Validation Study Research Articles

Artificial intelligence-enabled electrocardiogram for mortality and cardiovascular risk estimation: a model development and validation study

Artificial intelligence (AI)-enabled electrocardiography (ECG) can be used to predict risk of future disease and mortality but has not yet been adopted into clinical practice. Existing model predictions do not have actionability at an individual patient level, explainability, or biological plausibi. We sought to address these limitations of previous AI-ECG approaches by developing the AI-ECG risk estimator (AIRE) platform. The AIRE platform was developed in a secondary care dataset (Beth Israel Deaconess Medical Center [BIDMC]) of 1 163 401 ECGs from 189 539 patients with deep learning and a discrete-time survival model to create a patient-specific survival curve with a single ECG. Therefore, AIRE predicts not only risk of mortality, but also time-to-mortality. AIRE was validated in five diverse, transnational cohorts from the USA, Brazil, and the UK (UK Biobank [UKB]), including volunteers, primary care patients, and secondary care patients. AIRE accurately predicts risk of all-cause mortality (BIDMC C-index 0·775, 95% CI 0·773-0·776; C-indices on external validation datasets 0·638-0·773), future ventricular arrhythmia (BIDMC C-index 0·760, 95% CI 0·756-0·763; UKB C-index 0·719, 95% CI 0·635-0·803), future atherosclerotic cardiovascular disease (0·696, 0·694-0·698; 0·643, 0·624-0·662), and future heart failure (0·787, 0·785-0·789; 0·768, 0·733-0·802). Through phenome-wide and genome-wide association studies, we identified candidate biological pathways for the prediction of increased risk, including changes in cardiac structure and function, and genes associated with cardiac structure, biological ageing, and metabolic syndrome. AIRE is an actionable, explainable, and biologically plausible AI-ECG risk estimation platform that has the potential for use worldwide across a wide range of clinical contexts for short-term and long-term risk estimation. British Heart Foundation, National Institute for Health and Care Research, and Medical Research Council.

Nationwide prevalence and geographic variation of idiopathic intracranial hypertension among women in the United States

The prevalence of idiopathic intracranial hypertension (IIH) is increasing, but this has not been examined on a nationwide scale. Our objective was to determine the nationwide prevalence and geographic distribution of IIH among women in the U.S. Retrospective cross-sectional study using Medicaid claims and electronic health record data from the IRIS® Registry (Intelligent Research in Sight) and Sight Outcomes Research Collaborative (SOURCE). Female Medicaid beneficiaries aged 18-55 with IIH diagnoses and prescriptions for acetazolamide or methazolamide in 2018, excluding those with other causes of intracranial hypertension. We also calculated the proportion of female IIH patients in the U.S. who were insured by Medicaid by combining analyses from the IRIS® Registry and SOURCE. To calculate the total number of IIH patients in the U.S. and by state, we divided the number of Medicaid beneficiaries with IIH by the proportion of IIH patients insured by Medicaid. We then used census data from the 2018 American Community Survey to calculate prevalence. We compared the geographic distribution of IIH to obesity prevalence data from the 2018 Behavioral Risk Factor Surveillance System, using the Moran's I statistic to test for spatial variation. In a validation study, we compared the calculated prevalence of IIH in Minnesota to similar data from the Rochester Epidemiology Project. Of 13,959 female Medicaid beneficiaries with IIH, 6,828 had a prescription for acetazolamide or methazolamide. In the IRIS® Registry and SOURCE, 25% of IIH patients were insured by Medicaid (95 % CI: 16-33%), suggesting that there were 27,312 women aged 18-55 with IIH taking acetazolamide or methazolamide in 2018 (6,828 / 0.25 = 27,312). Prevalence was 3.44 per 10,000 (95% CI: 2.61-5.39), and there was significant geographic variation (Moran's I statistic 0.20, P = 0.03) with higher prevalence in states where obesity was more common. The calculated prevalence of IIH in Minnesota was statistically equivalent to Rochester Epidemiology Project data (P < 0.05 for equivalence test). IIH affects 3.44 per 10,000 women aged 18-55 in the U.S., and there is significant geographic variation, some of which is explained by variation in obesity prevalence.

National Liver Cancer Screening Trial (TRACER) study protocol.

Professional guidelines recommend HCC screening in at-risk patients using semi-annual ultrasound with or without alpha-fetoprotein (AFP); however, this strategy has limited effectiveness due to low adherence and sensitivity. Increasing data support the potential role of blood-based biomarker panels, which could improve both aspects. The biomarker panel GALAD, comprised of sex, age, and 3 blood biomarkers (AFP, AFP-L3, and des-carboxy prothrombin des-carboxy prothrombin), has shown high sensitivity and specificity in biomarker phase II (case-control) and phase III (retrospective cohort) validation studies. However, prospective validation in a large phase IV biomarker clinical utility trial is necessary before its adoption in practice. The National Liver Cancer Screening Trial is an adaptive pragmatic randomized phase IV trial, which began enrollment in January 2024, comparing ultrasound-based versus biomarker-based screening in 5500 patients with chronic hepatitis B infection or cirrhosis from any etiology. Eligible patients are randomly assigned in a 1:1 ratio to semi-annual screening with ultrasound ± alpha-fetoprotein (arm A) or semi-annual screening with GALAD (arm B). Randomization is stratified by enrollment site, liver disease severity (per Child-Pugh class), liver disease etiology (viral, nonviral, and noncirrhotic HBV), and sex. Patients are being recruited from 15 sites (a mix of tertiary care academic referral centers, safety-net health systems, and large community health systems) over a 3-year period, and the primary endpoint, reduction in late-stage HCC, will be assessed at the end of year 5.5. The results of this trial will inform the best strategy for HCC screening and early-stage detection in patients with chronic liver diseases. If GALAD shows superiority, HCC screening would primarily shift from an ultrasound-based strategy to the adoption of the biomarker panel. NCT06084234. The TRACER Study is actively enrolling.

Development of the two-factor modified Kids Eating Disorder Survey (M-KEDS): a validation study with hispanic adolescents

BackgroundDisordered eating behaviors and body dissatisfaction are highly prevalent among adolescents and linked to negative health outcomes. While Hispanic adolescents appear to be at high risk of disordered eating and body dissatisfaction, validated tools for assessment of these health concerns among this population are lacking.MethodsThis study used Confirmatory Factor Analysis to establish factorial validity for the Kids Eating Disorder Survey (KEDS) among a community sample of Hispanic adolescents. Internal consistency was measured by the Kuder-Richardson Formula 20 (KR-20).ResultsParticipants (N = 690) were Hispanic (100%) and female (53%), with a mean age of 12 years. After testing the psychometric properties of KEDS and implementing modifications, the resulting two-factor KEDS model (M-KEDS) showed acceptable fit (TLI = 0.98, CFI = 0.99, RMSEA = 0.06) for the Weight Dissatisfaction (renamed to Negative Weight Attitudes) and Purging/Restriction (renamed to Extreme Weight Control Behaviors) sub-scales and good internal consistency (KR-20 = 0.77).ConclusionM-KEDS is a factorial valid instrument for assessing Extreme Weight Control Behaviors and Negative Weight Attitudes among Hispanic adolescents. Hispanics are among the fastest-growing racial/ethnic groups in the United States, warranting further research on negative weight attitudes and extreme weight control behaviors in this population.

Characterization of small RNAs in the spleen of MASH in a non-human primate model

Metabolic dysfunction-associated steatotic liver disease (MASLD) and its advanced stage, metabolic dysfunction-associated steatohepatitis (MASH), are increasingly recognized as a global health issue. This study examines the role of small RNAs in the spleen of MASH using a non-human primate model. We performed high-throughput small RNA sequencing on spleen tissues from MASH-primates, revealing significant alterations in the expression of small non-coding RNAs, especially miRNAs. Notably, miR-96, miR-182, miR-183, and miR-122 showed differential expression in MASH spleens. Predictive and validation studies have identified potential target genes, such as PTX3 and NFIX, that were significantly dysregulated in spleens of MASH. These findings characterized small RNAs in spleen of MASH and offer a novel insight for further research for MASH.

Integrated measure for training transfer in nursing practice: Development and validation study

BackgroundThe persistent knowledge-practice gap in nursing, where competencies gained through continuing professional development fail to integrate into practice, remains a significant challenge. Effective transfer of acquired knowledge and skills to the workplace is essential for bridging this gap. However, there is a lack of comprehensive, validated instruments to assess factors influencing training transfer in nursing practice. ObjectiveThis study aims to develop a questionnaire capable of assessing training transfer as an integrated construct, encompassing all factors influencing this process in nursing practice. DesignThe study followed a developmental, iterative approach guided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Setting(s)Eight tertiary teaching hospitals in the Netherlands. ParticipantsEducational experts (n = 8) and nurses (n = 1588). MethodsThe questionnaire development consisted of three phases: Phase 1) content development, in which instruments were identified based on a literature study and translation of included instruments into Dutch, Phase 2) pilot phase: content validation and usability testing using Delphi studies with experts and nurses, Phase 3) psychometric validation: construct validation using exploratory and confirmatory factor analysis, composite reliability and discriminant validity. The phases were completed from January 2023 till June 2024. ResultsThe literature review led to the inclusion of two key instruments: the Learning Transfer System Inventory (LTSI) and the Learning Climate Questionnaire (LCQ). Following item reduction based on Delphi rounds, nurses completed the adapted instruments. Psychometric validation demonstrated a good fit for these instruments in nursing practice. The adapted LTSI showed loadings ranging from 0.37 to 0.99, with a Normed Χ2 of 1.996, TLI of 0.908, CFI of 0.920, and RMSEA of 0.050 [CI = 0.047–0.054]. The adapted LCQ exhibited loadings from 0.64 to 0.94, with a Normed Χ2 of 3.385, TLI of 0.963, CFI of 0.974, and RMSEA of 0.069 [CI = 0.061–0.078]. The combined model demonstrated a Normed Χ2 of 2.014, TLI of 0.900, CFI of 0.907, and RMSEA of 0.051 [CI = 0.048–0.054]. ConclusionsThe adapted LTSI and LCQ, both separately and combined, are reliable and valid instruments for use in the Dutch nursing hospital context. Together, they provide a comprehensive assessment of factors influencing training transfer. They can also be used independently to examine specific components such as trainers (LCQ), context (LTSI), personal aspects (LTSI), or training (LTSI/LCQ). Furthermore, these instruments can facilitate discussions between nurses, managers, and educational experts to address barriers to training transfer in nursing practice.

Diagnostic performance of deep learning for infectious keratitis: a systematic review and meta-analysis

Infectious keratitis (IK) is the leading cause of corneal blindness globally. Deep learning (DL) is an emerging tool for medical diagnosis, though its value in IK is unclear. We aimed to assess the diagnostic accuracy of DL for IK and its comparative accuracy with ophthalmologists. In this systematic review and meta-analysis, we searched EMBASE, MEDLINE, and clinical registries for studies related to DL for IK published between 1974 and July 16, 2024. We performed meta-analyses using bivariate models to estimate summary sensitivities and specificities. This systematic review was registered with PROSPERO (CRD42022348596). Of 963 studies identified, 35 studies (136,401 corneal images from >56,011 patients) were included. Most studies had low risk of bias (68.6%) and low applicability concern (91.4%) in all domains of QUADAS-2, except the index test domain. Against the reference standard of expert consensus and/or microbiological results (seven external validation studies; 10,675 images), the summary estimates (95% CI) for sensitivity and specificity of DL for IK were 86.2% (71.6-93.9) and 96.3% (91.5-98.5). From 28 internal validation studies (16,059 images), summary estimates for sensitivity and specificity were 91.6% (86.8-94.8) and 90.7% (84.8-94.5). Based on seven studies (4007 images), DL and ophthalmologists had comparable summary sensitivity [89.2% (82.2-93.6) versus 82.2% (71.5-89.5); P=0.20] and specificity [(93.2% (85.5-97.0) versus 89.6% (78.8-95.2); P=0.45]. DL models may have good diagnostic accuracy for IK and comparable performance to ophthalmologists. These findings should be interpreted with caution due to the image-based analysis that did not account for potential correlation within individuals, relatively homogeneous population studies, lack of pre-specification of DL thresholds, and limited external validation. Future studies should improve their reporting, data diversity, external validation, transparency, and explainability to increase the reliability and generalisability of DL models for clinical deployment. NIH, Wellcome Trust, MRC, Fight for Sight, BHP, and ESCRS.

Advanced graph neural network-based surrogate model for granular flows in arbitrarily shaped domains

In next-generation manufacturing, the introduction of a surrogate model is crucial for constructing a digital twin. This trend is no exception in powder industry. Various mesh-free approaches such as the discrete element method (DEM) are versatile tools for facilitating simulation-based digital twins of powder industries. Unfortunately, the DEM-based high-fidelity simulation of actual industrial processes poses a significant challenge because of the prohibitive computational costs. In this context, the surrogate model has emerged as a promising technique to solve this problem. However, surrogate modeling of powder processes within arbitrarily shaped boundaries is substantially impossible. To resolve this essential problem in the existing surrogate models, we propose a novel surrogate model, namely, a signed distance function-based graph neural network (SGN), to accelerate the simulations of granular flows. In the SGN, the wall boundary is efficiently modeled by combining the graph structure with a signed distance function. Validation studies were conducted in typical powder systems, such as a sandglass, and a rotating-paddle mixer. A systematic comparison of the simulation results between the high-fidelity and SGN simulations shows that the proposed SGN accurately simulates granular dynamics, with a remarkable increase in computational efficiency. This study significantly contributes to the next-generation manufacturing in the powder industry.

Beyond School Climate: Validating the School as a Protective Factor-Brief Survey.

The conceptual framework for School as a Protective Factorapproach was presented in a companion article in this issue of the journal. The current article describes the validation of the School as a Protective Factor-Brief (SPF-Brief), a 13-item survey measuring the 3 core constructs and 13 defining characteristics of this framework. The SPF-Brief was validated through 2 studies. The developmental study used a longitudinal design including 1349 participants who completed surveys over 5 semesters, while the validation study used a cross-sectional design with 2775 participants. Both studies included middle and high school students. Factor analysis, growth model analysis, criterion-related validation, and outcome analysis were employed. Analyses provided strong evidence supporting the reliability and validity of the instrument and conceptual framework. Higher SPF-Brief scores were associated with higher math grades, English grades, and quality of life, as well as lower rates of anxiety, depression, conduct disorder, alcohol, e-cigarette, tobacco, and cannabis use. Effect size estimates ranged from moderate to strong. These findings suggest the utility of the SPF-Brief instrument and the School as a Protective Factor framework. Together, they may offer advantages to the traditional school climate approach.

A novel clinical prediction model for hip fractures: a development and validation study in the total population of Sweden

Low bone density and osteoporosis are indications for bone-specific treatment. However, given the limited availability of bone density data in clinical practice and the fact that most patients with hip fracture do not have osteoporosis, accurate prediction of hip fracture risk in the absence of bone density data would be crucial. This development and validation study included the entire Swedish population aged 50 years or older in 2005 (N=3,340,977) and was conducted by cross-linking data from nationwide registers. Potential predictive variables included diagnoses, prescription medications, familial factors, frailty-related factors, and socioeconomic factors. The primary endpoint was the 5-year risk of hip fracture. Fracture prediction algorithms were developed and validated using multivariable models. Model performance and validation was also examined in a sub cohort restricted to 504,431 individuals with non-Swedish background. During a total follow-up of 15.2 million person-years, 87,089 individuals suffered a hip fracture within 5 years. In the final prediction model, 19 variables were associated with a population attributable fraction of 93.9% (95% CI, 93.7-94.1) in women and 92.7% (95% CI, 92.2-93.0) in men. The strongest predictor, besides old age, was the use of homemaker service, with a 5-year risk of hip fracture of 7.8% in women and 4.7% in men. The diagnoses most strongly predicting the 5-year risk of hip fracture was Parkinson's disease (6.8% in women, 4.6% in men) and dementia (6.1% in women, 3.6% in men). Validation of the prediction model suggested that the optimal threshold for treatment with bone-specific agents was an estimated 5-year hip fracture risk of 3%. Assuming a threshold of 3% and a 30% relative risk reduction from bone-specific treatment, the number needed to treat to prevent one hip fracture was estimated to 36 in women and 52 in men. Similar results were obtained in the sub cohort with non-Swedish background. A clinical prediction model developed and validated in the total Swedish population could predict the risk of hip fractures with high precision even in absence of data on bone density. The model was associated with a population attributable fraction for hip fracture of more than 90%, and the strongest predictor besides old age was the use of homemaker service, which likely reflect frailty. Based on the model, individuals with an estimated 5-year risk of hip fracture of at least 3% could be considered for bone-specific treatment. None.

Bioassay-guided isolation and in Silico characterization of cytotoxic compounds from Hemimycale sp. Sponge targeting A549 lung cancer cells

Bioassay-guided fractionation approach led to identification of two novel compounds; (4-(hydroxymethyl)-3-methoxy-1H-pyrazol (1) and mycalene (2), alongside with four known metabolites; octadecane (3), hexatriacontane (4), 1-heneicosanol (5) and heptatriacontanoic acid (6) from the Red Sea marine sponge Hemimycale sp. The ethyl acetate fraction showed a noticeable cytotoxic activity against the lung cancer cell line (A549) with IC50 value of 75.54 µg/ mL. Structural elucidation was achieved using a combination of 1D and 2D nuclear magnetic resonance (NMR) spectroscopy and high-resolution electrospray ionization-mass spectrometry (HR-ESI-MS). To elucidate the potential mechanism of action behind the cytotoxic effects against lung cancer, a multi-faceted approach combining in silico network pharmacology, experimental validation, and molecular docking studies were employed. Both compounds, designated as 1 and 2, demonstrated significant binding affinities to predicted target proteins, with docking scores of -4.789 and − 4.421 kcal/mol, respectively. These results lay the groundwork for further investigation into the therapeutic potential of these novel compounds from Hemimycale sp. as promising candidates for lung cancer treatment.

Comparative Evaluation of Multimarker Algorithms for Early-Stage HCC Detection in Multicenter Prospective Studies

Background and aimsWe compared the clinical performance of the novel GAAD (gender [biological sex], age, alpha-fetoprotein [AFP], des-gamma carboxy-prothrombin [DCP]) and GALAD (gender [biological sex], age, AFP, Lens culinaris agglutinin-reactive AFP [AFP-L3], DCP) algorithms to deduce the clinical utility of AFP-L3 for detecting early-stage hepatocellular carcinoma (HCC) from chronic liver disease (CLD). MethodsAn algorithm development study (STOP-HCC-ARP) and clinical validation study (STOP-HCC-MCE) were conducted, recruiting adult participants with HCC (confirmed by radiology or pathology) or CLD in an international, multicenter, case-control design. Serum biomarkers were measured using Elecsys assays (GAAD and GALAD [Cobas]) or μTASWAKO assays (GALAD [μTASWAKO]) while blinded to case/control status. ResultsIn STOP-HCC-ARP (algorithm development cohort), 1006 patients (297 HCC [41.4% early-stage [(Barcelona Clinic Liver Cancer [(BCLC)] 0/A)] and 709 CLD) were included. Area under the curve [AUCs] for discriminating between early-stage HCC vs CLD were 91.4%, 91.4%, and 90.8% for GAAD (Cobas), GALAD (Cobas), and GALAD (μTASWAKO), respectively. The clinical validation cohort of STOP-HCC-MCE comprised 1142 patients, (366 HCC cases (48% early-stage), 468 specificity samples and 302 CLD); AUCs for GAAD (Cobas), GALAD (Cobas), and GALAD (μTASWAKO) for discriminating between early-stage HCC vs CLD were 91.4%, 91.5%, and 91.0%, respectively; AUCs were 94.7-95.0% for all-stage HCC.The GAAD and GALAD algorithms demonstrated similar good performance regardless of disease etiology, presence of cirrhosis, geographical region, and within pan-tumor specificity panels (p<0.001). ConclusionsGAAD (Cobas) demonstrated good clinical performance, similar to GALAD (Cobas and μTASWAKO) algorithms, in differentiating HCC and CLD controls, across all disease stages, etiologies and regions; therefore, AFP-L3 may have a negligible role in GALAD for HCC surveillance. Impact and implicationsTo improve the detection of early-stage hepatocellular carcinoma (HCC) from benign chronic liver disease (CLD), algorithms combining demographic characteristics and serum biomarkers, such as GAAD and GALAD, have been developed. GAAD combines gender (biological sex), age, alpha-fetoprotein (AFP), des-gamma carboxy-prothrombin (DCP); GALAD combines the same characteristics and biomarkers as GAAD with the addition of Lens culinaris agglutinin-reactive AFP (AFP-L3). Changing disease etiologies and treatment paradigms have raised questions regarding the utility of AFP-L3 in HCC surveillance. Our work demonstrates that the GAAD (Cobas) algorithm demonstrated good clinical performance and was as sensitive and specific as the GALAD (Cobas) and GALAD (μTASWAKO) algorithms in differentiating HCC and CLD controls, across all disease stages, etiologies, and geographical regions; therefore, AFP-L3 may have a negligible role in HCC detection. Our study provides supporting evidence that in participants with CLD undergoing guideline-directed HCC surveillance, the GAAD (Cobas) algorithm may be used as an effective method for the detection of HCC, potentially resulting in improved patient outcomes.

Assessment of Early Vascular Aging Ambulatory Score (EVAAs): A Large Population-based External Validation Study.

Pulse Wave Velocity (PWV) remains the gold-standard method to assess Early Vascular Aging (EVA) defined by arterial stiffness. However, its high cost, time-consuming process, and need for qualified medical staff shows the importance of identifying alternative methods for the EVA evaluation. In order to simplify the process of assessing patients' EVA, we recently developed the Early Vascular Aging Ambulatory score (EVAAs), a simple tool to predict the risk of EVA. The aim of the present study was the external validation of EVAAs in an independent population. Eight hundred seventy-nine (46.3% men) patients who were referred to our Hypertension ESH Excellence Center were included in this study. The mean age was 46.43 ± 22.87 years. EVA was evaluated in two different ways. The first assessment included c-f PWV values, whereas the second one included EVAAs without the direct measurement of carotid-femoral PWV. The null hypothesis was that the prediction of EVA based on EVAAs does not present any statistically significant difference compared to the prediction based on the calculation from c-f PWV. Mean squared error (MSE) was used for the assessment of the null hypothesis, which was found to be 0.40. The results revealed that the EVAAs show the probability of EVA with 0.98 sensitivity and 0.75 specificity. The EVAAs present 95% positive predictive value and 92% negative predictive value. Our study revealed that EVAAs could be as reliable as the carotid-femoral PWV to identify patients with EVA. Hence, we hope that EVAAs will be a useful tool in clinical practice.

CAT rs1001179 Single Nucleotide Polymorphism Identifies an Aggressive Clinical Behavior in Chronic Lymphocytic Leukemia.

Chronic lymphocytic leukemia (CLL) is characterized by an extremely variable clinical course. Although several parameters have been shown to be associated with clinical outcomes in patients with CLL, there remains substantial intragroup clinical heterogeneity in otherwise molecularly and staging homogeneous CLL subgroups. We have recently shown that high catalase (CAT) expression identifies patients with an aggressive clinical course and that higher CAT expression is associated with the presence of the rs1001179 single nucleotide polymorphism (SNP) T allele in the CAT promoter. Herein, we genotyped CLL patients for CAT rs1001179 SNP in an exploratory study (n=235) and in a sequential independent validation study (n=531). Time-to-event modeling analyses for time-to-first-treatment (TTFT) from the two patients' cohorts showed that TT genotype was associated with a shorter TTFT, independently of other currently used prognostic parameters in CLL. Moreover, the TT genotype identifies CLL patients with a faster clinical progression even within subgroups of patients with low-risk biological and clinical hallmarks. In conclusion, our data show that the TT genotype identifies CLL patients with a shorter TTFT, pointing to this SNP as a possible prognostic factor, which can improve patients' risk stratification leading to better patient management and personalized therapeutic choices.

Assessing the Psychometric Properties of the French-Canadian Version of the Psychological Safety Climate Questionnaire (PSC-12)

BackgroundPsychosocial safety climate (PSC) refers to the collective belief among workers regarding the protection and support of their psychological health and safety by senior management. Despite the recognized importance of PSC in mitigating exposure to detrimental psychosocial risk factors at work, a validated instrument in French is lacking. This study aimed to evaluate the psychometric properties of the French-Canadian version of the Psychosocial Safety Climate (PSC)-12 and its associations with job satisfaction and psychological distress. MethodA cross-sectional validation study was conducted to evaluate the psychometric properties of the PSC-12. Using cross-sectional data from an online survey of adults in a French-Canadian university (n = 1,784), the psychometric properties of the PSC-12, a 12-item questionnaire, were assessed. Internal consistency, validity, and factor structure were examined through exploratory factor analysis conducted using SAS v.9.4 software. ResultsConfirming the original four-factor structure, the French-Canadian version of the PSC-12 demonstrated satisfactory internal consistency (Cronbach's α of 0.95) and validity indices. Its convergent and divergent validity were evidenced by a positive association with job satisfaction (r = 0.34, p < 0.05) and the negative association with psychological distress (r = -0.50, p < 0.05). ConclusionsThe French-Canadian adaptation of the PSC-12 maintains cross-cultural validity, providing a validated and concise tool for assessment within the French-Canadian community. Practical Applications: By facilitating the prevention of mental health problems among workers, this questionnaire has the potential to contribute to alleviating burdens for individuals, workplaces, and society.

An Analysis of SRSS-IE Externalizing Cut Scores to Facilitate Data-Informed Decision-Making in K–12 Schools

We report the results of a convergent validity study examining the externalizing subscale (SRSS-E5, five items) of the adapted Student Risk Screening Scale for Internalizing and Externalizing (SRSS-IE 9) with the externalizing subscale of the Teacher Report Form (TRF) with two samples of K–12 students. Results of logistic regression and receiver operating characteristic curves analyzed with a sample of 195 K–5 students from 13 schools across three states suggested the following preliminary cutting scores for the SRSS-E5 for use at the elementary level: 0 to 1 for low risk, 2 to 3 for moderate risk, and 4 to 15 for high risk for externalizing behaviors. Results of the same analyses with a sample of 227 students in Grades 6 to 12 suggested the following preliminary cutting scores for the SRSS-E5 for use in middle and high (secondary) schools: 0 to 4 for low risk, 5 to 6 for moderate risk, and 7 to 15 for high risk for externalizing behaviors. For both samples, sensitivity and specificity levels were acceptable, as was the correct classification rate. We discuss findings and limitations and emphasize the importance of replication before shifting screening practices from the SRSS-IE 12 (12 items) to the newly adapted SRSS-IE 9 (9 items).

Virtual reality-based simulation improves rotator cuff repair skill: a randomized transfer validity study.

Although virtual reality (VR) simulators have demonstrated their efficiency for basic technical skill training of healthcare professionals, validation for more complex and sequential procedures, especially in arthroscopic surgery, is still warranted. We hypothesized that the VR-based training simulation improves arthroscopic cuff repair skills when transferred to realistic visual and haptic conditions. VR-based training simulation improves arthroscopic cuff repair skills when transferred to realistic visual and haptic conditions. This study is prospective, multicentric and randomized. Thirty orthopedic surgery residents were enrolled in the study and randomized in two groups: VR training (VR+) and no VR training (VR-). Only the VR + group underwent a monthly VR-based training program for rotator cuff repair. The 1 -h VR training sessions were standardized and supervised by the same instructor. After six months, all participants performed a double-row arthroscopic rotator cuff repair procedure on a benchtop shoulder model providing realistic visual and haptic conditions with implants. Two independent surgeons with expertise in shoulder repair and blinded to the randomization rated the participants' performance using the Arthroscopic Surgical Skill Evaluation Tool (ASSET). Demographic characteristics and surgical experience were comparable between the two groups. The ASSET global rating score was higher in the VR + group than in the VR- group (34.4 ± 3.1 and 30.5 ± 5.7, respectively; p = 0.046) and the VR+ group performed the procedure faster than the VR- group (27.3 ± 3.6 vs. 31.7 ± 0.4 minutes, respectively; p = 0,003). This study demonstrated that a monthly VR-based program for 6 months was better than standard peer training alone for mastering a complex and sequential rotator cuff repair when using the validated ASSET Score. Overall, nonspecific arthroscopic skills were also higher in the VR + group. II, therapeutic study.

Targeted ultra-high performance liquid chromatography-tandem mass spectrometry assay for the quantification of medium-chain phosphatidylcholines in platelets of coronary artery disease patients

In a recent untargeted clinical lipidomics study of platelets of coronary artery disease (CAD) patients, medium-chain phosphatidylcholines (MCPCs) with C8 and C10 fatty acyl residues were found significantly upregulated in the patient group with acute coronary syndrome (ACS) as compared to chronic coronary syndrome (CCS) and healthy controls. To support this finding, this work presents the development and optimization of a targeted UHPLC-QTrap-MS/MS method with multiple reaction monitoring acquisition for the quantitative analysis of MCPCs (PC 10:0/8:0, PC 16:0/8:0, PC 10:0/20:4 and PC 10:0/10:0) in platelets for biomarker validation. A systematic optimization of chromatographic and mass spectrometric parameters was performed. A charged surface hybrid CSH C18 (1.7 µm, 130 Å) column and fine-tuned gradient elution with 2-propanol/acetonitrile and ammonium acetate as additive to the mobile phase was employed in the final method in ESI negative mode. Four selected PC standards (PC 6:0/6:0, PC 8:0/8:0, PC 10:0/10:0 and PC 12:0/12:0), which cover well the carbon and retention rime range of the target analytes, were used for the optimization process and calibration. Quantification was based on matrix-matched calibration with these four selected commercially available MCPC standards as surrogate calibrants and PC 6:0/6:0 (d22) as internal standard. Furthermore, an organic solvent and fatty acyl carbon number-corrected response factor approach gave also accuracies within acceptance limits of bioanalytical validation guidelines and has more generic applicability. Compared to the previous untargeted RPLC-ESI-QTOF-MS/MS method, the optimized targeted UHPLC-QTrap-MS/MS assay showed increased sensitivity and selectivity for the detection of medium-chain PCs in platelet samples of CAD (LOQs in the range of 0.5-5 nmol/L). The method performance parameters indicated its suitability for a future biomarker validation study of MCPCs in platelets.

Clinical Accuracy of the G.LAB MD41A0 Upper Arm Blood Pressure Monitor in Pregnancy and Pre-Eclampsia Using the AAMI/ESH/ISO as Reference Standard.

Validation of blood pressure (BP) monitors in pregnant women are needed to ensure the accurate measurement of BP in pregnancy. Therefore the study aimed to evaluate the measurement accuracy of the G.LAB MD41A0 oscillometric automatic upper-arm blood pressure monitor in pregnancy and pre-eclampsia women according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). A total of 45 pregnant women were included in the cross-sectional validation study. The same left-arm sequential method was used for blood pressure measurement, and the blood pressure differences between the test device and the mercury standard reference were assessed according to the AAMI/ESH/ISO Universal Standard. The participants included 15 normotensives, 15 gestational hypertension and 15 pre-eclampsia. The average (mean ± SD) differences between the device and mercury standard was -0.84±3.88mmHg and -0.58±3.35mmHg for systolic and diastolic blood pressure, respectively, for the validation Criterion 1. The SD of the averaged differences between the device and reference readings per participant was 2.92mmHg and 2.28mmHg for systolic and diastolic blood pressure, respectively, for the Criterion 2 of the universal standard. The G.LAB MD41A0 automatic upper-arm blood pressure monitor fulfills the criteria of the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement in pregnancy and pre-eclampsia.

12221 External Validation Study of Pre-Operative Ultrasound Based AAGL Staging System (AAGL-US) in Prediction of AAGL Surgical Stage

12221 External Validation Study of Pre-Operative Ultrasound Based AAGL Staging System (AAGL-US) in Prediction of AAGL Surgical Stage