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Nevin Manimala Statistics

Determinants of nonsuppression of HIV viral load among children receiving antiretroviral therapy in the Simiyu region: a cross-sectional study

AIDS Res Ther. 2023 Apr 13;20(1):22. doi: 10.1186/s12981-023-00515-1.

ABSTRACT

BACKGROUND: Despite substantial antiretroviral therapy (ART) coverage among individuals with human immunodeficiency virus (HIV) infection in Tanzania, viral load suppression (VLS) among HIV-positive children receiving ART remains intolerably low. This study was conducted to determine factors affecting the nonsuppression of VL in children with HIV receiving ART in the Simiyu region; thus, an effective, sustainable intervention to address VL nonsuppression can be developed in the future.

METHODS: We conducted a cross-sectional study including children with HIV aged 2-14 years who were currently presenting to care and treatment clinics in the Simiyu region. We collected data from the children/caregivers and care and treatment center databases. We used Stata™ to perform data analysis. We used statistics, including means, standard deviations, medians, interquartile ranges (IQRs), frequencies, and percentages, to describe the data. We performed forward stepwise logistic regression, where the significance level for removal was 0.10 and that for entry was 0.05. The median age of the patients at ART initiation was 2.0 years (IQR, 1.0-5.0 years), and the mean age at HIV VL (HVL) nonsuppression was 8.8 ± 2.99 years. Of the 253 patients, 56% were female, and the mean ART duration was 64 ± 33.07 months. In multivariable analysis, independent predictors of HVL nonsuppression were older age at ART initiation (adjusted odds ratio [AOR] = 1.21; 95% confidence interval [CI] 1.012-1.443) and poor medication adherence (AOR, 0.06; 95% CI 0.004-0.867).

CONCLUSIONS: This study showed that older age at ART initiation and poor medication adherence play significant roles in HVL nonsuppression. HIV/AIDS programs should have intensive interventions targeting early identification, ART initiation, and adherence intensification.

PMID:37055786 | DOI:10.1186/s12981-023-00515-1

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Effects of preoperative albumin-to-globulin ratio on overall survival and quality of life in esophageal cell squamous carcinoma patients: a prospective cohort study

BMC Cancer. 2023 Apr 13;23(1):342. doi: 10.1186/s12885-023-10809-2.

ABSTRACT

OBJECTIVE: This study aimed to investigate the effect of preoperative albumin-to-globulin ratio (AGR) on overall survival (OS) and health-related quality of life in patients with esophageal cell squamous carcinoma (ESCC).

METHODS: Serum albumin and globulin were measured within one week before surgery. Multiple follow-ups were conducted among patients with ESCC in the study in order to assess their life quality. The method used in the study was a telephone interview. Quality of life was measured using the EORTC Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30, version 3.0) and Esophageal Cancer Module (EORTC QLQ- OES18).

RESULTS: A total of 571 ESCC patients were included in the study. The results illustrated that 5-year OS of high AGR group (74.3%) was better than the low one (62.3%) (P = 0.0068). Univariate and multivariate Cox regression analysis found that preoperative AGR (HR = 0.642, 95%CI: 0.444-0.927) are prognostic factor for patients with ESCC after surgery. In terms of quality of life, found that low AGR associated with increased postoperative time to deterioration (TTD) events in ESCC patients, and compared to low AGR, high AGR could delay the deterioration of emotional functioning(P = 0.001), dysphagia(P = 0.033), trouble with taste(P = 0.043) and speech problems(P = 0.043). After using the multivariate Cox regression analysis showed that high AGR could improve patients’ emotional function (HR = 0.657, 95% CI: 0.507-0.852) and trouble with taste (HR = 0.706, 95% CI: 0.514-0.971).

CONCLUSIONS: Preoperative AGR in patients with ESCC after esophagectomy was positively correlated with overall survival rate and quality of life after operation.

PMID:37055773 | DOI:10.1186/s12885-023-10809-2

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Cross-platform comparison of immune signatures in immunotherapy-treated patients with advanced melanoma using a rank-based scoring approach

J Transl Med. 2023 Apr 13;21(1):257. doi: 10.1186/s12967-023-04092-9.

ABSTRACT

BACKGROUND: Gene expression profiling is increasingly being utilised as a diagnostic, prognostic and predictive tool for managing cancer patients. Single-sample scoring approach has been developed to alleviate instability of signature scores due to variations from sample composition. However, it is a challenge to achieve comparable signature scores across different expressional platforms.

METHODS: The pre-treatment biopsies from a total of 158 patients, who have received single-agent anti-PD-1 (n = 84) or anti-PD-1 + anti-CTLA-4 therapy (n = 74), were performed using NanoString PanCancer IO360 Panel. Multiple immune-related signature scores were measured from a single-sample rank-based scoring approach, singscore. We assessed the reproducibility and the performance in reporting immune profile of singscore based on NanoString assay in advance melanoma. To conduct cross-platform analyses, singscores between the immune profiles of NanoString assay and the previous orthogonal whole transcriptome sequencing (WTS) data were compared through linear regression and cross-platform prediction.

RESULTS: singscore-derived signature scores reported significantly high scores in responders in multiple PD-1, MHC-1-, CD8 T-cell-, antigen presentation-, cytokine- and chemokine-related signatures. We found that singscore provided stable and reproducible signature scores among the repeats in different batches and cross-sample normalisations. The cross-platform comparisons confirmed that singscores derived via NanoString and WTS were comparable. When singscore of WTS generated by the overlapping genes to the NanoString gene set, the signatures generated highly correlated cross-platform scores (Spearman correlation interquartile range (IQR) [0.88, 0.92] and r2 IQR [0.77, 0.81]) and better prediction on cross-platform response (AUC = 86.3%). The model suggested that Tumour Inflammation Signature (TIS) and Personalised Immunotherapy Platform (PIP) PD-1 are informative signatures for predicting immunotherapy-response outcomes in advanced melanoma patients treated with anti-PD-1-based therapies.

CONCLUSIONS: Overall, the outcome of this study confirms that singscore based on NanoString data is a feasible approach to produce reliable signature scores for determining patients’ immune profiles and the potential clinical utility in biomarker implementation, as well as to conduct cross-platform comparisons, such as WTS.

PMID:37055772 | DOI:10.1186/s12967-023-04092-9

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Nevin Manimala Statistics

Are women with preterm labour at risk for negative birth experience? a comparative cross-sectional study from Iran

BMC Pregnancy Childbirth. 2023 Apr 13;23(1):252. doi: 10.1186/s12884-023-05575-9.

ABSTRACT

BACKGROUND: The unpredictable nature of preterm labour can be a stressful experience for the mother. The occurrence of preterm birth can lead to the failure of the mother’s previous expectations regarding the process of labour and birth leading to negative perception towards birth.

METHODS: This descriptive-analytical cross-sectional study was conducted in Tabriz, Iran. We employed convenience sampling to recruit eligible mothers with term birth (314 women) and preterm birth (157 women). Childbirth Experience Questionnaire 2.0, Preterm Birth Experiences and Satisfaction Scale, and Delivery Fear Scale were used to measure the woman’s fear of delivery during labour and birth experience. Data were analysed by general linear model.

RESULTS: The prevalence of negative birth experience in the term and preterm birth groups was 31.8% and 14.3%, respectively. The results of the multivariable general linear model, after the adjustment of demographic and obstetric characteristics, showed that there was no statistically significant difference between the two groups of mothers with term and preterm birth [β (95% CI): -0.06 (-0.22 to 0.09); p = 0.414] in terms of childbirth experience. However, the fear of delivery had a significant relationship with the childbirth experience [-0.02 (-0.03 to -0.01); p < 0.001].

CONCLUSION: There was no statistically significant difference in terms of women’s childbirth experience between the mothers with term and preterm births. The fear of delivery during labour was the predictor of childbirth experience. In order to improve women’s childbirth experience, interventions should be made to reduce their fear during labour.

PMID:37055771 | DOI:10.1186/s12884-023-05575-9

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Nevin Manimala Statistics

Nonlinear analysis of heart rate variability signals in meditative state: a review and perspective

Biomed Eng Online. 2023 Apr 13;22(1):35. doi: 10.1186/s12938-023-01100-3.

ABSTRACT

INTRODUCTION: In recent times, an upsurge in the investigation related to the effects of meditation in reconditioning various cardiovascular and psychological disorders is seen. In majority of these studies, heart rate variability (HRV) signal is used, probably for its ease of acquisition and low cost. Although understanding the dynamical complexity of HRV is not an easy task, the advances in nonlinear analysis has significantly helped in analyzing the impact of meditation of heart regulations. In this review, we intend to present the various nonlinear approaches, scientific findings and their limitations to develop deeper insights to carry out further research on this topic.

RESULTS: Literature have shown that research focus on nonlinear domain is mainly concentrated on assessing predictability, fractality, and entropy-based dynamical complexity of HRV signal. Although there were some conflicting results, most of the studies observed a reduced dynamical complexity, reduced fractal dimension, and decimated long-range correlation behavior during meditation. However, techniques, such as multiscale entropy (MSE) and multifractal analysis (MFA) of HRV can be more effective in analyzing non-stationary HRV signal, which were hardly used in the existing research works on meditation.

CONCLUSIONS: After going through the literature, it is realized that there is a requirement of a more rigorous research to get consistent and new findings about the changes in HRV dynamics due to the practice of meditation. The lack of adequate standard open access database is a concern in drawing statistically reliable results. Albeit, data augmentation technique is an alternative option to deal with this problem, data from adequate number of subjects can be more effective. Multiscale entropy analysis is scantily employed in studying the effect of meditation, which probably need more attention along with multifractal analysis.

METHODS: Scientific databases, namely PubMed, Google Scholar, Web of Science, Scopus were searched to obtain the literature on “HRV analysis during meditation by nonlinear methods”. Following an exclusion criteria, 26 articles were selected to carry out this scientific analysis.

PMID:37055770 | DOI:10.1186/s12938-023-01100-3

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Nevin Manimala Statistics

Effects of intraoperative fluid balance during pancreatoduodenectomy on postoperative pancreatic fistula: an observational cohort study

BMC Surg. 2023 Apr 13;23(1):89. doi: 10.1186/s12893-023-01978-9.

ABSTRACT

BACKGROUND: Perioperative fluid management during major abdominal surgery has been controversial. Postoperative pancreatic fistula (POPF) is a critical complication of pancreaticoduodenectomy (PD). We conducted a retrospective cohort study to analyze the impact of intraoperative fluid balance on the development of POPF.

METHODS: This retrospective cohort study enrolled 567 patients who underwent open pancreaticoduodenectomy, and the demographic, laboratory, and medical data were recorded. All patients were categorized into four groups according to quartiles of intraoperative fluid balance. Multivariate logistic regression and restricted cubic splines (RCSs) were used to analyze the relationship between intraoperative fluid balance and POPF.

RESULTS: The intraoperative fluid balance of all patients ranged from -8.47 to 13.56 mL/kg/h. A total of 108 patients reported POPF, and the incidence was 19.0%. After adjusting for potential confounders and using restricted cubic splines, the dose‒response relationship between intraoperative fluid balance and POPF was found to be statistically insignificant. The incidences of bile leakage, postpancreatectomy hemorrhage, and delayed gastric emptying were 4.4%, 20.8%, and 14.8%, respectively. Intraoperative fluid balance was not associated with these abdominal complications. BMI ≥ 25 kg/m2, preoperative blood glucose < 6 mmol/L, long surgery time, and lesions not located in the pancreas were independent risk factors for POPF.

CONCLUSION: The study did not find a significant association between intraoperative fluid balance and POPF. Well-designed multicenter studies are necessary to explore the association between intraoperative fluid balance and POPF.

PMID:37055753 | DOI:10.1186/s12893-023-01978-9

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Integrated systems immunology approach identifies impaired effector T cell memory responses as a feature of progression to severe dengue fever

J Biomed Sci. 2023 Apr 13;30(1):24. doi: 10.1186/s12929-023-00916-4.

ABSTRACT

BACKGROUND: Typical symptoms of uncomplicated dengue fever (DF) include headache, muscle pains, rash, cough, and vomiting. A proportion of cases progress to severe dengue hemorrhagic fever (DHF), associated with increased vascular permeability, thrombocytopenia, and hemorrhages. Progression to severe dengue is difficult to diagnose at the onset of fever, which complicates patient triage, posing a socio-economic burden on health systems.

METHODS: To identify parameters associated with protection and susceptibility to DHF, we pursued a systems immunology approach integrating plasma chemokine profiling, high-dimensional mass cytometry and peripheral blood mononuclear cell (PBMC) transcriptomic analysis at the onset of fever in a prospective study conducted in Indonesia.

RESULTS: After a secondary infection, progression to uncomplicated dengue featured transcriptional profiles associated with increased cell proliferation and metabolism, and an expansion of ICOS+CD4+ and CD8+ effector memory T cells. These responses were virtually absent in cases progressing to severe DHF, that instead mounted an innate-like response, characterised by inflammatory transcriptional profiles, high circulating levels of inflammatory chemokines and with high frequencies of CD4low non-classical monocytes predicting increased odds of severe disease.

CONCLUSIONS: Our results suggests that effector memory T cell activation might play an important role ameliorating severe disease symptoms during a secondary dengue infection, and in the absence of that response, a strong innate inflammatory response is required to control viral replication. Our research also identified discrete cell populations predicting increased odds of severe disease, with potential diagnostic value.

PMID:37055751 | DOI:10.1186/s12929-023-00916-4

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Clinical and microbiological profiles in post-chemotherapy neutropenic fever in hematological malignancy: exploration of clinical phenotype patterns by two-step cluster analysis

BMC Infect Dis. 2023 Apr 13;23(1):226. doi: 10.1186/s12879-023-08218-8.

ABSTRACT

BACKGROUND: Epidemiology of infectious diseases causing febrile illness varies geographically with human attributes. Periodic institutional surveillance of clinical and microbiological profiles in adding data to updating trends, modulating pharmatherapeutics, signifying possible excessive treatments and risk of drug resistance in post-chemotherapy neutropenic fever (NF) in hematological malignancy (HM) is limited. We aimed to review institutional clinical and microbiological data and explore clinical phenotype pattern groups among data.

METHODS: Available data from 372 NF episodes were included. Demographics, types of malignancies, laboratory data, antimicrobial treatments and febrile-related outcome data such as predominant pathogens and microbiological diagnosed infections (MDIs) were collected. Descriptive statistics, two-step cluster analysis and non-parametric tests were employed.

RESULTS: The occurrences of microbiological diagnosed bacterial infections (MDBIs; 20.2%) and microbiological diagnosed fungal infections (MDFIs; 19.9%) were almost equal. Gram-negative pathogens (11.8%) were comparable with gram-positive pathogens (9.9%), with gram-negative being slightly predominant. Death rate was 7.5%. Two-step cluster analysis yielded four distinct clinical phenotype pattern (cluster) groups: cluster 1 ‘lymphomas without MDIs’, cluster 2 ‘acute leukemias MDBIs’, cluster 3 ‘acute leukemias MDFIs’ and cluster 4 ‘acute leukemias without MDIs’. Considerable NF events with antibiotic prophylaxis being not identified as MDI might have cases in low-risk with non-infectious reasons causing febrile reactions that might possibly not require prophylaxis.

CONCLUSIONS: Regular institutional surveillance with active parameter assessments to signify risk levels in the post-chemotherapy stage, even prior to the onset of fever, might be an evidence-based strategy in the management of NF in HM.

PMID:37055745 | DOI:10.1186/s12879-023-08218-8

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Nevin Manimala Statistics

Specific changes and clinical significance of plasma D-dimer during pregnancy and puerperium: a prospective study

BMC Pregnancy Childbirth. 2023 Apr 13;23(1):248. doi: 10.1186/s12884-023-05561-1.

ABSTRACT

BACKGROUND: Pregnant and puerperal women are high-risk populations for developing venous thromboembolism (VTE). Plasma D-dimer (D-D) is of good value in the diagnosis of exclusion of VTE in the nonpregnant population. Since there is no consensus reference range of plasma D-D applicable to pregnant and puerperal women, the application of plasma D-D is limited. To investigate the change characteristics and the reference range of plasma D-D levels during pregnancy and puerperium and to explore the pregnancy- and childbirth-related factors affecting plasma D-D levels and the diagnostic efficacy of plasma D-D for excluding VTE during early puerperium after caesarean section.

METHODS: A prospective cohort study was conducted with 514 pregnant and puerperal women (cohort 1), and 29 puerperal women developed VTE 24-48 h after caesarean section (cohort 2). In cohort 1, the effects of the pregnancy- and childbirth-related factors on the plasma D-D levels were analyzed by comparing the differences in plasma D-D levels between different groups and between different subgroups. The 95th percentiles were calculated to establish the unilateral upper limits of the plasma D-D levels. The plasma D-D levels at 24-48 h postpartum were compared between normal singleton pregnant and puerperal women in cohort 2 and women from the cesarean section subgroup in cohort 1, binary logistic analysis was used to analyze the relevance between plasma D-D level and the risk of VTE developing 24-48 h after caesarean section, and a receiver operating characteristic (ROC) curve was used to assess the diagnostic efficacy of plasma D-D for excluding VTE during early puerperium after caesarean section.

RESULTS: The 95% reference ranges of plasma D-D levels in the normal singleton pregnancy group were ≤ 1.01 mg/L in the first trimester, ≤ 3.17 mg/L in the second trimester, ≤ 5.35 mg/L in the third trimester, ≤ 5.47 mg/L at 24-48 h postpartum, and ≤ 0.66 mg/L at 42 days postpartum. The plasma D-D levels of the normal twin pregnancy group were significantly higher than those of the normal singleton pregnancy group during pregnancy (P < 0.05), the plasma D-D levels of the GDM group in the third trimester were significantly higher than those of the normal singleton pregnancy group (P < 0.05). The plasma D-D levels of the advanced age subgroup at 24-48 h postpartum were significantly higher than those of the nonadvanced age subgroup (P < 0.05), and the plasma D-D levels of the caesarean section subgroup at 24-48 h postpartum were significantly higher than those of the vaginal delivery subgroup (P < 0.05). The plasma D-D level was significantly correlated with the risk of VTE developing at 24-48 h after caesarean section (OR = 2.252, 95% CI: 1.611-3.149). The optimal cut-off value of plasma D-D for the diagnosis of exclusion of VTE during early puerperium after caesarean section was 3.24 mg/L. The negative predictive value for the diagnosis of exclusion of VTE was 96.1%, and the area under the curve (AUC) was 0.816, P < 0.001.

CONCLUSIONS: The thresholds of plasma D-D levels in normal singleton pregnancy and parturient women were higher than those of nonpregnant women. Plasma D-D had good value in the diagnosis of exclusion of VTE occurring during early puerperium after caesarean section. Further studies are needed to validate these reference ranges and assess the effects of pregnancy- and childbirth-related factors on plasma D-D levels and the diagnostic efficacy of plasma D-D for excluding VTE during pregnancy and puerperium.

PMID:37055718 | DOI:10.1186/s12884-023-05561-1

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The improved health utility of once-weekly subcutaneous semaglutide 2.4 mg compared with placebo in the STEP 1-4 obesity trials

Diabetes Obes Metab. 2023 Apr 13. doi: 10.1111/dom.15090. Online ahead of print.

ABSTRACT

AIMS: Clinicians and regulatory authorities are placing increasing emphasis on health-related quality of life (HRQoL) and health utilities when evaluating therapeutic efficacy of new agents. We assessed health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) trials.

MATERIALS AND METHODS: The STEP 1-4 phase 3a, 68-week, double-blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with BMI ≥30 kg/m2 or BMI ≥27 kg/m2 and ≥1 co-morbidity (STEP 1, 3 and 4), or BMI ≥27 kg/m2 and type 2 diabetes (STEP 2). Patients received lifestyle intervention plus intensive behavioural therapy in STEP 3. HRQoL was assessed using the Short Form 36-item Health Survey version 2 (SF-36v2) at baseline and week 68. Scores were converted into Short Form Six-Dimension version 2 (SF-6Dv2) utility scores or mapped onto the European Quality of Life Five-Dimension Three-Level (EQ-5D-3L) utility index using UK health utility weights.

RESULTS: At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo typically decreased. SF-6Dv2 treatment differences by week 68 for semaglutide versus placebo were significant in STEP 1 and 4 (p≤0.001), but not STEP 2 or 3. EQ-5D-3L treatment differences by week 68 for semaglutide versus placebo were significant in STEP 1, 2 and 4 (p<0.001 for all), but not STEP 3.

CONCLUSIONS: Semaglutide 2.4 mg was associated with improvement in health utility scores compared with placebo, reaching statistical significance in STEP 1, 2 and 4. This article is protected by copyright. All rights reserved.

PMID:37055712 | DOI:10.1111/dom.15090