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Nevin Manimala Statistics

Predicting intraoperative blood loss during cesarean sections based on multi-modal information: a two-center study

Abdom Radiol (NY). 2024 Jun 19. doi: 10.1007/s00261-024-04419-0. Online ahead of print.

ABSTRACT

PURPOSE: To develop and validate a nomogram model that combines radiomics features, clinical factors, and coagulation function indexes (CFI) to predict intraoperative blood loss (IBL) during cesarean sections, and to explore its application in optimizing perioperative management and reducing maternal morbidity.

METHODS: In this retrospective consecutive series study, a total of 346 patients who underwent magnetic resonance imaging (156 for training and 68 for internal test, center 1; 122 for external test, center 2) were included. IBL+ was defined as more than 1000 mL estimated blood loss during cesarean sections. The prediction models of IBL were developed based on machine-learning algorithms using CFI, radiomics features, and clinical factors. ROC analysis was performed to evaluate the performance for IBL diagnosis.

RESULTS: The support vector machine model incorporating all three modalities achieved an AUC of 0.873 (95% CI 0.769-0.941) and a sensitivity of 1.000 (95% CI 0.846-1.000) in the internal test set, with an AUC of 0.806 (95% CI 0.725-0.872) and a sensitivity of 0.873 (95% CI 0.799-0.922) in the external test set. It was also scored significantly higher than the CFI model (P = 0.035) on the internal test set, and both the CFI (P = 0.002) and radiomics-CFI models (P = 0.007) on the external test set. Additionally, the nomogram constructed based on three modalities achieved an internal testing set AUC of 0.960 (95% CI 0.806-0.999) and an external testing set AUC of 0.869 (95% CI 0.684-0.967) in the pregnant population without a pernicious placenta previa. It is noteworthy that the AUC of the proposed model did not show a statistically significant improvement compared to the Clinical-CFI model in both internal (P = 0.115) and external test sets (P = 0.533).

CONCLUSION: The proposed model demonstrated good performance in predicting intraoperative blood loss (IBL), exhibiting high sensitivity and robust generalizability, with potential applicability to other surgeries such as vaginal delivery and postpartum hysterectomy. However, the performance of the proposed model was not statistically significantly better than that of the Clinical-CFI model.

PMID:38896245 | DOI:10.1007/s00261-024-04419-0

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Nevin Manimala Statistics

Application of the adaptive Monte Carlo method for uncertainty evaluation in the determination of total testosterone in human serum by triple isotope dilution mass spectrometry

Anal Bioanal Chem. 2024 Jun 19. doi: 10.1007/s00216-024-05380-z. Online ahead of print.

ABSTRACT

The measurement uncertainty is a crucial quantitative parameter for assessing the reliability of the result. The study aimed to propose a new budget for uncertainty evaluation of a reference measurement procedure for the determination of total testosterone in human serum. The adaptive Monte Carlo method (aMCM) was used for the propagation of probability distributions assigned to various input quantities to determine the uncertainty of the testosterone concentration. The basic principles of the propagation and the statistical analysis were described based on the experimental results of the quality control serum sample. The analysis of the number of Monte Carlo trials was discussed. The procedure of validation of the GUM uncertainty framework using the aMCM was also provided. The number of Monte Carlo trials was 2.974 × 106 when the results had stabilized. The total testosterone concentration was 16.02 nmol/L, and the standard uncertainty was 0.30 nmol/L. The coverage interval at coverage probability of 95% was 15.45 to 16.62 nmol/L, while the probability distribution for testosterone concentration was approximately described by a Gaussian distribution. The validation of results was not passed as the expanded uncertainty result obtained by the aMCM was slightly lower, about 7%, than that by the GUM uncertainty framework with consistent results of the concentration.

PMID:38896240 | DOI:10.1007/s00216-024-05380-z

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Nevin Manimala Statistics

Test-set results can predict participants’ development in breast-screen cancer detection: An observational cohort study

Health Sci Rep. 2024 Jun 17;7(6):e2161. doi: 10.1002/hsr2.2161. eCollection 2024 Jun.

ABSTRACT

BACKGROUND AND AIM: Test-sets are standardized assessments used to evaluate reader performance in breast screening. Understanding how test-set results affect real-world performance can help refine their use as a quality improvement tool. The aim of this study is to explore if mammographic test-set results could identify breast-screening readers who improved their cancer detection in association with test-set training.

METHODS: Test-set results of 41 participants were linked to their annual cancer detection rate change in two periods oriented around their first test-set participation year. Correlation tests and a multiple linear regression model investigated the relationship between each metric in the test-set results and the change in detection rates. Additionally, participants were divided based on their improvement status between the two periods, and Mann-Whitney U test was used to determine if the subgroups differed in their test-set metrics.

RESULTS: Test-set records indicated multiple significant correlations with the change in breast cancer detection rate: a moderate positive correlation with sensitivity (0.688, p < 0.001), a moderate negative correlation with specificity (-0.528, p < 0.001), and a low to moderate positive correlation with lesion sensitivity (0.469, p = 0.002), and the number of years screen-reading mammograms (0.365, p = 0.02). In addition, the overall regression was statistically significant (F (2,38) = 18.456 p < 0.001), with an R² of 0.493 (adjusted R² = 0.466) based on sensitivity (F = 27.132, p < 0.001) and specificity (F = 9.78, p = 0.003). Subgrouping the cohort based on the change in cancer detection indicated that the improved group is significantly higher in sensitivity (p < 0.001) and lesion sensitivity (p = 0.02) but lower in specificity (p = 0.003).

CONCLUSION: Sensitivity and specificity are the strongest test-set performance measures to predict the change in breast cancer detection in real-world breast screening settings following test-set participation.

PMID:38895553 | PMC:PMC11183186 | DOI:10.1002/hsr2.2161

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Uncovering the power of neurofeedback: a meta-analysis of its effectiveness in treating major depressive disorders

Cereb Cortex. 2024 Jun 4;34(6):bhae252. doi: 10.1093/cercor/bhae252.

ABSTRACT

Neurofeedback, a non-invasive intervention, has been increasingly used as a potential treatment for major depressive disorders. However, the effectiveness of neurofeedback in alleviating depressive symptoms remains uncertain. To address this gap, we conducted a comprehensive meta-analysis to evaluate the efficacy of neurofeedback as a treatment for major depressive disorders. We conducted a comprehensive meta-analysis of 22 studies investigating the effects of neurofeedback interventions on depression symptoms, neurophysiological outcomes, and neuropsychological function. Our analysis included the calculation of Hedges’ g effect sizes and explored various moderators like intervention settings, study designs, and demographics. Our findings revealed that neurofeedback intervention had a significant impact on depression symptoms (Hedges’ g = -0.600) and neurophysiological outcomes (Hedges’ g = -0.726). We also observed a moderate effect size for neurofeedback intervention on neuropsychological function (Hedges’ g = -0.418). As expected, we observed that longer intervention length was associated with better outcomes for depressive symptoms (β = -4.36, P < 0.001) and neuropsychological function (β = -2.89, P = 0.003). Surprisingly, we found that shorter neurofeedback sessions were associated with improvements in neurophysiological outcomes (β = 3.34, P < 0.001). Our meta-analysis provides compelling evidence that neurofeedback holds promising potential as a non-pharmacological intervention option for effectively improving depressive symptoms, neurophysiological outcomes, and neuropsychological function in individuals with major depressive disorders.

PMID:38889442 | DOI:10.1093/cercor/bhae252

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Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial

Obstet Gynecol. 2024 Jun 18. doi: 10.1097/AOG.0000000000005648. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder.

METHODS: We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale-Desire, Arousal, Orgasm).

RESULTS: Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84). Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P=.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P≤.04).

CONCLUSION: Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04948151.

PMID:38889431 | DOI:10.1097/AOG.0000000000005648

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Could effective iodine-131 half-life be extended by lithium carbonate in Graves’ disease patients: Results from a retrospective analysis

Biomol Biomed. 2024 Jun 17. doi: 10.17305/bb.2024.10659. Online ahead of print.

ABSTRACT

The effective iodine-131 (I-131) half-life (EHL) plays an important role in the evaluation of radioactive iodine therapy for Graves’ disease (GD) patients. It has been observed that the EHL of GD patients varies after taking lithium carbonate. The purpose of this study is to investigate whether EHL can be extended and to identify the predictive factors associated with this outcome. The clinical data of 225 GD patients were retrospectively reviewed. Patients were divided into two groups based on whether the ΔEHL was ≥ 0.5 days. EHL tested after lithium carbonate was defined as Li-EHL. In the univariate analysis, age, sex, thyrotropin receptor antibody (TRAb), thyroglobulin antibody (TgAb), thyroid peroxidase antibody (TPOAb), and baseline-EHL exhibited significant differences between the two groups (P < 0.05). Cutoff values of age and baseline-EHL to predict significant EHL extension were 40.5 years and 4.85 days, respectively, as determined by receiver operating characteristic (ROC) curve analysis. Multiple linear regression analysis further revealed that the regression equation, which included age, sex, baseline-EHL, and the FT3, free triiodothyronine (FT4)/free thyroxine(FT3) ratio, was statistically significant (P < 0.05). Li-EHL positively correlated with baseline-EHL and the FT4/FT3 ratio, but negatively correlated with age. Li-EHL was also increased in female individuals. In conclusion, age, sex, baseline-EHL and the FT4/FT3 ratio were associated with Li-EHL in GD patients.

PMID:38889393 | DOI:10.17305/bb.2024.10659

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Nevin Manimala Statistics

Associations of Cerebral Small Vessel Disease and Chronic Kidney Disease in Patients With Acute Intracerebral Hemorrhage: A Cross-Sectional Study

Neurology. 2024 Jul 23;103(2):e209540. doi: 10.1212/WNL.0000000000209540. Epub 2024 Jun 18.

ABSTRACT

BACKGROUND AND OBJECTIVES: Chronic kidney disease (CKD) may be associated with the pathogenesis and phenotype of cerebral small vessel disease (SVD), which is the commonest cause of intracerebral hemorrhage (ICH). The purpose of this study was to investigate the associations of CKD with ICH neuroimaging phenotype, volume, and location, total burden of small vessel disease, and its individual components.

METHODS: In 2 cohorts of consecutive patients with ICH evaluated with MRI, we investigated the frequency and severity of CKD based on established Kidney Disease Improving Global Outcomes criteria, requiring estimated glomerular filtration rate (eGFR) measurements <60 mL/min/1.732 ≥ 3 months apart to define CKD. MRI scans were rated for ICH neuroimaging phenotype (arteriolosclerosis, cerebral amyloid angiopathy, mixed location SVD, or cryptogenic ICH) and the presence of markers of SVD (white matter hyperintensities [WMHs], cerebral microbleeds [CMBs], lacunes, and enlarged perivascular spaces, defined according to the STandards for ReportIng Vascular changes on nEuroimaging criteria). We used multinomial, binomial logistic, and ordinal logistic regression models adjusted for age, sex, hypertension, and diabetes to account for possible confounding caused by shared risk factors of CKD and SVD.

RESULTS: Of 875 patients (mean age 66 years, 42% female), 146 (16.7%) had CKD. After adjusting for age, sex, and comorbidities, patients with CKD had higher rates of mixed SVD than those with eGFR >60 (relative risk ratio 2.39, 95% CI 1.16-4.94, p = 0.019). Severe WMHs, deep microbleeds, and lacunes were more frequent in patients with CKD, as was a higher overall SVD burden score (odds ratio 1.83 for each point on the ordinal scale, 95% CI 1.31-2.56, p < 0.001). Patients with eGFR ≤30 had more CMBs (median 7 [interquartile range 1-23] vs 2 [0-8] for those with eGFR >30, p = 0.007).

DISCUSSION: In patients with ICH, CKD was associated with SVD burden, a mixed SVD phenotype, and markers of arteriolosclerosis. Our findings indicate that CKD might independently contribute to the pathogenesis of arteriolosclerosis and mixed SVD, although we could not definitively account for the severity of shared risk factors. Longitudinal and experimental studies are, therefore, needed to investigate causal associations. Nevertheless, stroke clinicians should be aware of CKD as a potentially independent and modifiable risk factor of SVD.

PMID:38889380 | DOI:10.1212/WNL.0000000000209540

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Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in PIK3CA-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance)

J Clin Oncol. 2024 Jun 18:JCO2301680. doi: 10.1200/JCO.23.01680. Online ahead of print.

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Observational studies have associated aspirin or cyclooxygenase 2 (COX-2) inhibitor usage either before or after colorectal cancer diagnosis with lower risk of recurrence and suggest that PIK3CA mutational status is predictive of better response to COX-2 inhibition. To prospectively test whether adding the COX-2 inhibitor celecoxib to standard adjuvant chemotherapy reduces the risk of recurrence and improves survival, the National Cancer Institute sponsored the CALGB/SWOG 80702 trial (ClinicalTrials.gov identifier: NCT01150045) for patients with stage III resected colon cancer. Although the primary hypothesis for all patients did not show a statistically significant improvement in disease-free survival (DFS) with celecoxib, subgroup analysis by PIK3CA mutational status was a preplanned study. PIK3CA gain-of-function mutations were detected in 259 of 1,197 tumors with available whole-exome sequencing data. When stratified by PIK3CA status, patients with PIK3CA gain-of-function mutations treated with celecoxib exhibited improved DFS (adjusted hazard ratio [HR], 0.56 [95% CI, 0.33 to 0.96]) compared with PIK3CA wildtype patients (adjusted HR, 0.89 [95% CI, 0.70 to 1.14]), although the interaction test was nonsignificant (Pinteraction = .13). Overall survival was similarly improved for patients with PIK3CA gain-of-function mutations (adjusted HR, 0.44 [95% CI, 0.22 to 0.85]) compared with PIK3CA wildtype patients (adjusted HR, 0.94 [95% CI, 0.68 to 1.30]; Pinteraction = .04). Although the test for heterogeneity in DFS did not reach statistical significance, the results suggest potential utility of PIK3CA to consider selective usage of COX-2 inhibitors in addition to standard treatment for stage III colon cancer.

PMID:38889377 | DOI:10.1200/JCO.23.01680

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Nevin Manimala Statistics

Computerized Rotational Head Impulse Test: Age-Dependent Normative Data

Am J Audiol. 2024 Jun 18:1-9. doi: 10.1044/2024_AJA-22-00190. Online ahead of print.

ABSTRACT

PURPOSE: The objective of this study was to determine the normative vestibulo-ocular reflex gain output values of the computerized rotational head impulse test (crHIT) with stationary visual targets (earth bound) in healthy participants in each decade age band of life: 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, and 70+ years.

METHOD: Seventy-seven community-dwelling participants (10-85 years of age) with normal lateral semicircular canal (SCC) functioning and no symptoms or history of vestibular dysfunction were recruited through convenience sampling and assessed with the crHIT using stationary targets. These participants were assessed using two standard protocols in a randomized order.

RESULTS: Results from 77 participants (M age = 46 years; 43 women, 34 men) were analyzed. Pearson’s correlation coefficient and simple linear regression indicated a statistically significant relationship between crHIT gain output and age (p > .05) for right gain, 1030°/s2, and left gain, 1005°/s2. Although a statistically significant relationship was found, the slope was minor, demonstrating that the clinical effect of age on crHIT gain output was insignificant. Furthermore, no statistically significant relationship exists between crHIT gain output and gender (p > .05). Age-dependent normative data were calculated using the 2.5th and 97.5th confidence interval (CI) percentile method. The responses of angular vestibulo-ocular reflex (aVOR) gain values for crHIT are expected to occur within the range for lower limit reference interval (RI) of 0.85-0.9 and upper limit RI of 1.11-1.18 for 1030°/s2 and lower limit RI of 0.86-0.92 and upper limit RI of 1.13-1.16 for 1005°/s2. It can be expected that 90% CI of the population with normal lateral SCC functioning will have aVOR gain values that fall within this range.

CONCLUSION: Despite a statistically significant relationship that exists with aVOR gain output and age, the changes are minor, declining by 0.0088 units per 10 years, justifying the same normative data for all decade age bands.

PMID:38889375 | DOI:10.1044/2024_AJA-22-00190

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Magnitude and Temporal Variations of Socioeconomic Inequalities in the Quality of Life After Early Breast Cancer: Results From the Multicentric French CANTO Cohort

J Clin Oncol. 2024 Jun 18:JCO2302099. doi: 10.1200/JCO.23.02099. Online ahead of print.

ABSTRACT

PURPOSE: Socioeconomic status (SES) influences the survival outcomes of patients with early breast cancer (EBC). However, limited research investigates social inequalities in their quality of life (QoL). This study examines the socioeconomic inequalities in QoL after an EBC diagnosis and their time trends.

PATIENTS AND METHODS: We used data from the French prospective multicentric CANTO cohort (ClinicalTrials.gov identifier: NCT01993498), including women with EBC enrolled between 2012 and 2018. QoL was assessed using the European Organisation for Research and Treatment of Cancer QoL Core 30 questionnaire (QLQ-C30). summary score at diagnosis and 1 and 2 years postdiagnosis. We considered three indicators of SES separately: self-reported financial difficulties, household income, and educational level. We first analyzed the trajectories of the QLQ-C30 summary score by SES group. Then, social inequalities in QLQ-C30 summary score and their time trends were quantified using the regression-based slope index of inequality (SII), representing the absolute change in the outcome along socioeconomic gradient extremes. The analyses were adjusted for age at diagnosis, Charlson Comorbidity Index, disease stage, and type of local and systemic treatment.

RESULTS: Among the 5,915 included patients with data on QoL at diagnosis and at the 2-year follow-up, social inequalities in QLQ-C30 summary score at baseline were statistically significant for all SES indicators (SIIfinancial difficulties = -7.6 [-8.9; -6.2], SIIincome = -4.0 [-5.2; -2.8]), SIIeducation = -1.9 [-3.1; -0.7]). These inequalities significantly increased (interaction P < .05) in year 1 and year 2 postdiagnosis, irrespective of prediagnosis health, tumor characteristics, and treatment. Similar results were observed in subgroups defined by menopausal status and type of adjuvant systemic treatment.

CONCLUSION: The magnitude of preexisting inequalities in QoL increased over time after EBC diagnosis, emphasizing the importance of considering social determinants of health during comprehensive cancer care planning.

PMID:38889372 | DOI:10.1200/JCO.23.02099