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Nevin Manimala Statistics

Revisiting the Role of Balloon Atrial Septostomy Prior to the Arterial Switch Operation

World J Pediatr Congenit Heart Surg. 2024 Aug 9:21501351241252428. doi: 10.1177/21501351241252428. Online ahead of print.

ABSTRACT

OBJECTIVES: Patients with dextro-transposition of the great arteries (d-TGA) frequently undergo balloon atrial septostomy (BAS) prior to the arterial switch operation (ASO) to promote atrial-level mixing. Balloon atrial septostomy has inherent risks as an invasive procedure and may not always be necessary. This study revisits the routine utilization of BAS prior to ASO.

METHODS: Single-center, retrospective review of d-TGA patients undergoing the ASO from July 2018 to March 2023. Preoperative patient characteristics, pulse oximetry oxygen saturations (SpO2), cerebral/renal near-infrared spectroscopy (NIRS) readings along with prostaglandin status at the time of the ASO were analyzed with descriptive and univariate statistics.

RESULTS: Thirty patients underwent the ASO. Of these, 7 (23%) were female, 25 (83%) were white, and median weight at ASO was 3.2 kg (range 0.8-4.2). Twenty-two (73%) patients underwent BAS. There were no demographic differences between BAS and no-BAS patients. Of those who underwent BAS, there was a significant increase in SpO2 (median 83% [range 54-92] to median 87% [range 72-95], P = .007); however, there was no change in NIRS from pre-to-post BAS. Six (27%) patients in the BAS group were prostaglandin-free at ASO. Balloon atrial septostomy patients underwent the ASO later compared with no-BAS patients (median 8 [range 3-32] vs 4 [range 2-10] days old, P = .016) and had a longer hospital length of stay (median 13 [range 7-43] vs 10 [range 8-131] days, P = .108).

CONCLUSIONS: While BAS is an accepted preoperative procedure in d-TGA patients to improve oxygen saturations, it is also an additional invasive procedure, does not guarantee prostaglandin-free status at the time of ASO, and may increase the interval to ASO. Birth to direct early ASO, with prostaglandin support, should be revisited as an alternative, potentially more expeditious strategy.

PMID:39119670 | DOI:10.1177/21501351241252428

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Nevin Manimala Statistics

A meta-analysis of whole-body and heart mass effect sizes from a long-term artificial selection experiment for high voluntary exercise

J Exp Biol. 2024 Aug 9:jeb.249213. doi: 10.1242/jeb.249213. Online ahead of print.

ABSTRACT

Selection experiments play an increasingly important role in comparative and evolutionary physiology. However, selection experiments can be limited by relatively low statistical power, in part because replicate line is the experimental unit for analyses of direct or correlated responses (rather than number of individuals measured). One way to increase the ability to detect correlated responses is through a meta-analysis of studies for a given trait across multiple generations. To demonstrate this, we applied meta-analytic techniques to two traits (body mass and heart ventricle mass, with body mass as a covariate) from a long-term artificial selection experiment for high voluntary wheel-running behavior. In this experiment, all 4 replicate High Runner (HR) lines reached apparent selection limits around generations 17-27, running approximately 2.5-3-fold more revolutions/day than the 4 non-selected Control (C) lines. Although both traits would also be expected to change in HR lines (relative heart size expected to increase, expected direction for body mass is less clear), the statistical significance has varied, despite repeated measurements. We compiled information from 33 unique studies and calculated a measure of effect size (Pearson’s R). Our results indicate that, despite a lack of statistical significance in most generations, HR mice have evolved larger hearts and smaller bodies relative to Controls. Moreover, plateaus in effect sizes for both traits coincides with the generational range during which the selection limit for wheel-running behavior was reached. Finally, since the selection limit, absolute effect sizes for body mass and heart ventricle mass have gotten smaller (i.e., closer to 0).

PMID:39119628 | DOI:10.1242/jeb.249213

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Nevin Manimala Statistics

Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial

Clin Rehabil. 2024 Aug 9:2692155241270921. doi: 10.1177/02692155241270921. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema.

DESIGN AND SETTING: Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil.

PARTICIPANTS: Women in control phase of the breast cancer-related lymphedema.

INTERVENTIONS: Compared use of ACWs versus compressive mesh.

MAIN MEASURES: Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval.

RESULTS: Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (p = .041, ES 0.20), with improved functionality (p = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (p = .023, ES 0.26) and demonstrated improvement functionality (p = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (p > .05) at both times.

CONCLUSIONS: Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.

PMID:39119622 | DOI:10.1177/02692155241270921

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Nevin Manimala Statistics

Commercial Chinese polyherbal preparation: current status and future perspectives

Front Pharmacol. 2024 Jul 24;15:1404259. doi: 10.3389/fphar.2024.1404259. eCollection 2024.

ABSTRACT

OBJECTIVE: With the modernization of traditional Chinese medicine (TCM) industry, the investment in research and development of new commercial Chinese polyherbal preparations (CCPPs) is increasing, and the varieties of CCPPs are growing. CCPPs play an increasingly important role in the TCM industry. This study has comprehensively summarized and analyzed the current situation of CCPPs that has been on the market in China, and provided suggestions for the research and promotion of CCPPs.

METHODS: This study took the CCPPs approved for marketing in domestic drug database of the National Medical Products Administration (NMPA) as the research object, and combined with the publication of related randomized controlled trials (RCTs) of CCPPs in 2020-2022 and the sales of CCPPs in domestic chain pharmacies, statistical analysis was carried out on the drug name, pharmaceutical companies, dosage form, number of flavors, CBDs, ICD-11 classification of diseases treated, etc.

RESULTS: Currently, 58,409 approvals for CCPPs have been issued in China, involving 9,986 varieties of CCPPs, 2,896 pharmaceutical companies and 39 dosage forms. The number of flavors of prescriptions of CCPPs varies from 1 to 90, among which Glycyrrhiza glabra L. [Fabaceae; Glycyrrhizae radix et rhizoma] and Angelica sinensis (Oliv.) Diels [Apiaceae; Angelicae sinensis radix] are the most widely used. The study found that the CCPPs with the most diverse variety is CCPPs for the treatment of respiratory diseases, some CCPPs can treat multiple system diseases. According to the survey, the sales of CCPPs for respiratory diseases in the chain pharmacies account for more than 1/3 of the total sales of the chain pharmacies, while the number of published randomized controlled trials (RCTs) on CCPPs for circulatory diseases was the largest.

CONCLUSION: The approval process of CCPPs should be further standardized, and the transformation of TCM prescriptions into CCPPs should be promoted. In the approval process of CCPPs, it is suggested to strengthen the supervision of drug names to clarify the differences between the CCPPs of same name but different prescriptions. Improve the effectiveness and safety of CCPPs by improving the quality of CBDs. It is suggested to optimize the design of new drug research program of CCPPs to avoid waste of research resources.

PMID:39119615 | PMC:PMC11306874 | DOI:10.3389/fphar.2024.1404259

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Nevin Manimala Statistics

Seriousness and outcomes of reported adverse drug reactions in old and new antiseizure medications: a pharmacovigilance study using EudraVigilance database

Front Pharmacol. 2024 Jul 24;15:1411134. doi: 10.3389/fphar.2024.1411134. eCollection 2024.

ABSTRACT

Introduction: Epilepsy is a widespread disease requiring long-term drug treatment. The aim of this study was to collect information on reported suspected adverse drug reactions (sADRs) of antiseizure medications (ASMs) and study their seriousness and outcomes in various system organ classifications (SOCs). We intended to compare old and new ASMs’ ADRs. Methods: Using EudraVigilance (EV) database, we extracted line listings of reported sADRs with different ASMs over the period from January 2012 to December 2021. The list of ASMs was compiled according to the Anatomical therapeutic chemical classification system. The Medical Dictionary for Regulatory Activities version 24.0 was used for determining the SOCs of individual reported preferred terms (PTs) sADRs. In addition, we calculated the Reporting Odds Ratio (ROR), 95% confidence interval (95% CI), p-value (statistically significant if p< 0.05) and chi-square statistics. Results: A total of 276,694 reports were contained in the exported line listings which included 1,051,142 individual sADRs reported as PTs such as seizure (3.49%), drug ineffective (2.46%), somnolence (1.32%), dizziness (1.29%) and represented four SOCs: nervous system disorders (19.26%), general disorders and administration site conditions (14.39%), psychiatric disorders (11.29%) and injury, poisoning and procedural complications (9.79). Among patients, the age group between 18 and 64 years had the highest percentage (52.40%), followed by those aged over 64 years (18.75%). Of all the reported PTs, 882,706 (83.98%) had reported seriousness. Old ASMs had a significant positive association with “caused/prolonged hospitalisation”, “congenital anomaly”, “disabling”, “life threatening” and “results in death”, while new ASMS with ‘other medically important condition’. There were 386 (0.04%) PTs related to Sudden Unexpected Death in Epilepsy (SUDEP). Conclusion: In our study, we examined 10 years’ reported sADRs of ASMs in the EV international database. The majority of PTs were serious. Old ASMs were generally more commonly associated with undesired outcomes and seriousness. Considering their expected seriousness and outcomes, the safety profile of the different ASMs, can play a cardinal role in the selection of ASMs.

PMID:39119609 | PMC:PMC11307265 | DOI:10.3389/fphar.2024.1411134

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Nevin Manimala Statistics

On quasi-linear reaction diffusion systems arising from compartmental SEIR models

Nonlinear Differ Equ Appl. 2024;31(5):98. doi: 10.1007/s00030-024-00985-w. Epub 2024 Aug 6.

ABSTRACT

The global existence and boundedness of solutions to quasi-linear reaction-diffusion systems are investigated. The system arises from compartmental models describing the spread of infectious diseases proposed in Viguerie et al. (Appl Math Lett 111:106617, 2021); Viguerie et al. (Comput Mech 66(5):1131-1152, 2020), where the diffusion rate is assumed to depend on the total population, leading to quasilinear diffusion with possible degeneracy. The mathematical analysis of this model has been addressed recently in Auricchio et al. (Math Methods Appl Sci 46:12529-12548, 2023) where it was essentially assumed that all sub-populations diffuse at the same rate, which yields a positive lower bound of the total population, thus removing the degeneracy. In this work, we remove this assumption completely and show the global existence and boundedness of solutions by exploiting a recently developed L p -energy method. Our approach is applicable to a larger class of systems and is sufficiently robust to allow model variants and different boundary conditions.

PMID:39119599 | PMC:PMC11303479 | DOI:10.1007/s00030-024-00985-w

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Nevin Manimala Statistics

Outcome of Camp Approach in Treatment of Alcohol Use Disorder: A Non-randomized Controlled Study

J Psychiatry Spectr. 2024 Jul-Dec;3(2):101-109. doi: 10.4103/jopsys.jopsys_48_23. Epub 2024 Jun 20.

ABSTRACT

BACKGROUND: Studies examining the outcome of the camp approach in the treatment of alcohol dependence are limited in India.

AIM: The aim of the study was to compare the outcomes of the community-based camp (CBC) approach and the hospital-based camp (HBC) approach in the treatment of persons with alcohol dependence.

METHODS: The study used a non-randomized controlled study design (quasi-experimental research design before and after with a control group). In total, 60 respondents were selected through the census method (30 in the study group and 30 in the control group). Thirty respondents from the CBC formed the experimental group, and another 30 from the HBC formed the control group. The CBC was held for 7 days, and the HBC was held for 10 days. The tools used are the Alcohol Use Disorders Identification Test and the World Health Organization quality of life (QoL)-BREF.

STATISTICAL ANALYSIS: Independent t-test and effect size analysis were used. Kasturba Hospital Institute Ethics Committee, Manipal, had given the ethical clearance.

RESULTS: The majority (73%) of the respondents in the CBC and 57% of the HBC participants maintained complete abstinence during the post-test. The relapse rate was lower in the CBC (27%) than in the HBC (43%). CBC is effective at increasing the number of follow-ups and decreasing alcohol intake during relapse. The effect of the camp intervention on increasing the number of follow-ups was medium (d = 0.36). The CBC had a small effect on enhancing the QoL of treated individuals with alcohol dependence syndrome during the post-test (d = 0.27).

CONCLUSION: The CBC approach is more effective than the hospital one at increasing follow-up and QoL and reducing the relapse rate.

PMID:39119596 | PMC:PMC11308949 | DOI:10.4103/jopsys.jopsys_48_23

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Nevin Manimala Statistics

Deconstructing demographic bias in speech-based machine learning models for digital health

Front Digit Health. 2024 Jul 25;6:1351637. doi: 10.3389/fdgth.2024.1351637. eCollection 2024.

ABSTRACT

INTRODUCTION: Machine learning (ML) algorithms have been heralded as promising solutions to the realization of assistive systems in digital healthcare, due to their ability to detect fine-grain patterns that are not easily perceived by humans. Yet, ML algorithms have also been critiqued for treating individuals differently based on their demography, thus propagating existing disparities. This paper explores gender and race bias in speech-based ML algorithms that detect behavioral and mental health outcomes.

METHODS: This paper examines potential sources of bias in the data used to train the ML, encompassing acoustic features extracted from speech signals and associated labels, as well as in the ML decisions. The paper further examines approaches to reduce existing bias via using the features that are the least informative of one’s demographic information as the ML input, and transforming the feature space in an adversarial manner to diminish the evidence of the demographic information while retaining information about the focal behavioral and mental health state.

RESULTS: Results are presented in two domains, the first pertaining to gender and race bias when estimating levels of anxiety, and the second pertaining to gender bias in detecting depression. Findings indicate the presence of statistically significant differences in both acoustic features and labels among demographic groups, as well as differential ML performance among groups. The statistically significant differences present in the label space are partially preserved in the ML decisions. Although variations in ML performance across demographic groups were noted, results are mixed regarding the models’ ability to accurately estimate healthcare outcomes for the sensitive groups.

DISCUSSION: These findings underscore the necessity for careful and thoughtful design in developing ML models that are capable of maintaining crucial aspects of the data and perform effectively across all populations in digital healthcare applications.

PMID:39119589 | PMC:PMC11306200 | DOI:10.3389/fdgth.2024.1351637

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Nevin Manimala Statistics

Resting-state electroencephalography delta and theta bands as compensatory oscillations in chronic neuropathic pain: a secondary data analysis

Brain Netw Modul. 2024 Apr-Jun;3(2):52-60. doi: 10.4103/bnm.bnm_17_24. Epub 2024 Jun 27.

ABSTRACT

Chronic neuropathic pain (CNP) remains a significant clinical challenge, with complex neurophysiological underpinnings that are not fully understood. Identifying specific neural oscillatory patterns related to pain perception and interference can enhance our understanding and management of CNP. To analyze resting electroencephalography data from individuals with chronic neuropathic pain to explore the possible neural signatures associated with pain intensity, pain interference, and specific neuropathic pain characteristics. We conducted a secondary analysis from a cross-sectional study using electroencephalography data from a previous study, and Brief Pain Inventory from 36 patients with chronic neuropathic pain. For statistical analysis, we modeled a linear or logistic regression by dependent variable for each model. As independent variables, we used electroencephalography data with such brain oscillations: as delta, theta, alpha, and beta, as well as the oscillations low alpha, high alpha, low beta, and high beta, for the central, frontal, and parietal regions. All models tested for confounding factors such as age and medication. There were no significant models for Pain interference in general activity, walking, work, relationships, sleep, and enjoyment of life. However, the model for pain intensity during the past four weeks showed decreased alpha oscillations, and increased delta and theta oscillations were associated with decreased levels of pain, especially in the central area. In terms of pain interference in mood, the model showed high oscillatory Alpha signals in the frontal and central regions correlated with mood impairment due to pain. Our models confirm recent findings proposing that lower oscillatory frequencies, likely related to subcortical pain sources, may be associated with brain compensatory mechanisms and thus may be associated with decreased pain levels. On the other hand, higher frequencies, including alpha oscillations, may disrupt top-down compensatory mechanisms.

PMID:39119588 | PMC:PMC11309019 | DOI:10.4103/bnm.bnm_17_24

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External validation of models to estimate gestational age in the second and third trimester using ultrasound: A prospective multicentre observational study

BJOG. 2024 Aug 8. doi: 10.1111/1471-0528.17922. Online ahead of print.

ABSTRACT

OBJECTIVES: Accurate assessment of gestational age (GA) is important at both individual and population levels. The most accurate way to estimate GA in women who book late in pregnancy is unknown. The aim of this study was to externally validate the accuracy of equations for GA estimation in late pregnancy and to identify the best equation for estimating GA in women who do not receive an ultrasound scan until the second or third trimester.

DESIGN: This was a prospective, observational cross-sectional study.

SETTING: 57 prenatal care centres, France.

PARTICIPANTS: Women with a singleton pregnancy and a previous 11-14-week dating scan that gave the observed GA were recruited over an 8-week period. They underwent a standardised ultrasound examination at one time point during the pregnancy (15-43 weeks), measuring 12 foetal biometric parameters that have previously been identified as useful for GA estimation.

MAIN OUTCOME MEASURES: A total of 189 equations that estimate GA based on foetal biometry were examined and compared with GA estimation based on foetal CRL. Comparisons between the observed GA and the estimated GA were made using R2, calibration slope and intercept. RMSE, mean difference and 95% range of error were also calculated.

RESULTS: A total of 2741 pregnant women were examined. After exclusions, 2339 participants were included. In the 20 best performing equations, the intercept ranged from -0.22 to 0.30, the calibration slope from 0.96 to 1.03 and the RSME from 0.67 to 0.87. Overall, multiparameter models outperformed single-parameter models. Both the 95% range of error and mean difference increased with gestation. Commonly used models based on measurement of the head circumference alone were not amongst the best performing models and were associated with higher 95% error and mean difference.

CONCLUSIONS: We provide strong evidence that GA-specific equations based on multiparameter models should be used to estimate GA in late pregnancy. However, as all methods of GA assessment in late pregnancy are associated with large prediction intervals, efforts to improve access to early antenatal ultrasound must remain a priority.

TRIAL REGISTRATION: The proposal for this study and the corresponding methodological review was registered on PROSPERO international register of systematic reviews (registration number: CRD4201913776).

PMID:39118202 | DOI:10.1111/1471-0528.17922