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Nevin Manimala Statistics

Application of glycemic qualification rate based on fingerstick glucose monitoring in women with gestational diabetes mellitus

J Matern Fetal Neonatal Med. 2023 Dec;36(1):2203797. doi: 10.1080/14767058.2023.2203797.

ABSTRACT

OBJECTIVE: To explore the appropriate application of glycemic qualification rate (GQR) calculated by fingerstick blood glucose (BG) monitoring for patients with gestational diabetes mellitus (GDM) by analyzing the relationship between BG control and adverse pregnancy outcomes.

METHODS: Fingerstick Blood Glucose data during the second and third trimester of singleton pregnant women diagnosed with GDM were collected. GQR which is defined as the percentage of fingerstick BG values reaching the targets of BG control in a period of time was calculated. Patients were divided into three groups according to tertiles (tertile 1, GQR <56.25%; tertile 2, GQR 56.25-75%; and tertile 3, GQR ≥75%). Pregnant outcomes were compared among the three groups. Univariate analysis and logistic regression were performed to analyze the potential relationship between GQR and pregnancy outcomes. Receiver operating characteristic (ROC) curves were calculated to determine the cutoff values. We also explored that whether twice or three times monitoring per day would be adequate for GQR calculation, so we brought in two or three glucose measuring times per day to explore the relationship between new GQR and adverse outcomes.

RESULTS: A total of 311 patients diagnosed with GDM were analyzed. In univariate analysis, the incidences of cesarean section of tertile 1-3 groups were 61.4%, 58.7%, and 44.9%, respectively (p < .05). The incidences of neonatal hypoglycemia of tertiles 1-3 groups were 19.8%, 18.6%, and 8.7% (p < .05). The difference of composite outcomes was statistically significant (p = .001). After adjustment, the patients with worse BG control (lower GQR) had higher risk of cesarean section (tertile 1 – aOR = 2.029, 1.128-3.648), neonatal hypoglycemia (tertile 1: aOR = 2.498, 1.082-5.766) as well as composite outcomes. The ROC curve of GQR indicated the predictive value for neonatal hypoglycemia (area under the ROC curve (AUC) 0.612 (0.532-0.692)) and neonatal composite outcomes (AUC 0.593 (0.528-0.657)) with optimal cutoff values of 81.1% and 73.5%, respectively. We also explored that whether twice or three times monitoring per day would be adequate for GQR calculation. The result showed that GQR only calculated by FBG + 2hPG after lunch (2h AL) per day also had well relationship with cesarean section (tertile 1: OR = 2.412, 1.322-4.398), neonatal hypoglycemia (tertile 1: aOR = 4.497, 1.607-12.586), and neonatal composite outcomes (tertile 1: aOR = 1.959, 95% confidence interval (CI): 1.114-3.444, p = .020).

CONCLUSIONS: The GQR calculated by the easily applicable fingerstick BG is related to occurrence of cesarean section and neonatal hypoglycemia in GDM women. GQR ≥ 80% is recommended for better pregnancy outcomes. As for the number of points monitoring per day, GQR calculated by FBG + 2h AL was an optimal option for better pregnancy outcomes if mothers needed to simplify the process of monitoring.

PMID:37080918 | DOI:10.1080/14767058.2023.2203797

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Nevin Manimala Statistics

Antisense oligonuleotides influences trophoblasts behaviors by changing LncNR_040117 expression in antiphospholipid antibody syndrome-induced recurrent pregnancy loss

J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183083. doi: 10.1080/14767058.2023.2183083.

ABSTRACT

OBJECTIVE: The primary objective of this study was to explore whether antisense oligonucleotides (ASOs) that reduce LncNR_040117 expression in patients with antiphospholipid antibody syndrome (APS)-induced recurrent pregnancy loss (RPL), and further decrease apoptosis and improve trophoblasts invasion through mitogen-activated protein kinase (MAPK) pathways. This paper aimed to provide a new strategy to treat APS-induced RPL.

METHODS: In this study, we used quantitative reverse transcription-polymerase chain reaction (RT-qPCR) to analyze the expression level of LncNR 040117 in HTR-8/SVneo cells following transfection with ASOs. Then we utilized Western blotting to test the expression levels of interleukin-1β (IL-1β), intracellular cell adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1) and key molecules of MAPK pathways, including the extracellular signal-regulated kinase (ERK), c-Jun N-terminal kinases (JNK) and p38. In addition, we examined the HTR-8/SVneo cells apoptosis by cell apoptosis assay, and migration and invasion by transwell antibody assay. Each experiment was repeated three times. The data are presented as the means ± SDs, and statistical comparisons were performed using Student’s t-test. p < 0.05 was considered significant.

RESULT: Transfected with ASOs, LncNR_040117 was downregulated in trophoblasts compared with APS-induced RPL patients. And LncNR_040117 low expression induced IL-1β and downstream adhesion molecules ICAM-1 and VCAM-1expression level decreased, as well as MAPK pathways downregulation, including the ERK pathway, JNK pathway and p38/MAPK pathway. Furthermore, all these changes resulted in decreased apoptosis and increased migration and invasion of trophoblasts.

CONCLUSION: This study indicated that ASOs that decrease LncNR_040117 expression can reduce apoptosis and enhance the invasion and migration of trophoblasts by regulating the MAPK pathway.

PMID:37080915 | DOI:10.1080/14767058.2023.2183083

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Nevin Manimala Statistics

A New Strategy for Evaluating the Quality of Laboratory Results for Big Data Research: Using External Quality Assessment Survey Data (2010-2020)

Ann Lab Med. 2023 Sep 1;43(5):425-433. doi: 10.3343/alm.2023.43.5.425.

ABSTRACT

BACKGROUND: To ensure valid results of big data research in the medical field, the input laboratory results need to be of high quality. We aimed to establish a strategy for evaluating the quality of laboratory results suitable for big data research.

METHODS: We used Korean Association of External Quality Assessment Service (KEQAS) data to retrospectively review multicenter data. Seven measurands were analyzed using commutable materials: HbA1c, creatinine (Cr), total cholesterol (TC), triglyceride (TG), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), and cardiac troponin I (cTnI). These were classified into three groups based on their standardization or harmonization status. HbA1c, Cr, TC, TG, and AFP were analyzed with respect to peer group values. PSA and cTnI were analyzed in separate peer groups according to the calibrator type and manufacturer, respectively. The acceptance rate and absolute percentage bias at the medical decision level were calculated based on biological variation criteria.

RESULTS: The acceptance rate (22.5%-100%) varied greatly among the test items, and the mean percentage biases were 0.6%-5.6%, 1.0%-9.6%, and 1.6%-11.3% for all items that satisfied optimum, desirable, and minimum criteria, respectively.

CONCLUSIONS: The acceptance rate of participants and their external quality assessment (EQA) results exhibited statistically significant differences according to the quality grade for each criterion. Even when they passed the EQA standards, the test results did not guarantee the quality requirements for big data. We suggest that the KEQAS classification can serve as a guide for building big data.

PMID:37080743 | DOI:10.3343/alm.2023.43.5.425

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Functional Reference Limits: Describing Physiological Relationships and Determination of Physiological Limits for Enhanced Interpretation of Laboratory Results

Ann Lab Med. 2023 Sep 1;43(5):408-417. doi: 10.3343/alm.2023.43.5.408.

ABSTRACT

Functional reference limits describe key changes in the physiological relationship between a pair of physiologically related components. Statistically, this can be represented by a significant change in the curvature of a mathematical function or curve (e.g., an observed plateau). The point at which the statistical relationship changes significantly is the point of curvature inflection and can be mathematically modeled from the relationship between the interrelated biomarkers. Conceptually, they reside between reference intervals, which describe the statistical boundaries of a single biomarker within the reference population, and clinical decision limits that are often linked to the risk of morbidity or mortality and set as thresholds. Functional reference limits provide important physiological and pathophysiological insights that can aid laboratory result interpretation. Laboratory professionals are in a unique position to harness data from laboratory information systems to derive clinically relevant values. Increasing research on and reporting of functional reference limits in the literature will enhance their contribution to laboratory medicine and widen the evidence base used in clinical decision limits, which are currently almost exclusively contributed to by clinical trials. Their inclusion in laboratory reports will enhance the intellectual value of laboratory professionals in clinical care beyond the statistical boundaries of a healthy reference population and pave the way to them being considered in shaping clinical decision limits. This review provides an overview of the concepts related to functional reference limits, clinical examples of their use, and the impetus to include them in laboratory reports.

PMID:37080741 | DOI:10.3343/alm.2023.43.5.408

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Head-to-head comparison of MR elastography-based liver stiffness, fat Fraction, and T1 relaxation time in identifying At-Risk NASH

Hepatology. 2023 Apr 24. doi: 10.1097/HEP.0000000000000417. Online ahead of print.

ABSTRACT

BACKGROUND AIMS: The presence of at-risk nonalcoholic steatohepatitis (NASH) is associated with an increased risk of cirrhosis and complications. Therefore, noninvasive identification of at-risk NASH with an accurate biomarker is a critical need for pharmacologic therapy. We aim to explore the performance of several magnetic resonance (MR)-based imaging parameters in diagnosing at-risk NASH.

APPROACH RESULTS: This prospective clinical trial (NCT02565446) includes 104 paired MR exams and liver biopsies performed in patients with suspected or diagnosed nonalcoholic fatty liver disease. MR Elastography (MRE)-assessed liver stiffness (LS), 6-point Dixon-derived proton density fat fraction (PDFF), single-point saturation-recovery acquisition-calculated T1 relaxation time were explored. Among all predictors, LS showed the significantly highest accuracy in diagnosing at-risk NASH (AUCLS: 0.89 [0.82, 0.95], AUCPDFF: 0.70 [0.58, 0.81], AUCT1: 0.72 [0.61, 0.82], z-score test z > 1.96 for LS vs. any of others). The optimal cut-off value of LS to identify at-risk NASH patients was 3.3kPa (sensitivity 79%, specificity 82%, NPV 91%), while the optimal cut-off value of T1 was 850ms (sensitivity 75%, specificity 63%, and NPV 87%). PDFF had the highest performance in diagnosing NASH with any fibrosis stage (AUCPDFF: 0.82 [0.72, 0.91], AUCLS: 0.73 [0.63, 0.84], AUCT1: 0.72 [0.61, 0.83], |z| < 1.96 for all).

CONCLUSIONS: MRE-assessed liver stiffness alone outperformed PDFF, and T1 in identifying patients with at-risk NASH for therapeutic trials.

PMID:37080558 | DOI:10.1097/HEP.0000000000000417

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Nevin Manimala Statistics

Disentangling temporal associations in marine microbial networks

Microbiome. 2023 Apr 21;11(1):83. doi: 10.1186/s40168-023-01523-z.

ABSTRACT

BACKGROUND: Microbial interactions are fundamental for Earth’s ecosystem functioning and biogeochemical cycling. Nevertheless, they are challenging to identify and remain barely known. Omics-based censuses are helpful in predicting microbial interactions through the statistical inference of single (static) association networks. Yet, microbial interactions are dynamic and we have limited knowledge of how they change over time. Here, we investigate the dynamics of microbial associations in a 10-year marine time series in the Mediterranean Sea using an approach inferring a time-resolved (temporal) network from a single static network.

RESULTS: A single static network including microbial eukaryotes and bacteria was built using metabarcoding data derived from 120 monthly samples. For the decade, we aimed to identify persistent, seasonal, and temporary microbial associations by determining a temporal network that captures the interactome of each individual sample. We found that the temporal network appears to follow an annual cycle, collapsing, and reassembling when transiting between colder and warmer waters. We observed higher association repeatability in colder than in warmer months. Only 16 associations could be validated using observations reported in literature, underlining our knowledge gap in marine microbial ecological interactions.

CONCLUSIONS: Our results indicate that marine microbial associations follow recurrent temporal dynamics in temperate zones, which need to be accounted for to better understand the functioning of the ocean microbiome. The constructed marine temporal network may serve as a resource for testing season-specific microbial interaction hypotheses. The applied approach can be transferred to microbiome studies in other ecosystems. Video Abstract.

PMID:37081491 | DOI:10.1186/s40168-023-01523-z

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Volume-based 18F-fluorodeoxyglucose positron emission tomography/computed tomography parameters correlate with delayed neck metastasis in clinical early-stage oral squamous cell carcinoma

Oral Radiol. 2023 Apr 21. doi: 10.1007/s11282-023-00686-7. Online ahead of print.

ABSTRACT

OBJECTIVE: There is no known preoperative marker that can effectively predict the risk of delayed neck metastasis (DNM), which is an important factor that determines the prognosis of early-stage oral cancer. In this study, we examined whether 18F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET)/computed tomography (CT) uptake parameters of primary cancer can predict the risk of DNM in early-stage oral squamous cell carcinoma (OSCC).

METHODS: Data from patients with stage I-II OSCC who underwent surgical resection of the primary tumor without elective neck dissection between January 2009 and December 2016 were retrospectively reviewed. Patient characteristics, histopathological factors, and PET/CT parameters (maximum standardized uptake value [SUVmax], metabolic tumor volume [MTV], and total lesion glycolysis [TLG]) were evaluated for their association with DNM. DNM rates were calculated, and the parameters that were statistically significant in the univariate analysis were used as explanatory variables. Independent factors associated with DNM were identified using multivariate analysis. For all statistical analyses, p-values < 0.05 were considered statistically significant.

RESULTS: Data from 71 patients were analyzed in the study. The overall DNM rate among all patients was 21.8%. The univariate analysis showed that the T classification, depth of invasion, pattern of invasion, lymphovascular invasion, SUVmax, MTV, and TLG were significant predictors of DNM. However, the multivariate analysis revealed that only the depth of invasion, MTV, and TLG were independent predictors of DNM.

CONCLUSION: This study suggests that, in addition to conventional predictors, volume-based PET parameters are useful predictors of DNM in those with early-stage OSCC.

PMID:37081306 | DOI:10.1007/s11282-023-00686-7

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Optimising Decision Making in Chronic Venous Disease Management with Micronised Purified Flavonoid Fraction

Clin Drug Investig. 2023 Apr 21. doi: 10.1007/s40261-023-01263-w. Online ahead of print.

ABSTRACT

Evidence-based medicine favours randomised controlled trials to limit bias and establish the effects of a treatment with statistical rigour. However, the controlled conditions and careful patient selection of randomised trials may produce results that cannot be generalised to a more diverse patient population in clinical practice. Therefore, there is growing recognition of the importance of supplementing randomised trial data with real-world evidence. Micronised purified flavonoid fraction has been investigated in several large-scale real-world studies, including the RELIEF and DECIDE studies, each of which included more than 1000 patients with chronic venous disease. These studies demonstrated a significant reduction in the prevalence and severity of chronic venous disease symptoms, and an improvement in quality of life. The chronic VEnous dIsorders maNagement and treatment effectivenesS evaluaTion in chronic vEnous disease, an international Program (VEINSTEP) study (NCT04574375), is currently underway in more than 6000 patients with chronic venous disease in nine countries. Preliminary data from one country (Morocco) indicate that chronic venous disease drug treatment, which was micronised purified flavonoid fraction in 75.7% of patients, was associated with a statistically significantly reduction in symptoms and improved quality of life. The overall results are awaited with interest. International chronic venous disease guidelines grade the evidence for micronised purified flavonoid fraction highly, as the benefits of micronised purified flavonoid fraction have been proven in randomised clinical trials and meta-analyses. Real-world studies demonstrate that the randomised evidence for micronised purified flavonoid fraction is generalisable to a clinical practice setting. Treatment decisions in chronic venous disease should consider evidence-based recommendations, including real-world data, as well as patient goals of symptom relief, functional improvement and/or better quality of life.

PMID:37081278 | DOI:10.1007/s40261-023-01263-w

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Improving the diagnosis of myelodysplastic syndrome by red blood cell parameters

Clin Transl Oncol. 2023 Apr 21. doi: 10.1007/s12094-023-03166-w. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the value of red blood cell parameters in Myelodysplastic syndrome (MDS) diagnosis and their relations to MDS subtypes and risk groups.

METHODS: The red blood cell parameter [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and red cell distribution width (RDW)] levels [203 MDS, 99 aplastic anemia (AA), 145 megaloblastic anemia (MA)] were collected from a single-center retrospective cohort. The cut-off values, area under the receiver operating characteristic curve (ROC) curve (AUC), sensitivity and specificity of the four parameters were calculated from the ROC. Furthermore, Kruskal-Wallis test and Dunn’s Test were performed to determine erythrocyte parameters in different subtypes and prognostic risks MDS.

RESULTS: There are significant statistic differences in RDW (P < 0.001), MCH (P = 0.036) and MCHC (P < 0.001) (MDS vs AA); RDW (P = 0.009), MCV (P < 0.001), MCH (P < 0.001) and MCHC (P = 0.001) (MDS vs MA); MCV (P = 0.011) and MCH (P = 0.008) (higher-risk MDS vs lower-risk MDS). Between MDS and MA, the area under the receiver operating characteristic curve (ROC) curve (AUC) values of MCV, MCH, MCHC, RDW were 0.846, 0.855, 0.617, and 0.593. Between MDS and AA, the AUC values of MCH, MCHC, RDW were 0.609, 0.671, and 0.662, respectively.

CONCLUSIONS: The red blood cell parameters contribute to the differential diagnosis of MDS, AA and MA and are related to MDS subtypes and risk groups.

PMID:37081223 | DOI:10.1007/s12094-023-03166-w

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The connection between diverticulosis and colonic superficial neoplastic lesions in patients who underwent screening colonoscopy

Int J Colorectal Dis. 2023 Apr 21;38(1):107. doi: 10.1007/s00384-023-04399-5.

ABSTRACT

PURPOSE: If could be a potential pathophysiological connection between colonic diverticula and colonic superficial neoplastic lesions, beyond the shared risk factors, has been a subject of debate in the last years. This study tries to evaluate the association between diverticulosis and colonic neoplastic lesions.

METHODS: This is a cross-sectional study including asymptomatic patients who underwent a screening colonoscopy (patients with a positive fecal occult blood test under the regional program of colorectal cancer (CRC) screening), surveillance after polypectomy resection, or familiarity (first-degree relatives) between 2020 and 2021 to evaluate the association between diverticula and colonic polyps. A multivariate analysis with multiple logistic regression and odds ratio (OR) to study the independent association between adenomas and adenocarcinomas was performed.

RESULTS: One thousand five hundred one patients were included. A statistically significant association between adenomas or CRC alone and colonic diverticula was found (p = 0.045). On a multivariate analysis of demographic (age, gender) and clinical parameters (familiarity for diverticula and adenoma/CRC), only age was significantly associated with the development of colorectal adenomas or cancer (OR 1.05, 95% CI 1.03-1.07, p < 0.0001).

CONCLUSIONS: This study showed a statistically significant association between diverticula and colonic adenomas. However, it is impossible to establish a cause-effect relationship due to the intrinsic characteristics of this study design. A study with a prospective design including both patients with diverticulosis and without colonic diverticula aimed at establishing the incidence of adenoma and CRC could help to answer this relevant clinical question, since a potential association could indicate the need for closer endoscopic surveillance.

PMID:37081187 | DOI:10.1007/s00384-023-04399-5