Tag: statistics

Shanghai Kou Qiang Yi Xue. 2022 Jun;31(3):270-273.

ABSTRACT

PURPOSE: To explore the differences between oral and intestinal microorganisms of 860 children aged 1-6 years in Nanjing city.

METHODS: Eight hundred and sixty children aged 1-6 years who met the inclusion criteria were enrolled. 860 saliva samples and equivalent stool samples were collected. Microbial DNA was extracted and amplified using PCR. High-throughput sequencing was performed using Miseq sequencer, and bioinformatics analysis was performed to compare the differences of oral and intestinal microflora. SPSS 20.0 software package was used to perform the statistical analysis.

RESULTS: At phylum level, Bacteroidetes (39.98%), Proteobacteria (25.32%) and Firmicutes (21.78%) were the most common microbes in oral cavity, while Firmicutes (45.21%) and Bacteroidetes (37.21%) were the most abundant microbes in the gut. At genus level, the top three microbes in the oral cavity included Prevotella(26.11%), Neisseria (12.39%), Porphyromonas(10.13%), while the top three microbes in the gut included Bacteroidetes(20.11%), Prevotella (9.13%), and Faecalibacterium (5.13%). There were significant alpha and beta differences in oral and intestinal microbial diversity.

CONCLUSIONS: Bacteroidetes and Proteobacteria are the dominant species in the oral cavity, while Firmicutes and Bacteroidetes are the dominant species in the gut. There are significant differences in species composition and abundance between oral and intestinal microorganisms.

PMID:36204955

Acute Crit Care. 2022 Aug 19. doi: 10.4266/acc.2022.00150. Online ahead of print.

ABSTRACT

BACKGROUND: Sepsis and septic shock remain the leading causes of death in critically ill patients worldwide. Various biomarkers are available to determine the prognosis and therapeutic effects of sepsis. In this study, we investigated the effectiveness of presepsin as a sepsis biomarker.

METHODS: Patients admitted to the intensive care unit with major or minor diagnosis of sepsis were categorized into survival and non-survival groups. The white blood cell count and serum C-reactive protein, procalcitonin, and presepsin levels were measured in all patients.

RESULTS: The study included 40 patients (survival group, 32; non-survival group, 8; mortality rate, 20%). The maximum serum presepsin levels measured during intensive care unit admission were significantly higher in the non-survival group (4,205.5 pg/ml [1,155.8-10,094.0] vs. 741.5 pg/ml [520.0-1,317.5], P<0.05). No statistically significant intergroup differences were observed in the maximum, minimum, and mean values of the white blood cell count, as well as serum C-reactive protein, and procalcitonin levels. Based on the receiver operating characteristic curve, the area under the curve for presepsin as a predictor of sepsis mortality was 0.764. At a cut-off value of 1,898.5 pg/ml, the sensitivity and specificity of presepsin for prediction of sepsis-induced mortality were 75.0% and 87.5%, respectively.

CONCLUSION: Early diagnosis of sepsis and prediction of sepsis-induced mortality are important for prompt initiation of treatment. Presepsin may serve as an effective biomarker for prediction of sepsis-induced mortality and for evaluation of treatment effectiveness.

PMID:36203234 | DOI:10.4266/acc.2022.00150

Biol Res Nurs. 2022 Oct 6:10998004221132247. doi: 10.1177/10998004221132247. Online ahead of print.

ABSTRACT

Food restriction (FR) enhances sensitivity to cardiopulmonary reflexes and α1-adrenoreceptors in females in the presence of hypotension. However, the effect of FR on cardiopulmonary and vascular function in males is not well-understood. This study examines the effects of FR on cardiopulmonary, isolated arterial function, and potential underlying mechanisms. Male Sprague-Dawley (SD) rats were randomly divided into 3 groups and monitored for 5 weeks: (1) control (n = 30), (2) 20% food reduction (FR20, n = 30), and (3) 40% food reduction (FR40, n = 30). Non-invasive blood pressure was measured twice a week. Pulmonary arterial pressure (PAP) was measured using isolated/perfused lungs. The isolated vascular reactivity was assessed using double-wire myographs. FR rats exhibited a lower mean arterial pressure and heart rate; however, only the FR40 group exhibited statistically significant differences. We observed that FR enhanced sensitivity (EC₅₀) to vasoconstriction induced by the α1-adrenoreceptor phenylephrine (PhE) but not to serotonin, U46619, or high K⁺ in the mesenteric arteries. PhE-mediated vasoconstriction in the mesenteric arteries was eliminated in the presence of the eNOS inhibitor (L-NAME). In addition, incubation with NOX2/4 inhibitors (apocynin, GKT137831, and VAS2870) and the reactive oxygen species (ROS) scavenger inhibitor (Tiron) eliminated the differences in PhE-mediated vasoconstriction, but the cyclooxygenase inhibitor (indomethacin) in the mesenteric arteries did not. Augmentation of α1-adrenergic-mediated contraction via the inhibition of the eNOS-NO pathway increased the activation of ROS through NOX2/4 in response to FR. Reduced eNOS-NO signaling may be a pathophysiological counterbalance to prevent hypovolemic shock in response to FR.

PMID:36203228 | DOI:10.1177/10998004221132247

Trials. 2022 Oct 6;23(1):854. doi: 10.1186/s13063-022-06799-4.

ABSTRACT

BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis plan outlines the planned statistical analyses for the TECTO trial.

METHODS: The TECTO trial is an investigator-initiated, independently funded, single-centre, parallel-group, superiority randomised clinical trial. Both groups undergo 14 sessions of 75 min each during a period of 16 weeks with either FCBT or FPRT depending on the allocation. Participants are randomised stratified by age and baseline Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score. The primary outcome is the CY-BOCS score. Secondary outcomes are health-related quality of life assessed using KIDSCREEN-10 and adverse events assessed by the Negative Effects Questionnaire (NEQ). Primary and secondary outcomes are assessed at the end of the intervention. Continuous outcomes will be analysed using linear regression adjusted for the stratification variables and baseline value of the continuous outcome. Dichotomous outcomes will be analysed using logistic regression adjusted for the stratification variables. The statistical analyses will be carried out by two independent blinded statisticians.

DISCUSSION: This statistical analysis plan includes a detailed predefined description of how data will be analysed and presented in the main publication before unblinding of study data. Statistical analysis plans limit selective reporting bias. This statistical analysis plan will increase the validity of the final trial results.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03595098. July 23, 2018.

PMID:36203215 | DOI:10.1186/s13063-022-06799-4

Trials. 2022 Oct 6;23(1):856. doi: 10.1186/s13063-022-06706-x.

ABSTRACT

BACKGROUND: The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in the pandemic to gain insight into and describe the experiences of organisations involved in clinical trials, with regard to the impact of COVID-19 on the conduct of trials, and the adoption of decentralised methods prior to, and as mitigation for the impact, of COVID-19.

METHODS: A survey with 11 open-ended and four multiple choice questions was conducted in June 2020 among member organisations of the public-private “Trials@Home” consortium. The survey investigated (1) the impact and challenges of COVID-19 on the continuation of ongoing clinical trials, (2) the adoption of decentralised methods in clinical trials prior to and as a mitigation strategy for COVID-19, (3) the challenges of conducting clinical trials during COVID-19, (4) the expected permanency of COVID-19-driven changes to the adoption of decentralised methods in clinical trials, and (5) lessons learned from conducting clinical trials during the COVID-19 pandemic. A thematic, inductive analysis of open survey questions was performed, complemented with descriptive statistics (frequencies and distributions).

RESULTS: The survey had a response rate of 81%. All organisations included in the analysis (n = 18) implemented (some) decentralised methods in their clinical trials prior to COVID-19, and 15 (83%) implemented decentralised methods as mitigation for COVID-19. Decentralised methods for IMP supply, patient-health care provider interaction and communication, clinic visits and source document verification were used more often as mitigation strategies than they were used prior to COVID-19. Many respondents expect to maintain those decentralised methods they implemented during COVID-19 in ongoing trials, as well as implement them in future trials.

CONCLUSIONS: Decentralised methods are a widely implemented mitigation strategy for trial conduct in the face of the COVID-19 pandemic. The results of this survey show that there is an interest to continue the use of decentralised methods in future trials, but important points of attention have been identified that need solutions to help guide the transition from the traditional trial model to a more decentralised trial model.

PMID:36203202 | DOI:10.1186/s13063-022-06706-x

Matern Health Neonatol Perinatol. 2022 Oct 6;8(1):8. doi: 10.1186/s40748-022-00143-z.

ABSTRACT

BACKGROUND: Several international studies have indicated an association between socioeconomic deprivation levels and adverse birth outcomes. In contrast, those investigating an association between socioeconomic status and low birth weight using nationwide data are limited in Japan. In this study, we investigated an association between municipal socioeconomic deprivation level and low birth weight by an ecological study.

METHODS: Nationwide municipal-specific Vital Statistics data from 2013 to 2017 were used. We calculated the low birth weight rate and standardized incidence ratio (SIR) for low birth weight for each municipality and plotted them on a Japanese map. Furthermore, the correlation coefficient between them and the deprivation level were calculated. In addition, a spatial regression model including other municipal characteristics was used to investigate an association between low birth weight and the deprivation level.

RESULTS: Municipalities with relatively high SIR for low birth weight were dispersed across all of Japan. The correlation coefficient between the socioeconomic deprivation level and low birth weight rate was 0.196 (p-value < 0.001) among municipalities, and that between the socioeconomic deprivation level and the SIR for low birth weight was 0.260 (p-value < 0.001). In addition, the spatial regression analysis showed the deprivation level was significantly and positively associated with low birth weight.

CONCLUSIONS: The socioeconomic deprivation level and low birth weight were positively associated, and a further study using individual data is warranted to verify reasons for the association.

PMID:36203206 | DOI:10.1186/s40748-022-00143-z

J Pharm Policy Pract. 2022 Oct 6;15(1):59. doi: 10.1186/s40545-022-00455-7.

ABSTRACT

BACKGROUND: To promote an acceptance rate of COVID-19 immunization among Thai children, concerns about parental vaccination hesitancy should be urgently studied. This study aimed to examine the parental COVID-19 vaccination hesitancy (PVh) level and influencing factors among Thai parents of children 5-18 years of age.

METHODS: This cross-sectional survey was conducted in Thailand during May and June of 2022. The Google forms for data collection were distributed to parents (a father, a mother, or one who nurtures and raises a child) via various online social media. Data regarding PVh level, relevant attitudes, experiences of COVID-19 and COVID-19 vaccination (EC&V), and family contexts (FC) were collected and analyzed using descriptive statistics. Mann-Whitney U test was used to compare the differences among groups of parents based on EC&V and FC. The factors influencing PVh were assessed by multiple regression analysis.

RESULTS: Four hundred and eighty-eight parents completed the online questionnaire. Their median (IQR) age was 41 (35-47) years. They lived in different provinces from all regions across Thailand. Ninety percent of them were authorized persons to make decision about children vaccination. Fifty-eight percent of the respondents had vaccine hesitancy, defined as PVh level at moderate or above. Parents who had ever refused COVID-19 vaccination for themselves or refused to vaccinate their children against any other diseases had statistically significant higher levels of PVh (p value < 0.001). Conversely, the parents who had finished the initial COVID-19 vaccine had lower PVh levels with statistical significance (p value = 0.001). Attitude towards COVID-19 (AC), attitude towards COVID-19 vaccine (AV), and perceived behavioral control (PC) of the parents negatively influenced PVh with statistical significance, according to the results of the multiple regression analysis (Betas = – 0.307, – 0.123, and – 0.232, respectively).

CONCLUSIONS: COVID-19 vaccination hesitancy was commonly found among Thai parents. The factors of the hesitancy were multifaceted. Different experiences regarding COVID-19 vaccination for themselves and any vaccinations for their children were associated with different PVhs. The attitudes especially AC, AV, and PC statistically influenced PVh. These findings should be exploited for national and local policy planning as well as public campaigns.

PMID:36203192 | DOI:10.1186/s40545-022-00455-7

BMC Palliat Care. 2022 Oct 6;21(1):174. doi: 10.1186/s12904-022-01059-3.

ABSTRACT

BACKGROUND: Prognostic accuracy is important throughout all stages of the illness trajectory as it has implications for the timing of important conversations and decisions around care. Physicians often tend to over-estimate prognosis and may under-recognize palliative care (PC) needs. It is therefore essential that all relevant stakeholders have as much information available to them as possible when estimating prognosis.

AIMS: The current study examined whether the interRAI Changes in Health, End-Stage Disease, Signs and Symptoms (CHESS) Scale is a good predictor of mortality in a known PC population and to see how it compares to the Palliative Performance Scale (PPS) in predicting 90-day mortality.

METHODS: This retrospective cohort study used data from 2011 to 2018 on 80,261 unique individuals receiving palliative home care and assessed with both the interRAI Palliative Care instrument and the PPS. Logistic regression models were used to evaluate the relationship between the main outcome, 90-day mortality and were then replicated for a secondary outcome examining the number of nursing visits. Comparison of survival time was examined using Kaplan-Meier survival curves.

RESULTS: The CHESS Scale was an acceptable predictor of 90-day mortality (c-statistic = 0.68; p < 0.0001) and was associated with the number of nursing days (c = 0.61; p < 0.0001) and had comparable performance to the PPS (c = 0.69; p < 0.0001). The CHESS Scale performed slightly better than the PPS in predicting 90-day mortality when combined with other interRAI PC items (c = 0.72; p < 0.0001).

CONCLUSION: The interRAI CHESS Scale is an additional decision-support tool available to clinicians that can be used alongside the PPS when estimating prognosis. This additional information can assist with the development of care plans, discussions, and referrals to specialist PC teams.

PMID:36203180 | DOI:10.1186/s12904-022-01059-3

BMC Oral Health. 2022 Oct 6;22(1):438. doi: 10.1186/s12903-022-02480-z.

ABSTRACT

BACKGROUND: Down syndrome (DS), a most frequently occurring genetic disorder, is associated with oral morphological abnormalities and higher incidence rates of oral diseases. Recent studies have analyzed the oral microbiome to elucidate their relationships with oral diseases and general health; however, reports on the oral microbiome in individuals with DS are scarce. This study aimed to characterize the oral microbiome in children with DS.

METHODS: A total of 54 children aged 1-13 years were enrolled in this case-control study. Of these children, 27 had DS (Case: DS group) and 27 were age-matched healthy children (Control: ND group). Saliva in the oral cavity was collected with a swab, cultured, and tested for cariogenic and periodontopathic bacteria by quantitative polymerase chain reaction (qPCR) detection, and the salivary microbiome was analyzed using next-generation sequencing. The student’s t-test, Fisher’s exact test, Mann-Whitney U test, and permutational multivariate analysis of variance were used for statistical analysis.

RESULTS: Results of culture and qPCR detection tests for cariogenic and periodontopathic bacteria showed no significant differences in the detected bacteria between the DS and ND groups, with the exception of a significantly higher detection rate of Candida albicans in children with DS with mixed dentition. A comparison of the salivary microbiomes by 16S sequencing showed no significant difference in α diversity; however, it showed a significant difference in β diversity. Children with DS had a higher relative abundance of Corynebacterium and Cardiobacterium, and lower relative abundance of TM7.

CONCLUSIONS: This study provided basic data on the salivary microbiome of children with DS and showed the microbiological markers peculiar to children with DS. However, further research to identify the relationship with oral diseases is warranted.

PMID:36203175 | DOI:10.1186/s12903-022-02480-z

Diabetol Metab Syndr. 2022 Oct 6;14(1):144. doi: 10.1186/s13098-022-00916-8.

ABSTRACT

AIM: Maternal complications of pregnancy, including hypertensive disorders of pregnancy, gestational diabetes mellitus, intrauterine growth restriction, preterm labour, and placental abruption, are associated with increased risk of future cardiometabolic disease. Lifestyle interventions that focus on preventative strategies for this young, high-risk population of women may assist in cardiometabolic disease risk reduction. The aim of this preliminary registry analysis was to observe the change in maternal metabolic syndrome status after receiving a nurse practitioner-led lifestyle intervention delivered soon after a complicated pregnancy.

METHOD: This preliminary analysis included 64 eligible women who had attended both baseline (approximately 6 months postpartum) and review (approximately eighteen months postpartum) appointments at the postpartum lifestyle clinic after an index pregnancy complicated by at least one maternal complication of pregnancy. Metabolic syndrome status at both appointments was assessed.

RESULTS: At the baseline appointment, 22 (34.4%) women met the criteria for metabolic syndrome. This number reduced at the review appointment to 19 (29.7%). This difference was not statistically significant. There were some modest improvements in the individual cardiometabolic risk factors, as well as marked improvements in the women who had recovered from metabolic syndrome over twelve months.

CONCLUSION: There was a high percentage of metabolic syndrome present early in the postpartum period. The results of this preliminary analysis highlight the importance of continuing preventative care and ongoing research for this group of high-risk women.

PMID:36203165 | DOI:10.1186/s13098-022-00916-8