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PubMed2001

Newborns with suspected occult spinal dysraphism: a cost-effectiveness analysis of diagnostic strategies.

OBJECTIVE: To assess the clinical and economic consequences of different diagnostic strategies in newborns with suspected occult spinal dysraphism. METHODS: A decision-analytic model was constructed to project the cost and health outcomes of magnetic resonance imaging (MRI), ultrasound (US), plain radiographs, and no imaging in newborns with suspected occult spinal dysraphism. Morbidity and mortality rates of early versus late diagnosis of dysraphism and the sensitivity and specificity of MRI, US, and plain radiographs were obtained from the literature. Cost estimates were obtained from a hospital cost accounting database and from the Medicaid fee schedule. RESULTS: We found that the choice of imaging strategy depends on the underlying risk of occult spinal dysraphism. In low-risk children with intergluteal dimple or newborns of diabetic mothers (pretest probability: 0.3%-0.34%), US was the most effective strategy with an incremental cost-effectiveness ratio of $55 100 per quality-adjusted life year gained. For children with lumbosacral dimples, who have a higher pretest probability of 3.8%, US was less costly and more effective than the other 3 strategies considered. In intermediate-risk newborns with low anorectal malformation (pretest probability: 27%), US was more effective and less costly than radiographs and no imaging. However, MRI was more effective than US at an incremental cost-effectiveness of $1000 per quality-adjusted life year gained. In the high-risk group that included high anorectal malformation, cloacal malformation, and exstrophy (pretest probability: 44%-46%), MRI was actually cost-saving when compared with the other diagnostic strategies. For the intermediate-risk group, we found our analysis to be sensitive to the costs and diagnostic performances (sensitivity and specificity) of MRI and US. Lower MRI cost or greater MRI diagnostic performance improved the cost-effectiveness of the MRI strategy, whereas lower US cost or greater US diagnostic performance worsened the cost-effectiveness of the MRI strategy. Therefore, individual or institutional expertise with a specific diagnostic modality (MRI versus US) may influence the optimal diagnostic strategy. CONCLUSIONS: In newborns with suspected occult dysraphism, appropriate selection of patients and diagnostic strategy may increase quality-adjusted life expectancy and decrease cost of medical work-up.

Cost-Benefit Analysis↗
PubMed2005

Effect of patient location on the performance of clinical models to predict pulmonary embolism.

INTRODUCTION: Current clinical likelihood models for predicting pulmonary embolism (PE) are used to categorize outpatients into low, intermediate and high clinical pre-test likelihood of PE. Since these clinical prediction rules were developed using outpatients it is not known if they can be applied universally to both inpatients and outpatients with suspected PE. Thus, the purpose of this study was to determine the effect of patient location on the performance of clinical models to predict PE. MATERIALS AND METHODS: Two clinical models (Wells and Wicki) were applied to data from the multi-centered PIOPED study. The Wells score was applied to 1359 patients and the Wicki score was applied to 998 patients. 361 patients (27%) from the PIOPED study did not have arterial gas measurement and were excluded from the Wicki score patient group. Patients were stratified by their location at the time of entry into the PIOPED study as follows: outpatient/emergency, surgical ward, medicine/coronary care unit or intensive care unit. The diagnostic performance of the two clinical models was applied to the various patient locations and the performance was evaluated using the area under a fitted receiver operating characteristic curve (AUC). RESULTS: The prevalence of PE in the three clinical probability categories were similar for the two scoring methods. Both clinical models yielded the lowest diagnostic performance in patients referred from surgical wards. The AUC for both clinical prediction rules decreased significantly when applied to inpatients in comparison to outpatients. CONCLUSIONS: Current clinical prediction rules for determining the pre-test likelihood of PE yielded different diagnostic performances depending upon patient location. The performance of the clinical prediction rules decreased significantly when applied to inpatients. In particular, the rules performed least well when applied to patients referred from surgical wards suggesting these rules should not be used in this patient group. As expected the clinical prediction rules performed best in outpatients with the optimum diagnostic performance in patients referred from emergency and outpatient wards.

Adult↗
PubMed2006

Comparison of different radiography systems in an experimental study for detection of forearm fractures and evaluation of the Müller-AO and Frykman classification for distal radius fractures.

OBJECTIVES: We sought to compare the diagnostic performance of screen-film radiography, storage-phosphor radiography, and a flat-panel detector system in detecting forearm fractures and to classify distal radius fractures according to the Müller-AO and Frykman classifications compared with the true extent, depicted by anatomic preparation. MATERIALS AND METHODS: A total of 71 cadaver arms were fractured in a material testing machine creating different fractures of the radius and ulna as well as of the carpal bones. Radiographs of the complete forearm were evaluated by 3 radiologists, and anatomic preparation was used as standard of reference in a receiver operating curve analysis. RESULTS: The highest diagnostic performance was obtained for the detection of distal radius fractures with area under the receiver operating curve (AUC) values of 0.959 for screen-film radiography, 0.966 for storage-phosphor radiography, and 0.971 for the flat-panel detector system (P > 0.05). Exact classification was slightly better for the Frykman (kappa values of 0.457-0.478) compared with the Müller-AO classification (kappa values of 0.404-0.447), but agreement can be considered as moderate for both classifications. CONCLUSIONS: The 3 imaging systems showed a comparable diagnostic performance in detecting forearm fractures. A high diagnostic performance was demonstrated for distal radius fractures and conventional radiography can be routinely performed for fracture detection. However, compared with anatomic preparation, depiction of the true extent of distal radius fractures was limited and the severity of distal radius fractures tends to be underestimated.

Area Under Curve↗
PubMedDate not supplied

A meta-analytic method for summarizing diagnostic test performances: receiver-operating-characteristic-summary point estimates.

The authors have devised a meta-analytic method to summarize diagnostic test performances, which they describe along with a clinical example wherein they analyze the performances of real-time ultrasonography in eight studies of the detection of proximal deep venous thrombosis of the lower extremity, selected on the basis of specific inclusion criteria. To evaluate the evidence for fitting a summary receiver operating characteristic (ROC) curve, a test of correlation between the estimates of true-positive rate (TPR) and false-positive rate (FPR) is performed. A high positive correlation argues for summarizing the studies with an ROC curve. In the absence of such correlation, a test of homogeneity is applied separately to the estimates of sensitivity (TPR) and specificity (TNR) to evaluate whether differences among studies are due to chance alone. If the estimates are homogeneous, a summary point estimate and confidence intervals (CIs) are calculated. As a final step, subgroup analyses can be performed to assess alternative explanations of variability in TPR and FPR. Within groups defined by the presence or absence of symptoms of venous thrombosis, a negative correlation between TPR and FPR and homogeneity among studies were found. For symptomatic patients, the summary TPR was 0.97 with a 95% CI of (0.94, 0.99) and the summary TNR was 0.97 (0.95, 0.99). For asymptomatic patients, the summary TPR was 0.66 (0.50, 0.81), and the summary TNR was 0.96 (0.90, 0.99). The difference in TPR between symptomatic and asymptomatic patients was statistically significant. There was no evidence that test referral bias or lack of independent interpretation of test results influenced these findings.(ABSTRACT TRUNCATED AT 250 WORDS)

Confidence Intervals↗
PubMed2001

[How to determine the diagnosis of Helicobacter pylori infection in the elderly?].

PURPOSE: The real prevalence of Helicobacter pylori (H. pylori) infection is difficult to determine in the elderly because of the frequency of drug intake (antibiotics or anti-secretory drugs). The aim of this study was to evaluate the diagnostic performance of five tests in the elderly. METHODS: The study population consisted of consecutive patients undergoing a routine endoscopy between August 1998 and December 1999. We evaluated the diagnostic performance of four tests in all of the included patients: culture and histology of biopsy specimens, serology (ELISA) and urea breath test (13C-UBT). Detection of H. pylori antigens in stool samples (HpSA) was realized in a subgroup. Patients were considered H. pylori + when result for culture was positive or when two tests were positive. RESULTS: One hundred and sixty-seven patients were included in this study (55 men, 112 women; mean age: 85.6 +/- 5.1 years). Only 38 (22.8%) patients were H. pylori+. Test performances showed the following results: serology sensitivity: 90.9% (IC 95%: 75.6-98.1) versus 86.9% (IC 95%: 63.6-96.9) for culture versus 77.8% (IC 95%: 60.8-89.9) for histology and 74.3% (IC 95%: 56.7-87.5) for 13C-UBT. Eighty-nine (53.3%) took antibiotics or anti-secretory drugs, only 13C-UBT performances decreased significantly (sensitivity: 94.4% [72.7-99.8] versus 52.9% [27.8-77]; P < 10(-6)). When gastric or duodenal ulcer were endoscopically diagnosed in older patients, both histology and 13C-UBT could not improve the diagnosis of H. pylori infection. HpSA was realized in 107 patients (sensitivity: 74.1%, specificity: 98.7%). We showed no statistical difference between HpSA performances and drug intake. CONCLUSION: Diagnostic performances decreased in older patients especially because of drug intake.

Age Factors↗
PubMed1997

Learning systems in biosignal analysis.

In biosignal analysis, the utility of artificial neural networks (ANN) in classifying electromyographic (EMG) data trained with the momentum back propagation algorithm has recently been demonstrated. In the current study, the self-organizing feature map algorithm, the genetics-based machine learning (GBML) paradigm, and the K-means nearest neighbour clustering algorithm are applied on the same set of data. The aim of this exercise is to show how these three paradigms can be used in practice, given that their diagnostic performance is problem- and parameter-dependent. A total of 720 macro EMG recordings were carried out from four groups, from seven normal, nine motor neuron disease, 14 Becker's muscular dystrophy, and six spinal muscular atrophy subjects, respectively. Twenty-three of the subjects were used for training and 13 for evaluating the various models. For each subject, the mean and the standard deviation of the parameters (i) amplitude, (ii) area, (iii) average power and (iv) duration were extracted. The feature vector was structured in two different ways for input to the models: an eight-input feature vector that consisted of both the mean and the standard deviation of the four parameters measured, and a four-input feature vector that included only the mean of the parameters. Also, due to the heterogenous nature of the spinal muscular atrophy group, three class models that excluded this group were investigated. In general, self-organizing feature map and GBML models resulted in comparable diagnostic performance of the order of 80-90% correct classifications (CCs) score for the evaluation set, whereas the K-means nearest neighbour algorithm models gave lower percentage CCs. Furthermore, for all three learning paradigms: better diagnostic performance was obtained for the three class models compared with the four class models; similar diagnostic performance was obtained for both the eight- and four-input feature vectors. Finally, it is claimed that the proposed methodology followed in this work can be applied for the development of diagnostic systems in the analysis of biosignals.

Algorithms↗
PubMed1998

Reporting requirements for skeletal digital radiography: comparison of soft-copy and hard-copy presentation.

PURPOSE: To assess diagnostic performance and reader preference when reporting results from digital hard-copy and two soft-copy formats of skeletal digital radiography. MATERIALS AND METHODS: The data comprised hand radiographs of patients undergoing renal dialysis. Normal hand radiographs obtained in trauma patients were assessed as control images. One hundred fifteen images acquired with a photostimulable-phosphor computed radiography system were analyzed. Image selection and initial assessment were by consensus of two experienced radiologists, who graded the radiographic changes of hyperparathyroidism with the Ritz scoring system. The images were then presented to four readers in three formats: hard-copy output and soft-copy presentations at 2K2 and 1K2 resolutions. These readers scored pathologic change and image preference. The results were analyzed with the receiver operating characteristic technique. RESULTS: There was a significant improvement in diagnostic performance for both soft-copy formats relative to the hard-copy format (P < .001). No significant difference in diagnostic performance was found between the two soft-copy formats. There was a significant preference for both soft-copy formats relative to the hard-copy format (P < .01), with the 2K2 soft-copy images preferred to the 1K2 images (P < .01). CONCLUSION: Soft-copy reporting can provide superior diagnostic performance even for images viewed at a modest (1K2) resolution. The lack of difference between the two soft-copy formats has important economic implications with respect to departmental hardware requirements.

Bone and Bones↗
PubMed1999

Effects of acid suppression and bismuth medications on the performance of diagnostic tests for Helicobacter pylori infection.

OBJECTIVE: This study was designed to investigate whether acid suppression and bismuth medications interfere with the performance of diagnostic tests for Helicobacter pylori (H. pylori) infection. METHODS: Sixty patients with previous diagnoses of atrophic gastritis and H. pylori infection made in gastric biopsies taken at Hospital Departmental, Pasto, Colombia, were enrolled in the study. 13C breath urea test (UBT) and stool antigen test (HpSA) were performed simultaneously. Two baseline tests were performed: one 7 days before and another the day before starting medications. A total of 20 patients received for 2 wk one of the following treatments: a) ranitidine; b) lansoprazole; or c) bismuth subsalicylate. The tests were repeated while the patients were on the prescribed medication on days 7 and 14 and then 2 wk after finishing the medication. RESULTS AND CONCLUSIONS: Utilizing standard cut-off values for the tests, our results indicate that in the case of the 13C UBT test, ranitidine does not interfere with the results, whereas lansoprazole and bismuth may be expected to yield a significant proportion of false negative results (30-40% for lansoprazole and 45-55% for bismuth). In the case of the HpSA test, ranitidine does not interfere, whereas lansoprazole and bismuth may be expected to yield a nonsignificant proportion of false negative results (15-25% for lansoprazole and 10-15% for bismuth). Absolute values for both tests may be used to study the effects of the pharmacological agents on the characteristics of the infection.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2002

Methods for evaluating the performance of diagnostic tests in the absence of a gold standard: a latent class model approach.

In many areas of medical research, 'gold standard' diagnostic tests do not exist and so evaluating the performance of standardized diagnostic criteria or algorithms is problematic. In this paper we propose an approach to evaluating the operating characteristics of diagnoses using a latent class model. By defining 'true disease' as our latent variable, we are able to estimate sensitivity, specificity and negative and positive predictive values of the diagnostic test. These methods are applied to diagnostic criteria for depression using Baltimore's Epidemiologic Catchment Area Study Wave 3 data.

Baltimore↗
PubMed1997

The effect of lead selection on traditional and heart rate-adjusted ST segment analysis in the detection of coronary artery disease during exercise testing.

Several methods of heart rate-adjusted ST segment (ST/HR) analysis have been suggested to improve the diagnostic accuracy of exercise electrocardiography in the identification of coronary artery disease compared with traditional ST segment analysis. However, no comprehensive comparison of these methods on a lead-by-lead basis in all 12 electrocardiographic leads has been reported. This article compares the diagnostic performances of ST/HR hysteresis, ST/HR index, ST segment depression 3 minutes after recovery from exercise, and ST segment depression at peak exercise in a study population of 128 patients with angiographically proved coronary artery disease and 189 patients with a low likelihood of the disease. The methods were determined in each lead of the Mason-Likar modification of the standard 12-lead exercise electrocardiogram for each patient. The ST/HR hysteresis, ST/HR index, ST segment depression 3 minutes after recovery from exercise, and ST segment depression at peak exercise achieved more than 85% area under the receiver-operating characteristic curve in nine, none, three, and one of the 12 standard leads, respectively. The diagnostic performance of ST/HR hysteresis was significantly superior in each lead, with the exception of leads a VL and V1. Examination of individual leads in each study method revealed the high diagnostic performance of leads I and -aVR, indicating that the importance of these leads has been undervalued. In conclusion, the results indicate that when traditional ST segment analysis is used for the detection of coronary artery disease, more attention should be paid to the leads chosen for analysis, and lead-specific cut points should be applied. On the other hand, ST/HR hysteresis, which integrates the ST/HR depression of the exercise and recovery phases, seems to be relatively insensitive to the lead selection and significantly increases the diagnostic performance of exercise electrocardiography in the detection of coronary artery disease.

Coronary Disease↗
PubMed2003

Detection of primary hepatic malignancy in liver transplant candidates: prospective comparison of CT, MR imaging, US, and PET.

PURPOSE: To determine and compare the diagnostic performance of computed tomography (CT), magnetic resonance (MR) imaging, ultrasonography (US), and positron emission tomography (PET) in the detection of hepatocellular carcinoma (HCC) or cholangiocarcinoma in liver transplant candidates and to determine interobserver variability between the readers. MATERIALS AND METHODS: Twenty-five patients were examined prospectively with CT, MR imaging, US, and PET. Each test result was interpreted independently by two radiologists. Explanted liver specimens were examined histologically to determine presence and type of lesion. Results were analyzed on a patient-by-patient basis with marginal homogeneity and effect likelihood ratio tests. RESULTS: HCC was diagnosed in nine patients. US diagnostic performance was superior to that of CT and MR imaging on a patient-by-patient basis. Sensitivities were higher for US (0.89 for both US readers) than they were for CT (0.67 and 0.56 for readers 1 and 2, respectively), MR imaging (0.56 and 0.50 for readers 1 and 2, respectively), and PET (0 for both readers). None of the differences (within test) between readers were significant (P >or=.32). Ratings by US and MR observers and one CT observer were significantly associated with truth (P <or=.04). One or more imaging tests depicted 68 lesions. Histologic analysis revealed 18 HCC nodules; of these, 13 were correctly identified at CT, 14 at MR imaging, 13 at US, and none at PET. There were nine false-positive diagnoses of HCC with CT, five with MR imaging, and nine with US. CONCLUSION: Although US had the best diagnostic performance in depicting HCC on a patient-by-patient basis and was substantially better than were MR imaging and CT (which had nearly equivalent diagnostic performances), CT, US, and MR imaging performed similarly on a lesion-by-lesion basis. Small tumor nodules were the most common cause of missed HCCs with all tests. PET did not depict any HCCs.

Adult↗
PubMed2006

Bilateral inferior petrosal sinuses sampling in the routine investigation of Cushing's syndrome: a comparison with MRI.

OBJECTIVE: Identifying the cause of Cushing's syndrome (CS) is a perplexing issue. Bilateral inferior petrosal sinuses sampling (BIPSS) is an invasive and elaborate but established procedure in distinguishing Cushing's disease (CD) from ectopic adrenocorticotropic hormone (ACTH) syndrome. We compare the diagnostic performance of BIPSS and MRI in detecting an ACTH-secreting source, and we suggest the diagnostic protocol that we found beneficial for the management of patients with CS. MATERIALS AND METHODS: Seventy-eight consecutive patients with CS were included. All patients underwent biochemical investigation and pituitary MRI. Consequently, patients were routinely referred for BIPSS; 25 received stimulation with corticotropin-releasing hormone (CRH) and 53 with CRH and desmopressin. The diagnosis of CD was established on the basis of complementary biochemical, imaging, and BIPSS criteria. The diagnostic performances of BIPSS and MRI were calculated for patients with final diagnosis. RESULTS: A final diagnosis was available for 54 patients (46 CD confirmed, five ectopic confirmed, three adrenals). No (known) patient was misclassified based on our suggested diagnostic criteria. MRI rendered 25 false-negatives and two false-positives (incidentalomas). Successful BIPSS yielded two false-negatives and three false-positives (adrenals). The calculated accuracy for detecting a pituitary source of ACTH was 50% and 88% for MRI and successful BIPSS, respectively. CONCLUSION: MRI is of only limited diagnostic performance, while BIPSS is the most accurate way to establish the diagnosis of CD. The routine use of a multimodality diagnostic approach including BIPSS, MRI, and biochemical tests is suggested to avoid the risk of mismanagement for patients with CS.

Adolescent↗
PubMedDate not supplied

Influence of case and physician characteristics on perceptions of decision support systems.

OBJECTIVE: This study examines how characteristics of clinical cases and physician users relate to the users' perceptions of the usefulness of the Quick Medical Reference (QMR) and their confidence in their diagnoses when supported by the decision support system. METHODS: A national sample (N = 108) of 67 internists, 35 family physicians, and 6 other U.S. physicians used QMR to assist in the diagnosis of written clinical cases. Three sets of eight cases stratified by diagnostic difficulty and the potential of QMR to produce high-quality information were used. A 2 x 2 repeated-measures analysis of variance was used to test whether these factors were associated with perceived usefulness of QMR and physicians' diagnostic confidence after using QMR. Correlations were computed among physician characteristics, ratings of QMR usefulness, and physicians' confidence in their own diagnoses, and between usefulness or confidence and actual diagnostic performance. RESULTS: The analyses showed that QMR was perceived to be significantly more useful (P < 0.05) on difficult cases, on cases where QMR could provide high-quality information, by non-board-certified physicians, and when diagnostic confidence was lower. Diagnostic confidence was higher when comfort with using certain QMR functions was higher. The ratings of usefulness or diagnostic confidence were not consistently correlated with diagnostic performance. CONCLUSIONS: The results suggest that users' diagnostic confidence and perceptions of QMR usefulness may be associated more with their need for decision support than with their actual diagnostic performance when using the system. Evaluators may fail to find a diagnostic decision support system useful if only easy cases are tested, if correct diagnoses are not in the system's knowledge base, or when only highly trained physicians use the system.

Attitude to Computers↗
PubMed1986

Evaluation of rapid methods for the detection of bacteriuria (screening) in primary health care.

The diagnostic performance of six methods for bacteriuria testing has been studied in 781 urine specimens obtained in primary health care, using conventional culture as reference method. The cut-off limits for classification of test results into positive and negative have been optimized with respect to diagnostic performance in primary health care. With optimized tests the following diagnostic efficiencies were obtained: Bacterial ATP, 0.94; Bacterial count in sediment, 0.93; Nitrite test, 0.92; Dipslide test, 0.92; White cell count in sediment; 0.87; Goffulocyte esterase test; 0.83. The diagnostic performance was also studied for all combinations of two tests. The highest diagnostic efficiency (0.96) was obtained by combining the ATP and dipslide tests. High diagnostic efficiencies can be obtained by a rapid primary test, using other tests for follow-up testing of specimens with intermediate or uninterpretable primary results. The most promising results were obtained by using ATP as the primary test, with follow-up testing of specimens with 3-25 nmol/l of ATP (12 per cent of the specimens). Follow-up testing by conventional culture resulted in overall diagnostic efficiency of 0.98. By performing the nitrite test on specimens with intermediary ATP-results, 81 per cent of the patients with UTI can be classified without culture. Only patients with intermediary ATP and negative nitrite results (10 per cent of the total number) will have to wait for final diagnosis based on conventional culture. Some alternative strategies to combine available methods are discussed in detail. Major advantages of the ATP test are that the test can be performed while the patients are waiting; it provides a numerical and objective result, and, in contrast to culture, it is not influenced by adhesion of bacteria to somatic cells.

Adenosine Triphosphate↗
PubMed2006

Insights into latent class analysis of diagnostic test performance.

Latent class analysis is used to assess diagnostic test accuracy when a gold standard assessment of disease is not available but results of multiple imperfect tests are. We consider the simplest setting, where 3 tests are observed and conditional independence (CI) is assumed. Closed-form expressions for maximum likelihood parameter estimates are derived. They show explicitly how observed 2- and 3-way associations between test results are used to infer disease prevalence and test true- and false-positive rates. Although interesting and reasonable under CI, the estimators clearly have no basis when it fails. Intuition for bias induced by conditional dependence follows from the analytic expressions. Further intuition derives from an Expectation Maximization (EM) approach to calculating the estimates. We discuss implications of our results and related work for settings where more than 3 tests are available. We conclude that careful justification of assumptions about the dependence between tests in diseased and nondiseased subjects is necessary in order to ensure unbiased estimates of prevalence and test operating characteristics and to provide these estimates clinical interpretations. Such justification must be based in part on a clear clinical definition of disease and biological knowledge about mechanisms giving rise to test results.

Algorithms↗
PubMed1997

In situ hybridization for Helicobacter pylori in gastric mucosal biopsy specimens: quantitative evaluation of test performance in comparison with the CLOtest and thiazine stain.

Numerous detection methods for Helicobacter Pylori (H. pylori) have been developed with varying degrees of purported diagnostic utility. We have developed a rapid nonradioactive in situ hybridization (ISH) method for H. pylori detection in paraffin-embedded tissue and assessed its relative diagnostic performance by receiver operator characteristics (ROC) in comparison to the thiazine stain and CLOtest. Forty-five patients undergoing endoscopy had antral biopsies and concomitant CLOtest performed. ISH for H. pylori was done using a 22-base, biotin-labeled oligonucleotide probe complementary to a portion of H. pylori 16s rRNA with the following sequence: 5'-GGACATAGGCTGATCTTAGC-3'. ISH using this probe was specific for H. pylori with no crossreactivity with other bacterial or fungal organisms. Receiver operator characteristic analysis was used to assess the diagnostic performance of ISH and thiazine techniques. ISH and thiazine stains were done on serial sections, reviewed independently, and scored on a graded scale from 1-5 based upon the degree of assurance of H. pylori presence. Diagnostic performance was assessed in "expert" and "nonexpert" pathologist groups with the CLOtest serving as the invariant test for relative test comparison. The ISH test performed slightly better (ROC area 0.9) than the thiazine (ROC area 0.8) in the nonexpert population, but equally well in the "expert" group (ROC area 0.95, 0.95). ISH followed by routine hematoxylin and eosin staining showed detailed mucosal histology with a dramatic visualization of H. pylori along the surface of the foveolar cells with no evidence of lamina propria invasion. In summary, ISH for H. pylori is an excellent test that is specific, easily read, and allows concomitant detailed histologic mucosal examination.

Biopsy↗
PubMed2005

Variations in performance characteristics of commercial enzyme immunoassay kits for detection of antineutrophil cytoplasmic antibodies: what is the optimal cut off?

BACKGROUND: Previous studies have shown considerable variation in diagnostic performance of enzyme linked immunosorbent assays (ELISAs) for measuring antineutrophil cytoplasmic antibodies (ANCA) specific for proteinase 3 (PR3) and myeloperoxidase (MPO). OBJECTIVE: To analyse the performance characteristics of different commercially available direct ANCA ELISA kits. METHODS: ELISA kits for detecting PR3-ANCA and MPO-ANCA from 11 manufacturers were evaluated. Serum samples were taken from patients with Wegener's granulomatosis (15), microscopic polyangiitis (15), other vasculitides (10), and controls (40). RESULTS: were compared with data obtained by indirect immunofluorescence (IFT). The diagnostic performance of the tests was analysed and compared by receiver operating characteristic (ROC) curve analysis.Results: Applying the manufacturers' cut off resulted in great variation in sensitivity of the commercial PR3-ANCA kits for diagnosing Wegener's granulomatosis (ranging from 13.3% to 66.7%), and of the MPO-ANCA kits for diagnosing microscopic polyangiitis (ranging from 26.7% to 66.7%). Specificities were relatively constant (from 96.0% to 100%). IFT was superior to all ELISAs (C-ANCA for Wegener's granulomatosis: sensitivity 73.3%, specificity 98%; P-ANCA for microscopic polyangiitis: sensitivity 86.7%, specificity 98%). The sensitivities of PR3-ANCA and MPO-ANCA ELISA kits were increased by lowering the cut off values. This reduced specificity but increased overall diagnostic performance. CONCLUSIONS: The low sensitivity of some commercial kits reflects the high cut off levels recommended rather than methodological problems with the assays. Comparative analyses using sera from well characterised patients may help identify optimum cut off levels of commercial ANCA ELISA tests, resulting in better comparability of results among assays from different manufacturers.

Adult↗
PubMed2026

Epigallocatechin gallate is associated with PDGFRB downregulation and altered PI3K-AKT signaling in gastric cancer.

BACKGROUND: Gastric cancer (GC) remains a major cause of cancer-related mortality worldwide. Epigallocatechin gallate (EGCG), a natural polyphenol derived from green tea, exhibits anticancer properties; however, its molecular targets and regulatory mechanisms in GC are not fully elucidated. This study aimed to identify candidate EGCG-associated genes in GC and generate a hypothesis for future mechanistic investigation. METHODS: Differentially expressed genes (DEGs) in GC were identified and intersected with EGCG-associated targets retrieved from The Cancer Genome Atlas (TCGA) and GeneCards public databases. Least absolute shrinkage and selection operator (LASSO) regression and Cox proportional hazards analyses were performed to screen prognostically relevant genes. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curves. Functional enrichment analysis was conducted to explore biological significance. Public single-cell RNA sequencing datasets were analyzed to determine the cellular localization of platelet-derived growth factor receptor beta (PDGFRB), while DepMap transcriptomic data were used to assess its expression across GC cell lines. In vitro assays, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT), Transwell migration, and Western blotting, were performed to evaluate the biological effects of EGCG on GC-associated signaling pathways. RESULTS: Thirty-eight EGCG-associated DEGs were identified. Enrichment analysis revealed these genes were involved in cancer-associated pathways. LASSO-Cox modelling identified four candidate genes. Among them, PDGFRB was selected for further investigation based on its prognostic relevance and favorable diagnostic performance. PDGFRB expression was significantly higher in the TCGA genomically stable (GS) subtype than in the other molecular subtypes and was predominantly localized to cancer-associated fibroblasts (CAFs) and pericytes in single-cell RNA sequencing analysis. DepMap data demonstrated heterogeneous PDGFRB expression across GC cell lines. In vitro experiments showed that EGCG inhibited proliferation, migration, and invasion, reduced PDGFRB protein expression, and was associated with apoptosis-related protein changes and altered PI3K-AKT signaling. CONCLUSIONS: Our findings suggest that EGCG treatment was associated with reduced PDGFRB expression and altered PI3K-AKT signaling in GC cells. These findings identify PDGFRB as a candidate EGCG-associated gene and provide a hypothesis for future mechanistic investigation.

Gastric cancer (GC)↗