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Nevin Manimala Statistics

Transcriptome analysis reveals the differential inflammatory effects between propofol and sevoflurane during lung cancer resection: a randomized pilot study

World J Surg Oncol. 2023 Jan 16;21(1):8. doi: 10.1186/s12957-023-02891-4.

ABSTRACT

BACKGROUND: Propofol and sevoflurane are two commonly used perioperative anesthetics. Some studies have found that these anesthetic drugs affect tumorigenesis. Previous studies have mostly focused on in vitro experiments, and the specimens collected were mainly peripheral body fluids, lacking direct evidence of the impact of anesthetic drugs on human tissues. This study aimed to elucidate the effects of propofol and sevoflurane on lung cancer using next-generation sequencing through an in vivo experiment.

METHODS: Patients were randomly assigned to a group receiving either propofol or sevoflurane during surgery. Then, the patients’ tumor and paired normal samples were collected and sequenced by next-generation sequencing. Differentially expressed genes (DEG) were analyzed by two statistical models, followed by cluster analysis, PCA, Gene Ontology, and KEGG pathway analysis. Candidate genes were confirmed by qRT-PCR.

RESULTS: The demographic data of the two study groups were not statistically significant. Through single-factor model analysis, 810 DEG in the propofol group and 508 DEG in the sevoflurane group were obtained. To better reflect the differential effects between propofol and sevoflurane while reducing the false-positive DEG, we used multifactor model analysis, which resulted in 124 DEG. In PCA and cluster analysis, four groups (propofol cancer group, propofol normal group, sevoflurane cancer group, sevoflurane normal group) were separated adequately, indicating the accuracy of the analysis. We chose seven significant pathways (cellular response to interleukin-1, chemokine-mediated signaling pathway, chemokine signaling pathway, cytokine-cytokine receptor interaction, inflammatory response, immune response, and TNF signaling pathway) for downstream analysis. Based on the pathway analysis, three candidate genes (CXCR1, CXCL8, and TNFAIP3) were chosen, and their qRT-PCR results were consistent with the sequencing results.

CONCLUSIONS: Through RNA-seq analysis, the effects of propofol and sevoflurane during lung cancer resection were different, mainly in inflammatory-related pathways, which might be possibly by targeting CXCL8.

TRIAL REGISTRATION: Trial registry number was ChiCTR1900026213 .

PMID:36647133 | DOI:10.1186/s12957-023-02891-4

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Nevin Manimala Statistics

Five-year follow-up of mitral valve repair versus replacement: a propensity score analysis

J Cardiothorac Surg. 2023 Jan 16;18(1):27. doi: 10.1186/s13019-023-02144-1.

ABSTRACT

BACKGROUND: Mitral valve repair (MVRe) is considered to have a superior outcome compared to replacement (MVRp) in patients with mitral valve regurgitation (MVR). It was the aim of the study to analyse the clinical results and identify risk factors for short and long-term mortality.

METHODS: In a retrospective single-center analysis, patients undergoing an isolated mitral valve procedure from June 2010 to December 2016 were identified. These were subsequently homogenized using 10 baseline characteristics for propensity-score matching. Comparative analyses were performed for early and long-term results, using adequate statistical tools, and identifying risk factors for the investigated endpoints, primary end-point: all-cause mortality within 5 years and secondary end-points: recurrent MVR, reoperation, endocarditis and/or mortality with 30 days, 1, 3 and 5 years.

RESULTS: 241 patients were identified in the entire patient cohort. After matching, patients were divided into 2 groups of 64 each respectively. The median age was similar in the two groups. There was a significant interaction between early mortality risk of MV in patients with coronary artery disease (CAD) (OR 11.94, 95% CI 1.49-285.92, p = 0.04) and late mortality in patients with higher EuroSCORE II (HR 1.14, 95% CI 1.06-1.23, p < 0.001). The primary end-point showed 5-year survival rate was significantly higher in MVRe versus MVRp (90.06% vs. 79.54% respectively, p = 0.04). The secondary end-point demonstrated recurrent MVR not to be statistically significant between the 2 groups (p = 0.09) as well as reoperation (p = 0.28). Endocarditis was observed in one patient after MVRp.

CONCLUSIONS: We concluded MVRe to be associated with lower operative and 5-year mortality and good postoperative outcomes compared to patients undergoing MVRp. Concomitant CAD was identified as one of the risk factors for increasing the in-hospital mortality rate. There was no significant difference in rehospitalisation over the follow-up period. MVRe should be the treatment of choice for severe MVR and should remain a central aspect in valve centers’ treatment algorithms and quality measures.

PMID:36647129 | DOI:10.1186/s13019-023-02144-1

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Nevin Manimala Statistics

Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART)

Trials. 2023 Jan 16;24(1):29. doi: 10.1186/s13063-022-07007-z.

ABSTRACT

BACKGROUND: MND-SMART is a platform, multi-arm, multi-stage, multi-centre, randomised controlled trial recruiting people with motor neuron disease. Initially, the treatments memantine and trazodone will each be compared against placebo, but other investigational treatments will be introduced into the trial later. The co-primary outcomes are the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R) functional outcome, which is assessed longitudinally, and overall survival.

METHODS: Initially in MND-SMART, participants are randomised 1:1:1 via a minimisation algorithm to receive placebo or one of the two investigational treatments with up to 531 to be randomised in total. The comparisons between each research arm and placebo will be conducted in four stages, with the opportunity to cease further randomisations to poorly performing research arms at the end of stages 1 or 2. The final ALS-FRS-R analysis will be at the end of stage 3 and final survival analysis at the end of stage 4. The estimands for the co-primary outcomes are described in detail. The primary analysis of ALS-FRS-R at the end of stages 1 to 3 will involve fitting a normal linear mixed model to the data to calculate a mean difference in rate of ALS-FRS-R change between each research treatment and placebo. The pairwise type 1 error rate will be controlled, because each treatment comparison will generate its own distinct and separate interpretation. This publication is based on a formal statistical analysis plan document that was finalised and signed on 18 May 2022.

DISCUSSION: In developing the statistical analysis plan, we had to carefully consider several issues such as multiple testing, estimand specification, interim analyses, and statistical analysis of the repeated measurements of ALS-FRS-R. This analysis plan attempts to balance multiple factors, including minimisation of bias, maximising power and precision, and deriving clinically interpretable summaries of treatment effects.

TRIAL REGISTRATION: EudraCT Number, 2019-000099-41. Registered 2 October 2019, https://www.clinicaltrialsregister.eu/ctr-search/search?query=mnd-smart ClinicalTrials.gov, NCT04302870 . Registered 10 March 2020.

PMID:36647114 | DOI:10.1186/s13063-022-07007-z

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Nevin Manimala Statistics

Disparities in routine healthcare utilization disruptions during COVID-19 pandemic among veterans with type 2 diabetes

BMC Health Serv Res. 2023 Jan 16;23(1):41. doi: 10.1186/s12913-023-09057-8.

ABSTRACT

BACKGROUND: While emerging studies suggest that the COVID-19 pandemic caused disruptions in routine healthcare utilization, the full impact of the pandemic on healthcare utilization among diverse group of patients with type 2 diabetes is unclear. The purpose of this study is to examine trends in healthcare utilization, including in-person and telehealth visits, among U.S. veterans with type 2 diabetes before, during and after the onset of the COVID-19 pandemic, by demographics, pre-pandemic glycemic control, and geographic region.

METHODS: We longitudinally examined healthcare utilization in a large national cohort of veterans with new diabetes diagnoses between January 1, 2008 and December 31, 2018. The analytic sample was 733,006 veterans with recently-diagnosed diabetes, at least 1 encounter with veterans administration between March 2018-2020, and followed through March 2021. Monthly rates of glycohemoglobin (HbA1c) measurements, in-person and telehealth outpatient visits, and prescription fills for diabetes and hypertension medications were compared before and after March 2020 using interrupted time-series design. Log-linear regression model was used for statistical analysis. Secular trends were modeled with penalized cubic splines.

RESULTS: In the initial 3 months after the pandemic onset, we observed large reductions in monthly rates of HbA1c measurements, from 130 (95%CI,110-140) to 50 (95%CI,30-80) per 1000 veterans, and in-person outpatient visits, from 1830 (95%CI,1640-2040) to 810 (95%CI,710-930) per 1000 veterans. However, monthly rates of telehealth visits doubled between March 2020-2021 from 330 (95%CI,310-350) to 770 (95%CI,720-820) per 1000 veterans. This pattern of increases in telehealth utilization varied by community type, with lowest increase in rural areas, and by race/ethnicity, with highest increase among non-hispanic Black veterans. Combined in-person and telehealth outpatient visits rebounded to pre-pandemic levels after 3 months. Despite notable changes in HbA1c measurements and visits during that initial window, we observed no changes in prescription fills rates.

CONCLUSIONS: Healthcare utilization among veterans with diabetes was substantially disrupted at the onset of the pandemic, but rebounded after 3 months. There was disparity in uptake of telehealth visits by geography and race/ethnicity.

PMID:36647113 | DOI:10.1186/s12913-023-09057-8

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Nevin Manimala Statistics

Correction: Statistical measures of motor, sensory and cognitive performance across repeated robot-based testing

J Neuroeng Rehabil. 2023 Jan 16;20(1):7. doi: 10.1186/s12984-022-01120-5.

NO ABSTRACT

PMID:36647093 | DOI:10.1186/s12984-022-01120-5

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Nevin Manimala Statistics

Accuracy of a Professional Continuous Glucose Monitoring Device in Individuals with Type 2 Diabetes Mellitus

Kobe J Med Sci. 2022 Oct 3;68(1):E5-E10.

ABSTRACT

Among continuous glucose monitoring (CGM) devices, which continuously measure glucose concentration in subcutaneous interstitial fluid for comprehensive monitoring of blood glucose profile, only FreeStyle Libre Pro® (Abbott Diabetes Care) is currently available in Japan as a professional system. FreeStyle Libre Pro® is easy to use because it does not require calibration by self-monitoring of blood glucose (SMBG), but information on its accuracy has been insufficient. To evaluate the measurement accuracy of FreeStyle Libre Pro®, we have now compared blood glucose levels determined by this device with those measured by SMBG in 40 individuals with type 2 diabetes mellitus. The mean absolute relative difference (MARD) for FreeStyle Libre Pro® measurements compared with SMBG measurements was calculated as an index of CGM accuracy. Overall blood glucose values measured by SMBG were 167.0 ± 60.1 mg/dL, and those determined by FreeStyle Libre Pro® were 155.0 ± 60.7 mg/dL, with this difference being statistically significant. The MARD for FreeStyle Libre Pro® relative to SMBG was 12.7 ± 9.3%. It was substantially higher in 2 of the 40 patients, at 49.2% and 47.5%, than in the other 38 individuals. MARD values did not differ significantly between before and 2 h after meals. However, the MARD was significantly higher for SMBG values of <100 mg/dL than for those of ≥250 mg/dL. Our results thus indicate that the measurement accuracy of FreeStyle Libre Pro® is relatively good, but that some cases in which values determined by the device deviate from SMBG values require caution in interpretation.

PMID:36647081

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Nevin Manimala Statistics

Prevalence and associated factors of delay antenatal care at public health institutions in Gondar city, Northwest Ethiopia, 2021: a cross-sectional study

Contracept Reprod Med. 2023 Jan 16;8(1):2. doi: 10.1186/s40834-022-00197-6.

ABSTRACT

BACKGROUND: Antenatal care is critical for women’s and unborn children’s health. In Ethiopia there is still a delay in getting antenatal care visit in the first trimester as recommended by the World Health Organization. Therefore, the purpose of this study was to assess the prevalence of delayed antenatal care visits and associated factors among pregnant women who attend antenatal care at a public health facility in Gondar town, Northwest Ethiopia.

METHODS: An institutional-based cross-sectional study was conducted between August 20 to September 15/2021. A simple random sampling technique was used to select 392 women. Data were collected using a pre-tested structured questionnaire through a face-to-face interview. Epi Info version 7 and SSPS 26.0 were used for data entry and further analysis. Descriptive statistics and multivariable logistic regression analyses were performed. An adjusted odds ratio with 95% confidence interval at p-value < 0.05 was declared that the outcome can be statistically significant.

RESULTS: A total of 392 study participants with a response rate of 98% were participated. The mean age of study participants was 29.1 ± 6.5 (SD) years. In this study, the prevalence of delay antenatal care was 63.8%( 95% CI: 58.9, 68.9). Age (Adjusted odds ratio = 0.51; 95% CI: 0.28, 0.93), types of health facilities (Adjusted odds ratio = 2.02; 95% CI 🙁 1.12, 3.64), and satisfaction with health service (Adjusted odds ratio = 3.23, 95%CI: (2.02, 5.16) were significantly associated with delay antenatal care.

CONCLUSION: The current study found high prevalence of delay antenatal care. Age between 31 and 34, hospital health facility and satisfaction with health service quality were associated factors for delay antenatal care visit. To begin antenatal care follow-up in the recommended time frame, a collaborative effort between the Minister of Health, health facilities, and relevant stakeholders is needed.

PMID:36647075 | DOI:10.1186/s40834-022-00197-6

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Nevin Manimala Statistics

Plasma concentration and eGFR in preterm and term neonates receiving gentamicin or successive amikacin therapy

BMC Pediatr. 2023 Jan 16;23(1):24. doi: 10.1186/s12887-023-03834-4.

ABSTRACT

BACKGROUND: Gentamicin and amikacin are aminoglycoside antibiotics which are renally excreted and known to be nephrotoxic. Estimate of glomerular filtration rate (eGFR) per body surface area is lower in neonates than in adults and exposure to these drugs could lead to more suppression in kidney function. The aim of this study was to determine maximum and minimum plasma concentrations (Cmax and Cmin), time to reach Cmin levels of gentamicin and amikacin, and to assess eGFR in preterm and term neonates.

METHODS: Two groups of patients were recruited, 44 neonates receiving gentamicin (5 mg/kg/24 h) and 35 neonates receiving amikacin (15 mg/kg/24 h) by slow intravenous injection. Patients on amikacin had been on gentamicin before being switched to amikacin. Two blood samples were drawn for the determination of the maximum and minimum plasma concentration. Primary outcomes were determination of Cmax, Cmin, and the time it took to clear the aminoglycoside to a plasma concentration below the toxicity threshold (gentamicin: < 1 mcg/mL; amikacin: < 5 mcg/mL.

RESULTS: Therapeutic range for Cmax of gentamicin (15-25 mcg/mL) or amikacin (30-40 mcg/mL) was achieved in only 27.3 and 2.9% of neonates, respectively. Percentage of neonates reaching plasma concentrations below the toxicity threshold within the 24-hour dosing interval was 72.7% for gentamicin and 97.1% for amikacin. Positive correlation between gentamicin clearance and postnatal age borderline statistical significance (p = 0.007), while the correlation between amikacin clearance and postnatal age was poor and not statistically significant (r2 = – 0.30, p = 0.971).

CONCLUSION: Although eGFR decreased significantly as a function of postnatal age in neonates receiving amikacin, the majority (91.4%) of these neonates were able to clear the drug to < 5 mcg/mL within a 24-hour dosing interval.

PMID:36647065 | DOI:10.1186/s12887-023-03834-4

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Nevin Manimala Statistics

Cortical Grey matter volume depletion links to neurological sequelae in post COVID-19 “long haulers”

BMC Neurol. 2023 Jan 17;23(1):22. doi: 10.1186/s12883-023-03049-1.

ABSTRACT

OBJECTIVE: COVID-19 (SARS-CoV-2) has been associated with neurological sequelae even in those patients with mild respiratory symptoms. Patients experiencing cognitive symptoms such as “brain fog” and other neurologic sequelae for 8 or more weeks define “long haulers”. There is limited information regarding damage to grey matter (GM) structures occurring in COVID-19 “long haulers”. Advanced imaging techniques can quantify brain volume depletions related to COVID-19 infection which is important as conventional Brain MRI often fails to identify disease correlates. 3-dimensional voxel-based morphometry (3D VBM) analyzes, segments and quantifies key brain volumes allowing comparisons between COVID-19 “long haulers” and normative data drawn from healthy controls, with values based on percentages of intracranial volume.

METHODS: This is a retrospective single center study which analyzed 24 consecutive COVID-19 infected patients with long term neurologic symptoms. Each patient underwent Brain MRI with 3D VBM at median time of 85 days following laboratory confirmation. All patients had relatively mild respiratory symptoms not requiring oxygen supplementation, hospitalization, or assisted ventilation. 3D VBM was obtained for whole brain and forebrain parenchyma, cortical grey matter (CGM), hippocampus, and thalamus.

RESULTS: The results demonstrate a statistically significant depletion of CGM volume in 24 COVID-19 infected patients. Reduced CGM volume likely influences their long term neurological sequelae and may impair post COVID-19 patient’s quality of life and productivity.

CONCLUSION: This study contributes to understanding effects of COVID-19 infection on patient’s neurocognitive and neurological function, with potential for producing serious long term personal and economic consequences, and ongoing challenges to public health systems.

PMID:36647063 | DOI:10.1186/s12883-023-03049-1

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Nevin Manimala Statistics

Direct and indirect medical costs of bladder cancer in Iran

Cost Eff Resour Alloc. 2023 Jan 16;21(1):5. doi: 10.1186/s12962-023-00416-0.

ABSTRACT

BACKGROUND: Bladder cancer is one of the most prevalent and costly cancers in the world. Estimating the economic burden of bladder cancer is essential for allocating resources to different sectors of health systems and determining the appropriate payment mechanisms. The present study aimed at estimating the economic burden of bladder cancer in Iran.

METHODS: In this study, we used a prevalence-based approach for estimating the economic burden of bladder cancer. Direct and indirect costs of bladder cancer were calculated using the cost of illness and human capital approaches. Data were collected using a researcher-made checklist obtained from several sources including Iran bladder cancer clinical practice guideline, the Statistical Center of Iran, Iran’s Ministry of Cooperatives, Labor, and Social Welfare, Relative Value of Health Services (RVHS) book and Iranian Food and Drug Administration organization. The analyses were done by Microsoft Excel 2013 and Stata 13.

RESULTS: The number of the cases of 5-year prevalence of bladder cancer in Iran was estimated as 21,807 people in 2018. The economic burden of bladder cancer in Iran was estimated at US$ 86,695,474. Indirect medical costs constituted about two-third of the economic burden of bladder cancer, and mostly related to productivity loss due to mortality. Most of the direct medical costs (29.7%) were related to the stage T2-T3 and transurethral resection of bladder (31.01%) and radical cystectomy (19.99%) procedures.

CONCLUSION: Our results showed that the costs of bladder cancer, imposed on the healthcare system, were significant and mostly related to lost production costs. The implementation of screening and diagnostic programs can improve the survival rate and quality of life of patients and reduce the cost of lost productivity due to mortality in these patients.

PMID:36647054 | DOI:10.1186/s12962-023-00416-0