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Nevin Manimala Statistics

Virtual reality reduces anxiety of children in the plaster room: a randomized controlled trial

Bone Joint J. 2024 Jul 1;106-B(7):728-734. doi: 10.1302/0301-620X.106B7.BJJ-2023-0756.R2.

ABSTRACT

AIMS: Paediatric fractures are highly prevalent and are most often treated with plaster. The application and removal of plaster is often an anxiety-inducing experience for children. Decreasing the anxiety level may improve the patients’ satisfaction and the quality of healthcare. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings, and it seems to have a similar effect during plaster treatment. This study aims to further investigate the effect of VR on the anxiety level of children with fractures who undergo plaster removal or replacement in the plaster room.

METHODS: A randomized controlled trial was conducted. A total of 255 patients were included, aged five to 17 years, who needed plaster treatment for a fracture of the upper or lower limb. Randomization was stratified for age (five to 11 and 12 to 17 years). The intervention group was distracted with VR goggles and headphones during the plaster treatment, whereas the control group received standard care. As the primary outcome, the post-procedural level of anxiety was measured with the Child Fear Scale (CFS). Secondary outcomes included the children’s anxiety reduction (difference between CFS after and CFS before plaster procedure), numerical rating scale (NRS) pain, NRS satisfaction of the children and accompanying parents/guardians, and the children’s heart rates during the procedure. An independent-samples t-test and Mann-Whitney U test (depending on the data distribution) were used to analyze the data.

RESULTS: The post-procedural CFS was significantly lower (p < 0.001) in the intervention group (proportion of children with no anxiety = 78.6%) than in the control group (56.8%). The anxiety reduction, NRS pain and satisfaction scores, and heart rates showed no significant differences between the control group and the intervention group. Subanalyses showed an increased effect of VR on anxiety levels in young patients, females, upper limb fractures, and those who had had previous plaster treatment.

CONCLUSION: VR effectively reduces the anxiety levels of children in the plaster room, especially in young girls. No statistically significant effects were seen regarding pain, heart rate, or satisfaction scores.

PMID:38945536 | DOI:10.1302/0301-620X.106B7.BJJ-2023-0756.R2

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A modified Nishida procedure for management of myopic strabismus fixus

J AAPOS. 2024 Jun 28:103962. doi: 10.1016/j.jaapos.2024.103962. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the outcomes of a novel modification of the Nishida procedure with medial rectus recession (Nishida-MRc) for myopic strabismus fixus (MSF) and to compare this modified procedure with the half Jensen’s union with medial rectus recession (U-MRc).

METHODS: The medical records of MSF patients who underwent strabismus surgery at a single institution between January 2017 and June 2022 were retrospectively reviewed. The main outcome measures assessed were postoperative improvements in ocular alignment and motility. Surgical success was defined as horizontal and vertical deviations ≤15Δ.

RESULTS: A total of 45 patients were included, of whom 39 had no previous strabismus surgery. All but 3 had follow-up ≥8 months. Nishida-MRc, with or without a traction suture (Ts), had a success rate (9/16 [56%]) higher, though not statistically significantly so, than U-MRc with or without Ts (11/29 [38%]). The Nishida-MRc group tended to have less frequent use of Ts (25% vs 52%; P = 0.076), and 94% of these patients had a deviation within 20Δ, compared with 59% for U-MRc (P = 0.012). In cases with esotropia of ≥123Δ, final residual esotropia in the Nishida-MRc without Ts (12.40Δ ± 8.30Δ) and U-MRc-Ts (19.75Δ ± 18.62Δ) groups was significantly lower (P = 0.019) than in the U-MRc without Ts group (63.40Δ ± 40.83Δ), and the average correction of esotropia was significantly greater (P = 0.014).

CONCLUSIONS: In our study cohort, Nishida-MRc produced a greater effect in the treatment of MSF than U-MRc.

PMID:38945521 | DOI:10.1016/j.jaapos.2024.103962

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Persistence of pesticide residues in weathered avian droppings

Environ Res. 2024 Jun 28:119475. doi: 10.1016/j.envres.2024.119475. Online ahead of print.

ABSTRACT

Avian droppings (combination of fecal matter and urates) provide a non-lethal and non-invasive matrix for measuring pesticide exposures. In the field, droppings may be collected days or weeks after excretion and the persistence of pesticide residues in weathered droppings is not known. Thus, we studied the effects of weathering on pesticide residues in droppings. Domestic chicken (Gallus gallus domesticus) hens were used as a representative species for Order Galliformes. We collected droppings from hens before they were exposed to the pesticides (reference or pre-dose dropping samples). Thereafter, the hens were orally administered encapsulated wheat seeds coated with Raxil® PRO Shield (containing the active ingredients imidacloprid, prothioconazole, metalaxyl, and tebuconazole) for consecutive 7 days. During this time, their droppings were collected on days 3, 5, and 8 from the start of the exposure period (post-dose dropping samples). The pre-dose and post-dose droppings were weathered for up to 30 days in autumn and spring in shrubsteppe habitat. Droppings were analyzed using HPLC coupled to triple quad LC/MS for parent compound and metabolite residues. No pesticide or its metabolite residues were detected in the weathered reference droppings. No parent pesticide compounds were detected in weathered post-dose droppings but imidacloprid metabolites, imidacloprid-5-hydroxy and imidacloprid-olefin, and the prothioconazole metabolite, desthio-prothioconazole, were detected in all post-dose weathered samples from both seasons. The active ingredients metalaxyl and tebuconazole and their metabolites were not detected in any of the samples. Our results suggest that, depending on the pesticide, its concentration, and the environmental conditions, residues of some pesticides can be detected in droppings weathered for at least 30 days. Knowledge of pesticide persistence in weathered droppings can help refine the quality and quantity of fecal samples that are collected for monitoring pesticide exposures to birds.

PMID:38945513 | DOI:10.1016/j.envres.2024.119475

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Effectiveness of mHealth interventions to improve pain intensity and functional disability in patients with hip or knee osteoarthritis: a systematic review and meta-analysis

Arch Phys Med Rehabil. 2024 Jun 28:S0003-9993(24)01068-2. doi: 10.1016/j.apmr.2024.06.008. Online ahead of print.

ABSTRACT

OBJECTIVE: This review aimed to investigate the effectiveness of mHealth-supported active exercise interventions to reduce pain intensity and disability level in persons with hip or knee OA.

DATA SOURCES: Three databases (PubMed, Cochrane Library, and Web of science) were systematically searched for randomized-controlled trials (RCTs) published between 01-01-2012 and 31-07-2023. PROSPERO registration number of this review was CRD42023394119.

STUDY SELECTION: We included only RCTs that were identified and screened by two independent reviewers (JM and GN). In addition, the reference lists of the identified studies were manually checked for further inclusion. Included studies had to provide a mHealth-supported active exercises for persons with hip or knee OA, and evaluate pain intensity and disability using both questionnaires and performance tests.

DATA EXTRACTION: From the included studies, the two independent authors extracted data using a predetermined Excel form. Characteristics of the interventions were described and a meta-analysis was performed.

DATA SYNTHESIS: Twelve RCTs were included, representing 1,541 patients with a mean age of 58.7±5 years, and a BMI of 28.8±3.1; females being more predominant than males with a total ratio female/male of 2.2. The methodological quality of the included studies was of moderate quality in 75% of the studies. There was no statistically significant difference between mHealth-supported active exercises compared to the interventions without mHealth in terms of pain reduction (SMD= -0.42 [95%CI -0.91; 0.07], p = 0.08) and disability mitigation (SMD = -0.36 [95%CI -0.81; 0.09], p = 0.10). However, a statistically significant difference was found between patient education combined with mHealth-supported active exercises compared to patient education alone in terms of pain (SMD= -0.42 [95%CI -0.61; -0.22], p<0.01) and disability (SMD= -0.27 [95%CI -0.46; -0.08], p < 0.01) reduction.

CONCLUSION: mHealth-supported exercises were found to be effective, especially when combined with patient education, in reducing pain and mitigating disability in patients with hip or knee OA.

PMID:38945508 | DOI:10.1016/j.apmr.2024.06.008

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Dermatologic adverse events associated with chimeric antigen receptor T-cell therapy: a pharmacovigilance analysis of the FDA reporting system

Transplant Cell Ther. 2024 Jun 28:S2666-6367(24)00486-X. doi: 10.1016/j.jtct.2024.06.024. Online ahead of print.

ABSTRACT

BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapy, including axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel), has demonstrated significant efficacy in treating refractory or relapsed diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia. Though adverse events such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are well characterized, the dermatologic adverse event (DAE) profile is less thoroughly described.

OBJECTIVES: This study aims to provide the first comprehensive analysis of DAEs associated with axi-cel and tisa-cel using real-world data from the FDA Adverse Event Reporting System (FAERS) database.

STUDY DESIGN: FAERS database reports citing axi-cel or tisa-cel in patients aged 16 years or older were included, excluding duplicate reports and off-label indications. Disproportionality analysis by reporting odds ratio (ROR) was utilized to detect increased reporting of drug-adverse event combinations.

RESULTS: Of the 11,256,845 reports in the FAERS database, 5,559 identified CAR-T therapy as the primary suspected drug. After exclusions, 3,666 reports were analyzed (2,168 for axi-cel and 1,498 for tisa-cel). Among these, 2.7% of axi-cel and 5.1% of tisa-cel cases reported DAEs. There was a statistically significant increased reporting of 2 DAE groups associated with CAR-T therapy: severe cutaneous eruptions (ROR 5.18, 95% CI 1.29, 20.76) and vascular cutaneous (ROR 2.91, 95% CI 1.51, 5.60). The median time to DAE onset was 3 days after CAR T-cell infusion. Death was a reported outcome in 11.9% and 13.0% of axi-cel and tisa-cel DAE cases, respectively, and in 50% and 25% of severe cutaneous eruptions and vascular cutaneous cases, respectively.

CONCLUSIONS: This study reveals a significantly increased reporting rate of severe cutaneous eruptions and vascular cutaneous DAEs associated with CAR-T therapy, with both event groups associated with high mortality. These results emphasize the importance of monitoring dermatologic toxicities in clinical practice to ensure timely identification and management of potentially severe adverse events.

PMID:38945480 | DOI:10.1016/j.jtct.2024.06.024

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Data-driven mathematical modeling of sleep consolidation in early childhood

J Theor Biol. 2024 Jun 28:111892. doi: 10.1016/j.jtbi.2024.111892. Online ahead of print.

ABSTRACT

Across early childhood development, sleep behavior transitions from a biphasic pattern (a daytime nap and nighttime sleep) to a monophasic pattern (only nighttime sleep). The transition to consolidated nighttime sleep, which occurs in most children between 2- and 5-years-old, is a major developmental milestone and reflects interactions between the developing homeostatic sleep drive and circadian system. Using a physiologically-based mathematical model of the sleep-wake regulatory network constrained by observational and experimental data from preschool-aged participants, we analyze how developmentally-mediated changes in the homeostatic sleep drive may contribute to the transition from napping to non-napping sleep patterns. We establish baseline behavior by identifying parameter sets that model typical 2-year-old napping behavior and 5-year-old non-napping behavior. Then we vary six model parameters associated with the dynamics of and sensitivity to the homeostatic sleep drive between the 2-year-old and 5-year-old parameter values to induce the transition from biphasic to monophasic sleep. We analyze the individual contributions of these parameters to sleep patterning by independently varying their age-dependent developmental trajectories. Parameters vary according to distinct evolution curves and produce bifurcation sequences representing various ages of transition onset, transition durations, and transitional sleep patterns. Finally, we consider the ability of napping and non-napping light schedules to reinforce napping or promote a transition to consolidated sleep, respectively. These modeling results provide insight into the role of the homeostatic sleep drive in promoting interindividual variability in developmentally-mediated transitions in sleep behavior and lay foundations for the identification of light- or behavior-based interventions that promote healthy sleep consolidation in early childhood.

PMID:38945471 | DOI:10.1016/j.jtbi.2024.111892

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Prospective antimicrobial stewardship interventions by multidisciplinary teams to reduce neonatal antibiotic use in South Africa: the Neonatal Antimicrobial Stewardship (NeoAMS) study

Int J Infect Dis. 2024 Jun 28:107158. doi: 10.1016/j.ijid.2024.107158. Online ahead of print.

ABSTRACT

BACKGROUND: Hospitalised neonates are vulnerable to infection and have high rates of antibiotic utilisation.

METHODS: Fourteen South African neonatal units (seven public, seven private sector) assembled multidisciplinary teams involving neonatologists, microbiologists, pharmacists, and nurses to implement prospective audit and feedback neonatal antimicrobial stewardship (NeoAMS) interventions. The teams attended seven online training sessions. Pharmacists conducted weekday antibiotic prescription reviews in the neonatal intensive care unit and/or neonatal wards providing feedback to the clinical teams. Anonymised demographic and NeoAMS interventions data were aggregated for descriptive purposes and statistical analysis.

FINDINGS: During the 20-week NeoAMS intervention in 2022, 565 neonates were enrolled. Pharmacists evaluated seven hundred antibiotic prescription episodes; rule-out sepsis (180; 26%) and culture-negative sepsis (138; 20%) were the most frequent indications for antibiotic prescription. For infection episodes with an identified pathogen, only 51% (116/229) of empiric treatments provided adequate antimicrobial coverage. Pharmacists recommended 437 NeoAMS interventions (0·6 per antibiotic prescription episode), with antibiotic discontinuation (42%), therapeutic drug monitoring (17%), and dosing (15%) recommendations most frequent. Neonatal clinicians’ acceptance rates for AMS recommendations were high (338; 77%). Mean antibiotic length of therapy decreased by 24% from 9·1 to 6·9 days (0·1 day decrease per intervention week; p=0·001), with the greatest decline in length of therapy for culture-negative sepsis (8·2 days (95%CI 5·7-11·7) to 5·9 days (95% CI 4·6-7·5); p=0·032).

INTERPRETATION: This neonatal AMS programme was successfully implemented in heterogenous and resource-limited settings. Pharmacist-recommended AMS interventions had high rates of clinician acceptance. The NeoAMS intervention significantly reduced neonatal antibiotic use, particularly for culture-negative sepsis.

FUNDING: A grant from Merck provided partial support.

PMID:38945432 | DOI:10.1016/j.ijid.2024.107158

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An observational cohort study examined the change point of kidney function stabilization in the initial period after transplantation

Kidney Int. 2024 Jun 28:S0085-2538(24)00448-4. doi: 10.1016/j.kint.2024.05.030. Online ahead of print.

ABSTRACT

Baseline kidney function following kidney transplantation is often used in research and clinical decision-making yet is not well defined. Here, a method to determine baseline function was proposed and validated on three single-center retrospective cohorts consisting of 922 patients from Belgium (main cohort) and two validation cohorts of 987 patients from the Netherlands and 519 patients from Germany. For each transplant, a segmented regression model was fitted on the estimated glomerular filtration rate (eGFR) evolution during the first-year post-transplantation. This yielded estimates for change point timing, rate of eGFR change before and after change point and eGFR value at change point, now considered the “baseline function”. Associations of eGFR evolution with recipient/donor characteristics and the graft failure rate were assessed with linear regression and Cox regression respectively. The change point occurred on average at an eGFR value of 43.7±14.6 mL/min/1.73m2, at a median time of 6.5 days post-transplantation. Despite significant associations with several baseline donor-recipient characteristics (particularly, donor type; living vs deceased), the predictive value of these characteristics for eGFR value and timing of the change point was limited. This followed from a large heterogeneity within eGFR trajectories, which in turn indicated that favorable levels of kidney function could be reached despite a suboptimal initial evolution. Segmented regression consistently provided a good fit to early eGFR evolution, and its estimate of the change point can be a useful reference value in future analyses. Thus, our study shows that baseline kidney function after transplantation is heterogeneous and partly related to pretransplant donor characteristics.

PMID:38945395 | DOI:10.1016/j.kint.2024.05.030

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“Comparing scoring systems for Fournier Gangrenes in predicting morbidity and mortality: is FGSI still reliable?

Fr J Urol. 2024 Jun 28:102673. doi: 10.1016/j.fjurol.2024.102673. Online ahead of print.

ABSTRACT

INTRODUCTION: Compare scoring systems using Fournier gangrene severity index (FGSI), Uludag Fournier gangrene severity index (UFGSI), Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC), and neutrophil-lymphocyte ratio (NLR) to predict the outcome of patients with Fournier gangrene Materials and Methods: This is a retrospective cohort study that includes FG patients from 2012 to 2021. NLR, FGSI, UFGSI, and LRINEC values were calculated and analyzed. Each scoring system was analyzed using a receiver operating curve (ROC) analysis to determine its sensitivity, specificity, and area under the curve (AUC). Statistical analysis was performed using SPSS version 25.

RESULTS: A total of 158 patients were included in this study. Regarding the mortality outcome, FGSI comprised the highest value of AUC with 80.9, with a sensitivity of 91.7% and specificity of 68.5%. LRINEC comprised the AUC value of 61.1, with 79.2% sensitivity and 64.2% specificity. NLR comprised an AUC value of 63.7, 91.7% of sensitivity, and 98.1% of specificity. In terms of length of stay, LRINEC and NLR were associated as significant predictor.

CONCLUSION: FGSI, UFGSI, and NLR are significant predictors associated with mortality in patients with Fournier gangrene. FGSI and UFGSI comprised the highest sensitivity and specificity value in predicting mortality prognosis. Moreover, this study highlighted the role of NLR and LRINEC as significant predictors for the length of hospitalization. This study shows that FGSI is still a reliable scoring system for predicting mortality in patients with Fournier Gangrene.

PMID:38945366 | DOI:10.1016/j.fjurol.2024.102673

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The Conclusion Generator

Ann Epidemiol. 2024 Jun 28:S1047-2797(24)00104-2. doi: 10.1016/j.annepidem.2024.06.008. Online ahead of print.

ABSTRACT

PURPOSE: Reliance on null hypothesis significance testing often leads to misinterpretation of research results. Common misinterpretations include that a statistically nonsignificant difference (p≥0.05) implies no difference between groups, and that a statistically significant finding (p<0.05) is unbiased and clinically important. We aimed to develop a tool – the Conclusion Generator – to mitigate these misconceptions.

METHODS: We reviewed the content of the Conclusion Generator and validated its output using published and simulated data.

RESULTS: The Conclusion Generator is a free online application designed to generate conclusions for scientific papers based on the values and clinical interpretation of the point estimate and confidence interval. Both relative and absolute measures of effect are supported. It offers two modes for interpretation: (1) Statistical mode provides an accurate statistical interpretation of results, with an optional specification of superiority and noninferiority bounds; (2) Clinical mode evaluates the clinical importance of the point estimate and confidence limits as specified by the user. Both modes assume no uncontrolled biases. Users must specify the number of decimals, the direction of a beneficial effect (e.g., relative risk <1 vs. >1), and the level of detail (concise vs. elaborated) for the output. The validation confirmed the Conclusion Generator’s capability to interpret research results, considering random error and clinical relevance, while avoiding common misinterpretations associated with null hypothesis significance testing.

CONCLUSIONS: The Conclusion Generator facilitates an appropriate interpretation of research results by emphasizing estimation and clinical relevance over hypothesis testing.

PMID:38945314 | DOI:10.1016/j.annepidem.2024.06.008