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Baricitinib or imatinib in hospitalized COVID-19 patients: results from COVINIB, an exploratory randomized clinical trial

J Med Virol. 2023 Jan 13. doi: 10.1002/jmv.28495. Online ahead of print.

ABSTRACT

BACKGROUND: Baricitinib and imatinib are considered therapies for COVID-19, but their ultimate clinical impact remains to be elucidated, so our objective is to determine whether these kinase inhibitors provide benefit when added to standard care in hospitalized COVID-19 patients.

METHODS: Phase-2, open-label, randomized trial with a pick-the-winner design conducted from September 2020 to June 2021 in a single Spanish center. Hospitalized adults with COVID-19 pneumonia and a symptom duration ≤ 10 days were assigned to 3 arms: imatinib (400 mg qd, 7 days) plus standard-care, baricitinib (4 mg qd, 7 days) plus standard-care, or standard-care alone. Primary outcome was time to clinical improvement (discharge alive or a reduction of 2 points in an ordinal scale of clinical status) compared on a day-by-day basis in order to identify differences ≥ 15% between the most and least favorable groups. Secondary outcomes included oxygenation and ventilatory support requirements, additional therapies administered all-cause mortality and safety.

RESULTS: 165 patients analyzed. Predefined criteria for selection of the most advantageous arm were met for baricitinib, but not for imatinib. However, no statistically significant differences were observed in formal analysis, but a trend towards better results in patients receiving baricitinib was found compared to standard care alone (HR for clinical improvement 1.41, 95%CI 0.96-2.06; HR for discontinuing oxygen 1.46, 95%CI 0.94-2.28). No differences were found regarding additional therapies administered or safety.

CONCLUSIONS: Baricitinib plus standard care showed better results for hospitalized COVID-19 patients, being the most advantageous therapeutic strategy among those proposed in this exploratory clinical trial. This article is protected by copyright. All rights reserved.

PMID:36639911 | DOI:10.1002/jmv.28495

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Colchicine and risk of hospitalisation due to COVID-19: a population-based study

J Med Virol. 2023 Jan 13. doi: 10.1002/jmv.28496. Online ahead of print.

ABSTRACT

BACKGROUND: Colchicine is one of the most widely studied and best-known anti-inflammatory treatments. This study aimed to assess the effect of colchicine on risk of hospitalisation due to COVID-19; and its effect on susceptibility to and severity of the virus in patients with COVID-19.

METHODS: We carried out a population-based case-control study. The following groups were applied: (1) to assess risk of hospitalisation , cases were patients with a positive PCR who were hospitalised due to COVID-19, and controls without a positive PCR; (2) to assess susceptibility to COVID-19, cases were patients with a positive PCR (hospitalised and non-hospitalised), and the same controls; (3) to determine potential severity , cases were subjects with COVID-19 hospitalised, and controls patients with COVID-19 non-hospitalised. Different electronic, linked, administrative health and clinical databases were used to extract data on socio-demographic variables, comorbidities, and medications dispensed.

RESULTS: The study covered 3,060 subjects with a positive PCR who were hospitalised, 26,757 with a positive PCR who were not hospitalised, and 56,785 healthy controls. After adjustment for socio-demographic variables, comorbidities and other treatments, colchicine did not modify risk of hospitalisation due to COVID-19 (adjusted OR 1.08 (95%CI 0.76-1.53)), patients’ susceptibility to contracting the disease (adjusted OR 1.12 (95%CI 0.91-1.37)) or the severity of the infection (adjusted OR 1.03 (95%CI 0.67-1.59)).

CONCLUSION: Our results would neither support the prophylactic use of colchicine for prevention of the infection or hospitalisation in any type of patient, nor justify the withdrawal of colchicine treatment due to a higher risk of contracting COVID-19. This article is protected by copyright. All rights reserved.

PMID:36639903 | DOI:10.1002/jmv.28496

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LMS-based continuous reference percentiles for 14 laboratory parameters in the CALIPER cohort of healthy children and adolescents

Clin Chem Lab Med. 2023 Jan 16. doi: 10.1515/cclm-2022-1077. Online ahead of print.

ABSTRACT

OBJECTIVES: Marked physiological changes in growth and development present challenges in defining pediatric reference intervals for biomarkers of health and disease. Lambda, Mu, and Sigma (LMS)-based statistical modeling provides a continuous normal distribution by negating skewness and variation, and is commonly used to establish growth charts. Such LMS reference curves are suggested to enhance laboratory test result interpretation. The current study establishes LMS-based continuous reference percentiles for 14 biomarkers in the CALIPER cohort of healthy children and adolescents.

METHODS: Data from healthy children and adolescents aged 1-<19 years were used to establish continuous reference percentiles using a novel LMS-based statistical method, including 2.5th, 25th, 50th, 75th, and 97.5th percentiles. The LMS approach applies a Box-Cox data transformation and summarizes continuous distributions by age via three curves: skewness (Lambda), median (Mu), and coefficient of variation (Sigma).

RESULTS: LMS-based percentiles and z-scores were generated for 14 common pediatric biomarkers that demonstrate dynamic concentration patterns with age (e.g., alkaline phosphatase) and/or wherein the magnitude of difference from the population mean may be clinically relevant (e.g., triglycerides). The LMS model captured age- and sex-specific distributions accurately and was not substantially influenced by outlying points.

CONCLUSIONS: This is the first study to establish LMS-based continuous reference percentiles for biochemical markers in a healthy Canadian pediatric population. The current LMS-based approach builds upon previous continuous reference interval models by providing graded percentiles to improve test result interpretation, particularly with repeated measures over time. This method may assist in facilitating a patient-centered approach to laboratory medicine.

PMID:36639844 | DOI:10.1515/cclm-2022-1077

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Factors associated for exclusive formula feeding among individuals with low-risk pregnancies in the United States

Birth. 2023 Jan 13. doi: 10.1111/birt.12707. Online ahead of print.

ABSTRACT

BACKGROUND: Better understanding of the factors associated with formula feeding during the hospital stay can help in identifying potential lactation problems and promote early intervention. Our aim was to ascertain factors associated with exclusive formula feeding in newborns of low-risk pregnancies.

METHODS: A population-based, retrospective study using the United States vital statistics datasets (2014-2018) evaluating low-risk pregnancies with a nonanomalous singleton delivery from 37 to 41 weeks. People with hypertensive disorders, or diabetes, were excluded. Primary outcome was newborn feeding (breast vs exclusive formula feeding) during hospital stay. Adjusted relative risks (aRRs) with 95% confidence intervals (CI) were calculated.

RESULTS: Of the 19 623 195 live births during the study period, 11 605 242 (59.1%) met inclusion criteria and among them, 1 929 526 (16.6%) were formula fed. Factors associated with formula feeding included: age < 20 years (aRR 1.31 [95% CI 1.31-1.32]), non-Hispanic Black (1.42, 1.41-1.42), high school education (1.69, 1.69-1.70) or less than high school education (1.94, 1.93, 1.95), Medicaid insurance (1.52, 1.51, 1.52), body mass index (BMI) < 18.5 (1.10, 1.09-1.10), BMI 25-29.9 (1.09, 1.09-1.09), BMI 30-34.9 (1.19, 1.19-1.20), BMI 35-39.9 (1.31, 1.30-1.31), BMI ≥ 40 (1.43, 1.42-1.44), multiparity (1.29, 1.29-1.30), lack of prenatal care (1.49, 1.48-1.50), smoking (1.75, 1.74-1.75), and gestational age (ranged from 37 weeks [1.44, 1.43-1.45] to 40 weeks [1.11, 1.11-1.12]).

CONCLUSIONS: Using a large cohort of low-risk pregnancies, we identified several modifiable factors associated with newborn feeding (eg, prepregnancy BMI, access to prenatal care, and smoking cessation). Improving the breast feeding initiation rate should be a priority in our current practice to ensure equitable care for all neonates.

PMID:36639828 | DOI:10.1111/birt.12707

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Insecticide susceptibility status of Anopheles gambiae (s.l.) in and surrounding areas of Lake Tana, northwest Ethiopia

Trop Med Health. 2023 Jan 13;51(1):3. doi: 10.1186/s41182-023-00497-w.

ABSTRACT

BACKGROUND: Vector control is the most effective malaria control and prevention measure. Among these, IRS and LLINs are the most important chemical insecticide interventions used in malaria prevention and control strategies in Ethiopia. However, the long-term effectiveness of these strategies is under threat due to the emergency and spread of insecticide resistance in the principal malaria vector. Therefore, this study was carried out, under standardized laboratory conditions to assess the killing effect of some insecticides against An. gambiae s.l.

METHODS: Mosquitoes in late instar larvae and pupae stages were collected from different breeding habitats of the study sites using a soup ladle (350 ml capacity). The immature was reared to adults at optimum temperature and humidity in a field insectary using the WHO protocol. Four insecticides representing three chemical classes were used against adult mosquitoes. These were permethrin, deltamethrin, pirimiphos-methyl and bendiocarb. Susceptibility tests were carried out from September to December 2021 using the WHO standard procedures. Mortality rate, variation, interaction effect and knockdown times (KDT50 and KDT95%) were computed using descriptive statistics, multivariate analysis of variance and log-probit regression model using SPSS version 20 software.

RESULTS: Totally, 1300 Anopheles gambiae s.l. were tested to determine the susceptibility status to the four insecticides. Among these, 90.7% of them were susceptible to insecticides, whereas the remaining 9.3% of specimens were resistant to the insecticides. The results of the analysis of variance showed that mortality significantly varied between insecticides (F = 26.06, DF = 3, P < .0001), but not between study locations (F = 1.56, DF = 3, P = 0.212). On the other hand, the mean comparison of dead mosquitoes showed some signs of interaction between bendiocarb and locations, but not other insecticides and locations.

CONCLUSIONS: This study revealed that the knockdown times and effectiveness of different insecticides varied in different study sites. Therefore, insecticide resistance information is very essential for concerned bodies to make informed and evidence-based decisions on vector control.

PMID:36639818 | DOI:10.1186/s41182-023-00497-w

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Pediatric trauma and emergency surgery: an international cross-sectional survey among WSES members

World J Emerg Surg. 2023 Jan 13;18(1):6. doi: 10.1186/s13017-022-00473-5.

ABSTRACT

BACKGROUND: In contrast to adults, the situation for pediatric trauma care from an international point of view and the global management of severely injured children remain rather unclear. The current study investigates structural management of pediatric trauma in centers of different trauma levels as well as experiences with pediatric trauma management around the world.

METHODS: A web-survey had been distributed to the global mailing list of the World Society of Emergency Surgery from 10/2021-03/2022, investigating characteristics of respondents and affiliated hospitals, case-load of pediatric trauma patients, capacities and infrastructure for critical care in children, trauma team composition, clinical work-up and individual experiences with pediatric trauma management in response to patients´ age. The collaboration group was subdivided regarding sizes of affiliated hospitals to allow comparisons concerning hospital volumes. Comparable results were conducted to statistical analysis.

RESULTS: A total of 133 participants from 34 countries, i.e. 5 continents responded to the survey. They were most commonly affiliated with larger hospitals (> 500 beds in 72.9%) and with level I or II trauma centers (82.0%), respectively. 74.4% of hospitals offer unrestricted pediatric medical care, but only 63.2% and 42.9% of the participants had sufficient experiences with trauma care in children ≤ 10 and ≤ 5 years of age (p = 0.0014). This situation is aggravated in participants from smaller hospitals (p < 0.01). With regard to hospital size (≤ 500 versus > 500 in-hospital beds), larger hospitals were more likely affiliated with advanced trauma centers, more elaborated pediatric intensive care infrastructure (p < 0.0001), treated children at all ages more frequently (p = 0.0938) and have higher case-loads of severely injured children < 12 years of age (p = 0.0009). Therefore, the majority of larger hospitals reserve either pediatric surgery departments or board-certified pediatric surgeons (p < 0.0001) and in-hospital trauma management is conducted more multi-disciplinarily. However, the majority of respondents does not feel prepared for treatment of severe pediatric trauma and call for special educational and practical training courses (overall: 80.2% and 64.3%, respectively).

CONCLUSIONS: Multi-professional management of pediatric trauma and individual experiences with severely injured children depend on volumes, level of trauma centers and infrastructure of the hospital. However, respondents from hospitals at all levels of trauma care complain about an alarming lack of knowledge on pediatric trauma management.

PMID:36639810 | DOI:10.1186/s13017-022-00473-5

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Exploring adverse childhood experiences (ACEs) among Ugandan university students: its associations with academic performance, depression, and suicidal ideations

BMC Psychol. 2023 Jan 13;11(1):11. doi: 10.1186/s40359-023-01044-2.

ABSTRACT

BACKGROUND: Adverse childhood experiences (ACEs) among university students have been linked to a variety of factors and have been shown to have a dose-response relationship with adult health and behavior.

OBJECTIVE: To investigate the effect of exposure to ACEs on academic performance, depression, and suicidal ideations among university students.

METHODS: A cross-sectional survey among university students at a public university in southwestern Uganda was conducted in 2021, integrating the Adverse Childhood Experiences International Questionnaire for assessing ACEs, the Patient Health Questionnaire for assessing depression symptoms and suicidal ideations, and questions assessing the family structure and academic performance as adopted from similar studies. Regression analysis was performed, and 3 models were generated to answer the study hypotheses.

RESULTS: A total of 653 undergraduate university students with a mean age of 22.80 (± 3.16) years were recruited. Almost all students (99.8%) experienced one or more ACEs, with physical abuse being the common ACE reported. The average depression symptom severity was statistically higher among individuals who experienced any form of ACEs. No relationship was observed between the ACEs experienced and self-rated academic performance. Similarly, on regression analysis, the cumulative number of ACEs was not associated with self-rated academic performance (β = – 0.007; 95% CI – 0.031 to 0.016; p = 0.558). However, the cumulative number of ACEs was positively associated with depression symptom severity (β = 0.684; 95% CI 0.531-0.837; p < 0.001), as well as increased the likelihood of suicidal ideations (aOR = 1.264; 95% CI 01.090-1.465; p < 0.001).

CONCLUSIONS: The burden of ACEs is exceedingly high among Ugandan university students, highlighting the urgency in strengthening effective child protection strategies to protect Uganda’s rapidly growing population from mental ill-health and avoid future psychological disability, a burden to the healthcare system. The study’s findings will also be useful to practitioners/policymakers working to prevent/limit child maltreatment globally.

PMID:36639808 | DOI:10.1186/s40359-023-01044-2

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Fusion rates based on type of bone graft substitute using minimally invasive scoliosis surgery for adolescent idiopathic scoliosis

BMC Musculoskelet Disord. 2023 Jan 14;24(1):30. doi: 10.1186/s12891-023-06134-1.

ABSTRACT

BACKGROUND: Minimally invasive scoliosis surgery (MISS) is currently introduced on novel technique for surgical treatment of adolescent idiopathic scoliosis (AIS). This study is aimed to evaluate the efficacy of facet fusion in MISS compared to posterior fusion in conventional open scoliosis surgery (COSS) and compare facet fusion rates based on three bone graft substitutes in MISS for adolescent idiopathic scoliosis (AIS).

METHODS: Eighty six AIS patients who underwent scoliosis surgery were divided into two groups: the COSS group and the MISS group. COSS was performed through posterior fusion with allograft. MISS was applied via facet fusion with three bone graft substitutes. The MISS group was further divided into three subgroups based on graft substitute: Group A (allograft), Group B (demineralized bone matrix [DBM]), and group C (demineralized cancellous bone chips). Fusion rate was measured using conventional radiographs to visualize loss of correction > 10°, presence of lysis around implants, breaks in fusion mass, and abnormal mobility of the fused segment.

RESULTS: The fusion rates showed no significant difference in COSS and MISS groups (p = 0.070). In the MISS group, the fusion rates were 85, 100, and 100% in groups A, B, and C, respectively, with no significant difference (p = 0.221). There were no statistical differences between groups A, B, and C in terms of correction rate, fusion rate, and SRS-22 scores (p > 0.05).

CONCLUSIONS: The facet fusion in MISS showed comparable to posterior fusion in COSS with regard to radiological and clinical outcomes. Furthermore, the type of graft substitute among allograft, DBM, and demineralized cancellous bone chips did not affect facet fusion rate or clinical outcomes in MISS. Therefore, MISS showed comparable fusion rate (with no influences on the type of graft substitute) and clinical outcomes to those of COSS in the surgical treatment of AIS.

PMID:36639795 | DOI:10.1186/s12891-023-06134-1

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The prevalence of violence and its association with mental health among the Iranian population in one year after the outbreak of COVID-19 disease

BMC Psychiatry. 2023 Jan 13;23(1):33. doi: 10.1186/s12888-022-04444-7.

ABSTRACT

BACKGROUND: COVID-19 spread between and across nearly every country, with considerable negative health consequences. The current study aimed to determine the prevalence of violence and its association with mental health among Iranians older than 15 years in 2020.

METHODS: Data was collected through National Mental Health Survey on 24,584 Iranians older than 15 years in 2020. were analyzed to determine the prevalence of violence and its association with mental health. Multi-stage sampling method was used, and data on demographic characteristics and domestic-social violence and mental health (GHQ-28) were collected. Data analysis was administered using descriptive statistics and a chi-square test at a 95% level.

RESULTS: The mean age of participants was 44.18 ± 16.4 years. The overall prevalence of domestic and social violence was 11.4% and 5.5%, respectively. Verbal violence was the most common type; with 61.8% and 66.8% for domestic and social violence, respectively. A suspected case of mental disorder, female gender, being younger than 25 years, living apart together, unemployment, low education, and history of COVID-19 infection presented a significant association with domestic and social violence (p > 0.05).

CONCLUSION: In comparison to the previous study in 2015, the prevalence of violence has increased. Therefore, domestic and social violence are the social concerns of Iranian society, indicating the necessity of appropriate interventions, particularly for those suspected of mental disorders and young women with low education levels.

PMID:36639790 | DOI:10.1186/s12888-022-04444-7

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Publisher Correction: A repeated cross-sectional and longitudinal study of mental health and wellbeing during COVID-19 lockdowns in Victoria, Australia

BMC Public Health. 2023 Jan 13;23(1):97. doi: 10.1186/s12889-022-14963-3.

NO ABSTRACT

PMID:36639758 | DOI:10.1186/s12889-022-14963-3