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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.

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.

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.

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.

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.

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.

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.

Abstract Background In meta-analyses of diagnostic test accuracy, routinely only one pair of sensitivity and specificity per study is used. However, for tests based on a biomarker or a questionnaire often more than one threshold and the corresponding values of true positives, true negatives, false positives and false negatives are known. Methods We present a new meta-analysis approach using this additional information. It is based on the idea of estimating the distribution functions of the underlying biomarker or questionnaire within the non-diseased and diseased individuals. Assuming a normal or logistic distribution, we estimate the distribution parameters in both groups applying a linear mixed effects model to the transformed data. The model accounts for across-study heterogeneity and dependence of sensitivity and specificity. In addition, a simulation study is presented. Results We obtain a summary receiver operating characteristic (SROC) curve as well as the pooled sensitivity and specificity at every specific threshold. Furthermore, the determination of an optimal threshold across studies is possible through maximization of the Youden index. We demonstrate our approach using two meta-analyses of B type natriuretic peptide in heart failure and procalcitonin as a marker for sepsis. Conclusions Our approach uses all the available information and results in an estimation not only of the performance of the biomarker but also of the threshold at which the optimal performance can be expected.

In the landscape of modern medicine, the ability to accurately diagnose various clinical conditions is paramount. As new diagnostic tools continue to emerge, their accuracy must be rigorously assessed before clinical implementation. This paper introduces a systematic review protocol tailored for diagnostic accuracy studies, drawing inspiration from a review on dysphagia screening in post-stroke patients. The protocol, designed with precision and transparency at its core, facilitates a thorough synthesis of evidence, employing tools such as the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and the Standards for Reporting of Diagnostic Accuracy Studies (STARD) checklist for robust evaluation. The protocol emphasizes registration with the PROSPERO database and adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The systematic search approach encompasses a comprehensive exploration of databases and precise keyword combinations. Distinctive inclusion and exclusion criteria, coupled with a dual-reviewer methodology, ensure the selection of high-quality studies. This framework has the potential to serve as a benchmark for systematic reviews in diagnostic accuracy, highlighting the importance of standardization, transparency, and adaptability in clinical research. This approach paves the way for a research methodology that delves deeper into diagnostic tools across various clinical scenarios, promoting evidence-based advancements in patient care., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier B.V.)

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.

Objectives: To study the accuracy and reliability of two point of care devices (Hemocue 201 [HC201]) and Hemoglobin Colour Scale (HCS) with reference to automated laboratory analyser Sysmex XP 100 (LabSXP) and determine factors influencing their performances. To discuss certain design issues while ascertaining these parameters for its judicious use in both clinical context and disease burden studies. Methods: Reliability and accuracy statistics were calculated for four population subgroups that were selected randomly using cluster sampling in a rural community of eastern India. Appropriate measures were taken to reduce biases in the study. Bland Altmann Plot was used to determine Bias and ROC curve analysis was used to suggest new cut-offs for HCS method. Results: True prevalence varied across subgroups ranging from 12.56% in adolescent boys to 40.71% in adult women. Sensitivity for HC201 was lowest among boys (80.39%) and highest among adult females (92.82%), while specificity was highest among adult males (86.94%) and lowest among adult females (75.00%). The variation across subgroups was due to differences in distribution of underlying Hb values. HC201 has potential for use in clinical practice as well as disease burden estimation study. HCS was not suitable for use in clinical setting as the bias (−4.1 g/dl) was unacceptable. However, ROC analysis suggested certain cut-offs for different age groups and can be employed in poor resource settings for disease burden estimation study. Conclusions: HC201 is better than HCS as per the study. However, accuracy parameters are likely to vary depending on the distribution of underlying Hb distribution. Thus, same machines can demonstrate different accuracy parameters in different settings. There is need for designing studies that could help estimate these parameters each time on a subsample which would go a long way in efficiently using technology be it for guiding clinical decisions or public health actions. [ABSTRACT FROM AUTHOR]

Background: Delirium is a common and serious clinical syndrome which is often missed in routine clinical care. The core cognitive feature is inattention. We developed a novel bedside neuropsychological test for assessing inattention in delirium implemented on a smartphone platform (DelApp). We aim to evaluate the diagnostic performance of the DelApp in a representative cohort of older hospitalised patients.Methods: This is a prospective study of older non-scheduled hospitalised patients (target n = 500, age ≥ 65), recruited from elderly care and acute orthopaedic wards. Exclusion criteria are: non-English speakers; severe vision or hearing impairment; photosensitive epilepsy. A structured reference standard delirium assessment based on DSM-5 criteria will be used, which includes a cognitive test battery administered by a trained assessor (Orientation-Memory-Concentration Test, Abbreviated Mental Test-10, Delirium Rating Severity Scale-Revised-98, digit span, months and days backwards, Vigilance A' test) and assessment of arousal (Observational Scale of Level of Arousal, Richmond Agitation Sedation Scale). Prior change in cognition will be documented using the Informant Questionnaire on Cognitive Decline in the Elderly. Patients will be categorized as delirium (with/without dementia), possible delirium, dementia, no cognitive impairment, or undetermined. A separate assessor (blinded to diagnosis and assessments) will administer the DelApp index test within 3 h of the reference standard assessment. The DelApp comprises assessment of arousal (score 0-4) and sustained attention (score 0-6), yielding a total score between 0 and 10 (higher score = better performance). Outcomes (length of stay, mortality and discharge location) will be collected at 12 weeks. We will evaluate a priori cutpoints derived from a previous case-control study. Measures of the accuracy of DelApp will include sensitivity, specificity, positive and negative predictive values, and area under the ROC curve. We plan repeat assessments on up to 4 occasions in a purposive subsample of 30 patients (15 delirium, 15 no delirium) to examine changes over time.Discussion: This study evaluates the diagnostic test accuracy of a novel smartphone test for delirium in a representative cohort of older hospitalised patients, including those with dementia. DelApp has the potential to be a convenient, objective method of improving delirium assessment for older people in acute care.Trial Registration: Clinical trials.gov, NCT02590796 . Registered on 29 Oct 2015. Protocol version 5, dated 25 July 2016. [ABSTRACT FROM AUTHOR]

Objective: In recent years, a large number of studies have been published on the clinical relevance of pelvic floor three-dimensional (3D) transperineal ultrasound. Several studies compare sonography with other imaging modalities or clinical examination. The quality of reporting in these studies is not known. The objective of this systematic review was to determine the compliance of diagnostic accuracy studies investigating pelvic floor 3D ultrasound with the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines.Methods: Published articles on pelvic floor 3D ultrasound were identified by a systematic literature search of MEDLINE, Web of Science and Scopus databases. Prospective and retrospective studies that compared pelvic floor 3D ultrasound with other clinical and imaging diagnostics were included in the analysis. STARD compliance was assessed and quantified by two independent investigators, using 22 of the original 25 STARD checklist items. Items with the qualifier 'if done' (Items 13, 23 and 24) were excluded because they were not applicable to all papers. Each item was scored as reported (score = 1) or not reported (score = 0). Observer variability, the total number of reported STARD items per article and summary scores for each item were calculated. The difference in total score between STARD-adopting and non-adopting journals was tested statistically, as was the effect of year of publication.Results: Forty studies published in 13 scientific journals were included in the analysis. Mean ± SD STARD checklist score of the included articles was 16.0 ± 2.5 out of a maximum of 22 points. The lowest scores (< 50%) were found for reporting of handling of indeterminate results or missing responses, adverse events and the time interval between tests. Interobserver agreement for rating the STARD items was excellent (intraclass correlation coefficient, 0.77). An independent t-test showed no significant mean difference ± SD in total STARD checklist score between STARD-adopting and non-adopting journals (16.4 ± 2.2 vs 15.9 ± 2.6, respectively). Mean ± SD STARD checklist score for articles published in 2003-2009 was lower, but not statistically different, compared with those published in 2010-2015 (15.2 ± 2.5 vs 16.6 ± 2.4, respectively).Conclusion: The overall compliance with reporting guidelines of diagnostic accuracy studies on pelvic floor 3D transperineal ultrasound is relatively good compared with other fields of medicine. However, specific checklist items require more attention when reported. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. [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.

Background: In meta-analyses of diagnostic test accuracy, routinely only one pair of sensitivity and specificity per study is used. However, for tests based on a biomarker or a questionnaire often more than one threshold and the corresponding values of true positives, true negatives, false positives and false negatives are known.Methods: We present a new meta-analysis approach using this additional information. It is based on the idea of estimating the distribution functions of the underlying biomarker or questionnaire within the non-diseased and diseased individuals. Assuming a normal or logistic distribution, we estimate the distribution parameters in both groups applying a linear mixed effects model to the transformed data. The model accounts for across-study heterogeneity and dependence of sensitivity and specificity. In addition, a simulation study is presented.Results: We obtain a summary receiver operating characteristic (SROC) curve as well as the pooled sensitivity and specificity at every specific threshold. Furthermore, the determination of an optimal threshold across studies is possible through maximization of the Youden index. We demonstrate our approach using two meta-analyses of B type natriuretic peptide in heart failure and procalcitonin as a marker for sepsis.Conclusions: Our approach uses all the available information and results in an estimation not only of the performance of the biomarker but also of the threshold at which the optimal performance can be expected. [ABSTRACT FROM AUTHOR]