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Nevin Manimala Statistics

Serum lipids and prostate cancer

J Clin Lab Anal. 2021 Mar 16:e23705. doi: 10.1002/jcla.23705. Online ahead of print.

ABSTRACT

BACKGROUND: Conflicting results are found in the literature relating serum lipids levels and prostate cancer. Some results imply a relationship between them; others contradict this association. The purpose of this study was to investigate a possible association between serum lipids levels and prostate cancer, at time of diagnosis.

METHODS: We measured serum levels of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides in 237 patients submitted to a prostate biopsy, with PSA between 2 and 10 ng/ml. Patients without cancer at biopsy were used as controls, and the others were considered as cases. No information about lipid-lowering therapy, including statins, was available neither in cases nor in controls. Cases were divided into risk groups, according to the disease severity, based on staging. Lipids levels were compared between groups, using parametric and nonparametric tests. Logistic regression analysis and odds ratios were calculated.

RESULTS: LDL and total cholesterol levels were lower in patients with cancer, with the difference being statistically significant for LDL cholesterol (p = 0.010) and borderline for total cholesterol (p = 0.050). No significant differences were found between the several risk groups. Odds ratios for low LDL cholesterol (<130 mg/dl) and low total cholesterol (<200 mg/dl), with prostate cancer as the outcome, were 1.983 and 1.703, respectively. There were no significant differences between cases and controls for the other lipids.

CONCLUSION: Lower LDL cholesterol (<130 mg/dl) and lower total cholesterol (<200 mg/dl) serum levels seem to associate with prostate cancer, at time of diagnosis.

PMID:33724557 | DOI:10.1002/jcla.23705

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Influence of seminal plasma during different stages of bovine sperm cryopreservation

Reprod Domest Anim. 2021 Mar 16. doi: 10.1111/rda.13928. Online ahead of print.

ABSTRACT

This study aimed to evaluate the effect of seminal plasma on bovine sperm cryopreservation and to assess the integrity of plasma and acrosomal membranes, mitochondrial potential, remodeling of F-actin cytoskeleton and sperm chromatin fragmentation during the cooling, equilibrium and freezing/thawing stages. Six ejaculates collected from 7 Nelore bulls (n=42) were used in this study. Each ejaculate was divided into two aliquots (with seminal plasma=SP group; without seminal plasma=NSP group) and packed to a final concentration of 50 x 106 sperm per straw. Statistical analyses were performed using SAS software (version 9.3) and P≤0.05 was considered significant. A time effect was observed for all sperm characteristics (P<0.05), except for chromatin fragmentation (P>0.05). The presence of seminal plasma better preserved the acrosomal integrity (SP=75.2% and NSP=71.7%; P<0.05) and also provided lower F-actin remodeling during cryopreservation process (SP=29.9% and NSP=32.4%; P<0.05). Regarding to the cryopreservation stages, it was observed that cooling step induced higher remodeling of F-actin than the equilibrium and freezing/thawing stages (56.3%, 32.2% and 23.9%, respectively; P<0.05). The equilibrium step had minor influence on overall sperm characteristics while the freezing/thawing stage was responsible for the highest percentage of damage in plasma membrane (-65.2%), acrosomal membrane (-34.0%) and mitochondrial potential (-48.1%). On the other hand, none of the cryopreservation stages affected chromatin integrity. It was concluded that the presence of seminal plasma provides increased acrosomal integrity and reduced remodeling of F-actin cytoskeleton. Higher F-actin remodeling is observed after the cooling step while the freezing/thawing step is most damaging to sperm membranes and mitochondrial potential during bovine sperm cryopreservation.

PMID:33724558 | DOI:10.1111/rda.13928

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Vaginal birth after Cesarean section and levator ani avulsion: a case-control study

Ultrasound Obstet Gynecol. 2021 Mar 16. doi: 10.1002/uog.23629. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to explore the risk of levator ani avulsion and levator hiatus enlargement following vaginal birth after cesarean section (VBAC) in comparison to primiparous women after their first vaginal delivery.

METHODS: In this multicenter observational cohort study we identified all women who had a term VBAC for their second delivery at the Departments of Gynecology and Obstetrics, Faculty of Medicine in Pilsen and the 1st Faculty of Medicine , Prague, Charles University, Czech Republic between 2012 and 2016. Women having a repeat VBAC, preterm birth or stillbirth were excluded from the study. As a control group, we enrolled a cohort of primiparous women who had their first vaginal birth during the studied period. To increase our control sample we also invited all primiparous women who delivered vaginally between May and June 2019 . All participants were invited for a 4D pelvic floor ultrasound to assess levator trauma. Levator avulsion and the levator hiatus area at rest and on maximal Valsalva were assessed off-line from the stored pelvic floor volumes during contraction and Valsalva. The laterality of the avulsion was additionally noted. The cohorts were then compared using Chi-square test and Wilcoxon two-sample test according to the distribution of normality, p-value <0.05 was considered statistically significant. Multivariate regression controlling for age and BMI was additionally performed.

RESULTS: A total of 301 women had a VBAC for their second delivery during the studied period. Of these, 152 (50.5%) attended the ultrasound examination and full data were available for 141 women for statistical analyses. The control group comprised 113 primiparous women. A significant difference between VBAC and control group in age (32.7 vs. 30.1 years, p < 0.05), BMI (28.4 vs 27.4, p < 0.05), durations of the first (293.1 vs 346.9 min, p < 0.05) and the second (27.6 vs 35.5 min, p < 0.05) stages of labor at time of the index birth was observed. The levator avulsion rate was significantly higher in the VBAC compared to the control group (32.6 vs 18.6 %, p = 0.01). The difference was observed dominantly in unilateral avulsions and remained significant after controlling for age and BMI (adjusted OR 2.061; 95% CI:1.103 – 3.852). There were no statistically significant differences in the size of levator hiatus at rest (12.0 vs. 12.6 cm2 , p = 0.28) or Valsalva (18.6 vs. 18.7 cm2 , p = 0.55). The incidence of levator ballooning was comparable in VBAC and Controls (17.7 % and 18.6 %, p = 0.9).

CONCLUSIONS: VBAC is associated with a significantly higher rate of levator ani avulsion compared to the first vaginal birth in nulliparous women. The difference was significant even after controlling for age and BMI. This article is protected by copyright. All rights reserved.

PMID:33724564 | DOI:10.1002/uog.23629

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Phytonutrient supplements and metabolic biomarkers of cardiovascular disease: An umbrella review of meta-analyses of clinical trials

Phytother Res. 2021 Mar 16. doi: 10.1002/ptr.7079. Online ahead of print.

ABSTRACT

Phytonutrients exert several pharmacological effects on humans. In this study, we performed an umbrella review of the association of phytonutrient supplements (PNSs) with biomarkers of cardiovascular disease. Relevant published systematic reviews and meta-analyses of clinical trials were identified by searching PubMed, Embase, and Cochrane Library until July 4, 2020. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) for summarized effects and I2 statistics of heterogeneity were extracted from individual studies or reanalyzed using a random-effects model. Of the 50 included studies, pooled effects of PNSs on blood pressure, lipid profiles, and glycemic control were reported in 16, 25, and 14 articles, respectively. The findings appeared to be highly heterogeneous among individual trials of included systematic reviews and meta-analyses. Ginger (WMD = -6.36 mmHg, 95% CI = -11.27, -1.46) and Hibiscus sabdariffa (WMD = -7.58 mmHg, 95% CI = -9.69, -5.46) were associated with lowered systolic blood pressure, whereas Aloe vera, Nigella sativa, and spirulina were associated with beneficial effects on both lipid profiles and glycemic control. In summary, this umbrella review has provided up-to-date evidence for the effect of PNSs on biomarkers related to hypertension, dyslipidemia, and diabetes. The results must be interpreted with caution due to potential heterogeneity.

PMID:33724587 | DOI:10.1002/ptr.7079

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Can R2 ‘ mapping evaluate hypoxia in renal ischemia reperfusion injury quantitatively? An experimental study

Magn Reson Med. 2021 Mar 16. doi: 10.1002/mrm.28696. Online ahead of print.

ABSTRACT

PURPOSE: To explore if R2 ‘ mapping can assess renal hypoxia in rabbits with ischemia reperfusion injury (IRI).

METHODS: Forty rabbits were randomly divided into 4 groups according to the clipping time: the sham group and 45 min, 60 min, and 75 min for the mild, moderate, and severe groups (with n = 10 each group), respectively. Intravenous furosemide (FU) was administered 24 h after IRI. All rabbits were performed 5 times (IRIpre , IRI24h , FU5min , FU12min , and FU24min ) with a 3.0 Tesla MR. The R2 ‘ values and the hypoxic scores were then recorded. The repeated measurement analysis of variance and Spearman correlation analysis was used for statistical analysis.

RESULTS: Compared to the baseline, the medullary R2 ‘ values increased significantly 24 h after the IRI (baseline 19.31 ± 1.21 s-1 , mild group 20.05 ± 1.26 s-1 , moderate group 25.38 ± 1.38 s-1 , and severe group 25.79 ± 1.10 s-1 ; each P < .001). FU led to a significant decrease in the medullary R2 ‘ value (sham group 11.17 ± 4.33 s-1 , mild group 7.80 ± 0.74 s-1 , moderate group 3.92 ± 0.28 s-1 , and severe group 3.82 ± 0.23 s-1 ; each P < .05). Quantitative hypoxic scores revealed significant differences among the 4 groups in the outer medulla (P < .001 each). The medullary R2 ‘ differences (before and after intravenous FU) were significantly correlated with the hypoxic scores, respectively (P < .001).

CONCLUSION: R2 ‘ mapping can evaluate the renal hypoxia in the procession of IRI in rabbits and might serve as a quantitative biomarker for IRI.

PMID:33724527 | DOI:10.1002/mrm.28696

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On the design and the analysis of stratified biomarker trials in the presence of measurement error

Stat Med. 2021 Mar 16. doi: 10.1002/sim.8928. Online ahead of print.

ABSTRACT

A major emphasis in precision medicine is to optimally treat subgroups of patients who may benefit from certain therapeutic agents. And as such, enormous resources and innovative clinical trials designs in oncology are devoted to identifying predictive biomarkers. Predictive biomarkers are ones that will identify patients that are more likely to respond to specific therapies and they are usually discovered through retrospective analysis from large randomized phase II or phase III trials. One important design to consider is the stratified biomarker design, where patients will have their specimens obtained at baseline and the biomarker status will be assessed prior to random assignment. Regardless of their biomarker status, patients will be randomized to either an experimental arm or the standard of care arm. The stratified biomarker design can be used to test for a treatment-biomarker interaction in predicting a time-to event outcome. Many biomarkers, however, are derived from tissues from patients, and their levels may be heterogeneous. As a result, biomarker levels may be measured with error and this would have an adverse impact on the power of a stratified biomarker clinical trial. We present a trial design and an analysis framework for the stratified biomarker design. We show that the naïve test is biased and provide bias-corrected estimators for computing the sample size and the 95% confidence interval when testing for a treatment-biomarker interaction in predicting a time to event outcome. We propose a sample size formula that adjusts for misclassification and apply it in the design of a phase III clinical trial in renal cancer.

PMID:33724513 | DOI:10.1002/sim.8928

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Correlations between Serum P2X7, Vitamin A, 25-hydroxy Vitamin D, and Mycoplasma Pneumoniae Pneumonia

J Clin Lab Anal. 2021 Mar 16:e23760. doi: 10.1002/jcla.23760. Online ahead of print.

ABSTRACT

BACKGROUND: Identifying new molecular diagnostic markers for Mycoplasma Pneumoniae Pneumonia (MPP) has always been an essential topic since MPP cases have increased every year, especially among children. Here, we examined the correlation between serum level of Purinergic receptor P2X7, vitamin A, and 25-hydroxy vitamin D (25(OH)D) and the severity of MPP, aiming to identify molecules that have the potential to become diagnostic markers.

METHODS: This study was conducted on 186 cases aged 1-14 (136 MPP and 50 non-MPP patients). Serum levels of Purinergic receptor P2X7, vitamin A, 25(OH)D, and multiple inflammatory and immune factors were measured, compared, and tested for statistical significance.

RESULTS: Serum P2X7, tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β) levels were significantly increased in severe MPP patients, while serum vitamin A, 25(OH)D, IgA, and IgG levels were significantly decreased.

CONCLUSION: Our results demonstrated a positive correlation between serum P2X7 level and the severity of MPP, and negative correlations between serum levels of vitamin A and 25(OH)D and the severity of MPP, suggesting that high serum levels of P2X7 and low serum levels of vitamin A and 25(OH)D may indicate relatively severer MPP.

PMID:33724522 | DOI:10.1002/jcla.23760

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The efficacy of mobile health in alleviating risk factors related to the occurrence and development of coronary heart disease: A systematic review and meta-analysis

Clin Cardiol. 2021 Mar 16. doi: 10.1002/clc.23596. Online ahead of print.

ABSTRACT

The association between the efficacy of mobile health and the occurrence and development of coronary heart disease (CHD) is still unclear. Mobile health can alleviate the risk factors for CHD. PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, WanFang, and VIP databases were searched from inception through May 28, 2020. Randomized controlled trials of the effect of mobile health in alleviating the risk factors of CHD’s occurrence and development were included. Risks of bias were assessed by two independent reviewers by using the RevMan 5.3, GRADEpro, and RoB2.0 to generate findings. Meta-analyses were performed to investigate the effects of mobile health on risk factors for CHD. Subgroup analyses were conducted. Sixteen randomized controlled trials, including 3898 patients with CHD, were included. Meta-analysis results showed that mobile health can reduce BMI (mean difference [MD] = – 1.24, 95% CI = – 2.02 to – 0.45, p < .05), waist circumference (MD = – 4.40, 95% CI = – 4.72 to – 4.08, p < .00001), total cholesterol (TC) level (MD = – 0.43, 95% CI = – 0.64 to – 0.22, p < 0.00001), low-density lipoprotein cholesterol (LDL-C) level (MD = – 0.31, 95% CI = – 0.48 to – 0.15, p < .05), diastolic blood pressure (MD = – 2.01, 95% CI = – 3.40 to – 0.623, p < .05), and depression (MD = – 8.32, 95% CI = – 12.83 to – 3.81, p < .05) and increase high-density lipoprotein cholesterol level (MD = 0.16, 95% CI = 0.01 to 0.32, p < .05) with statistically significant differences. The results of subgroup analyses indicated that the simple mobile health intervention has more remarkable advantages in reducing BMI, TC, LDL-C, and systolic blood pressure than the complex mobile health intervention. Mobile health can alleviate the risk factors for CHD and has a certain effect on the prevention and recovery of CHD. Simple mobile health has a remarkable advantage. Limited by the quantity and quality of included studies, future research enrolling high-quality studies should be taken to verify the above conclusions.

PMID:33724494 | DOI:10.1002/clc.23596

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Plateau is a prognostic factor of lenalidomide therapy for previously treated multiple myeloma

Hematol Oncol. 2021 Mar 16. doi: 10.1002/hon.2863. Online ahead of print.

ABSTRACT

OBJECTIVES: The plateau phase emerging during the treatment of multiple myeloma (MM) is known to last steadily for a certain period, even without treatment. Therefore, the treatment started at plateau phase is expected to be associated with a better outcome. In this study, this hypothesis was evaluated retrospectively for previously treated MM patients in Kansai Myeloma Forum database who received lenalidomide (LEN) with or without dexamethasone for the first time.

METHOD: Disease stability index (DSI) was defined as: (maximum – minimum values of M-protein during the 90 days before the start of LEN) divided by M-protein values at the start of LEN. The patients were classified to 3 groups: stable (S), DSI ≤0.25; increasing (I), DSI >0.25 with increasing M-protein; decreasing (D), DSI>0.25 with decreasing M-protein.

OUTCOMES: In univariate analysis of 352 patients, DSI, age, non-IgG type, and low albumin were statistically significant prognostic factor for both progression-free survival and overall survival. Multivariate analysis revealed that the median overall survival of the group I was significantly worse compared with that of group S or D (p=0.015).

CONCLUSION: DSI is an independent prognostic factor for treatment with LEN for previously treated MM. This article is protected by copyright. All rights reserved.

PMID:33724498 | DOI:10.1002/hon.2863

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Transvaginal Color Mapping Ultrasound in the First Trimester Predicts Placenta Accreta Spectrum: A Retrospective Cohort Study

J Ultrasound Med. 2021 Mar 16. doi: 10.1002/jum.15674. Online ahead of print.

ABSTRACT

OBJECTIVES: Ultrasound (US) prediction of placenta accreta spectrum (PAS) in the first trimester may be aided by postprocessing mechanisms employing color pixel quantification near the bladder-uterine serosal interface. Our objective was to create a postprocessing algorithm of color images to identify findings associated with PAS and compare quantification to sonologist impression in prospectively obtained cine US images.

METHODS: Transverse transvaginal (TV) US color cines obtained in the first trimester as part of a prospective study were reviewed. Investigators blinded to clinical outcomes reviewed anonymized cines that were archived and labeled the bladder-uterine serosal interface. Color pixels within 2 cm of the defined bladder-uterine serosal interface were ascertained using a Python-based plugin in the Horos open-source DICOM viewer. A sonologist classified the findings as suspicious for invasion, indeterminate, or normal. Statistical analysis was performed using Wilcoxon rank-sum test, Cochran-Armitage trend test, and calculation of receiver-operating characteristic (ROC) curves.

RESULTS: Fifty-four studies met inclusion criteria. Of those, six (11%) required hysterectomy with pathologic confirmation of PAS. Women requiring hysterectomy had a significantly higher color Doppler pixel area than those not requiring hysterectomy (P = .0205). A significant trend was identified in the sonologist impression of invasion (P = .0003). ROC’s comparing sonologist impression to Doppler color imaging areas were comparable (P = .054).

CONCLUSIONS: Color Doppler mapping in the first trimester showed an increase in color pixel area near the bladder-uterine serosal interface in women requiring cesarean hysterectomy with histologically confirmed PAS at time of delivery, compared to women without hysterectomy or pathologic evidence of PAS.

PMID:33724510 | DOI:10.1002/jum.15674