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The introduction of self‐sampling in cervical cancer screening has raised the importance of HPV test validation on self‐collected samples. This study aimed to evaluate the clinical accuracy of the OncoPredict HPV Screening (SCR) assay on self‐collected vaginal and first‐void urine (FVU) samples, relative to cervical specimens, using the VALHUDES Framework. FVU and vaginal self‐samples followed by a clinician‐collected cervical brushing were collected from 500 women referred to colposcopy and tested using OncoPredict HPV SCR assay. The assay demonstrated clinical sensitivity to detect cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) similar to cervical samples in FVU (ratio: 0.95, [95% CI: 0.88–1.02]) and vaginal self‐samples (ratio: 0.96 [95% CI: 0.90–1.02]). The clinical specificity for < CIN2 was lower in vaginal (ratio: 0.90 [95% CI: 0.84–0.96]) but not in FVU samples (ratio: 1.03 [95% CI: 0.96–1.12) when compared to cervical samples. However, the relative specificity improved following cut‐off optimization (ratio: 0.94, 95% CI: [0.88–1.01]). Moderate to excellent agreement in HPV detection between self‐collected and cervical samples was demonstrated (Kappa values: 0.53–1.00). To conclude, OncoPredict HPV SCR assay demonstrated similar accuracy on FVU and cervical samples. On vaginal compared to cervical samples sensitivity was similar with a lower specificity, which improved with cut‐off optimization. [ABSTRACT FROM AUTHOR]

Background: Transfusion of packed red blood cells (PRBCs) following severe bleeding from multiple trauma can reduce mortality.Objectives: The present study aimed to compare the accuracy of eight different scoring systems for predicting the need for blood transfusion in such patients.Methods: The present diagnostic accuracy study was conducted at the emergency department of Shohadaye Tajrish Hospital in Tehran, From March to September 2023. Medical records of multiple trauma patients admitted to the emergency department were reviewed. The predictive performances of eight scoring systems including Glasgow coma scale (GCS), revised trauma score (RTS), trauma associated severe hemorrhage (TASH), Prince of Wales hospital score (PWH), emergency transfusion score (ETS), base deficit, assessment of blood consumption (ABC), and the Shock index in predicting the need for PRBC transfusion were assessed.Results: The area under the ROC curve of TASH in predicting PRBC transfusion was calculated 0.959, significantly higher than the area under the ROC curves for PWH, GCS, Shock index, Base deficit, ETS, RTS, and ABC (0.902, 0.899, 0.882, 0.857, 0.846, 0.824, and 0.810 respectively; p < 0.001). Sensitivity and specificity of TASH at the optimal cut-off were 98.72% and 51.56% respectively. A new score, the MTTP (Multiple Trauma Transfusion Predictor), developed by evaluating the association of clinical and laboratory variables with PRBC transfusion in the ED, showed an AUC of 0.964, not significantly higher than the AUC of TASH (p=0.804). The sensitivity and specificity of MTTP at the optimal cut-off were 93.59% and 91.84%, respectively.Conclusion: Among the evaluated scores, TASH was the most accurate for predicting PRBC transfusion in multiple trauma patients in the ED. Furthermore, among the pre-hospital scores, the Shock index was identified as the most accurate predictor for PRBC transfusion. This score is recommended for use in the ED due to its simplicity, rapid calculation and high prediction accuracy. The MTTP, the newly developed scoring system in this study, outperformed all the other scores.

This retrospective clinical study aimed to compare the sensitivity of cone-beam computed tomographic (CBCT) images and periapical (PA) radiographs to reveal cracked teeth, split teeth, and teeth with vertical root fractures (VRFs). Methods The authors included 98 patients (98 teeth) diagnosed with a longitudinal tooth fracture (LTF) (cracked tooth, split tooth, VRF) through direct visualization after extraction and with comprehensive clinical and radiographic records. They collected demographic, clinical, and radiographic data. The authors evaluated PA radiographs and CBCT images to identify fractures, fracture lines, and the different patterns of bone loss associated with these teeth. They used the McNemar test to compare PA radiographs and CBCT scans when assessing bone loss. They used the Fisher test to determine statistical relationships between fracture types and demographic, clinical, and radiologic traits. They used an analysis of variance test to compare patient age with fracture types. Results CBCT images were significantly more effective (P < .05) in detecting bone loss patterns associated with LTFs than with PA radiographs, with 71 % of cases detected via CBCT images compared with 42% via radiographs. Mean age was significantly greater (P < .05) in patients with teeth with VRFs than in patients with split teeth. A significant relationship was observed between the type of fracture and the following variables: root canal treatment (split, VRF, P = .002), deep probing depth (> 5 mm) (VRF, P = .026), and having more than 8 teeth extracted from the mouth (VRF, P = .032). Overall, there was a significant difference (P < .001) between the visualization of fracture lines (45% on PA radiographs, 65% on CBCT images). Conclusions CBCT scans provided more information on LTFs than PA radiographs, particularly in the identification of periradicular bone changes. Practical Implications CBCT imaging can assist in making the clinical diagnosis of LTFs through observation of bone loss patterns, providing more information than PA radiographs. [ABSTRACT FROM AUTHOR]

Infectious diseases caused by fungal sources are of great interest owing to their increasing prevalence. Invasive fungal infections, including invasive pulmonary aspergillosis caused by Aspergillus fumigatus, and Pneumocystis pneumonia caused by Pneumocystis jirovecii, are significant causes of morbidity and mortality among immunocompromised patients. The accurate and timely detection of these pathogens in this high-risk population is crucial for effective patient management. We developed a multiplex real-time polymerase chain reaction (PCR) assay, RF2 mRT-PCR, specifically designed to detect two respiratory fungi, P. jirovecii and A. fumigatus, and evaluated its performance in specimens of patients with lower respiratory tract infection. The performance was evaluated using 731 clinical samples, 55 reference species, and one synthetic DNA. The reproducibility test yielded a probit curve with a lower limit of detection of 19.82 copies/reaction for P. jirovecii and 64.20 copies/reaction for A. fumigatus. The RF2 mRT-PCR assay did not cross-react with non-A. fumigatus Aspergillus species or other common bacterial and viral species, and showed 100% in vitro sensitivity and specificity with reference assays. Additionally, it simultaneously detected A. fumigatus and P. jirovecii in co-infected samples. Therefore, the RF2 mRT-PCR assay is an efficient and reliable tool for in vitro diagnosis of A. fumigatus and P. jirovecii pulmonary infections. [ABSTRACT FROM AUTHOR]

Abstract Background To identify the sensitivity, specificity, and overall diagnostic accuracy of infrared thermography in diagnosing lumbosacral radicular pain. Methods Patients sequentially presenting with lower extremity pain were enrolled. A clinical certainty score ranging from 0 to 10 was used to assess the likelihood of lumbosacral radicular pain, with higher scores indicating higher likelihood. Infrared Thermography scans were performed and the temperature difference (ΔT) was calculated as ΔT = T1 - T2, where T2 represents the skin temperature of the most painful area on the affected limb and T1 represents the skin temperature of the same area on the unaffected limb. Upon discharge from the hospital, two independent doctors diagnosed lumbosacral radicular pain based on intraoperative findings, surgical effectiveness, and medical records. Results A total of 162 patients were included in the study, with the adjudicated golden standard diagnosis revealing that 101 (62%) patients had lumbosacral radicular pain, while the lower extremity pain in 61 patients was attributed to other diseases. The optimal diagnostic value for ΔT was identified to fall between 0.8℃ and 2.2℃, with a corresponding diagnostic accuracy, sensitivity, and specificity of 80%, 89%, and 66% respectively. The diagnostic accuracy, sensitivity, and specificity for the clinical certainty score were reported as 69%, 62%, and 79% respectively. Combining the clinical certainty score with ΔT yielded a diagnostic accuracy, sensitivity, and specificity of 84%, 77%, and 88% respectively. Conclusion Infrared thermography proves to be a highly sensitive tool for diagnosing lumbosacral radicular pain. It offers additional diagnostic value in cases where general clinical evaluation may not provide conclusive results. Trial registration ChiCTR2300078786, 19/22/2023.

Abstract Background Accurate assessment of remaining dentin thickness (RDT) is paramount for restorative decisions and treatment planning of vital teeth to avoid any pulpal injury. This diagnostic accuracy study compared the validity and patient satisfaction of an electrical impedance based device Prepometer™ (Hager & Werken, Duisburg, Germany) versus intraoral digital radiography for the estimation of remaining dentin thickness in carious posterior permanent teeth. Methods Seventy patients aged 12–25 years with carious occlusal or proximal permanent vital posterior teeth were recruited. Tooth preparation was performed to receive an adhesive restoration. Pre- and post-excavation RDT were measured radiographically by two calibrated raters using the paralleling periapical technique. Prepometer™ measurements were performed by the operator. Patients rated their satisfaction level with each tool on a 4-point Likert scale and 100 mm visual analog scale (VAS). Inter and intragroup comparisons were analyzed using signed rank test, while agreement between devices and observations was tested using weight kappa (WK) coefficient. Results the intergroup comparisons showed that, before and after excavation, there was a significant difference between measurements made by both techniques (p

ObjectiveThis study assesses the concordance in migraine diagnosis between an online, self-administered, Computer-based, Diagnostic Engine (CDE) and semi-structured interview (SSI) by a headache specialist, both using International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.BackgroundDelay in accurate diagnosis is a major barrier to headache care. Accurate computer-based algorithms may help reduce the need for SSI-based encounters to arrive at correct ICHD-3 diagnosis.MethodsBetween March 2018 and August 2019, adult participants were recruited from three academic headache centers and the community via advertising to our cross-sectional study. Participants completed two evaluations: phone interview conducted by headache specialists using the SSI and a web-based expert questionnaire and analytics, CDE. Participants were randomly assigned to either the SSI followed by the web-based questionnaire or the web-based questionnaire followed by the SSI. Participants completed protocols a few minutes apart. The concordance in migraine/probable migraine (M/PM) diagnosis between SSI and CDE was measured using Cohen's kappa statistics. The diagnostic accuracy of CDE was assessed using the SSI as reference standard.ResultsOf the 276 participants consented, 212 completed both SSI and CDE (study completion rate = 77%; median age = 32 years [interquartile range: 28-40], female:male ratio = 3:1). Concordance in M/PM diagnosis between SSI and CDE was: κ = 0.83 (95% confidence interval [CI]: 0.75-0.91). CDE diagnostic accuracy: sensitivity = 90.1% (118/131), 95% CI: 83.6%-94.6%; specificity = 95.8% (68/71), 95% CI: 88.1%-99.1%. Positive and negative predictive values = 97.0% (95% CI: 91.3%-99.0%) and 86.6% (95% CI: 79.3%-91.5%), respectively, using identified migraine prevalence of 60%. Assuming a general migraine population prevalence of 10%, positive and negative predictive values were 70.3% (95% CI: 43.9%-87.8%) and 98.9% (95% CI: 98.1%-99.3%), respectively.ConclusionThe SSI and CDE have excellent concordance in diagnosing M/PM. Positive CDE helps rule in M/PM, through high specificity and positive likelihood ratio. A negative CDE helps rule out M/PM through high sensitivity and low negative likelihood ratio. CDE that mimics SSI logic is a valid tool for migraine diagnosis.

Background: Public health issues involving anemia affect people of all ages. To prevent incorrect diagnosis classification, point-of-care-tests (POCTs) that are accessible in community settings must be accurate. Objectives: The purpose of this study was to quantify the prevalence of anemia among teenagers and to assess the accuracy and reliability of two point-of-care assays, the World Health Organization hemoglobin color scale (HCS) and the Sahli's Method. Methodology: In the Jabalpur district, 600 urban and rural teenagers participated in a community-based cross-sectional survey. Both Strip and Sahli's approaches were administered to participants at the same time. After that, a venous sample was taken for autoanalyzer testing. Statistics for accuracy and reliability were computed. The level of agreement between the POCTs and the gold standard was determined using the Altmann Bland plot and the receiver operating characteristic (ROC) curve analysis indicated revised cut-offs for the HCS approach. Results: The actual prevalence of anemia was found to be 20.5%. Sahli's technique had the highest specificity, whereas HCS had the lowest sensitivity (52.0% and 72.9%, respectively) (86.4%). Despite the fact that the color scale is a cheap and portable approach for field studies, it has been determined that anemics are overreported. However, ROC analysis indicated specific cutoffs for various age groups that can be used for disease burden estimation studies in contexts with limited resources. Conclusion: For estimating hemoglobin, HCS is less effective than Sahli's and autoanalyzer methods. We established that the HCS technique overreported anemia, while Sahli's method had poorer levels of agreement.

Infectious diseases caused by fungal sources are of great interest owing to their increasing prevalence. Invasive fungal infections, including invasive pulmonary aspergillosis caused by Aspergillus fumigatus, and Pneumocystis pneumonia caused by Pneumocystis jirovecii, are significant causes of morbidity and mortality among immunocompromised patients. The accurate and timely detection of these pathogens in this high-risk population is crucial for effective patient management. We developed a multiplex real-time polymerase chain reaction (PCR) assay, RF2 mRT-PCR, specifically designed to detect two respiratory fungi, P. jirovecii and A. fumigatus, and evaluated its performance in specimens of patients with lower respiratory tract infection. The performance was evaluated using 731 clinical samples, 55 reference species, and one synthetic DNA. The reproducibility test yielded a probit curve with a lower limit of detection of 19.82 copies/reaction for P. jirovecii and 64.20 copies/reaction for A. fumigatus. The RF2 mRT-PCR assay did not cross-react with non-A. fumigatus Aspergillus species or other common bacterial and viral species, and showed 100% in vitro sensitivity and specificity with reference assays. Additionally, it simultaneously detected A. fumigatus and P. jirovecii in co-infected samples. Therefore, the RF2 mRT-PCR assay is an efficient and reliable tool for in vitro diagnosis of A. fumigatus and P. jirovecii pulmonary infections.

Abstract Background In a pandemic setting, it is critical to evaluate and deploy accurate diagnostic tests rapidly. This relies heavily on the sample size chosen to assess the test accuracy (e.g. sensitivity and specificity) during the diagnostic accuracy study. Too small a sample size will lead to imprecise estimates of the accuracy measures, whereas too large a sample size may delay the development process unnecessarily. This study considers use of a Bayesian method to guide sample size determination for diagnostic accuracy studies, with application to COVID-19 rapid viral detection tests. Specifically, we investigate whether utilising existing information (e.g. from preceding laboratory studies) within a Bayesian framework can reduce the required sample size, whilst maintaining test accuracy to the desired precision. Methods The method presented is based on the Bayesian concept of assurance which, in this context, represents the unconditional probability that a diagnostic accuracy study yields sensitivity and/or specificity intervals with the desired precision. We conduct a simulation study to evaluate the performance of this approach in a variety of COVID-19 settings, and compare it to commonly used power-based methods. An accompanying interactive web application is available, which can be used by researchers to perform the sample size calculations. Results Results show that the Bayesian assurance method can reduce the required sample size for COVID-19 diagnostic accuracy studies, compared to standard methods, by making better use of laboratory data, without loss of performance. Increasing the size of the laboratory study can further reduce the required sample size in the diagnostic accuracy study. Conclusions The method considered in this paper is an important advancement for increasing the efficiency of the evidence development pathway. It has highlighted that the trade-off between lab study sample size and diagnostic accuracy study sample size should be carefully considered, since establishing an adequate lab sample size can bring longer-term gains. Although emphasis is on its use in the COVID-19 pandemic setting, where we envisage it will have the most impact, it can be usefully applied in other clinical areas.

Study Objective: Umbilical cord abnormalities increase neonatal morbidity and mortality. Considering uncertainties about the best time of an antenatal ultrasonography scan to evaluate the umbilical coiling index (UCI), this systematic review was designed to assess the diagnostic accuracy value of antenatal ultrasound assessments to predict abnormal postpartum UCI. Methods: All observational, cross‐sectional, case–control, cohort, and diagnostic accuracy studies up to March 26, 2022, were searched and assessed according to PRISMA guidelines in Ovid, Cochrane, Scopus, PubMed, Web of Science, Embase, Proquest, Science Direct, and Clinical Key databases, and Google Scholar search engine. Results: The total number of 63 190 documents were retrieved from databases. The duplicates (19 272) were removed, 43 918 articles were screened for relevance, and 56 papers were selected for full‐text evaluation, resulting in 14 qualified pieces subjected to the quality CASP tools for each type of study. Finally, six articles were evaluated, extracted, and confirmed. Overall, we had 16 evaluations (11 normal pregnancies, 4 gestational diabetes mellitus, and 1 group at risk for small gestational age), from which 9 and 7 were respectively performed in the second and third trimesters. Most of the evaluations considered both hypocoiling and hypercoiling. The sensitivity, specificity, and area under curves (AUCs) change range between the evaluations were 0.09–0.97, 0.59–0.96, and 0.262–0.84, respectively. Conclusion: Observing any coiling abnormalities in every trimester, both the second and third, is highly sensitive to predicting abnormal postnatal UCI (pUCI). Conclusively, any detected antenatal abnormality is worth attention. Both trimesters' evaluations are essential, and no superiority is seen for any of them. The systematic review revealed statistical and clinical heterogeneity; a meta‐analysis was impossible. [ABSTRACT FROM AUTHOR]

Tuberculosis (TB) affects a third of the global population, and a large population of infected individuals still remain undiagnosed—making the visible burden only the tip of the iceberg. The detection of tuberculosis in close-proximity patients is one of the key priorities for attaining the Sustainable Development Goals (SDG) of TB elimination by 2030. With the current battery of screening tests failing to cover this need, the authors of this paper examined a simple and inexpensive point-of-care breath analyzer (TSI-3000(I)), which is based on detecting the volatile organic compounds that are emitted from infected cells and released in exhaled breath as a screening tool for the detection of TB. A single-center pilot study for assessing the diagnostic accuracy of the point-of-care Tuberculosis Breath Analyzer was conducted, and it was compared against the WHO-recommended TrueNat assay, which is a rapid molecular test and was also treated as the reference standard in this study. Of the 334 enrolled participants with TB signs/symptoms, 42.51% were TrueNat positive for Mycobacterium tuberculosis. The sensitivity of the Tuberculosis Breath Analyzer was found to be 95.7%, with a specificity of 91.3% and a ROC area of 0.935. The test kit showed considerable/significant high sensitivity and specificity as reliability indicators. The performance of the Tuberculosis Breath Analyzer tested was found to be comparable in efficiency to that of the TrueNat assay. A large cohort-based multicentric study is feasibly required to further validate and extrapolate the results of the pilot study.

Shear-wave elastography (SWE) is an imaging method that can be used to estimate shear wave speed and the Young's modulus based on the measured shear wave speed under certain conditions. Up to date, no research has analyzed whether body composition factors contribute to ultrasound attenuation, refraction, reflection, and, consequently, SWE measurement errors. Therefore, this study aimed to analyze the association between demographic and body composition features with SWE errors for assessing the anterior scalene stiffness (which is a key structure in patients with neck pain and nerve compressive syndromes). Demographic (sex, age, height, weight, and body mass index), body composition (water volume, fat mass, and lean mass), and anterior scalene muscle stiffness (Young's modulus and shear wave speed) data were collected from a sample of asymptomatic subjects. After calculating the absolute SWE differences between trials and the reliability estimates, a correlation matrix was generated to quantify the association among all the variables. A total of 34 asymptomatic subjects (24 males) were included in the analyses. Test–retest reliability was excellent for assessing the Young's modulus and shear wave velocity (ICC = 0.912 and 0.923, respectively). No significant associations were found between age, height, weight, body mass index, body fat, lean mass, or water volume with SWE errors (p > 0.05). However, the Young's modulus error was associated with the stiffness properties (p < 0.01), whereas shear wave speed was associated with none of them (all, p > 0.05). A detailed procedure can reliably assess the AS muscle stiffness. None of the sociodemographic or body composition features assessed were correlated with SWE errors. However, baseline stiffness seems to be associated with Young's modulus error. [ABSTRACT FROM AUTHOR]

(1) Background: NHS England recommended faecal immunochemical testing (FIT) for symptomatic patients in June 2020 to rationalise limited diagnostic services during COVID-19. (2) Aim: to investigate the diagnostic performance of FIT, analysing the proportion of FIT-negative colorectal cancers (CRC) missed in symptomatic patients and how this risk could be mitigated. (3) Design and Setting: a retrospective study of biochemistry and cancer databases involving patients referred from primary healthcare with suspected CRC to a single secondary care trust in North East London. (4) Methods: a retrospective cohort diagnostic accuracy study was undertaken to determine the performance of FIT for detecting CRC at 10 µgHb/g. (5) Results: between January and December 2020, 7653 patients provided a stool sample for FIT analysis; 1679 (22%) samples were excluded due to inadequate or incorrect specimens; 48% of suspected CRC referrals completed FIT before evaluation; 86 FIT tested patients were diagnosed with histologically proven CRC. At 10 µgHb/g, FIT performance was comparable with the existing literature with a sensitivity of 0.8140 (95% CI 0.7189–0.8821), a specificity of 0.7704 (95% CI 0.7595–0.7809), a positive predictive value (PPV) of 0.04923 (95% CI 0.03915–0.06174), a negative predictive value (NPV) of 0.9965 (95% CI 0.9943–0.9978), and a likelihood ratio (LR) of 3.545; 16 patients with CRC had an FIT of ≤10 µgHb/g (18.6% 95% CI 11.0–28.4%). (6) Conclusions: this study raises concerns about compliance with FIT testing and the incidence of FIT-negative CRC at the NICE recommended threshold and how this risk can be mitigated without colonic imaging. Whilst FIT may have facilitated prioritisation during COVID-19, we must be cautious about using FIT alone to determine which patients are referred to secondary care or receive further investigation. [ABSTRACT FROM AUTHOR]

Abstract Background There is increasing evidence supporting the use of faecal immunochemical tests (FIT) in patients reporting symptoms associated with colorectal cancer (CRC), but most studies until now have focused on selected subjects already referred for investigation. We therefore set out to determine the accuracy and predictive values of FIT in a primary care population. Method A prospective, multicentre, single-gated comparative diagnostic study on quantitative FIT in patients aged 40 years and above presenting in primary care with symptoms associated with CRC will be conducted. Patients representing the whole spectrum of severity of such symptoms met with in primary care will be eligible and identified by GPs. Participants will answer a short form on symptoms during the last month. They will provide two faecal samples from two separate days. Analyses will be performed within 5 days (QuikRead go®, Aidian Oy). The analytical working range is 10–200 μg Hb/g faeces. Reference test will be linked to the Swedish Colorectal Cancer Registry up to 2 years after inclusion. Accuracy, area under ROC curves, and predictive values will be calculated for one FIT compared to the highest value of two FIT and at cutoff

Ultrasound imaging (US) is widely used in several healthcare disciplines (including physiotherapy) for assessing multiple muscle metrics such as muscle morphology and quality. Since measuring instruments are required to demonstrate their reliability, accuracy, sensitivity, and specificity prior to their use in clinical and research settings, identifying factors affecting their diagnostic accuracy is essential. Since previous studies analyzed the impact of sociodemographic but not body composition characteristics in US errors, this study aimed to assess whether body composition metrics are correlated with ultrasound measurement errors. B-mode images of the lumbar multifidus muscle at the fifth lumbar vertebral level (L5) were acquired and analyzed in 49 healthy volunteers by two examiners (one experienced and one novel). Cross-sectional area, muscle perimeter and mean echo intensity were calculated bilaterally. A multivariate correlation matrix was calculated for assessing the inter-examiner differences with body composition metrics. Results demonstrated excellent reliability (intraclass correlation coefficient, ICC > 0.9) for assessing the muscle cross-sectional area and perimeter, and good reliability for assessing the muscle shape and mean echo intensity (ICC > 0.7). Inter-examiner errors for estimating muscle size were correlated with participants' age (p value, p < 0.01), weight (p < 0.05), total and trunk lean mass (both, p < 0.01) and water volume (p < 0.05). Greater shape descriptors and mean brightness disagreements were correlated with older ages (p < 0.05) and total lean mass (p < 0.05). No correlations between age and body composition metrics were found (p > 0.05). This study found US to be a reliable tool for assessing muscle size, shape and mean brightness. Although aging showed no correlations with body composition changes in this sample, it was the main factor correlated with US measurement errors. [ABSTRACT FROM AUTHOR]

Objective To innovatively utilize the open artificial intelligence （AI） platform EasyDL to independently develop an AI auxiliary diagnosis model for diabetic retinopathy （DR）, and evaluate its diagnostic accuracy indicators. Methods 35 126 fundus photos of the diabetes fundus disease data set published by Kaggle were used as the training set, and uploaded to the EasyDL open platform to establish an AI auxiliary diagnosis model. A total of 300 color fundus photographs of bilateral eyes of 150 patients with diabetes mellitus who received clinical DR screening were collected as the test set. The diagnosis of 3 ophthalmologists with deputy director title or above was considered as the gold standard. The diagnostic accuracy for the grading of DR by the AI diagnosis model, junior physicians, intermediate physicians and these combined was evaluated, respectively. Results There were 170 patients with non-DR （NDR） and mild non-proliferative DR （NPDR）, and 130 patients with moderate and severe NPDR and proliferative DR （PDR）. AI diagnostic model had high sensitivity but low specificity. AI diagnostic indexes were close to those of intermediate doctors and better than primary doctors. When AI diagnostic model was combined with physician diagnosis, the accuracy and sensitivity of diagnosis were improved. In the consistency evaluation with the gold standard, the Kappa coefficient of the AI diagnosis model was 1.00, and 0.88 for the intermediate physicians （both P < 0.01）. Conclusions The AI diagnosis model based on the open platform EasyDL is simple and easy to operate, which can contribute to the preliminary screening of DR. It also provides effective scientific research tools for physicians who lack of the knowledge of deep learning algorithms.

• Accuracy of full genotyping oncopredict QT assay was evaluated on self-samples. • HPV testing in self-samples was similarly sensitive for CIN2+ versus cervical samples. • OncoPredict QT assay provides genotype specific viral load normalised by cellularity. The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated. 490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep. The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94–1.05] and 1.00 [95 % CI 0.96–1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for

The levator scapulae muscle is a key structure in the etiopathology of neck and shoulder musculoskeletal pain. Although previous studies used shear-wave elastography (SWE) for characterizing this muscle elasticity, limited evidence assessed the inter-examiner reliability of this procedure. This study aimed to analyze the inter-examiner reliability for calculating Young’s modulus and shear wave speed in a cohort of participants with and without chronic neck pain. A diagnostic accuracy study was conducted, acquiring a set of SWE images at the C5 level in participants with and without neck pain (n = 34 and 33, respectively) by two examiners (one experienced and one novel). After blinding the participants’ identity, examiner involved, and side, the stiffness indicators were calculated by an independent rater in a randomized order. Intra-class correlation coefficients (ICC), standard error of measurement, minimal detectable changes, and coefficient of variation were calculated. Both cohorts had comparable sociodemographic characteristics (p > 0.05). No significant levator scapulae elasticity differences were found between genders, sides, or cohorts (all, p > 0.05). Inter-examiner reliability for calculating Young’s modulus and shear wave speed was moderate-to-good for assessing asymptomatic individuals (ICC = 0.714 and 0.779, respectively), while poor-to-moderate in patients with neck pain (ICC = 0.461 and 0.546, respectively). The results obtained in this study support the use of this procedure for assessing asymptomatic individuals. However, reliability estimates were unacceptable to support its use for assessing elasticity in patients with chronic neck pain. Future studies might consider that the shear wave speed is more sensitive to detect real changes in comparison with Young’s modulus.

Objective: To determine the accuracy of self‐testing for proteinuria during pregnancy. Design: Diagnostic accuracy study. Setting: Antenatal clinics, maternity assessment units and inpatient wards at three hospital sites. Population or Sample: 345 pregnant women. Methods: Pregnant women self‐tested in‐clinic for urinary protein using visually read dipsticks with samples then sent for laboratory estimation of the spot protein‐creatinine ratio (PCR) (primary reference test). Secondary index tests included testing by antenatal healthcare professionals and an automated colorimetric reader. Main outcome measures: Sensitivity, specificity, negative predictive value, positive predictive value and likelihood ratios were calculated for self‐testing (primary index test) along with healthcare professional and colorimetric testing compared to the primary reference test (PCR). Results: 335/345 (97%) had sufficient data to be included in the analysis. Self‐testing had a sensitivity of 0.71 (95% confidence interval [CI] 0.62–0.79) and a specificity of 0.89 (95% CI 0.84–0.92) compared to PCR. Sensitivity and specificity of testing by healthcare professionals and the colorimetric reader were similar: sensitivity 0.73 (95% CI 0.64–0.80) and 0.78 (95% CI 0.69–0.85), respectively; specificity 0.88 (95% CI 0.82–0.92) and 0.83 (95% CI 0.78–0.88), respectively. Conclusion: Pregnant women can visually read a dipstick for urinary protein with similar accuracy to antenatal healthcare professionals. Automated colorimetric testing was not significantly different, in contrast to some previous studies. Self‐testing has the potential to form part of a self‐monitoring regime in pregnancy. Linked article: This article is commented on by Wessel Ganzevoort, pp. 2149 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471‐0528.17202 [ABSTRACT FROM AUTHOR]

Abstract Background Rapid treatment of stroke improves outcomes, but accurate early recognition can be challenging. Between 20 and 40% of patients suspected to have stroke by ambulance and emergency department staff later receive a non-stroke ‘mimic’ diagnosis after stroke specialist investigation. This early diagnostic uncertainty results in displacement of mimic patients from more appropriate services, inappropriate demands on stroke specialist resources and delayed access to specialist therapies for stroke patients. Blood purine concentrations rise rapidly during hypoxic tissue injury, which is a key mechanism of damage during acute stroke but is not typical in mimic conditions. A portable point of care fingerprick test has been developed to measure blood purine concentration which could be used to triage patients experiencing suspected stroke symptoms into those likely to have a non-stroke mimic condition and those likely to have true stroke. This study is evaluating test performance for identification of stroke mimic conditions. Methods Design: prospective observational cohort study Setting: regional UK ambulance and acute stroke services Participants: a convenience series of two populations will be tested: adults with a label of suspected stroke assigned (and tested) by attending ambulance personnel and adults with a label of suspected stroke assigned at hospital (who have not been tested by ambulance staff). Index test: SMARTChip Purine assay Reference standard tests: expert clinician opinion informed by brain imaging and/or other investigations will assign the following diagnoses which constitute the suspected stroke population: ischaemic stroke, haemorrhagic stroke, TIA and stroke mimic conditions. Sample size: ambulance population (powered for mimic sensitivity) 935 participants; hospital population (powered for mimic specificity) 377 participants. Analyses: area under the receiver operating curve (ROC) and optimal sensitivity, specificity, and negative and positive predictive values for identification of mimic conditions. Optimal threshold for the ambulance population will maximise sensitivity, minimum 80%, and aim to keep specificity above 70%. Optimal threshold for the hospital population will maximise specificity, minimum 80%, and aim to keep sensitivity above 70%. Discussion The results from this study will determine how accurately the SMARTChip purine assay test can identify stroke mimic conditions within the suspected stroke population. If acceptable performance is confirmed, deployment of the test in ambulances or emergency departments could enable more appropriate direction of patients to stroke or non-stroke services. Trial registration Registered with ISRCTN (identifier: ISRCTN22323981) on 13/02/2019 http://www.isrctn.com/ISRCTN22323981

(1) Background: NHS England recommended faecal immunochemical testing (FIT) for symptomatic patients in June 2020 to rationalise limited diagnostic services during COVID-19. (2) Aim: to investigate the diagnostic performance of FIT, analysing the proportion of FIT-negative colorectal cancers (CRC) missed in symptomatic patients and how this risk could be mitigated. (3) Design and Setting: a retrospective study of biochemistry and cancer databases involving patients referred from primary healthcare with suspected CRC to a single secondary care trust in North East London. (4) Methods: a retrospective cohort diagnostic accuracy study was undertaken to determine the performance of FIT for detecting CRC at 10 µgHb/g. (5) Results: between January and December 2020, 7653 patients provided a stool sample for FIT analysis; 1679 (22%) samples were excluded due to inadequate or incorrect specimens; 48% of suspected CRC referrals completed FIT before evaluation; 86 FIT tested patients were diagnosed with histologically proven CRC. At 10 µgHb/g, FIT performance was comparable with the existing literature with a sensitivity of 0.8140 (95% CI 0.7189–0.8821), a specificity of 0.7704 (95% CI 0.7595–0.7809), a positive predictive value (PPV) of 0.04923 (95% CI 0.03915–0.06174), a negative predictive value (NPV) of 0.9965 (95% CI 0.9943–0.9978), and a likelihood ratio (LR) of 3.545; 16 patients with CRC had an FIT of ≤10 µgHb/g (18.6% 95% CI 11.0–28.4%). (6) Conclusions: this study raises concerns about compliance with FIT testing and the incidence of FIT-negative CRC at the NICE recommended threshold and how this risk can be mitigated without colonic imaging. Whilst FIT may have facilitated prioritisation during COVID-19, we must be cautious about using FIT alone to determine which patients are referred to secondary care or receive further investigation.

Shear-wave elastography (SWE) is an imaging method that can be used to estimate shear wave speed and the Young’s modulus based on the measured shear wave speed under certain conditions. Up to date, no research has analyzed whether body composition factors contribute to ultrasound attenuation, refraction, reflection, and, consequently, SWE measurement errors. Therefore, this study aimed to analyze the association between demographic and body composition features with SWE errors for assessing the anterior scalene stiffness (which is a key structure in patients with neck pain and nerve compressive syndromes). Demographic (sex, age, height, weight, and body mass index), body composition (water volume, fat mass, and lean mass), and anterior scalene muscle stiffness (Young’s modulus and shear wave speed) data were collected from a sample of asymptomatic subjects. After calculating the absolute SWE differences between trials and the reliability estimates, a correlation matrix was generated to quantify the association among all the variables. A total of 34 asymptomatic subjects (24 males) were included in the analyses. Test–retest reliability was excellent for assessing the Young’s modulus and shear wave velocity (ICC = 0.912 and 0.923, respectively). No significant associations were found between age, height, weight, body mass index, body fat, lean mass, or water volume with SWE errors (p > 0.05). However, the Young’s modulus error was associated with the stiffness properties (p < 0.01), whereas shear wave speed was associated with none of them (all, p > 0.05). A detailed procedure can reliably assess the AS muscle stiffness. None of the sociodemographic or body composition features assessed were correlated with SWE errors. However, baseline stiffness seems to be associated with Young’s modulus error.

Background: Neonatal sepsis is a major contributor to neonatal mortality in India. Blood culture, the gold standard for the diagnosis of sepsis takes 48-72 h while the serological markers have suboptimal diagnostic test characteristics. Perfusion index (PI) is a real time, non-invasive marker that can detect microcirculatory changes before other clinical manifestation of sepsis.Objective: To determine the diagnostic accuracy of PI in detecting hospital-acquired sepsis before overt clinical manifestations.Study Design: A prospective observational study conducted in the Neonatal Intensive Care Unit (NICU) of a tertiary care hospital.Participants: Preterm neonates admitted to NICU.Methods: PI was continuously monitored in all enrolled neonates. Clinical sepsis was defined using the NeonatalKrankenhaus-Infektions-Surveillance-System (NeoKISS). The time of fall of PI below 0.88 and time of clinical sepsis as per NeoKISS were noted and the difference was calculated.Results: Among 65 preterm neonates (gestational age: 31.5 ± 2.6 weeks, birth weight: 1350, IQR 1100-1700 g), a total of 86 events of suspected sepsis were noted, of which 69 were sepsis screen positive. Fifteen events were associated with culture positive sepsis. PI yielded a sensitivity of 89.47% (95% CI 78.48-96.04%), specificity of 56% (95% CI 34.93-75.60%), positive predictive value of 82.26% (95% CI 74.70-87.92%) and negative predictive value of 70% (95% CI 50.36-84.29%) in detection of hospital-acquired sepsis.Conclusion: PI might serve as an early, non-invasive marker of hospital-acquired sepsis in preterm neonates. [ABSTRACT FROM AUTHOR]

Purpose: Gonadotropin-releasing hormone (GnRH) stimulation test is the gold standard for diagnosing central precocious puberty (CPP). However, intravenous GnRH is not always readily available. The aim of the present study was to evaluate the diagnostic accuracy of triptorelin-stimulated luteinizing hormone (LH) concentrations in the diagnosis of CPP among girls presenting with premature thelarche compared to the gold standard GnRH test. Methods: A prospective, case–control (CPP vs isolated premature thelarche), clinical study evaluating the diagnostic accuracy of triptorelin-stimulated LH concentrations in 60 girls with premature thelarche was performed. All girls underwent stimulation with subcutaneous triptorelin injection and intravenous GnRH in a randomized order. During the stimulation test with triptorelin, LH and FSH were measured at time 0, 30, 60, 90, 120, and 180 min after the injection. Estradiol was sampled 24 h after the injection. During the GnRH test, LH and FSH were measured at time 0, 30, 45, and 60 min. Girls with peak GnRH-stimulated LH concentrations ≥5.0 IU/L were classified as having CPP. Area under the curve (AUC) for triptorelin-stimulated LH concentrations was assessed using the receiver operating characteristic (ROC) analysis. Results: Triptorelin-stimulated LH concentrations were significantly higher in girls who had CPP according to the GnRH test (53.3%). LH peaked at 180 min after the triptorelin injection. The highest diagnostic accuracy for CPP (AUC = 0.973, sensitivity 96.9%, specificity 89.3%) at 180 min was at a LH concentration ≥3.4 IU/L. The 24 h estradiol concentration did not improve the predictive model. Conclusions: Measuring LH concentrations 180 min after triptorelin injection with a cut-off value of ≥3.4 IU/L demonstrated a high diagnostic accuracy compared to the GnRH test. Thus, stimulation with triptorelin can be used as a reliable alternative for diagnosing CPP in girls with premature thelarche. [ABSTRACT FROM AUTHOR]

Diagnostic accuracy, a measure of diagnostic tests for correctly identifying patients with or without a target disease, plays an important role in evidence‐based medicine. Diagnostic accuracy of a new test ideally should be evaluated by comparing to a gold standard; however, in many medical applications it may be invasive, costly, or even unethical to obtain a gold standard for particular diseases. When the accuracy of a new candidate test under evaluation is assessed by comparison to an imperfect reference test, bias is expected to occur and result in either overestimates or underestimates of its true accuracy. In addition, diagnostic test studies often involve repeated measurements of the same patient, such as the paired eyes or multiple teeth, and generally lead to correlated and clustered data. Using the conventional statistical methods to estimate diagnostic accuracy can be biased by ignoring the within‐cluster correlations. Despite numerous statistical approaches have been proposed to tackle this problem, the methodology to deal with correlated and clustered data in the absence of a gold standard is limited. In this article, we propose a method based on the composite likelihood function to derive simple and intuitive closed‐form solutions for estimates of diagnostic accuracy, in terms of sensitivity and specificity. Through simulation studies, we illustrate the relative advantages of the proposed method over the existing methods that simply treat an imperfect reference test as a gold standard in correlated and clustered data. Compared with the existing methods, the proposed method can reduce not only substantial bias, but also the computational burden. Moreover, to demonstrate the utility of this approach, we apply the proposed method to the study of National‐Eye‐Institute‐funded Telemedicine Approaches to Evaluating of Acute‐Phase Retinopathy of Prematurity (e‐ROP), for estimating accuracies of both the ophthalmologist examination and the image evaluation. [ABSTRACT FROM AUTHOR]

Abstract Background Early identification and treatment of stroke improve outcome. Ischaemic stroke due to large vessel occlusion (LVO) benefits from time-critical thrombectomy but this is only available in highly specialised healthcare services. Cerebral Bioimpedance Asymmetry (CBA) measurement obtained with the portable and rapid Cerebrotech Visor™ System device may be able to identify certain types of stroke including LVO. This test could be deployed pre-hospital and used to immediately direct patients to the most appropriate healthcare service for treatment. This study is evaluating the diagnostic accuracy of CBA measurements obtained from a real-world population of suspected stroke. Methods Study design: Prospective observational cohort study. Setting: A hyperacute stroke unit and neuroscience centre in North East England. Participants: Adults with a paramedic assigned diagnosis of suspected stroke arriving at hospital within 6 hours of symptom onset. Index Test: Cerebral Bioimpedance Asymmetry measurement performed using the Cerebrotech Visor™ System. Measurement values produce continuous data (range 0 –100); pre-defined threshold for positive state ≥ 10. Reference Standard Tests: Standard CT brain +/- CT/MR angiography, and expert clinician opinion will establish the following clinical outcomes which constitute the suspected stroke population: ischaemic stroke +/- large vessel occlusion; symptomatic severe anterior vessel stenosis; large (≥60ml) and small (

Ultrasound imaging (US) is widely used in several healthcare disciplines (including physiotherapy) for assessing multiple muscle metrics such as muscle morphology and quality. Since measuring instruments are required to demonstrate their reliability, accuracy, sensitivity, and specificity prior to their use in clinical and research settings, identifying factors affecting their diagnostic accuracy is essential. Since previous studies analyzed the impact of sociodemographic but not body composition characteristics in US errors, this study aimed to assess whether body composition metrics are correlated with ultrasound measurement errors. B-mode images of the lumbar multifidus muscle at the fifth lumbar vertebral level (L5) were acquired and analyzed in 49 healthy volunteers by two examiners (one experienced and one novel). Cross-sectional area, muscle perimeter and mean echo intensity were calculated bilaterally. A multivariate correlation matrix was calculated for assessing the inter-examiner differences with body composition metrics. Results demonstrated excellent reliability (intraclass correlation coefficient, ICC > 0.9) for assessing the muscle cross-sectional area and perimeter, and good reliability for assessing the muscle shape and mean echo intensity (ICC > 0.7). Inter-examiner errors for estimating muscle size were correlated with participants’ age (p value, p < 0.01), weight (p < 0.05), total and trunk lean mass (both, p < 0.01) and water volume (p < 0.05). Greater shape descriptors and mean brightness disagreements were correlated with older ages (p < 0.05) and total lean mass (p < 0.05). No correlations between age and body composition metrics were found (p > 0.05). This study found US to be a reliable tool for assessing muscle size, shape and mean brightness. Although aging showed no correlations with body composition changes in this sample, it was the main factor correlated with US measurement errors.

Background: CO2-derived parameters are increasingly used to identify either low-flow status or anaerobic metabolism in shock resuscitation. However, the performance of CO2-derived parameters in cardiac surgical patients is poorly understood. This study aims to compare the performance of lactate and CO2-derived parameters in predicting major postoperative complications after cardiac surgery with cardiopulmonary bypass.Methods: This is a prospective, single-center, diagnostic accuracy study. All patients who receive elective cardiac surgery involving cardiopulmonary bypass will be screened for study eligibility. Blood samples will be taken for the calculation of CO2-derived parameters, including the venous-arterial difference in CO2 partial pressure (PCO2 gap), venous-arterial difference in CO2 content to arterial-venous O2 content ratio (Cv-aCO2/Ca-vO2), and venous-arterial difference in CO2 partial pressure to arterial-venous O2 content ratio (Pv-aCO2/Ca-vO2) at ICU admission, and 3, 6, and 12 h later. Baseline, perioperative data will be collected daily for 7 days; patients will be followed up for 28 days to collect outcome data. The primary endpoint is the occurrence of major postoperative complications. Receiver-operating characteristics (ROC) curve analysis will be carried out to assess the predictive performance of lactate and CO2-derived parameters. The performance of the ROC curves will be compared.Discussion: The performance of lactate and CO2-derived parameters in predicting major postoperative complications will be investigated in the non-sepsis population, which has not been extensively investigated. Our study will compare the two surrogates of respiratory quotient directly, which is an important strength.Trial Registration: ChiCTR, ChiCTR2000029365. Registered January 26th, 2020, http://www.chictr.org.cn/showproj.aspx?proj=48744.

Objective. Preoperative imaging in primary hyperparathyroidism (PHPT) is essential for planning of parathyroidectomy—particularly for selection of a minimally invasive approach. The objective of this cohort study was to evaluate the diagnostic precision of 3D virtual neck exploration (3D-VNE), to evaluate its impact on choice of surgical approach, and to document the correlation with long-term outcomes. Methods. 235 consecutive patients with PHPT were studied (January 2014 to December 2018), with 6-month follow-up. 220 patients had a preoperative computed tomography (CT), 172 of these had a 3D-VNE based on the CT, and 226 patients had a Tc-99m sestamibi scan. Results. Sensitivity of exact, per gland, adenoma localization was 57.09% (95% CI: 50.85–63.10%) for nonspecialized radiologist interpretation of CT scan, 58.17% (95% CI: 51.99–64.10%) for Tc-99m sestamibi scan, and 90.21% (95% CI: 85.21–93.64%) for 3D-VNE, and thereby favoring 3D-VNE compared to CT scan alone (OR 34.5, 95% CI: 9.19–290.56%, P < 2.2 × 10−16) and to Tc-99m sestamibi scan (OR 16.25, 95% CI: 6.05–61.42%, P = 3.1 × 10−15). Specificity was 87.38% for CT scan, 86.36% for 3D-VNE, and 90% for Tc-99m sestamibi scan (P >.05). The cure rate was 100%. The long-term recurrence rate (RR) was 2.978%. The RR was 1.324% in the video-assisted parathyroidectomy group of 151 patients and 5.952% in the group of 84 patients with cervicotomy (P =.0459). Conclusion. CT-based 3D-VNE proved to be the most accurate localizing study in PHPT and aided in selecting patients for targeted minimally invasive parathyroidectomy, which was associated with the lower recurrence rate. 3D-VNE could be proposed as a first-line imaging study in patients with PHPT. [ABSTRACT FROM AUTHOR]

Background: There is lack of reliable predictors for success of conventional complete denture (CCD) therapy, which in turn might affect the effectiveness of subsequent implant‐retained overdenture (IOD) therapy. Purpose To investigate relationships between digitally obtained geometrical mandibular residual ridge measures and perceived CCD‐stability. Materials and Methods: 30 CCD wearing patients (67.9 ± 7.0 years) for whom a new set of CCDs was advised, were treated with new CCDs. Digitalized mandibular gypsum models were measured using the Geomagic Studio 2013 software. Data were obtained for (1) height, width, and cross‐section surface area of the residual ridge at different locations (midline, premolar, and anterior edge of retromolar pad) and (2) denture base surface area. Scatter plots and multivariate regression analyses were used to investigate associations between the geometric data and denture base surface area, and correlated with denture stability scores (Spearman rank test). Results: Scatter plots showed that best model fit for denture base surface area was mean ridge height (R2 = 0.906). Multivariate regression showed that height at premolar location (p = 0.001) had largest effect on denture base surface area (R2 = 0.796). Ridge morphology variables, except width at midline location, were significantly correlated with CCD‐stability (p‐values <0.05). CCD‐stability was significantly correlated with denture base surface area (p ≤ 0.001). Conclusion: Residual ridge height at premolar location was most predictive for denture base surface area and perceived CCD‐stability. [ABSTRACT FROM AUTHOR]

Background: The significance of mandibular residual ridge height and satisfaction with conventional complete dentures (CCD) as predictors for the added value of implant‐overdenture (IOD) therapy is unknown. Purpose To investigate the predictive value of thresholds for (1) residual ridge height at premolar location (PRH), and (2) satisfaction with CCD‐stability for the added value of two intraforaminal implants supporting the mandibular CCD. Methods: Thirty CCD wearing patients (67.9 ± 7.0 years) for whom a new CCD was advised, received a new CCD. Mandibular gypsum models were digitally measured. After 3 months free of complaints (T1), perceived CCD‐stability was evaluated, and participants received two intraforaminal implants. At T1 and T2 (3 months free of complaints after IOD therapy) participants completed OHIP14‐CN, and denture satisfaction (VAS) questionnaires, and performed mixing ability tests. Participants were grouped according to PRH of ≥6.15 mm versus < 6.15 mm, and perceived CCD‐stability satisfied vs. dissatisfied. Scores at T2 were compared to T1 (paired t‐tests). Predictive values of PRH and CCD‐stability were analyzed with logistic multivariate regression models. Results: At T2, only participants with PRH of <6.15 mm or dissatisfied with CCD‐stability had significant lower OHIP‐total and domain scores for 'physical pain' and 'physical disability' and significantly higher VAS scores for perceived chewing function, denture retention and oral comfort. Regression analyses showed that participants with PRH of <6.15 mm, or dissatisfied with CCD‐stability had significantly higher chance for lower OHIP‐total and domain scores 'physical pain' and 'physical disability', and for higher VAS scores for perceived chewing function, denture retention and oral comfort at T2. Masticatory performance improved significantly after IOD therapy, but independent of PRH and CCD‐stability. Conclusion: PRH and satisfaction with CCD‐stability were adequate prognostic indicators for improvement of oral health‐related quality of life and denture satisfaction by mandibular IOD therapy. [ABSTRACT FROM AUTHOR]

Background: This retrospective clinical study aimed to compare the sensitivity of cone-beam computed tomographic (CBCT) images and periapical (PA) radiographs to reveal cracked teeth, split teeth, and teeth with vertical root fractures (VRFs)., Methods: The authors included 98 patients (98 teeth) diagnosed with a longitudinal tooth fracture (LTF) (cracked tooth, split tooth, VRF) through direct visualization after extraction and with comprehensive clinical and radiographic records. They collected demographic, clinical, and radiographic data. The authors evaluated PA radiographs and CBCT images to identify fractures, fracture lines, and the different patterns of bone loss associated with these teeth. They used the McNemar test to compare PA radiographs and CBCT scans when assessing bone loss. They used the Fisher test to determine statistical relationships between fracture types and demographic, clinical, and radiologic traits. They used an analysis of variance test to compare patient age with fracture types., Results: CBCT images were significantly more effective (P < .05) in detecting bone loss patterns associated with LTFs than with PA radiographs, with 71% of cases detected via CBCT images compared with 42% via radiographs. Mean age was significantly greater (P < .05) in patients with teeth with VRFs than in patients with split teeth. A significant relationship was observed between the type of fracture and the following variables: root canal treatment (split, VRF, P = .002), deep probing depth (≥ 5 mm) (VRF, P = .026), and having more than 8 teeth extracted from the mouth (VRF, P = .032). Overall, there was a significant difference (P < .001) between the visualization of fracture lines (45% on PA radiographs, 65% on CBCT images)., Conclusions: CBCT scans provided more information on LTFs than PA radiographs, particularly in the identification of periradicular bone changes., Practical Implications: CBCT imaging can assist in making the clinical diagnosis of LTFs through observation of bone loss patterns, providing more information than PA radiographs., Competing Interests: Disclosures None of the authors reported any disclosures., (Copyright © 2024 American Dental Association. Published by Elsevier Inc. All rights reserved.)

Objective: To analyze and evaluate the value of serum human epididymis protein 4 (HE4) for the diagnosis of endometrial cancer (EC).Methods: Studies involving HE4 and the diagnosis of EC were retrieved from the following medical literature databases: Medline, PubMed, Web of Science, China National Knowledge Infrastructure, China Biology Medicine Disc, Vip Journal Integration Platform, and Wanfang Data Knowledge Service Platform. Quality assessment was performed independently by two reviewers using Review Manager 5.3 (Cochrane Collaboration Group). A quality table of included studies was made using Review Manager 5.3, and the pooled sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic accuracy, and receiver operating characteristic curve (SROC) were analyzed using Review Manager 5.3 and Meta-Disc 1.4 software.Results: Of 887 studies, 17 passed quality assessment and were included in the final study. The pooled SEN was 0.65 (95 % confidence interval [CI]: 0.63-0.67), SPE was 0.913 (95 % CI: 0.92-0.95), PLR was 10.06 (95 % CI: 4.75-21.35), NLR was 0.41 (95 % CI: 0.33-0.50), diagnostic odds ratio (DOR) was 26.7 (95 % CI: 11.7-60.93), and the area under curve (AUC) of the receiver operating characteristic curve (SROC) curve was 0.75 (95 % CI: 0.81-0.87).Conclusions: HE4 is a potential biomarker for the diagnosis of EC with a high specificity and relatively low sensitivity. Considering high heterogeneity and selection bias, the value of HE4 for diagnosing EC should be further evaluated in strictly-designed diagnostic studies as well as in different pathological types and stages of EC. [ABSTRACT FROM AUTHOR]

Purpose: Mesorectal lymph node staging plays an important role in treatment decision making. Here, we explore the benefit of higher‐order diffusion MRI models accounting for non‐Gaussian diffusion effects to classify mesorectal lymph nodes both 1) ex vivo at ultrahigh field correlated with histology and 2) in vivo in a clinical scanner upon patient staging. Methods: The preclinical investigation included 54 mesorectal lymph nodes, which were scanned at 16.4 T with an extensive diffusion MRI acquisition. Eight diffusion models were compared in terms of goodness of fit, lymph node classification ability, and histology correlation. In the clinical part of this study, 10 rectal cancer patients were scanned with diffusion MRI at 1.5 T, and 72 lymph nodes were analyzed with Apparent Diffusion Coefficient (ADC), Intravoxel Incoherent Motion (IVIM), Kurtosis, and IVIM‐Kurtosis. Results: Compartment models including restricted and anisotropic diffusion improved the preclinical data fit, as well as the lymph node classification, compared to standard ADC. The comparison with histology revealed only moderate correlations, and the highest values were observed between diffusion anisotropy metrics and cell area fraction. In the clinical study, the diffusivity from IVIM‐Kurtosis was the only metric showing significant differences between benign (0.80 ± 0.30 μm2/ms) and malignant (1.02 ± 0.41 μm2/ms, P =.03) nodes. IVIM‐Kurtosis also yielded the largest area under the receiver operating characteristic curve (0.73) and significantly improved the node differentiation when added to the standard visual analysis by experts based on T2‐weighted imaging. Conclusion: Higher‐order diffusion MRI models perform better than standard ADC and may be of added value for mesorectal lymph node classification in rectal cancer patients. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether evaluations of antenatal umbilical coiling index (aUCI) could predict postnatal umbilical coiling index (UCI) (pUCI) in people with gestational diabetes mellitus (GDM) compared with normal pregnancy independent of maternal demographic and reproductive characteristics.Method: In this prospective study, 105 women with normal pregnancy, and 117 women with pregnancy complicated by GDM were recruited. Ultrasound scan of umbilical cord was performed at 18-23 and 37-41 weeks of gestation (WG). Evaluation of pUCI, as the reference standard, was performed within 24 hours after delivery.Findings: There was no significant relationship between aUCI and maternal demographic and reproductive characteristics. The mean for pUCI was 0.21 ± 0.12 in the GDM group, and 0.21 ± 0.09 in the normal pregnancy (p = .61). In the GDM group, a significant association was found between aUCI and pUCI categories (p = .004). The area under curve (AUC) was less than 0.5 for hypocoiling in both groups. For hypercoiling it was 0.84 ± 0.04 in the GDM group and 0.75 ± 0.06 in the normal pregnancy group (18-23 WG). In the GDM group the cutoff points that predict hypercoiling were 0.28 (18-23WG), and 0.21 (37-41WG). These were 0.35 (18-23WG), and 0.33 (37-41WG) in the normal pregnancy group. Diagnostic accuracy analysis revealed that in the GDM group, the sensitivity and specificity of hypercoiling for prediction of pUCI were 0.94 and 0.70 respectively at 18-23 WG.Conclusions: Antenatal hypercoiling at the second trimester of pregnancy strongly predict postnatal hypercoiling in pregnancies complicated by GDM. [ABSTRACT FROM AUTHOR]

Multivariate meta‐analysis is gaining prominence in evidence synthesis research because it enables simultaneous synthesis of multiple correlated outcome data, and random‐effects models have generally been used for addressing between‐studies heterogeneities. However, coverage probabilities of confidence regions or intervals for standard inference methods for random‐effects models (eg, restricted maximum likelihood estimation) cannot retain their nominal confidence levels in general, especially when the number of synthesized studies is small because their validities depend on large sample approximations. In this article, we provide permutation‐based inference methods that enable exact joint inferences for average outcome measures without large sample approximations. We also provide accurate marginal inference methods under general settings of multivariate meta‐analyses. We propose effective approaches for permutation inferences using optimal weighting based on the efficient score statistic. The effectiveness of the proposed methods is illustrated via applications to bivariate meta‐analyses of diagnostic accuracy studies for airway eosinophilia in asthma and a network meta‐analysis for antihypertensive drugs on incident diabetes, as well as through simulation experiments. In numerical evaluations performed via simulations, our methods generally provided accurate confidence regions or intervals under a broad range of settings, whereas the current standard inference methods exhibited serious undercoverage properties. [ABSTRACT FROM AUTHOR]

Background and aims: Deciding when to repeat and when to stop transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC) can be difficult even for experienced investigators. Our aim was to develop a survival prediction model for such patients undergoing TACE using novel machine learning algorithms and to compare it to conventional prediction scores, ART, ABCR and SNACOR. Methods: For this retrospective analysis, 282 patients who underwent TACE for HCC at our tertiary referral centre between January 2005 and December 2017 were included in the final analysis. We built an artificial neural network (ANN) including all parameters used by the aforementioned risk scores and other clinically meaningful parameters. Following an 80:20 split, the first 225 patients were used for training; the more recently treated 20% were used for validation. Results: The ANN had a promising performance at predicting 1‐year survival, with an area under the ROC curve (AUC) of 0.77 ± 0.13. Internal validation yielded an AUC of 0.83 ± 0.06, a positive predictive value of 87.5% and a negative predictive value of 68.0%. The sensitivity was 77.8% and specificity 81.0%. In a head‐to‐head comparison, the ANN outperformed the aforementioned scoring systems, which yielded lower AUCs (SNACOR 0.73 ± 0.07, ABCR 0.70 ± 0.07 and ART 0.54 ± 0.08). This difference reached significance for ART (P <.001); for ABCR and SNACOR significance was not reached (P =.143 and P =.201). Conclusions: Artificial neural networks could be better at predicting patient survival after TACE for HCC than traditional scoring systems. Once established, such prediction models could easily be deployed in clinical routine and help determine optimal patient care. [ABSTRACT FROM AUTHOR]

There is a need for accurate diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19). This study aimed to evaluate the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody assay (GenBody™ COVI040) for detecting SARS-CoV-2 antibody seroconversion in COVID-19 patients. A total of 130 samples, serially collected from patients with confirmed COVID-19, and 100 negative control samples were tested for anti-SARS-CoV-2 IgM and IgG using the GenBody™ COVI040 assay following the South Korean Ministry of Food and Drug Safety guidelines on the review and approval of in vitro diagnostic devices for COVID-19. Reverse-transcription polymerase chain reaction results were used as the comparator. The overall sensitivity of the GenBody™ COVI040 assay was 97.69% (95% confidence interval (CI): 93.40–99.52%). The sensitivity of the assay increased with time post symptom onset (PSO) (sensitivity ≤6 days PSO: 78.57%, 95% CI: 49.20–95.34%; sensitivity 7–13 days PSO: 100%, 95% CI: 87.23–100%; and sensitivity ≥14 days PSO: 100%, 95% CI: 95.94–100%). The specificity of the assay was 100% (95% CI: 96.38–100%). The GenBody™ COVI040 assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19.