Category: Nevin Manimala

Pediatr Int. 2023 Mar 5:e15520. doi: 10.1111/ped.15520. Online ahead of print.

ABSTRACT

BACKGROUND: Concerns about the safety and adverse reactions of rapidly developed vaccines against COVID-19 contributed to parents’ vaccine hesitancy and this situation created an opportunity for anti-vaccine campaigners. The aim of this study is to examine the changes in parents’ attitudes towards childhood vaccines during the course of COVID-19 pandemic.

METHODS: In this cross-sectional study, parents of children who applied to the outpatient clinic of pediatric department of Trakya University Hospital between August 2020 and February 2021 were recruited into two study groups according to COVID-19 peak time in Türkiye. Group 1 included parents who applied after first peak of COVID-19 pandemic and Group 2 included parents of children who applied after second peak. The WHO’s 10-item Vaccine Hesitancy Scale was applied to each group.

RESULTS: 610 parents agreed to participate in the study. Group 1 and 2 consisted of 160 and 450 parents, respectively. While the number of parents who were hesitant about childhood vaccines was 17 (10.6 %) in Group 1, it was 90 (20 %) in Group 2. Statistically significant difference was found between the two groups (p = 0.008). The WHO’s 10-item Vaccine Hesitancy Scale mean score was found to be higher in Group 2 (23.7 ± 6.9) than Group 1 (21.3 ± 7.3) (p < 0.001). The WHO’s 10-item Vaccine Hesitancy Scale mean scores (20.0 ± 6.5) of parents who experienced COVID-19 infection themselves or their family or acquaintances had significantly lower than those who did not (24.7 ± 6.9) (p < 0.001).

CONCLUSIONS: The hesitant attitudes towards childhood and COVID-19 vaccines were low in parents who somehow encountered COVID-19 or were worried about the devastating effects of this disease. On the other hand, it has been shown that as the COVID-19 pandemic progresses, parents’ hesitations towards childhood vaccines increase.

PMID:36872424 | DOI:10.1111/ped.15520

J Educ Eval Health Prof. 2023;20:2. doi: 10.3352/jeehp.2023.20.2. Epub 2023 Jan 18.

ABSTRACT

PURPOSE: This study evaluated the validity of student feedback derived from Medicine Student Experience Questionnaire (MedSEQ), as well as the predictors of students’ satisfaction in the Medicine program.

METHODS: Data from MedSEQ applying to the University of New South Wales Medicine program in 2017, 2019, and 2021 were analyzed. Confirmatory factor analysis (CFA) and Cronbach’s α were used to assess the construct validity and reliability of MedSEQ respectively. Hierarchical multiple linear regressions were used to identify the factors that most impact students’ overall satisfaction with the program.

RESULTS: A total of 1,719 students (34.50%) responded to MedSEQ. CFA showed good fit indices (root mean square error of approximation=0.051; comparative fit index=0.939; chi-square/degrees of freedom=6.429). All factors yielded good (α>0.7) or very good (α>0.8) levels of reliability, except the “online resources” factor, which had acceptable reliability (α=0.687). A multiple linear regression model with only demographic characteristics explained 3.8% of the variance in students’ overall satisfaction, whereas the model adding 8 domains from MedSEQ explained 40%, indicating that 36.2% of the variance was attributable to students’ experience across the 8 domains. Three domains had the strongest impact on overall satisfaction: “being cared for,” “satisfaction with teaching,” and “satisfaction with assessment” (β=0.327, 0.148, 0.148, respectively; all with P<0.001).

CONCLUSION: MedSEQ has good construct validity and high reliability, reflecting students’ satisfaction with the Medicine program. Key factors impacting students’ satisfaction are the perception of being cared for, quality teaching irrespective of the mode of delivery and fair assessment tasks which enhance learning.

PMID:36872423 | DOI:10.3352/jeehp.2023.20.2

Int Urol Nephrol. 2023 Mar 6. doi: 10.1007/s11255-023-03539-8. Online ahead of print.

ABSTRACT

BACKGROUND: Amelioration of proteinuria is one of main treatment targets in patients with glomerulonephritis, yet the remission rates are suboptimal.

AIM OF THE STUDY: To examine the effect of the sodium-glucose transporter 2 inhibitor (empagliflozin) on proteinuria and kidney function progression, in patients with glomerulonephritis not due to diabetic kidney diseases.

SUBJECTS AND METHODS: Fifty patients were recruited. The entry criteria were diagnosis of glomerulonephritis, and proteinuria (proteinuria ≥ 500 mg⁄g) in spite of the use of the maximal tolerated dose of RAAS blocking agents together with specific immunosuppression treatment regimens. Group 1 (Empagliflozin arm): 25 patients who received 25 mg of empagliflozin once daily for 3 months as add-on to their regular treatment protocol (RAAS blockers and immunosuppression). Group 2 (Placebo arm): 25 patients treated with RAAS blockers and immunosuppression. The primary efficacy endpoints were the change in creatinine eGFR, and proteinuria 3 months after starting treatment.

RESULTS: Progression of proteinuria was lower with empagliflozin as compared to placebo (odds ratio, 0.65; 95% CI, 0.55 to 0.72, p = 0.002). Decline in eGFR was lower with empagliflozin as compared to placebo; however, this was statistically not significant (odds ratio, 0.84; 95% CI, 0.82 to 1.2, p = .31). The percentage change in proteinuria was greater with empagliflozin as compared to placebo (median, – 77 (- 97-105) vs – 48 (- 80-117).

CONCLUSION: Empagliflozin has a favorable effect on amelioration of proteinuria in patients with glomerulonephritis. Empagliflozin has tendency to preserve kidney function in patients with glomerulonephritis as compared to placebo; however, longer term studies are required.

PMID:36872420 | DOI:10.1007/s11255-023-03539-8

J Egypt Natl Canc Inst. 2023 Mar 6;35(1):5. doi: 10.1186/s43046-023-00165-4.

ABSTRACT

BACKGROUND: Multi-parametric magnetic resonance imaging may improve the detection of prostate cancer. The aim of this work is to compare between PI-RADS 3-5 and PI-RADS 4-5 as a threshold for targeted prostatic biopsy.

METHODS: This is a prospective clinical study that included 40 biopsy-naïve patients referred for prostate biopsy. Patients underwent prebiopsy multi-parametric (mp-MRI), followed by 12-core transrectal ultrasound-guided systematic biopsy and cognitive MRI/TRUS fusion targeted biopsy from each detected lesion. The primary endpoint was to assess the diagnostic accuracy of the PI-RAD 3-4 versus PI-RADS 4-5 lesion by mpMRI for prostate cancer detection in biopsy-naive men.

RESULTS: The overall prostate cancer detection rate and the clinically significant cancer detection rate were 42.5% and 35%, respectively. Targeted biopsies from PI-RADS 3-5 lesions showed a sensitivity of 100%, specificity of 44%, positive predictive value of 51.7%, and negative predictive value of 100%. Restricting targeted biopsies to PI-RADS 4-5 lesions resulted in a decrease in sensitivity and negative predictive value to 73.3% and 86.2%, respectively, while specificity and positive predictive value were increased to 100% for both parameters which was statistically significant (P value < 0.0001 and P value = 0.004, respectively).

CONCLUSIONS: Limiting the TBs to PI-RADS 4-5 lesions improves the performance of mp-MRI in the detection of prostate cancer especially aggressive tumors.

PMID:36872409 | DOI:10.1186/s43046-023-00165-4

Neuropsychol Rev. 2023 Mar 6. doi: 10.1007/s11065-023-09582-7. Online ahead of print.

ABSTRACT

Performance validity tests (PVTs) are used to measure the validity of the obtained neuropsychological test data. However, when an individual fails a PVT, the likelihood that failure truly reflects invalid performance (i.e., the positive predictive value) depends on the base rate in the context in which the assessment takes place. Therefore, accurate base rate information is needed to guide interpretation of PVT performance. This systematic review and meta-analysis examined the base rate of PVT failure in the clinical population (PROSPERO number: CRD42020164128). PubMed/MEDLINE, Web of Science, and PsychINFO were searched to identify articles published up to November 5, 2021. Main eligibility criteria were a clinical evaluation context and utilization of stand-alone and well-validated PVTs. Of the 457 articles scrutinized for eligibility, 47 were selected for systematic review and meta-analyses. Pooled base rate of PVT failure for all included studies was 16%, 95% CI [14, 19]. High heterogeneity existed among these studies (Cochran’s Q = 697.97, p < .001; I² = 91%; τ² = 0.08). Subgroup analysis indicated that pooled PVT failure rates varied across clinical context, presence of external incentives, clinical diagnosis, and utilized PVT. Our findings can be used for calculating clinically applied statistics (i.e., positive and negative predictive values, and likelihood ratios) to increase the diagnostic accuracy of performance validity determination in clinical evaluation. Future research is necessary with more detailed recruitment procedures and sample descriptions to further improve the accuracy of the base rate of PVT failure in clinical practice.

PMID:36872398 | DOI:10.1007/s11065-023-09582-7

Eur J Drug Metab Pharmacokinet. 2023 Mar 5. doi: 10.1007/s13318-023-00821-z. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Understanding predictive potential of parameters to perform early bioequivalence (BE) risk assessment is crucial for good planning and risk mitigation during product development. The objective of the present study was to evaluate predictive potential of various biopharmaceutical and pharmacokinetic parameters on the outcome of BE study.

METHODS: Retrospective analysis was performed on 198 Sandoz (Lek Pharmaceuticals d.d., A Sandoz Company, Verovskova 57, 1526 Ljubljana, Slovenia) sponsored BE studies [52 active pharmaceutical ingredients (API)] where characteristics of BE study and APIs were collected for immediate-release products and their predictive potential on the study outcome was assessed using univariate statistical analysis.

RESULTS: Biopharmaceutics Classification System (BCS) was confirmed to be highly predictive of BE success. BE studies with poorly soluble APIs were riskier (23% non-BE) than with highly soluble APIs (0.1% non-BE). APIs with either lower bioavailability (BA), presence of first-pass metabolism, and/or being substrate for P-glycoprotein substrate (P-gP) were associated with higher non-BE occurrence. In silico permeability and time at peak plasma concentrations (T_max) were shown as potentially relevant features for predicting BE outcome. In addition, our analysis showed significantly higher occurrence of non-BE results for poorly soluble APIs with disposition described by multicompartment model. The conclusions for poorly soluble APIs were the same on a subset of fasting BE studies; for a subset of fed studies there were no significant differences between factors in BE and non-BE groups.

CONCLUSION: Understanding the association of parameters and BE outcome is important for further development of early BE risk assessment tools where focus should be first in finding additional parameters to differentiate BE risk within a group of poorly soluble APIs.

PMID:36872388 | DOI:10.1007/s13318-023-00821-z

Eur J Pediatr. 2023 Mar 6. doi: 10.1007/s00431-023-04902-8. Online ahead of print.

ABSTRACT

Pancreatitis is the most common adverse event following endoscopic retrograde cholangiopancreatography (ERCP). Meanwhile, the national temporal trend of post-ERCP pancreatitis (PEP) in children remains to be reported. The purpose of this study is to investigate the temporal trend and factors associated with PEP in children. We conducted a nationwide study using data from the National Inpatient Sample database during 2008-2017 and included all patients aged ≤ 18 years who underwent ERCP. The primary outcomes were temporal trends and factors associated with PEP. The secondary outcomes were in-hospital mortality, total charges (TC), and total length of stay (LOS). A total of 45,268 hospitalized pediatric patients who underwent ERCP were analyzed; of whom, 2043 (4.5%) were diagnosed with PEP. The prevalence of PEP decreased from 5.0% in 2008 to 4.6% in 2017 (P = 0.0002). In multivariable logistic analysis, adjusted risk factors of PEP were hospitals located in the West (aOR 2.09, 95% CI 1.36-3.20; P < .0001), bile duct stent insertion (aOR 1.49, 95% CI, 1.08-2.05; P = 0.0040), and end-stage renal disease (aOR 8.05, 95% CI 1.66-39.16; P = 0.0098). Adjusted protective factors of PEP were increasing age (aOR 0.95, 95% CI 0.92-0.98; P = 0.0014) and hospitals located in the South (aOR 0.53, 95% CI 0.30-0.94; P < .0001). In-hospital mortality, TC, and LOS were higher in patients with PEP than those without PEP.

CONCLUSION: This study shows a decreasing national trend over time and identifies multiple protective and risk factors for pediatric PEP. Endoscopists can use the insights from this study to evaluate relevant factors before performing ERCP in children to prevent PEP and reduce the medical-care burden.

WHAT IS KNOWN: • Although ERCP has become indispensable procedure in children as they are in adults, education and training programs for ERCP in children are underdeveloped in many countries. • PEP is the most common and most serious adverse event following ERCP. Research on PEP in adults showed rising hospital admission and mortality rates associated with PEP in the USA.

WHAT IS NEW: • The national temporal trend of PEP among pediatric patients in the USA was decreasing from 2008 to 2017. • Older age was a protective factor for PEP in children, while end-stage renal disease and stent insertion into the bile duct were risk factors.

PMID:36872379 | DOI:10.1007/s00431-023-04902-8

Curr Microbiol. 2023 Mar 5;80(4):124. doi: 10.1007/s00284-023-03225-z.

ABSTRACT

The objective of the study was to determine the efficacy of ultrasound-treatment Saccharomyces cerevisiae and spray drying in preserving the viability of Lactiplantibacillus plantarum. The combination of ultrasound-treated S. cerevisiae and L. plantarum was evaluated. Next, the mixture was blended with maltodextrin and either Stevia rebaudiana-extracted fluid, prior to undergoing spray drying. The L. plantarum viability was assessed after the spray drying process, during storage, and in simulated digestive fluid (SDF) conditions. The results showed that the impact of ultrasound caused the crack and holes in the yeast cell wall. Besides, the moisture content values were not significantly different in all samples after spray drying. Although the amount of powder recovery in stevia-supplemented samples was not higher than that of the control sample, the L. plantarum viability was significantly improved after the spray drying process. The density of L. plantarum tended to be stable during the first 30 days of storage and decreased more rapidly after that. The results reveal that there was no statistically significant difference in the trend of the samples before and after storage. In the SDF test, the L. plantarum viability mixing with ultrasound-treated yeast cells in the spray drying samples was significantly improved. Besides, the presence of Stevia showed positive efficiency on the L. plantarum viability. The L. plantarum viability mixing with ultrasound-treated yeast cells and stevia-extracted fluid by spray drying process showed potential application due to making powder form which helped to improve the L. plantarum stability during the storage time.

PMID:36872377 | DOI:10.1007/s00284-023-03225-z

J Intensive Care. 2023 Mar 5;11(1):8. doi: 10.1186/s40560-023-00656-5.

ABSTRACT

BACKGROUND: The development of disseminated intravascular coagulation (DIC) in patients with sepsis has been repeatedly confirmed as a factor associated with poor prognosis. Anticoagulant therapy has been expected to improve sepsis patient outcomes, whereas no randomized controlled trials have demonstrated the survival benefit of anticoagulant therapies in non-specific overall sepsis. Patient selection based on the component of “high disease severity” in addition to “sepsis with DIC” has recently proved important in identifying appropriate targets for anticoagulant therapy. The aims of this study were to characterize “severe” sepsis DIC patients and to identify the patient population benefiting from anticoagulant therapy.

METHODS: This retrospective sub-analysis of a prospective multicenter study included 1,178 adult patients with severe sepsis from 59 intensive care units in Japan from January 2016 to March 2017. We examined the association of patient outcomes, including organ dysfunction and in-hospital mortality, with the DIC score and prothrombin time-international normalized ratio (PT-INR), one of the components of the DIC score, using multivariable regression models including the cross-product term between these indicators. Multivariate Cox proportional hazard regression analysis with non-linear restricted cubic spline including a three-way interaction term (anticoagulant therapy × the DIC score × PT-INR) was also performed. Anticoagulant therapy was defined as the administration of antithrombin, recombinant human thrombomodulin, or their combination.

RESULTS: In total, we analyzed 1013 patients. The regression model showed that organ dysfunction and in-hospital mortality deteriorated with higher PT-INR values in the range of < 1.5 and that this trend was more pronounced with higher DIC scores. Three-way interaction analysis demonstrated that anticoagulant therapy was associated with better survival outcome in patients with a high DIC score and high PT-INR. Furthermore, we identified a DIC score ≥ 5 and PT-INR ≥ 1.5 as the clinical threshold for identification of optimal targets for anticoagulant therapy.

CONCLUSIONS: The combined use of the DIC score and PT-INR helps in selecting the optimal patient population for anticoagulant therapy in sepsis-induced DIC. The results obtained from this study will provide valuable information regarding the study design of randomized controlled trials examining the effects of anticoagulant therapy for sepsis.

TRIAL REGISTRATION: UMIN-CTR, UMIN000019742. Registered on November 16, 2015.

PMID:36872342 | DOI:10.1186/s40560-023-00656-5

Osteoporos Int. 2023 Mar 6. doi: 10.1007/s00198-022-06627-0. Online ahead of print.

ABSTRACT

The study results indicate that women with osteoporosis initiated on gastro-resistant risedronate have a lower risk of fracture than those initiated on immediate release risedronate or alendronate. A large proportion of women discontinued all oral bisphosphonate therapies within 1 year of treatment start.

PURPOSE: Using a US claims database (2009-2019), we compared risk of fractures between women with osteoporosis initiated on gastro-resistant (GR) risedronate and those initiated on (a) immediate release (IR) risedronate or (b) immediate release alendronate.

METHODS: Women aged ≥ 60 years with osteoporosis who had ≥ 2 oral bisphosphonate prescription fills were followed for ≥ 1 year after the first observed bisphosphonates dispensing (index date). Fracture risk was compared between the GR risedronate and IR risedronate/alendronate cohorts using adjusted incidence rate ratios (aIRRs), both overall and in subgroups with high fracture risk due to older age or comorbidity/medications. Site-specific fractures were identified based on diagnosis codes recorded on medical claims using a claims-based algorithm. Persistence on bisphosphonate therapy was evaluated for all groups.

RESULTS: aIRRs generally indicated lower fracture risk for GR risedronate than IR risedronate and alendronate. When comparing GR risedronate to IR risedronate, statistically significant aIRRs (p < 0.05) were observed for pelvic fractures in the full cohorts (aIRRs = 0.37), for any fracture and pelvic fractures among women aged ≥ 65 years (aIRRs = 0.63 and 0.41), for any fracture and pelvic fractures among women aged ≥ 70 years (aIRRs = 0.69 and 0.24), and for pelvic fracture among high-risk women due to comorbidity/medications (aIRR = 0.34). When comparing GR risedronate to alendronate, statistically significant aIRRs were observed for pelvic fractures in the full cohorts (aIRR = 0.54), for any fracture and wrist/arm fractures among women aged ≥ 65 years (aIRRs = 0.73 and 0.63), and for any fracture, pelvic, and wrist/arm fractures among women aged ≥ 70 years (aIRRs = 0.72, 0.36, and 0.58). In all cohorts, ~ 40% completely discontinued oral bisphosphonates within 1 year.

CONCLUSIONS: Discontinuation rates of oral bisphosphonate therapy were high. However, women initiated on GR risedronate had a significantly lower risk of fracture for several skeletal sites than women initiated on IR risedronate/alendronate, particularly those aged ≥ 70 years.

PMID:36872338 | DOI:10.1007/s00198-022-06627-0