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Nevin Manimala Statistics

Effect of statin use on head and neck cancer prognosis in a multicenter study using a Common Data Model

Sci Rep. 2023 Nov 13;13(1):19770. doi: 10.1038/s41598-023-45654-7.

ABSTRACT

Few studies have found an association between statin use and head and neck cancer (HNC) outcomes. We examined the effect of statin use on HNC recurrence using the converted Observational Medical Outcome Partnership (OMOP) Common Data Model (CDM) in seven hospitals between 1986 and 2022. Among the 9,473,551 eligible patients, we identified 4669 patients with HNC, of whom 398 were included in the target cohort, and 4271 were included in the control cohort after propensity score matching. A Cox proportional regression model was used. Of the 4669 patients included, 398 (8.52%) previously received statin prescriptions. Statin use was associated with a reduced rate of 3- and 5-year HNC recurrence compared to propensity score-matched controls (risk ratio [RR], 0.79; 95% confidence interval [CI], 0.61-1.03; and RR 0.89; 95% CI 0.70-1.12, respectively). Nevertheless, the association between statin use and HNC recurrence was not statistically significant. A meta-analysis of recurrence based on subgroups, including age subgroups, showed similar trends. The results of this propensity-matched cohort study may not provide a statistically significant association between statin use and a lower risk of HNC recurrence. Further retrospective studies using nationwide claims data and prospective studies are warranted.

PMID:37957229 | DOI:10.1038/s41598-023-45654-7

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Significance of micro-EGFR T790M mutations on EGFR-tyrosine kinase inhibitor efficacy in non-small cell lung cancer

Sci Rep. 2023 Nov 13;13(1):19729. doi: 10.1038/s41598-023-45337-3.

ABSTRACT

Small amounts of epidermal growth factor receptor (EGFR) T790M mutation (micro-T790M), which is detected using droplet digital PCR (ddPCR) but not conventional PCR, in formalin-fixed and paraffin-embedded (FFPE) samples have been investigated as a predictive factor for the efficacy of EGFR-tyrosine kinase inhibitors (TKIs). However, the predictive value of micro-T790M remains controversial, possibly owing to the failure to examine artificial T790M in FFPE specimens. Therefore, we examined the predictive value of micro-T790M in first-generation (1G), second-generation (2G), and third-generation (3G) EGFR-TKI efficacy using a new method to exclude FFPE-derived artificial mutations in our retrospective cohort. The primary objective was time to treatment failure (TTF) of 1G, 2G, and 3G EGFR-TKIs according to micro-T790M status. In total, 315 patients with EGFR-positive non-small cell lung cancer treated with 1G, 2G, and 3G EGFR-TKIs were included in this study. The proportion of patients positive for micro-T790M in the 1G, 2G, and 3G EGFR-TKI groups was 48.2%, 47.1%, and 47.6%, respectively. In the micro-T790M-positive group, the TTF was significantly longer in the 2G and 3G EGFR-TKI groups than in the 1G TKI group. No differences in the micro-T790M-negative group were observed. Micro-T790M status detected using ddPCR, eliminating false positives, may be a valuable predictor of EGFR-TKI efficacy.

PMID:37957228 | DOI:10.1038/s41598-023-45337-3

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Content and specificity of the Anti-SARS-CoV-2 antibodies in solutions for immunoglobulin replacement therapy

Int Immunopharmacol. 2023 Nov 11;125(Pt B):111159. doi: 10.1016/j.intimp.2023.111159. Online ahead of print.

ABSTRACT

BACKGROUND: Specific antibodies are important for post-vaccination and post-infection immune responses against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The role of antibodies in preventing and treating Coronavirus disease 2019 (COVID-19) in high-risk populations has been highlighted through the use of virus-specific monoclonal antibodies, which has raised the question of immunoglobulin replacement therapy (IRT) used in immunocompromised patients.

METHODS: Virus-specific anti-receptor-binding domain (RBD) and anti-nucleocapsid protein (NCAP) antibodies (assessed using a chemiluminescence assay and virus-neutralizing antibodies (virus neutralization test against Delta and Omicron variants)) were analyzed in 20 batches of 10 % (100 mg/mL) immunoglobulin solutions for intravenous IRT from two commercially available producers between January 2022 and March 2023 for clinical use.

RESULTS: Anti-RBD and anti-NCAP antibodies were detected in all 20 batches of assessed IRT solutions (mean concentrations of 2817 IU/mL and 2380 IU/mL, respectively). Notably, the concentration of the virus-specific antibodies increased continuously during the follow-up period (from 822.5 IU/mL to 4066.4 IU/mL and 102 IU/mL to 3455.9 IU/mL). These antibodies demonstrated high virus-neutralizing activity against the Delta variant (mean titers of 436 and 325) but were limited to the Omicron variant (mean titers 78 and 70). The differences observed between the two brands were not statistically significant.

CONCLUSION: IRT solutions contain high concentrations of anti-SARS-CoV-2 specific antibodies, which may prevent COVID-19; however, the efficacy can be influenced by variable virus-neutralizing activities against different viral strains. Therefore, appropriate IRT should be combined with other approaches, such as vaccination or pre- and post-exposure prophylaxis. Passively transmitted specific antibodies may also lead to false-positive serological test results.

PMID:37956487 | DOI:10.1016/j.intimp.2023.111159

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Racial disparities in the timely receipt of adjuvant radiotherapy for head and neck cancer

Oral Oncol. 2023 Nov 11;147:106611. doi: 10.1016/j.oraloncology.2023.106611. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the influence of socioeconomic and demographic factors which might predict for excessive delays in the receipt of adjuvant radiotherapy for head and neck cancer.

METHODS AND MATERIALS: The medical records of 430 consecutive patients referred for adjuvant radiation after surgical resection for squamous cell carcinoma of the head and neck were reviewed. The number of days from surgery to initiation of radiation was recorded. To study the variability in which adjuvant radiation was delivered, descriptive statistics were used to determine the percentage of patients who deviated from starting treatment beyond the recommended benchmark of 42 days. The chi-square statistic was used to compare differences in proportion among subsets. A Cox proportional hazards model was constructed to perform a multi-variate analysis to identify factors which independently influenced the likelihood for non-adherence.

RESULTS: The interval between surgery and the start of radiation therapy ranged from 5 to 128 days (mean, 36 days). The mean number of days from surgery to radiation therapy was 31 days, 35 days, 40 days, and 42 days for Caucasians, Asians, Latino, and Black patients (p = 0.01). In all, 359 of 430 patients (83 %) started adjuvant radiation within 42 days. The proportion of patients who initiated radiation therapy within 42 days of surgery was 91 %, 86 %, 71 %, 65 %, and 80 % for Caucasians, Asians, Latinos, Blacks, and Native Hawaiian/Pacific Islanders, respectively (p < 0.001). Patient characteristics associated with higher odds of non-adherence to the timely receipt of adjuvant radiation therapy within then 42-day benchmark from surgery to radiation included race ([OR] = 4.23 95 % CI (1.30-7.97), non-English speaking status ([OR] = 2.38, 95 % CI: 0.61-4.50), and low socioeconomic status ([OR] = 1.21, 95 % CI: 1.01-1.86).

CONCLUSION: Underrepresented minorities are more likely to experience delays in the receipt of adjuvant radiation for head and neck cancer. The potential underlying reasons are discussed.

PMID:37956484 | DOI:10.1016/j.oraloncology.2023.106611

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Sleep in psoriasis: A meta-analysis

J Psychosom Res. 2023 Nov 8;176:111543. doi: 10.1016/j.jpsychores.2023.111543. Online ahead of print.

ABSTRACT

OBJECTIVE: Currently, there are discrepant results regarding the quantitative effect of psoriasis on sleep, which may, in part, be attributed to the use of non-standardised questionnaires.

METHODS: The PubMed/Medline, Embase, and Cochrane databases were searched for cross-sectional, case-control or cohort studies that recruited patients with psoriasis and healthy controls and reported data regarding Pittsburgh Sleep Quality Index (PSQI) and the prevalence of sleep disturbance (SD) based on the PSQI, published from inception up to January 2023. Secondary outcomes included scores for the Insomnia Severity Index (ISI), Beck Depression Inventory (BDI), and Epworth Sleepiness Scale (ESS), and risk for restless legs syndrome (RLS). Meta-analyses using random-effects models were used for statistical analyses.

RESULTS: Fifteen studies including 1274 patients with psoriasis and 775 controls were analysed. A higher PSQI (weighted mean difference [WMD] = 3.397, P < 0.001, I2 = 84.2%) and a higher risk for SD (odds ratio [OR] = 6.640, P < 0.001, I2 = 67.5%) were observed in patients with psoriasis compared with controls. Subgroup analyses revealed a greater difference in PSQI score and/or risk for SD between patients with psoriasis and controls in subgroups of psoriatic arthritis, moderate-to-severe psoriasis, shorter psoriasis duration, and younger age. Moreover, patients with psoriasis exhibited higher ISI (WMD = 2.709, P < 0.001) and BDI scores (WMD = 4.565, P = 0.001), and risk for RLS (OR = 4.689, P = 0.01). However, there was no significant difference in ESS scores (WMD = -0.229, P = 0.77) compared with controls.

CONCLUSION: Psoriasis was associated with poor sleep quality and higher risk for SD, especially among patients with psoriatic arthritis, severe psoriasis, shorter duration of psoriasis, and younger age. Patients with psoriasis were also more likely to experience insomnia, RLS, and depression.

PMID:37956475 | DOI:10.1016/j.jpsychores.2023.111543

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Acute acquired concomitant esotropia: May COVID-19 lockdowns have changed its presentation?

Eur J Ophthalmol. 2023 Nov 13:11206721231213415. doi: 10.1177/11206721231213415. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the effects of COVID-19 lockdown in Italy on the features of Acute Acquired Concomitant Esotropia (AACE).

SUBJECTS: Patients of the Polyclinic Hospital of Bari diagnosed with AACE between January 2018 and December 2021, subdivided in pre-lockdown group – diagnosed before March 2020 – and post-lockdown group.

METHODS: Medical records were reviewed, and statistical analysis performed. Deviation size was assessed in the 9 cardinal positions of gaze with refractive correction. Wilcoxon test for unpaired samples was used to compare data of age, near maximum deviation and best corrected visual acuity (BCVA) for each eye; Student’s t test was used to compare far maximum deviation, difference far/near maximum deviation and spherical equivalent data. Fisher exact test was used to compare subtype cases (Bielschowsky vs Non-Bielschowsky) in the two groups. A p-value lower than 0.05 was considered statistically significant.The primary outcome measure was the difference in AACE subtypes between the two groups.

RESULTS: Nineteen patients were included, of which 12 males (63.2%); 7 belong to the pre-lockdown group and 12 to the post-lockdown group. The difference in types between the two groups proved to be statistically significant (p = 0.01977).The differences in the mean of age, right BCVA, right spherical equivalent and mean spherical equivalent between the two groups proved to be statistically significant (p < 0.05).

CONCLUSIONS: After the COVID-19 pandemic, the profile of the typical patient with AACE has probably changed, and now it is more probably myopic and elderly than before. Thus, we observed an increase in the Bielschowsky subtype.

PMID:37956466 | DOI:10.1177/11206721231213415

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Precision and agreement of axial length in paediatric population measured with MYAH and AL-Scan biometers

Clin Exp Optom. 2023 Nov 13:1-6. doi: 10.1080/08164622.2023.2277287. Online ahead of print.

ABSTRACT

CLINICAL RELEVANCE: Measuring axial length is key in the field of myopia development and control. Hence, the precision and agreement of commercially available biometers is of vital interest to understand their variability and interchangeability in the paediatric population.

BACKGROUND: Different biometers are available to measure axial length and monitor myopia progression in clinical practice. The purpose of this study was to assess the precision (repeatability and reproducibility) and agreement of the MYAH and AL-Scan biometers in a paediatric population.

METHODS: Three consecutive measurements were performed using MYAH and AL-Scan biometers in each subject by the same operator to test for repeatability. To test for reproducibility, two measurements were performed for each subject by two different observers with a 5-min interval between measurements. To test the agreement, each subject was measured once with each instrument.

RESULTS: A total of 187 subjects, with a mean age of 8.5 ± 0.3 years and mean spherical equivalent refractive error of +0.22 ± 0.77 D participated in the study. For the repeatability study, the within-subject standard deviation was 0.01 mm, and the repeatability limit was 0.04 mm for both instruments, with no statistically significant differences among repeated measures (p = 0.162 for MYAH and p = 0.774 for AL-Scan). For the reproducibility study, the within-subject standard deviation was 0.01 mm and the repeatability limit was 0.04 mm. There were statistically significant differences for the repeated measures for the AL-Scan (p = 0.002) but not for the MYAH (p = 0.643). Regarding the agreement between both instruments, the 95% limit of agreement ranged from -0.04 to 0.05 mm, and the differences were statistically significant (p = 0.021).

CONCLUSIONS: The repeatability, reproducibility, and agreement of the MYAH and AL-Scan biometers seem optimal for following children with myopia.

PMID:37956406 | DOI:10.1080/08164622.2023.2277287

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Osteosarcoma Explorer: A Data Commons With Clinical, Genomic, Protein, and Tissue Imaging Data for Osteosarcoma Research

JCO Clin Cancer Inform. 2023 Sep;7:e2300104. doi: 10.1200/CCI.23.00104.

ABSTRACT

PURPOSE: Osteosarcoma research advancement requires enhanced data integration across different modalities and sources. Current osteosarcoma research, encompassing clinical, genomic, protein, and tissue imaging data, is hindered by the siloed landscape of data generation and storage.

MATERIALS AND METHODS: Clinical, molecular profiling, and tissue imaging data for 573 patients with pediatric osteosarcoma were collected from four public and institutional sources. A common data model incorporating standardized terminology was created to facilitate the transformation, integration, and load of source data into a relational database. On the basis of this database, a data commons accompanied by a user-friendly web portal was developed, enabling various data exploration and analytics functions.

RESULTS: The Osteosarcoma Explorer (OSE) was released to the public in 2021. Leveraging a comprehensive and harmonized data set on the backend, the OSE offers a wide range of functions, including Cohort Discovery, Patient Dashboard, Image Visualization, and Online Analysis. Since its initial release, the OSE has experienced an increasing utilization by the osteosarcoma research community and provided solid, continuous user support. To our knowledge, the OSE is the largest (N = 573) and most comprehensive research data commons for pediatric osteosarcoma, a rare disease. This project demonstrates an effective framework for data integration and data commons development that can be readily applied to other projects sharing similar goals.

CONCLUSION: The OSE offers an online exploration and analysis platform for integrated clinical, molecular profiling, and tissue imaging data of osteosarcoma. Its underlying data model, database, and web framework support continuous expansion onto new data modalities and sources.

PMID:37956387 | DOI:10.1200/CCI.23.00104

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Comparison of two multiplex PCR tests for common pathogen detection in hospitalized children with acute respiratory infection

J Infect Dev Ctries. 2023 Oct 31;17(10):1474-1479. doi: 10.3855/jidc.17999.

ABSTRACT

INTRODUCTION: Multiplex PCR methods have significantly improved the diagnosis of acute respiratory tract infections (ARTIs) in children. The ResP-CE System coupled with capillary electrophoresis is a highly specialized, automated, and expensive technology for detecting common pathogens in ARTIs. The XYRes-MCA System, a remarkably less expensive multiplex PCR instrument, employs hybridization for the detection of ARTI pathogens. Both methods detect 9 common microorganisms in ARTIs, i.e., RSV, FLUAV, FLUBV, ADV, PIV, HMPV, HBOV, HCOV, and MP. In this study, we aimed to compare the performance of these two methods in the detection of pathogens from sputum specimens collected from children with ARTIs.

METHODOLOGY: Sputum specimens were collected from 237 hospitalized children with ARTIs. Nucleic acid was extracted on an automated workstation. The ResP-CE and XYres-MCA systems were applied to detect pathogens from the samples, and the test result agreement between the two methods was evaluated using Kappa statistics.

RESULTS: The ResP-CE and XYres-MCA identified pathogens, single or in combination, in 151 (63.7%) and 171 (72.1%) of 237 samples, respectively. Approximately 85% of positive samples identified by either method contained a single pathogen. Moderate to almost perfect concordance between the two methods was found in detecting the following 7 pathogens: RSV, FLUAV, FLUBV, PIV, HMPV, HBOV, and MP.

CONCLUSIONS: These two methods are comparable in detecting common pathogens of ARTIs in children. As XYres-MCA analysis is more cost-effective, it could play an important role in diagnosing ARTIs in children in less economically developed regions.

PMID:37956382 | DOI:10.3855/jidc.17999

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Serum vitamin D concentration in children with pneumonia and acute respiratory infections, risk factors for its low level

J Infect Dev Ctries. 2023 Oct 31;17(10):1413-1419. doi: 10.3855/jidc.17749.

ABSTRACT

INTRODUCTION: While there is extensive literature discussing the link between various respiratory infections and risk factors that contribute to low vitamin D levels, there is still no consensus on this relationship. The aim of this study was to test whether low vitamin D levels are associated with pneumonia and acute respiratory infections (ARI) and to identify risk factors for low vitamin D levels in children with these conditions.

METHODOLOGY: The study was conducted at the Muratsan Hospital in Yerevan from February to December 2017. It included 140 randomly selected children aged 1 to 5 years, half of whom had pneumonia and the other half had ARI. Based on serum vitamin D levels, the children were further divided into groups with low (52 patients with pneumonia and 38 patients with ARI) and normal vitamin D levels (18 patients with pneumonia and 32 patients with ARI). Factors such as feeding, age, gender, and mother’s education were included as indicators of risk for low vitamin D.

RESULTS: The difference between the mean values of vitamin D in groups of children with pneumonia and ARI was statistically significant (p < 0.05). Feeding was positively, and age was negatively associated with the level of vitamin D (p < 0.05).

CONCLUSIONS: We found that children with pneumonia had a lower vitamin D level. We also found that poor nutrition and the age of the child (1 to 5 years) were risk factors for low vitamin D levels with respiratory infections.

PMID:37956365 | DOI:10.3855/jidc.17749