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Nevin Manimala Statistics

Respiratory Distress Syndrome is Associated with Increased Morbidity and Mortality in Late Preterm Births

Am J Obstet Gynecol MFM. 2024 Apr 5:101374. doi: 10.1016/j.ajogmf.2024.101374. Online ahead of print.

ABSTRACT

BACKGROUND: Respiratory Distress Syndrome (RDS) is strongly associated with prematurity, including late preterm births. RDS has been shown to be associated with certain neonatal morbidities and mortality, but these associations are not well described among late preterm births.

OBJECTIVE: We sought to determine the association between RDS and adverse neonatal outcomes among late preterm (34-36 weeks) born singleton neonates.

STUDY DESIGN: This is a retrospective cohort study using California’s linked vital statistics-patient discharge data (2008-2019). We included singleton, non-anomalous births with gestational age of 34-36 weeks. Outcomes of interest were interventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), neonatal sepsis, length of hospital stay, neonatal death and infant death. Chi-square and multivariable Poisson regression analyses were used to examine the association of RDS with outcomes at each gestational age. Adjusted risk ratios (aRR) and 95% confidence intervals (CI) were estimated.

RESULTS: A total of 242,827 births were included, of which 11,312 (4.7%) had RDS. We found that among neonates with RDS, NEC was higher at 35 weeks (aRR= 3.97; 95% CI: 1.88, 8.41) and 36 weeks (aRR= 4.53; 95% CI: 1.45, 14.13). IVH, ROP, neonatal sepsis and length of hospital stay were significantly higher at 34-36 weeks’ gestation in neonates with RDS. Neonatal death was significantly higher among neonates with RDS at 35 weeks (aRR=3.04; 95% CI: 1.58, 5.85) and 36 weeks (aRR=3.25; 95% CI: 1.59, 6.68). Infant death was also significantly higher at 35 weeks (aRR=2.27; 95% CI: 1.43, 3.61) and 36 weeks (aRR=2.60; 95% CI: 1.58, 4.28).

CONCLUSION: We found that RDS was associated with IVH, ROP and sepsis at 34-36 weeks’ gestation; while RDS was associated with neonatal death, infant death and NEC at 35 and 36 weeks. Clinicians should keep these outcomes in mind when making decisions about delivery timing and the potential benefits of antenatal steroids in pregnancies in the late preterm period as well as management of RDS in late preterm neonates.

PMID:38583712 | DOI:10.1016/j.ajogmf.2024.101374

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Incidence, Predictors and Outcomes of Non-Home Discharge Following Transcatheter Aortic Valve Implantation: A Multicentre Australian Experience – The NHD TAVI Study

Am J Cardiol. 2024 Apr 5:S0002-9149(24)00235-2. doi: 10.1016/j.amjcard.2024.04.001. Online ahead of print.

ABSTRACT

Patients undergoing transcatheter aortic valve implantation (TAVI) commonly experience non-home discharge (NHD), a phenomenon associated with increased health-care expenditure and possibly poorer outcomes. Despite its clinical relevance in TAVI, the incidence and predictors of NHD and its impact on quality of life remain poorly characterised. Also unknown is the proportion of TAVI patients that require long-term residential care following initial NHD. Therefore, we aimed to address these questions using a large and multi-centre Australian cohort. 2229 patients undergoing TAVI from 2010-2023 included in the Alfred-Cabrini-Epworth TAVI Registry were analysed. Median age was 82 (IQR: 78-86) years and 41% were female. 257 (12%) patients were not discharged home following TAVI, with incidence falling over time (R2=0.636, p<0.001). Multivariable logistic regression modelling for NHD prediction was developed with excellent calibration and discrimination (C-Statistic 0.835). Independent predictors of NHD were post-procedural stroke (adjusted odds ratio [aOR] 11.05), procedure at a private hospital (aOR 3.01), living alone (aOR 2.35), vascular access site complications (aOR 2.09), frailty (aOR 1.89), age>80 (aOR 1.82), hypoalbuminemia (aOR 1.76), NYHA III-IV (aOR 1.74) and hospital length of stay (aOR 1.13) (all p<0.05). NHD was not associated with mortality at 30-days and less than one percent of all patients required longer-term residential care. In conclusion, while common following TAVI, NHD does not predict short-term mortality, most patients successfully return home within 30-days and when used appropriately, NHD may serve as a brief and effective method of optimising functional status without compromising long-term independence.

PMID:38583699 | DOI:10.1016/j.amjcard.2024.04.001

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HPA axis function in patients with right and left focal lateralized epilepsy

Neuro Endocrinol Lett. 2024 Apr 7;45(2). Online ahead of print.

ABSTRACT

OBJECTIVES: There is a complex, reciprocal link between epilepsy and the hypothalami pituitary-adrenal (HPA) axis. This study aimed to evaluate the role of the HPA axis in individuals with focal epilepsy, including those with right- or left-hemispheric lateralized epilepsy.

MATERIAL AND METHODS: The study comprised 60 individuals with focal epilepsy, ages 18 to 85, with seizures coming from a single hemisphere, no destructive lesions on cranial magnetic resonance imaging, and 32 healthy persons. Blood was drawn from the patient and control groups at 8.00 for serum cortisol level and at 23.00 for serum melatonin level. The Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale were administered to both the patient and control groups.

RESULTS: Patients showed decreased melatonin levels (p < 0.001) and poorer sleep quality (p = 0.035). The cortisol level of the patients was found to be lower than the cortisol level of healthy individuals, although it was not statistically significant (p = 0.107). Cortisol and melatonin levels did not significantly differ between patients with seizures coming from the right or left hemisphere. The patients with seizures originating from the left hemisphere had a longer duration of epilepsy disease (p = 0.013), higher seizure frequency (p = 0.013), lower age of first seizure onset (p = 0.038), and a higher rate of polytherapy (p = 0.05).

CONCLUSION: Low cortisol and melatonin levels in patients with focal epilepsy may be an indicator of disruption in the HPA axis. There is no significant difference in the HPA axis function between patients with focal epilepsy according to the epileptic hemisphere.

PMID:38583190

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CD14 Polymorphism Is Not Associated with SARS-CoV-2 Infection in Central European Population

Folia Biol (Praha). 2023;69(5-6):181-185. doi: 10.14712/fb2023069050181.

ABSTRACT

A 2021 in silico study highlighted an association between the CD14 polymorphism rs2569190 and increased susceptibility to SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19). The aim of our study was to confirm this finding. We analysed the CD14 polymorphism (C→T; rs2569190) in 516 individuals who tested positive for SARS-CoV-2, with differing disease severity (164 asymptomatic, 245 symptomatic, and 107 hospitalized). We then compared these patients with a sample from the general population consisting of 3,037 individuals using a case-control study design. In comparison with carriers of the C allele, TT homozygotes accounted for 21.7 % of controls and 20.5 % in SARS-CoV-2-positive individuals (P = 0.48; OR; 95 % CI – 0.92; 0.73-1.16). No significant differences in the distribution of genotypes were found when considering co-dominant and recessive genetic models or various between-group comparisons. The CD14 polymorphism is unlikely to be an important predictor of COVID-19 in the Caucasian population in Central Europe.

PMID:38583179 | DOI:10.14712/fb2023069050181

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Does Mixing Activated Charcoal With Cola Improve Tolerability Without Affecting Pharmacokinetics? A Randomized Controlled Crossover Trial

J Emerg Nurs. 2024 Apr 6:S0099-1767(24)00077-1. doi: 10.1016/j.jen.2024.03.001. Online ahead of print.

ABSTRACT

INTRODUCTION: Activated charcoal is the most common form of gastrointestinal decontamination used for the poisoned patient. One limitation to its use is patient tolerability due to palatability. Some recommend mixing activated charcoal with cola to improve palatability. An important question is whether mixing activated charcoal with cola affects the ability of the activated charcoal to adsorb xenobiotic.

METHODS: This was a prospective randomized controlled crossover trial. Five healthy adults aged 18 to 40 years were recruited. Participants received 45 mg/kg acetaminophen rounded down to the nearest whole tablet. One hour later, they were randomized to receive 50 g of an activated charcoal-water premixture alone or mixed with cola. Acetaminophen levels were collected. The area under the curve of acetaminophen concentrations over time was measured as a marker for degree of absorption. Participants also completed an appeal questionnaire in which they rated the activated charcoal preparations. Participants would then return after at least 7 days to repeat the study with the other activated charcoal preparation.

RESULTS: Four male participants and 1 female participant were recruited. There was no statistical difference in preference score for activated charcoal alone versus the cola-activated charcoal mixture. There was no statistical difference in the area under the curve of acetaminophen concentrations over time between activated charcoal alone and the cola-activated charcoal mixture. Of note, the study is limited by the small sample size, limiting its statistical power.

DISCUSSION: The absorption of acetaminophen in an overdose model is no different when participants received activated charcoal alone or a cola-activated charcoal mixture as suggested by area under the curve. In this small study, there was no difference in preference for activated charcoal alone or a cola-activated charcoal mixture across a range of palatability questions. On an individual level, some participants preferred the activated charcoal-cola mixture, and some preferred the activated charcoal alone.

PMID:38583171 | DOI:10.1016/j.jen.2024.03.001

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Near-infrared fluorescence lymph node template region dissection plus backup lymphadenectomy in open radical cystectomy for bladder cancer using an innovative handheld device: A single center experience

J Surg Oncol. 2024 Apr 7. doi: 10.1002/jso.27618. Online ahead of print.

ABSTRACT

BACKGROUND: The extent of pelvic lymphadenectomy (PLND) as part of radical cystectomy (RC) for bladder cancer (BC) remains unclear. Sentinel-based and lymphangiographic approaches could lead to reduced morbidity without sacrificing oncologic safety.

OBJECTIVE: To evaluate the feasibility and diagnostic value of fluorescence-guided template sentinel region dissection (FTD) using a handheld near-infrared fluorescence (NIRF) camera in open radical cystectomy.

DESIGN, SETTING, AND PARTICIPANTS: After peritumoral cystoscopic injection of indocyanine green (ICG) 21 patients underwent open RC with FTD due to BC between June 2019 and June 2021. Intraoperatively, the FIS-00 Hamamatsu Photonics® NIRF camera was used to identify and resect fluorescent template sentinel regions (FTRs) followed by extended pelvic lymphadenectomy (ePLND) as oncological back-up.

OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Descriptive analysis of positive and negative results per template region.

RESULTS AND LIMITATIONS: FTRs were identified in all 21 cases. Median time (range) from ICG injection to fluorescence detection was 75 (55-125) minutes. On average (SD), 33.4 (9.6) lymph nodes were dissected per patient. Considering template regions as the basis of analysis, 67 (38.3%) of 175 resected regions were NIRF-positive, with 13 (7.4%) regions harboring lymph node metastases. We found no metastatic lymph nodes in NIRF-negative template regions. Outside the standard template, two NIRF-positive benign nodes were identified.

CONCLUSION: The concept of NIRF-guided FTD proved for this group all lymph node metastases to be found in NIRF-positive template regions. Pending validation in a larger collective, resection of approximately 40% of standard regions may be sufficient and may result in less morbidity.

PMID:38583145 | DOI:10.1002/jso.27618

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Massed written exposure therapy delivered to veterans with posttraumatic stress symptoms on an acute inpatient mental health unit

J Trauma Stress. 2024 Apr 7. doi: 10.1002/jts.23042. Online ahead of print.

ABSTRACT

Written exposure therapy (WET) is a brief, manualized trauma-focused treatment typically delivered in five individual weekly sessions. Given the brevity and effectiveness of WET, researchers have begun to focus on its delivery in a massed format. However, only one case study examining massed delivery has been published to date. As such, the objective of the current study was to examine the acceptability, feasibility, and preliminary effectiveness of massed WET among veterans with a trauma- and stressor-related disorder receiving care on an acute inpatient mental health unit. Veterans (N = 26) were assessed prior to, immediately after, and 1 month following massed WET. Most veterans found massed WET to be useful and acceptable. Recruitment and retention rates suggested that the treatment was feasible. Notably, the results revealed statistically significant reductions in overall posttraumatic stress symptoms, ηp 2 = .81, p < .001; depressive symptoms, ηp 2 = .71, p < .001; and functional impairment, ηp 2 = .42, p = .002. These findings add to a growing body of literature highlighting the preliminary effectiveness of WET across various settings, populations, and delivery formats. Limitations include the small sample size and uncontrolled design.

PMID:38583141 | DOI:10.1002/jts.23042

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Yoga-based lifestyle intervention for healthy ageing in older adults: a two-armed, waitlist randomized controlled trial with multiple primary outcomes

Geroscience. 2024 Apr 7. doi: 10.1007/s11357-024-01149-5. Online ahead of print.

ABSTRACT

Yoga-based clinical research has shown considerable promise in varied ageing-related health outcomes in older adults. However, robust frameworks have yet to be used in intervention research to endorse yoga as a healthy ageing intervention to test the multidimensional construct of healthy ageing. This was an assessor-masked, randomized controlled trial conducted among 258 sedentary, community-dwelling older adults aged 60-80 years, randomly allocated to 26-week yoga-based intervention (YBI) (n = 132) or waitlist control (WLC) (n = 126). The effectiveness of YBI was assessed through two separate global statistical tests, generalized estimating equations and rank sum-based test, against a comprehensive healthy aging panel comprised of ten markers representing the domains of physiological and metabolic, cognitive, physical capability, psychological, and social well-being. The secondary outcomes were individual primary marker scores, Klotho, inflammatory markers, and auxiliary blood markers. We could establish the healthy aging effect of the 26-week YBI over WLC using two models of global statistical test (GEE, β = 0.29; 95% CI = 0.20 to 0.38, p < 0.001), and rank sum-based test (β = 0.28, 95% CI = 0.19 to 0.36, p < 0.001). There were also significant improvements in direction of benefit at individual levels of all the aging markers. Exploratory evaluation with adopted indices from contemporary clinical trials also validated the potential of YBI for healthy aging; HATICE adapted composite score (mean difference = – 0.18; 95% CI = – 0.26 to – 0.09, p < 0.001) and healthy ageing index (mean difference = – 0.33; 95% CI = – 0.63 to – 0.02, p = 0.03). The global effect of YBI across multiple ageing-related outcomes provides a proof of concept for further large-scale validation. The findings hold a great translational value given the accelerated pace of population aging across the globe. Trial registration: CTRI/2021/02/031373.

PMID:38583114 | DOI:10.1007/s11357-024-01149-5

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Value of Information for Clinical Trial Design: The Importance of Considering All Relevant Comparators

Pharmacoeconomics. 2024 Apr 7. doi: 10.1007/s40273-024-01372-0. Online ahead of print.

ABSTRACT

Value of Information (VOI) analyses calculate the economic value that could be generated by obtaining further information to reduce uncertainty in a health economic decision model. VOI has been suggested as a tool for research prioritisation and trial design as it can highlight economically valuable avenues for future research. Recent methodological advances have made it increasingly feasible to use VOI in practice for research; however, there are critical differences between the VOI approach and the standard methods used to design research studies such as clinical trials. We aimed to highlight key differences between the research design approach based on VOI and standard clinical trial design methods, in particular the importance of considering the full decision context. We present two hypothetical examples to demonstrate that VOI methods are only accurate when (1) all feasible comparators are included in the decision model when designing research, and (2) all comparators are retained in the decision model once the data have been collected and a final treatment recommendation is made. Omitting comparators from either the design or analysis phase of research when using VOI methods can lead to incorrect trial designs and/or treatment recommendations. Overall, we conclude that incorrectly specifying the health economic model by ignoring potential comparators can lead to misleading VOI results and potentially waste scarce research resources.

PMID:38583100 | DOI:10.1007/s40273-024-01372-0

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A novel scoring system for early prediction of massive transfusion requirement in trauma patients

Intern Emerg Med. 2024 Apr 7. doi: 10.1007/s11739-024-03541-7. Online ahead of print.

ABSTRACT

Early resuscitation using blood products is critical for patients with severe hemorrhagic shock. We aimed to develop and validate a new scoring system, hemorrhagic shock transfusion prediction (HSTP) score, to predict the need for massive transfusion (MT) in these patients, compared to the widely used Assessment of Blood Consumption (ABC) score. Trauma patients admitted to Emtiaz Hospital in Iran from 2017 to 2021 were retrospectively included. Patients assigned a code 1 or 2 according to the Emergency severity index (ESI) triage system have been divided into MT and non-MT groups. MT was defined as receiving ≥ 10 units of packed cells (PCs) in 24 h. Demographic information, admission vital signs, and lab results available within 15 min were compared between the groups. A new predictive score was developed using logistic regression of statistically significant parameters. Out of 1029 patients, 651 (63.3%) required MT. An arrival, diastolic blood pressure < 79.5 mm Hg, absolute lymphocyte count > 1850/μL, base excess < – 4.25, and blood glucose > 156 mg/dL were independent predictors included in the HSTP score. The sensitivity and specificity were 74.36% and 53.87% for the HSTP score, compared to 31.03% and 76.16% for the ABC score. Moreover, the positive and negative predictive values were 77.88% and 49.03% for the HSTP score, versus 74.15% and 33.66% for ABC. The new scoring system demonstrated higher sensitivity and improved positive and negative predictive values compared to the ABC score. This score can assist physicians in making accurate transfusion decisions quickly, but further prospective studies are warranted to validate its clinical utility.

PMID:38583098 | DOI:10.1007/s11739-024-03541-7