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Nevin Manimala Statistics

Evaluating Efficacy and Safety of Crisaborole in Managing Childhood Mild to Moderate Atopic Dermatitis: A Systematic Review and Meta-Analysis

Br J Hosp Med (Lond). 2025 Jan 24;86(1):1-19. doi: 10.12968/hmed.2024.0575. Epub 2025 Jan 24.

ABSTRACT

Aims/Background Atopic dermatitis (AD) is a common chronic inflammatory skin disorder globally. Crisaborole, a nonsteroidal topical phosphodiesterase 4 inhibitor (PDE4i), has been utilized in treating AD. Crisaborole regulates the production of inflammatory cytokines, which are usually overactive among AD patients. Therefore, this study aimed to explore the efficacy and safety of crisaborole in treating AD in patients aged ≤18 years. Methods A literature search was performed across PubMed, MEDLINE, Embase, Cochrane, and Google Scholar. The inclusion criteria involved primary studies evaluating the effect of crisaborole in treating dermatitis, articles exploring the use of crisaborole in AD patients below 18 years (>two years), and articles published in English between 2000 and 2022. However, the studies evaluating AD in adult patients, those reporting treatments other than crisaborole, those published before 2000, and articles written in languages other than English were excluded from this analysis. Furthermore, secondary data sources such as case reports, newspaper articles, magazines, and other systematic reviews and meta-analyses were excluded. A meta-analysis was conducted using RevMan 5.4. The risk of bias in the manuscripts was assessed using the Cochrane tool. The I-square test statistic was used to determine heterogeneity, and Egger’s test was used to evaluate publication bias. Results Ten studies met the eligibility criteria and were included in the final analysis. Most of the studies exhibited a low risk of bias with no publication bias. Meta-analysis indicated a significant difference in the number of patients attaining Investigator Static Global Assessment (ISGA) success at day 29, with significantly higher patients in the crisaborole group than in the vehicle group (odds ratio (OR) 1.56, 95% CI 1.24 to 1.96; I2 = 77%; p = 0.0001). Similarly, pruritus improvement was significant between the two cohorts at day 29, indicating significantly higher heterogeneity (OR 1.70, 95% CI 1.10 to 2.63; I2 = 91%; p = 0.02). Furthermore, the safety profiling of the treatments was insignificant, demonstrating no statistical difference in the treatment-emergent adverse events (TEAEs) between the two groups with high heterogeneity (OR 0.53, 95% CI 0.14 to 1.98; I2 = 99%; p = 0.35). Conclusion Crisaborole demonstrates substantial efficacy in treating mild to moderate AD compared to vehicle therapies, as it reduces the signs and symptoms of the disease. Furthermore, crisaborole is well tolerated and has an acceptable safety profile in treating mild to moderate AD patients.

PMID:39862023 | DOI:10.12968/hmed.2024.0575

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Nevin Manimala Statistics

Comparison of Different Thromboprophylaxis Regimens in Elderly Patients Following Hip Arthroplasty

Br J Hosp Med (Lond). 2025 Jan 24;86(1):1-13. doi: 10.12968/hmed.2024.0538. Epub 2025 Jan 14.

ABSTRACT

Aims/Background Deep venous thrombosis (DVT) represents a significant postoperative complication after artificial femoral head replacement, with the incidence increasing proportionally with patient age. This study aimed to evaluate the effect of early postoperative use of intermittent pneumatic compression devices (IPC), followed by the combined use of low molecular weight heparin (LMWH) after 48 hours, for the prevention of postoperative lower limb DVT in elderly patients undergoing hip arthroplasty. Methods The retrospective study included 100 elderly patients who underwent unilateral femoral head replacement. The control group (n = 55) received combined LMWH initiated 12 hours postoperatively, while the observation group (n = 45) started combined LMWH 48 hours postoperatively. Changes in coagulation parameters, perioperative complications, and the incidence of postoperative lower limb DVT were compared between the two groups. Results Coagulation parameters showed significant changes post-intervention in both groups, with no statistically significant inter-group differences observed post-intervention (p > 0.05). The incidence of postoperative lower limb DVT did not differ significantly between the two groups (p > 0.05). However, the observation group demonstrated significantly lower postoperative blood loss, incidence of periwound hematoma, and transfusion rates compared to the control group (p < 0.05). Conclusion The sequential application of IPC in the early postoperative period, followed by combined LMWH administration after 48 hours, demonstrates comparable efficacy in preventing lower limb DVT formation in elderly patients undergoing hip arthroplasty when compared to the initiation of combined LMWH starting 12 hours postoperatively. In addition, this approach significantly reduces the risk of postoperative bleeding and exhibits a high safety profile.

PMID:39862017 | DOI:10.12968/hmed.2024.0538

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Nevin Manimala Statistics

Effects of Electrical Stimulation on Activation of Mirror Neuron Network in Healthy Adults during Motor Execution and Imitation: An fNIRS Study

J Integr Neurosci. 2025 Jan 7;24(1):25731. doi: 10.31083/JIN25731.

ABSTRACT

BACKGROUND: Observation, execution, and imitation of target actions based on mirror neuron network (MNN) have become common physiotherapy strategies. Electrical stimulation (ES) is a common intervention to improve muscle strength and motor control in rehabilitation treatments. It is possible to enhance MNN’s activation by combining motor execution (ME) and motor imitation (MI) with ES simultaneously. This study aims to reveal whether ES could impact cortical activation during ME and MI.

METHODS: We recruited healthy individuals and assigned them randomly to the control group (CG) or experiment group (EG). Participants in EG performed ME and MI tasks with ES, while participants in CG performed the same two tasks with sham ES. We utilized functional near-infrared spectroscopy (fNIRS) to detect brain activation of MNN during ME and MI with and without ES, a randomized block design experiment paradigm was designed. Descriptive analysis of oxy-hemoglobin (HbO) and deoxy-hemoglobin (HbR) were used to show the hemoglobin (Hb) concentration changes after different event onsets in both CG and EG, a linear mixed-effects model (LMM) of HbO data was employed to analyze the effect of ES on the activation of MNN.

RESULTS: A total of 102 healthy adults were recruited and 72 participants’ data were analysed in the final report. The block averaged Hb data showed that HbO concentration increased and HbR concentration decreased in most MNN regions during ME and MI in both groups. The LMM results showed that ES can significantly improve the activation of inferior frontal gyrus, middle frontal gyrus, and precentral gyrus during MI, the supplementary motor area, inferior parietal lobule, and superior temporal gyri showed increased activation, but without statistical significance. Although the results did not reach statistical significance during ME, ES still showed positive effects on increased overall activations.

CONCLUSIONS: In this study, we present potential novel rehabilitation approaches that combines MNN strategies and low-frequency ES to enhance cortical activation. Our results revealed that ES has potential to increase activation of most MNN brain areas, providing evidence for related rehabilitative interventions and device development.

CLINICAL TRIAL REGISTRATION: This study was registered on the China Clinical Trial Registration Center (identifier: ChiCTR2200064082, registered 26, September 2022, https://www.chictr.org.cn/showproj.html?proj=178285).

PMID:39862008 | DOI:10.31083/JIN25731

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Nevin Manimala Statistics

Short (2-Hour) Non-Oxygenated End-Ischemic Hypothermic Perfusion Versus Cold Storage in the Setting of Renal Transplantation

Artif Organs. 2025 Jan 24. doi: 10.1111/aor.14953. Online ahead of print.

ABSTRACT

BACKGROUND: Kidney transplantation (KT) is the most effective treatment for end-stage renal disease. End-ischemic hypothermic machine perfusion (EI-HMP) has emerged as a promising method for preserving grafts before transplantation. This study aimed to compare graft function recovery in KT recipients of deceased brain-death (DBD) grafts preserved with EI-HMP versus static cold storage (SCS). The primary outcome was the rate of delayed graft function (DGF). Secondary outcomes included urine output, intensive care unit (ICU) stay, hospital stay duration, and survival rates.

METHODS: A retrospective, single-center observational study was conducted at Sapienza University of Rome, analyzing 313 KT patients between January 2014 and September 2021. Patients were stratified into two groups based on graft preservation methods (EI-HMP, n = 95; SCS, n = 218). A stabilized inverse probability treatment weighting (IPTW) method was employed to adjust for potential confounders.

RESULTS: There were no significant differences in DGF rates between the two groups (17.9% vs. 15.6% in SCS and EI-HMP cases, respectively; p = 0.75). EI-HMP group demonstrated a higher urine output on day 2 (p = 0.046), a shorter ICU stay (p < 0.0001), and a trend toward a shorter overall hospital stay (p = 0.07). No statistically significant differences were found between EI-HMP and SCS cases in 1- and 3-year overall survival rates (3.2% and 6.7% vs. 5.6% and 6.6%, respectively; log-rank p = 0.53) or in death-censored graft loss rates (5.4% and 8.9% vs. 5.7% and 7.3%, respectively; log-rank p = 0.88). In a sub-analysis of expanded criteria donors (ECD), EI-HMP demonstrated a protective effect by reducing the risk of DGF (OR = 0.31, 95% CI = 0.09-0.95; p = 0.047).

CONCLUSION: EI-HMP was associated with certain short-term benefits, including increased urine output and reduced ICU stays, but showed no significant impact on long-term survival outcomes. A reduction in DGF rates was observed only in the ECD subgroup. Randomized controlled trials are necessary to further investigate the long-term clinical benefits of EI-HMP.

PMID:39861988 | DOI:10.1111/aor.14953

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Nevin Manimala Statistics

Measurement properties of the Trunk Impairment Scale-modified Norwegian version among people with mild to moderate multiple sclerosis

Disabil Rehabil. 2025 Jan 24:1-9. doi: 10.1080/09638288.2025.2454299. Online ahead of print.

ABSTRACT

PURPOSE: The Trunk Impairment Scale-modified Norwegian version (TIS-modNV) measures trunk control for clinical and research purposes. This study examined the validity and reliability of the TIS-modNV in people with multiple sclerosis (pwMS).

MATERIALS AND METHODS: Sixty-eight pwMS (mild to moderate) participated. The TIS-modNV and the Mini-Balance Evaluation Systems Test (Mini-BESTest) scores were compared for construct validity using Spearman’s rho (rs). TIS-modNV performance was videotaped and rated by four physiotherapists on two occasions. The inter- and intrarater reliability was analyzed via intraclass correlation coefficients (ICC), standard errors of measurement (SEM), Bland-Altman plots, and kappa statistics (k).

RESULTS: Validity was demonstrated (rs = 0.55-0.61). Interrater reliability for the total score was moderate to good (ICC(A,1) =0.67; ICC(C,1) = 0.78), and the SEM was 2 points (12.8%). Interrater reliability varied across the rater pairs (ICC(A,1) = 0.54-0.81) as displayed in the Bland-Altman plots. Item-level interrater agreement varied from poor to good (k = 0.10-0.79). Intrarater reliability of the total scores was moderate to good (ICC(A,1) = 0.67-0.82).

CONCLUSION: This study supports the construct validity and overall reliability of the TIS-modNV in pwMS with mild to moderate disability. However, variations in rater reliability need to be addressed.

PMID:39861987 | DOI:10.1080/09638288.2025.2454299

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Nevin Manimala Statistics

Feasibility and acceptability of randomized controlled trial of intervention vs expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy

Ultrasound Obstet Gynecol. 2025 Jan 24. doi: 10.1002/uog.29175. Online ahead of print.

NO ABSTRACT

PMID:39861966 | DOI:10.1002/uog.29175

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Nevin Manimala Statistics

Measuring the effect of RFID and marker recognition tags on cockroach (Blattodea: Blaberidae) behavior using AI-aided tracking

J Insect Sci. 2025 Jan 20;25(1):5. doi: 10.1093/jisesa/ieaf002.

ABSTRACT

Radio frequency identification (RFID) technology and marker recognition algorithms can offer an efficient and non-intrusive means of tracking animal positions. As such, they have become important tools for invertebrate behavioral research. Both approaches require fixing a tag or marker to the study organism, and so it is useful to quantify the effects such procedures have on behavior before proceeding with further research. However, frequently studies do not report doing such tests. Here, we demonstrate a time-efficient and accessible method for quantifying the impact of tagging on individual movement using open-source automated video tracking software. We tested the effect of RFID tags and tags suitable for marker recognition algorithms on the movement of Argentinian wood roaches (Blapicta dubia, Blattodea: Blaberidae) by filming tagged and untagged roaches in laboratory conditions. We employed DeepLabCut on the resultant videos to track cockroach movement and extract measures of behavioral traits. We found no statistically significant differences between RFID tagged and untagged groups in average speed over the trial period, the number of unique zones explored, and the number of discrete walks. However, groups that were tagged with labels for marker recognition had significantly higher values for all 3 metrics. We therefore support the use of RFID tags to monitor the behavior of B. dubia but note that the effect of using labels suitable for label recognition to identify individuals should be taken into consideration when measuring B.dubia behavior. We hope that this study can provide an accessible and viable roadmap for further work investigating the effects of tagging on insect behavior.

PMID:39861965 | DOI:10.1093/jisesa/ieaf002

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Nevin Manimala Statistics

Bayesian Borrowing With Multiple Heterogeneous Historical Studies Using Order Restricted Normalized Power Prior

Stat Med. 2025 Feb 10;44(3-4):e10302. doi: 10.1002/sim.10302.

ABSTRACT

The recent U.S. Food and Drug Administration guidance on complex innovative trial designs acknowledges the use of Bayesian strategies to incorporate historical information based on clinical expertise and data similarity. Also, data from multiple previous studies with similar settings often qualify for historical borrowing. Although several classes of informative priors can semi-automatically leverage historical information based on data compatibility, it is common that some exogenous factors, such as the year of patient enrollment, can also influence the relevance of each historical study to the current trial. Consequently, a natural a priori ordering among historical trials often arises, a constraint that many current informative priors fail to accommodate. Motivated by a pediatric lupus clinical study and an oncology trial, we introduce a variant of the power prior, named the ordered normalized power prior, which ensures a targeted order restriction on the power parameters and maintains data-adaptive borrowing. We further explore and compare two distinct normalization strategies and outline computational details with efficient sampling algorithms. The clinical datasets mentioned are analyzed, and extensive simulations are conducted for comparison. An efficient implementation is provided in our updated package NPP available on the Comprehensive R Archive Network.

PMID:39861964 | DOI:10.1002/sim.10302

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Nevin Manimala Statistics

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study

Cancer Med. 2025 Feb;14(3):e70369. doi: 10.1002/cam4.70369.

ABSTRACT

BACKGROUND: Real-world data regarding patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations receiving mobocertinib are limited. This study describes these patients’ characteristics and outcomes.

METHODS: A chart review was conducted across three countries (Canada, France, and Hong Kong), abstracting data from eligible patients (NCT05207423). The inclusion criteria were: ≥ 18 years old; diagnosis of stage IIIB-IV NSCLC with EGFR ex20ins between January 1, 2017 and November 30, 2021; received mobocertinib. Data on demographics, clinical parameters, treatment patterns, mobocertinib exposure, real-world outcomes, and adverse events (AEs) were collected. Results are also reported by Asian/Non-Asian races.

RESULTS: Overall, 105 patients were enrolled (median [IQR] age at initial diagnosis: 64.0 years [56, 71]; women: 62.9%). The most common first-line of therapy (LoT) was chemotherapy; the most common second LoT was EGFR tyrosine kinase inhibitors. Most patients received mobocertinib during LoT two and three (74.3%); the maximum dose was 160 mg/day for 67.6% of the cohort (mean [SD] daily dose: 130.6 mg [36.68]). The median real-world progression-free survival (PFS) on mobocertinib was 4.76 months (95% CI: 3.98, 6.21). The overall response rate and disease control rate were 20.0% and 48.6%, respectively (median duration of response: 8.34 months [95% CI: 3.61, 9.49]). The median overall survival (OS) was 26.28 months (95% CI: 20.21, 36.44). Asian patients had numerically superior PFS and OS compared with non-Asian patients. Regarding safety analysis, 73 patients (69.5%) experienced any AE. The most common AE was diarrhea (any grade) (52 patients; 49.5%).

CONCLUSIONS: These data illustrate the real-world effectiveness of mobocertinib.

PMID:39861957 | DOI:10.1002/cam4.70369

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Efficacy of Orthognathic Surgery in OSAS Patients: A Systematic Review and Meta-Analysis

J Oral Rehabil. 2025 Jan 24. doi: 10.1111/joor.13936. Online ahead of print.

ABSTRACT

BACKGROUND: Obstructive sleep apnea syndrome (OSAS) is a prevalent condition characterised by repeated episodes of partial or complete obstruction of the upper airway during sleep, leading to disrupted sleep and associated morbidities. Orthognathic surgery (OGS) has been proposed as a treatment option for OSAS, aimed at anatomically repositioning the maxillofacial structures to alleviate airway obstruction. This systematic review and meta-analysis aimed to evaluate the efficacy of OGS in reducing apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) scores among OSAS patients.

METHODS: We conducted a comprehensive literature search across multiple databases for studies assessing the outcomes of OGS in OSAS patients, focusing on changes in AHI and ESS scores. The inclusion criteria encompassed observational studies, cohort studies, and randomised control trials. Data extraction and quality assessment were performed independently by two reviewers. Random-effects meta-analysis was utilised to pool mean differences (MD) of AHI and ESS scores preoperatively and postoperatively, with 95% confidence intervals (CI) calculated.

RESULTS: A total of 8 studies met the inclusion criteria, where OGS was shown to be slightly more effective in correcting OSAS than the other modalities assessed, primarily CPAP. The pooled MD for AHI demonstrated a significant reduction in scores post-OGS (MD = 29.84, 95% CI: 14.17-45.50, p < 0.0001) with substantial heterogeneity (I2 = 95%). For ESS, the pooled MD indicated a non-significant reduction (MD = 1.91, 95% CI: -1.29 to 5.12, p = 0.24) with high heterogeneity (I2 = 81%).

CONCLUSION: Orthognathic surgery appears to be an effective intervention for reducing AHI in patients with OSAS, suggesting a potential to improve the objective measures of sleep apnea. However, the effect on subjective sleepiness scores, as evaluated by ESS, was not statistically significant. The high heterogeneity among studies warrants individualised patient assessment when considering OGS for OSAS. Further research is needed to identify factors contributing to the variability of outcomes and to assess the long-term benefits and risks associated with the procedure.

PMID:39861956 | DOI:10.1111/joor.13936