Diagnostic Validity Research Articles

Comparison of Diagnostic Validity of Cephalometric Analyses of the ANB Angle and Tau Angle for Assessment of the Sagittal Relationship of Jaw and Mandible.

Cephalometric analysis is an essential tool used in orthodontic diagnosis and treatment planning. The aim of this study was to evaluate the reliability and repeatability of new cephalometric points introduced in Tau angle analysis, in contrast to the gold standard, which is the analysis of the ANB angle. For this purpose, an attempt was made to assess the repeatability and reliability of the introduction of anthropometric points by evaluating both inter- and intraobserver parameters, as well as the agreement among the orthodontists participating in the study. Repeatability and reliability assessments for all six anthropometric points (N, A, B, T, M, G) used in the analysis of the ANB and Tau angles were conducted individually by 29 orthodontists. This assessment was performed in triplicate on the day of the study, on the day following the first study, and on the seventh day after the second study. Measurement errors for the ANB and Tau angles were evaluated using the Dahlberg formula and intraclass correlation coefficients (ICCs). The orthodontists in the study measured sagittal discrepancy significantly more accurately using the ANB angle compared to the Tau angle (p < 0.001). The Dahlberg error for measuring the Tau angle was three times greater than that for the ANB angle (p < 0.001). Additionally, the ICC for the Tau angle was more than 3.5 times smaller than that for the ANB angle, while the R&R error for Tau measurement was more than three times greater than that for the ANB angle (p < 0.001). The results of ANB angle measurements exhibit fewer errors in comparison to Tau angle measurements.

Diagnostic validity of MRI for central nervous system tuberculosis: protocol for a systematic review and meta-analysis

IntroductionCentral nervous system tuberculosis (CNSTB) is a severe condition, sometimes associated with a poor prognosis. Early diagnosis of CNSTB remains challenging, considering that conventional methods lack sensitivity or might lead...

Picture naming test: Linguistic challenges of the method and ways to solve them

The paper considers benefits and drawbacks of the Picture Naming Test (PNT) as a diagnostic method suggesting the ways to improve its diagnostic and research validity. Although this test is popular in both national and international neuropsychological assessment and research practice, its use is largely due to tradition and practical convenience. However, theoretical underpinnings for its effectiveness are not sufficiently represented in the pertinent literature, which determines the relevance of the study. The major objective of the paper is to consider the PNT as a research technique from the point of view of psycholinguistics, cognitive science, and corpus linguistics and to propose integrated approaches for the further development of these tests. The material comprises picture naming tests developed for the Russian and English languages. The study sets the following aims: 1) to define the main features of PNT and the principles of its application viewed from a historical perspective; 2) to identify the theoretical foundations (linguistic and neuropsychological) for its use as a diagnostic tool; 3) to highlight the problematic aspects of the method; 4) to suggest possible ways to eliminate them. To accomplish these tasks, various methods of corpus linguistics are applied throughout the article. The historical outline of PNT development suggests that the current design might stem from earlier contexts of use. A review of existing models of lexical access provides a theoretical basis for the test in its current form and suggests possible avenues for its development grounded in experimental research, advances in linguistics and big data analysis. A separate section of the article presents critique of the most popular tests. Finally, the analysis of the existing English and Russian tests through the corpus-based methodology clearly demonstrates the need for more detailed norming and stimuli selection. By way of conclusion the authors outline the principles of designing Picture Naming Tests for specific purposes and put forward a step-by-step algorithm that enables careful selection of the necessary indicators and parameters.

Threshold Optimization for Tumor Markers S100b and MIA in Uveal Melanoma - A Single Center Analysis.

Uveal melanoma (UM) is the most common malignant tumor of the eye in adults. Metastases develop in 50% of the patients, predominantly in the liver. In UM, the cut-off concentrations of the blood-based tumor markers S100b and MIA are inconclusive. In this retrospective monocenter study, we statistically evaluated 1,878 S100b and 1,768 MIA measurements in 244 patients with UM from 2011-2020. Threshold optimization was performed using receiver operating characteristic (ROC) curves. A total of 171 patients with non-metastatic UM (nmUM) and 73 patients with metastatic UM (mUM) showed no differences in sex, age at diagnosis or the affected eye. In mUM, 80% of the patients developed metastases to the liver at a median of 46 months after initial diagnosis. The sensitivity and specificity of S100b was 16.10% and 94.52%, and that of MIA was 31.86% and 81.42%, respectively. ROC curves revealed poor values for the area under the curve of 0.57 for S100b and 0.55 for MIA. The optimal cut-off concentration to detect metastases was 0.14 μg/l for S100b and 17.4 ng/ml for MIA. With at least one tumor marker elevated, optimized sensitivity was 20.40% and specificity 96.76%. Current thresholds for S100b and MIA in UM are not able to detect early metastatic disease and require additional diagnostics to clarify false positive results. Threshold optimization considering both S100b and MIA results in a better diagnostic validity with an acceptable specificity and a poor sensitivity. Highly sensitive blood-based and imaging methods to detect metastases early in UM are urgently needed.

Is a sFlt-1/PlGF cutoff of 38 suitable to predict adverse outcomes in pregnancies with abnormal uterine artery Doppler velocimetry in the second trimester?

ObjectiveTo determine the optimal cutoff value for the soluble fms-like tyrosine kinase-1 (sFlt-1)/placental growth factor (PlGF) ratio to predict maternal and fetal adverse events in pregnancies with uterine artery Doppler scans results above the 95th percentile in the late second trimester. Study designRetrospective, observational cohort study on 116 asyntomatic patients with abnormal uterine artery Doppler scans at gestational week 25. The sFlt-1/PlGF ratio was determined within the weeks 25 to 29 of gestation and ROC curve analysis performed. The diagnostic validity of different cutoff values to predict severe maternal and fetal complications, i.e. preeclampsia, fetal growth restriction, placental abruption, and fetal death, was analyzed. Main outcome measuresAn ideal cutoff for sFlt-1/PlGF ratios in pregnancies with abnormal uterine artery Doppler in the second trimester. ResultsApplying a cutoff point of 38, the area under the ROC curve was 0.89, generally considered low risk in fetal and maternal complication prediction. The sensitivity was 32.1%, the specificity 98.4%, the positive predictive value (PPV) 94.4%, and the negative predictive value (NPV) 63.3%. A cutoff value of 10, leading to the highest Youden index, performed best at detecting overall complications, increasing sensitivity to 69.8% and the NPV to 76.8%. at the cost of a reduced specificity and PPV. ConclusionsIn pregnancies with abnormal uterine artery Doppler in the second trimester, an sFlt-1/PlGF cutoff value greater than equal to 38 improves its predictive power for adverse events.

Surveillance and treatment of primary hepatocellular carcinoma (aka. STOP HCC): protocol for a prospective cohort study of high-risk patients for HCC using GALAD-score

BackgroundVietnam and Saudi Arabia have high disease burden of primary hepatocellular carcinoma (HCC). Early detection in asymptomatic patients at risk for HCC is a strategy to improve survival outcomes in HCC management. GALAD score, a serum-based panel, has demonstrated promising clinical utility in HCC management. However, in order to ascertain its potential role in the surveillance of the early detection of HCC, GALAD needs to be validated prospectively for clinical surveillance of HCC (i.e., phase IV biomarker validation study). Thus, we propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients with advanced fibrosis or compensated cirrhosis, irrespective of etiologies, using semi-annual abdominal ultrasound and GALAD score for five years.MethodsWe plan to recruit a cohort of 1,600 patients, male or female, with advanced fibrosis or cirrhosis (i.e., F3 or F4) and MELD ≤ 15, in Vietnam and Saudi Arabia (n = 800 each). Individuals with a liver mass ≥ 1 cm in diameter, elevated alpha-fetoprotein (AFP) (≥ 9 ng/mL), and/or elevated GALAD score (≥ -0.63) will be scanned with dynamic contrast-enhanced magnetic resonance imaging (MRI), and a diagnosis of HCC will be made by Liver Imaging Reporting and Data System (LiRADS) assessment (LiRADS-5). Additionally, those who do not exhibit abnormal imaging findings, elevated AFP titer, and/or elevated GALAD score will obtain a dynamic contrast-enhanced MRI annually for five years to assess for HCC. Only MRI nearest to the time of GALAD score measurement, ultrasound and/or AFP evaluation will be included in the diagnostic validation analysis. MRI will be replaced with an abdominal computed tomography scan when MRI results are poor due to patient conditions such as movement etc. Gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid-enhanced MRI will not be carried out in study sites in both countries. Bootstrap resampling technique will be used to account for repeated measures to estimate standard errors and confidence intervals. Additionally, we will use the Cox proportional hazards regression model with covariates tailored to the hypothesis under investigation for time-to-HCC data as predicted by time-varying biomarker data.DiscussionThe present work will evaluate the performance of GALAD score in early detection of liver cancer. Furthermore, by leveraging the prospective cohort, we will establish a biorepository of longitudinally collected biospecimens from patients with advanced fibrosis or cirrhosis to be used as a reference set for future research in early detection of HCC in the two countries.Trial registrationName of the registry: ClinicalTrials.govRegistration date: 22 April 2022Trial registration number: NCT05342350URL of trial registry record

Detection the severity of organophosphate intoxication using sensitive serum biomarkers S100B and amyloid β (Aβ) in Egyptian subjects

Organophosphate (OP) is a compound considered the main leading cause of morbidity and mortality from poisoning worldwide. Serum pseudocholinesterase was evaluated as a diagnostic indicator; it cannot be used to monitor therapy or severity of the intoxication. The rationale of the current study was to evaluate sensitivity, specificity, and cut-off values of serum S100B and amyloid β for neurological affection severity. This study was carried out on sixty OP-impaired patients; in addition, 20 normal controls were included. Serum liver and kidney function tests, malondialdehyde, pseudocholinesterase, and the levels of S100B and amyloid β (Aβ) were determined. Data showed that Pearson’s analysis indicated that the serum level of S100B was positively correlated with Aβ. On the contrary, the activity of pseudocholinesterase was negatively correlated with both of S100B and Aβ. Serum ALT, AST, creatinine, urea, acetylcholine, and MDA levels were elevated while pseudocholinesterase activity was reduced in moderate and severe OP intoxication versus control. A drastic elevation (p<0.001) in the levels of S100B and Aβ was performed in the patient group suffering from OP intoxication versus the normal group. The diagnostic statistical validation of targeted parameters in distinguishing between moderate OP intoxication and control clarifies that S100B displayed the best AUC (0.997) followed by Aβ (AUC=0.992), while the diagnostic veracity of S100B and Aβ in setting apart severe OP-intoxicated and normal subjects stated the symmetric efficacy of potential markers. It was concluded that the significant changes in the levels of S100B and Aβ were directly proportional to the degree of severity of OP intoxication.

Identifying Crucial Biomarkers in Osteoporosis and Ulcerative Colitis Through Bioinformatics Analysis of Co-expressed Genes.

Osteoporosis (OP) and ulcerative colitis (UC), prevalent immune diseases, exert a substantial socioeconomic impact globally. This study identifies biomarkers for these diseases, paving the way for in-depth research. Initially, the Gene Expression Omnibus (GEO) database was employed to analyze datasets GSE35958 and GSE87466. This analysis aimed to pinpoint co-expression differential genes (DEGs) between OP and UC. Subsequently, the Metascape database facilitated the Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis of these DEGs' co-expression. For network construction and visualization, the STRING11.5 database along with Cytoscape 3.7.2 (Cytoscape Team, USA) were utilized to create a protein-protein interaction (PPI) network. Moreover, Cytoscape's cytoHubba plugin was instrumental in identifying the central genes, known as hub genes. In the datasets GSE35958 and GSE87466, 156 co-expressed DEGs were discovered. The PPI network, constructed using STRING11.5 and Cytoscape 3.7.2, comprises 96 nodes and 222 connections. Notably, seven hub genes were identified, namely COL6A1, COL6A2, BGN, NID1, PLAU, TGFB1, and PLAUR. These DEGs were predominantly enriched in pathways such as extracellular matrix organization and collagen-containing extracellular matrix, as per GO analysis. For diagnostic model construction and hub gene validation, datasets GSE56815 and GSE107499 from the GEO database were employed. The top five hub genes were validated. In conclusion, the hub genes identified in this study played a significant role in the early diagnosis, prevention, and treatment of OP and UC. Furthermore, they provide fresh insights into the underlying mechanisms of these diseases' development and progression.

Diagnostic accuracy of brain age prediction in a memory clinic population and comparison with clinically available volumetric measures

The aim of this study was to assess the diagnostic validity of a deep learning-based method estimating brain age based on magnetic resonance imaging (MRI) and to compare it with volumetrics obtained using NeuroQuant (NQ) in a clinical cohort. Brain age prediction was performed on minimally processed MRI data using deep convolutional neural networks and an independent training set. The brain age gap (difference between chronological and biological age) was calculated, and volumetrics were performed in 110 patients with dementia (Alzheimer’s disease, frontotemporal dementia (FTD), and dementia with Lewy bodies), and 122 with non-dementia (subjective and mild cognitive impairment). Area-under-the-curve (AUC) based on receiver operating characteristics and logistic regression analyses were performed. The mean age was 67.1 (9.5) years and 48.7% (113) were females. The dementia versus non-dementia sensitivity and specificity of the volumetric measures exceeded 80% and yielded higher AUCs compared to BAG. The explained variance of the prediction of diagnostic stage increased when BAG was added to the volumetrics. Further, BAG separated patients with FTD from other dementia etiologies with > 80% sensitivity and specificity. NQ volumetrics outperformed BAG in terms of diagnostic discriminatory power but the two methods provided complementary information, and BAG discriminated FTD from other dementia etiologies.

Internal Validation of the ASFV MONODOSE dtec-qPCR Kit for African Swine Fever Virus Detection under the UNE-EN ISO/IEC 17025:2005 Criteria.

African swine fever virus is considered an emerging virus that causes African swine fever, a disease characterised by high mortality and elevated transmission rates and that, as it is for most other viral diseases, cannot be treated with specific drugs. Effective and reliable detection of the virus is relevant to prevent uncontrolled contagion among boar populations and to reduce economic losses. Moreover, animal health laboratories are demanding standardisation, optimisation and quality assurance of the available diagnostic assays. In the present study, the ASFV MONODOSE dtec-qPCR kit was validated following the UNE-EN ISO/IEC 17025:2005 guidelines. Analytical validation terms include in silico and in vitro specificity, sensitivity, efficiency and reliability (repeatability/reproducibility). Diagnostic validation of the method was assessed through the analysis of a total of 181 porcine samples originating from six different matrix types doped with African swine fever virus DNA received from the European reference laboratory for African Swine Fever (INIA-CISA, Madrid, Spain): whole blood, blood serum, kidney, heart, liver and tonsil. Results agreed with those obtained from a reference detection method also based on real-time PCR, endorsed by WOAH, but the ASFV MONODOSE dtec-qPCR kit incorporates some technical innovations and improvements which may benefit end-users. This kit, available worldwide with full analytical and diagnostic validation, can recognise all known ASFV genotypes and brings additional benefits to the current qPCR technology.

The value of transanal multipoint full-layer puncture biopsy in determining the response degree of rectal cancer following neoadjuvant therapy: a prospective multicenter study

Objective: To verify the feasibility and accuracy of the transanal multipoint full-layer puncture biopsy (TMFP) technique in determining the residual status of cancer foci after neoadjuvant therapy (nCRT) in rectal cancer. Methods: Between April 2020 and November 2022, a total of 78 patients from the Beijing Chaoyang Hospital of Capital Medical University, the Beijing Friendship Hospital of Capital Medical University, the Qilu Hospital of Shandong University, the Zhongnan Hospital of Wuhan University with advanced rectal cancer received TMFP after nCRT participated in this prospective multicenter trial. There were 53 males and 25 females, aged (M(IQR)) 61 (13) years (range: 35 to 77 years). The tumor distance from the anal verge was 5 (3) cm (range: 2 to 10 cm). The waiting time between nCRT and TMFP was 73 (26) days (range: 33 to 330 days). 13-point transanal puncture was performed with a 16 G tissue biopsy needle with the residual lesion as the center. The specimens were submitted for independent examination and the complications of the puncture were recorded. The consistency of TMFP and radical operation specimen was compared. The consistency of TMPF with clinical remission rates for the diagnosis of complete pathological remission was compared by sensitivity, specificity, negative predictive value, positive predictive value and accuracy. Statistical analysis between groups was performed using the χ2 analysis, and a paired χ2 test was used to compare diagnostic validity. Results: Before TMFP, clinical complete response (cCR) was evaluated in 27 cases. Thirty-six cases received in vivo puncture, the number of punctures in each patient was 13 (8) (range: 4 to 20), 24 cases of tumor residue were found in the puncture specimens. The sensitivity to judgment (100% vs. 60%, χ2=17.500, P<0.01) and accuracy (88.5% vs. 74.4%, χ2=5.125, P=0.024) of TMFP for the pathologic complete response (pCR) were significantly higher than those of cCR. Implement TMFP based on cCR judgment, the accuracy increased from 74.4% to 92.6% (χ2=4.026, P=0.045). The accuracy of the in vivo puncture was 94.4%, which was 83.3% of the in vitro puncture (χ2=1.382, P=0.240). Overall, the accuracy of TMFP improved gradually with an increasing number of cases (χ2=7.112, P=0.029). Conclusion: TMFP is safe and feasible, which improves the sensitivity and accuracy of rectal cancer pCR determination after nCRT, provides a pathological basis for cCR determination, and contributes to the safe development of the watch and wait policy.

Comparison of three measures for insomnia in ischemic stroke patients: Pittsburgh sleep quality index, insomnia severity index, and Athens insomnia scale.

This study investigated the consistency and determined the optimal threshold values of three scales in the diagnosis of insomnia of ischemic stroke (IS) patients. Participants in this study consisted of 569 acute IS patients. All 569 patients completed the assessment of the three insomnia scales. Insomnia of IS patients were assessed by Pittsburgh sleep quality index (PSQI), Insomnia Severity Index (ISI), and Athens insomnia scale (AIS). Also, basic patient information, neurological function, and activities of daily living were assessed. General information was compared between the insomnia group and the no-insomnia group. Cronbach's α coefficients, Cohen's Kappa consistency, Receiver operating characteristic (ROC) curve and DeLong's test analysis were used to analyze the reliability and diagnostic validity of PSQI, ISI, and AIS. The PSQI and ISI showed high reliability with Cronbach's α of 0.875 and 0.858, respectively, while the AIS had an α coefficient of 0.734, demonstrating acceptable reliability. The PSQI, ISI, and AIS showed outstanding diagnostic ability with an AUC of 0.960 (95% CI: 0.946, 0.974), 0.911 (95% CI: 0.882, 0.941), and 0.876 (95% CI:0.837, 0.916). The best diagnostic cutoffs for PSQI, ISI, and AIS are ≥9, ≥15, and ≥8. Each of the three questionnaires has advantages and disadvantages when assessing insomnia. In the evaluation of insomnia in IS patients, the best questionnaire selection should be made according to the purpose of clinical evaluation and considering the sensitivity and specificity.

Reproducibility analysis of automated deep learning based localisation of mandibular canals on a temporal CBCT dataset

Preoperative radiological identification of mandibular canals is essential for maxillofacial surgery. This study demonstrates the reproducibility of a deep learning system (DLS) by evaluating its localisation performance on 165 heterogeneous cone beam computed tomography (CBCT) scans from 72 patients in comparison to an experienced radiologist’s annotations. We evaluated the performance of the DLS using the symmetric mean curve distance (SMCD), the average symmetric surface distance (ASSD), and the Dice similarity coefficient (DSC). The reproducibility of the SMCD was assessed using the within-subject coefficient of repeatability (RC). Three other experts rated the diagnostic validity twice using a 0–4 Likert scale. The reproducibility of the Likert scoring was assessed using the repeatability measure (RM). The RC of SMCD was 0.969 mm, the median (interquartile range) SMCD and ASSD were 0.643 (0.186) mm and 0.351 (0.135) mm, respectively, and the mean (standard deviation) DSC was 0.548 (0.138). The DLS performance was most affected by postoperative changes. The RM of the Likert scoring was 0.923 for the radiologist and 0.877 for the DLS. The mean (standard deviation) Likert score was 3.94 (0.27) for the radiologist and 3.84 (0.65) for the DLS. The DLS demonstrated proficient qualitative and quantitative reproducibility, temporal generalisability, and clinical validity.

Coronary CT angiography and coronary atherosclerosis : Where do we stand today?

Cardiac computed tomography (CT) has made substantial progress in recent years. The main field of application is CT coronary angiography for visualization of the coronary arteries and for the detection and exclusion of coronary artery stenosis. This has been included in international guidelines for the management of stable coronary artery disease or chronic coronary syndrome as well as for the diagnostic work-up of patients with acute chest pain; however, it must be taken into account that the diagnostic validity is only sufficiently high when the image quality is good and therefore alternative diagnostic procedures should be included in patients where an unrestricted good image quality is not to be expected. The fact that CT angiography enables the detection not only of coronary stenosis but also of nonobstructive atherosclerotic plaque is interesting for the estimation of the risk of atherosclerotic events. It is practically certain that in the absence of detectable atherosclerotic plaque in CT angiography, statin treatment does not lower the risk of atherosclerotic events. To what extent CT is suitable to provide indications for statin treatment and the threshold for which the presence of nonobstructive plaque should prompt initiation of statin treatment are currently the subject of intensive research.

Diagnostic validation of vertebral heart score machine learning algorithm for canine lateral chest radiographs.

The vertebral heart score is a measurement used to index heart size relative to thoracic vertebra. Vertebral heart score can be a useful tool for identifying and staging heart disease and providing prognostic information. The purpose of this study is to validate the use of a vertebral heart score algorithm compared to manual vertebral heart scoring by three board-certified veterinary cardiologists. A convolutional neural network centred around semantic segmentation of relevant anatomical features was developed to predict heart size and vertebral bodies. These predictions were used to calculate the vertebral heart score. An external validation study consisting of 1200 canine lateral radiographs was randomly selected to match the underlying distribution of vertebral heart scores. Three American College of Veterinary Internal Medicine board-certified cardiologists were enrolled to manually score 400 images each using the traditional Buchanan method. Post-scoring, the cardiologists evaluated the algorithm for misaligned anatomic landmarks and overall image quality. The 95th percentile absolute difference between the cardiologist vertebral heart score and the algorithm vertebral heart score was 1.05 vertebrae (95% confidence interval: 0.97 to 1.20 vertebrae) with a mean bias of -0.09 vertebrae (95% confidence interval: -0.12 to -0.05 vertebrae). In addition, the model was observed to be well calibrated across the predictive range. We have found the performance of the vertebral heart score algorithm comparable to three board-certified cardiologists. While validation of this vertebral heart score algorithm has shown strong performance compared to veterinarians, further external validation in other clinical settings is warranted before use in those settings.

N-Terminal Pro-B Type Natriuretic Peptide as a Predictive Biomarker of Bronchopulmonary Dysplasia or Death Due to Bronchopulmonary Dysplasia in Preterm Neonates: A Systematic Review and Meta-Analysis.

Emerging evidence suggests the clinical utility of N terminal pro B type natriuretic peptide (NT-proBNP) in multiple cardiac and pulmonary abnormalities both in adult and pediatric populations. To date, however, there is no consensus regarding its efficacy for the prediction and severity of bronchopulmonary dysplasia in premature neonates. The objective of the present meta-analysis was to determine differences in NT-proBNP among neonates that develop BPD or die from BPD and to evaluate if there is relative information on the diagnostic accuracy of the method. We conducted a systematic search according to the PRISMA guidelines and looked into Medline (1966-2023), Scopus (2004-2023), Clinicaltrials.gov (2008-2023), EMBASE (1980-2023), Cochrane Central Register of Controlled Trials CENTRAL (1999-2022) and Google Scholar (2004-2023) together with the reference lists from included studies. The potential risk of bias encountered in our study was evaluated using the QUADAS -2 tool. Finally, a total of 9 studies met the eligibility criteria, comprising 1319 newborns, from which 397 developed BPD and 922 were unaffected controls. The results retrieved from our meta-analysis showed that newborns suffering from BPD had notably elevated NT-proBNP levels after birth when compared with healthy neonates (SMD 2.57, 95% CI 0.41, 4.72). The summary effect of the AUC meta-analysis showed that NT-proBNP was very accurate in detecting neonates at risk of developing severe BPD or dying from the disease (AUC -0.16, 95% CI -0.23, -0.08). No studies reported data relevant to the sensitivity and/or specificity of the method in diagnosing BPD. Serum NT-proBNP levels represent a potential future biomarker with great diagnostic validity for the prediction of BPD complicating preterm deliveries. The limited amount of studies included and the significant variations in cutoff values and timing of measurement still restrict the application of NT-proBNP as an established clinical biomarker for BPD. The design of larger prospective studies will provide a more representative number of participants and will address the discrepancies in existing literature.

Diagnostic validity of molecular diagnostic assays for white spot syndrome virus at different severity grades

The high virulence of the white spot syndrome virus (WSSV) in acute infections and the lack of effective treatments underscore the necessity for a rapid, accurate, and efficient diagnostic process to control white spot disease. The analytical sensitivity of diagnostic assays (polymerase chain reactions; PCRs and rapid diagnostic kit) at different severity grades of WSSV infection were determined using the 95% limit of detection (LOD95%). The LOD95% of nested, real-time, and one-step PCRs and rapid diagnostic kit were 0.70, 4.67, 1.19, and 79,434.65 viral genome copies/reactions, respectively. From the intramuscular challenge tests conducted under different dose and temperature conditions, the WSSV severity grades of time-course collected whiteleg shrimp (Litopenaeus vannamei) and dead or live shrimps were determined based on the viral loads of the pleopod. By applying the WSSV severity grades, a total of 92 shrimps were classified as G0. Furthermore, 92, 66, 199, and 79 shrimps were classified as G1, G2, G3, and G4, respectively. Additionally, 222 shrimps were classified as negative as WSSV was not confirmed in the nested PCR assay. Diagnostic sensitivity (DSe) and specificity (DSp) values of molecular diagnostic assays were compared with those of nested PCR in artificial WSSV-infected shrimp to evaluate diagnostic performance. The real-time and one-step PCRs exhibited a DSe >92.4% for G0 grade (approximately 101–102 copies/mg), indicating WSSV detection at low copy numbers. The rapid diagnostic kit presented a DSe >92.4% for G2 grade (approximately 104–105 copies/mg), suggesting the detection of WSSV-infected shrimp with clinical signs during the endemic period. These results suggest that the strategy of presumptive diagnosis using one-step PCR and rapid diagnostic kit at different seasonal periods followed by confirmatory diagnosis using real-time PCR assay could aid in controlling WSD with rapidity, accuracy, and cost-effectiveness.

Chondro-osseous border in baby hip ultrasonography for developmental dysplasia of the hip: an indispensable litmus paper for the accuracy of scientific publications.

The aim of our study was to use the chondro-osseous border (COB) as an indispensable assessment criterion to evaluate the quality of baby hip ultrasonography (US) images in the literature pertaining to the application of Graf's technique. Our literature review search yielded 144 articles. Of these, 41 contained images that were stated to be based on the application of Graf's technique. Two reviewers, a radiologist and an orthopaedic surgeon, both course instructors for the use of baby hip US for developmental dysplasia of the hip (DDH), independently evaluated the articles to assess the diagnostic validity of the published images on the basis of a single criterion: the identification of the COB. Of the 41 articles which were analyzed, 15 contained images without a COB, which corresponds to 36% (roughly, one out of three). Articles from countries where universal screening is performed (Germany, Italy, Switzerland, Mongolia) were all correct. All the articles from Turkey, a country which has made significant contribution with published material about Graf's technique over many years, and most of the articles from China (80%), where Graf's technique has become popular in recent years, contained correct images. Published literature lacks strict criteria for the publication of correct images corresponding to Graf's technique in baby hip US. This fact raises concerns about the quality of published material (and, as a corollary, the quality of clinical application of the technique) and should have ramifications on scientific journal policies regarding the publication of such manuscripts.

Comparison of glass and digital slides for cervical cytopathology screening and interpretation.

Cervical cancer is the second most common form of cancer and a leading cause of premature death among women aged 15 to 44 worldwide. In Brazil, there is a high prevalence of infection by the human papillomavirus - HPV. Digital pathology optimizes time and space for reading cervicovaginal cytology slides. We evaluated the feasibility of using whole slide images (WSI) for the routine interpretation of cytology exams. A total of 99 cases of vaginal cytology were selected from a reference laboratory in Northeastern Brazil. Three cytotechnicians participated in the study. Cellular atypia was the one that most presented concordance values. Two observers almost perfectly agreed (k = 0.86 and k = 0.84, respectively) on the negative diagnoses. The performance of the evaluators for NILM (negative for intraepithelial lesion and malignancy) showed high reproducibility and sensitivity in the digital slides, mainly between evaluators A and C. In contrast, the microbiology group showed disagreement between the diagnoses by digital slides and the standard- gold. The concordance between the digital diagnoses and the gold standard for ASCUS was 89%. In the inflammatory category, Spearman's test showed similar results between raters A, B, and C (rs = 0.47, rs = 0.41, and rs = 0.47, respectively). This study reports the diagnostic validation using digital slides in view of the need to optimize the cytology visualization process. Our experience shows good diagnostic agreement between digital and optical microscopy in several analyzed categories, but mainly in relation to cellular atypia and inflammatory processes.

Factors associated with the diagnosis and treatment of obstructive sleep apnoea in chronic heart failure: a mixed methods study

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): This study was co-funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care East Midlands (CLAHRC EM), now recommissioned as NIHR Applied Research Collaboration East Midlands (ARC EM) and Leicestershire Partnership NHS Trust - Raising Health Charitable Funds Award and supported by the NIHR Leicester Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Background Heart Failure (HF) is associated with a considerable burden of disability that includes frequent hospitalisation and high risk of mortality. Despite advances in HF treatment, many patients continue to experience symptoms and will die from progressive HF, often exacerbated by the presence of co-morbidities, such as obstructive sleep apnea (OSA). Despite the high prevalence of OSA in chronic HF and the association with the development and progression of chronic HF, OSA remains largely under diagnosed and under treated. Purpose To explore factors associated with the diagnosis and treatment of OSA in CHF. Methods A convergent parallel mixed methods research design was utilised. Quantitative methods included a systematic review and meta-analysis, diagnostic validation study and a survey study, whilst semi-structured interviews and reflexive thematic analysis was utilised for the qualitative component. Data collection and data analysis were conducted simultaneously with the integration of the findings in the discussion. Results The systematic review and meta-analysis showed that the STOP-Bang screening questionnaire had a high sensitivity to detect OSA in the sleep clinic and surgical populations but lacked adequate specificity. The diagnostic validation study indicated a high sensitivity of the STOP-Bang questionnaire, but due to differences in prevalence, risk of selection bias and spectrum effect, validation in a sleep clinic population is unlikely to reflect the true performance of the STOP-Bang questionnaire in a stable CHF population. The survey study demonstrated a knowledge deficit in the diagnosis and treatment of OSA, and variable practice among HF clinicians in the UK. Findings from the qualitative component identified several key barriers and enablers across the OSA diagnostic pathway from both patients’ and clinicians’ accounts. Conclusion Due to a lack of typical OSA symptoms, there is currently no real evidence of cardiovascular hospitalisation and mortality benefit for OSA treatment in CHF. This contributed to a paucity of guidance on the management of OSA in CHF clinical guidelines. Due to a lack of typical OSA symptoms, screening questionnaires that rely on patient symptoms may be less effective. Although clinicians felt that OSA was an important clinical condition, findings demonstrated a disconnect between the stated level of clinical importance and clinicians’ actual level of knowledge. The current absence of evidence to support the treatment of OSA in CHF and paucity of CHF guidelines to inform the management of OSA in CHF, are likely to contribute to clinicians not prioritising the recognition and treatment of OSA in CHF.