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Nevin Manimala Statistics

Impact of a Clinical Intervention to Decrease Opioid Prescribing in a Post Cesarean Delivery

J Obstet Gynaecol Can. 2021 Nov 27:S1701-2163(21)00835-5. doi: 10.1016/j.jogc.2021.11.009. Online ahead of print.

ABSTRACT

A quality assurance study was completed following the implementation of a standardized opioid prescribing and education protocol post cesarean delivery. The primary goal was to determine the need for a policy on postpartum opioid prescribing practices and whether the protocol worked. There was a decrease in the number of tablets provided post intervention and no statistically significant maternal or neonatal readmissions for suspected opioid toxicity or pain control. Combination prescribing of Tylenol 3 and/or tramadol and another opioid occurred in both groups. Our results show a need for concise guidelines regarding opioid prescribing following cesarean delivery.

PMID:34848352 | DOI:10.1016/j.jogc.2021.11.009

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Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

J Allergy Clin Immunol Pract. 2021 Nov 27:S2213-2198(21)01295-2. doi: 10.1016/j.jaip.2021.11.017. Online ahead of print.

ABSTRACT

BACKGROUND: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin™ Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children.

OBJECTIVE: To examine the safety of VP250 in children, using a study design approximating potential real-world use.

METHODS: REALISE is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported.

RESULTS: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n=294) or placebo (n=99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued due to adverse events. Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall adverse event rates were similar among participants with and without history of peanut anaphylaxis.

CONCLUSIONS: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

PMID:34848381 | DOI:10.1016/j.jaip.2021.11.017

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Reliability of structural MRI measurements: The effects of scan session, head tilt, inter-scan interval, acquisition sequence, FreeSurfer version and processing stream

Neuroimage. 2021 Nov 27:118751. doi: 10.1016/j.neuroimage.2021.118751. Online ahead of print.

ABSTRACT

BACKGROUND: Large-scale longitudinal and multi-centre studies are used to explore neuroimaging markers of normal aging, and neurodegenerative and mental health disorders. Longitudinal changes in brain structure are typically small, therefore the reliability of automated techniques is crucial. Determining the effects of different factors on reliability allows investigators to control those adversely affecting reliability, calculate statistical power, or even avoid particular brain measures with low reliability. This study examined the impact of several image acquisition and processing factors and documented the test-retest reliability of structural MRI measurements.

METHODS: In Phase I, 20 healthy adults (11 females; aged 20-30 years) were scanned on two occasions three weeks apart on the same scanner using the ADNI-3 protocol. On each occasion, individuals were scanned twice (repetition), after re-entering the scanner (reposition) and after tilting their head forward. At one year follow-up, nine returning individuals and 11 new volunteers were recruited for Phase II (11 females; aged 22-31 years). Scans were acquired on two different scanners using the ADNI-2 and ADNI-3 protocols. Structural images were processed using FreeSurfer (v5.3.0, 6.0.0 and 7.1.0) to provide subcortical and cortical volume, cortical surface area and thickness measurements. Intra-class correlation coefficients (ICC) were calculated to estimate test-retest reliability. We examined the effect of repetition, reposition, head tilt, time between scans, MRI sequence and scanner on reliability of structural brain measurements. Mean percentage differences were also calculated in supplementary analyses.

RESULTS: Using the FreeSurfer v7.1.0 longitudinal pipeline, we observed high reliability for subcortical and cortical volumes, and cortical surface areas at repetition, reposition, three weeks and one year (mean ICCs>0.97). Cortical thickness reliability was lower (mean ICCs>0.82). Head tilt had the greatest adverse impact on ICC estimates, for example reducing mean right cortical thickness to ICC=0.74. In contrast, changes in ADNI sequence or MRI scanner had a minimal effect. We observed an increase in reliability for updated FreeSurfer versions, with the longitudinal pipeline consistently having a higher reliability than the cross-sectional pipeline.

DISCUSSION: Longitudinal studies should monitor or control head tilt to maximise reliability. We provided the ICC estimates and mean percentage differences for all FreeSurfer brain regions, which may inform power analyses for clinical studies and have implications for the design of future longitudinal studies.

PMID:34848299 | DOI:10.1016/j.neuroimage.2021.118751

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Comparison of perioperative outcomes and clinical characteristics of Calcium, Matrix and Struvite stones from a single institution

Urology. 2021 Nov 27:S0090-4295(21)01092-X. doi: 10.1016/j.urology.2021.11.019. Online ahead of print.

ABSTRACT

OBJECTIVE: To define risk factors and perioperative outcomes for matrix stones and compare these outcomes with struvite and calcium stone cohorts.

METHODS: A retrospective cohort study comparing matrix stones (n=32), struvite stones (n=23) and a matched, calcium stone control group (n=32) was performed. Two-way ANOVA was used to compare the groups for continuous variables. Chi-square tests were used to compare categorical variables. Significance was set at p<0.05. All statistical tests were performed using R (v1.73).

RESULTS: We identified no differences in age, gender, or BMI between the three groups. Matrix and struvite stones were more likely to have a history of prior stone surgery and recurrent UTIs compared to calcium stones (p=0.027 and p<0.001, respectively). Struvite stones were more likely to present as staghorn calculi compared to matrix or calcium stones (56.5% vs 21.7% vs 18.8%, p=0.006). There were no significant differences in postoperative stone free rates (p=0.378). No significant differences in postoperative infectious complications were identified. Matrix stones were more likely to have Candida on stone culture compared to the struvite or calcium stones (p<0.0001).

CONCLUSION: Matrix and struvite stones were more likely have a history of stone surgery and preoperative recurrent UTIs. Struvite stones were more likely to present as staghorn calculi. Matrix stones were more likely to have Candida present in stone cultures. However, no difference in postoperative infectious outcomes or stone free rates were identified. Further study with larger cohorts is necessary to distinguish matrix stone postoperative outcomes from struvite and calcium stones.

PMID:34848277 | DOI:10.1016/j.urology.2021.11.019

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Nevin Manimala Statistics

Occurrence of Plant-Parasitic Nematodes of Turfgrass in Korea

Plant Pathol J. 2021 Oct;37(5):446-454. doi: 10.5423/PPJ.OA.04.2021.0059. Epub 2021 Oct 1.

ABSTRACT

Plant-parasitic nematodes are not only an important constraint on agricultural crop production, but also cause both direct and indirect damage to turfgrass, which is a ground cover plant. However, studies on plant-parasitic nematodes of turfgrass in Korea are scarce. A survey for plant-parasitic nematodes was carried out on 13 golf courses in Korea. The results yielded 28 species/taxa belonging to 16 genera and 12 families of plant-parasitic nematodes. Among the isolated species, Helicotylenchus microlobus, Mesocriconema nebraskense, Tylenchorhynchus claytoni, Mesocriconema sp., and Meloidogyne graminicola were the most prevalent species in all management zones. Twelve species were new records of plant-parasitic nematodes in Korea. Highest maximum densities were showed by T. claytoni, Paratylenchus nanus, M. nebraskense, M. graminicola, and H. microlobus. Diversity (H’), was significantly higher in fairways compared to tees and greens, though species evenness (J’) and dominance (D) showed no statistically significant differences. This information is crucial in nematode problem diagnosis, and the subsequent formulation of management strategies.

PMID:34847631 | DOI:10.5423/PPJ.OA.04.2021.0059

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Novel cut-off values of time from diagnosis to systematic therapy predict the overall survival and the efficacy of targeted therapy in renal cell carcinoma: A long-term, follow-up, retrospective study

Int J Urol. 2021 Nov 30. doi: 10.1111/iju.14751. Online ahead of print.

ABSTRACT

OBJECTIVES: Metastatic renal cell carcinoma can occur synchronously or metachronously. We characterized the time from diagnosis to systematic therapy as a categorical variable to analyze its effect on the overall survival and first-line treatment efficacy of metastatic renal cell carcinoma patients.

METHODS: We initially enrolled 949 consecutive metastatic renal cell carcinoma patients treated with targeted therapies retrospectively from December 2005 to December 2019. X-tile analysis was used to determine cut-off values of time from diagnosis to systematic therapy referring to overall survival. Patients were divided into different groups based on the time from diagnosis to systematic therapy and then analyzed for survival.

RESULTS: Of 358 eligible patients with metastatic renal cell carcinoma, 125 (34.9%) had synchronous metastases followed by cytoreductive nephrectomy, and 233 (65.1%) had metachronous metastases. A total of 28 patients received complete metastasectomy. Three optimal cut-off values for the time from diagnosis to systematic therapy (months) – 1.1, 7.0 and 35.9 – were applied to divide the population into four groups: the synchro group (time from diagnosis to systematic therapy ≤1.0), early group (1.0 < time from diagnosis to systematic therapy ≤ 7.0), intermediate group (7.0 < time from diagnosis to systematic therapy < 36.0) and late group (time from diagnosis to systematic therapy ≥36.0). The targeted therapy-related overall survival (P < 0.001) and progression-free survival (P < 0.001) values were significantly different among the four groups. Patients with longer time from diagnosis to systematic therapy had better prognoses and promising efficacy of targeted therapy. With the prolongation of time from diagnosis to systematic therapy, complete metastasectomy was more likely to achieve and bring a better prognosis.

CONCLUSIONS: The time from diagnosis to systematic therapy impacts the survival of metastatic renal cell carcinoma patients treated with targeted therapy. The cutoff points of 1, 7 and 36 months were statistically significant. The statistical boundaries might be valuable in future model establishment.

PMID:34847622 | DOI:10.1111/iju.14751

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Clinical utility of family history of depression for prognosis of adolescent depression severity and duration assessed with predictive modeling

J Child Psychol Psychiatry. 2021 Nov 30. doi: 10.1111/jcpp.13547. Online ahead of print.

ABSTRACT

BACKGROUND: Family history of depression (FHD) is a known risk factor for the new onset of depression. However, it is unclear if FHD is clinically useful for prognosis in adolescents with current, ongoing, or past depression. This preregistered study uses a longitudinal, multi-informant design to examine whether a child’s FHD adds information about future depressive episodes and depression severity applying state-of-the-art predictive out-of-sample methodology.

METHODS: We examined data in adolescents with current or past depression (age 11-17 years) from the National Institute of Mental Health Characterization and Treatment of Adolescent Depression (CAT-D) study. We asked whether a history of depression in a first-degree relative was predictive of depressive episode duration (72 participants) and future depressive symptom severity in probands (129 participants, 1,439 total assessments).

RESULTS: Family history of depression, while statistically associated with time spent depressed, did not improve predictions of time spent depressed, nor did it improve models of change in depression severity measured by self- or parent-report.

CONCLUSIONS: Family history of depression does not improve the prediction of the course of depression in adolescents already diagnosed with depression. The difference between statistical association and predictive models highlights the importance of assessing predictive performance when evaluating questions of clinical utility.

PMID:34847615 | DOI:10.1111/jcpp.13547

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Fracture Strength of Monolithic Zirconia Crowns with Modified Vertical Preparation: A Comparative In Vitro Study

Eur J Dent. 2021 Nov 30. doi: 10.1055/s-0041-1735427. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to evaluate the influence of different marginal designs (deep chamfer, vertical, and modified vertical with reverse shoulder) on the fracture strength and failure modes of monolithic zirconia crowns.

MATERIALS AND METHODS: Thirty sound human maxillary first premolar teeth with comparable size were used in this study. The teeth were divided randomly into three groups according to the preparation design (n = 10): (1) group A: teeth prepared with a deep chamfer finish line; (2) group B: teeth prepared with vertical preparation; and (3) group C: teeth prepared with modified vertical preparation, where a reverse shoulder of 1 mm was placed on the buccal surface at the junction of middle and occlusal thirds. All samples were scanned by using an intraoral scanner (CEREC Omnicam, Sirona, Germany), and then the crowns were designed by using Sirona InLab 20.0 software and milled with a 5-axis machine. Each crown was then cemented on its respective tooth with self-adhesive resin cement by using a custom-made cementation device. A single load to failure test was used to assess the fracture load of each crown by using a computerized universal testing machine that automatically recorded the fracture load of each sample in Newton (N).

STATISTICAL ANALYSIS: The data were analyzed statistically by using one-way analysis of variance test and Bonferroni test at a level of significance of 0.05.

RESULTS: The highest mean of fracture load was recorded by chamfer (2,969.8 N), which followed by modified vertical (2,899.3 N) and the lowest mean of fracture load was recorded by vertical (2,717.9 N). One-way ANOVA test revealed a significant difference among the three groups. Bonferroni test showed a significant difference between group A and group B, while a nonsignificant difference was revealed between group C with group A and group B.

CONCLUSION: Within the limitations of this in vitro study, the mean values of fracture strength of monolithic zirconia crowns of all groups were higher than the maximum occlusal forces in the premolar region. The modification of the vertical preparation with a reverse shoulder placed at the buccal surface improved the fracture strength up to the point that it was statistically nonsignificant with the chamfer group.

PMID:34847612 | DOI:10.1055/s-0041-1735427

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Positive direct antiglobulin test: is it a risk factor for significant hyperbilirubinemia in neonates with ABO incompatibility?

Am J Perinatol. 2021 Nov 30. doi: 10.1055/a-1709-5036. Online ahead of print.

ABSTRACT

OBJECTIVE: ABO incompatibility is a common cause of neonatal indirect hyperbilirubinemia. The direct antiglobulin test (DAT) can identify infants developing hemolytic disease. This study aims to evaluate the significance of DAT positivity among neonates with ABO incompatibility.

STUDY DESIGN: This retrospective study included 820 neonates with blood group A or B who were born to blood group O mothers. The study group consisted of neonates (n = 79) who had positive DAT, and the control group consisted of infants (n = 741) who had negative DAT. Demographic and clinical data of the neonates regarding jaundice were collected and compared statistically.

RESULTS: The bilirubin level at 24 hours of life (study group 8 ± 2.6 mg/dl, control group 6 ± 2.2 mg/dl, p < 0.001) and the highest bilirubin level (study group 12.7 ± 3.6 mg/dl, control group 10.4 ± 4.2 mg/dl, p < 0.001) were higher in infants with positive DAT. In the study group 37 (46.8%) infants and in the control group 83 (11.2%) infants received PT in the nursery (p < 0.001). In neonates with positive DAT; direct bilirubin level, duration of hospitalization, and PT in the nursery were higher (p = 0.002, p < 0.001, and p < 0.001), whereas hemoglobin level was lower (p < 0.001).

CONCLUSION: In neonates with ABO incompatibility, a positive DAT is a risk factor for developing significant hyperbilirubinemia. Close follow-up of newborn infants with ABO incompatibility is crucial for early detection and treatment of neonatal jaundice to avoid early and late complications.

PMID:34847590 | DOI:10.1055/a-1709-5036

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Endocannabinoid Modulation Using Monoacylglycerol Lipase Inhibition in Tourette Syndrome: A Phase 1 Randomized, Placebo-Controlled Study

Pharmacopsychiatry. 2021 Nov 30. doi: 10.1055/a-1675-3494. Online ahead of print.

ABSTRACT

INTRODUCTION: Tourette syndrome (TS) is a complex neurodevelopmental disorder characterized by chronic motor and vocal tics. While consistently effective treatment is lacking, evidence indicates that the modulation of endocannabinoid system is potentially beneficial. Lu AG06466 (previously ABX-1431) is a highly selective inhibitor of monoacylglycerol lipase, the primary enzyme responsible for the degradation of the endocannabinoid ligand 2-arachidonoylglycerol. This exploratory study aimed to determine the effect of Lu AG06466 versus placebo on tics and other symptoms in patients with TS.

METHODS: In this phase 1b cross-over study, 20 adult patients with TS on standard-of-care medications were randomized to a single fasted dose of Lu AG06466 (40 mg) or placebo in period 1, followed by the other treatment in period 2. The effects on tics, premonitory urges, and psychiatric comorbidities were evaluated using a variety of scaled approaches at different time points before and after treatment.

RESULTS: All scales showed an overall trend of tic reduction, with two out of three tic scales (including the Total Tic Score of the Yale Global Tic Severity Score) showing a significant effect of a single dose of Lu AG06466 versus placebo at various timepoints. Treatment with Lu AG06466 resulted in a significant reduction in premonitory urges versus placebo. Single doses of Lu AG06466 were generally well-tolerated, and the most common adverse events were headache, somnolence, and fatigue.

CONCLUSION: In this exploratory trial, a single dose of Lu AG06466 showed statistically significant positive effects on key measures of TS symptoms.

PMID:34847610 | DOI:10.1055/a-1675-3494