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Nevin Manimala Statistics

Survival prognostic in different age groups of patients undergoing local versus radical excision for rectal cancer: a study based on the SEER database

Updates Surg. 2024 May 5. doi: 10.1007/s13304-024-01846-y. Online ahead of print.

ABSTRACT

Age significantly affects the prognosis of patients with rectal cancer after radical excision (RE), and local excision (LE) is an alternative surgical procedure to RE. To compare the survival prognosis in different age groups of LE versus RE for rectal cancer. Patients diagnosed with rectal adenocarcinoma treated by LE or RE from 2010 to 2017 were obtained from the SEER database. The primary outcomes are 5-year OS and CSS. A total of 11,170 patients were eventually included, and there were 490 patients in LE and RE groups, respectively, after 1:1 propensity score matching. The 5-year OS and CSS after LE were significantly better in < 50 years and 50-66 years groups than in > 66 years group (5-year OS: 95.70% vs 88.40% vs 67.00%, P < 0.001; 5-year CSS: 95.70% vs 96.30% vs 82.60%, P < 0.001). No statistical significance was found for the differences in 5-year OS and CSS between LE and RE in < 50, 50-66, and > 66 years group (P > 0.05). Multivariate analysis showed age > 66 years, poorly differentiated or undifferentiated (Grade III/IV), and tumor size 3 to 5 cm was independent risk factors for 5-year OS after LE; age > 66 years, perineural invasion, and tumor size 3 to 5 cm were the 5-year CSS independent risk factors for after LE. We found that the survival prognosis of younger rectal cancer patients treated with LE was significantly better than older (> 66 years) patients, and the survival prognosis of rectal cancer patients in the three age groups was similar between LE and RE.

PMID:38704811 | DOI:10.1007/s13304-024-01846-y

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Hydrochemical characterization and comprehensive water quality assessment of groundwater within the main stream area of Yishu River

Environ Monit Assess. 2024 May 5;196(6):512. doi: 10.1007/s10661-024-12669-0.

ABSTRACT

To gain a comprehensive understanding of the hydrochemical characteristics, controlling factors, and water quality of groundwater in the main stream area of Yishu River (MSYR), a study was conducted using water quality data collected during both the dry and wet seasons. Through statistical analysis, hydrochemical methods, fuzzy comprehensive evaluation, and health risk evaluation modeling, the water chemical characteristics of the main stream area of Yishu River were studied, and the water quality of the area was comprehensively evaluated. The findings indicate that HCO3 and Ca2+ are the predominant anions and cations in the MSYR during the dry and wet seasons, respectively. Moreover, anion concentration in groundwater follows HCO3 > SO42- > NO3 > Cl, while cations are ranked as Ca2+ > Na+ > Mg2+ > K+. Overall, the groundwater manifests as weakly alkaline and is predominantly classified as hard-fresh water. During the wet season, there is greater groundwater leaching and filtration, with rock and soil materials more readily transferred to groundwater, and the concentrations of main chemical components in groundwater are higher than those during the dry season, and the hydrochemical types are primarily characterized as HCO3-Ca·Mg and SO4·Cl-Ca·Mg types. These results also suggest that the chemical composition of the groundwater in the MSYR is influenced mainly by water-rock interaction. The primary ions originate from the dissolution of silicate rock and carbonate rock minerals, while cation exchange plays a critical role in the hydrogeochemical process. Groundwater in the MSYR is classified mostly as class II water, indicating that it is generally of good quality. However, areas with high levels of class IV and V water are present locally, and NO3 concentration is a crucial factor affecting groundwater quality. In the wet season, more groundwater and stronger mobility lead to greater mobility of NO3 and wider diffusion. Therefore, the risk evaluation model shows that nitrate health risk index is higher in the wet season than it is in the dry season, with children being more vulnerable to health risks than adults. To study groundwater in this area, its hydrochemical characteristics, water quality, and health risk assessment are of great practical significance for ensuring water safety for residents and stable development of social economy.

PMID:38704803 | DOI:10.1007/s10661-024-12669-0

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A Pilot, Predictive Surveillance Model in Pharmacovigilance Using Machine Learning Approaches

Adv Ther. 2024 May 5. doi: 10.1007/s12325-024-02870-5. Online ahead of print.

ABSTRACT

INTRODUCTION: The identification of a new adverse event (AE) caused by a drug product is one of the key activities in the pharmaceutical industry to ensure the safety profile of a drug product. Machine learning (ML) has the potential to assist with signal detection and supplement traditional pharmacovigilance (PV) surveillance methods. This pilot ML modeling study was designed to detect potential safety signals for two AbbVie products and test the model’s capability of detecting safety signals earlier than humans.

METHODS: Drug X, a mature product with post-marketing data, and Drug Y, a recently approved drug in another therapeutic area, were selected. Gradient boosting-based ML approaches (e.g., XGBoost) were applied as the main modeling strategy.

RESULTS: For Drug X, eight true signals were present in the test set. Among 12 potential new signals generated, four were true signals with a 50.0% sensitivity rate and a 33.3% positive predictive value (PPV) rate. Among the remaining eight potential new signals, one was confirmed as a signal and detected six months earlier than humans. For Drug Y, nine true signals were present in the test set. Among 13 potential new signals generated, five were true signals with a 55.6% sensitivity rate and a 38.5% PPV rate. Among the remaining eight potential new signals, none were confirmed as true signals upon human review.

CONCLUSION: This model demonstrated acceptable accuracy for safety signal detection and potential for earlier detection when compared to humans. Expert judgment, flexibility, and critical thinking are essential human skills required for the final, accurate assessment of adverse event cases.

PMID:38704799 | DOI:10.1007/s12325-024-02870-5

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A study of the association between single nucleotide polymorphisms of the endoplasmic reticulum aminopeptidase 2 (ERAP2) gene and the risk of ankylosing spondylitis in Egyptians

Mol Biol Rep. 2024 May 5;51(1):614. doi: 10.1007/s11033-024-09404-w.

ABSTRACT

BACKGROUND: Ankylosing spondylitis (AS) is often regarded as the prototypical manifestation of spondylo-arthropathies that prevalently involves the axial skeleton with the potential attribution of ERAP2 polymorphisms to AS predisposition. The purpose of this study was to determine the genetic association between ERAP2 gene rs2910686, and rs2248374 single nucleotide polymorphisms (SNPs) and the risk of ankylosing spondylitis in the Egyptian population.

METHODS AND RESULTS: A cross-sectional work involved 200 individuals: 100 AS individuals diagnosed based on modified New York criteria in 1984 with 100 healthy controls matched in age and gender. The study included a comprehensive evaluation of historical data, clinical examinations, and evaluation of the activity of the disease using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). A comprehensive laboratory and radiological evaluation were conducted, accompanied by an assessment and genotyping of the ERAP2 gene variants rs2248374 and rs2910686. This genotyping was performed utilizing a real-time allelic discrimination methodology.Highly statistically substantial variations existed among the AS patients and the healthy control group regarding rs2910686 and rs2248374 alleles. There was a statistically significant difference between rs2910686 and rs2248374 regarding BASDAI, BASFI, mSASSS, ASQoL, V.A.S, E.S.R, and BASMI in the active AS group.

CONCLUSIONS: ERAP2 gene SNPs have been identified as valuable diagnostic biomarkers for AS patients in the Egyptian population being a sensitive and non-invasive approach for AS diagnosis especially rs2910686. Highly statistically significant variations existed among the AS patients and the healthy control group regarding rs2910686 alleles and genotypes.Further research is recommended to explore the potential therapeutic implications of these SNPs.

PMID:38704785 | DOI:10.1007/s11033-024-09404-w

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Nevin Manimala Statistics

Real-World Impact of Upfront Cytoreductive Nephrectomy in Metastatic Non-Clear Cell Renal Cell Carcinoma Treated with First-Line Immunotherapy Combinations or Tyrosine Kinase Inhibitors (A Sub-Analysis from the ARON-1 Retrospective Study)

Target Oncol. 2024 May 5. doi: 10.1007/s11523-024-01065-w. Online ahead of print.

ABSTRACT

BACKGROUND: About 20% of patients with renal cell carcinoma present with non-clear cell histology (nccRCC), encompassing various histological types. While surgery remains pivotal for localized-stage nccRCC, the role of cytoreductive nephrectomy (CN) in metastatic nccRCC is contentious. Limited data exist on the role of CN in metastatic nccRCC under current standard of care.

OBJECTIVE: This retrospective study focused on the impact of upfront CN on metastatic nccRCC outcomes with first-line immune checkpoint inhibitor (IO) combinations or tyrosine kinase inhibitor (TKI) monotherapy.

METHODS: The study included 221 patients with nccRCC and synchronous metastatic disease, treated with IO combinations or TKI monotherapy in the first line. Baseline clinical characteristics, systemic therapy, and treatment outcomes were analyzed. The primary objective was to assess clinical outcomes, including progression-free survival (PFS) and overall survival (OS). Statistical analysis involved the Fisher exact test, Pearson’s correlation coefficient, analysis of variance, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models.

RESULTS: Median OS for patients undergoing upfront CN was 36.8 (95% confidence interval [CI] 24.9-71.3) versus 20.8 (95% CI 12.6-24.8) months for those without CN (p = 0.005). Upfront CN was significantly associated with OS in the multivariate Cox regression analysis (hazard ratio 0.47 [95% CI 0.31-0.72], p < 0.001). In patients without CN, the median OS and PFS was 24.5 (95% CI 18.1-40.5) and 13.0 months (95% CI 6.6-23.5) for patients treated with IO+TKI versus 7.5 (95% CI 4.3-22.4) and 4.9 months (95% CI 3.0-8.1) for those receiving the IO+IO combination (p = 0.059 and p = 0.032, respectively).

CONCLUSIONS: Our study demonstrates the survival benefits of upfront CN compared with systemic therapy without CN. The study suggests that the use of IO+TKI combination or, eventually, TKI monotherapy might be a better choice than IO+IO combination for patients who are not candidates for CN regardless of IO eligibility. Prospective trials are needed to validate these findings and refine the role of CN in current mRCC management.

PMID:38704759 | DOI:10.1007/s11523-024-01065-w

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Adnexal masses and pregnancy: a single-center experience of 9 years

Arch Gynecol Obstet. 2024 May 5. doi: 10.1007/s00404-024-07527-w. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to analyze the experience of a tertiary health center about the management of adnexal masses that have been diagnosed during pregnancy or detected accidentally during cesarean delivery.

METHODS: This is a retrospective review of 160 women who underwent concurrent surgery for adnexal mass during cesarean section, 24 women who delivered vaginally and subsequently had surgery due to the prenatal diagnosis of adnexal mass and 10 women who underwent surgery for adnexal mass during pregnancy. Corresponding to the delivery and surgery times, 200 women who had no diagnosis of pregnancy-associated adnexal mass served as controls.

RESULTS: The women in the control group and study groups had statistically similar gestational age at delivery, birth weight and preterm delivery (p > 0.05 for all). Miscarriage was significantly more frequent in women undergoing surgery for adnexal mass during pregnancy (p = 0.001). The women who had surgery for adnexal mass during pregnancy, at the time of cesarean section and following delivery were statistically similar with respect to surgery type and histopathological diagnosis (p > 0.05 for both). Malignancy was detected in none of the patients who underwent surgery for adnexal mass during pregnancy. Acute abdomen was the indication for the emergency surgery in six patients (3.5%) who had surgery for adnexal mass during pregnancy. Four patients (2.4%) had surgery for adnexal mass during pregnancy due to the high index of suspicion for malignancy.

CONCLUSION: The risk of malignancy was relatively lower in this cohort of adnexal masses detected during pregnancy and cesarean delivery. Surgical management of adnexal masses should be postponed to postpartum period as such management leads to an increased risk of miscarriage. Unless there is a need for emergent surgery or cancer staging, vaginal delivery should be encouraged in women diagnosed with adnexal mass during pregnancy.

PMID:38704757 | DOI:10.1007/s00404-024-07527-w

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Nevin Manimala Statistics

Why are triploid quaking aspen (Populus tremuloides) common?

Am J Bot. 2024 May 5:e16325. doi: 10.1002/ajb2.16325. Online ahead of print.

ABSTRACT

PREMISE: Quaking aspen is a clonal tree species that has mixed ploidy, often with high relative abundance of both diploids and triploids but no haploids or tetraploids. Triploids typically have low fertility, leaving their occurrence apparently unlikely from an evolutionary perspective, unless they provide a “triploid bridge” to generating higher-fitness tetraploids-which are not observed in this species. This study focused on how triploidy can be maintained in quaking aspen.

METHODS: A computational model was used to simulate gamete production, sexual reproduction, asexual reproduction, parent survival, and offspring survival in a population. All parameters were assumed to be cytotype-dependent and environment-independent. Sampling methods were used to identify parameter combinations consistent with observed cytotype frequencies.

RESULTS: Many processes and parameter values were sufficient to yield a moderate frequency of triploids, and very few were necessary. The most plausible route involved higher triploid survival at the parent or offspring stage and limited unreduced gamete production by either diploid or triploid parents. Triploid fertility was helpful but not necessary.

CONCLUSIONS: The coexistence of diploids and triploids in quaking aspen is statistically likely and promoted by the existence of commonly observed, long-lived triploid clones. However, other mechanisms not captured by the model related to environmental variation could also occur. Further empirical data or more complex but difficult-to-parameterize models are needed to gain further insight.

PMID:38704729 | DOI:10.1002/ajb2.16325

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Evaluation of the Oral Hygiene Ability Instrument (OHAI): Test of reliability

Int J Dent Hyg. 2024 May 5. doi: 10.1111/idh.12792. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the reliability of the new Oral Hygiene Ability Instrument (OHAI) developed to assess the cause of any inability for older adults to manage oral hygiene self-care. Oral hygiene is an important part of oral health. The inability to manage oral hygiene, combined with other risk factors, often results in poor oral health and impaired quality of life. A reliable OHAI could benefit preventive oral health care.

METHODS: The preliminary OHAI uses 33 items in three parts: (I) interview, (II) clinical examination and (III) observation of oral hygiene activities. A total of 37 older adults participated in a test-retest study of Part I. Inclusion criteria were age ≥ 65 years, have at least one tooth and be able to oral hygiene self-care. The intra- and inter-rater reliability of parts II and III used films and photographs of OHAI assessments of 15 different individuals. These films/photographs were assessed twice by four dental professionals who had participated in the OHAI data collection. For statistical analyses of the reliability, per cent agreement, Krippendorff’s alpha and E. Svensson’s method were used.

RESULTS: The test-retest for Part I items showed acceptable-to-good agreement and no systematic disagreement. In Part II, two items showed somewhat limited reliability. Part III showed good intra- and inter-rater reliability.

CONCLUSION: The OHAI items seem stable and reliable for the intended sample, and the instrument may be a valuable tool to identify older adults at risk of impaired oral health. However, two items may need to be reformulated.

PMID:38704665 | DOI:10.1111/idh.12792

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Farmworker Acceptability of Backpack Hydration Systems

J Agromedicine. 2024 May 4:1-9. doi: 10.1080/1059924X.2024.2349022. Online ahead of print.

ABSTRACT

OBJECTIVE: To improve water access while working and contribute to fewer heat-related illnesses (HRI), backpack hydration systems were provided to over 200 farmworkers to use during the 2022 growing season. Acceptability of the water intake intervention was assessed among farmworkers in eastern North Carolina, USA.

METHODS: With a pre-established community-university partnership, the acceptability of the intervention was assessed using a cross-sectional survey. The backpack brand selected included a 3-liter water bladder and attached drinking hose. Data analysis included descriptive and correlation statistics.

RESULTS: Among 47 male, migrant farmworkers, most (90%) reported the hydration backpack to be acceptable or completely acceptable to workplace fluid intake. Most (53%) reported using the backpack some of the time, compared to 28% who used it often. The participants reported an average of 4.8 (SD 2.2) liters of water intake from the backpack on a typical workday. Most reported the backpack improved the quantity and frequency of their water consumption.

CONCLUSION: This study was an important first step in implementation of hydration backpack systems as an HRI-preventative intervention among farmworkers. Future interventional studies could assess the efficacy of the backpacks on health outcomes, including incidence of dehydration and symptoms of HRI.

PMID:38704610 | DOI:10.1080/1059924X.2024.2349022

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A simple risk stratification model for prostate cancer using histopathologic findings of radical prostatectomy

Am J Clin Pathol. 2024 May 5:aqae049. doi: 10.1093/ajcp/aqae049. Online ahead of print.

ABSTRACT

OBJECTIVES: To develop a simple postoperative risk stratification based on histopathologic findings from radical prostatectomy specimens.

METHODS: This study included 3 cohorts of patients with a preoperative diagnosis of clinically localized prostate cancer: 1 derivation cohort (n = 432) and 2 validation cohorts (n = 506 and n = 720). First, a postoperative risk stratification model was developed in the derivation cohort using the factors extraprostatic extension, surgical margin status, seminal vesicle invasion, and lymph node involvement. Each of the first 3 factors was assigned 0 or 1 point for negative or positive results, respectively, and the sum of the points, ranging from 0 to 3, was scored. pN1 was not scored but was analyzed separately. Validation cohorts were then used to evaluate the predictive accuracy of the model. Additionally, we compared the model with the Cancer of the Prostate Risk Assessment (CAPRA) score.

RESULTS: Because the log-rank test showed no statistically significant differences between scores 1 vs 2 or score 3 vs pN1 in the derivation cohort, the following 3-level risk stratification was created: low risk (score 0), intermediate risk (score 1-2), and high risk (score 3 or pN1). There were statistically significant differences in recurrence-free survival between any of 2 groups of 3-level risk stratification. This model similarly worked in both validation cohorts. The C indexes for the model were higher than those for the CAPRA score.

CONCLUSIONS: This simple postoperative risk stratification model, based on radical prostatectomy findings, has a prognostic impact that has been validated in a multicenter population.

PMID:38704590 | DOI:10.1093/ajcp/aqae049