of VXI in quantifying the curve type and severity of AIS on retrospective internal (n=100), external (n=135), and prospective test datasets (n=268). The prospective test dataset included 268 participants treated in Nanjing, China, from April 19th, 2023, to November 28th, 2023, comprising 220 patients with AIS and 48 potential patients with AIS. Their data underwent strict quality control to ensure optimal data quality and consistency. Our Swin-pix2pix model generated realistic VXI, with the mean absolute error (MAE) for predicting the main and secondary Cobb angles of AIS significantly lower than other baseline cGAN models, at 3.2° and 3.1° on prospective test dataset. The diagnostic accuracy for scoliosis severity grading exceeded that of two spine surgery experts, with accuracy of 0.93 (95% CI [0.91, 0.95]) in main curve and 0.89 (95% CI [0.87, 0.91]) in secondary curve. For main curve position and curve classification, the predictive accuracy of the Swin-pix2pix model also surpassed that of the baseline cGAN models, with accuracy of 0.93 (95% CI [0.90, 0.95]) for thoracic curve and 0.97 (95% CI [0.96, 0.98]), achieving satisfactory results on three external datasets as well. Our developed Swin-pix2pix model holds promise for using a single photo taken with a smartphone or camera to rapidly assess AIS curve type and severity without radiation, enabling large-scale screening. However, limited data quality and quantity, a homogeneous participant population, and rotational errors during imaging may affect the applicability and accuracy of the system, requiring further improvement in the future. National Key R&D Program of China, Natural Science Foundation of Jiangsu Province, China Postdoctoral Science Foundation, Nanjing Medical Science and Technology Development Foundation, Jiangsu Provincial Key Research and Development Program, and Jiangsu Provincial Medical Innovation Centre of Orthopedic Surgery.

Validation of Novel Risk Prediction Models in Patients with Brugada Syndrome: A Multicenter Study in Japan

Risk stratification in patients with Brugada syndrome (BrS) is challenging, especially in those at intermediate risk. The Predicting Arrhythmic evenT (PAT) score has recently been demonstrated to be excellent for predicting future arrhythmic events in patients without prior ventricular fibrillation (VF). However, validation studies are lacking. This study aimed to assess the performance of a novel risk stratification model in predicting future VF events in patients with BrS in a Japanese multicenter cohort. The PAT score was calculated for 413 patients with BrS (mean age, 50.9±13.6 years; 395 men) from 59 hospitals in Japan, including 314 patients without prior VF. The incidence of developing VF during the follow-up period was investigated. During the 106.8-month follow-up period, 54 patients (13.1%) experienced VF events. Of the 314 patients without prior VF at enrollment, 14 (4.5%) experienced VF events. The incidence of VF events during the follow-up period was significantly higher in patients with PAT scores ≥10 than in those with scores <10 (41/173 [23.7%] vs. 13/240 [5.4%], p<0.0001) in the total cohort. No difference was observed in the incidence of VF events between patients with PAT scores ≥10 and <10 among the 314 patients without prior VF (6/86 [7.0%] vs. 8/228 [3.5%], p=0.22). PAT scores ≥10 predicted future VF events with a sensitivity and specificity of 42.9% and 73.3%, respectively. This Japanese multicenter registry demonstrated that the novel risk stratification model could not accurately predict future VF events in patients with BrS, but without prior VF.

Accelerating Transient Aerothermal Simulations of the BOLT II Flight Experiment

Aircraft with short flight durations may not reach thermal steady state due to limited time for aeroheating to conduct throughout their internal structure. Consequently, predictions of the solid temperature field require time-accurate simulation of the transient heat conduction. In this work, the use of an explicit super-time-stepping scheme to accelerate the time-accurate solution of the heat equation has been explored. The experience with this technique is documented here because, to the authors’ knowledge, it is not widely used in the hypersonics simulation community. The performance of the super-time-stepping scheme was investigated by comparison to a standard explicit scheme and an implicit time-differencing scheme. Both the super-time-stepping scheme and the implicit time-differencing scheme demonstrate significant speedup over the standard explicit scheme, with comparable wall-clock performance. The solid solver has been coupled with an existing open-source fluid solver to perform conjugate heat transfer simulations. The efficacy of the developed solver in simulating hypersonic aerothermal problems is demonstrated through verification and validation studies. By applying the coupled solver to the aerothermal analysis of the BOLT II flight experiment, the effectiveness of the super-time-stepping scheme in mitigating the computational expense associated with transient conjugate heat transfer simulations is demonstrated.

Derivation of a clinical decision rule for termination of resuscitation in non-traumatic pediatric out-of-hospital cardiac arrest

AimPrehospital termination of resuscitation (ToR) rules are used to predict medical futility in adult out-of-hospital cardiac arrest (OHCA), however, the available evidence for pediatric patients is limited. The primary aim of this study is to derive a Pediatric Termination of Resuscitation (PToR) prediction rule for use in pediatric non-traumatic OHCA patients. MethodsWe analyzed a retrospective cohort of pediatric OHCA patients within the CARES database over a 10-year period (2013 – 2022). We split the dataset into training and test datasets and fit logistic regressions with Least Absolute Shrinkage and Selection Operator (LASSO) to select predictor variables and estimate predictive test characteristics for the primary outcome of death and a secondary composite outcome of death or survival to hospital discharge with unfavorable neurologic outcome. ResultsWe analyzed a sample of 21,240 children where 2,326 (11.0%) survived to hospital discharge, and 1,894 (8.9%) survived to hospital discharge with favorable neurologic outcome. We derived a PToR rule for death demonstrating a specificity of 99.1% and a positive predictive value (PPV) of 99.8% and a PToR rule for death or survival with poor neurologic outcome with a specificity of 99.7% and PPV of 99.9% within the test dataset. ConclusionWe derived a clinical prediction rule with high specificity and positive predictive value in prehospital settings utilizing Advanced Life Support (ALS) providers which may inform termination of resuscitation considerations in pediatric patients. Further prospective and validation studies will be necessary to define the appropriateness and applicability of these PToR criteria for routine use.

Validation of Serbian version of the LittlEARS® Early Speech Production Questionnaire for the assessment of early language development in typically developing children.

The LittlEARS® Early Speech Production Questionnaire (LEESPQ) was developed to provide professionals with valuable information about children's earliest language development and has been successfully validated in several languages. This study aimed to validate the Serbian version of the LEESPQ in typically developing children and compare the results with validation studies in other languages. The English version of the LEESPQ was back-translated into Serbian. Parents completed the questionnaire in paper or electronic form either during the visit to the paediatric clinic or through personal contact. A total of 206 completed questionnaires were collected. Standardized expected values were calculated using a second-order polynomial model for children up to 18 months of age to create a norm curve for the Serbian language. The results were then used to determine confidence intervals, with the lower limit being the critical limit for typical speech-language development. Finally, the results were compared with German and Canadian English developmental norms. The Serbian LEESPQ version showed high homogeneity (r = .622) and internal consistency (α = .882), indicating that it almost exclusively measures speech production ability. No significant difference in total score was found between male and female infants (U = 4429.500, p = .090), so it can be considered a gender-independent questionnaire. The results of the comparison between Serbian and German (U = 645.500, p = .673) and Serbian and English norm curves (U = 652.000, p = .725) show that the LEESPQ can be applied to different population groups, regardless of linguistic, cultural or sociological differences. The LEESPQ is a valid, age-dependent and gender-independent questionnaire suitable for assessing early speech development in children aged from birth to 18 months.

Dense SNP-based analyses complement forensic anthropology biogeographical ancestry assessments

Identification of unidentified human remains (UHRs) is crucial yet challenging, especially with traditional forensic techniques. Forensic anthropological examinations can yield ancestry estimations; however, the utility of these estimates is limited by the data points that can be collected from partial remains, complexities of admixture, and variation of phenotypic expression due to environmental effects. While it is generally known that anthropological estimates can be imprecise, the performance of these methods has not been studied at scale. Genome-wide SNP testing is an orthogonal approach for estimating ancestry and offers a unique opportunity to measure the magnitude of anthropological ancestry misattribution. Genomic ancestry inference leverages principal component analysis (PCA) and model-based clustering approaches. This study compares anthropologically determined ancestry with those estimated using genome-wide SNP markers. A dataset of 611 UHR samples with publicly available ancestry assessments from National Missing and Unidentified Persons System (NamUs) was analyzed. The genetic ancestry approach, validated against reference population samples, offers robust ancestry calculations for major population groups. Inconsistency between anthropological and genomic ancestry assignments were observed, particularly for admixed populations. Although forensic anthropological examinations remain valuable, their limitations emphasize the need for refinement and enhancement through the augmentation of SNP-based analyses. Further validation studies are crucial to define the uncertainty associated with both anthropological and genome-based ancestry estimates to resolve cases and aid law enforcement investigations. Additionally, current policy and practices for reporting ancestry for UHRs should be revisited to reduce potential misinformation.

Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening.

While HC2 and GP5+/6+ PCR-EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second-generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second-generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC-group I), and show consistent non-inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first-generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta-analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately.

An intermittent recovery test for soccer players: a validation study.

Soccer is an intermittent team sport that demands high aerobic capacity. On field, soccer players' aerobic capacity, assessed through the maximal oxygen uptake (VO<inf>2</inf>max), is usually determined by an intermittent recovery test. The aim of this study was to obtain a construct validity of a new intermittent recovery test (IRT) with a fixed speed and a progressive decrement of rest period. Twenty-five male soccer players were recruited to perform an incremental continuous test (ICT) and the new IRT, to compare their physiological data. Fifteen male soccer players were involved to perform a test-retest of IRT to assess its reliability. VE<inf>peak</inf>, absolute VO<inf>2</inf>max, relative VO<inf>2</inf>max and VCO<inf>2</inf>peak registered during ICT and IRT correlated strongly (Pearson's correlation coefficient ranges from 0.75 to 0.80, with very large as magnitude of effects and with P<0.001). IRT showed reliability from good to excellent regarding VE<inf>peak</inf>, absolute VO<inf>2</inf>max, relative VO<inf>2</inf>max, VCO<inf>2</inf>peak and covered distance (ICC values ranged from 0.82 to 0.95). These findings and its underlying physiological and muscular demands, suggest that IRT can be considered as a valid and reliable test to assess aerobic capacity in soccer players during the competitive period.

Artificial intelligence for predicting response to neoadjuvant chemotherapy for bladder cancer A comprehensive systematic review and meta-analysis.

Neoadjuvant cisplatin-based combination chemotherapy (NAC) followed by radical cystectomy is the standard of care for cisplatin-fit patients harboring muscle-invasive bladder cancer (MIBC). Prediction of response to NAC is essential for clinical decision-making regarding alternatives in case of non-response, and bladder-sparing in case of complete response. This research aimed to assess the performance of machine learning in predicting therapeutic response following NAC treatment in patients with MIBC. A systematic review adhering to the PRISMA guidelines was conducted until July 2023. The study integrated articles relating to artificial intelligence and NAC response in MIBC from various databases. The quality of articles was evaluated using the Quality Assessment Tool for Diagnostic Accuracy Studies 2 (QUADAS-2). A meta-analysis was subsequently performed on selected studies to determine the sensitivity and specificity of machine learning algorithms in predicting NAC response. Of 655 articles identified, 12 studies comprising 1523 patients were included, and four studies were eligible for meta-analysis. The sensitivity and specificity of the studies were 0.62 (95% confidence interval [CI] 0.50-0.72) and 0.82 (95% CI 0.72-0.89), respectively, with a heterogeneity score (I2) of 38.5%. The machine learning algorithms used computed tomography, genetic, and anatomopathologic data as input and exhibited promising potential for predicting NAC response. Machine-learning algorithms, especially those using computed tomography, genetic, and pathologic data, demonstrate significant potential for predicting NAC response in MIBC. Standardization of methodologic data analysis and response criteria are needed as validation studies.

CN103 Is my patient constipated? How do I assess? Validity and reliability study of the constipation assessment scale in cancer patients: The case of Türkiye

CN103 Is my patient constipated? How do I assess? Validity and reliability study of the constipation assessment scale in cancer patients: The case of Türkiye

Proposing novel body-centered cubic lattice core sandwich panels as satellite structure

In the present paper, a comparative study on the load-bearing as well as shielding performance against hypervelocity impact of space debris of sandwich panels with body-centered cubic lattice core is performed numerically in order to evaluate their eligibility to be utilized as the satellite structure. To this end, four types of body-centered cubic lattice structures, with similar areal densities which are assumed to be made of 5A06 aluminum alloy, including BCC, BCCz (BCC reinforced in Z direction), and also BCCz-I and BCCz-II were considered. Whipple shield structure of same material and areal density was also investigated in order to justify the necessity of lattice structures application, especially in protection field. The present study simulates hypervelocity impact of a spherical projectile with 2 mm diameter, represented the space debris, collides with the structures at the velocity range of 2-6 km/s. Current numerical simulation process accuracy and efficiency were verified through comparing its obtained data based on simulating a problem had been investigated at a valid experimental study to the data proposed by the mentioned research. BCCz-II structure which is newly proposed at this study provided outstanding shielding and load-bearing capabilities in comparison to other structures. Furthermore, the detailed effects of projectile impact location and a middle structure placed plate on the protection performance were investigated and the mentioned items were found to have crucial impact on the structure shielding performance.

A Dose-Finding, Biomarker Validation, and Effectiveness Study of Transcranial Magnetic Stimulation for Adolescents With Depression

Research and clinical application of transcranial magnetic stimulation (TMS) for adolescents with major depressive disorder (MDD) has advanced slowly. Significant gaps persist in our understanding of optimized, age-specific protocols and dosing strategies. This study aimed to compare the clinical effects of 1 Hz versus 10 Hz TMS regimens and examine a biomarker-informed treatment approach with glutamatergic intracortical facilitation (ICF). Participants with moderate-to-severe symptoms of MDD were randomized to 30 sessions of left prefrontal 1 Hz or 10 Hz TMS, stratified by baseline ICF measures. The primary clinical outcome measure was the Children's Depression Rating Scale, Revised (CDRS-R). The CDRS-R and ICF biomarker were collected weekly. Forty-one participants received either 1 Hz (n = 22) or 10 Hz (n = 19) TMS treatments. CDRS-R scores improved compared to baseline in both 1 Hz and 10 Hz groups. For participants with low ICF at baseline, the overall least squares means of CDRS-R scores over the 6-week trial showed that depressive symptom severity was lower for the group treated with 1 Hz TMS than for those who received 10 Hz TMS. There were no significant changes in weekly ICF measurements across the 6 weeks of TMS treatment. Low ICF may reflect optimal glutamatergic N-methyl-d-aspartate (NMDA) receptor activity that facilitates the therapeutic effect of 1 Hz TMS through long-term depression-like mechanisms on synaptic plasticity. The stability of ICF suggests that it is a tonic, trait-like measure of NMDA receptor-mediated neurotransmission, with potential utility to inform parameter selection for therapeutic TMS in adolescents with MDD.

OS03-06 Aggregated exposure to perfluorooctane sulfonic acid coupled with PBPK model and parameter optimization using a human study for validation

OS03-06 Aggregated exposure to perfluorooctane sulfonic acid coupled with PBPK model and parameter optimization using a human study for validation

Potential of salivary biomarkers for diagnosing and prognosing rheumatoid arthritis: A systematic review and meta-analysis: Salivary biomarkers in Rheumatoid Arthritis patients – A systematic review with Meta-analysis

BackgroundRheumatoid arthritis (RA) is a chronic debilitating autoimmune disorder. Blood biomarkers, like rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPAs), lack the sensitivity and specificity for early diagnosis, delaying treatment. This review while highlighting the need for new diagnostic tools, emphasizes the promising avenue of saliva for developing RA biomarkers. ObjectiveThis systematic review and meta-analysis assess the effectiveness of salivary biomarkers in the diagnosis and prognosis of RA, examining current evidence and proposing avenues for future research. MethodologyA literature review following PRISMA 2021 guidelines was conducted using PubMed, Scopus, Web of Science, and Google Scholar to identify studies from the past five years on salivary biomarkers in RA patients compared to healthy controls. ResultThe review focused on original research articles, and meta-analysis was performed on studies reporting standard deviation values for inflammatory markers such as IL-6, IL-8, MMP-8, and TNF-alpha. The meta-analysis included eleven studies with 394 RA patients and 255 healthy controls, evaluating IL-8, IL-6, MMP-8, and TNF-α as RA biomarkers. IL-8 showed a mean difference of 7.32 (CI: -5.48 to 20.13), not statistically significant, favouring controls. IL-6 had a CI of -0.09 (CI: -2.20 to 2.02) with high heterogeneity (I² = 98%), suggesting its potential as a diagnostic and prognostic biomarker. TNF-α and MMP-8 showed no significant differences (CIs: 4.54 and 2.71, respectively). ConclusionThis systematic review and meta-analysis emphasize saliva's potential in identifying RA biomarkers, especially IL-6, which is associated with the disease's pathogenesis. However, significant evidence heterogeneity necessitates larger, multicentric studies for validation.