Background The patient-reported Dimensional Anhedonia Rating Scale(DARS)has been adapted into Chinese,so there is a need to evaluate its measurement properties in a Chinese population.Aims To evaluate the reliability ...Background The patient-reported Dimensional Anhedonia Rating Scale(DARS)has been adapted into Chinese,so there is a need to evaluate its measurement properties in a Chinese population.Aims To evaluate the reliability and validity of the DARS among Chinese individuals with major depressive disorder(MDD)and its treatment sensitivity in a prospective clinical study.Methods Data were from a multicentre,prospective clinical study(NCT03294525),which recruited both patients with MDD,who were followed for 8 weeks,and healthy controls(HCs),assessed at baseline only.The analysis included confirmatory factor analysis,validity and sensitivity to change.Results Patients’mean(standard deviation(SD))age was 34.8(11.0)years,with 68.7%being female.75.2%of patients with MDD had melancholic features,followed by 63.8%with anxious distress.Patients had experienced MDD for a mean(SD)of 9.2(18)months.DARS scores covered the full range of severity with no major floor or ceiling effects.Confirmatory factor analysis showed adequate fit statistics(comparative fit index 0.976,goodness-of-fit index 0.935 and root mean square error of approximation 0.055).Convergent validity with anhedonia-related measures was confirmed.While the correlation between the DARS and the Hamilton Depression Rating Scale was not strong(r=0.31,baseline),the DARS was found to differentiate between levels of depression.Greater improvements in DARS scores were seen with the Hamilton Rating Scale for Depression responder group(effect size 1.16)compared with the non-responder group(effect size 0.46).Conclusions This study comprehensively evaluated the measurement properties of the DARS using a Chinese population with MDD.Overall,the Chinese version of DARS demonstrates good psychometric properties and has been found to be responsive to change during antidepressant treatment.The DARS is a suitable scale for assessing patient-reported anhedonia in future clinical trials.展开更多
Verification and validation(V&V)is a helpful tool for evaluating simulation errors,but its application in unsteady cavitating flow remains a challenging issue due to the difficulty in meeting the requirement of an...Verification and validation(V&V)is a helpful tool for evaluating simulation errors,but its application in unsteady cavitating flow remains a challenging issue due to the difficulty in meeting the requirement of an asymptotic range.Hence,a new V&V approach for large eddy simulation(LES)is proposed.This approach offers a viable solution for the error estimation of simulation data that are unable to satisfy the asymptotic range.The simulation errors of cavitating flow around a projectile near the free surface are assessed using the new V&V method.The evident error values are primarily dispersed around the cavity region and free surface.The increasingly intense cavitating flow increases the error magnitudes.In addition,the modeling error magnitudes of the Dynamic Smagorinsky-Lilly model are substantially smaller than that of the Smagorinsky-Lilly model.The present V&V method can capture the decrease in the modeling errors due to model enhancements,further exhibiting its applicability in cavitating flow simulations.Moreover,the monitoring points where the simulation data are beyond the asymptotic range are primarily dispersed near the cavity region,and the number of such points grows as the cavitating flow intensifies.The simulation outcomes also suggest that the re-entrant jet and shedding cavity collapse are the chief sources of vorticity motions,which remarkably affect the simulation accuracy.The results of this study provide a valuable reference for V&V research.展开更多
BACKGROUND The computed tomography(CT)-based preoperative risk score was developed to predict recurrence after upfront surgery in patients with resectable pancreatic ductal adenocarcinoma(PDAC)in South Korea.However,w...BACKGROUND The computed tomography(CT)-based preoperative risk score was developed to predict recurrence after upfront surgery in patients with resectable pancreatic ductal adenocarcinoma(PDAC)in South Korea.However,whether it performs well in other countries remains unknown.AIM To externally validate the CT-based preoperative risk score for PDAC in a country outside South Korea.METHODS Consecutive patients with PDAC who underwent upfront surgery from January 2016 to December 2019 at our institute in a country outside South Korea were retrospectively included.The study utilized the CT-based risk scoring system,which incorporates tumor size,portal venous phase density,tumor necrosis,peripancreatic infiltration,and suspicious metastatic lymph nodes.Patients were categorized into prognosis groups based on their risk score,as good(risk score<2),moderate(risk score 2-4),and poor(risk score≥5).RESULTS A total of 283 patients were evaluated,comprising 170 males and 113 females,with an average age of 63.52±8.71 years.Follow-up was conducted until May 2023,and 76%of patients experienced tumor recurrence with median recurrence-free survival(RFS)of 29.1±1.9 months.According to the evaluation results of Reader 1,the recurrence rates were 39.0%in the good prognosis group,82.1%in the moderate group,and 84.5%in the poor group.In comparison,Reader 2 reported recurrence rates of 50.0%,79.5%,and 88.9%,respectively,across the same prognostic categories.The study validated the effectiveness of the risk scoring system,demonstrating better RFS in the good prognosis group.CONCLUSION This research validated that the CT-based preoperative risk scoring system can effectively predict RFS in patients with PDAC,suggesting that it may be valuable in diverse populations.展开更多
Lightweight structures for gears enable a reduction in material usage while maintaining the technical function of the gear.Previous approaches have pursued the strategy of lightweight structures in the gear wheel body...Lightweight structures for gears enable a reduction in material usage while maintaining the technical function of the gear.Previous approaches have pursued the strategy of lightweight structures in the gear wheel body.By taking inspiration from biological models and utilizing material savings in the gear rim,new design approaches for the lightweight design of gears can be realized.For this reason,a holistic biological design approach for spur gears is presented.In addition to the method of topology optimization,a biologically inspired approach based on diatoms is introduced,which achieves a weight reduction of over 50%compared to conventional solid gears.Diatom structures are extracted from the oceans,digitally modelled,and adapted to the load conditions of a reference gear by parametric design and simulation optimization.For the experimental validation of the design,a manufactured gear is statically loaded in the nominal load range and analyzed using a tactile geometry gear measurement.The measurement results of selected standard gear parameters show that the gear does not exhibit any plastic deformation for the nominal load capacity of 383 Nm,validating the presented design approach.展开更多
Traditional Medicine Research published an article entitled Investigation on the mechanism of Qi-Hong-Tang-Zu ointment in thetreatmentofdiabetic wound by network pharmacology and experimental validation on 24 January ...Traditional Medicine Research published an article entitled Investigation on the mechanism of Qi-Hong-Tang-Zu ointment in thetreatmentofdiabetic wound by network pharmacology and experimental validation on 24 January 2025.The author confirmed this article’s proof on 23 January 2025 without any questions.But on 06 July 2025,the editorial team found,there was an error in Figure 8.Specifically,Figure 8E,Figure 8F and Figure 8G were mistakenly duplicated.The authors acknowledge that the original version of Figure 8 was incorrect and have provided the revised,correct version in this corrigendum.The authors would like to assert that there is no change in the body text of the article.展开更多
systematic verification and validation(V&V)of our previously proposed momentum source wave generation method is performed.Some settings of previous numerical wave tanks(NWTs)of regular and irregular waves have bee...systematic verification and validation(V&V)of our previously proposed momentum source wave generation method is performed.Some settings of previous numerical wave tanks(NWTs)of regular and irregular waves have been optimized.The H2-5 V&V method involving five mesh sizes with mesh refinement ratio being 1.225 is used to verify the NWT of regular waves,in which the wave height and mass conservation are mainly considered based on a Lv3(H s=0.75 m)and a Lv6(H s=5 m)regular wave.Additionally,eight different sea states are chosen to validate the wave height,mass conservation and wave frequency of regular waves.Regarding the NWT of irregular waves,five different sea states with significant wave heights ranging from 0.09 m to 12.5 m are selected to validate the statistical characteristics of irregular waves,including the profile of the wave spectrum,peak frequency and significant wave height.Results show that the verification errors for Lv3 and Lv6 regular wave on the most refined grid are−0.018 and−0.35 for wave height,respectively,and−0.14 and for−0.17 mass conservation,respectively.The uncertainty estimation analysis shows that the numerical error could be partially balanced out by the modelling error to achieve a smaller validation error by adjusting the mesh size elaborately.And the validation errors of the wave height,mass conservation and dominant frequency of regular waves under different sea states are no more than 7%,8% and 2%,respectively.For a Lv3(H_(s)=0.75 m)and a Lv6(H_(s)=5 m)regular wave,simulations are validated on the wave height in wave development section for safety factors FS≈1 and FS≈0.5-1,respectively.Regarding irregular waves,the validation errors of the significant wave height and peak frequency are both lower than 2%.展开更多
OBJECTIVE:To explore the potential molecular mechanism of Qigu capsule(芪骨胶囊,QGC) in the treatment of sarcopenia through network pharmacology and to verify it experimentally.METHODS:The active compounds of QGC and ...OBJECTIVE:To explore the potential molecular mechanism of Qigu capsule(芪骨胶囊,QGC) in the treatment of sarcopenia through network pharmacology and to verify it experimentally.METHODS:The active compounds of QGC and common targets between QGC and sarcopenia were screened from databases.Then the herbs-compounds-targets network,and protein-protein interaction(PPI) network was constructed.Gene ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis were performed by R software.Next,we used a dexamethasone-induced sarcopenia mouse model to evaluate the anti-sarcopenic mechanism of QGC.RESULTS:A total of 57 common targets of QGC and sarcopenia were obtained.Based on the enrichment analysis of GO and KEGG,we took the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) signaling pathway as a key target to explore the mechanism of QGC on sarcopenia.Animal experiments showed that QGC could increase muscle strength and inhibit muscle fiber atrophy.In the model group,the expression of muscle ring finger-1 and Atrogin-1 were increased,while myosin heavy chain was decreased,QGC treatment reversed these changes.Moreover,compared with the model group,the expressions of pPI3K,p-Akt,p-mammalian target of rapamycin and pForkhead box O3 in the QGC group were all upregulated.CONCLUSION:QGC exerts an anti-sarcopenic effect by activating PI3K/Akt signaling pathway to regulate skeletal muscle protein metabolism.展开更多
Objective Forsythia suspensa has long been utilized in traditional Chinese medicine(TCM)for the treatment of IgA nephropathy(IgAN),the most prevalent form of primary glomerular disease.However,the precise mechanisms r...Objective Forsythia suspensa has long been utilized in traditional Chinese medicine(TCM)for the treatment of IgA nephropathy(IgAN),the most prevalent form of primary glomerular disease.However,the precise mechanisms remain inadequately understood.This study seeks to elucidate the underlying mechanisms of Forsythia suspensa extract(FSE)in the treatment of IgAN by employing an integrated approach that combines network pharmacology with in vivo experimental validation.Methods The chemical components of FSE were identified using high-performance liquid chromatography-mass spectrometry(HPLC–MS/MS).Additional chemical components and targets were determined through the Traditional Chinese Medicine Systems Pharmacology database.Potential therapeutic targets for IgAN were sourced from GeneCards and the Comparative Toxicogenomics Database.Subsequently,the enrichment analyses were conducted to evaluate the biological functions and pathways associated with the core targets.Finally,a mousemodel of IgAN was developed to validate the findings of the network pharmacology analysis.Results Through network analysis and HPLC–MS/MS,31 chemical components of FSE were identified.A total of 99 common targets were discovered between FSE and IgAN.The enrichment analyses suggested that FSE may mitigate IgAN primarily by inhibiting the TLR and NF-κB signaling pathways.In vivo experiments demonstrated that FSE reduced inflammation and preserved renal function in mice with IgAN through the Tolllike receptor 9(TLR9)/NF-κB pathway.Conclusion The integration of network pharmacology and animal experiments suggests that FSE alleviates renal inflammation and damage in IgAN through the TLR9/NF-κB signaling pathway.展开更多
The ongoing revolution in information technology is reshaping human life. In the realm of health behavior, wearable technology emerges as a leading digital solution,capturing physical behaviors (i.e., physical activit...The ongoing revolution in information technology is reshaping human life. In the realm of health behavior, wearable technology emerges as a leading digital solution,capturing physical behaviors (i.e., physical activity, sedentary habits, sleep patterns) within the 24-h cycle of daily life. Wearables are applied in research, clinical practice, and as lifestyle devices;most obvious, they promise to be a key element for increasing human physical activity, one of the biggest health challenges nowadays.展开更多
Objective:Pelvic floor dysfunction is common among pregnant and postpartum women and significantly impacts quality of life.This study aims to translate the German Pelvic Floor Questionnaire for Pregnant and Postpartum...Objective:Pelvic floor dysfunction is common among pregnant and postpartum women and significantly impacts quality of life.This study aims to translate the German Pelvic Floor Questionnaire for Pregnant and Postpartum Women into Chinese and to evaluate its reliability and validity in the Chinese population.Methods:The questionnaire was translated using the Brislin model.A cross-sectional study was conducted among pregnant and postpartum women to assess the content validity,construct validity,Cronbach’sαcoefficient,test-retest reliability,and split-half reliability of the Chinese version.Results:A total of 72 women were included,with 6.9% being pregnant and 93.1% postpartum;the age was(32.3±3.6)years.The Chinese version of the questionnaire contains 4 dimensions and 45 items.The content validity index of individual items ranged from 0.833 to 1.000,with a scale-level content validity index of 0.977 and intraclass correlation coefficients(ICCs)exceeding 0.90.The overall Cronbach’s α coefficient was 0.891,with subscale coefficients ranging from 0.732 to 0.884(all ICCs>0.70).The testretest reliability of the total scale was 0.833,and for the 4 dimensions,bladder,bowel,prolapse,and sexual function,the values were 0.776,0.579,0.732,and 0.645,respectively.The split-half reliability was 0.74.Conclusion:The Chinese version of the questionnaire demonstrated good reliability and validity,indicating its applicability in assessing pelvic floor dysfunction and associated risk factors during pregnancy and postpartum.展开更多
The purpose of this paper is to look into how reliable and valid the Persian version of the Cannabis Use Disorder Identification Test-Revised (CUDIT-R-Pr) is. It will also compare the screening features of the CUDIT-R...The purpose of this paper is to look into how reliable and valid the Persian version of the Cannabis Use Disorder Identification Test-Revised (CUDIT-R-Pr) is. It will also compare the screening features of the CUDIT-R with those of the DSM-5 criteria for cannabis use disorder (CUD) based on the SCID-5-CT in a group of university students in Tehran, Iran. The study used the stratified random sampling technique to collect data from 541 students (19 to 24 years old) who used cannabis in Tehran universities in 2024. Confirmatory factor analysis confirmed the uni-dimensionality of the CUDIT-R-Pr. We checked the reliability of the CUDIT-R-Pr using Cronbach Alpha, split-half, inter-rater, test-retest stability over time, and parallel testing equivalence. The results indicated that CUDIT-R-Pr is reliable, reproducible, and responsive, with substantial agreement and adequate interpretability. The CUDIT-R shows that it can tell the difference between different levels of cannabis use severity, which is known as discriminant validity. Receiver operating characteristic analyses confirmed this, using an area under the receiver operating characteristics curve (AUC = 0.95) at a cutoff of ten or less. This allowed CUDIT-R-Pr to accurately predict any DSM-5 based on the highest correctly classified value (0.89), demonstrating high levels of sensitivity (0.96), specificity (0.69), and Youden value (0.65). The exact maximum Youden index (0.72) showed that CUDIT-R-Pr could also predict moderate DSM-5 with a cutoff of twelve or less. To validate and generalize the CUDIT-R-Pr for use among Iranian cannabis users, we need more research.展开更多
Ecosystem services(ES)mapping and models have advanced in recent years.Improvements were made,and the assessments have transitioned from qualitative to quantitative.Although this is an important advancement,the ES map...Ecosystem services(ES)mapping and models have advanced in recent years.Improvements were made,and the assessments have transitioned from qualitative to quantitative.Although this is an important advancement,the ES mapping and modelling validation step has been overlooked,and this raises an important question in the credibility of the outcomes.This has been an important and unsolved issue in the ES research community that needs to be tackled.This highlight paper discusses the importance of validating single ES mapping and models.Conducting this using field or proximal/remote sensing raw data and not data from other models or stakeholder evaluation is important.A validation step should be mandatory in ES frameworks since it can assess the models’veracity,contribute to identifying the model’s weaknesses/strengths and ultimately represent a scientific advance in the field.This is easier to apply to the biophysical mapping and models of regulating and provisioning ES than to cultural ES,as the latter rely more on perception and cultural contexts.Also,ES supply models are easier to validate than demand and flow models.Robust and well-grounded models are essential for ensuring the reliability of individual ES maps and models and should be integrated into decision-making processes.Although several challenges arise related to the costs of data collection,in several cases prohibitive,and the time and the expertise needed to conduct this sampling and analysis,this is likely an imperative step that needs to be considered in the future.This will be beneficial in establishing ES research and improving decision-making and wellbeing.展开更多
Objective:To translate,adapt,and validate the Indonesian version of the Prenatal Health Behavior Scale.Methods:This cross-sectional,cross-cultural adaptation study was conducted between September 2024 and October 2024...Objective:To translate,adapt,and validate the Indonesian version of the Prenatal Health Behavior Scale.Methods:This cross-sectional,cross-cultural adaptation study was conducted between September 2024 and October 2024 in Ngrambe and Sine,subdistricts in Ngawi,East Java,Indonesia.We selected participants using purposive convenience sampling and matched them with inclusion and exclusion criteria.We collected sociodemographic,Prenatal Health Behavior Scale,and anthropometrics(height,weight,body mass index,and middle-upper arm circumference)data.We analyzed the content validity using the content validity index and Gwet's chance-corrected Agreement Coefficient 2,face validity by pilot-testing on several pregnant women,and construct validity using exploratory factor analysis.We measured reliability using McDonald's omega coefficient.Results:We recruited 183 pregnant women in this study(median age 28 years).The item-content validity index(I-CVI)of all items was 1.00,with Gwet's chance-corrected Agreement Coefficient 2 was 0.945.The face validity resulted in a clear statement of all items.The exploratory factor analysis showed the two-factor model best suited to the questionnaire.Omega coefficients for the overall scale,health-impairing,and health-promoting domains were 0.696,0.507,and 0.678,respectively.Conclusions:The Indonesian version of the Prenatal Health Behavior Scale is a valid and reliable instrument to assess prenatal health behavior in Indonesian-speaking pregnant women.Future studies may implement this scale in community and clinical settings.展开更多
To solve the problem of the lack of reference material(RM)for determination of allergenic ingredients in food,a RM of cashew nut powder was developed in the study.Cashew nut powder was prepared from cashew nut kernel ...To solve the problem of the lack of reference material(RM)for determination of allergenic ingredients in food,a RM of cashew nut powder was developed in the study.Cashew nut powder was prepared from cashew nut kernel by selecting,cleaning,crushing,n-hexane degreasing and sieving treatment.The reliability and traceability of RM was verified using real-time quantitative polymerase chain reaction(qPCR)and phylogenetic tree analysis.The cashew nut powder RM showed good homogeneity,and good stability under long-term storage at 4℃and short-term simulated transportation from-20 to 45℃.The RM was determined jointly by 8 collaborative laboratories,and the characteristic CT value was 24.732,and the extended uncertainty was 1.052%(k=2).The RM was applied to verify the amplification efficiency and the limit of detection for qPCR assay,and showed good applicability.The RM could be used for method validation and quality control,for the determination of allergenic ingredients in food mixed with trace amounts of cashew nut.展开更多
Objective:To translate and adapt the dementia knowledge assessment scale(DKAS)into Sinhala version and to evaluate its psychometric properties among nursing students.Methods:A cross-sectional validation study was cond...Objective:To translate and adapt the dementia knowledge assessment scale(DKAS)into Sinhala version and to evaluate its psychometric properties among nursing students.Methods:A cross-sectional validation study was conducted in two phases:(i)translation and adaptation and(ii)evaluating psychometric properties(N=394 nursing students).Results:The DKAS was adapted to the Sinhala(Si-DKAS)version,and the content validity index(CVI=0.9)was satisfactory.Exploratory factor analysis(EFA)and confirmatory factor analysis(CFA)resulted in an 18-item Si-DKAS with a four-factor model:“care considerations,”“causes and characteristics of dementia,”“health promotion,”and“misconceptions about dementia.”The model fit indices were suboptimal(comparative fix index[CFI]=0.809 and Turker-Lewis index[TLI]=0.773),and some indices were acceptable(standardized root-mean-squared residual[SRMR]=0.040 and root-mean-squared error of approximation[RMSEA]=0.053).Internal consistency(0.7)and test-retest correlation(0.9)were acceptable.Discriminant validity was confirmed by knowledge score differences based on academic years.Conclusions:This is a valid and reliable tool for assessing knowledge of dementia among Sinhala-speaking nursing students.展开更多
Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-...Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial(RCT)conducted in China from December 2018 to September 2021.The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale.The scale’s reliability was assessed using Cronbach’s a and test-retest reliability,while content validity was evaluated with the content validity index.We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores.Results:Of the 378 patients analyzed in the original RCT,352(93.2%)completed the TCM-KDP questionnaire.The Cronbach’s a of the eight-item TCM-KDP scale was 0.734,and the test-retest reliability was 0.745.Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%.The mean TCM-KDP score was 2.80±0.92.Compared with patients with stage II CRC,those with stage III CRC had significantly higher TCM-KDP scores(2.25 vs.2.50,P=.026).We categorized all patients into highor low-KDP score groups(the cut-off score was 2.8).Patients with lower TCM-KDP scores had significantly higher serum interleukin-1b expression levels(P=.04).Conclusion:The patient-reported TCM-KDP scale demonstrated relatively good feasibility,internal consistency,and test-retest reliability among patients with CRC.Future studies could apply this scale to other cancer types and diseases.展开更多
BACKGROUND The rising global prevalence of gastroesophageal reflux disease(GERD)has been closely linked to lifestyle changes driven by globalization.GERD imposes a substantial public health burden,affecting quality of...BACKGROUND The rising global prevalence of gastroesophageal reflux disease(GERD)has been closely linked to lifestyle changes driven by globalization.GERD imposes a substantial public health burden,affecting quality of life and leading to potential complications.Early intervention through lifestyle modification can prevent disease onset;however,there is a lack of effective risk prediction models that emphasize primary prevention.AIM To develop and validate a GERD Risk Scoring System(GRSS)aimed at identifying high-risk individuals and promoting primary prevention strategies.METHODS A 45-item questionnaire encompassing major lifestyle and demographic risk factors was developed and validated.It was administered to healthy controls and GERD patients.Two regression models-one using continuous variables and another using categorized variables-were used to develop a computational prediction equation and a clinically applicable scoring scale.An independent validation cohort of 355 participants was used to assess model performance in terms of discrimination(C-index),calibration,sensitivity,specificity,internal consistency(Cronbach's alpha),and test-retest reliability(intraclass correlation coefficient,Bland-Altman analysis).RESULTS Significant associations were observed between GERD and key lifestyle factors.The derived GRSS equation and scoring scale demonstrated strong discriminative ability,with high sensitivity and specificity.The scoring system exhibited excellent internal consistency(Cronbach’s alpha)and strong test-retest reliability.The C-index indicated excellent predictive accuracy in both derivation and validation cohorts.CONCLUSION GRSS offers a novel and validated approach to GERD risk prediction,combining a robust equation for digital applications and a practical scale for clinical use.Its ability to accurately identify at-risk individuals supports a paradigm shift toward primary prevention,underscoring its significance in addressing the growing burden of GERD at the population level.展开更多
The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in ...The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.展开更多
A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevaryin...A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevarying but bounded uncertainty within the vertical electric stabilization system:model parameter uncertainty and uncertain nonlinearity.First,the vertical electric stabilization system is constructed as an uncertain nonlinear dynamic system that can reflect the practical mechanics transfer process of the system.Second,the dynamical equation in the form of state space is established by designing the angular tracking error.Third,the comprehensive parameter of system uncertainty is designed to estimate the most conservative effects of uncertainty.Finally,an adaptive robust servo control which can effectively handle the combined effects of complex nonlinearity and uncertainty is proposed.The feasibility of the proposed control strategy under the practical physical condition is validated through the tests on the experimental platform.This paper pioneers the introduction of the internal nonlinearity and uncertainty of the vertical electric stabilization system into the settlement of the tracking stability control problem,and validates the advanced servo control strategy through experiment for the first time.展开更多
基金supported by the National Natural Science Foundation of China(No.82371530,82171529)the Capital Health Development Special Research Project(2022-1-4111)the National Key Technology R and D Program(No.2015BAI13B01).
文摘Background The patient-reported Dimensional Anhedonia Rating Scale(DARS)has been adapted into Chinese,so there is a need to evaluate its measurement properties in a Chinese population.Aims To evaluate the reliability and validity of the DARS among Chinese individuals with major depressive disorder(MDD)and its treatment sensitivity in a prospective clinical study.Methods Data were from a multicentre,prospective clinical study(NCT03294525),which recruited both patients with MDD,who were followed for 8 weeks,and healthy controls(HCs),assessed at baseline only.The analysis included confirmatory factor analysis,validity and sensitivity to change.Results Patients’mean(standard deviation(SD))age was 34.8(11.0)years,with 68.7%being female.75.2%of patients with MDD had melancholic features,followed by 63.8%with anxious distress.Patients had experienced MDD for a mean(SD)of 9.2(18)months.DARS scores covered the full range of severity with no major floor or ceiling effects.Confirmatory factor analysis showed adequate fit statistics(comparative fit index 0.976,goodness-of-fit index 0.935 and root mean square error of approximation 0.055).Convergent validity with anhedonia-related measures was confirmed.While the correlation between the DARS and the Hamilton Depression Rating Scale was not strong(r=0.31,baseline),the DARS was found to differentiate between levels of depression.Greater improvements in DARS scores were seen with the Hamilton Rating Scale for Depression responder group(effect size 1.16)compared with the non-responder group(effect size 0.46).Conclusions This study comprehensively evaluated the measurement properties of the DARS using a Chinese population with MDD.Overall,the Chinese version of DARS demonstrates good psychometric properties and has been found to be responsive to change during antidepressant treatment.The DARS is a suitable scale for assessing patient-reported anhedonia in future clinical trials.
基金Supported by the National Key R&D Program of China(2022YFB3303501)the National Natural Science Foundation of China(Project Nos.52176041 and 12102308)the Fundamental Research Funds for the Central Universities(Project Nos.2042023kf0208 and 2042023kf0159).
文摘Verification and validation(V&V)is a helpful tool for evaluating simulation errors,but its application in unsteady cavitating flow remains a challenging issue due to the difficulty in meeting the requirement of an asymptotic range.Hence,a new V&V approach for large eddy simulation(LES)is proposed.This approach offers a viable solution for the error estimation of simulation data that are unable to satisfy the asymptotic range.The simulation errors of cavitating flow around a projectile near the free surface are assessed using the new V&V method.The evident error values are primarily dispersed around the cavity region and free surface.The increasingly intense cavitating flow increases the error magnitudes.In addition,the modeling error magnitudes of the Dynamic Smagorinsky-Lilly model are substantially smaller than that of the Smagorinsky-Lilly model.The present V&V method can capture the decrease in the modeling errors due to model enhancements,further exhibiting its applicability in cavitating flow simulations.Moreover,the monitoring points where the simulation data are beyond the asymptotic range are primarily dispersed near the cavity region,and the number of such points grows as the cavitating flow intensifies.The simulation outcomes also suggest that the re-entrant jet and shedding cavity collapse are the chief sources of vorticity motions,which remarkably affect the simulation accuracy.The results of this study provide a valuable reference for V&V research.
文摘BACKGROUND The computed tomography(CT)-based preoperative risk score was developed to predict recurrence after upfront surgery in patients with resectable pancreatic ductal adenocarcinoma(PDAC)in South Korea.However,whether it performs well in other countries remains unknown.AIM To externally validate the CT-based preoperative risk score for PDAC in a country outside South Korea.METHODS Consecutive patients with PDAC who underwent upfront surgery from January 2016 to December 2019 at our institute in a country outside South Korea were retrospectively included.The study utilized the CT-based risk scoring system,which incorporates tumor size,portal venous phase density,tumor necrosis,peripancreatic infiltration,and suspicious metastatic lymph nodes.Patients were categorized into prognosis groups based on their risk score,as good(risk score<2),moderate(risk score 2-4),and poor(risk score≥5).RESULTS A total of 283 patients were evaluated,comprising 170 males and 113 females,with an average age of 63.52±8.71 years.Follow-up was conducted until May 2023,and 76%of patients experienced tumor recurrence with median recurrence-free survival(RFS)of 29.1±1.9 months.According to the evaluation results of Reader 1,the recurrence rates were 39.0%in the good prognosis group,82.1%in the moderate group,and 84.5%in the poor group.In comparison,Reader 2 reported recurrence rates of 50.0%,79.5%,and 88.9%,respectively,across the same prognostic categories.The study validated the effectiveness of the risk scoring system,demonstrating better RFS in the good prognosis group.CONCLUSION This research validated that the CT-based preoperative risk scoring system can effectively predict RFS in patients with PDAC,suggesting that it may be valuable in diverse populations.
基金funded by the Federal Ministry for Economic Affairs and Climate Action as part of the Technology Transfer Program Lightweight Construction(Grant no.03LB1000A).
文摘Lightweight structures for gears enable a reduction in material usage while maintaining the technical function of the gear.Previous approaches have pursued the strategy of lightweight structures in the gear wheel body.By taking inspiration from biological models and utilizing material savings in the gear rim,new design approaches for the lightweight design of gears can be realized.For this reason,a holistic biological design approach for spur gears is presented.In addition to the method of topology optimization,a biologically inspired approach based on diatoms is introduced,which achieves a weight reduction of over 50%compared to conventional solid gears.Diatom structures are extracted from the oceans,digitally modelled,and adapted to the load conditions of a reference gear by parametric design and simulation optimization.For the experimental validation of the design,a manufactured gear is statically loaded in the nominal load range and analyzed using a tactile geometry gear measurement.The measurement results of selected standard gear parameters show that the gear does not exhibit any plastic deformation for the nominal load capacity of 383 Nm,validating the presented design approach.
文摘Traditional Medicine Research published an article entitled Investigation on the mechanism of Qi-Hong-Tang-Zu ointment in thetreatmentofdiabetic wound by network pharmacology and experimental validation on 24 January 2025.The author confirmed this article’s proof on 23 January 2025 without any questions.But on 06 July 2025,the editorial team found,there was an error in Figure 8.Specifically,Figure 8E,Figure 8F and Figure 8G were mistakenly duplicated.The authors acknowledge that the original version of Figure 8 was incorrect and have provided the revised,correct version in this corrigendum.The authors would like to assert that there is no change in the body text of the article.
基金supported by the National Key R&D Program of China(Grant No.2022YFB3303500).
文摘systematic verification and validation(V&V)of our previously proposed momentum source wave generation method is performed.Some settings of previous numerical wave tanks(NWTs)of regular and irregular waves have been optimized.The H2-5 V&V method involving five mesh sizes with mesh refinement ratio being 1.225 is used to verify the NWT of regular waves,in which the wave height and mass conservation are mainly considered based on a Lv3(H s=0.75 m)and a Lv6(H s=5 m)regular wave.Additionally,eight different sea states are chosen to validate the wave height,mass conservation and wave frequency of regular waves.Regarding the NWT of irregular waves,five different sea states with significant wave heights ranging from 0.09 m to 12.5 m are selected to validate the statistical characteristics of irregular waves,including the profile of the wave spectrum,peak frequency and significant wave height.Results show that the verification errors for Lv3 and Lv6 regular wave on the most refined grid are−0.018 and−0.35 for wave height,respectively,and−0.14 and for−0.17 mass conservation,respectively.The uncertainty estimation analysis shows that the numerical error could be partially balanced out by the modelling error to achieve a smaller validation error by adjusting the mesh size elaborately.And the validation errors of the wave height,mass conservation and dominant frequency of regular waves under different sea states are no more than 7%,8% and 2%,respectively.For a Lv3(H_(s)=0.75 m)and a Lv6(H_(s)=5 m)regular wave,simulations are validated on the wave height in wave development section for safety factors FS≈1 and FS≈0.5-1,respectively.Regarding irregular waves,the validation errors of the significant wave height and peak frequency are both lower than 2%.
基金Shanghai Clinical Research Center for Chronic Musculoskeletal Diseases (20MC1920600)Shanghai Key Clinical Specialty "Traditional Chinese Medicine Orthopaedic Traumatology"(shslczdzk03901)+3 种基金The Second Round of Construction Project of National TCM Academic School Inheritance Studio "Shi's Trauma Department"[Letter of the People's Education of Traditional Chinese Medicine (2019) No.62]Shanghai High-level Local Universities "Chronic Muscle and Bone Damage Research and Transformation" Innovation Team [No.3 of Shanghai Education Commission (2022)]Program for Shanghai High-Level Local University Innovation Team (SZY20220315)Shanghai Shenkang Hospital Development Center Clinical Three-year Action Plan (SHDC2020CR3090B)。
文摘OBJECTIVE:To explore the potential molecular mechanism of Qigu capsule(芪骨胶囊,QGC) in the treatment of sarcopenia through network pharmacology and to verify it experimentally.METHODS:The active compounds of QGC and common targets between QGC and sarcopenia were screened from databases.Then the herbs-compounds-targets network,and protein-protein interaction(PPI) network was constructed.Gene ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis were performed by R software.Next,we used a dexamethasone-induced sarcopenia mouse model to evaluate the anti-sarcopenic mechanism of QGC.RESULTS:A total of 57 common targets of QGC and sarcopenia were obtained.Based on the enrichment analysis of GO and KEGG,we took the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) signaling pathway as a key target to explore the mechanism of QGC on sarcopenia.Animal experiments showed that QGC could increase muscle strength and inhibit muscle fiber atrophy.In the model group,the expression of muscle ring finger-1 and Atrogin-1 were increased,while myosin heavy chain was decreased,QGC treatment reversed these changes.Moreover,compared with the model group,the expressions of pPI3K,p-Akt,p-mammalian target of rapamycin and pForkhead box O3 in the QGC group were all upregulated.CONCLUSION:QGC exerts an anti-sarcopenic effect by activating PI3K/Akt signaling pathway to regulate skeletal muscle protein metabolism.
基金supported by the Natural Science Foundation of China(82560923)Natural Science Foundation of InnerMongolia(2019MS08008)+1 种基金Natural Science Foundation of Inner Mongolia Joint Program(2023LHMS08075)General Project of Inner Mongolia Medical University(YKD2025MS026).
文摘Objective Forsythia suspensa has long been utilized in traditional Chinese medicine(TCM)for the treatment of IgA nephropathy(IgAN),the most prevalent form of primary glomerular disease.However,the precise mechanisms remain inadequately understood.This study seeks to elucidate the underlying mechanisms of Forsythia suspensa extract(FSE)in the treatment of IgAN by employing an integrated approach that combines network pharmacology with in vivo experimental validation.Methods The chemical components of FSE were identified using high-performance liquid chromatography-mass spectrometry(HPLC–MS/MS).Additional chemical components and targets were determined through the Traditional Chinese Medicine Systems Pharmacology database.Potential therapeutic targets for IgAN were sourced from GeneCards and the Comparative Toxicogenomics Database.Subsequently,the enrichment analyses were conducted to evaluate the biological functions and pathways associated with the core targets.Finally,a mousemodel of IgAN was developed to validate the findings of the network pharmacology analysis.Results Through network analysis and HPLC–MS/MS,31 chemical components of FSE were identified.A total of 99 common targets were discovered between FSE and IgAN.The enrichment analyses suggested that FSE may mitigate IgAN primarily by inhibiting the TLR and NF-κB signaling pathways.In vivo experiments demonstrated that FSE reduced inflammation and preserved renal function in mice with IgAN through the Tolllike receptor 9(TLR9)/NF-κB pathway.Conclusion The integration of network pharmacology and animal experiments suggests that FSE alleviates renal inflammation and damage in IgAN through the TLR9/NF-κB signaling pathway.
基金funded in part by the German Research Foundation(Grant reference:496846758).
文摘The ongoing revolution in information technology is reshaping human life. In the realm of health behavior, wearable technology emerges as a leading digital solution,capturing physical behaviors (i.e., physical activity, sedentary habits, sleep patterns) within the 24-h cycle of daily life. Wearables are applied in research, clinical practice, and as lifestyle devices;most obvious, they promise to be a key element for increasing human physical activity, one of the biggest health challenges nowadays.
基金supported by the Natural Science Foundation of Hunan Province(2024JJ6626)the Hunan Provincial Key Laboratory of Regional Hereditary Birth Defects Prevention and Control(HPKL202320),China.
文摘Objective:Pelvic floor dysfunction is common among pregnant and postpartum women and significantly impacts quality of life.This study aims to translate the German Pelvic Floor Questionnaire for Pregnant and Postpartum Women into Chinese and to evaluate its reliability and validity in the Chinese population.Methods:The questionnaire was translated using the Brislin model.A cross-sectional study was conducted among pregnant and postpartum women to assess the content validity,construct validity,Cronbach’sαcoefficient,test-retest reliability,and split-half reliability of the Chinese version.Results:A total of 72 women were included,with 6.9% being pregnant and 93.1% postpartum;the age was(32.3±3.6)years.The Chinese version of the questionnaire contains 4 dimensions and 45 items.The content validity index of individual items ranged from 0.833 to 1.000,with a scale-level content validity index of 0.977 and intraclass correlation coefficients(ICCs)exceeding 0.90.The overall Cronbach’s α coefficient was 0.891,with subscale coefficients ranging from 0.732 to 0.884(all ICCs>0.70).The testretest reliability of the total scale was 0.833,and for the 4 dimensions,bladder,bowel,prolapse,and sexual function,the values were 0.776,0.579,0.732,and 0.645,respectively.The split-half reliability was 0.74.Conclusion:The Chinese version of the questionnaire demonstrated good reliability and validity,indicating its applicability in assessing pelvic floor dysfunction and associated risk factors during pregnancy and postpartum.
文摘The purpose of this paper is to look into how reliable and valid the Persian version of the Cannabis Use Disorder Identification Test-Revised (CUDIT-R-Pr) is. It will also compare the screening features of the CUDIT-R with those of the DSM-5 criteria for cannabis use disorder (CUD) based on the SCID-5-CT in a group of university students in Tehran, Iran. The study used the stratified random sampling technique to collect data from 541 students (19 to 24 years old) who used cannabis in Tehran universities in 2024. Confirmatory factor analysis confirmed the uni-dimensionality of the CUDIT-R-Pr. We checked the reliability of the CUDIT-R-Pr using Cronbach Alpha, split-half, inter-rater, test-retest stability over time, and parallel testing equivalence. The results indicated that CUDIT-R-Pr is reliable, reproducible, and responsive, with substantial agreement and adequate interpretability. The CUDIT-R shows that it can tell the difference between different levels of cannabis use severity, which is known as discriminant validity. Receiver operating characteristic analyses confirmed this, using an area under the receiver operating characteristics curve (AUC = 0.95) at a cutoff of ten or less. This allowed CUDIT-R-Pr to accurately predict any DSM-5 based on the highest correctly classified value (0.89), demonstrating high levels of sensitivity (0.96), specificity (0.69), and Youden value (0.65). The exact maximum Youden index (0.72) showed that CUDIT-R-Pr could also predict moderate DSM-5 with a cutoff of twelve or less. To validate and generalize the CUDIT-R-Pr for use among Iranian cannabis users, we need more research.
基金supported by the project Monetary valuation of soil ecosystem services and creation of initiatives to invest in soil health:setting a framework for the inclusion of soil health in business and in the policy making process(InBestSoil)(Horizon Europe)Grant agreement ID:101091099。
文摘Ecosystem services(ES)mapping and models have advanced in recent years.Improvements were made,and the assessments have transitioned from qualitative to quantitative.Although this is an important advancement,the ES mapping and modelling validation step has been overlooked,and this raises an important question in the credibility of the outcomes.This has been an important and unsolved issue in the ES research community that needs to be tackled.This highlight paper discusses the importance of validating single ES mapping and models.Conducting this using field or proximal/remote sensing raw data and not data from other models or stakeholder evaluation is important.A validation step should be mandatory in ES frameworks since it can assess the models’veracity,contribute to identifying the model’s weaknesses/strengths and ultimately represent a scientific advance in the field.This is easier to apply to the biophysical mapping and models of regulating and provisioning ES than to cultural ES,as the latter rely more on perception and cultural contexts.Also,ES supply models are easier to validate than demand and flow models.Robust and well-grounded models are essential for ensuring the reliability of individual ES maps and models and should be integrated into decision-making processes.Although several challenges arise related to the costs of data collection,in several cases prohibitive,and the time and the expertise needed to conduct this sampling and analysis,this is likely an imperative step that needs to be considered in the future.This will be beneficial in establishing ES research and improving decision-making and wellbeing.
文摘Objective:To translate,adapt,and validate the Indonesian version of the Prenatal Health Behavior Scale.Methods:This cross-sectional,cross-cultural adaptation study was conducted between September 2024 and October 2024 in Ngrambe and Sine,subdistricts in Ngawi,East Java,Indonesia.We selected participants using purposive convenience sampling and matched them with inclusion and exclusion criteria.We collected sociodemographic,Prenatal Health Behavior Scale,and anthropometrics(height,weight,body mass index,and middle-upper arm circumference)data.We analyzed the content validity using the content validity index and Gwet's chance-corrected Agreement Coefficient 2,face validity by pilot-testing on several pregnant women,and construct validity using exploratory factor analysis.We measured reliability using McDonald's omega coefficient.Results:We recruited 183 pregnant women in this study(median age 28 years).The item-content validity index(I-CVI)of all items was 1.00,with Gwet's chance-corrected Agreement Coefficient 2 was 0.945.The face validity resulted in a clear statement of all items.The exploratory factor analysis showed the two-factor model best suited to the questionnaire.Omega coefficients for the overall scale,health-impairing,and health-promoting domains were 0.696,0.507,and 0.678,respectively.Conclusions:The Indonesian version of the Prenatal Health Behavior Scale is a valid and reliable instrument to assess prenatal health behavior in Indonesian-speaking pregnant women.Future studies may implement this scale in community and clinical settings.
基金supported by the National Key Research and Development Pro-gram of China(2021YFF0601902)the National Reference Material Development Project(S2022234).
文摘To solve the problem of the lack of reference material(RM)for determination of allergenic ingredients in food,a RM of cashew nut powder was developed in the study.Cashew nut powder was prepared from cashew nut kernel by selecting,cleaning,crushing,n-hexane degreasing and sieving treatment.The reliability and traceability of RM was verified using real-time quantitative polymerase chain reaction(qPCR)and phylogenetic tree analysis.The cashew nut powder RM showed good homogeneity,and good stability under long-term storage at 4℃and short-term simulated transportation from-20 to 45℃.The RM was determined jointly by 8 collaborative laboratories,and the characteristic CT value was 24.732,and the extended uncertainty was 1.052%(k=2).The RM was applied to verify the amplification efficiency and the limit of detection for qPCR assay,and showed good applicability.The RM could be used for method validation and quality control,for the determination of allergenic ingredients in food mixed with trace amounts of cashew nut.
文摘Objective:To translate and adapt the dementia knowledge assessment scale(DKAS)into Sinhala version and to evaluate its psychometric properties among nursing students.Methods:A cross-sectional validation study was conducted in two phases:(i)translation and adaptation and(ii)evaluating psychometric properties(N=394 nursing students).Results:The DKAS was adapted to the Sinhala(Si-DKAS)version,and the content validity index(CVI=0.9)was satisfactory.Exploratory factor analysis(EFA)and confirmatory factor analysis(CFA)resulted in an 18-item Si-DKAS with a four-factor model:“care considerations,”“causes and characteristics of dementia,”“health promotion,”and“misconceptions about dementia.”The model fit indices were suboptimal(comparative fix index[CFI]=0.809 and Turker-Lewis index[TLI]=0.773),and some indices were acceptable(standardized root-mean-squared residual[SRMR]=0.040 and root-mean-squared error of approximation[RMSEA]=0.053).Internal consistency(0.7)and test-retest correlation(0.9)were acceptable.Discriminant validity was confirmed by knowledge score differences based on academic years.Conclusions:This is a valid and reliable tool for assessing knowledge of dementia among Sinhala-speaking nursing students.
基金supported by Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences,Youth Program(C12021A01819)China National Key R&D Plan Special Program for Modernization of Traditional Chinese Medicine,Ministry of Science and Technology of the People’s Republic of China,2017YFC1700604+1 种基金Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences(CI2021B009)Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(ZYYCXTD-C-202205).
文摘Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial(RCT)conducted in China from December 2018 to September 2021.The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale.The scale’s reliability was assessed using Cronbach’s a and test-retest reliability,while content validity was evaluated with the content validity index.We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores.Results:Of the 378 patients analyzed in the original RCT,352(93.2%)completed the TCM-KDP questionnaire.The Cronbach’s a of the eight-item TCM-KDP scale was 0.734,and the test-retest reliability was 0.745.Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%.The mean TCM-KDP score was 2.80±0.92.Compared with patients with stage II CRC,those with stage III CRC had significantly higher TCM-KDP scores(2.25 vs.2.50,P=.026).We categorized all patients into highor low-KDP score groups(the cut-off score was 2.8).Patients with lower TCM-KDP scores had significantly higher serum interleukin-1b expression levels(P=.04).Conclusion:The patient-reported TCM-KDP scale demonstrated relatively good feasibility,internal consistency,and test-retest reliability among patients with CRC.Future studies could apply this scale to other cancer types and diseases.
文摘BACKGROUND The rising global prevalence of gastroesophageal reflux disease(GERD)has been closely linked to lifestyle changes driven by globalization.GERD imposes a substantial public health burden,affecting quality of life and leading to potential complications.Early intervention through lifestyle modification can prevent disease onset;however,there is a lack of effective risk prediction models that emphasize primary prevention.AIM To develop and validate a GERD Risk Scoring System(GRSS)aimed at identifying high-risk individuals and promoting primary prevention strategies.METHODS A 45-item questionnaire encompassing major lifestyle and demographic risk factors was developed and validated.It was administered to healthy controls and GERD patients.Two regression models-one using continuous variables and another using categorized variables-were used to develop a computational prediction equation and a clinically applicable scoring scale.An independent validation cohort of 355 participants was used to assess model performance in terms of discrimination(C-index),calibration,sensitivity,specificity,internal consistency(Cronbach's alpha),and test-retest reliability(intraclass correlation coefficient,Bland-Altman analysis).RESULTS Significant associations were observed between GERD and key lifestyle factors.The derived GRSS equation and scoring scale demonstrated strong discriminative ability,with high sensitivity and specificity.The scoring system exhibited excellent internal consistency(Cronbach’s alpha)and strong test-retest reliability.The C-index indicated excellent predictive accuracy in both derivation and validation cohorts.CONCLUSION GRSS offers a novel and validated approach to GERD risk prediction,combining a robust equation for digital applications and a practical scale for clinical use.Its ability to accurately identify at-risk individuals supports a paradigm shift toward primary prevention,underscoring its significance in addressing the growing burden of GERD at the population level.
文摘The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.
基金supported in part by the Nation Natural Science Foundation of China under Grant No.52175099China Postdoctoral Science Foundation under Grant No.2020M671494Jiangsu Planned Projects for Postdoctoral Research Funds under Grant No.2020Z179。
文摘A tracking stability control problem for the vertical electric stabilization system of moving tank based on adaptive robust servo control is addressed.This paper mainly focuses on two types of possibly fast timevarying but bounded uncertainty within the vertical electric stabilization system:model parameter uncertainty and uncertain nonlinearity.First,the vertical electric stabilization system is constructed as an uncertain nonlinear dynamic system that can reflect the practical mechanics transfer process of the system.Second,the dynamical equation in the form of state space is established by designing the angular tracking error.Third,the comprehensive parameter of system uncertainty is designed to estimate the most conservative effects of uncertainty.Finally,an adaptive robust servo control which can effectively handle the combined effects of complex nonlinearity and uncertainty is proposed.The feasibility of the proposed control strategy under the practical physical condition is validated through the tests on the experimental platform.This paper pioneers the introduction of the internal nonlinearity and uncertainty of the vertical electric stabilization system into the settlement of the tracking stability control problem,and validates the advanced servo control strategy through experiment for the first time.
