Categories
Nevin Manimala Statistics

Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007-2018

PLoS One. 2021 Apr 1;16(4):e0248898. doi: 10.1371/journal.pone.0248898. eCollection 2021.

ABSTRACT

Whereas time trends in the epidemiologic burden of US pediatric mental health disorders are well described, little is known about trends in how these disorders are studied through clinical research. We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials. We identified all US pediatric interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 (n = 1,019) and manually characterized disorders and treatments studied. We assessed trial growth and design characteristics by funding source, treatments, and disorders. US pediatric mental health trials grew over the past decade (compound annual growth rate [CAGR] 4.1%). The number of studies funded by industry and US government remained unchanged, whereas studies funded by other sources (e.g., academic medical centers) grew (CAGR 11.3%). Neurodevelopmental disorders comprised the largest proportion of disorders studied, and Non-DSM-5 (Diagnostic and Statistical Manual-5) conditions was the only disorder category to grow (14.5% to 24.6%; first half to second half of decade). There was significant growth of trials studying non-psycho/pharmacotherapy treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%), though these trends differed by funding source. There were also notable differences in funding sources and treatments studied within each disorder category. Trials using double blinding declined (26.2% to 18.0%). Limitations include that ClinicalTrials.gov is not an exhaustive list of US clinical trials, and trends identified may in part reflect changes in trial registration rather than changes in clinical research. Nevertheless, ClinicalTrials.gov is among the largest databases available for evaluating trends and patterns in pediatric mental health research that might otherwise remain unassessable. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.

PMID:33793587 | DOI:10.1371/journal.pone.0248898

Categories
Nevin Manimala Statistics

Neonatal and maternal outcomes with trial of labor after two prior cesarean births: stratified by history of vaginal birth

J Matern Fetal Neonatal Med. 2021 Apr 1:1-8. doi: 10.1080/14767058.2021.1903862. Online ahead of print.

ABSTRACT

INTRODUCTION: To determine the impact of prior vaginal birth on neonatal and maternal outcomes among individuals undergoing a trial of labor after two cesarean births.

MATERIALS AND METHODS: This was a cross-sectional study using the U.S. National Vital Statistics 2014-2018 period linked birth and infant death data. Inclusion criteria were term, cephalic, singleton pregnancies with two prior cesarean births. The primary exposure variable was a trial of labor after cesarean vs prelabor repeat cesarean birth. Cohorts were defined by the presence or absence of a prior vaginal birth. The primary outcome was a composite of adverse neonatal outcomes (Apgar score <5 at 5 min, assisted ventilation >6 h, neonatal seizures, or neonatal death within 27 days). Secondary outcomes included a maternal composite and the cesarean birth rate. Propensity score matching was used to account for baseline differences in treatment allocation within each cohort, and conditional logistic regression assessed the association between the exposure and outcomes.

RESULTS: The composite neonatal adverse outcome was significantly higher in those undergoing a trial of labor after cesarean compared to prelabor repeat cesarean birth in both individuals without a prior vaginal birth (8.2 vs 11.6 per 1000 live births, OR 1.41; 95% CI 1.12-1.70) and with a prior vaginal birth (9.6 vs 12.4 per 1000 live births, OR 1.30; 95% CI 1.08-1.57). The composite maternal adverse outcome was significantly higher among individuals without a prior vaginal birth undergoing trial of labor after cesarean (6.0 vs 9.5 per 1000 live births, OR 1.59; 95% CI 1.26-2.09), but was similar in those with a prior vaginal birth (7.9 vs 9.3 per 1000 live births, OR 1.18; 95% CI 0.97-1.46).

CONCLUSION: In individuals with two prior cesarean births, trial of labor after cesarean was associated with increased neonatal adverse outcomes when compared to prelabor repeat cesarean birth, irrespective of a history of vaginal birth. In individuals with a prior vaginal birth, the composite maternal adverse outcome was not elevated in the trial of labor cohort.

PMID:33792462 | DOI:10.1080/14767058.2021.1903862

Categories
Nevin Manimala Statistics

The impact of gender on long-term outcomes following supratentorial brain tumor resection

Br J Neurosurg. 2021 Apr 1:1-8. doi: 10.1080/02688697.2021.1907307. Online ahead of print.

ABSTRACT

PURPOSE: Gender is a known social determinant of health which has been linked disparities in medical care. This study intends to assess the impact of gender on 90-day and long-term morbidity and mortality outcomes following supratentorial brain tumor resection in a coarsened-exact matched population.

MATERIALS AND METHODS: A total of 1970 consecutive patients at a single, university-wide health system undergoing supratentorial brain tumor resection over a six-year period (09 June 2013 to 26 April 2019) were analyzed retrospectively. Coarsened Exact Matching was employed to match patients on key demographic factors including history of prior surgery, smoking status, median household income, American Society of Anesthesiologists (ASA) grade, and Charlson Comorbidity Index (CCI), amongst others. Primary outcomes assessed included readmission, ED visit, unplanned reoperation, and mortality within 90 days of surgery. Long-term outcomes such as mortality and unplanned return to surgery during the entire follow-up period were also recorded.

RESULTS: Whole-population regression demonstrated significantly increased mortality throughout the entire follow-up period for the male cohort (p = 0.004, OR = 1.32, 95% CI = 1.09 – 1.59); however, no significant difference was found after coarsened exact matching was performed (p = 0.08). In both the whole-population regression and matched-cohort analysis, no significant difference was observed between gender and readmission, ED visit, unplanned reoperation, or mortality in the 90-day post-operative window, in addition to return to surgery after throughout the entire follow-up period.

CONCLUSION: After controlling for confounding variables, female birth gender did not significantly predict any difference in morbidity and mortality outcomes following supratentorial brain tumor resection. Difference between mortality outcomes in the pre-matched population versus the matched cohort suggests the need to better manage the underlying health conditions of male patients in order to prevent future disparities.

PMID:33792446 | DOI:10.1080/02688697.2021.1907307

Categories
Nevin Manimala Statistics

What factors determine the pregnancy outcome in patients with essential thrombocythemia?

J Matern Fetal Neonatal Med. 2021 Apr 1:1-5. doi: 10.1080/14767058.2020.1863362. Online ahead of print.

ABSTRACT

Objectives: Treatment of essential thrombocythemia (ET) is particularly challenging in pregnancy due to the increased risk of thromboembolic complications. Therefore, the use of antithrombotic regimens are recommended in pregnant women with ET.Methods: The study included 52 pregnancies in 27 patients diagnosed with ET, who were treated in Department of Haematology. The influence of anticoagulant, antiplatelet and cytoreductive therapy on the course and outcome of pregnancy was analysed. This study also examined if there was any correlation between molecular and clinical features such as mutational profile, blood count, presence of acquired von Willebrand syndrome (AvWS), the International Prognostic Score for Essential Thrombocythemia (IPSET) risk group and the IPSET-thrombosis risk group and pregnancy outcome.Results: Study participants who received antithrombotic therapy were significantly more likely to give birth to a healthy child. The best outcomes were observed in patients who received low dose acetylsalicylic acid (ASA) together with low-molecular-weight heparin (LMWH). There was a statistically significant correlation between classification to the high-risk group according to the IPSET-thrombosis score and incidence of miscarriage. Cytoreductive treatment with interferon-α2, as well as the presence of AvWS did not increase the likelihood of pregnancy loss. Blood counts and presence of specific gene mutations profile were also not found to be significant determinants of pregnancy outcome.Conclusion: To our best knowledge, this is the first clinical study investigating the correlation between risk group (according to IPSET and IPSET-thrombosis) and pregnancy outcome in women with ET.

PMID:33792458 | DOI:10.1080/14767058.2020.1863362

Categories
Nevin Manimala Statistics

Effect Sizes for Symptomatic and Cognitive Improvements in Traumatic Brain Injury Following Hyperbaric Oxygen Therapy

J Appl Physiol (1985). 2021 Apr 1. doi: 10.1152/japplphysiol.01084.2020. Online ahead of print.

ABSTRACT

Hyperbaric oxygen therapy has been proposed as a method to treat traumatic brain injuries. The combination of pressure and increased oxygen concentration produces a higher content of dissolved oxygen in the bloodstream, which could generate a therapeutic benefit for brain injuries. This dissolved oxygen penetrates deeper into damaged brain tissue than otherwise possible and promotes healing. The result includes improved cognitive functioning and an alleviation of symptoms. However, randomized controlled trials have failed to produce consistent conclusions across multiple studies. There are numerous explanations that might account for the mixed evidence, although one possibility is that prior evidence focuses primarily on statistical significance. The current analyses explored existing evidence by calculating an effect size from each active treatment group and each control group among previous studies. An effect size measure offers several advantages when comparing across studies as it can be used to directly contrast evidence from different scales, and it provides a proximal measure of clinical significance. When exploring the therapeutic benefit through effect sizes, there was a robust and consistent benefit to individuals who underwent hyperbaric oxygen therapy. Placebo effects from the control condition could account for approximately one-third of the observed benefits, but there appeared to be a clinically significant benefit to using hyperbaric oxygen therapy as a treatment intervention for traumatic brain injuries. This evidence highlights the need for design improvements when exploring interventions for traumatic brain injury as well as the importance of focusing on clinical significance in addition to statistical significance.

PMID:33792399 | DOI:10.1152/japplphysiol.01084.2020

Categories
Nevin Manimala Statistics

Age Knows No Bounds: A Latent Content Analysis of Social Media Comments Toward Older Adults’ Engagement in Sports Activities

J Appl Gerontol. 2021 Apr 1:7334648211004687. doi: 10.1177/07334648211004687. Online ahead of print.

ABSTRACT

With the growing statistics of older adults across societies, sustaining their health and well-being through active participation in sports cannot be neglected nor overlooked. This qualitative study purports to characterize the ontology of social media comments relative to older person’s engagement in sports via latent content analysis. Specifically, a set of YouTube comments (n = 7,546), extracted from select videos featuring older adults in sports (n = 62), through YouTube Data Application Programming Interface (API) Version 3, was subjected to inductive analytic procedures of content analysis. Interestingly, this study afforded the emergence of a playing field model emanating from the dualistic perspectives of aging as engagement and aged as engaged that represent how YouTube users view older adult’s continual involvement in sports. Limitations and future directions of this study are also discussed in this article.

PMID:33792416 | DOI:10.1177/07334648211004687

Categories
Nevin Manimala Statistics

Quantification of mitral regurgitation using transthoracic echocardiography and cardiac magnetic resonance imaging

Rev Cardiovasc Med. 2021 Mar 30;22(1):215-223. doi: 10.31083/j.rcm.2021.01.20216.

ABSTRACT

Both Transthoracic echocardiography (TTE) and cardiac magnetic resonance (CMR) have well-established role in mitral regurgitation (MR) quantification for optimal management strategy. We assessed the correlation between TTE and CMR in the quantification of MR. Participants with isolated MR and echocardiographic mitral regurgitant volume (RVol) ≥ 30 mL/beat were included. A consecutive sample of 30 participants (Mean age 52.7 ± 19.3 years, 50% males) was selected and referred for indirect and direct CMR quantification of mitral RVol. There was a statistically significant strong positive correlation between the echocardiographic and indirect CMR quantification of the mitral RVol (r = 0.753, P < 0.001) and a statistically significant moderate positive correlation between the echocardiographic and direct CMR quantification of the mitral RVol (r = 0.530, P < 0.003). The inter-observer reliability of the MR grade between TTE and CMR showed a statistically significant moderate agreement (κ = 0.502, P = 0.0001) when the observers used the echocardiographic mitral RVol for grading of MR. On the other hand, the inter-observer reliability of the MR grade between TTE and CMR showed a statistically significant faint agreement (κ = 0.251, P = 0.024) when the observers used the echocardiographic regurgitant fraction (RF) for grading of MR. The positive reciprocal relationship between the CMR and the TTE highlights the potential role of the CMR as a concomitant imaging tool for quantification of the mitral RVol and grading of isolated MR, especially with limited or inconclusive TTE studies. This will enhance the management strategy and improve outcomes.

PMID:33792265 | DOI:10.31083/j.rcm.2021.01.20216

Categories
Nevin Manimala Statistics

Frequency of ST-segment elevation myocardial infarction, non-ST-segment myocardial infarction, and unstable angina: results from a Southwest Chinese Registry

Rev Cardiovasc Med. 2021 Mar 30;22(1):239-245. doi: 10.31083/j.rcm.2021.01.103.

ABSTRACT

The burden of cardiovascular disease is predicted to escalate in developing countries. The aim of this study is to assess the characteristics, management strategies and outcomes of the patients with acute coronary syndrome (ACS) who were admitted to hospitals under the chest pain center mode in southwest P. R. China. Adults hospitalized with a diagnosis of ACS were enrolled in the retrospective, observational registry between January 2017 and June 2019 at 11 hospitals in Chengdu, P. R. China. The collected data included the patients’ baseline characteristics, clinical management and in-hospital outcomes. After Statistical analysis, (1) A total of 2857 patients with ACS, among which 1482 have ST-segment elevation myocardial infarction (STEMI), 681 have non-STEMI (NSTEMI) and 694 have unstable angina (UA) were enrolled in the study. (2) 61.3% of the ACS patients received reperfusion therapy. More patients with STEMI underwent percutaneous coronary intervention (PCI) compared with NSTEMI/UA patients (80.6% vs. 38.8%, P < 0.001), while thrombolytics were administered in only 1.8% of STEMI patients. (3) The median time from symptoms to hospital was 190 min (IQR 94-468) in STEMI, 283 min (IQR 112-1084) in NSTEMI and 337 min (IQR 97-2220) in UA (P < 0.001), and the door-to-balloon time for primary PCI (pPCI) was 85 min (IQR 55-121) in STEMI. (4) The in-hospital outcomes for STEMI patients included death (8.1%) and acute heart failure (22.6%), while the outcomes for those with NSTEMI and UA were better: death (4.0% and 0.9%, P < 0.001) and acute heart failure (15.3% and 9.9%, P < 0.001). (5) Antiplatelet drugs, lipid-lowering drugs, β-blockers and angiotensin-converting enzyme inhibitors (ACEI) /angiotensin receptor blockers (ARB) were used in about 98.3%, 95.0%, 67.7% and 54.3% of the ACS patients, respectively. Therefore, the management capacity in Chengdu has relatively increased compared with previous studies, but important gaps still exist compared with developed countries, especially regarding the management of the NSTEMI/UA patients.

PMID:33792268 | DOI:10.31083/j.rcm.2021.01.103

Categories
Nevin Manimala Statistics

Molecular Characterization of Polymer Networks

Chem Rev. 2021 Apr 1. doi: 10.1021/acs.chemrev.0c01304. Online ahead of print.

ABSTRACT

Polymer networks are complex systems consisting of molecular components. Whereas the properties of the individual components are typically well understood by most chemists, translating that chemical insight into polymer networks themselves is limited by the statistical and poorly defined nature of network structures. As a result, it is challenging, if not currently impossible, to extrapolate from the molecular behavior of components to the full range of performance and properties of the entire polymer network. Polymer networks therefore present an unrealized, important, and interdisciplinary opportunity to exert molecular-level, chemical control on material macroscopic properties. A barrier to sophisticated molecular approaches to polymer networks is that the techniques for characterizing the molecular structure of networks are often unfamiliar to many scientists. Here, we present a critical overview of the current characterization techniques available to understand the relation between the molecular properties and the resulting performance and behavior of polymer networks, in the absence of added fillers. We highlight the methods available to characterize the chemistry and molecular-level properties of individual polymer strands and junctions, the gelation process by which strands form networks, the structure of the resulting network, and the dynamics and mechanics of the final material. The purpose is not to serve as a detailed manual for conducting these measurements but rather to unify the underlying principles, point out remaining challenges, and provide a concise overview by which chemists can plan characterization strategies that suit their research objectives. Because polymer networks cannot often be sufficiently characterized with a single method, strategic combinations of multiple techniques are typically required for their molecular characterization.

PMID:33792299 | DOI:10.1021/acs.chemrev.0c01304

Categories
Nevin Manimala Statistics

Statistical profiling reveals correlations between the cell response to and the primary structure of Rho-GAPs

Cytoskeleton (Hoboken). 2021 Apr 1. doi: 10.1002/cm.21659. Online ahead of print.

ABSTRACT

Rho-GTPase-activating proteins (Rho-GAPs) are essential upstream regulators of the Rho family of GTPases. Currently, it remains unclear if the phenotypic change caused by perturbations to a Rho-GAP is predictable from its amino acid sequence. Here we analyze the relationship between the morphological response of cells to the silencing of Rho-GAPs and their primary structure. For all possible pairs of 57 different Rho-GAPs expressed in MCF10A epithelial cells, the similarity in the Rho-GAP silencing-induced morphological change was quantified and compared to the similarity in the primary structure of the corresponding pairs. We found a distinct correlation between the morphological and sequence similarities in a specific group of RhoA-targeting Rho-GAPs. Thus, the family-wide analysis revealed a common feature shared by the specific Rho-GAPs. This article is protected by copyright. All rights reserved.

PMID:33792196 | DOI:10.1002/cm.21659