Category: Statistics

Front Pediatr. 2021 Aug 12;9:666904. doi: 10.3389/fped.2021.666904. eCollection 2021.

ABSTRACT

Rationale and Aim: Infants with Congenital Heart Disease (CHD) are at risk for neurodevelopmental delays, emotional, social and behavioral difficulties. Hospitalization early in life and associated stressors may contribute to these challenges. Family-centered Care (FCC) is a health care approach that is respectful of and responsive to the needs and values of a family and has shown to be effective in improving health outcomes of premature infants, as well as the mental well-being of their parents. However, there is limited empirical data available on FCC practices in pediatric cardiology and associations with parent and infant outcomes. Methods and Analysis: In this cross-sectional study, we will explore FCC practices at two pediatric cardiac intensive care units in Germany, assess parent satisfaction with FCC, and investigate associations with parental mental well-being and parenting stress, as well as infant physical and mental well-being. We will collect data of 280 infants with CHD and their families. Data will be analyzed using multivariate statistics and multilevel modeling. Implications and Dissemination: The study protocol was approved by the medical ethics committees of both partner sites and registered with the German registry for clinical trials (NR DRKS00023964). This study serves as a first step to investigate FCC practices in a pediatric cardiology setting, providing insight into the relationship between FCC and parent and infant outcomes in a population of infants with CHD. Results will be disseminated in peer-reviewed journals.

PMID:34458208 | PMC:PMC8397409 | DOI:10.3389/fped.2021.666904

Front Public Health. 2021 Aug 12;9:600906. doi: 10.3389/fpubh.2021.600906. eCollection 2021.

ABSTRACT

Objectives: This study aims to evaluate the impact of Microburst Insulin Infusion (MII) treatment on Type 1 and 2 diabetic patients’ HbA1c, lipids, peripheral neuropathy, and patient-reported health status. Methods: We reviewed clinical charts, including lab results, for more than 80 diabetic and pre-diabetic patients treated at one U.S. outpatient clinic in St. Louis, Missouri between February 2017 and December 2019. Data included patient demographics, treatment data, lab and neuropathy tests, and self-reported patient health status questions. The explanatory variable was number of months of MII treatment. Treatments are 3-4 h in length, with two intensive infusions the first week and one treatment each week thereafter, usually for 12 weeks total. Lab tests were at 12-week intervals. Generalized linear modeling and t-tests assessed the significance of differences between patients’ baseline lab values, neuropathy measures, and health status before treatment vs. after final treatment. Results: Number of MII treatments per patient ranged from 1 to 262, over 1-24 months. Time in MII treatment was significantly associated with reductions in HbA1c by nearly 0.04 points per month, and triglycerides declined 3 points per month. Neuropathy measures of large toe vibratory sensation (clanging tuning fork) improved significantly, as did patient-reported health and feelings of improvement since beginning treatment. Discussion: The MII therapy appears to be efficacious in treating diabetic patients, particularly those with complications like neuropathy. Our findings affirmed several other studies. We uniquely incorporated patient health questionnaires, and empirically studied MII treatment efficacy for diabetes in a population large enough to permit statistically valid inferences. With multiple waves of data for over 80 patients, this is one of the most extensive quantitative studies of microburst insulin infusion therapy conducted to date, with protocols more uniformly implemented and survey instruments more consistently administered by the same clinical team. Given the advances in insulin infusion therapy brought by MII, and early indications of its efficacy, the time is right for more in-depth studies of the outcomes patients can achieve, the physiological mechanisms by which they occur, MII’s comparative effectiveness vis-à-vis traditional treatments, and cost-effectiveness.

PMID:34458216 | PMC:PMC8387654 | DOI:10.3389/fpubh.2021.600906

Front Cell Infect Microbiol. 2021 Aug 12;11:671074. doi: 10.3389/fcimb.2021.671074. eCollection 2021.

ABSTRACT

Infant gut microbiota plays a vital role in immune response, mediates neurobehavioral development and health maintenance. Studies of twins’ gut microbiota found that gut microbiota composition and diversity tend to be mature and stable with increasing postnatal age (PNA). Preterm infant gut microbiome shifts dramatically when they were staying in the neonatal intensive care unit (NICU). Compositions and shifting characteristics of gut microbiota among neonatal preterm twins and triplets during their early life are still unknown, which impedes a better understanding of the mechanism underpinning neurobehavioral development and precise intervention/health of preterm neonates. This longitudinal cohort study used a twins/triplets design to investigate the interaction of genetic (e.g., male vs. female) and environmental factors influencing the development of the gut microbiome in early life. We included 39 preterm infants, 12 were Female twins/triplets (Female T/T) including 3 twins pairs and 2 triplets, 12 were male twins (Male T) including 6 twins pairs, and 15 were mixed-sex twins/triplets (Mix T/T) including 6 twins pairs and 1 triplet (8 females and 7 males) during the first four weeks of NICU stay. Weekly gut microbiota patterns between females and males were compared by linear discriminant analysis (LDA) effect size (LEfSe). Metagenomics function of gut microbiota was predicted by using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt). Weekly function (KEGG pathways) differences between females and males were detected by using Statistical Analysis of Metagenomic Profiles (STAMP). Results found that female pairs and male pairs were significantly different in gut microbiome diversity, compositions, and predicted metabolic profiles, importantly, females and males were also significantly dissimilar within their co-twin/triplet pairs of the mixed-sex group, infants of co-twins/triplets shared more similar features than un-related infants from different twins’ pair. Future research developing personalized interventions for vulnerable high-risk infants should consider sex, and the interaction of sex and environmental factors.

PMID:34458157 | PMC:PMC8387566 | DOI:10.3389/fcimb.2021.671074

J Biomed Phys Eng. 2021 Aug 1;11(4):551-560. doi: 10.31661/jbpe.v0i0.2103-1294. eCollection 2021 Aug.

ABSTRACT

Preeclampsia is one of the most common complications of pregnancy that is very difficult to control and manage during the outbreak of COVID-19. One way to control and manage this disease is to use self-care applications. Therefore, the aim of this study was to design and develop a mobile-based application to facilitate self-care for women, who suffer from pregnancy poisoning in the COVID-19 pandemic. This study was conducted in two stages: In the first stage, according to the opinion of 20 obstetricians and pregnant women, a needs assessment was performed. In the second stage, based on the identified needs, the application prototype was designed and then evaluated. For evaluation, 20 pregnant women were asked to use the application for 10 days. QUIS questionnaire version 5.5 was used for evaluation. Descriptive statistics and mann-whitney test in SPSS software version 23 were used for data analysis. Out of the 66 information needs that were identified via the questionnaire, 58 were considered in designing the application. Features of the designed application were placed in 5 categories: User’s profile, lifestyle, disease prevention and control, application capabilities and user’s satisfaction. The capabilities of the application consist of introducing specialized COVID-19 medical centers, search for the location of medical centers and doctors’ offices, drug management, drug allergies, self-assessment, stress reduction and control, nutrition and diet management, sleep management, doctor’s appointment reminders, communication with other patients and physicians, application settings. Pregnant women rated the usability of the application at a good level. The designed application can reduce the anxiety and stress due to preeclampsia feel and also improve their knowledge as well as attitude towards the COVID-19 pandemic and preeclampsia.

PMID:34458202 | PMC:PMC8385215 | DOI:10.31661/jbpe.v0i0.2103-1294

Front Oncol. 2021 Aug 11;11:716962. doi: 10.3389/fonc.2021.716962. eCollection 2021.

ABSTRACT

BACKGROUND: Hepatoid adenocarcinoma of the stomach (HAS) is a rare type of primary gastric cancer, and most previous studies have reported that HAS has a poor prognosis due to its aggressive biological behavior. The aim of this study was to compare the prognosis of HAS to that of gastric signet ring cell carcinoma (SRC).

METHODS: This was a single-center, retrospective, observational cohort study (January 2010 to January 2016) of gastric cancer patients with pathological HAS and SRC. Overall survival was compared between HAS and SRC patients. We used univariate Cox regression, multivariate Cox regression, propensity score matching (PSM), inverse probability of treatment weighting, standardized mortality ratio weighting, standardized mortality ratio weighting, and overlap weighting to perform a prognostic analysis.

RESULTS: A total of 725 (672 SRC and 53 HAS) patients were included. After nearest-neighbor 1:4 PSM, 200 SRC patients and 50 HAS patients were matched. Only in univariate Cox regression analysis with the cohort before PSM did HAS show a significantly worse prognosis than SRC [hazard ratio (HR), 1.66; 95% confidence interval (CI), 1.02-2.69, p = 0.040]. However, in the analysis of multivariate Cox regression with the cohort before PSM and series analysis based on the propensity score, all of the results indicated that there was no statistically significant difference in overall survival between HAS and SRC (all p > 0.05). Furthermore, in the subgroup of proximal location (p = 0.027), T stage 4a & 4b (p = 0.001), N stage 3a & 3b (p = 0.022), with cancer nodules (p = 0.026), serum CEA higher than the normal value (p = 0.038), and serum CA199 higher than the normal value (p = 0.023), the prognosis of HAS was significantly worse than that of SRC.

CONCLUSION: Based on our study, there was no statistically significant difference in overall survival between HAS and gastric SRC patients. However, in patients with an advanced tumor stage, HAS may have a worse overall survival than SRC.

PMID:34458152 | PMC:PMC8385756 | DOI:10.3389/fonc.2021.716962

Front Oncol. 2021 Aug 11;11:725549. doi: 10.3389/fonc.2021.725549. eCollection 2021.

ABSTRACT

BACKGROUND: Gastritis induced by checkpoint inhibitors (CPI) is a rare but severe drug-related side effect. The reference standard for confirming CPI-associated gastritis (CPI-assGastritis) is histopathological assessment; however, the histopathological features of CPI-assGastritis are not yet adequately defined.

MATERIALS AND METHODS: Gastric biopsies of melanoma patients with histopathologically suspected CPI-assGastritis were compared with gastric biopsies of patients with inflammation free gastric mucosa (IFGM), type A, B, and C gastritis with respect to apoptosis count and predominant histopathological features. Immunohistochemical anti-caspase-3 staining was performed to identify apoptosis. Quantification was performed by manually counting the number of apoptotic events per 10 high-power fields (HPF). Clinical symptoms, treatment, and follow-up data of patients with CPI-assGastritis were examined. The nonparametric Mann-Whitney U test was used for statistical testing.

RESULTS: Five melanoma patients (three women, two men; median age: 45 years) were treated with PD-1-based CPI. The patients reported epigastric pain, weight loss, nausea, and vomiting. Histologically, the patients with CPI-assGastritis showed a partly lymphocytic, partly granulocytic inflammatory infiltrate. Manual counting of apoptotic cells in biopsy tissue slides stained against caspase 3 revealed a median of 6 apoptotic events/10 HPF (95% CI, 2.75-17.30) in the patients with CPI-assGastritis. Results for the comparison cohort (patients n = 21) were a median of 1 apoptotic event/10 HPF (95% CI, 0.5-4.5) for type-A gastritis (six patients), a median of 2 apoptotic events/10 HPF (95% CI, 0-4.5) for type-B gastritis (five patients), and no apoptosis for IFGM and type-C gastritis (five patients). Patients with CPI-assGastritis had a significantly higher apoptosis count than patients with IFGM (p<0.01), type A (p<0.05), B (p<0.05), and C gastritis (p<0.01). None of the CPI-assGastritis biopsies showed evidence of Helicobacter pylori. All CPI-assGastritis patients responded to systemic treatment with corticosteroids.

CONCLUSION: CPI-assGastritis manifests with nonspecific symptoms but histologically shows a high number of apoptotic events, which can best be visualized by anti-caspase-3 immunohistochemistry. This histopathological feature may help to histologically differentiate CPI-assGastritis from other forms of gastritis and inform decision-making regarding its optimal management.

PMID:34458154 | PMC:PMC8385713 | DOI:10.3389/fonc.2021.725549

Int J Appl Basic Med Res. 2021 Jul-Sep;11(3):182-187. doi: 10.4103/ijabmr.ijabmr_61_21. Epub 2021 Jul 19.

ABSTRACT

BACKGROUND: The correlation of SARS-CoV-2 viral load with disease severity in different population subsets is still elusive. There is a scarcity of literature regarding this aspect in Indian Population.

AIM: To study retrospectively the risk factors and the role of viral load with disease severity among different age groups of North Indian population.

METHODS: Here we quantified the viral load of 239 positive participants and collected data retrospectively from April 2020 to May 2020 and categorised the patients as per disease severity and population subsets.

RESULTS: Asymptomatic patients were found to have higher viral load than the symptomatic patients, though the difference was not found to be statistically significant. The logistic regression analysis showed that contact with laboratory confirmed cases, SARI and ILI were independent risk factors for acquiring COVID-19 infection.

CONCLUSION: SARS-CoV-2 viral load is not significantly associated with disease severity among different population subsets. However, there is a need to carry out more studies with a larger number of patients to validate and confirm the above findings.

PMID:34458122 | PMC:PMC8360218 | DOI:10.4103/ijabmr.ijabmr_61_21

Front Oncol. 2021 Aug 11;11:699200. doi: 10.3389/fonc.2021.699200. eCollection 2021.

ABSTRACT

AIM: To evaluate the evidence concerning the quality of surgical resection in laparoscopic (LapTME), robotic (RobTME) and transanal (TaTME) total mesorectal excision for mid-/low rectal cancer.

METHODS: A systematic literature search of the PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases was performed. A Bayesian network meta-analysis was utilized to compare surgical resection involved in these 3 surgical techniques by using ADDIS software. Rates of positive circumferential resection margins (CRMs) were the primary endpoint.

RESULTS: A total of 34 articles, 2 randomized clinical trials (RCTs) and 32 non-RCTs, were included in this meta-analysis. Pooled data showed CRM positivity in 114 of 1763 LapTME procedures (6.5%), 54 of 1051 RobTME procedures (5.1%) and 60 of 1276 TaTME procedures (4.7%). There was no statistically significant difference among these 3 surgical approaches in terms of CRM involvement rates and all other surgical resection quality outcomes. The incomplete mesorectal excision rates were 9.6% (69/720) in the LapTME group, 1.9% (11/584) in the RobTME group and 5.6% (45/797) in the TaTME group. Pooled network analysis observed a higher but not statistically significant risk of incomplete mesorectum when comparing both LapTME with RobTME (OR = 1.99; 95% CI = 0.48-11.17) and LapTME with TaTME (OR = 1.90; 95% CI = 0.99-5.25). By comparison, RobTME was most likely to be ranked the best or second best in terms of CRM involvement, complete mesorectal excision, rate of distal resection margin (DRM) involvement and length of DRMs. In addition, RobTME achieved a greater mean tumor distance to the CRM than TaTME. It is worth noting that TaTME was most likely to be ranked the worst in terms of CRM involvement for intersphincteric resection of low rectal cancer.

CONCLUSION: Overall, RobTME was most likely to be ranked the best in terms of the quality of surgical resection for the treatment of mid-/low rectal cancer. TaTME should be performed with caution in the treatment of low rectal cancer.

PMID:34458142 | PMC:PMC8385749 | DOI:10.3389/fonc.2021.699200

Clin Chem Lab Med. 2021 Aug 27. doi: 10.1515/cclm-2021-0694. Online ahead of print.

ABSTRACT

OBJECTIVES: We hypothesized that the amount of antigen produced in the body during a COVID-19 infection might differ between patients, and that maximum concentrations would predict the degree of both inflammation and outcome for patients.

METHODS: Eighty-four hospitalized and SARS-CoV-2 PCR swab-positive patients, were followed with blood sampling every day until discharge or death. A total of 444 serial EDTA plasma samples were analyzed for a range of biomarkers: SARS-CoV-2 nuclear antigen and RNA concentration, complement activation as well as several inflammatory markers, and KL-6 as a lung marker. The patients were divided into outcome groups depending on need of respiratory support and death/survival.

RESULTS: Circulating SARS-CoV-2 nuclear antigen levels were above the detection limit in blood in 65 out of 84 COVID-19 PCR swab-positive patients on day one of hospitalization, as was viral RNA in plasma in 30 out of 84. In all patients, complete antigen clearance was observed within 24 days. There were definite statistically significant differences between the groups depending on their biomarkers, showing that the concentrations of virus RNA and antigen were correlated to the inflammatory biomarker levels, respiratory treatment and death.

CONCLUSIONS: Viral antigen is cleared in parallel with the virus RNA levels. The levels of antigens and SARS-CoV-2 RNA in the blood correlates with the level of IL-6, inflammation, respiratory failure and death. We propose that the antigens levels together with RNA in blood can be used to predict the severity of disease, outcome, and the clearance of the virus from the body.

PMID:34455731 | DOI:10.1515/cclm-2021-0694

Zhongguo Fei Ai Za Zhi. 2021 Aug 30. doi: 10.3779/j.issn.1009-3419.2021.102.26. Online ahead of print.

ABSTRACT

BACKGROUND: Programmed cell death 1 or programmed cell death-ligand 1 inhibitor (PD-1/PD-L1 inhibitor) and docetaxel, as the standard second-line treatments of advanced non-small cell lung cancer (NSCLC) patients, have limited effects. There are few studies on whether docetaxel combined with PD-1/PD-L1 inhibitor can increase the efficacy and make patients better benefit. The aim of this study is to evaluate the efficacy and safety of docetaxel combined with PD-1/PD-L1 inhibitor for the second-line treatment of stage IV NSCLC patients.

METHODS: Stage IV NSCLC patients (n=118) who received treatment at Shandong Cancer Hospital between October 1, 2018, and December 31, 2020, were retrospectively analyzed. They were divided into observation group (n=69) and control group (n=49) according to different treatment plan. Observation group was given docetaxel plus PD-1/PD-L1 inhibitor, while control group was given PD-1/PD-L1 inhibitor. The clinical curative effect and the incidence of adverse reactions of grade 3 and above were compared between the two groups.

RESULTS: The disease control rate (DCR) was higher in the observation group (89.9%) than that in the control group (73.5%) (P=0.019), and the objective response rate (ORR) showed no significant difference between observation group (24.6%) and control group (16.3%) (P=0.276). Till June 22, 2021, the 1-year PFS rate showed no difference between observation group (16.5%) and control group (7.7%) (P=0.205). During the treatment period, the adverse reactions of the two groups were mostly grade 1 to 2, and could be tolerated. The incidence of bone marrow suppression in observation group was higher than that in the control group (P<0.05), and the remaining adverse reactions were not statistically different from control group. Cox regression analysis showed that performance status (PS) (P=0.020) and age (P=0.049) were independent prognostic factors for the effect of docetaxel combined with PD-1/PD-L1 inhibitor.

CONCLUSIONS: The second-line treatment with docetaxel plus PD-1/PD-L1 inhibitor in patients with stage IV NSCLC can improve the DCR and prolong the PFS, and the adverse reactions are tolerable.

PMID:34455735 | DOI:10.3779/j.issn.1009-3419.2021.102.26