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Severe Respiratory Disease Among Children With and Without Medical Complexity During the COVID-19 Pandemic

JAMA Netw Open. 2023 Nov 1;6(11):e2343318. doi: 10.1001/jamanetworkopen.2023.43318.

ABSTRACT

IMPORTANCE: Severe respiratory disease declined during the COVID-19 pandemic, partially due to decreased circulation of respiratory pathogens. However, the outcomes of children with higher risk have not been described using population-based data.

OBJECTIVE: To compare respiratory-related hospitalizations, intensive care unit (ICU) admissions, and mortality during the pandemic vs prepandemic, among children with medical complexity (CMC) and without medical complexity (non-CMC).

DESIGN, SETTING, AND PARTICIPANTS: This population-based repeated cross-sectional study used Canadian health administrative data of children aged younger than 18 years in community and pediatric hospitals during a pandemic period (April 1, 2020, to February 28, 2022) compared with a 3-year prepandemic period (April 1, 2017, to March 31, 2020). The pandemic period was analyzed separately for year 1 (April 1, 2020, to March 31, 2021) and year 2 (April 1, 2021, to February 28, 2022). Statistical analysis was performed from October 2022 to April 2023.

MAIN OUTCOMES AND MEASURES: Respiratory-related hospitalizations, ICU admissions, and mortality before and during the pandemic among CMC and non-CMC.

RESULTS: A total of 139 078 respiratory hospitalizations (29 461 respiratory hospitalizations for CMC and 109 617 for non-CMC) occurred during the study period. Among CMC, there were fewer respiratory hospitalizations in both 2020 (rate ratio [RR], 0.44 [95% CI, 0.42-0.46]) and 2021 (RR, 0.55 [95% CI, 0.51-0.62]) compared with the prepandemic period. Among non-CMC, there was an even larger relative reduction in respiratory hospitalizations in 2020 (RR, 0.18 [95% CI, 0.17-0.19]) and a similar reduction in 2021 (RR, 0.55 [95% CI, 0.54-0.56]), compared with the prepandemic period. Reductions in ICU admissions for respiratory illness followed a similar pattern for CMC (2020: RR, 0.56 [95% CI, 0.53-0.59]; 2021: RR, 0.66 [95% CI, 0.63-0.70]) and non-CMC (2020: RR, 0.22 [95% CI, 0.20-0.24]; RR, 0.65 [95% CI, 0.61-0.69]). In-hospital mortality for these conditions decreased among CMC in both 2020 (RR, 0.63 [95% CI, 0.51-0.77]) and 2021 (RR, 0.72 [95% CI, 0.59-0.87]).

CONCLUSIONS AND RELEVANCE: This cross-sectional study found a substantial decrease in severe respiratory disease resulting in hospitalizations, ICU admissions, and mortality during the first 2 years of the pandemic compared with the 3 prepandemic years. These findings suggest that future evaluations of the effect of public health interventions aimed at reducing circulating respiratory pathogens during nonpandemic periods of increased respiratory illness may be warranted.

PMID:37962886 | DOI:10.1001/jamanetworkopen.2023.43318

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Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

JAMA Netw Open. 2023 Nov 1;6(11):e2343425. doi: 10.1001/jamanetworkopen.2023.43425.

ABSTRACT

IMPORTANCE: Industry involvement is prominent in influential clinical trials, and commitments to transparency of trials are highly variable.

OBJECTIVE: To evaluate the modes of industry involvement and the transparency features of the most cited recent clinical trials across medicine.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was a meta-research assessment including randomized and nonrandomized clinical trials published in 2019 or later. The 600 trials of any type of disease or setting that attracted highest number of citations in Scopus as of December 2022 were selected for analysis. Data were analyzed from March to September 2023.

MAIN OUTCOMES AND MEASURES: Outcomes of interest were industry involvement (sponsor, author, and analyst) and transparency (protocols, statistical analysis plans, and data and code availability).

RESULTS: Among 600 trials with a median (IQR) sample size of 415 (124-1046) participants assessed, 409 (68.2%) had industry funding and 303 (50.5%) were exclusively industry-funded. A total of 354 trials (59.0%) had industry authors, with 280 trials (46.6%) involving industry analysts and 125 trials (20.8%) analyzed exclusively by industry analysts. Among industry-funded trials, 364 (89.0%) reached conclusions favoring the sponsor. Most trials (478 trials [79.7%]) provided a data availability statement, and most indicated intention to share the data, but only 16 trials (2.7%) had data already readily available to others. More than three-quarters of trials had full protocols (482 trials [82.0%]) or statistical analysis plans (446 trials [74.3%]) available, but only 27 trials (4.5%) explicitly mentioned sharing analysis code (8 readily available; 19 on request). Randomized trials were more likely than nonrandomized studies to involve only industry analysts (107 trials [22.9%] vs 18 trials [13.6%]; P = .02) and to have full protocols (405 studies [86.5%] vs 87 studies [65.9%]; P < .001) and statistical analysis plans (373 studies [79.7%] vs 73 studies [55.3%]; P < .001) available. Almost all nonrandomized industry-funded studies (90 of 92 studies [97.8%]) favored the sponsor. Among industry-funded trials, exclusive industry funding (odds ratio, 2.9; 95% CI, 1.5-5.4) and industry-affiliated authors (odds ratio, 2.9; 95% CI, 1.5-5.6) were associated with favorable conclusions for the sponsor.

CONCLUSIONS AND RELEVANCE: This cross-sectional study illustrates how industry involvement in the most influential clinical trials was prominent not only for funding, but also authorship and provision of analysts and was associated with conclusions favoring the sponsor. While most influential trials reported that they planned to share data and make both protocols and statistical analysis plans available, raw data and code were rarely readily available.

PMID:37962883 | DOI:10.1001/jamanetworkopen.2023.43425

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Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine – a one-year randomized clinical trial study

Acta Odontol Scand. 2023 Nov 14:1-6. doi: 10.1080/00016357.2023.2281486. Online ahead of print.

ABSTRACT

Periodontitis is a bacterial-induced disease and for this reason controlling the microbiota is a necessity. Therapy includes self-performed daily oral hygiene in combination with supra- and sub-gingival instrumentation. An adjunctive antimicrobial agent may improve the outcome.

AIMS: To assess whether a chloramine (Perisolv®) has an adjunctive effect to non-surgical periodontal therapy and whether non-surgical periodontal therapy affects quality of life.

MATERIAL AND METHODS: Thirty-eight patients were randomized to a test or a control group. Clinical indices were performed at baseline and at three and twelve months. In the test group, Perisolv® was applied initially and after the sub-gingival instrumentation in pathological pockets. Oral health-related quality of life was measured with the Oral Health Impact Profile (OHIP) instrument at baseline and twelve months.

RESULTS: In both groups, an initial probing pocket depth (PPD) of > 4 mm and bleeding on probing (BOP) were statistically reduced (p < 0.002 and p < 0.002 respectively) at twelve months and after adjustment for Bonferroni. There were no significant differences between the test and the control group in terms of the number of PPD, BOP or plaque index, or in the mean OHIP score.

CONCLUSIONS: Chloramine did not have an adjunctive effect, but the overall therapy was significantly efficacious both clinically and in terms of quality of life.

TRIAL REGISTRATION: Registered at www.clinicaltrials.gov: NCT05757921.

PMID:37962876 | DOI:10.1080/00016357.2023.2281486

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Does Gaia Play Dice? Simple Models of Non-Darwinian Selection

Astrobiology. 2023 Nov;23(11):1238-1244. doi: 10.1089/ast.2023.0036.

ABSTRACT

In this article, we introduce some simple models, based on rolling dice, to explore mechanisms proposed to explain planetary habitability. The idea is to study these selection mechanisms in an analytically tractable setting, isolating their consequences from other details which can confound or obscure their effect in more realistic models. We find that the observable of interest, the face value shown on the die, “improves” over time in all models. For two of the more popular ideas, Selection by Survival and Sequential Selection, this is down to sampling effects. A modified version of Sequential Selection, Sequential Selection with Memory, implies a statistical tendency for systems to improve over time. We discuss the implications of this and its relationship to the ideas of the “Inhabitance Paradox” and the “Gaian bottleneck.”

PMID:37962839 | DOI:10.1089/ast.2023.0036

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Implementation of an electroencephalogram-guided propofol anesthesia practice in a large academic pediatric hospital: A quality improvement project

Paediatr Anaesth. 2023 Nov 14. doi: 10.1111/pan.14791. Online ahead of print.

ABSTRACT

BACKGROUND: Propofol-based total intravenous anesthesia is gaining popularity in pediatric anesthesia. Electroencephalogram can be used to guide propofol dosing to the individual patient to mitigate against overdosing and adverse events. However, electroencephalogram interpretation and propofol pharmacokinetics are not sufficiently taught in training programs to confidently deploy electroencephalogram-guided total intravenous anesthesia.

AIMS: We conducted a quality improvement project with the smart aim of increasing the percentage of electroencephalogram-guided total intravenous anesthesia cases in our main operating room from 0% to 80% over 18 months. Balancing measures were number of total intravenous anesthesia cases, emergence times, and perioperative emergency activations.

METHODS: The project key drivers were education, equipment, and electronic health record modifications. Plan-Do-Study-Act cycles included: (1) providing journal articles, didactic lectures, intraoperative training, and teaching documents; (2) scheduling electroencephalogram-guided total intravenous anesthesia teachers to train faculty, staff, and fellows for specific cases and to assess case-based knowledge; (3) adding age-based propofol dosing tables and electroencephalogram parameters to the electronic health record (EPIC co, Verona, WI); (4) procuring electroencephalogram monitors (Sedline, Masimo Inc). Electroencephalogram-guided total intravenous anesthesia cases and balancing measures were identified from the electronic health record. The smart aim was evaluated by statistical process control chart.

RESULTS: After the four Plan-Do-Study-Act cycles, electroencephalogram-guided total intravenous anesthesia increased from 5% to 75% and was sustained at 72% 9 months after project completion. Total intravenous anesthesia cases/mo and number of perioperative emergency activations did not change significantly from start to end of the project, while emergence time for electroencephalogram-guided total intravenous anesthesia was greater statistically but not clinically (total intravenous anesthesia without electroencephalogram [16 ± 10 min], total intravenous anesthesia with electroencephalogram [18 ± 9 min], sevoflurane [17 ± 9 min] p < .001).

CONCLUSION: Quality improvement methods may be deployed to adopt electroencephalogram-guided total intravenous anesthesia in a large academic pediatric anesthesia practice. Keys to success include education, in operating room case training, scheduling teachers with learners, electronic health record modifications, and electroencephalogram devices and supplies.

PMID:37962837 | DOI:10.1111/pan.14791

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Dimensional Reduction in Barriers and Facilitators to Pre-exposure Prophylaxis (PrEP) Uptake Willingness for Full-Service Sex Workers

Arch Sex Behav. 2023 Nov 14. doi: 10.1007/s10508-023-02742-z. Online ahead of print.

ABSTRACT

Full-Service Sex Workers (FSSWs) face heightened risk of acquiring HIV, yet exhibit relatively low adoption of pre-exposure prophylaxis (PrEP)-an antiviral that substantially reduces HIV acquisition risk. Little work examines barriers and facilitators to PrEP uptake willingness among FSSWs. This study aimed to identify the distinct components of barriers and facilitators to PrEP uptake willingness for FSSWs. Here, we subjected 19 PrEP barriers and facilitators identified in the literature to a principal component analysis (PCA) among a sample of 83 FSSWs. Preliminary statistics supported factorability of data. PCA revealed three distinct components of barriers and facilitators that explained 62.80% of the total variance in survey responses. We labeled these components Behavioral and Social Concerns (α = 0.93), Access and Affordability (α = 0.67), and Biologically Based Health Concerns (α = 0.79). This study shows promise for future clinical and research utility of these factors and provides a basis for future psychometric studies of barriers and facilitators to PrEP uptake willingness among FSSWs.

PMID:37962828 | DOI:10.1007/s10508-023-02742-z

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Shear wave elastography as a non-invasive tool for staging liver fibrosis in children: A study in Algerian pediatric patients

Indian J Gastroenterol. 2023 Nov 14. doi: 10.1007/s12664-023-01464-3. Online ahead of print.

ABSTRACT

BACKGROUND: Traditionally, liver biopsy has been the gold standard for fibrosis staging. However, it is an invasive, expensive and uncomfortable procedure that is associated with the risk of complications. Thus, non-invasive methods such as shear wave elastography (SWE) have been developed as potential alternatives to liver biopsy. The aim of this study is to evaluate the diagnostic performance of SWE in pediatric patients with liver fibrosis, specifically in a group of Algerian children and to determine whether this method can be a reliable alternative to liver biopsy.

METHODS: This prospective, descriptive, monocentric study evaluated the non-invasive diagnostic performance of 2D-SWE in assessing liver fibrosis in pediatric patients. The assessment was carried out using various statistical methods, including Spearman’s correlation coefficient, Kappa concordance coefficients, regression analysis, as well as the calculation of area under the receiver operating characteristic (AUROC) values and corresponding cut-off points based on the receiver operating characteristic (ROC) curve.

RESULTS: Our study found that 2D-SWE is strongly correlated with liver biopsy in estimating liver fibrosis in children, with a correlation coefficient greater than 0.8. Furthermore, the Kappa correlation coefficients exceeded 0.8, indicating a strong agreement between 2D-SWE and liver biopsy results. The AUROC value was not less than 0.9 for significant fibrosis and above (≥ F2), indicating that it has satisfactory diagnostic performance in detecting liver fibrosis in children.

CONCLUSION: 2D-SWE shows promise as a non-invasive method for evaluating liver fibrosis in children, offering a potential alternative to liver biopsy. Larger studies are needed to substantiate the findings of this study and to confirm the accuracy and reliability of 2D-SWE for assessing liver fibrosis in children.

PMID:37962819 | DOI:10.1007/s12664-023-01464-3

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Joint Involvement Can Predict Chikungunya in a Dengue Syndemic Setting in India

J Epidemiol Glob Health. 2023 Nov 14. doi: 10.1007/s44197-023-00163-8. Online ahead of print.

ABSTRACT

Dengue and chikungunya have been endemic in India but have the tendency to cause periodic epidemics, often together, wherein they are termed ‘syndemic’. Such a syndemic was observed in 2016 in India which resulted in a further scarcity of already resource-poor specific diagnostic infrastructure even in many urban conglomerates. A cross-sectional study was thus conducted, on 978 fever patients that consulted the ICMR-NIMR fever clinic, New Delhi, in September 2016, with an objective to identify symptom/s that could predict chikungunya with certainty. The overall aim was to rationally channelize the most clinically suitable patients for the required specific diagnosis of chikungunya. Based on their clinical profile, febrile patients attending NIMR’s clinic, appropriate laboratory tests and their association analyses were performed. Bivariate analysis on 34 clinical parameters revealed that joint pain, joint swelling, rashes, red spots, weakness, itching, loss of taste, red eyes, and bleeding gums were found to be statistically significantly associated predictors of chikungunya as compared to dengue. While, in multivariate analysis, only four symptoms (joint pain in elbows, joint swelling, itching and bleeding gums) were found in statistically significant association with chikungunya. Hence, based on the results, a clinician may preferably channelize febrile patients with one or more of these four symptoms for chikungunya-specific diagnosis and divert the rest for dengue lab diagnosis in a dengue-chikungunya syndemic setting.

PMID:37962782 | DOI:10.1007/s44197-023-00163-8

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Associations of telomere length with risk of mortality from influenza and pneumonia in US adults: a prospective cohort study of NHANES 1999-2002

Aging Clin Exp Res. 2023 Nov 14. doi: 10.1007/s40520-023-02607-4. Online ahead of print.

ABSTRACT

BACKGROUND: Due to the ongoing Coronavirus disease 2019 (COVID-19) pandemic, interest has arisen to realize the relationship between telomere length (TL) and influenza and pneumonia mortality.

AIM: Our study attempted to investigate this correlation by analyzing information gathered from the National Health and Nutrition Examination Survey (NHANES) 1999-2002.

METHODS: A total of 7229 participants were involved in the conducted research. We utilized Cox proportional risk model analysis to determine the hazard ratio (HR) and 95% confidence interval (CI) for TL and influenza and pneumonia mortality.

RESULTS: During the average follow-up time of 204.10 ± 51.26 months, 33 (0.45%) participants died from influenza and pneumonia. After adjusting for multiple variables, shorter TL was associated with higher influenza-pneumonia mortality. In subgroup analyses stratified by sex, men exhibited stronger associations with influenza-pneumonia mortality than women (Model 1: HRmale: 0.014 vs HRfemale: 0.054; Model 2: HRmale: 0.082 vs HRfemale: 0.890; Model 3: HRmale: 0.072 vs HRfemale: 0.776). For subgroup analyses by visceral adiposity index (VAI), all statistically significant (P < 0.05) models displayed an inverse relationship between TL and influenza and pneumonia mortality.

CONCLUSIONS: Our research provides further proof for the connection between shorter telomeres and higher influenza-pneumonia mortality. Larger prospective researches are essential to support our results and explain the underlying mechanisms.

PMID:37962763 | DOI:10.1007/s40520-023-02607-4

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Early mobilisation in critically ill COVID-19 patients: a subanalysis of the ESICM-initiated UNITE-COVID observational study

Ann Intensive Care. 2023 Nov 14;13(1):112. doi: 10.1186/s13613-023-01201-1.

ABSTRACT

BACKGROUND: Early mobilisation (EM) is an intervention that may improve the outcome of critically ill patients. There is limited data on EM in COVID-19 patients and its use during the first pandemic wave.

METHODS: This is a pre-planned subanalysis of the ESICM UNITE-COVID, an international multicenter observational study involving critically ill COVID-19 patients in the ICU between February 15th and May 15th, 2020. We analysed variables associated with the initiation of EM (within 72 h of ICU admission) and explored the impact of EM on mortality, ICU and hospital length of stay, as well as discharge location. Statistical analyses were done using (generalised) linear mixed-effect models and ANOVAs.

RESULTS: Mobilisation data from 4190 patients from 280 ICUs in 45 countries were analysed. 1114 (26.6%) of these patients received mobilisation within 72 h after ICU admission; 3076 (73.4%) did not. In our analysis of factors associated with EM, mechanical ventilation at admission (OR 0.29; 95% CI 0.25, 0.35; p = 0.001), higher age (OR 0.99; 95% CI 0.98, 1.00; p ≤ 0.001), pre-existing asthma (OR 0.84; 95% CI 0.73, 0.98; p = 0.028), and pre-existing kidney disease (OR 0.84; 95% CI 0.71, 0.99; p = 0.036) were negatively associated with the initiation of EM. EM was associated with a higher chance of being discharged home (OR 1.31; 95% CI 1.08, 1.58; p = 0.007) but was not associated with length of stay in ICU (adj. difference 0.91 days; 95% CI – 0.47, 1.37, p = 0.34) and hospital (adj. difference 1.4 days; 95% CI – 0.62, 2.35, p = 0.24) or mortality (OR 0.88; 95% CI 0.7, 1.09, p = 0.24) when adjusted for covariates.

CONCLUSIONS: Our findings demonstrate that a quarter of COVID-19 patients received EM. There was no association found between EM in COVID-19 patients’ ICU and hospital length of stay or mortality. However, EM in COVID-19 patients was associated with increased odds of being discharged home rather than to a care facility. Trial registration ClinicalTrials.gov: NCT04836065 (retrospectively registered April 8th 2021).

PMID:37962748 | DOI:10.1186/s13613-023-01201-1