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Nevin Manimala Statistics

Persistent status of metabolic syndrome and risk of cholangiocarcinoma: A Korean nationwide population-based cohort study

Eur J Cancer. 2021 Aug 6;155:97-105. doi: 10.1016/j.ejca.2021.06.052. Online ahead of print.

ABSTRACT

OBJECTIVE: It is unknown whether persistent metabolic syndrome (MetS) is associated with an increased risk of cholangiocarcinoma (CCA). Therefore, we investigated the risk of CCA according to changes in MetS status.

RESEARCH DESIGN AND METHODS: This nationwide cohort study included 8,581,407 adults who underwent anthropometric measurements and laboratory tests in two consecutive national health screenings during 2009-2012 and observed the subjects until 2017. Individuals with cancer, or follow-up duration <1 year were excluded (n = 377,915). Subjects were classified into the MetS-free, MetS-developed, MetS-improved, and MetS-persistent groups. The outcome was the incidence of CCA, identified using the claims database. Multivariable Cox proportional hazards regression models were used.

RESULTS: Among the 8,203,492 subjects (mean age 48.9 ± 12.8 years; 56.7% male), 7506 CCA patients were newly identified during a median follow-up of 5.1 years. The probability of CCA was consistently higher in the MetS-persistent group than in the MetS-free group (P < 0.001). MetS-persistent status was significantly associated with an increased risk of CCA compared with the MetS-free status (unadjusted hazard ratio [HR] 2.8, 95% confidence interval [CI] 2.66-2.95), even after adjusting for multiple covariates (adjusted HR 1.07, 95% CI 1.01-1.13). Improved or newly developed MetS was not associated with CCA risk in the fully adjusted model (aHR 1.02, 95% CI 0.94-1.10 and aHR 0.99, 95% CI 0.92-1.06, respectively).

CONCLUSIONS: MetS was associated with an increased risk of CCA if it persisted for ≥2 years. Our finding suggests that MetS may be a potentially modifiable risk factor for CCA.

PMID:34371446 | DOI:10.1016/j.ejca.2021.06.052

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Nevin Manimala Statistics

Optimization of a robust and reliable FITC labeling process for CE-LIF analysis of pharmaceutical compounds using design of experiments strategy

J Pharm Biomed Anal. 2021 Aug 4;205:114304. doi: 10.1016/j.jpba.2021.114304. Online ahead of print.

ABSTRACT

Fluorescence, especially laser induced fluorescence (LIF), is a powerful detection technique thanks to its specificity and high sensitivity. The use of fluorescence detection hyphenated to separation technique often requires the labeling of analytes with suitable fluorescent dye, such as FITC for the labeling of molecules presenting amino groups. Nevertheless, the labeling of analytes could be a tedious, time consuming and a non-robust step of the analytical workflow. In this context, the objective of the present work was to propose a robust and reliable FITC labeling process. Primary and secondary amino compounds (i.e. synthetic cathinones) were selected as model compounds because they are representative of a large proportion of pharmaceutical small molecules. Based on prior knowledge, DoE combined with multivariate statistical modeling was performed to optimize the process. Reaction time and pH of reaction buffer were highlighted as the most critical parameters to control the process. The study showed also the benefit of short reaction time to maximize the labeling efficiency. Indeed, optimal condition was defined as reaction time of 32 min with ratio between FITC and analytes of 40.4 and the buffer reaction pH of 9.7. In addition, variance component analysis was integrated to the DoE to estimate the variability of process and to evaluate its applicability for quantitative purpose. These chemometric approaches helped to develop an efficient labeling process able to reach high sensitivity for CE-LIF analysis (i.e. 10 nM) with good precision (i.e. intermediate precision values lower or close to 5 %).

PMID:34371450 | DOI:10.1016/j.jpba.2021.114304

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Nevin Manimala Statistics

A waveform test for variance inequality, with a comparison of ground reaction force during walking in younger vs. older adults

J Biomech. 2021 Jul 29;127:110657. doi: 10.1016/j.jbiomech.2021.110657. Online ahead of print.

ABSTRACT

Various methods have been suggested for estimating the variability in biomechanical variables during gait. However, all current measures of variability are performed on discrete measurements extracted from the kinematic or kinetic waveforms, which provide no temporal information on where differences in variability occur. This study used a variance equality test to compare temporal differences in group variance along the entire ground reaction force waveform. The variance equality test used an F-statistic whose critical value was determined using the random field theory function within the one-dimensional statistical parametric mapping package. Twenty healthy younger and twenty older adults were included in the study and completed gait analysis as they walked along a level walkway at a self-selected pace. Variance for each group was calculated and compared at each interval along the waveform to produce the F-value. The F-value was compared against a calculated F-critical value to determine where in the waveform significant differences in ground reaction force variance occurred. Results suggest that younger individuals may exhibit greater ground reaction force variance during heel contact in the vertical and posterior directions, and that older individuals may exhibit greater variability in the mediolateral direction at toe-off. This study was able to identify differences in ground reaction force variance within the gait cycle between younger and older adults. The findings of this study warrant the use of the function as a suitable method to compare variance along the entire waveform between two groups.

PMID:34371475 | DOI:10.1016/j.jbiomech.2021.110657

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Nevin Manimala Statistics

Integrating functional traits into correlative species distribution models to investigate the vulnerability of marine human activities to climate change

Sci Total Environ. 2021 Jul 31;799:149351. doi: 10.1016/j.scitotenv.2021.149351. Online ahead of print.

ABSTRACT

Climate change and particularly warming are significantly impacting marine ecosystems and the services they provided. Temperature, as the main factor driving all biological processes, may influence ectotherms metabolism, thermal tolerance limits and distribution species patterns. The joining action of climate change and local stressors (including the increasing human marine use) may facilitate the spread of non-indigenous and native outbreak forming species, leading to associated economic consequences for marine coastal economies. Marine aquaculture is one among the most economic anthropogenic activities threatened by multiple stressors and in turn, by increasing hard artificial substrates at sea would facilitate the expansion of these problematic organisms and face negative consequences regarding facilities management and farmed organisms’ welfare. Species Distribution Models (SDMs) are considered powerful tools for forecasting the future occurrences and distributions of problematic species used to preventively aware stakeholders. In the current study, we propose the use of combined correlative SDMs and mechanistic models, based on individual thermal performance curve models calculated through non-linear least squares regression and Bayesian statistics (functional-SDM), as an ecological relevant tool to increase our ability to investigate the potential indirect effect of climate change on the distributions of harmful species for human activities at sea, taking aquaculture as a food productive example and the benthic cnidarian Pennaria disticha (one of the most pernicious fouling species in aquaculture) as model species. Our combined approach was able to improve the prediction ability of both mechanistic and correlative models to get more ecologically informed “whole” niche of the studied species. Incorporating the mechanistic links between the organisms’ functional traits and their environments into SDMs through the use of a Bayesian functional-SDM approach would be a useful and reliable tool in early warning ecological systems, risk assessment and management actions focused on important economic activities and natural ecosystems conservation.

PMID:34371417 | DOI:10.1016/j.scitotenv.2021.149351

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Nevin Manimala Statistics

Maintenance versus discontinuation of androgen deprivation therapy during continuous or intermittent docetaxel administration in castration-resistant prostate cancer patients: A multicentre, randomised Phase III study by the Piemonte Oncology Network

Eur J Cancer. 2021 Aug 6;155:127-135. doi: 10.1016/j.ejca.2021.06.034. Online ahead of print.

ABSTRACT

BACKGROUND: This study was designed to demonstrate the non-inferiority (NI) in overall survival (OS) of suspension of androgen deprivation therapy (ADT) versus maintenance and intermittent versus continuous docetaxel administration in metastatic castration-resistant prostate cancer (mCRPC) patients.

PATIENTS AND METHODS: mCRPC patients were randomised to first-line docetaxel with maintenance or suspension of ADT. Patients attaining a prostate-specific antigen (PSA) response after four chemotherapy cycles underwent second randomisation to receive continuous or intermittent docetaxel therapy. Six hundred patients were to be randomised to achieve 80% statistical power to demonstrate an NI hazard ratio (HR) of 1.25 of interruption versus maintenance of ADT.

RESULTS: The trial was prematurely closed when 198 participants were randomised. OS was similar in patients who continued (N = 96) versus those who interrupted (n = 102) ADT during docetaxel therapy (HR 0.98, 95% confidence interval [CI] 0.72-1.33] and those on a continuous (N = 35) versus an intermittent (N = 42) docetaxel schedule (HR 0.86, 95% CI 0.55-1.43). No difference in radiological progression-free survival, PSA response, or toxicity was observed between the study arms. The actual NI hazard margins of OS in Arms A and B patients were 1.33 and 1.43, respectively.

CONCLUSIONS: This trial enrolled one-third of the planned patients; this main weakness dramatically limits the interpretation of the results. ADT discontinuation and switching to an intermittent schedule did not seem to affect docetaxel efficacy. The absence of testosterone recovery in the majority of patients could have been a contributory factor. In men with mCRPC, ADT discontinuation should only be done with regular biochemical and clinical monitoring, with the option of quickly restarting ADT at disease progression.

PMID:34371442 | DOI:10.1016/j.ejca.2021.06.034

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Examining the ultraviolet optical screening tool as a viable means for delineating a contaminated organic sediment

Sci Total Environ. 2021 Aug 2;799:149408. doi: 10.1016/j.scitotenv.2021.149408. Online ahead of print.

ABSTRACT

Rapid and accurate delineation of contaminated sediments in marine environments is critical for the effective assessment of site risks and the development of appropriate remedial action plans. In this study, a new application of the ultraviolet optical screening tool (UVOST) equipped with electrical conductivity measurement (UVOST-EC) is proposed to delineate a water-covered sediment contaminated with dioxins and furans in a decommissioned pulp and paper wastewater stabilization basin. Bench scale experiments are presented that were used to develop a UVOST-EC interpretation method for delineating between two different sediment types present in the basin: an anthropogenically derived organic rich contaminated sediment (“black sediment”) and a naturally occurring grey organic silt sediment with marine provenance (“grey sediment”). The method involves comparative analysis of fluorescence and electrical conductivity signatures between the two sediments. Results indicate that each sediment type presents unique “signatures” related to fluorescence and electrical signals which corresponds to variability in their physio-chemical structure. Almost 100 UVOST-EC tests performed at the study site were paired with ex situ physical gravity core measurements of the black sediment to test the accuracy of the UVOST-EC-based method. A statistical analysis at seven sample “cluster” sites (i.e. multiple sub-samples within a defined area) indicated that the mean of sediment thickness obtained by the UVOST-EC measurement technique at a given site were not significantly different (p = 0.05) from measurements derived from sediment gravity core measurements. The UVOST-EC-based sediment thickness delineation method reliably determined the thickness of the dioxin and furan contaminated sediments as compared to gravity core determination for the sediment in this study. Application of this approach to other studies should be assessed in a similar manner. The UVOST-EC method offers health and safety, cost, logistics, and data interpretation benefits.

PMID:34371404 | DOI:10.1016/j.scitotenv.2021.149408

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Nevin Manimala Statistics

Clinical benefit of systemic therapies for recurrent ovarian cancer-ESMO-MCBS scores

ESMO Open. 2021 Aug 6;6(4):100229. doi: 10.1016/j.esmoop.2021.100229. Online ahead of print.

ABSTRACT

BACKGROUND: Licensed systemic treatment options for platinum-sensitive recurrent ovarian cancer are platinum-based chemotherapy and maintenance treatment with bevacizumab and poly (ADP-ribose) polymerase inhibitors. For platinum-resistant disease, several non-platinum options are available. We aimed to assess the clinical benefit of these treatments according to the European Society of Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS).

MATERIALS AND METHODS: A PubMed search was carried out including all studies evaluating systemic treatment of recurrent epithelial ovarian cancer, from 1990 onwards. Randomised trials with an adequate comparator and design showing a statistically significant benefit of the study arm were independently scored by two blinded observers using the ESMO-MCBS.

RESULTS: A total of 1127 papers were identified, out of which 61 reported results of randomised trials of sufficient quality. Nineteen trials showed statistically significant results and the studied treatments were graded according to ESMO-MCBS. Only three treatments showed substantial benefit (score of 4 on a scale of 1-5) according to the ESMO-MCBS: platinum-based chemotherapy with paclitaxel in the platinum-sensitive setting and the addition of bevacizumab to chemotherapy in the platinum-resistant setting. The WEE1 inhibitor adavosertib (not licensed) also scores a 4, based on a recent small phase II study. Assessment of quality-of-life data and toxicity using the ESMO-MCBS showed to be complex, which should be taken into account in using this score for clinical decision making.

CONCLUSION: Only a few licensed systemic therapies for recurrent ovarian cancer show substantial clinical benefit based on ESMO-MCBS scores. Trials demonstrating overall survival benefit are sparse.

PMID:34371383 | DOI:10.1016/j.esmoop.2021.100229

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Prevalence and Associated Factors of Female Sexual Dysfunction Among Sexually Active Students of the University of Buea

Sex Med. 2021 Aug 6;9(5):100402. doi: 10.1016/j.esxm.2021.100402. Online ahead of print.

ABSTRACT

INTRODUCTION: Female sexual dysfunction (FSD) is a common public health issue. Most studies, especially in the sub-Saharan region are typically carried out in the older married female population, but the post-secondary education period is crucial for the development of the sexuality of young women. Poor awareness and management of FSD may lead to adverse physical and psychosocial complications later on in the lives of these women.

AIM: To determine the prevalence of the risk of having FSD and the factors associated with having FSD among sexually active students of the University of Buea.

METHODS: This was a cross-sectional study carried out in the University of Buea involving 405 sexually active students; 16 years of age and above. Quantitative data on sociodemographic, biological, interpersonal and psychosocial characteristics were collected. A validated Japanese modified version of the Female Sexual Function Index (FSFI-J) was used to assess the risk of having female sexual dysfunction. Data analysis involved descriptive statistics, binary and multivariate logistic analyses.

MAIN OUTCOME MEASURES: Prevalence of risk of having FSD and its associated factors among students of the University of Buea.

RESULTS: A total of 171 (42.0%) out of 405 students showed a risk of having at least one form of FSD. The commonest forms of dysfunction were problems of sexual pain (46.9%), orgasm (42.0%), desire (29.1%) and arousal (21.2%). Participants who were unmarried but in a relationship (P = .002) were less likely to experience FSD. Lower levels of education (first year [P = .005], second year [P = .001]), having a history of sexual assault (P = 0.012) and poor health (P = .012) were all independently associated with a higher risk of having FSD.

CONCLUSION: The prevalence of students at risk of having FSD was high with 4 out of every 10 students showing a risk of having at least one form. Lower levels of education, having a history of sexual assault and poor health were independent risk factors of FSD. Being unmarried but in a relationship was the sole protective factor against FSD. Halle-Ekane GE, Timti LF, Tanue EA, Ekukole CM, Yenshu EV. Prevalence and Associated Factors of Female Sexual Dysfunction Among Sexually Active Students of the University of Buea. Sex Med 2021;XX:XXXXXX.

PMID:34371387 | DOI:10.1016/j.esxm.2021.100402

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Nevin Manimala Statistics

The impact of widowhood on wellbeing, health, and care use: A longitudinal analysis across Europe

Econ Hum Biol. 2021 Jul 24;43:101049. doi: 10.1016/j.ehb.2021.101049. Online ahead of print.

ABSTRACT

OBJECTIVE: To estimate whether becoming widowed had a significant effect on individual’s health status as well as on healthcare and non-healthcare resources use, compared to people who remained in a couple in Europe.

DATA AND METHOD: It was used the Survey of Health, Aging and Retirement in Europe from 2004 to 2015. The statistical technique used was genetic matching which analysed the differences in wellbeing, mental health, health status, risk of death, health care resources and long-term care utilization of people who have become widowed, comparing with people who remained married or with a partner. We considered shortterm and medium-term effects.

RESULTS: In the short term, those who became widowed had a worse wellbeing and mental health, in addition to a greater probability of receiving formal care and informal care from outside the household. There seems to be a significant effect in the use of formal and informal care from outside the household in the medium term.

CONCLUSIONS: The results might help to concentrate a major effort of any policy or strategy, not only in the field of health but also in the provision of long-term care, immediately after the negative shock occurs.

PMID:34371339 | DOI:10.1016/j.ehb.2021.101049

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Nevin Manimala Statistics

Human serum elements’ levels and leukemia: A first pilot study from an adult Greek cohort

J Trace Elem Med Biol. 2021 Aug 2;68:126833. doi: 10.1016/j.jtemb.2021.126833. Online ahead of print.

ABSTRACT

BACKGROUND: The present study focuses on the evaluation of potential relationships between trace elements and acute and chronic types of leukemia, via the determination of their levels in human blood serum.

METHODS: A total of 199 serum samples from a Greek cohort were examined, including both leukemia cases and controls. Elements’ analysis was carried out using inductively coupled plasma mass spectrometry (ICP-MS) and demographic features such as age, gender, smoking habits and area of residence were recorded and statistically treated applying Shapiro-Wilk, Kolmogorov-Smirnov, Mann Whitney and Kruskal Wallis tests (p < 0.05). Spearman correlation and principal component analysis (PCA) were also performed to investigate possible associations.

RESULTS: The results demonstrated significantly higher (p < 0.05) trace elements concentrations in cases’ serum compared to that of controls excluding Ba, with Cu (median concentration 1295 μg L-1) being the most abundant in cases. Additionally, concentration of toxic Pb and Cd were found at seven and four fold higher concentrations in cases, respectively. Among the trace elements examined, only Rb (164 μg L-1) was detected in higher concentrations in controls. Ba, Cd and Co presented the lowest concentrations (lower than 1 μg L-1). PCA was performed for overall and classified data, indicating a stronger relation among the toxic As, Cd, Ni and Pb in cases than controls, particularly referring to smokers and industrial sites’ residents. Hematological parameters and factors such as age and gender did not present any significant outcome or correlation.

CONCLUSIONS: The findings from this pilot study suggest a potential relationship between metals and leukemia, especially concerning the toxic ones. Results from the employed source apportionment tools imply that smoking and atmospheric degradation may be positively related with higher metal serum levels in leukemia patients.

PMID:34371329 | DOI:10.1016/j.jtemb.2021.126833