scholarly journals Diagnostic Performance Improvement with Combined use of Proteomics Biomarker Assay and Breast Ultrasound

Author(s):  
Su Min Ha ◽  
Hong-Kyu Kim ◽  
Yumi Kim ◽  
Dong-Young Noh ◽  
Wonshik Han ◽  
...  

Abstract Purpose: To investigate the combined use of blood-based 3-protein signature and breast ultrasound (US) for validating US detected lesions.Methods: From July 2011 to April 2020, women who underwent whole-breast US within at least 6 months from sampling period were retrospectively included. Blood-based 3-protein signature (Mastocheck®) value and US findings were evaluated. Following outcome measures were compared between US alone and the combination of Mastocheck® value with US: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the receiver operating characteristic curve (AUC), and biopsy rate. Results: Among the 237 women included, 59 (24.9%) were healthy individuals and 178 (75.1%) cancer patients. Mean size of cancers was 1.2±0.8 cm. Median value of Mastocheck® was significantly different between non-malignant (-0.24, interquartile range [IQR], -0.48, -0.03) and malignant lesions (0.55, IQR, -0.03, 1.42) (P < .001). Utilizing Mastocheck® value with US increased the AUC from 0.67 (95% confidence interval [CI], 0.61, 0.73) to 0.81 (95% CI: 0.75, 0.88; P < .001), specificity from 35.6% (95% CI: 23.4, 47.8) to 64.4% (95% CI: 52.2, 76.6; P < .001) without loss in sensitivity. PPV was increased from 82.2% (95% CI: 77.1, 87.3) to 89.3% (95% CI: 85.0, 93.6; P < .001), and biopsy rate was significantly decreased from 79.3% (188/237) to 72.1% (171/237) (P < .001). Consistent improvements in specificity, PPV, and AUC were observed in asymptomatic women and in those with normal/benign mammographic findings. Conclusion: Mastocheck® is an effective tool that can be used with US to improve diagnostic specificity and reduce false-positive findings and unnecessary biopsies.

2020 ◽  
pp. 028418512097362
Author(s):  
Xiefeng Yang ◽  
Yu Lin ◽  
Zhen Xing ◽  
Dejun She ◽  
Yan Su ◽  
...  

Background Isocitrate dehydrogenase (IDH)-mutant lower-grade gliomas (LGGs) are further classified into two classes: with and without 1p/19q codeletion. IDH-mutant and 1p/19q codeleted LGGs have better prognosis compared with IDH-mutant and 1p/19q non-codeleted LGGs. Purpose To evaluate conventional magnetic resonance imaging (cMRI), diffusion-weighted imaging (DWI), susceptibility-weighted imaging (SWI), and dynamic susceptibility contrast perfusion-weighted imaging (DSC-PWI) for predicting 1p/19q codeletion status of IDH-mutant LGGs. Material and Methods We retrospectively reviewed cMRI, DWI, SWI, and DSC-PWI in 142 cases of IDH mutant LGGs with known 1p/19q codeletion status. Features of cMRI, relative ADC (rADC), intratumoral susceptibility signals (ITSSs), and the value of relative cerebral blood volume (rCBV) were compared between IDH-mutant LGGs with and without 1p/19q codeletion. Receiver operating characteristic curve and logistic regression were used to determine diagnostic performances. Results IDH-mutant and 1p/19q non-codeleted LGGs tended to present with the T2/FLAIR mismatch sign and distinct borders ( P < 0.001 and P = 0.038, respectively). Parameters of rADC, ITSSs, and rCBVmax were significantly different between the 1p/19q codeleted and 1p/19q non-codeleted groups ( P < 0.001, P = 0.017, and P < 0.001, respectively). A combination of cMRI, SWI, DWI, and DSC-PWI for predicting 1p/19q codeletion status in IDH-mutant LGGs resulted in a sensitivity, specificity, positive predictive value, negative predictive value, and an AUC of 80.36%, 78.57%, 83.30%, 75.00%, and 0.88, respectively. Conclusion 1p/19q codeletion status of IDH-mutant LGGs can be stratified using cMRI and advanced MRI techniques, including DWI, SWI, and DSC-PWI. A combination of cMRI, rADC, ITSSs, and rCBVmax may improve the diagnostic performance for predicting 1p/19q codeletion status.


2020 ◽  
Vol 8 ◽  
pp. 205031212096646
Author(s):  
Achara Tongpoo ◽  
Pimjai Niparuck ◽  
Charuwan Sriapha ◽  
Winai Wananukul ◽  
Satariya Trakulsrichai

Objectives: GGreen pit vipers (GPV) envenomation causes consumptive coagulopathy mainly by thrombin-like enzymes. Fibrinogen levels are generally investigated to help evaluate systemic envenomation. However, tests of fibrinogen levels may not be available in every hospital. This study aimed to determine the sensitivity, specificity and accuracy for a range of various coagulation tests (20 minute whole blood clotting test (20WBCT), prothrombin time, international normalized ratio and thrombin time (TT)), comparing to the two gold standards performed in patients with GPV bite. Methods: This was the pilot study which we retrospectively reviewed fibrinogen level results including the hospital records of 24 GPV ( Trimeresurus albolabris or macrops) bite patients visiting Ramathibodi Hospital, Thailand during 2013–2017 with 65 results of fibrinogen levels. The fibrinogen levels <164 and <100 mg/dL were used as the standard cut-off points or gold standards as the abnormal low and critical levels, respectively. Results: Most were male. All had local effects. For fibrinogen levels <164 and <100 mg/dL, prolonged TT had the highest sensitivity of 57.1% and 82.4%; the negative predictive value of 74.5% and 93.6%; the accuracy of 81.0% and 92.1%; and the area under a receiver operating characteristic curve of 0.762 and 0.873, respectively. For fibrinogen levels <164, unclotted 20WBCT and prolonged TT had the highest specificity and positive predictive value of 100% all. For fibrinogen levels <100, unclotted 20WBCT had the highest specificity and positive predictive value of 100% both, while prolonged TT had the specificity and positive predictive value of 95.7% and 87.5%, respectively. One patient developed isolated thrombocytopenia without hypofibrinogenemia and coagulopathy. Conclusions: Among four coagulation tests, TT was the most sensitive and accurate test to indicate hypofibrinogenemia in GPV bite patients. In case of unavailable fibrinogen levels thrombin time might be investigated to help evaluate patients’ fibrinogen status. Isolated thrombocytopenia could occur in GPV envenomation.


2019 ◽  
pp. emermed-2019-208456
Author(s):  
S M Osama Bin Abdullah ◽  
Rune Husås Sørensen ◽  
Ram Benny Christian Dessau ◽  
Saifullah Muhammed Rafid Us Sattar ◽  
Lothar Wiese ◽  
...  

BackgroundFew prospective studies have evaluated the quick Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA) criteria in emergency department (ED)settings. The aim of this study was to determine the prognostic accuracy of qSOFA compared with systemic inflammatory response syndrome (SIRS) in predicting the 28-day mortality of infected patients admitted to an ED.MethodsA prospective observational cohort study of all adult (≥18 years) infected patients admitted to the ED of Slagelse Hospital, Denmark, was conducted from 1 October 2017 to 31 March 2018. Patients were enrolled consecutively and data related to SIRS and qSOFA criteria were obtained from electronic triage record. Information regarding mortality was obtained from the Danish Civil Registration System. The original cut-off values of ≥2 was used to determine the prognostic accuracy of SIRS and qSOFA criteria for predicting 28-day mortality and was assessed by analyses of sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios and area under the receiver operating characteristic curve (AUROC) with 95% confidence intervals (CI).ResultsA total of 2112 patients were included in this study. A total of 175 (8.3%) patients met at least two qSOFA criteria, while 1012 (47.9%) met at least two SIRS criteria on admission. A qSOFA criteria of at least two for predicting 28-day mortality had a sensitivity of 19.5% (95% CI 13.6% to 26.5%) and a specificity of 92.6% (95% CI 91.4% to 93.7%). A SIRS criteria of at least two for predicting 28-day mortality had a sensitivity of 52.8% (95% CI 44.8% to 60.8%) and a specificity of 52.5% (95% CI 50.2% to 54.7%). The AUROC values for qSOFA and SIRS were 0.63 (95% CI 0.59 to 0.67) and 0.52 (95% CI 0.48 to 0.57), respectively.ConclusionBoth SIRS and qSOFA had poor sensitivity for 28-day mortality. qSOFA improved the specificity at the expense of the sensitivity resulting in slightly higher prognostic accuracy overall.


F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 1244
Author(s):  
Phornwipa Panta ◽  
Win Techakehakij

Background: Screening for albuminuria is generally recommended among patients with hypertension. While the urine dipstick is commonly used for screening urine albumin, there is little evidence about its diagnostic accuracy among these patients in Thailand. This study aimed to assess the diagnostic accuracy of a dipstick in Thai hypertensive patients for detecting albuminuria. Methods: This study collected the data of 3,067 hypertensive patients, with the results of urine dipstick and urine albumin-to-creatinine ratio (ACR) from random single spot urine being examined in the same day at least once, at Lampang Hospital, Thailand, during 2018. For ACR, a reference standard of ≥ 30 mg/g was applied to indicate the presence of albuminuria. Results: The sensitivity, specificity, positive predictive value (PPV), and negative predictive value of the trace result from dipsticks were 53.6%, 94.5%, 86.5%, and 75.5%, respectively. The area under the receiver operating characteristic curve of the dipstick was 0.748. Conclusion: Using the dipstick for screening albuminuria among hypertensive patients should not be recommended for mass screening due to its low sensitivity. In response to high PPV, a trace threshold of the dipstick may be used to indicate presence of albuminuria.


2020 ◽  
Vol 60 (3) ◽  
pp. 159-65
Author(s):  
Hendra Salim ◽  
Soetjiningsih Soetjiningsih ◽  
I Gusti Ayu Trisna Windiani ◽  
I Gede Raka Widiana ◽  
PITIKA ASPR

Background Autism is a developmental disorder for which early detection in toddlers is recommended because of its increased prevalence. The Modified Checklist for Autism in Toddlers (M-CHAT) is an easy-to-interprete tool that can be filled out by parents. It has been translated into the Indonesian language but needs to be validated. Objective To evaluate the diagnostic validity of the Indonesian version of M-CHAT in detection of autism spectrum disorder in Indonesia. Methods A diagnostic study was conducted at Sanglah Hospital, Denpasar, Bali, from March 2011 to August 2013. Pediatric outpatients aged 18 to 48 months were included. The Indonesian version of the M-CHAT tool was filled by parents. Autism assessment was done according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV-TR). The assessment results were analyzed with the MedCalc program  software, in several steps: (i) reliability of M-CHAT; (ii) description, distribution, and proportion to determine the characteristics of the subjects of research; and (iii) validity of M-CHAT compared to the gold standard DSM-IV-TR by a receiver operating characteristic curve and several area under the curve cut-off points, in order to assess the sensitivity, specificity, positive predictive value, negative predictive value, and positive and negative likelihood ratio, accompanied by the 95% confidence interval of each value. Results The Indonesian version of M-CHAT in toddlers had 82.35% sensitivity and 89.68% specificity, using the cut-off point of more than 6 failed questions. Conclusion The Indonesian version M-CHAT translated by Soetjiningsih has optimal diagnostic validity for detection of autism in toddlers.


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 1244
Author(s):  
Phornwipa Panta ◽  
Win Techakehakij

Background: Screening for albuminuria is generally recommended among patients with hypertension. While the urine dipstick is commonly used for screening urine albumin, there is little evidence about its diagnostic accuracy among these patients. This study aimed to assess the diagnostic accuracy of a dipstick in Thai hypertensive patients for detecting albuminuria. Methods: This study collected the data of 3,067 hypertensive patients, with the results of urine dipstick and urine albumin-to-creatinine ratio (ACR) from random single spot urine being examined in the same day at least once, at Lampang Hospital, Thailand, during 2018. For ACR, a reference standard of ≥ 30 mg/g was applied to indicate the presence of albuminuria. Results: The sensitivity, specificity, positive predictive value (PPV), and negative predictive value of the trace result from dipsticks were 53.6%, 94.5%, 86.5%, and 75.5%, respectively. The area under the receiver operating characteristic curve of the dipstick was 0.748. Conclusion: Using the dipstick for screening albuminuria among hypertensive patients should not be recommended due to its low sensitivity. In response to high PPV, a trace threshold of the dipstick may be used to indicate presence of albuminuria.


Author(s):  
Saman Tauheed Ali ◽  
Khalid Samad ◽  
Syed Amir Raza ◽  
Muhammad Qamarul Hoda

Objectives: We conducted this study to compare the accuracy of three diagnostic tests; ratio of height to thyromental distance (RHTMD), Modified Mallampati Test (MMT) and Upper Lip Bite Test (ULBT) in predicting difficult laryngoscopy using Cormack and Lehane grade as gold standard.Methods: This study was conducted in Aga Khan University Hospital, Karachi. Based on calculated sample size, 383 patients who required endotracheal intubation for elective surgical procedures were enrolled with consecutive sampling techniques during August 2014 to August 2015 for this cross-sectional study. Primary investigator used RHTMD, ULBT, and MMT for assessing the airway and correlated with laryngoscopic view.Results: A total of 383 patients were incorporated in this research, out of which 59(15.4%) classified as difficult laryngoscopy based on Cormack and Lehane (CL) grading. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of RHTMD (84.7%, 90.1%, 60.9%, 97%, 89.3%) and ULBT (83.1%, 89.2%, 58.3%, 96.7%, 88.3%) values were highest as compared to MMT (30.5%, 84.3%, 26.1%, 86.9%, 79.9%). The area under a receiver-operating characteristic curve (AUC of ROC curve) for ULBT and RHTMD was significantly more than for MMT (P<0.01). RHTMD and ULBT both are acceptable alternatives for prediction of difficult laryngoscopy as a simple, single bed-side test. Continuous...


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pakanat Decharatanachart ◽  
Roongruedee Chaiteerakij ◽  
Thodsawit Tiyarattanachai ◽  
Sombat Treeprasertsuk

Abstract Background The gold standard for the diagnosis of liver fibrosis and nonalcoholic fatty liver disease (NAFLD) is liver biopsy. Various noninvasive modalities, e.g., ultrasonography, elastography and clinical predictive scores, have been used as alternatives to liver biopsy, with limited performance. Recently, artificial intelligence (AI) models have been developed and integrated into noninvasive diagnostic tools to improve their performance. Methods We systematically searched for studies on AI-assisted diagnosis of liver fibrosis and NAFLD on MEDLINE, Scopus, Web of Science and Google Scholar. The pooled sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic odds ratio (DOR) with their 95% confidence intervals (95% CIs) were calculated using a random effects model. A summary receiver operating characteristic curve and the area under the curve was generated to determine the diagnostic accuracy of the AI-assisted system. Subgroup analyses by diagnostic modalities, population and AI classifiers were performed. Results We included 19 studies reporting the performances of AI-assisted ultrasonography, elastrography, computed tomography, magnetic resonance imaging and clinical parameters for the diagnosis of liver fibrosis and steatosis. For the diagnosis of liver fibrosis, the pooled sensitivity, specificity, PPV, NPV and DOR were 0.78 (0.71–0.85), 0.89 (0.81–0.94), 0.72 (0.58–0.83), 0.92 (0.88–0.94) and 31.58 (11.84–84.25), respectively, for cirrhosis; 0.86 (0.80–0.90), 0.87 (0.80–0.92), 0.85 (0.75–0.91), 0.88 (0.82–0.92) and 37.79 (16.01–89.19), respectively; for advanced fibrosis; and 0.86 (0.78–0.92), 0.81 (0.77–0.84), 0.88 (0.80–0.93), 0.77 (0.58–0.89) and 26.79 (14.47–49.62), respectively, for significant fibrosis. Subgroup analyses showed significant differences in performance for the diagnosis of fibrosis among different modalities. The pooled sensitivity, specificity, PPV, NPV and DOR were 0.97 (0.76–1.00), 0.91 (0.78–0.97), 0.95 (0.87–0.98), 0.93 (0.80–0.98) and 191.52 (38.82–944.81), respectively, for the diagnosis of liver steatosis. Conclusions AI-assisted systems have promising potential for the diagnosis of liver fibrosis and NAFLD. Validations of their performances are warranted before implementing these AI-assisted systems in clinical practice. Trial registration: The protocol was registered with PROSPERO (CRD42020183295).


2020 ◽  
pp. 088506662090323
Author(s):  
Areesha Alam ◽  
Sarika Gupta

Purpose: To investigate association of static and dynamic lactate indices with early mortality (within 48 hours of admission), as well as need for vasopressors and mechanical ventilation in pediatric severe sepsis/shock. To explore optimal cutoffs of lactate indices. We hypothesized that dynamic indices are superior to static indices in predicting early mortality. Methods: This prospective cohort study involved children (aged <14 years) admitted in emergency department, tertiary care teaching hospital in North India with severe sepsis/shock (2015-2016). Arterial lactate was measured at admission (X0) and after 6 hours (X6). Primary outcome of the measurement was early mortality. Association between lactate indices— lactate at 0 hours (Lac0), lactate after 6 hours (Lac6), time-weighted average (LacTW), delta (ΔLac), clearance (LacCl%) and early mortality, need for vasopressors, and mechanical ventilation—was assessed using Student t test/Mann-Whitney test. Area under the receiver operating characteristic curve (AUROC) for early mortality deduced for all lactate indices and compared with reference (Lac0). Optimal cutoffs (maximizing both sensitivity and specificity) and their positive predictive value (PPV) and negative predictive value (NPV) were determined. Results: During the study period, 116 children were assessed. Septic shock was present at admission in 56.9% children; 50% of children died during the next 48 hours. Lac0, Lac6, and LacTW were significantly higher, and LacCl% was lower in nonsurvivors versus survivors (all P < .001). Lac6 (0.837 [0.76-0.91]) had significantly higher AUROC (95% confidence interval) than Lac0 (0.77; P = .03). Abnormal lactate metrics (higher Lac0, Lac6, LacTW, and lower LacCl%) were associated with vasopressors need and mechanical ventilation. On logistic regression, Lac6 emerged as an independent predictor of early mortality as well as vasopressor and mechanical ventilation need. The optimal cutoff of Lac6 for identifying early mortality with good sensitivity, specificity, PPV, and NPV was ≥2.65 (76, 85, 83, 78). Conclusions: Lactate6 is the best marker associated with early mortality and higher level of care in severe sepsis/septic shock in resource-poor regions.


2000 ◽  
Vol 83 (06) ◽  
pp. 892-895 ◽  
Author(s):  
Wouter de Monyé ◽  
Jeroen Lijmer ◽  
Willem Nieuwenhuizen ◽  
Harry Büller ◽  
Menno Huisman ◽  
...  

SummaryWe prospectively evaluated the diagnostic accuracy of the Fibrinostika® FbDP assay in 304 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off points at which the disease can be excluded. The prevalence of pulmonary embolism was 31%. The assay generated an area under the Receiver Operating Characteristic curve of 0.79 (95% CI 0.73–0.84). A cut-off point of 0.05 µ,g/ml yielded a sensitivity, specificity, negative predictive value and an exclusion efficiency of 100% (95% CI 96–100), 5% (95% CI 2–9), 100% (95% CI 69–100) and 3% (95% CI 2–6), respectively. A clinically useful cut-off point seems to be 0.11 µ,g/ml which corresponded with a sensitivity, specificity, negative predictive value and an exclusion efficiency of 96% (95% CI 90–99), 27% (95% CI 24–28), 93% (95% CI 84–98) and 20% (95% CI 16–25), respectively. We conclude that the assay has potential clinical utility for the exclusion of pulmonary embolism, but it cannot be used as a sole test.


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