Sample Size Research Articles

Accuracy of immunological tests on serum and urine for diagnosis of Taenia solium neurocysticercosis: A systematic review.

Taenia solium neurocysticercosis is a zoonotic neglected tropical disease, for which adequate diagnostic management is paramount, especially in patients with active cysts for whom improved and timely management could prove beneficial. Immunodiagnosis can potentially partially mitigate the necessity for neuroimaging, shortening the diagnostic -and treatment- pathway. An up-to-date review of immunological test performance is however lacking. Searches were performed in PubMed, EMBASE, Web of Science, and Scopus (up to January 2024), with included records fitting the review scope, i.e. accuracy evaluation of an antibody-/or antigen-detecting immunological test, using serum or urine of humans confirmed via reference standard (i.e. neuroimaging or surgery/biopsy). Record data was assessed, with classification of descriptive data on cyst localization and stage according to a developed confidence scale, and with selection of tests evaluated on a sufficiently high sample size. A QUADAS-2 risk of bias assessment was performed. After screening, 169 records were included for data collection, with 53 records-corresponding to 123 tests- selected for analysis. Absence of data and large data heterogeneity complicated result interpretation. The lentil lectin-bound glycoprotein enzyme-linked immunoelectrotranfser blot seems to fulfill high accuracy standards regarding detection of parenchymal active multiple cysts; also antigen-detecting tests on serum and urine performed well, additionally in detection of extraparenchymal neurocysticercosis. A novel multi-antigen print immunoassay is highly promising, with sensitivity for detection of extraparenchymal and parenchymal active single and multiple cysts of 100.0%, and specificity of 98.5%. Point-of-care tests showed promising results, however require further evaluation in targeted resource-poor settings. The review highlights the importance of transparent and unambiguous data reporting. With promising immunological tests in development, the challenge before usage in targeted settings will be to perform large-scale evaluations whilst holding into account both optimized test performance and ease of use. Accessibility to validated tests and feasibility of implementation should also be considered.

NIMG-70. COMPARISON OF VOLUMETRIC AND CROSS-SECTIONAL MEASUREMENTS IN DIFFUSE MIDLINE GLIOMAS: RETHINKING RESPONSE ASSESSMENT

Abstract BACKGROUND The Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria, which are based on bidimensional or cross-sectional product (CP) measurements of tumor size, are the standard for assessing treatment response in diffuse midline glioma (DMG). This study aims to investigate the correlation between CP and volumetric measurements in progressive disease (PD) and compare their prognostic impact in pediatric patients with DMG. METHODS We retrospectively reviewed clinical and imaging data from 27 subjects with newly diagnosed DMG, encompassing 16 subjects from the PNOC003 and PNOC007 clinical trials and 11 subjects from the Children’s Hospital of Philadelphia. Tumors were segmented using a pretrained pediatric-specific autosegmentation model followed by manual revisions. Tumor volume and CP measurements were automatically derived from the outlined tumor. Cox regression analysis was used to compare the performance of CP and volumetric measurements in predicting overall survival (OS). The correlation between CP and volumetric thresholds for PD was assessed by linear regression. Comparison of survival of patients classified as PD versus non-PD by CP and volumetric measurements at 7 months post-baseline scan was performed using log-rank analysis. RESULTS Cox regression analysis demonstrated that volumetric measurements were significantly associated with OS (p=0.04), whereas CP measurements were not a significant predictor (p=0.07). An approximate 55% increase in segmented volume corresponded to a 25% increase in CP, which is the definition of PD according to RAPNO criteria (R2 = 0.71). At 7 months, volumetric classification of PD more accurately predicted survival than the CP method (p=0.06 for volumetric vs 0.14 for CP). CONCLUSION Our study showed that volumetric measurements are better predictors of survival compared to bidimensional measurements. We are extending this analysis to a larger sample size, examining survival at additional time points, and incorporating other factors influencing OS, such as treatment approaches.

Detection of low-level fentanyl concentrations in mixtures of cocaine, MDMA, methamphetamine, and caffeine via surface-enhanced Raman spectroscopy.

Surface-enhanced Raman spectroscopy (SERS) was utilized to measure low-level fentanyl concentrations mixed in common cutting agents, cocaine, 3,4-methylenedioxymethamphetamine (MDMA), methamphetamine, and caffeine. Mixtures were prepared with a fentanyl concentration range of 0-339 μM. Data was initially analyzed by plotting the area of a diagnostic peak (1026 cm-1) against concentration to generate a calibration model. This method was successful with fentanyl/MDMA samples (LOD 0.04 μM) but not for the other mixtures. A chemometric approach was then employed. The data was evaluated using principal component analysis (PCA), partial least squares (PLS1) regression, and linear discriminant analysis (LDA). The LDA model was used to classify samples into one of three designated concentration ranges, low = 0-0.4 mM, medium = 0.4-14 mM, or high >14 mM, with fentanyl concentrations correctly classified with greater than 85% accuracy. This model was then validated using a series of "blind" fentanyl mixtures and these unknown samples were assigned to the correct concentration range with an accuracy >95%. The PLS1 model failed to provide accurate quantitative assignments for the samples but did provide an accurate prediction for the presence or absence of fentanyl. The combination of the two models enabled accurate quantitative assignment of fentanyl in binary mixtures. This work establishes a proof of concept, indicating a larger sample size could generate a more accurate model. It demonstrates that samples, containing variable, low concentrations of fentanyl, can be accurately quantified, using SERS.

The Impact of Frenotomy on Gastroesophageal Reflux in Pediatric Ankyloglossia: A Systematic Review.

This systematic review was conducted to assess if there are changes in gastroesophageal reflux (GER) outcomes after frenotomy in infants with ankyloglossia. Systematic Review. CINAHL, Cochrane, EMBASE, Pubmed, and Scopus were searched from inception to May 20, 2023. Inclusion criteria consisted of all study designs, infants ≤12 months of age with ankyloglossia, and use of quantitative GER measures (esophageal pH manometry (pH) or multi-channel intraluminal impedance (MII), and/or patient-reported symptom scores) pre- and post-frenotomy. Quality assessment and data extraction were performed in duplicate. Of 37 articles screened, 7 met inclusion criteria (6 prospective cohort studies and 1 RCT). No studies utilized objective measures to quantify reflux, that is MII or pH. The number of infants with ankyloglossia ranged from 47 to 237 (mean age of 4.4-8.3 weeks). Qualitative analysis included all 7 studies which used the GIGER, I-GERQ-R, and GSQ-I scales to assess GER. Parent-reported GER scores decreased post-frenotomy. However, the lack of control groups in the prospective cohort studies precludes conclusive findings that changes are related to frenotomy. Meta-analysis was not possible due to the high risk of bias from limited sample sizes, poor methodology, and lack of adequate control groups. Limited work has been conducted on the relationship between frenotomy and GER in infants with ankyloglossia. The lack of high-quality studies precludes definitive conclusions, as GER symptoms are known to improve spontaneously with time. Future RCT studies are warranted to further elucidate the effect of frenotomy on symptoms of GER in infants with ankyloglossia. III.

The Impact of Peer Relationships, Moral Development, and Family Relationships on Collective Violence with the Mediating Role of Psychological Security

Background: Collective violence is a significant global and national social and health issue, particularly in Iran. Objectives: This study investigated the impact of peer relationships, moral development, and family relationships on collective violence, with the mediating role of psychological security, among male high school students in Mashhad. Methods: This correlational study involved a statistical population of all male high school students in Mashhad, with a sample size of 1,300 selected through cluster sampling. The tools used included multidimensional questionnaires: The Multidimensional Peer Acceptance of Collective Violence (MPACV) scale, the Moral Development Questionnaire (MDQ), Fine's Parent-Child Relationship Questionnaire (FP-CRQ), the adolescent peer relations instrument (APRI), and Maslow's Psychological Security Questionnaire (MPSQ). Data were collected between November 2023 and January 2024 and analyzed using SPSS18 and LISREL8.8 software. Path analysis was conducted to explore the relationships between variables. Results: The findings revealed that moral development has a negative and significant impact on collective violence (standard coefficient -0.16, significance coefficient -2.45). Additionally, the father-child relationship (standard coefficient -0.59, significance coefficient -8.98) and the mother-child relationship (standard coefficient -0.46, significance coefficient -7.06) negatively and significantly affect collective violence. In contrast, peer relationships positively and significantly influence collective violence (standard coefficient 0.24, significance coefficient 3.70). Psychological security plays a crucial mediating role: Moral development (standard coefficient 0.41, significance coefficient 6.21), the father-child relationship (standard coefficient 0.54, significance coefficient 8.24), and the mother-child relationship (standard coefficient 0.50, significance coefficient 7.65) positively and significantly affect psychological security, which in turn reduces collective violence (standard coefficient -0.24, significance coefficient -3.70). However, peer relationships negatively impact psychological security (standard coefficient -0.53, significance coefficient -8.06), contributing to increased collective violence. Conclusion: Enhancing moral development and strengthening family relationships can significantly reduce collective violence among students by improving their psychological security.

State of Play in the Implementation of the Principles of Inclusive Leadership in Fintech Companies in Lithuania

The multifaceted challenges posed by globalization, medical advancements, conflicts and crises necessitate a critical examination of social and organizational inclusion. Despite the acknowledged advantages of inclusive leadership (IL), there remains a significant research gap concerning the perceptions of IL among diverse employee groups, particularly within heterogeneous organizations. This study aims to bridge this gap by exploring the perceptions of IL across various sociodemographic groups within fintech companies in Lithuania. By concentrating on this rapidly evolving sector, this research enhances the understanding of IL by assessing how sociodemographic variables influence perceptions of inclusive leadership practices. A total of 236 responses were analyzed using the Mann–Whitney U and Kruskal–Wallis tests, supplemented by the Bonferroni correction to ensure statistical robustness. The findings elucidate the dynamics of IL within the fast-paced fintech environment, revealing unique challenges and opportunities to foster organizational inclusivity. The implications of this research provide actionable insights for industry leaders striving to implement IL strategies that empower minority groups and enhance overall organizational performance. Although the results indicate that fintech organizations have made strides in embedding IL principles, these advancements are not uniformly experienced across diverse employee demographics. Specifically, this study identifies significant disparities in IL perceptions between employees of other genders and those with health-related impairments. Acknowledging certain limitations, particularly the small sample sizes of some examined employee subgroups, this study advocates for further research to yield generalizable findings that can inform and improve inclusive organizational practices.

SURG-55. NOVEL IQ-DOME APPROACH FOR SUPERIOR SEMICIRCULAR CANAL DEHISCENCE REPAIR REDUCES REVISIONAL SURGERY RATE

Abstract Superior Semicircular Canal Dehiscence (SSCD) is characterized by a thinning of the bony ceiling of the superior semicircular canal, manifesting in auditory and vestibular deficits. Surgical repair is the standard treatment modality of SSCD, with conventional methods including plugging or recapping the defective canal with bone wax, bone chips, muscle, and others. Previous research has shown multiple complications with these conventional materials, including a high rate of failure of the primary repair and the need for revisional surgeries. To address this challenge, we investigated a novel surgical sealing technique using IQ-Dome, a titanium mesh plate overlying the arcuate eminence. We aim to assess the efficacy of IQ-Dome in the repair of SSCD compared to conventional material while evaluating outcome measures including postoperative symptom resolution, complication, and revisional surgery rates. We performed a retrospective analysis of patients undergoing SSCD repair via the middle cranial fossa approach at UCLA between 2017 and 2021. We compared demographics and post-operative outcomes between the application of IQ-Dome and conventional materials. A total of 160 patients undergoing SSCD repair were included in our study, with 80 patients receiving IQ-Dome and 80 patients receiving non-IQ-Dome approaches. 60% of patients in the IQ-Dome cohort and 66.7% of patients in the non-IQ-Dome cohort were female. The mean ages of patients were 45.7 years (range 13-78) in the IQ-Dome cohort and 48.9 years (range 17-69) in the non-IQ-Dome cohort. The surgical revision rates for the IQ-Dome and non-IQ-Dome cohorts were 5.7% and 8.5%, respectively. There was no significant difference in postoperative complications between groups. Thus, IQ-Dome is a safe approach for the surgical management of SSCD, decreasing failure and revision rate by nearly 3% in our patient population and offering an alternative surgical sealing repair intervention. Future studies with larger sample sizes are warranted to further assess the efficacy of IQ-Dome.

QLTI-22. TEMOZOLOMIDE CHEMOTHERAPY EFFECTS ON GLIOMA PATIENT FERTILITY AND THEIR OFFSPRING: A RETROSPECTIVE REVIEW

Abstract Gliomas represent ~30% of primary brain tumors. Temozolomide (TMZ) chemotherapy with concurrent radiation or following radiation is the main course of treatment. Avoidance of pregnancy in female patients and partner of male patients is strongly encouraged due to unknown teratogenic and long-term effects to the health and development of fetus. Patients of childbearing age must wrestle with receiving TMZ treatment, potentially impacting fertility, and the desire for biological children in the future. Gamete preservation prior to TMZ induction is the current solution, which is often financially prohibitive, leaving patients to consider natural conception after completion of TMZ. We intend to identify potential difficulties in conception, pregnancy complications, birth abnormalities, and childhood developmental deficiencies that may be correlated to TMZ exposure prior to conception. Included patients conceived and delivered one or two children after completing treatment with TMZ. All patients received antiepileptic drugs (range = 1-4) which have variable known teratogenic effects during pregnancy. We identified 13 patients (7 male, 6 female; median age of 29) with diagnoses of astrocytoma (n=5), oligodendroglioma (n=5), oligoastrocytoma (n=2; diagnosed prior to 2021 WHO classification), and glioblastoma (n=1). Two reported issues with conceiving (1 male and 1 female) and 17 children were born. One child had developmental abnormalities (6%), and all other 16 children were healthy per parental assessment. Complete results of pregnancy complication and childhood development data will be updated at the meeting. Information on teratogenic and developmental effects of TMZ in humans is largely unknown. Animal studies have shown an increase in fetal malformations when exposed to TMZ during pregnancy. Despite the limitations of a retrospective study, our findings suggest that natural conception after the conclusion of TMZ treatment may be safer than suspected. Given the limited sample size, future comprehensive studies are warranted to corroborate these observations.

MIMC-β: microdosimetric assessment method for internal exposure of β-emitters based on mesh-type cell cluster model

The method combining Monte Carlo (MC) simulation and mesh-type cell models provides a way to accurately assess the cellular dose induced byβ-emitters. Although this approach allows for a specific evaluation of various nuclides and cell type combinations, the associated time cost for obtaining results is relatively high. In this work, we propose a Microdosimetric assessment method for Internal exposure ofβ-emitters based on Mesh-type Cell cluster models (abbreviated as MIMC-β). This approach is applied to evaluate the dose in various types of cells (human bronchial epithelial cells, BEAS-2B; normal human liver cells, L-O2; and normal human small intestine epithelial cells, FHs74Int) exposed toβ-emitters. Furthermore, microdosimetric quantity based on the cell cluster model are employed to estimate the relative biological effectiveness (RBE) ofβ-emitters. The results indicate that this method can accurately and rapidly predict cellular doses caused by different types ofβ-emitters, significantly mitigating the efficiency challenges associated with directly employing MC to estimate the overall dose of the mesh-type cell cluster model. In comparison with results obtained from direct simulations of uniform administration ofβ- sources using PHITS for validation, the cellular cluster overallS-values obtained through MIMC-βshow discrepancies mostly below 5%, with the minimum deviation reaching 1.35%. Small sampling sizes within the cell nucleus led to larger average lineal energies. In comparison to C-14, the differences in cellular cluster average lineal energy for Cs-134, Cs-137, and I-131 are negligible, resulting in close numerical estimations of RBE based on lineal energy. The MIMC-βcan be extended to diverse cell types andβ-emitters. Additionally, the RBE assessment based on the cell cluster model offers valuable insights for predicting radiobiological damage resulting from internal exposure byβ-emitters. This method is expected to find applicability in various realistic scenarios, including radiation protection and radioligand therapy.

TMIC-72. MECHANISMS TO ENHANCE IMMUNOTHERAPY EFFICACY IN A RAT MODEL OF MEDULLOBLASTOMA

Abstract Medulloblastoma is the most common malignant brain tumor in children. Current treatments are limited by irreversible CNS damage, particularly in high-risk subgroups. Innate immune cells constitute a significant portion of the brain tumor microenvironment, nurturing tumor growth and suppressing key defense mechanisms. Leveraging the innate immune system for improved clinical outcomes remains unrealized. We aimed to determine if Baicalein (Bac), a known tumoricidal M1 macrophage potentiator, improves efficacy in medulloblastoma models. Nude rats (N=10) were implanted with MB002 medulloblastoma intracerebellar patient-derived non-WNT/non-SHH, group 3 xenografts. Baseline T2 and gadolinium-enhanced MRI (Gd-MRI) T1 estimated pre-therapy tumor volumes. Single fraction 2Gy irradiation to the tumor-bearing hemisphere with 20mg/kg temozolomide (CRT) combined with Bac 100mg/kg PO QD daily x8 (N= 3) was administered. CRT alone (N= 3) and no treatment (N= 4) served as controls. Seven days post-therapy, Gd-MRI and histology established tumor volume and CD68 and CD163 expression (T-test; p≤ 0.05). MRI demonstrated the therapeutic effect of Bac+CRT compared to CRT only (P< 0.01) and untreated controls (P= 0.01). This was confirmed via histology volumes; untreated group (P< 0.01) and a trend toward significance vs. CRT only (P= 0.22). The normal brain demonstrated a near significant increase in CD68 expression in the Bac+CRT compared to CRT and control (P< 0.06). A near statistically significant decrease in CD163 expression was observed at the tumor margin for Bac+CRT compared to CRT only (P< 0.06). Likewise when comparing CRT to untreated control (P< 0.05). Preliminary data suggests Bac+CRT uniquely induces an innate immune response within the brain that expresses features of M1 polarization, resulting in effective tumoricidal efficacy in preclinical medulloblastoma models. Current studies are evaluating the mechanisms of efficacious innate immune targeted therapies in larger sample sizes with the eventual goal of clinical translation.

Better accuracy of robotic-assisted total knee arthroplasty compared to conventional technique in patients with failed high tibial osteotomy.

This study aimed to compare the clinical outcomes, mechanical axis, component positioning, leg length discrepancy (LLD), and polyethylene liner thickness between robotic-assisted total knee arthroplasty (TKA) and conventional TKA in patients with failed high tibial osteotomy (HTO). A total of 30 patients (30 knees) with failed HTO who underwent TKA using a robot-assisted system between June 2020 and December 2023 were included in this study (robotic group). Additionally, 60 patients (60 knees) with failed HTO who underwent conventional TKA were included as controls (conventional group). Propensity score matching was performed using a 2:1 ratio between the matched participants. The mean follow-up period was 2.1 years in the robotic group and 2.2 years in the conventional group. Clinical evaluations were performed using the Knee Society Score (KSS) rating system. Mechanical axis, component coronal and sagittal positioning, and LLD were evaluated using postoperative radiographs. The thickness of the polyethylene liner was also determined. The mean error values and outliers were calculated and compared between the two groups to determine the accuracy of the mechanical axis, postoperative component positioning, and LLD. The postoperative KSSs in the robotic and conventional groups were not statistically different. The robotic group achieved better accuracy than the conventional group in terms of postoperative mean mechanical axis (1.7° vs. 2.4°, p < 0.05), femur coronal inclination (90.0° vs. 91.6°, p < 0.05), tibial coronal inclination (90.3° vs. 91.3°, p < 0.05), tibial sagittal inclination (90.5° vs. 91.4°, p < 0.05), and LLD (2.2 vs. 7.0 mm, p < 0.05). A significant difference in polyethylene liner thickness was observed between the two groups (p < 0.05). Robotic-assisted TKA showed improved mechanical axis, higher accuracy of component positioning and polyethylene liner thickness, and reduced LLD compared with those of conventional TKA in patients with failed HTO. Further studies with a larger sample size and long-term follow-up are warranted to ascertain whether the accuracy of robotic-assisted TKA can translate into better clinical outcomes and patient satisfaction.

THE RELATIONSHIP OF AGE AND PARITY ON THE INCIDENT OF POSTPARTUM BLUESS IN PUBLIC WOMEN

The prevalence of postpartum blues varies throughout the world. Tanzania is 80% while in Japan it is 8%. The exact incidence of postpartum blues in Indonesia is not yet known, but several studies show that the incidence of postpartum blues is in the range of 50-70%. The aim of the research is to determine the relationship between age and parity on the incidence of postpartum blues among postpartum women at the Rosita Maternity Home in Pekanbaru. This research method uses quantitative methods through a correlative analytical design with a cross sectional approach. The research population was postpartum mothers at the Rosita Pekanbaru Maternity Home with a sample size of 30 respondents with a sampling technique using total sampling. Univariate and bivariate data analysis using the chi square statistical test. The results of the study based on univariate analysis showed that 66.6% of mothers experienced postpartum blues, 33.3% did not experience it, 60% of those aged at risk experienced postpartum blues, 40% of those who did not experience postpartum blues, 73% of primiparous mothers experienced postpartum blues. .3% who did not experience postpartum blues were 26.7%. The results of the bivariate analysis showed that there was a relationship between age and the incidence of postpartum blues with a P value of 0.045&lt;0.05, there was no relationship between parity and the incidence of postpartum blues with a P value of 0.078&gt;0.05. The conclusion is that there is a relationship between age and the incidence of postpartum blues, there is no relationship between parity and the incidence of postpartum blues, it is recommended that expectant mothers can prepare for pregnancy well so that it will prevent the incidence of postpartum blues, and for midwives to detect early the symptoms of postpartum blues so that they can also prevent its occurrence. postpartum blues

PATH-51. CENTRAL NERVOUS SYSTEM METASTASES ARE GENOMICALLY DIVERGENT FROM THEIR RESPECTIVE EXTRACRANIAL SITES

Abstract INTRODUCTION Next-generation sequencing (NGS) has become standard of care in establishing the diagnosis and guiding treatment of cancers. Our understanding of genomic evolution of brain metastases (BM) and leptomeningeal disease (LMD) from solid tumor malignancies remains limited. Here we present updated data from our pilot study. METHODS We prospectively collected clinical data and NGS of seventeen patients undergoing craniotomy for symptomatic BM from solid tumor malignancies or cerebrospinal fluid (CSF) sampling for LMD. Matched systemic and CNS analyses were performed using a research-based NGS assay. When extracranial disease tissue was unavailable, liquid NGS served as a surrogate. RESULTS CNS metastases were present at initial diagnosis in 10/17 and 11/17 patients had not received systemic therapy prior to CNS tissue sampling. The predominant cancer type was NSCLC (n=11), followed by breast cancer (n=3), ovarian high grade serous carcinoma (n=1), GEJ adenocarcinoma (n=1), and basosquamous carcinoma of skin (n=1). The mean tumor mutational burden in extracranial samples was 3.65 (SD 3.34; SEM 0.97), in contrast to CNS samples 21.63 (SD 26.47; SEM 7.64). Concordant mutations in matched sampling had an increase in CNS variant allele frequency (VAF) (27.8% vs 17.3%; arithmetic difference = 10.5, p=0.054) and CNS gene copy number alterations (CNA) (2.4 copies vs 0.8 copies; arithmetic difference = 1.6, p=0.171). Known driver alterations in EGFR, KRAS and PIK3CA were retained. LMD was present in 4/17 patients, with two present at enrollment and two developing during the study. CONCLUSIONS Matched sequencing reveals CNS metastases to harbor a significantly higher TMB, retention of primary driver alterations with a trend towards higher VAF and CNA of concordant mutations. While limited by small sample size, these data indicate genetic evolution in CNS metastases regardless of prior treatment status.

Principle-based decision-making: realising benefits in a scaled agile environment

PurposeThis paper examines the conflict between rule-based and principle-based approaches to benefits realisation in agile projects. It proposes a principle-based framework as a more effective alternative, aligned with the iterative and adaptive nature of agile methodologies.Design/methodology/approachThe research utilises semi-structured interviews to gather qualitative data from professionals experienced in agile projects. Causal loop diagrams are employed to illustrate the relationships between identified principles. The study identifies 12 key principles essential for agile benefits realisation, with a particular focus on visibility and consequence management.FindingsThe study finds that a principle-based approach to benefits realisation is more compatible with agile methodologies compared to a rule-based approach. The flexibility of principle-based decision-making allows for continuous adaptation and improvement, aligning with the dynamic and iterative nature of agile projects. The principles of visibility and consequence management emerge as critical factors in successfully realising benefits in an agile environment.Research limitations/implicationsThe findings are based on qualitative data from a limited number of interviews, which may not be generalisable across all agile projects. Further research with a larger sample size and diverse project types is recommended to validate and refine the proposed principles.Practical implicationsAgile teams and project managers can leverage the identified principles to enhance their decision-making processes and improve benefits realisation outcomes. Adopting a principle-based approach can lead to more flexible, responsive and effective project management practices.Social implicationsBy promoting more adaptive and responsive project management practices, the adoption of a principle-based approach can contribute to greater satisfaction and collaboration among project stakeholders, leading to more successful project outcomes.Originality/valueThis research contributes to the existing body of knowledge by highlighting the limitations of rule-based approaches in agile contexts and proposing a principle-based framework for benefits realisation. The identification of specific principles and their interrelationships provides a novel perspective and practical guidance for agile practitioners.

NIMG-08. IMAGING FINDINGS AND PROGNOSTIC FACTORS IN DIFFUSE HEMISPHERIC GLIOMA, H3 G34-MUTANT

Abstract INTRODUCTION Diffuse hemispheric glioma, H3 G34-mutant (DHGs), are a newly categorized tumor in pediatric-type diffuse high-grade gliomas in the 2021 World Health Organization classification, with a poor prognosis. DHGs has been reported to occur in less than 1% of all gliomas, but prognostic factors have not been fully investigated in previous studies due to small sample sizes. In this study, we investigated the relationship between clinical factors, including imaging findings, and prognosis in patients with DHGs. METHODS We searched Medline through the PubMed database using two search terms: “G34” and “glioma”, between 1 April 2012 and 1 July 2023. We retrieved articles that described imaging findings and overall survival (OS), and added one DHG case from our institution. We defined midline invasion (MI) as invasion to the contralateral cerebrum, brainstem, corpus callosum, thalamus, and basal ganglia on magnetic resonance imaging. The primary outcome was 12-month survival, estimated using Kaplan–Meier curves and logistic regression. RESULTS A total of 96 patients were included in this study. The median age was 22 years, and the proportion of male patients was 48.4%. Lesions were most frequently located in the frontal lobe (52.6%). MI was positive in 39.6% of all patients. The median OS of all cases was 14.4 months. Univariate logistic regression analysis with 12-month OS as the outcome showed that the MI-positive group had a significantly higher mortality than that in the MI-negative group, and the gross total resection achieved group had a significantly lower mortality than that in the group that underwent biopsy alone. Multivariate logistic regression analysis revealed that MI was an independent prognostic factor in DHGs. CONCLUSIONS Similar to glioblastomas, DHGs have a poor prognosis if they invade deep structures or the contralateral cerebrum; however, safe and maximal tumor resection may prolong survival.

RTID-03. A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL OF FOCUSED-ULTRASOUND-MEDIATED BLOOD-BRAIN BARRIER DISRUPTION PLUS SYSTEMIC PEMBROLIZUMAB FOR PATIENTS WITH NSCLC BRAIN METASTASES (LIMITLESS)

Abstract BACKGROUND Systemic therapy for brain metastases (BM) is hindered by blood-brain barrier (BBB). Low-intensity focused ultrasound (LIFU), combined with IV microbubble oscillators, leads to non-invasive BBB disruption, which could enhance intracranial delivery of systemic immune checkpoint inhibitors. This randomized controlled trial (RCT) aims to evaluate safety and efficacy of LIFU-mediated BBB disruption plus systemic pembrolizumab for NSCLC BM. METHODS LIMITLESS (NCT05317858) is an ongoing, multicenter, parallel-arm, open-label RCT that randomizes NSCLC BM patients on standard-of-care pembrolizumab monotherapy to LIFU plus pembrolizumab (arm 1) or pembrolizumab alone (arm 2) in a 2:1 ratio. Included patients have age ≥18 years, normal organ function, KPS ≥70, EGFR- and ALK-negative primary tumor, and ≤3 BM with ≥1 BM meeting RANO-BM measurable disease criteria. All patients receive standard-of-care therapy, while those on arm 1 undergo LIFU before each pembrolizumab dose (200mg IV q3weeks). Patients undergo pre-treatment brain MRI, followed by IV microbubbles for enhanced sonication effects. MR-guided BBB disruption is performed using transcranial 220kHz LIFU device with real-time acoustic-feedback-based power control for maintaining effective microbubble activation. Pembrolizumab is infused immediately after sonication, and repeat MRI is done 24-48 hours later to assess treatment effects. Primary study outcome is overall objective response rate (ORR) at 6 months as assessed using RANO-BM. Using Bayesian design for power analysis, a superior ORR of 60% is assumed for LIFU arm versus 30% for control arm for total sample size of N=96 (64 participants in LIFU and 32 in control arm), for 80% power using two-sided chi-square test with alpha=0.05. For upper-bound estimate, ORR of 45% in LIFU arm and 30% in control arm, the study needs N=369 participants (246 in LIFU arm and 123 in control arm). Secondary outcomes are best ORR and median time-to-response. Exploratory outcomes are median progression-free survival (PFS), overall survival (OS), median intracranial PFS, median extracranial PFS, and quality of life. Patient enrollment commenced in 2022 and remains ongoing.

Hotelling T2 control chart based on minimum vector variance for monitoring high‐dimensional correlated multivariate process

AbstractMultivariate control charts are practical tools that simultaneously monitor several correlated quality characteristics in a process. Monitoring high‐dimensional data structures is challenging because, in most cases, the process sample size for monitoring parameters is greater than the number of process characteristics. Many researchers have used the multivariate Hotelling's T2 chart to monitor high‐dimensional data using the maximum‐likelihood methods (MLM) to estimate the covariance matrices. However, the multivariate Hotelling's T2chart based on MLM suffers from low statistical performance. In this paper, we proposed a multivariate Hotelling's T2 chart based on the minimum vector variance (MVV) and some regularized methods for monitoring high‐dimensional data structures. The performance of the proposed chart is evaluated in terms of the average run length (ARL). The results reveal the superiority of the proposed MVV Hotelling's T2 chart over the existing Hotelling's T2 charts for high‐dimensional correlated processes.

Sex differences in prognosis of primary bone cancer: a propensity score-matched study

Abstract Objectives Sex differences in survival in primary bone cancer have not been fully explored. Hence, this study was conducted to investigate the impact of sex on survival outcomes in patients with primary bone cancer. Methods The Surveillance, Epidemiology, and End Results (SEER)-17 database was used to identify patients with primary bone cancer. One-to-one propensity score matching (PSM) was employed to balance baseline characteristics. Kaplan-Meier curves and log-rank tests were used to evaluate differences in cancer-specific survival (CSS) and overall survival (OS) between sexes. Multivariate Cox regression analysis was performed to verify the independent effect of sex on survival, and sensitivity analysis was performed to determine the robustness of the results. Results A total of 8,791 patients were included, with 4,928 males (56.1 %) and 3,863 females (43.9 %), and a median follow-up time of 38 months. After PSM, 3,812 males and 3,812 females were included in the study, with balanced baseline characteristics between the groups. Post-PSM, females show significantly better CSS (HR=0.88, 95 % CI, 0.81–0.96, p=0.004) and OS (HR=0.87, 95 % CI, 0.81–0.94, p&lt;0.001) compared to males. In multivariable Cox regression, the female sex was identified as an independent protective factor for both CSS (HR=0.86, 95 % CI, 0.79–0.94, p&lt;0.001) and OS (HR=0.83, 95 % CI, 0.77–0.89, p&lt;0.001). Conclusions Based on the analysis of SEER data with a large sample size, this study revealed that female patients with primary bone cancer have significantly better survival compared to males.

Prevalence of Type 2 Diabetes, Overweight, Obesity, and Metabolic Syndrome in Adults in Bogot&amp;aacute;, Colombia, 2022&amp;ndash;2023: A Cross‑Sectional Population Survey

Objective: To establish the prevalence of type 2 diabetes, overweight/obesity, and metabolic syndrome in individuals aged &gt;18 years in Bogotá, Colombia and the variables associated with diabetes prevalence. Research Design and Methods: This was a cross‑sectional population survey with a representative, probabilistic sample of Bogotá, Colombia collected between 2022 and 2023. The final sample size included 2,860 households, distributed among 19 localities of Bogotá. Clinical laboratory samples were taken from randomly selected individuals (n = 1,070). Data on the Adult Treatment Panel III (ATP III) and Latin American Diabetes Association (ALAD) criteria for metabolic syndrome were collected, including physical measurements. Results: The prevalence of type 2 diabetes in Bogotá was 11.0% (95% confidence interval [CI], 9.0–13.5%). According to the ATP III and ALAD criteria, the prevalence proportions of metabolic syndrome were 33.9% (95% CI, 29.5–38.6) and 29.3% (95% CI, 26.1–32.7), respectively. The age of ≥55 years, abdominal obesity, hypertriglyceridemia, and noneducational level had higher adjusted prevalence ratios (APRs) of diabetes. The APRs of metabolic syndrome were higher in adults with a low education level (LEL) and female sex, with the ATP III and ALAD criteria, and noninsured adults or those with unknown affiliation with the healthcare system, with the ATP III criteria. Conclusions: We found a higher prevalence of type 2 diabetes in adults in Bogotá than expected in previous studies. Intervention from public policy should be requested, especially in those of lowest socioeconomic and education levels, to avoid a future increase in this prevalence. Studies on other Colombian cities are required.

Proto-DS: A Self-Supervised Learning-Based Nondestructive Testing Approach for Food Adulteration with Imbalanced Hyperspectral Data

Conventional food fraud detection using hyperspectral imaging (HSI) relies on the discriminative power of machine learning. However, these approaches often assume a balanced class distribution in an ideal laboratory environment, which is impractical in real-world scenarios with diverse label distributions. This results in suboptimal performance when less frequent classes are overshadowed by the majority class during training. Thus, the critical research challenge emerges of how to develop an effective classifier on a small-scale imbalanced dataset without significant bias from the dominant class. In this paper, we propose a novel nondestructive detection approach, which we call the Dice Loss Improved Self-Supervised Learning-Based Prototypical Network (Proto-DS), designed to address this imbalanced learning challenge. The proposed amalgamation mitigates the label bias on the most frequent class, further improving robustness. We validate our proposed method on three collected hyperspectral food image datasets with varying degrees of data imbalance: Citri Reticulatae Pericarpium (Chenpi), Chinese herbs, and coffee beans. Comparisons with state-of-the-art imbalanced learning techniques, including the Synthetic Minority Oversampling Technique (SMOTE) and class-importance reweighting, reveal our method’s superiority. Notably, our experiments demonstrate that Proto-DS consistently outperforms conventional approaches, achieving the best average balanced accuracy of 88.18% across various training sample sizes, whereas the Logistic Model Tree (LMT), Multi-Layer Perceptron (MLP), and Convolutional Neural Network (CNN) approaches attain only 59.42%, 60.38%, and 66.34%, respectively. Overall, self-supervised learning is key to improving imbalanced learning performance and outperforms related approaches, while both prototypical networks and the Dice loss can further enhance classification performance. Intriguingly, self-supervised learning can provide complementary information to existing imbalanced learning approaches. Combining these approaches may serve as a potential solution for building effective models with limited training data.