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Nevin Manimala Statistics

Current State of Evidence on Kidney Transplantation: How Fragile Are the Results?

Transplantation. 2021 May 6. doi: 10.1097/TP.0000000000003805. Online ahead of print.

ABSTRACT

BACKGROUND: The study aims is to use the fragility index (FI) to examine the strength of evidence of randomized controlled trials (RCTs) published in the last decade on kidney transplantation.

METHODS: We searched MEDLINE for studies on kidney transplantation. We included the RCTs that compared 2 groups with 1:1 randomization and reported significant P-values (<0.05) for a dichotomous outcome and were published in the top 10 transplant journals. We calculated the FI; a calculation used to determine the minimum number of subjects needed to change from a nonevent to an event to make the study results nonsignificant (P-value >0.05).

RESULTS: 57 RCTs met our inclusion criteria. The median sample size was 100 participants in each arm, the median number of events was 16(IQR 8-30) in the intervention group. Among the included trials, 79% were industry-funded, 93% involved medications, and the majority were open-label. The median FI was 3 (IQR 1-11). In 43% of the trials, the number of patients reported lost to follow-up was higher than or equal to the FI. Only 4% of the RCTs imputed a value for the missing dichotomous outcome. Furthermore, the median number of subjects who discontinued the trial due to adverse effects was 21, which was greater than the FI in 60% of the RCTs.

CONCLUSION: The arbitrary classification of results into “significant” and “nonsignificant” based on p-value <0.05 should perhaps be interpreted with the help of other statistical parameters and FI is one of them.

PMID:33966022 | DOI:10.1097/TP.0000000000003805

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Correlation between BNT162b2 mRNA Covid-19 vaccine-associated hypermetabolic lymphadenopathy and humoral immunity in patients with hematologic malignancy

Eur J Nucl Med Mol Imaging. 2021 May 8. doi: 10.1007/s00259-021-05389-x. Online ahead of print.

ABSTRACT

PURPOSE: Vaccine-associated hypermetabolic lymphadenopathy (VAHL) is frequently observed on [18F]FDG PET-CT following BNT162b2 administration. Recent data suggest a prominent B cell germinal-center (GC) response elicited by mRNA vaccines in draining lymph nodes. Thus, in this study we aimed to explore the correlation between VAHL and humoral immunity as reflected by post-vaccination serologic testing and by comparing the incidence of VAHL between lymphoma patients treated recently with B cell depleting therapy and those that were not.

METHODS: A total of 137 patients with hematologic malignancy that had post-vaccination [18F]FDG PET-CT were included (All-PET group), 86 received both vaccine doses before imaging (PET-2 group). Their VAHL status and grade on imaging were recorded. Among 102 lymphoma patients, 34 (33.3%) were treated during the year prior vaccination with anti-CD20 antibody containing therapy. A subgroup of 54 patients also underwent serologic testing 2-3 weeks after the booster dose, and their anti-spike titers were recorded and graded as well.

RESULTS: The overall incidence of VAHL in patients with hematologic malignancy was 31.4%. The 34 lymphoma patients treated during the year prior vaccination with anti-CD20 antibody containing therapy had significantly lower rates of VAHL comparted with all other lymphoma patients (8.8 versus 41.2% in all-PET patients, Pv < 0.01). VAHL rates were 10% in patients with negative serology, 31.3% in patients with low anti-spike titers, and 72.2% in patients with high anti-spike titers. The positive predictive values of VAHL were 90 and 93.3% in all-PET and PET-2 patients, respectively. A positive statistically significant correlation was found between VAHL and serology ranks in All-PET patients (rs = 0.530, Pv < 0.001), and stronger correlation was found in PET-2 patients (rs = 0.642, Pv < 0.001).

CONCLUSION: VAHL on [18F]FDG PET-CT of patients with hematologic malignancy may reflect GC B cell proliferation and an effective humoral response elicited by BNT162b2 vaccine.

PMID:33966088 | DOI:10.1007/s00259-021-05389-x

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Apolipoprotein E4 Allele in Subjects with COVID-19

Gerontology. 2021 May 7:1-3. doi: 10.1159/000516200. Online ahead of print.

NO ABSTRACT

PMID:33965962 | DOI:10.1159/000516200

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NORMALIZING EFFECT OF ELECTROMAGNETIC STIMULATION ON BLOOD QUANTITATIVE INDICES IN DEPRESSED RATS ON THE BACKGROUND OF OXYTOCIN

Georgian Med News. 2021 Mar;(312):100-104.

ABSTRACT

Depression is linked to systemic inflammation. There is an association between blood cell count and/or hematological inflammatory markers with depression symptoms. Oxytocin reduces the activity of brain regions that produce anxiety and might involve in the rehabilitation of depressive-like behavior. Repetitive EMS is used in the treatment of moderate depression. So, the goal of this investigation was to study the quantitative characteristics of blood cells after EMS on the background of oxytocin premedication of in depressed rats. In the implementation of the project the depressed rats (250-450 g) were used (n=20). For each task two groups of the animal were conducted: experimental group (with EMS) and control group (without EMS). For repetitive (10-days) EMF exposure, the following parameters were used: 10000 -15000 Hz frequency, 1,5 m/Tesla, for 15 min. An animal model of depression was received by subcutaneous injection of Clomipramine from 8 to 21 days of neonatal development. The blood counts were performed 2 months later after clomipramine injection using blood HumaCount 30 TS. This analyzer allows quantifying the number of red blood cells, white blood cells (agranulocytes and granulocytes), platelets, hemoglobin, the hematocrit in 1 ml blood of rats. The hematological analysis was performed 2 weeks later after oxytocin (4 mcg/per animal during 10 days) injection and EMS. The obtained results were processed using an adequate statistical program. In clomipramine -induced depressed rats, EMS independently or with simultaneous injection of Oxytocin caused normalization of blood cells count (Red blood cells, white blood cells and Platelets). More important was the simultaneous impact of EMS and oxytocin. In depressed rats, the oxytocin alone, or together with EMS can restore the blood cell imbalance.

PMID:33964836

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Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016

Am J Clin Nutr. 2021 May 8:nqab113. doi: 10.1093/ajcn/nqab113. Online ahead of print.

ABSTRACT

BACKGROUND: Food insecurity is associated with poorer nutrient intakes from food sources and lower dietary supplement use. However, its association with total usual nutrient intakes, inclusive of dietary supplements, and biomarkers of nutritional status among US children remains unknown.

OBJECTIVE: The objective was to assess total usual nutrient intakes, Healthy Eating Index-2015 (HEI-2015) scores, and nutritional biomarkers by food security status, sex, and age among US children.

METHODS: Cross-sectional data from 9147 children aged 1-18 y from the 2011-2016 NHANES were analyzed. Usual energy and total nutrient intakes and HEI-2015 scores were estimated using the National Cancer Institute method from 24-h dietary recalls.

RESULTS: Overall diet quality was poor, and intakes of sodium, added sugars, and saturated fat were higher than recommended limits, regardless of food security status. Food-insecure girls and boys were at higher risk of inadequate intakes for vitamin D and magnesium, and girls also had higher risk for inadequate calcium intakes compared with their food-secure counterparts, when total intakes were examined. Choline intakes of food-insecure children were less likely to meet the adequate intake than those of their food-secure peers. No differences by food security status were noted for folate, vitamin C, iron, zinc, potassium, and sodium intakes. Food-insecure adolescent girls aged 14-18 y were at higher risk of micronutrient inadequacies than any other subgroup, with 92.8% (SE: 3.6%) at risk of inadequate intakes for vitamin D. No differences in biomarkers for vitamin D, folate, iron, and zinc were observed by food security status. The prevalence of iron deficiency was 12.7% in food-secure and 12.0% in food-insecure adolescent girls.

CONCLUSIONS: Food insecurity was associated with compromised intake of some micronutrients, especially among adolescent girls. These results highlight a need for targeted interventions to improve children’s overall diet quality, including the reduction of specific nutrient inadequacies, especially among food-insecure children. This study was registered at clinicaltrials.gov as NCT03400436.

PMID:33964856 | DOI:10.1093/ajcn/nqab113

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Post-diagnostic reliance on plant-compared with animal-based foods and all-cause mortality in omnivorous long-term colorectal cancer survivors

Am J Clin Nutr. 2021 May 8:nqab061. doi: 10.1093/ajcn/nqab061. Online ahead of print.

ABSTRACT

BACKGROUND: Plant-rich diets are associated with lower cardiometabolic risks and longer survival in the general population, but their association with mortality in cancer survivors is still unclear.

OBJECTIVES: We aimed to examine the associations of 3 postdiagnostic plant-based diet indices with all-cause mortality in omnivorous long-term colorectal cancer (CRC) survivors.

METHODS: Diet was assessed with FFQs at a median of 6 years after diagnosis in 1404 CRC survivors (56% male; median age, 69 years) in a Northern German prospective cohort study. An overall, a healthful plant-based, and an unhealthful plant-based diet index were derived by scoring intakes of animal foods reversely and intakes of healthy (whole grains, vegetables, fruits, legumes, nuts, oils, tea/coffee) and less healthy plant foods (refined grains, fruit juices, sugar-sweetened beverages, potatoes, sweets/desserts) positively or reversely, depending on the index. Vital status follow-up was conducted via population registries. Cox proportional hazards regression was applied to estimate HRs for all-cause mortality according to plant-based diet adherence.

RESULTS: Within 7 years (median) after diet assessment, 204 deaths occurred. The overall plant-based diet index displayed a significant, inverse association with all-cause mortality (HR per 10-point increase in diet index, 0.72; 95% CI, 0.57-0.91). Although not statistically significant, higher healthful plant-based diet scores showed a strong tendency towards lower mortality (HR, 0.82; 95% CI, 0.67-1.01). The unhealthful plant-based diet index was associated with higher mortality, but lost statistical significance after multivariable adjustment (HR, 1.19; 95% CI, 0.96-1.48). A subgroup analysis revealed that the tendency towards a positive association of the unhealthful plant-based diet with mortality was restricted to less physically active individuals (<95 metabolic equivalent of task hours/week).

CONCLUSIONS: An overall plant-based diet was inversely associated with all-cause mortality in long-term CRC survivors. However, more research is needed to further disentangle the impacts of different qualities of plant-based diets on cancer survivors’ health.

PMID:33964858 | DOI:10.1093/ajcn/nqab061

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COVID-19 infection in severe Alpha 1-antitrypsin deficiency: Looking for a rationale

Respir Med. 2021 Apr 30;183:106440. doi: 10.1016/j.rmed.2021.106440. Online ahead of print.

ABSTRACT

The clinical manifestations of COVID-19 are heterogeneous: 46.4% of patients admitted into hospital reported to have at least one comorbidity. Comorbidities such as COPD, diabetes, hypertension and malignancy predispose patients with Covid-19 to adverse clinical outcomes. Alpha 1-antitrypsin deficiency (AATD) is a genetic disorder caused by pathological mutation(s) in the SERPINA1 gene resulting in an imbalance in proteinase activity which may lead to premature emphysema and COPD. Our aim was to investigate whether people with severe AAT deficiency (AATD) have an increased risk of (severe) COVID-19 infection. We collected data on COVID-19 symptoms, laboratory-confirmed infection, hospitalization and treatment by means of a telephone survey, directly administered to Italian severe AATD subjects in May 2020. We then compared our findings with data collected by the Istituto Superiore di Sanità on the total population in Italy during the same period. We found an higher frequency of SARS-CoV-2 infection in our cohort (3.8%) compared to national data regarding infection, thus giving severe AATD a relative risk of 8. 8 (95%CI 5.1-20,0; p<0.0001) for symptomatic SARS-CoV-2 infection. Moreover, the relative risk (RR) was higher in AATD patients with pre-existing lung diseases (RR 13.9; 95%CI 8.0-33.6; p<0.001), but with a similar death rate (1 in 8, 12.5%) compared to the general population (13.9%; RR 0.9). These preliminary findings highlight the importance of close surveillance in the spread of COVID-19 in patients with severe AATD and underlines the need for further studies into the role of the antiprotease shield in preventing SARS-Cov-2 infection.

PMID:33964815 | DOI:10.1016/j.rmed.2021.106440

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ILEOSIGMOID POUCH AS A URINARY DIVERSION APPROACH FOLLOWING RADICAL CYSTECTOMY IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER

Georgian Med News. 2021 Mar;(312):36-42.

ABSTRACT

Goal – to determine efficacy of the Ileosigmo-pouch (ISP) as a method of transrectal urinary diversion in invasive bladder cancer (BC) treatment. Retrospective analysis of clinical data of patients that undergone radical cystectomy (RC), followed by ISP method of urinary diversion. Study compared two groups of patients: the first group of 22 (23.6%) patients with ISP and the control group included 71 (76.4%) patients with Mainz pouch II (MP II) diversion. The groups were statistically comparable by major clinical parameters. Complication rates were evaluated with Clavien-Dindo classification. There were no significant differences in the duration of surgery procedure, – ISP 210 – 562 (380.4±38.4) minutes vs. 190 – 557 (311.3±49.5) minutes for MP II. Levels of intraoperative blood loss in both groups were comparable: 110 – 2850 (707.42±97.2) ml vs. 170 – 3000 (788.51±141.3) ml. Peroiperative complications after ISP and MP II (1 (4.5%) vs. 6 (4.8%)) did not exceed 3 grade according to Clavien-Dindo. The frequency of postoperative chronic pyelonephritis (CP) was higher in MP II 26 (24.3%) vs. ISP 3 (15.7%). Gas reflux into the kidneys was observed only in MP II 18 (16.8%). Metabolic acidosis was revealed in 27 (25.2%) after MP II and in 2 (10.5%) after ISP. During the ISP formation comparing to MP II, the pouch volume increased in average up to 1000 ml vs. 750 ml., the pressure in a sigmoid colon decreases to 18 cm of water column against 35 cm wc. Urination/defecation frequency was improved in patients after ISP – every 3-4 hours during the day and 5-6 hours at night vs. MP II every 2-3 hours during the day and 3-4 hours at night. The ISP method of urinary diversion in our study showed improvements of urodynamic parameters and eliminated the body metabolic disorders when compared to transrectal diversion with MP2. This viable option of diversion in patients with invasive bladder cancer who are not candidates for neobladder, but strongly afraid of cutaneous urinary stoma.

PMID:33964823

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CLINICAL AND GENETIC FACTORS OF CARDIOVASCULAR EVENTS DEVELOPMENT AFTER PERCUTANEOUS CORONARY INTERVENTION

Georgian Med News. 2021 Mar;(312):52-56.

ABSTRACT

The new cardiovascular events development remains the main factors limiting its long-term effectiveness despite technological progress and the widespread use of percutaneous coronary intervention (PCI). Objective – to assess the effect of clinical and genetic factors on the development of complication after percutaneous coronary intervention with double antiplatelet therapy (DAT). Case-control. The main group included 34 (46.57%) patients with ischemic heart disease after the procedure of percutaneous coronary intervention with bleeding, the control group included 39 (53.43%) patients with verified ischemic heart disease after the procedure of percutaneous coronary intervention without bleeding signs. The average age of the patients in the main group was 63.25±8.7, this group included 65% men and 35% women. The average age of the patients in the control group was 63.82±8.9, this group included 87% men and 13% women, respectively. It was found on the base of the clinical and laboratory characteristics of the bleeding risk in patients after percutaneous coronary intervention that the bleeding predictors after PCI against a background of DAT were: female gender (OR=3.405, p=0.027), the presence of diabetes mellitus (OR=2.399, p=0.046), body mass index (BMI) (OR=1.200, p=0.038), coronary artery stenting (OR=1.045, p=0.030), erythrocytes level (OR=2.292, p=0.049), platelet count (OR=3.964, p=0.048), hemoglobin (Hb) (OR=1.333, p=0.042), erythrocyte sedimentation rate (ESR) (OR=1.008, p=0.009), ejection fraction (OR=1.248, p=0.043), glomerular filtration rate (OR=1.227, p=0.002). According to a genetic study, CYP2C19*17 C/T gene polymorphism was detected in 9% of patients with double antiplatelet therapy. There was no statistically significant difference in genotypes of the 17th allele CYP2C19 in accordance with the results of the analysis of genotypes in the first and second groups. The Odds Ratio values (OR=0.658), 95% confidence interval [0.145-2.984] were obtained for all the studied polymorphisms, which indicates the absence of polymorphism association of СYP2C19*17 gene with a risk of bleeding.

PMID:33964826

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Introducing intense rainfall and snowmelt variables to implement a process-related non-stationary shallow landslide susceptibility analysis

Sci Total Environ. 2021 Apr 27;786:147360. doi: 10.1016/j.scitotenv.2021.147360. Online ahead of print.

ABSTRACT

The study objective was to derive a susceptibility model for shallow landslides that could include process-related non-stationary variables, to be adaptable to climate changes. We selected the territory of the Mont-Emilius and Mont-Cervin Mountain Communities (northern Italy) as the study area. To define summary variables related to landslide predisposing and triggering processes, we investigated the relationships between landslide occurrences and intense rainfall and snowmelt events (period 1991-2020). For landslide susceptibility mapping, we set up a Generalized Additive Model. We defined a reference model through variable penalization (relief, NDVI, land cover and geology predictors). Similarly, we optimized a model including the climate variables, checking their smooth functions to ensure physical plausibility. Finally, we validated the optimized model through a k-fold cross-validation and performed an evaluation based on contingency tables, area under the receiver operating characteristic curve (AUROC) and variable importance (decrease in explained variance). The climate variables that resulted as being statistically and physically significant are the effective annual number of rainfall events with intensity-duration characteristics above a defined threshold (EATean) and the average number of melting events occurring in a hydrological year (MEn). In the optimized model, EATean and MEn accounted for 5% of the explained deviance. Compared to the reference model, their introduction led to an increase in true positive rate and AUROC of 2.4% and 0.8%, respectively. Also, their inclusion caused a transition of the vulnerability class in 11.0% of the study area. The k-fold validation confirmed the statistical significance and physical plausibility of the meteorological variables in 74% (EATean) and 93% (MEn) of the fitted models. Our results demonstrate the validity of the proposed approach to introduce process-related, non-stationary, physically-plausible climate variables within a shallow landslide susceptibility analysis. Not only do the variables improve the model performance, but they make it adaptable to map the future evolution of landslide susceptibility including climate changes.

PMID:33964775 | DOI:10.1016/j.scitotenv.2021.147360