Application of One-Step IADPSG Versus Two-Step Diagnostic Criteria for Gestational Diabetes in the Real World: Impact on Health Services, Clinical Care, and Outcomes.
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SUBMITTER: Brown FM
PROVIDER: S-EPMC5552830 | biostudies-other | 2017 Aug
REPOSITORIES: biostudies-other
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Project description:Objectives There is considerable worldwide controversy regarding optimal screening and diagnostic approaches for GDM. This study aimed to compare the prevalence, maternal and neonatal outcomes of a One-step with a Two-step approach for the screening and diagnosis of GDM in a large community sample of pregnant women. Methods We conducted a secondary analysis of a randomized community non-inferiority trial of GDM screening in Iran. For the current study, all pregnant women who met the inclusion criteria were randomized into two groups for GDM screening. The first group of women (n = 14611) was screened by a One-step screening approach [75-g 2-h oral glucose tolerance test (OGTT)] and the second group (n = 14160) by a Two-step method (the 50-g glucose challenge test followed by the 100-g OGTT). All study participants were followed up until delivery, and the adverse maternal and neonatal outcomes were recorded in detail. Results GDM was diagnosed in 9.3% of the pregnant women who were assigned to the One-step and in 5.4% of those assigned to the Two-step approach with a statistically significant difference between them (p < 0.001). Intention-to-treat analyses showed no significant differences between the One-step and the Two-step group in the unadjusted risks of the adverse pregnancy outcomes of macrosomia, primary cesarean-section, preterm birth, hypoglycemia, hypocalcemia, hyperbilirubinemia, preeclampsia, neonatal intensive care unit admission, birth trauma, low birth weight, and intrauterine fetal death. Results remained unchanged after adjustment for potential confounder variables including gestational age at enrollment and delivery, maternal body mass index, gestational weight gain, type of delivery, treatment modality, and GDM diagnosis in the first trimester. Conclusion We found that although the rates of GDM more than doubled with the One-step strategy, the One-step approach was similar to the Two-step approach in terms of maternal and neonatal outcomes. These findings may warn that more caution should be exercised in adopting the One-step method worldwide. Future research is needed to assess the long-term harm and benefits of those approaches to GDM screening for both mothers and their offspring. Clinical trial registration https://www.irct.ir/trial/518, identifier (IRCT138707081281N1).
| S-EPMC9932332 | biostudies-literature
Project description:To analyze the effect of applying alternative diagnostic criteria for gestational diabetes mellitus (GDM) during the COVID-19 pandemic on GDM prevalence and obstetrical and perinatal outcomes, in comparison to usual diagnostic approaches. Data from women referred to GDM diagnosis from 1 September to 30 November 2019 were retrospectively collected (2019-group). The same data from the same period in 2020 were prospectively collected (2020-group). In both cases, a two-step diagnostic approach was used, the first step being a screening test (1 h 50 goral glucose tolerance test, OGTT). In 2019 it was followed by a 100 gr OGTT for diagnosis. In 2020, this was replaced by a blood test for the measurement of plasma glucose and HbA1c, according to alternative GDM diagnostic criteria during the COVID-19 pandemic. From 237 women in the 2019 group, 40 (16.9%) were diagnosed with GDM, while from 255 women in the 2020 group, 37 (14.5%) had GDM (p = 0.470). More women in the 2020 group, in comparison to the 2019 group, were nulligravid (41.9% vs. 47.2%, p = 0.013), had a personal history of GDM (11.4% vs. 4.6%, p = 0.013) and had macrosomia in previous pregnancies (10.2% vs. 2.1%, p = 0.001). Obstetrical and perinatal outcomes were similar when comparing women with GDM to non-GDM women in the 2019 and 2020 groups and between GDM women and non-GDM women. In a Spanish population, GDM prevalence during the COVID-19 pandemic using the alternative diagnostic criteria was similar to that found in 2019 using the usual diagnostic criteria. Despite women referred for GDM diagnosis during the pandemic having more GDM risk factors, obstetrical and perinatal outcomes were comparable to those observed before the pandemic.
| S-EPMC8585066 | biostudies-literature
Project description:Benchmarks for molecular docking have historically focused on re-docking the cognate ligand of a well-determined protein-ligand complex to measure geometric pose prediction accuracy, and measurement of virtual screening performance has been focused on increasingly large and diverse sets of target protein structures, cognate ligands, and various types of decoy sets. Here, pose prediction is reported on the Astex Diverse set of 85 protein ligand complexes, and virtual screening performance is reported on the DUD set of 40 protein targets. In both cases, prepared structures of targets and ligands were provided by symposium organizers. The re-prepared data sets yielded results not significantly different than previous reports of Surflex-Dock on the two benchmarks. Minor changes to protein coordinates resulting from complex pre-optimization had large effects on observed performance, highlighting the limitations of cognate ligand re-docking for pose prediction assessment. Docking protocols developed for cross-docking, which address protein flexibility and produce discrete families of predicted poses, produced substantially better performance for pose prediction. Performance on virtual screening performance was shown to benefit by employing and combining multiple screening methods: docking, 2D molecular similarity, and 3D molecular similarity. In addition, use of multiple protein conformations significantly improved screening enrichment.
| S-EPMC3398190 | biostudies-literature
Project description:There is a growing focus on making clinical trials more inclusive but the design of trial eligibility criteria remains challenging1-3. Here we systematically evaluate the effect of different eligibility criteria on cancer trial populations and outcomes with real-world data using the computational framework of Trial Pathfinder. We apply Trial Pathfinder to emulate completed trials of advanced non-small-cell lung cancer using data from a nationwide database of electronic health records comprising 61,094 patients with advanced non-small-cell lung cancer. Our analyses reveal that many common criteria, including exclusions based on several laboratory values, had a minimal effect on the trial hazard ratios. When we used a data-driven approach to broaden restrictive criteria, the pool of eligible patients more than doubled on average and the hazard ratio of the overall survival decreased by an average of 0.05. This suggests that many patients who were not eligible under the original trial criteria could potentially benefit from the treatments. We further support our findings through analyses of other types of cancer and patient-safety data from diverse clinical trials. Our data-driven methodology for evaluating eligibility criteria can facilitate the design of more-inclusive trials while maintaining safeguards for patient safety.
| S-EPMC9007176 | biostudies-literature
Project description:INTRODUCTION:Influenza A is known as a public health concern worldwide. In this study, a novel one-step real-time reverse transcription polymerase chain reaction (rtRT-PCR) assay was designed and optimized for the detection of influenza A viruses. MATERIAL AND METHODS:The primers and probe were designed based on the analysis of 90 matrix nucleotide sequence data of influenza type A subtypes from the GenBank database of the National Center for Biotechnology Information (NCBI). The influenza virus A/Tehran/5652/2010 (H1N1 pdm09) was used as a reference. The rtRT-PCR assay was optimized, compared with that of the World Health Organization (WHO), and its analytical sensitivity, specificity and reproducibility were evaluated. In total, 64 nasopharyngeal swabs from patients with influenza-like illness (ILI) and 41 samples without ILI symptoms were tested for the virus, using conventional cell culture, direct immunofluorescence antibody (DFA) methods, and one-step rtRT-PCR with the designed primer set and probe and the WHO's. RESULTS:The optimized assay results were similar to the WHO's. The optimized assay results were similar to WHO's, with non-significant differences for 10-103 copies of viral RNA/reaction (p > 0.05). It detected 10 copies of viral RNA/reaction with high reproducibility and no cross reactivity with other respiratory viruses. A specific cytopathic effect was observed in 6/64 (9.37%) of the ILI group using conventional culture and DFA staining methods; however, it was not seen in non-ILI. Also, the results of our assay and the WHO's were similar to those of viral isolation and DFA staining. CONCLUSIONS:Given the high specificity, sensitivity and reproducibility of this novel assay, it can serve as a reliable diagnostic tool for the detection of influenza A viruses in clinical specimens and lab experiments.
| S-EPMC5108395 | biostudies-literature
Project description:ObjectiveNonalcoholic steatohepatitis (NASH) is the most common liver disease in the USA. Clinical trials have stringent study criteria which may limit real-world generalizability. Thus, we studied whether a real-world, university-based cohort of patients could be eligible for a pivotal phase 3 NASH clinical trial.MethodsWe queried Yale-New Haven Health System electronic medical records for patients with a diagnosis of NASH from 2013 to 2017. Of those who received liver biopsy, we extracted demographic, clinical, laboratory, and biopsy data. We compared patient characteristics to enrollment criteria of the Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment.ResultsOf 14 403 patients with NASH, 478 (3.3%) completed liver biopsy, of whom 237 (49.6%) had histological confirmation by a gastrointestinal pathologist. Histologically-confirmed NASH patients were 51.1 ± 13.2 years old, 56.5% female, 69.6% white race, and 24.6% had cirrhosis. In this group, 68 (28.7%) patients met all inclusion criteria, 87 (36.7%) had no exclusions, and 34 (14.4%) met all enrollment criteria. Other than cirrhosis, common reasons for ineligibility were presence of medical comorbidity (n = 83) or laboratory abnormalities (n = 47). Multiple logistic regression did not reveal significant predictors of eligibility.ConclusionWithin a university-based cohort of NASH patients, few met phase 3 clinical trial enrollment criteria, mostly due to low rates of liver biopsy. Of those with histologic confirmation, 14.4% met enrollment criteria. Validation of generalizability for safety and efficacy of NASH investigational agents in real-world populations is needed.
| S-EPMC7674230 | biostudies-literature
Project description:BackgroundCoronavirus-2019 (COVID-2019) is a novel coronavirus known as Acute Respiratory Syndrome (SARS-CoV-2). The premier standard test for SARS-CoV-2 diagnosis is a one-step RT-qPCR method, which requires specific probes and reagents. Therefore, detection on a large scale is expensive and cannot be very accurate.MethodsA cost-effective technique based on SYBR green was evaluated in the current study. The specific primers for S and N genes were designed, then performed the cross-reactivity test with other coronavirus and respiratory viruses positive samples. Moreover, the analytical sensitivity test was carried out with 8 dilutions (1:10). Lastly, the SARS-CoV-2 clinical samples (n = 210) were tested by these two methods, and receiver operating characteristic (ROC) analysis was performed to investigate the incremental diagnostic value of each gene in the study methods.ResultsThe two-step method detected up to 6th dilutions of the SARS-CoV-2 samples and did not show any amplification of the positive samples of other respiratory viruses. ROC analysis revealed a diagnostic ability of the two-step method for SARS-CoV-2 with an area under the ROC curve of ≥ 0.7 (P ˂ 0.05) and relatively high sensitivity and specificity. The combination of N and S genes increased the sensitivity up to 88%, specificity up to 86%, and area under the ROC curve up to 0.85 (95% confidence interval (95% CI) 0.72 to 0.93, P = 0.0461).ConclusionOur findings indicated that the two-step method has comparable sensitivity and specificity to the one-step method. Therefore, this method can be considered a potential diagnostic method for diagnosing and monitoring COVID-19 patients. It suggests that when the one-step RT-qPCR method is not available, the two-step RT-qPCR can be used to identify SARS-CoV-2.
| S-EPMC9152310 | biostudies-literature
Project description:Organohydrogels with distinct antifreezing and antidehydration properties have aroused great interest among researchers, and various organohydrogels and organohydrogel-based applications have emerged recently. There are two popular synthesis strategies to prepare these antifreezing and antidehydration organohydrogels: the in-situ gelling and the solvent displacement strategies. Although both strategies have been widely applied, there is a lack of comparative study of these two strategies. In this work, to elucidate the comparative advantages of the two synthesis strategies, we studied and compared the mechanical and environmental tolerant properties of the organohydrogels synthesized from both strategies. The glycerol-based and ethylene glycol-based chemical polyacrylamide (PAAm) organohydrogel and the glycerol-based physical gelatin organohydrogel were synthesized and studied. Through the comparative study, we have found that the organohydrogels from different strategies with the same dispersion medium showed similar antifreezing and antidehydration properties but different mechanical properties. The mechanical properties of these organohydrogels are influenced by two opposite factors for each strategy: the enhanced physical interactions induced strengthening and solvent effect or swelling induced weakening. We hope this study may provide a better understanding of the synthesis strategies of organohydrogels and provide a valuable guide to choose the suitable synthesis strategy for each application.
| S-EPMC7696091 | biostudies-literature
Project description:BackgroundTwo criteria based on a 2 h 75 g OGTT are being used for the diagnosis of gestational diabetes (GDM), those recommended over the years by the World Health Organization (WHO), and those recently recommended by the International Association for Diabetes in Pregnancy Study Group (IADPSG), the latter generated in the HAPO study and based on pregnancy outcomes. Our aim is to systematically review the evidence for the associations between GDM (according to these criteria) and adverse outcomes.MethodsWe searched relevant studies in MEDLINE, EMBASE, LILACS, the Cochrane Library, CINHAL, WHO-Afro library, IMSEAR, EMCAT, IMEMR and WPRIM. We included cohort studies permitting the evaluation of GDM diagnosed by WHO and or IADPSG criteria against adverse maternal and perinatal outcomes in untreated women. Only studies with universal application of a 75 g OGTT were included. Relative risks (RRs) and their 95% confidence intervals (CI) were obtained for each study. We combined study results using a random-effects model. Inconsistency across studies was defined by an inconsistency index (I2) > 50%.ResultsData were extracted from eight studies, totaling 44,829 women. Greater risk of adverse outcomes was observed for both diagnostic criteria. When using the WHO criteria, consistent associations were seen for macrosomia (RR = 1.81; 95%CI 1.47-2.22; p < 0.001); large for gestational age (RR = 1.53; 95%CI 1.39-1.69; p < 0.001); perinatal mortality (RR = 1.55; 95% CI 0.88-2.73; p = 0.13); preeclampsia (RR = 1.69; 95%CI 1.31-2.18; p < 0.001); and cesarean delivery (RR = 1.37;95%CI 1.24-1.51; p < 0.001). Less data were available for the IADPSG criteria, and associations were inconsistent across studies (I2 ? 73%). Magnitudes of RRs and their 95%CIs were 1.73 (1.28-2.35; p = 0.001) for large for gestational age; 1.71 (1.38-2.13; p < 0.001) for preeclampsia; and 1.23 (1.01-1.51; p = 0.04) for cesarean delivery. Excluding either the HAPO or the EBDG studies minimally altered these associations, but the RRs seen for the IADPSG criteria were reduced after excluding HAPO.ConclusionsThe WHO and the IADPSG criteria for GDM identified women at a small increased risk for adverse pregnancy outcomes. Associations were of similar magnitude for both criteria. However, high inconsistency was seen for those with the IADPSG criteria. Full evaluation of the latter in settings other than HAPO requires additional studies.
| S-EPMC3352245 | biostudies-literature
Project description:BACKGROUND:To directly achieve cytochrome P450 2C19 gene ( CYP2C19) classification using one-step real-time fluorescent PCR detection and to verify the capabilities of this method with nucleic acid extracted from whole blood samples. METHODS:A human CYP2C19 genotyping kit based on one-step real-time fluorescent PCR detection was used to analyze whole blood or genomic DNA samples. This method was compared with pyrosequencing and another quantitative (q)PCR kit for its accuracy, repeatability, detection range analysis, sensitivity, specificity, and anti-interference analysis. RESULTS:The one-step real-time PCR method achieved a 100% accuracy rate compared with pyrosequencing and the other qPCR kit. When detecting different concentrations of known genes, concentrations of each sample ranging from 0.2 to 125 ng/µL could be correctly detected. The genotypes of samples treated with anticoagulants, including EDTA and sodium citrate, and chyle blood samples could be correctly detected. CONCLUSION:The one-step detection method demonstrated high accuracy and a wide detection range. It also had high levels of repeatability, sensitivity, and specificity for the assessment of genomic DNA test samples.
| S-EPMC6300956 | biostudies-literature