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Nevin Manimala Statistics

Efficacy and safety of topical timolol 0.5% plus saline 0.9% versus each one alone in acne scar TCA-CROSS therapy: A blinded RCT

Dermatol Ther. 2022 Jan 29:e15341. doi: 10.1111/dth.15341. Online ahead of print.

ABSTRACT

Trichloroacetic acid-CROSS (TCA-CROSS) or chemical reconstruction of scars is an approved method in the treatment of ICE-PICK scars. Timolol is a blocker of beta-adrenergic receptors that speeds up the healing of skin wounds. In this study, for the first time, the TCA-CROSS technique was combined with the use of saline injection and topical timolol to increase the effectiveness of treatment, and reduce the number of treatment sessions and complications, and thus improve the aesthetic result. In this parallel-group split-face randomized controlled assessor and analyst-blinded study, 45 patients with atrophic acne scars were randomly divided into 3 equal groups. TCA-CROSS treatment was performed on all facial scars of patients. In group 1, before TCA-CROSS, saline was injected under the scars on one side of the face, in group 2, after TCA-CROSS, 0.5% timolol eye drops were applied on the scars on one side, and in group 3, saline was injected before TCA-CROSS. After that, timolol eye drops were applied on the scars of the same side. In all groups, the choice of control side was random. The number of scars and patient and physician satisfaction were the main variables evaluating the effectiveness of the treatment. TCA-CROSS improved scars in both control and treatment sides of all 3 groups. Although the number of scars decreased on the treatment side of groups 2 and 3, the decrease was not statistically significant. In the saline + TCA group, the number of scars on the treatment side was slightly more than on the control side. In the group of patients who used timolol, the severity and duration of scar hyperpigmentation were significantly lower (group 2 P = 0.016, group 3 P = 0.002). No permanent complication was observed in the patients. Patients’ satisfaction in groups 2 and 3 was higher in the treatment side than the control side. The combination of saline injection followed by TCA-CROSS is not recommended. Application of 0.5% timolol after TCA-CROSS caused a slight decrease in scar severity and a significant reduction of post-inflammatory hyperpigmentation (PIH) duration. So, the topical timolol makes a better result of TCA-CROSS for acne scar treatment.

PMID:35094447 | DOI:10.1111/dth.15341

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Nevin Manimala Statistics

Troubled spots: Human impacts constrain the density of an apex predator inside protected areas

Ecol Appl. 2022 Jan 30:e2551. doi: 10.1002/eap.2551. Online ahead of print.

ABSTRACT

Effective conservation requires understanding the processes that determine population outcomes. Too often, we assume that protected areas conserve wild populations despite evidence that they frequently fail to do so. Without large-scale studies, however, we cannot determine what relationships are the product of localized conditions versus general patterns that inform conservation more broadly. Leopards’ (Panthera pardus) basic ecology is well-studied but little research has investigated anthropogenic effects on leopard density at broad scales. We investigated the drivers of leopard density among 27 diverse protected areas in northeastern South Africa to understand what conditions facilitate abundant populations. We formulated ten working hypotheses that considered the relative influence of bottom-up biological factors and top-down anthropogenic factors on leopard density. Using camera-trap survey data, we fit a multi-session spatial capture-recapture model with inhomogenous density for each hypothesis and evaluated support using an information theoretic approach. The four supported hypotheses indicated that leopard density is primarily limited by human impacts, but that habitat suitability and management conditions also matter. The proportion of camera stations that recorded domestic animals, a proxy for the extent of human impacts and protected area effectiveness, was the only predictor variable present in all four supported models. Protected areas are the cornerstone of large felid conservation, but only when the human-wildlife interface is well-managed and protected areas shelter wildlife populations from anthropogenic impacts. To ensure the long-term abundance of large carnivore populations, reserve managers should recognize the ineffectiveness of “paper parks” and promote contiguous networks of protected areas that offer leopards and other large mammal populations greater space and reduced human impacts.

PMID:35094452 | DOI:10.1002/eap.2551

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Automatic segmentation of MR images for high-dose-rate cervical cancer brachytherapy using deep learning

Med Phys. 2022 Jan 30. doi: 10.1002/mp.15506. Online ahead of print.

ABSTRACT

PURPOSE: Magnetic resonance (MR) imaging is the gold standard in image-guided brachytherapy (IGBT) due to its superior soft-tissue contrast for target and organ-at-risk (OARs) delineation. Accurate and fast segmentation of MR images are very important for high-quality IGBT treatment planning. The purpose of this work is to implement and evaluate deep learning models for the automatic segmentation of targets and OARs in MR image-based high-dose-rate (HDR) brachytherapy for cervical cancer.

METHODS: A 2D deep learning (DL) model using residual neural network architecture (ResNet50) was developed to contour the targets (GTV, HR CTV, and IR CTV) and OARs (bladder, rectum, sigmoid, and small intestine) automatically on axial MR slices of HDR brachytherapy patients. Furthermore, two additional 2D DL models using sagittal and coronal images were also developed. A 2.5D model was generated by combining the outputs from axial, sagittal, and coronal DL models. Similarly, a 2D and 2.5D DL models were also generated for the inception residual neural network (InceptionResNetv2 (InRN)) architecture. The geometric (dice similarity coefficient (DSCs), 95th percentile of Hausdorff distance (HD)) and dosimetric accuracy of 2D (axial only) and 2.5D (axial + sagittal + coronal) DL model generated contours were calculated and compared.

RESULTS: The mean (range) DSCs of ResNet50 across all contours were 0.674 (0.05-0.96) and 0.715 (0.26-0.96) for the 2D and 2.5D models, respectively. For InRN, these were 0.676 (0.11-0.96) and 0.723 (0.35-0.97) for the 2D and 2.5D models, respectively. The mean HD of ResNet50 across all contours was 15.6 mm (1.8-69 mm) and 12.1 mm (1.7-44 mm) for the 2D and 2.5D models, respectively. The similar results for InRN were 15.4 mm (2-68 mm) and 10.3 mm (2.7-39 mm) for the 2D and 2.5D models, respectively. The dosimetric parameters (D90) of GTV and HR CTV for manually contoured plans matched better with the 2.5D model (P > 0.6) and the results from the 2D model were slightly lower (P < 0.08). On the other hand, the IR CTV doses (D90) for all of the models were slightly lower (2D: -1.3 to -1.5 Gy and 2.5D: -0.5 to -0.6 Gy) and the differences were statistically significant for the 2D model (2D: P < 0.000002 and 2.5D: P > 0.06). In case of OARs, the 2.5D model segmentations resulted in closer dosimetry than 2D models (2D: P = 0.07-0.91 and 2.5D: P = 0.16-1.0).

CONCLUSIONS: The 2.5D deep learning models outperformed their respective 2D models for the automatic contouring of targets and OARs in MR image-based high-dose-rate (HDR) brachytherapy for cervical cancer. The InceptionResNetv2 model performed slightly better than ResNet50. This article is protected by copyright. All rights reserved.

PMID:35094405 | DOI:10.1002/mp.15506

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Comparative analysis between extra-short implants (≤ 6mm) and 6mm-longer implants: A Meta-Analysis of Randomized Controlled Trial

Aust Dent J. 2022 Jan 30. doi: 10.1111/adj.12900. Online ahead of print.

ABSTRACT

The goal of this systematic study was to compare the survival rate (SR), marginal bone loss (MBL), and clinical complications between extra-short implants (≤6mm) and 6mm-longer implants in randomized clinical trials. A systematic electronic and manual search was performed using the PubMed, Web of Science, Scopus, and DOAJ databases. A meta-analysis was conducted to compare the SR and MBL between both groups. We have selected seventeen studies out of 1016 articles for qualitative and quantitative analysis. The data from 956 patients and 1779 implants were used with an overall mean clinical follow-up of 3.88 years ranging from 1 to 8 years. Overall, the SR of extra-short implants (93.12%) was lower than the observed in 6mm-longer implants (95.98%); however, there was no statistical significance on these findings (p>0.10). MBL analysis showed that extra-short implants and the 6mm-longer group presented an average of -0.71mm and -0.92mm after 1-year, respectively. Three years follow-up showed MBL of -0.42mm (≤6mm) and -0.43mm (>6mm); five years follow-up showed an MBL of -0.69mm (≤6mm) and -0.46mm (>6mm); and after 8 years of follow-up, it was found an MBL of -1.58mm (≤6mm) and -2.46mm (>6mm). Within the limitation of this study, the results indicated that SR of extra-short implants was similar to 6mm-longer implants. In contrast, MBL and the presence of clinical complications were observed at a lessened rate on extra-short implants. © 2022 Australian Dental Association.

PMID:35094419 | DOI:10.1111/adj.12900

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Academic motivation and self-directed learning readiness of nursing students during the COVID-19 pandemic in three countries: A cross-sectional study

Nurs Forum. 2022 Jan 30. doi: 10.1111/nuf.12698. Online ahead of print.

ABSTRACT

BACKGROUND: It is crucial to evaluate student academic motivation and self-directed learning (SDL) readiness while teaching online or flexibly. During the coronavirus disease 2019 epidemic, there were few investigations on the link between academic motivation and SDL readiness.

AIM: This study investigated the connection between academic motivation and SDL readiness and the three academic motivation domains’ predictive features.

METHODS: This cross-sectional study used convenience sampling to recruit 1187 nursing students from four nursing colleges in three countries. We utilized the Academic Motivation Scale College Version and Self-directed Learning Readiness Scale for Nurse Education to collect data. Descriptive and inferential statistics were employed to analyze the data.

RESULTS: Extrinsic motivation received the highest mean. Most nursing students exhibited SDL readiness, whereas “desire for learning” was rated the highest dimension of SDL readiness. We found significant differences in nursing students’ intrinsic and extrinsic motivation and amotivation between the three countries. Finally, country, gender, and intrinsic motivation were significant predictors of the nursing students’ SDL readiness.

CONCLUSION: Among Filipino, Saudi, and Thai nursing students, their SDL readiness is influenced by the intrinsic motivation domain. Therefore, nursing students with higher levels of intrinsic motivation are proactive learners for SDL.

PMID:35094399 | DOI:10.1111/nuf.12698

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Comparing Laparoscopic Sacrocolpopexy with Vaginal Sacrospinous Ligament Fixation in the Treatment of Vaginal Apical Prolapse; the First Randomized Clinical Trial: A pilot study

Urol J. 2022 Jan 30. doi: 10.22037/uj.v19i.7039. Online ahead of print.

ABSTRACT

PURPOSE: To compare two methods of laparoscopic sacrocolpopexy (LSCP) and sacrospinous ligament fixation (SSLF) in terms of efficacy and safety in the treatment of vaginal apical prolapse. Materials and Methods This prospective, randomized controlled clinical trial was conducted on 32 patients with symptomatic vaginal apical prolapse, referred to the female urology clinic of …, during 2018-2019. The patients were re-examined at 12 months after surgery. Objective success was recorded using Pelvic Organ Prolapse Quantification (POP-Q) classification as primary outcome. The subjective success of the methods was determined with the quality-of-life parameters, based on Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20), and Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) scores as secondary outcome. Moreover, complications were recorded in both groups.

RESULTS: The amount of intraoperative bleeding was significantly higher in the SSLF group, compared to the LSCP group (P=0.01). Persistent pain was observed in two (12%) patients in the LSCP group and five (31%) patients in the SSLF group (P=0.2). The decrease in the total PFIQ-7 score was in favor of the LSCP group but not statistically significant (p= 0.06). The LSCP group showed bigger improvement in vaginal (p=0.04) and bowel (p=0.03) scores. The results of the PISQ-12 and PFDI-20 questionnaires as well as POP-Q examination were not different in two groups.

CONCLUSION: Although the surgical methods of LSCP and SSLF can be equally effective in the treatment of apical prolapse, LSCP appears to be superior to SSLF regarding less bleeding.

PMID:35094377 | DOI:10.22037/uj.v19i.7039

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On the Q statistic with constant weights for standardized mean difference

Br J Math Stat Psychol. 2022 Jan 30. doi: 10.1111/bmsp.12263. Online ahead of print.

ABSTRACT

Cochran’s Q statistic is routinely used for testing heterogeneity in meta-analysis. Its expected value is also used in several popular estimators of the between-study variance, τ2 . Those applications generally have not considered the implications of its use of estimated variances in the inverse-variance weights. Importantly, those weights make approximating the distribution of Q (more explicitly, QIV ) rather complicated. As an alternative, we investigate a new Q statistic, QF , whose constant weights use only the studies’ effective sample sizes. For the standardized mean difference as the measure of effect, we study, by simulation, approximations to distributions of QIV and QF , as the basis for tests of heterogeneity and for new point and interval estimators of τ2 . These include new DerSimonian-Kacker-type moment estimators based on the first moment of QF , and novel median-unbiased estimators. The results show that: an approximation based on an algorithm of Farebrother follows both the null and the alternative distributions of QF reasonably well, whereas the usual chi-squared approximation for the null distribution of QIV and the Biggerstaff-Jackson approximation to its alternative distribution are poor; in estimating τ2 , our moment estimator based on QF is almost unbiased, the Mandel – Paule estimator has some negative bias in some situations, and the DerSimonian-Laird and restricted maximum likelihood estimators have considerable negative bias; and all 95% interval estimators have coverage that is too high when τ2=0 , but otherwise the Q-profile interval performs very well.

PMID:35094381 | DOI:10.1111/bmsp.12263

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Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies

Ther Innov Regul Sci. 2022 Jan 30. doi: 10.1007/s43441-021-00368-8. Online ahead of print.

ABSTRACT

BACKGROUND: In recent years, population pharmacokinetics (PK) has been widely used in neonatal pharmacology. However, the sample size selection for neonatal PK studies has been highly variable and without clear consensus, especially for drugs with large individual variability. Therefore, this study’s objective was to investigate the optimal sample size for use in neonatal PK studies.

METHODS: A comprehensive and reliable population PK model (1631 neonates) of vancomycin was selected as a reference model. The original sparse PK dataset was divided into several sub-datasets according to different sample sizes. NONMEM was used for sub-datasets PK analysis. Statistical powers were calculated to evaluate different sample sizes (> 80% was expected).

RESULTS: During population clearance estimations, the average power was 40%, 85%, 100%, and 100% for sample sizes of 10, 25, 50, and 100 neonates, respectively. And the frequency of model-estimated median clearance values within ± 10% (relative errors) of target value (0.057 L/h) were 75.0%, 68.8%, 57.8%, and 35.0%, respectively. Regarding age sub-groups (postmenstrual age (PMA) < or ≥ 37 weeks) clearance estimation, a sample size of 50 was better to complete the assessment of the neonatal age sub-group even in some cases of unbalanced age distribution.

CONCLUSION: A sample size of 25 neonates provided a consistent estimation of the overall population (PMA: 23.3-52.4 weeks) clearance for a drug with high individual variability using a sparse PK sampling design. A sample size of 50 was recommended to complete neonatal age sub-group assessments.

PMID:35094368 | DOI:10.1007/s43441-021-00368-8

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Assessment of the predictive capability of modelling and simulation to determine bioequivalence of inhaled drugs: A systematic review

Daru. 2022 Jan 30. doi: 10.1007/s40199-021-00423-7. Online ahead of print.

ABSTRACT

OBJECTIVES: There are a multitude of different modelling techniques that have been used for inhaled drugs. The main objective of this review was to conduct an exhaustive survey of published mathematical models in the area of asthma and chronic obstructive pulmonary disease (COPD) for inhalation drugs. Additionally, this review will attempt to assess the applicability of these models to assess bioequivalence (BE) of orally inhaled products (OIPs).

EVIDENCE ACQUISITION: PubMed, Science Direct, Web of Science, and Scopus databases were searched from 1996 to 2020, to find studies that described mathematical models used for inhaled drugs in asthma/COPD.

RESULTS: 50 articles were finally included in this systematic review. This research identified 22 articles on in silico aerosol deposition models, 20 articles related to population pharmacokinetics and 8 articles on physiologically based pharmacokinetic modelling (PBPK) modelling for inhaled drugs in asthma/COPD. Among all the aerosol deposition models, computational fluid dynamics (CFD) simulations are more likely to predict regional aerosol deposition pattern in human respiratory tracts. Across the population PK articles, body weight, gender, age and smoking status were the most common covariates that were found to be significant. Further, limited published PBPK models reported approximately 29 parameters relevant for absorption and distribution of inhaled drugs. The strengths and weaknesses of each modelling technique has also been reviewed.

CONCLUSION: Overall, while there are different modelling techniques that have been used for inhaled drugs in asthma and COPD, there is very limited application of these models for assessment of bioequivalence of OIPs. This review also provides a ready reference of various parameters that have been considered in various models which will aid in evaluation if one model or hybrid in silico models need to be considered when assessing bioequivalence of OIPs.

PMID:35094370 | DOI:10.1007/s40199-021-00423-7

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Bibliometric analysis of metabolic surgery for type 2 diabetes: current status and future prospects

Updates Surg. 2022 Jan 30. doi: 10.1007/s13304-021-01201-5. Online ahead of print.

ABSTRACT

Metabolic surgery has become a powerful treatment for obese type 2 diabetes (T2DM). Experts have been devoting to the research of metabolic surgery in the treatment of T2DM. The debate continues, and there is no comprehensive statistical and intuitive analysis for it. To explore the current research status, the latest hotspots and the changing trend in this field, we conducted a bibliometric analysis. This paper made a bibliometric analysis based on the data source from Science Core Collection Network (WoSCC). Vosviewer v.1.6.10 software is used to construct a knowledge map. From 2011 to 2020, 1424 peer-reviewed papers on metabolic surgery for T2DM were retrieved. The United States contributed the most publications and gained global impact with the most citations. Obesity Surgery was the most prolific journal in this field. Prof. Schauer Philip R., Prof. Buchwald H. and Prof. Sjostrom L. were the most renowned experts in this aspect. The top cited references discussed the status of metabolic surgery for the treatment of T2DM worldwide and the importance of regular evaluation. The extracted keywords mainly formed three clusters: (1) research on the selection of different metabolic surgery methods; (2) possible mechanisms; (3) improvement of T2DM complications by metabolic surgery. Our study makes a comprehensive and objective analysis of metabolic surgery in obese patients with T2DM, providing valuable information for further clinical application and related scientific research. Researchers can quickly locate research hotspots in a large number of relevant literature.

PMID:35094308 | DOI:10.1007/s13304-021-01201-5