Estimates Of Diagnostic Accuracy Research Articles

Ancillary immunohistochemistry testing for loss of p16 in melanoma: A systematic review and meta-analysis of diagnostic accuracy studies.

Ancillary immunohistochemistry testing for p16 loss has been proposed as a diagnostic tool for melanoma, but its accuracy remains uncertain. A systematic review and meta-analysis were conducted on 26 studies involving 979 melanomas and 974 nevi. Through bivariate analysis of data across all cut-off values, the sensitivity and specificity were calculated to be 0.55 (95% confidence interval [CI]: 0.38, 0.70) and 0.85 (95% CI: 0.70, 0.94), respectively. Summary estimates of diagnostic accuracy fell below recommended thresholds for effective tests, but subgroup analysis suggested that p16 loss could aid in diagnosing ambiguous lesions as melanoma in certain scenarios. However, the presence of p16 expression in these contexts does not definitively rule out melanoma. The findings were limited by underpowered exploratory study designs at risk for bias in patient selection and test interpretation. While the use of p16 immunohistochemistry for detecting melanoma is not universally reliable, it may serve as a confirmatory test in differential diagnoses involving common, congenital, acral, Spitz, and deep penetrating nevi. Nevertheless, further studies are needed to validate its utility. Until then, the application of p16 immunohistochemistry in melanoma diagnosis should be regarded as experimental.

Can clinicians identify community-acquired pneumonia on ultralow-dose CT? A diagnostic accuracy study

BackgroundWithout increasing radiation exposure, ultralow-dose computed tomography (CT) of the chest provides improved diagnostic accuracy of radiological pneumonia diagnosis compared to a chest radiograph. Yet, radiologist resources to rapidly report the chest CTs are limited. This study aimed to assess the diagnostic accuracy of emergency clinicians’ assessments of chest ultralow-dose CTs for community-acquired pneumonia using a radiologist’s assessments as reference standard.MethodsThis was a cross-sectional diagnostic accuracy study. Ten emergency department clinicians (five junior clinicians, five consultants) assessed chest ultralow-dose CTs from acutely hospitalised patients suspected of having community-acquired pneumonia. Before assessments, the clinicians attended a focused training course on assessing ultralow-dose CTs for pneumonia. The reference standard was the assessment by an experienced emergency department radiologist. Primary outcome was the presence or absence of pulmonary opacities consistent with community-acquired pneumonia. Sensitivity, specificity, and predictive values were calculated using generalised estimating equations.ResultsAll clinicians assessed 128 ultralow-dose CTs. The prevalence of findings consistent with community-acquired pneumonia was 56%. Seventy-eight percent of the clinicians’ CT assessments matched the reference assessment. Diagnostic accuracy estimates were: sensitivity = 83% (95%CI: 77–88), specificity = 70% (95%CI: 59–81), positive predictive value = 80% (95%CI: 74–84), negative predictive value = 78% (95%CI: 73–82).ConclusionThis study found that clinicians could assess chest ultralow-dose CTs for community-acquired pneumonia with high diagnostic accuracy. A higher level of clinical experience was not associated with better diagnostic accuracy.

Update on PI-RADS Version 2.1 Diagnostic Performance Benchmarks for Prostate MRI: Systematic Review and Meta-Analysis.

Background Prostate MRI for the detection of clinically significant prostate cancer (csPCa) is standardized by the Prostate Imaging Reporting and Data System (PI-RADS), currently in version 2.1. A systematic review and meta-analysis infrastructure with a 12-month update cycle was established to evaluate the diagnostic performance of PI-RADS over time. Purpose To provide estimates of diagnostic accuracy and cancer detection rates (CDRs) of PI-RADS version 2.1 categories for prostate MRI, which is required for further evidence-based patient management. Materials and Methods A systematic search of PubMed, Embase, Cochrane Library, and multiple trial registers (English-language studies published from March 1, 2019, to August 30, 2022) was performed. Studies that reported data on diagnostic accuracy or CDRs of PI-RADS version 2.1 with csPCa as the primary outcome were included. For the meta-analysis, pooled estimates for sensitivity, specificity, and CDRs were derived from extracted data at the lesion level and patient level. Sensitivity and specificity for PI-RADS greater than or equal to 3 and PI-RADS greater than or equal to 4 considered as test positive were investigated. In addition to individual PI-RADS categories 1-5, subgroup analyses of subcategories (ie, 2+1, 3+0) were performed. Results A total of 70 studies (11 686 lesions, 13 330 patients) were included. At the patient level, with PI-RADS greater than or equal to 3 considered positive, meta-analysis found a 96% summary sensitivity (95% CI: 95, 98) and 43% specificity (95% CI: 33, 54), with an area under the summary receiver operating characteristic (SROC) curve of 0.86 (95% CI: 0.75, 0.93). For PI-RADS greater than or equal to 4, meta-analysis found an 89% sensitivity (95% CI: 85, 92) and 66% specificity (95% CI: 58, 74), with an area under the SROC curve of 0.89 (95% CI: 0.85, 0.92). CDRs were as follows: PI-RADS 1, 6%; PI-RADS 2, 5%; PI-RADS 3, 19%; PI-RADS 4, 54%; and PI-RADS 5, 84%. The CDR was 12% (95% CI: 7, 19) for transition zone 2+1 lesions and 19% (95% CI: 12, 29) for 3+0 lesions (P = .12). Conclusion Estimates of diagnostic accuracy and CDRs for PI-RADS version 2.1 categories are provided for quality benchmarking and to guide further evidence-based patient management. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Tammisetti and Jacobs in this issue.

Diagnostic accuracy of OCT angiography for macular neovascularization in central serous chorioretinopathy: A systematic review and meta-analysis.

Identifying macular neovascularization (MNV) in eyes with central serous chorioretinopathy (CSC) has important implications for its management. Optical coherence tomography angiography (OCTA) is increasingly used for this purpose. Here, we systematically reviewed the literature and conducted meta-analysis to determine the diagnostic accuracy of OCTA for detecting MNV in eyes with CSC. We systematically searched the literature in 12 databases for relevant studies from database inception until 18 November 2023. Eligible studies had eyes with CSC with MNV and CSC without MNV. Index test was OCTA. Reference test was retinal dye angiography. Study selection and data extraction were performed in duplicate, and study was evaluated using the Quality Assessment of Diagnostic Accuracy Studies 2. Our main outcome of interest was the sensitivity and specificity of OCTA for detecting MNV in CSC. Pooled diagnostic test accuracy estimates were computed using MetaDTA. Of 177 records screened, seven fulfilled the eligibility criteria for our study. These studies summarized data from a total of 1061 eyes. Summary estimate sensitivity and specificity to diagnose MNV in eyes with CSC using OCTA was 92.9% (95% CI: 81.7%-97.5%) and 99.4% (95% CI: 84.1%-100.0%), respectively. The main source of bias across studies was the reference standard, as four studies used multimodal imaging including OCTA for the reference standard. OCTA alone is excellent for detecting MNV in CSC compared to retinal dye angiography or multimodal imaging. Using OCTA first before considering retinal dye angiography could potentially save an important number of retinal dye angiographies.

Understanding the value of monocyte distribution width (MDW) in acutely ill medical patients presenting to the emergency department: a prospective single center evaluation

The monocyte distribution width (MDW) has emerged as a promising biomarker for accurate and early identification of patients with potentially life-threatening infections. Here we tested the diagnostic performance of MDW in adult patients requiring hospital admission for community-acquired infections and sepsis, evaluated sources of heterogeneity in the estimates of diagnostic accuracy, and assessed the meaning of MDW in a patient population presenting to the emergency department (ED) for acute non-infectious conditions. 1925 consecutive patients were categorized into three groups: non-infection (n = 1507), infection (n = 316), and sepsis/septic shock (n = 102). Diagnostic performance for infection or sepsis of MDW alone or in combination with components of SOFA was tested using AUC of ROC curves, sensitivity, and specificity. The relationship between MDW and different pathogens as well as the impact of non-infectious conditions on MDW values were explored. For the prediction of infection, the AUC/ROC of MDW (0.84) was nearly overlapping that of procalcitonin (0.83), and C-reactive protein (0.89). Statistical optimal cut-off value for MDW was 21 for predicting infection (sensitivity 73%, specificity 82%) and 22 for predicting sepsis (sensitivity 79%, specificity 83%). The best threshold to rule out infection was MDW ≤ 17 (NPV 96.9, 95% CI 88.3–100.0), and ≤ 18 (NPV 99.5, 95% CI 98.3–100.0) to rule out sepsis. The combination of MDW with markers of organ dysfunction (creatinine, bilirubin, platelets) substantially improved the AUC (0.96 (95% CI 0.94–0.97); specificity and sensitivity of 88% and 94%, respectively). In conclusion, MDW has a good diagnostic performance in diagnosing infection and sepsis in patients presenting in ED. Its use as an infection marker even increases when combined with other markers of organ dysfunction. Understanding the impact of interactions of non-infectious conditions and comorbidities on MDW and its diagnostic accuracy requires further elucidation.

Simultaneous alleviation of verification and reference standard biases in a community-based tuberculosis screening study using Bayesian latent class analysis.

Estimation of prevalence and diagnostic test accuracy in tuberculosis (TB) prevalence surveys suffer from reference standard and verification biases. The former is attributed to the imperfect reference test used to bacteriologically confirm TB disease. The latter occurs when only the participants screening positive for any TB-compatible symptom or chest X-ray abnormality are selected for bacteriological testing (verification). Bayesian latent class analysis (LCA) alleviates the reference standard bias but suffers verification bias in TB prevalence surveys. This work aims to identify best-practice approaches to simultaneously alleviate the reference standard and verification biases in the estimates of pulmonary TB prevalence and diagnostic test performance in TB prevalence surveys. We performed a secondary analysis of 9869 participants aged ≥15 years from a community-based multimorbidity screening study in a rural district of KwaZulu-Natal, South Africa (Vukuzazi study). Participants were eligible for bacteriological testing using Xpert Ultra and culture if they reported any cardinal TB symptom or had an abnormal chest X-ray finding. We conducted Bayesian LCA in five ways to handle the unverified individuals: (i) complete-case analysis, (ii) analysis assuming the unverified individuals would be negative if bacteriologically tested, (iii) analysis of multiply-imputed datasets with imputation of the missing bacteriological test results for the unverified individuals using multivariate imputation via chained equations (MICE), and simultaneous imputation of the missing bacteriological test results in the analysis model assuming the missing bacteriological test results were (iv) missing at random (MAR), and (v) missing not at random (MNAR). We compared the results of (i)-(iii) to the analysis based on a composite reference standard (CRS) of Xpert Ultra and culture. Through simulation with an overall true prevalence of 2.0%, we evaluated the ability of the models to alleviate both biases simultaneously. Based on simulation, Bayesian LCA with simultaneous imputation of the missing bacteriological test results under the assumption that the missing data are MAR and MNAR alleviate the reference standard and verification biases. CRS-based analysis and Bayesian LCA assuming the unverified are negative for TB alleviate the biases only when the true overall prevalence is <3.0%. Complete-case analysis produced biased estimates. In the Vukuzazi study, Bayesian LCA with simultaneous imputation of the missing bacteriological test results under the MAR and MNAR assumptions produced overall PTB prevalence of 0.9% (95% Credible Interval (CrI): 0.6-1.9) and 0.7% (95% CrI: 0.5-1.1) respectively alongside realistic estimates of overall diagnostic test sensitivity and specificity with substantially overlapping 95% CrI. The CRS-based analysis and Bayesian LCA assuming the unverified were negative for TB produced 0.7% (95% CrI: 0.5-0.9) and 0.7% (95% CrI: 0.5-1.2) overall PTB prevalence respectively with realistic estimates of overall diagnostic test sensitivity and specificity. Unlike CRS-based analysis, Bayesian LCA of multiply-imputed data using MICE mitigates both biases. The findings demonstrate the efficacy of these advanced techniques in alleviating the reference standard and verification biases, enhancing the robustness of community-based screening programs. Imputing missing values as negative for bacteriological tests is plausible under realistic assumptions.

Accuracy of a deep learning-based algorithm for the detection of thoracic aortic calcifications in chest computed tomography and cardiovascular surgery planning.

To assess the accuracy of a deep learning-based algorithm for fully automated detection of thoracic aortic calcifications in chest computed tomography (CT) with a focus on the aortic clamping zone. We retrospectively included 100 chest CT scans from 91 patients who were examined on second- or third-generation dual-source scanners. Subsamples comprised 47 scans with an ECG-gated aortic angiography and 53 unenhanced scans. A deep learning model performed aortic landmark detection and aorta segmentation to derive eight vessel segments. Associated calcifications were detected and their volumes measured using a mean-based density thresholding. Algorithm parameters (calcium cluster size threshold, aortic mask dilatation) were varied to determine optimal performance for the upper ascending aorta that encompasses the aortic clamping zone. A binary visual rating served as a reference. Standard estimates of diagnostic accuracy and inter-rater agreement using Cohen's Kappa were calculated. Thoracic aortic calcifications were observed in 74% of patients with a prevalence of 27% to 70% by aorta segment. Using different parameter combinations, the algorithm provided binary ratings for all scans and segments. The best-performing parameter combination for the presence of calcifications in the aortic clamping zone yielded a sensitivity of 93% and a specificity of 82% with an area under the receiver operating characteristic curve of 0.874. Using these parameters, the inter-rater agreement ranged from κ 0.66 to 0.92 per segment. Fully automated segmental detection of thoracic aortic calcifications in chest CT performs with high accuracy. This includes the critical preoperative assessment of the aortic clamping zone.

Oral swabs with a rapid molecular diagnostic test for pulmonary tuberculosis in adults and children: a systematic review

Tuberculosis is a leading cause of infectious disease mortality worldwide, but diagnosis of pulmonary tuberculosis remains challenging. Oral swabs are a promising non-sputum alternative sample type for the diagnosis of pulmonary tuberculosis. We aimed to assess the diagnostic accuracy of oral swabs to detect pulmonary tuberculosis in adults and children and suggest research implications. In this systematic review, we searched published and preprint studies from Jan 1, 2000, to July 5, 2022, from eight databases (MEDLINE, Embase, Scopus, Science Citation Index, medRxiv, bioRxiv, Global Index Medicus, and Google Scholar). We included diagnostic accuracy studies including cross-sectional, cohort, and case-control studies in adults and children from which we could extract or derive sensitivity and specificity of oral swabs as a sample type for the diagnosis of pulmonary tuberculosis against a sputum microbiological (nucleic acid amplification test [NAAT] on sputum or culture) or composite reference standard. Of 550 reports identified by the search, we included 16 eligible reports (including 20 studies and 3083 participants) that reported diagnostic accuracy estimates on oral swabs for pulmonary tuberculosis. Sensitivity on oral swabs ranged from 36% (95% CI 26-48) to 91% (80-98) in adults and 5% (1-14) to 42% (23-63) in children. Across all studies, specificity ranged from 66% (95% CI 52-78) to 100% (97-100), with most studies reporting specificity of more than 90%. Meta-analysis was not performed because of sampling and testing heterogeneity. Sensitivity varies in both adults and children when diverse methods are used. Variability in sampling location, swab type, and type of NAAT used in accuracy studies limits comparison. Although data are suggestive that high accuracy is achievable using oral swabs with molecular testing, more research is needed to define optimal methods for using oral swabs as a specimen for tuberculosis detection. The current data suggest that tongue swabs and swab types that collect increased biomass might have increased sensitivity. We would recommend that future studies use these established methods to continue to refine sample processing to maximise sensitivity. Bill and Melinda Gates foundation (INV-045721) and FIND (Netherlands Enterprise Agency on behalf of the Minister for Foreign Trade and Development Cooperation [NL-GRNT05] and KfW Development Bank, German Federal Ministry of Education and Research [KFW-TBBU01/02]).

Diagnostic Accuracy of Conventional Ultrasound (US) Compared to Contrast Enhanced Ultrasound (CEUS) for Diagnosing Liver Tumours: A Systematic Review and Meta -analysis

The accurate diagnosis of liver tumours is essential for effective treatment. This study is aimed at comparing the diagnostic accuracy of conventional ultrasound (US) and contrast enhanced ultrasound (CEUS) for detecting and characterizing liver tumours. There is still an unsolved problem regarding differentiation of benign and malignant liver tumours. Thus, an evaluation of the overall sensitivity and specificity of conventional US and CEUS for diagnosing benign and malignant liver tumours is presented in this systematic literature review and meta-analysis. This study followed the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). A search of relevant databases including Scopus, PubMed, and Cochrane Library was conducted from inception to March 31, 2023 using specific keywords. Among the studies included, diagnostic performance was assessed and data was extracted. Average weighted was carried out to calculate the pooled estimates of overall sensitivity and specificity as well as 95% confidence interval (95% CI) by using Wilson score interval of the sensitivity and specificity of the studies. The selected studies were evaluated for reliability using the Quality Assessment of Diagnostic Performance Studies (QUADAS-2). A total of 11 studies involving 1605 patients were included in the study, with publication years ranging from 2022 to 2004. A comparison of conventional US and CEUS showed that CEUS demonstrated high diagnostic accuracy for diagnosing liver tumours. Based on the pooled estimation of diagnostic accuracy (95% CI), liver tumour diagnosis for differentiation of benign and malignant tumours (CEUS: sensitivity: 0.89 [0.87-0.90], specificity: 0.80 [0.78-0.82] and conventional US: sensitivity: 0.51 [0.49-0.53], specificity: 0.44 [0.42-0.53]). It is clear from this study that CEUS has a significant role to play in clinical practice. These results indicate its value in detecting and diagnosing liver tumours, resulting in better outcomes for patients

Automated image quality assessment for selecting among multiple magnetic resonance image acquisitions in the German National Cohort study

In magnetic resonance imaging (MRI), the perception of substandard image quality may prompt repetition of the respective image acquisition protocol. Subsequently selecting the preferred high-quality image data from a series of acquisitions can be challenging. An automated workflow may facilitate and improve this selection. We therefore aimed to investigate the applicability of an automated image quality assessment for the prediction of the subjectively preferred image acquisition. Our analysis included data from 11,347 participants with whole-body MRI examinations performed as part of the ongoing prospective multi-center German National Cohort (NAKO) study. Trained radiologic technologists repeated any of the twelve examination protocols due to induced setup errors and/or subjectively unsatisfactory image quality and chose a preferred acquisition from the resultant series. Up to 11 quantitative image quality parameters were automatically derived from all acquisitions. Regularized regression and standard estimates of diagnostic accuracy were calculated. Controlling for setup variations in 2342 series of two or more acquisitions, technologists preferred the repetition over the initial acquisition in 1116 of 1396 series in which the initial setup was retained (79.9%, range across protocols: 73–100%). Image quality parameters then commonly showed statistically significant differences between chosen and discarded acquisitions. In regularized regression across all protocols, ‘structured noise maximum’ was the strongest predictor for the technologists’ choice, followed by ‘N/2 ghosting average’. Combinations of the automatically derived parameters provided an area under the ROC curve between 0.51 and 0.74 for the prediction of the technologists’ choice. It is concluded that automated image quality assessment can, despite considerable performance differences between protocols and anatomical regions, contribute substantially to identifying the subjective preference in a series of MRI acquisitions and thus provide effective decision support to readers.

Concurrent and predictive validity of the Alberta Infant Motor Scale and the Peabody Developmental Motor Scales-2 administered to infants born preterm in Norway

BackgroundThe correlation between the Alberta Infant Motor Scale (AIMS) and the Peabody Developmental Motor Scales-2 (PDMS-2) has not previously been assessed in Norwegian infants. Our purpose was to investigate the concurrent validity of the AIMS and the PDMS-2 in a group of high-risk infants, and to investigate the predictive validity of the two tests for atypical motor function at 24 months post term age (PTA).MethodsThis is a retrospective study of the AIMS and the PDMS-2 administered to infants born preterm with gestational age ≤ 32 weeks (n = 139) who had participated in a randomized controlled trial of early parent-administered physiotherapy. The infants’ motor development had been assessed using the AIMS and the PDMS-2 at 6- and 12-months. The primary outcome was PDMS-2 at 24-months PTA. To explore the correlation between the two tests we used Spearman’s rho. Bland Altman plots were used to detect if there were systematic differences between the measurements. Receiver-operating characteristics curves were used to calculate area under the curve as an estimate of diagnostic accuracy of the AIMS and the PDMS- with respect to motor outcome at 24 months.ResultsThe correlation between the AIMS and the PDMS-2 (total motor and locomotion subscale), at 6 months, was r = 0.44 and r = 0.76, and at 12 months r = 0.56 and r = 0.80 respectively. The predictive validity for atypical motor function at 24 months, assessed using the area under the curve at 6- and at 12- months, was for the AIMS 0.87 and 0.86, respectively, and for the PDMS-2 locomotion subscale 0.82 and 0.76 respectively.ConclusionThe correlation between the AIMS and the PDMS-2 locomotion subscale, at 6- and 12- months PTA, was good to excellent in a group of infants born preterm in Norway. And the AIMS and the locomotion subscale of the PDMS-2 were equally good predictors for atypical motor outcomes at 24 months PTA. These findings indicate that the AIMS and the locomotion subscale of the PDM-2, could be used interchangeable when assessing motor development in infants at 6- or 12 months of age.Trial registrationClinicalTrials.gov NCT01089296.

Diagnostic accuracy of NI-RADS for prediction of head and neck squamous cell carcinoma: a systematic review and meta-analysis.

This study aimed to assess the diagnostic performance of NI-RADS for the prediction of recurrence in patients treated for Head and Neck Squamous Cell Carcinoma (HNSCC). A literature search was conducted using various databases to identify relevant articles published from June 2016 onwards. We included studies reporting the diagnostic accuracy of NI-RADS in distinguishing recurrence in patients undergoing imaging surveillance, with pathologic results and/or follow-up as the reference standard. Summary estimates of diagnostic accuracy in terms of sensitivity, specificity, positive likelihood ratio (LR +), negative likelihood ratio (LR -), and diagnostic odds ratio (DOR) were calculated with the hierarchical summary receiver operating characteristic (HSROC) model. Meta-regression and subgroup analyses were conducted to investigate different clinical settings. Study quality was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. A total of 12 studies were included in the current meta-analysis. The pooled sensitivity and specificity were 0.69 (95% CI 0.59-0.79) and 0.94 (95% CI 0.89-0.97), respectively. For the primary site, the pooled summary estimates were 0.67 (95% CI 0.53-0.78) and 0.95 (95% CI 0.90-0.97), for the nodal sites were 0.64 (95% CI 0.44-0.80) and 0.99 (95% CI 0.98-0.99), respectively. The recurrence rate for NI-RADS categories 1-3 was 0.03 (95% CI 0.02-0.05), 0.13 (95% CI 0.10-0.15), and 0.77 (95% CI 0.73-0.81). Meta-regression revealed that the type of analysis (per person vs. per site) and number of sites (≤ 200 vs. > 200) were significant factors associated with heterogeneity. NI-RADS demonstrated high specificity but moderate sensitivity in patients after treatment for HNSCC. Summary estimates showed a significantly higher malignancy rate for NI-RADS category 3 compared to category 2.

Diagnostic accuracy of RBC scintigraphy and CTA for detection of patients with suspected lower gastrointestinal bleeding: a systematic review and meta-analysis.

Detection of lower gastrointestinal bleeding (LGIB) through noninvasive modalities is very important in the successful management of LGIB. RBC scintigraphy and CT have a role in the detection of LGIB and guiding the management of patient by localization of the bleeding site. However, only a small number of studies have evaluated the role of RBC scintigraphy and CT in the diagnosis of LGIB. This systematic review was conducted to evaluate the diagnostic performance of RBC scintigraphy and CT in the detection of LGIB in patients with clinical or biochemical findings suspicious of LGIB. This systematic review followed PRISMA guidelines. Searches in PubMed, Scopus, and Embase were conducted using relevant keywords, and articles published through 30 April 2022, were included. Using endoscopy or surgical outcomes as the reference standard, the numbers of true and false positives and true and false negatives were extracted. Pooled estimates of diagnostic test accuracy - including sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and summary ROC (SROC) curve - were generated using bivariate random-effects meta-analysis. Three studies comprising 171 patients were included in the systematic review and meta-analysis. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio for the detection of LGIB using RBC scintigraphy were 0.787 (95% CI, 0.643-0.893), 0.289 (95% CI, 0.164-0.443), 1.214 (95% CI, 0.923-1.597) and 0.576 (95% CI, 0.296-1.121) respectively. The area under the SROC curve was 0.73. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio for the detection of LGIB using CT were 0.931 (95% CI, 0.772-0.992), 0.870 (95% CI, 0.737-0.951), 6.085 (95% CI, 0.840-44.097), 0.126 (95% CI, 0.006-2.509) respectively. The area under the SROC curve was 0.095. RBC scintigraphy has overall good sensitivity and CTA has excellent sensitivity specificity, positive and negative likelihood ratio in the detection of LGIB in patients with clinical or biochemical findings suspicious for LGIB.CTA along with RBC scintigraphy can be used algorithmically to rule out patients who do not have a localization for the site of LGIB thereby helping these patients to avoid invasive procedures like endoscopy or surgical explorations.

The Olfaction Ability of Medical Detection Canine to Detect Prostate Cancer From Urine Samples: Progress Captured in Systematic Review and Meta-Analysis.

To date, early cancer detection is considered vital to reduce the global cancer burden through low-cost, but accurate screening modalities. The anatomical positioning of prostate cancer (PCa) created a potentially distinctive diagnostic method through the identification of volatile organic compounds (VOCs) in urine, which might be detectable not by humans but by canine species. This review aimed to capture the potential of the medical detection canine (MDC) to detect PCa by providing its diagnostic accuracy estimation on urine odor testing. Databases, e.g., MEDLINE, Cochrane, ScienceDirect, and ProQuest, were searched to identify the studies. We focused on accessible original research, comparing the diagnostic utility of trained female MDC and histopathology examination as the gold standard for PCa diagnosis. The statistical analysis was performed in Meta-DiSc 1.4 and presented in diagnostic values, i.e., sensitivity (Sn), specificity (Sp), positive or negative likelihood ratio (LR+ or LR-), diagnostic odd ratio (DOR), and area under the curve (AUC) value, to conclude the Sn-Sp in a single outcome. Female German Shepherds were the most commonly utilized MDC from the five studies included in the final analysis. We estimate the pooled diagnostic value of eight different MDCs, with the findings as follows: Sn (0.95 (0.94 - 0.97)), Sp (0.92 (0.90 - 0.93)), LR+ (4.48 (1.90 - 10.58)), LR- (0.12 (0.01 - 1.42)), DOR (35.39 (2.90 - 432.53)), and an AUC value of 0.9232. MDC's olfaction ability holds considerable potential on its diagnostic accuracies to distinguish the urine of PCa individuals by identifying its volatilome property.

Identification of patients at high risk for brain death using an automated digital screening tool: a prospective diagnostic accuracy study

BackgroundAn automated digital screening tool (DETECT) has been developed to aid in the early identification of patients who are at risk of developing brain death during critical care.MethodsThis prospective diagnostic accuracy study included consecutive patients ≥ 18 years admitted to neurocritical care for primary or secondary acute brain injury. The DETECT screening tool searched routinely monitored patient data in the electronic medical records every 12 h for a combination of coma and absence of bilateral pupillary light reflexes. In parallel, daily neurological assessment was performed by expert neurointensivists in all patients blinded to the index test results. The primary target condition was the eventual diagnosis of brain death. Estimates of diagnostic accuracy along with their 95%-confidence intervals were calculated to assess the screening performance of DETECT.ResultsDuring the 12-month study period, 414 patients underwent neurological assessment, with 8 (1.9%) confirmed cases of brain death. DETECT identified 54 positive patients and sent 281 notifications including 227 repeat notifications. The screening tool had a sensitivity of 100% (95% CI 63.1–100%) in identifying patients who eventually developed brain death, with no false negatives. The mean time from notification to confirmed diagnosis of brain death was 3.6 ± 3.2 days. Specificity was 88.7% (95% CI 85.2–91.6%), with 46 false positives. The overall accuracy of DETECT for confirmed brain death was 88.9% (95% CI 85.5–91.8%).ConclusionsOur findings suggest that an automated digital screening tool that utilizes routinely monitored clinical data may aid in the early identification of patients at risk of developing brain death.

Diagnostic accuracy and clinical impact of MRI-based technologies for patients with non-alcoholic fatty liver disease: systematic review and economic evaluation.

Magnetic resonance imaging-based technologies are non-invasive diagnostic tests that can be used to assess non-alcoholic fatty liver disease. The study objectives were to assess the diagnostic test accuracy, clinical impact and cost-effectiveness of two magnetic resonance imaging-based technologies (LiverMultiScan and magnetic resonance elastography) for patients with non-alcoholic fatty liver disease for whom advanced fibrosis or cirrhosis had not been diagnosed and who had indeterminate results from fibrosis testing, or for whom transient elastography or acoustic radiation force impulse was unsuitable, or who had discordant results from fibrosis testing. The data sources searched were MEDLINE, MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects and the Health Technology Assessment. A systematic review was conducted using established methods. Diagnostic test accuracy estimates were calculated using bivariate models and a summary receiver operating characteristic curve was calculated using a hierarchical model. A simple decision-tree model was developed to generate cost-effectiveness results. The diagnostic test accuracy review (13 studies) and the clinical impact review (11 studies) only included one study that provided evidence for patients who had indeterminate or discordant results from fibrosis testing. No studies of patients for whom transient elastography or acoustic radiation force impulse were unsuitable were identified. Depending on fibrosis level, relevant published LiverMultiScan diagnostic test accuracy results ranged from 50% to 88% (sensitivity) and from 42% to 75% (specificity). No magnetic resonance elastography diagnostic test accuracy data were available for the specific population of interest. Results from the clinical impact review suggested that acceptability of LiverMultiScan was generally positive. To explore how the decision to proceed to biopsy is influenced by magnetic resonance imaging-based technologies, the External Assessment Group presented cost-effectiveness analyses for LiverMultiScan plus biopsy versus biopsy only. Base-case incremental cost-effectiveness ratio per quality-adjusted life year gained results for seven of the eight diagnostic test strategies considered showed that LiverMultiScan plus biopsy was dominated by biopsy only; for the remaining strategy (Brunt grade ≥2), the incremental cost-effectiveness ratio per quality-adjusted life year gained was £1,266,511. Results from threshold and scenario analyses demonstrated that External Assessment Group base-case results were robust to plausible variations in the magnitude of key parameters. Diagnostic test accuracy, clinical impact and cost-effectiveness data for magnetic resonance imaging-based technologies for the population that is the focus of this assessment were limited. Magnetic resonance imaging-based technologies may be useful to identify patients who may benefit from additional testing in the form of liver biopsy and those for whom this additional testing may not be necessary. However, there is a paucity of diagnostic test accuracy and clinical impact data for patients who have indeterminate results from fibrosis testing, for whom transient elastography or acoustic radiation force impulse are unsuitable or who had discordant results from fibrosis testing. Given the External Assessment Group cost-effectiveness analyses assumptions, the use of LiverMultiScan and magnetic resonance elastography for assessing non-alcoholic fatty liver disease for patients with inconclusive results from previous fibrosis testing is unlikely to be a cost-effective use of National Health Service resources compared with liver biopsy only. This study is registered as PROSPERO CRD42021286891. Funding for this study was provided by the Evidence Synthesis Programme of the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 10. See the NIHR Journals Library website for further project information.

Diagnostic and Prognostic Value of Stress Cardiovascular Magnetic Resonance Imaging in Patients With Known or Suspected Coronary Artery Disease

The clinical utility of stress cardiovascular magnetic resonance imaging (CMR) in stable chest pain is still debated, and the low-risk period for adverse cardiovascular (CV) events after a negative test result is unknown. To provide contemporary quantitative data synthesis of the diagnostic accuracy and prognostic value of stress CMR in stable chest pain. PubMed and Embase databases, the Cochrane Database of Systematic Reviews, PROSPERO, and the ClinicalTrials.gov registry were searched for potentially relevant articles from January 1, 2000, through December 31, 2021. Selected studies evaluated CMR and reported estimates of diagnostic accuracy and/or raw data of adverse CV events for participants with either positive or negative stress CMR results. Prespecified combinations of keywords related to the diagnostic accuracy and prognostic value of stress CMR were used. A total of 3144 records were evaluated for title and abstract; of those, 235 articles were included in the full-text assessment of eligibility. After exclusions, 64 studies (74 470 total patients) published from October 29, 2002, through October 19, 2021, were included. This systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Diagnostic odds ratios (DORs), sensitivity, specificity, area under the receiver operating characteristic curve (AUROC), odds ratio (OR), and annualized event rate (AER) for all-cause death, CV death, and major adverse cardiovascular events (MACEs) defined as the composite of myocardial infarction and CV death. A total of 33 diagnostic studies pooling 7814 individuals and 31 prognostic studies pooling 67 080 individuals (mean [SD] follow-up, 3.5 [2.1] years; range, 0.9-8.8 years; 381 357 person-years) were identified. Stress CMR yielded a DOR of 26.4 (95% CI, 10.6-65.9), a sensitivity of 81% (95% CI, 68%-89%), a specificity of 86% (95% CI, 75%-93%), and an AUROC of 0.84 (95% CI, 0.77-0.89) for the detection of functionally obstructive coronary artery disease. In the subgroup analysis, stress CMR yielded higher diagnostic accuracy in the setting of suspected coronary artery disease (DOR, 53.4; 95% CI, 27.7-103.0) or when using 3-T imaging (DOR, 33.2; 95% CI, 19.9-55.4). The presence of stress-inducible ischemia was associated with higher all-cause mortality (OR, 1.97; 95% CI, 1.69-2.31), CV mortality (OR, 6.40; 95% CI, 4.48-9.14), and MACEs (OR, 5.33; 95% CI, 4.04-7.04). The presence of late gadolinium enhancement (LGE) was associated with higher all-cause mortality (OR, 2.22; 95% CI, 1.99-2.47), CV mortality (OR, 6.03; 95% CI, 2.76-13.13), and increased risk of MACEs (OR, 5.42; 95% CI, 3.42-8.60). After a negative test result, pooled AERs for CV death were less than 1.0%. In this study, stress CMR yielded high diagnostic accuracy and delivered robust prognostication, particularly when 3-T scanners were used. While inducible myocardial ischemia and LGE were associated with higher mortality and risk of MACEs, normal stress CMR results were associated with a lower risk of MACEs for at least 3.5 years.

Diagnostic accuracy of water-soluble contrast enema, contrast-enema computed tomography and endoscopy in detecting anastomotic leakage after (Colo) proctectomy: A meta-analysis.

Anastomotic leakage (AL) as a result of creation of a colorectal/anal anastomosis still represents a frequent complication of colorectal surgery, with short- and long-term consequences on postoperative morbidity, quality of life and oncological outcomes. However, early diagnosis of AL may result in improved outcomes. The aims of this study were to evaluate the diagnostic accuracy of water-soluble contrast enema (WSCE), contrast enema computed tomography (CECT) and endoscopy in identifying AL and to identify the diagnostic procedure that is most accurate. A systematic review and meta-analysis of 19 studies accounting for a total of 25 tests reporting diagnostic accuracy estimates was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy Studies (PRISMA-DTA) guidelines up to June 2021. For the diagnostic tests we evaluated the pooled estimates and conducted pairwise comparisons. For WSCE, the pooled sensitivity was 0.50, the pooled specificity was 0.99 and the area under the curve (AUC) was 0.91. For endoscopy, the pooled sensitivity was 0.69, specificity was 1.00 and AUC was 0.99. The pooled sensitivity and specificity for CECT were 0.89 and 1.00, respectively; the AUC was 0.99. The comparison between CECT and WSCE highlighted a significantly greater sensitivity (p = 0.04) for CECT, whereas no difference was found for specificity. Compared with CECT, endoscopy was not significantly more accurate in terms of either sensitivity or specificity. Endoscopy was found to be significantly more specific than WSCE (p = 0.031) but no difference was found for sensitivity. Water-soluble contrast enema, endoscopy and CECT have an elevated diagnostic accuracy. However, WSCE is less accurate than either endoscopy or CECT. Although greater sensitivity was demonstrated for CECT compared with endoscopy, this was not significant.

Comparison of measles IgG enzyme immunoassays (EIA) versus plaque reduction neutralization test (PRNT) for measuring measles serostatus: a systematic review of head-to-head analyses of measles IgG EIA and PRNT

BackgroundAs countries move towards or achieve measles elimination status, serosurveillance is an important public health tool. However, a major challenge of serosurveillance is finding a feasible, accurate, cost-effective, and high throughput assay to measure measles antibody concentrations and estimate susceptibility in a population. We conducted a systematic review to assess, characterize, and – to the extent possible – quantify the performance of measles IgG enzyme-linked assays (EIAs) compared to the gold standard, plaque reduction neutralization tests (PRNT).MethodsWe followed the PRISMA statement for a systematic literature search and methods for conducting and reporting systematic reviews and meta-analyses recommended by the Cochrane Screening and Diagnostic Tests Methods Group. We identified studies through PubMed and Embase electronic databases and included serologic studies detecting measles virus IgG antibodies among participants of any age from the same source population that reported an index (any EIA or multiple bead-based assays, MBA) and reference test (PRNT) using sera, whole blood, or plasma. Measures of diagnostic accuracy with 95% confidence intervals (CI) were abstracted for each study result, where reported.ResultsWe identified 550 unique publications and identified 36 eligible studies for analysis. We classified studies as high, medium, or low quality; results from high quality studies are reported. Because most high quality studies used the Siemens Enzygnost EIA kit, we generate individual and pooled diagnostic accuracy estimates for this assay separately. Median sensitivity of the Enzygnost EIA was 92.1% [IQR = 82.3, 95.7]; median specificity was 96.9 [93.0, 100.0]. Pooled sensitivity and specificity from studies using the Enzygnost kit were 91.6 (95%CI: 80.7,96.6) and 96.0 (95%CI: 90.9,98.3), respectively. The sensitivity of all other EIA kits across high quality studies ranged from 0% to 98.9% with median (IQR) = 90.6 [86.6, 95.2]; specificity ranged from 58.8% to 100.0% with median (IQR) = 100.0 [88.7, 100.0].ConclusionsEvidence on the diagnostic accuracy of currently available measles IgG EIAs is variable, insufficient, and may not be fit for purpose for serosurveillance goals. Additional studies evaluating the diagnostic accuracy of measles EIAs, including MBAs, should be conducted among diverse populations and settings (e.g., vaccination status, elimination/endemic status, age groups).

How to Critically Appraise and Interpret Systematic Reviews and Meta-Analyses of Diagnostic Accuracy: A User Guide.

Systematic reviews of diagnostic accuracy studies can provide the best available evidence to inform decisions regarding the use of a diagnostic test. In this guide, the authors provide a practical approach for clinicians to appraise diagnostic accuracy systematic reviews and apply their results to patient care. The first step is to identify an appropriate systematic review with a research question matching the clinical scenario. The user should evaluate the rigor of the review methods to evaluate its credibility (Did the review use clearly defined eligibility criteria, a comprehensive search strategy, structured data collection, risk of bias and applicability appraisal, and appropriate meta-analysis methods?). If the review is credible, the next step is to decide whether the diagnostic performance is adequate for clinical use (Do sensitivity and specificity estimates exceed the threshold that makes them useful in clinical practice? Are these estimates sufficiently precise? Is variability in the estimates of diagnostic accuracy across studies explained?). Diagnostic accuracy systematic reviews that are judged to be credible and provide diagnostic accuracy estimates with sufficient certainty and relevance are the most useful to inform patient care. This review discusses comparative, noncomparative, and emerging approaches to systematic reviews of diagnostic accuracy using a clinical scenario and examples based on recent publications.