Design Characteristics Research Articles

P.034 Cost-effectiveness of treatment strategies for medically refractory pediatric epilepsy: a systematic review

Background: Medically refractory pediatric epilepsy is a disorder that can cause significant financial and physical burden. Although multiple treatments exist, cost-effectiveness remains unclear. We conducted a systematic review to assess cost-effectiveness of treatments for medically refractory pediatric epilepsy and to summarize key issues and areas for further inquiry. Methods: We searched MEDLINE and 6 other databases up to July 2022. We included partial and full economic evaluations (EEs) on treatments for medically refractory pediatric epilepsy. Pairs of reviewers independently screened the literature, extracted data, and assessed quality using the 24-item Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. We extracted data on study characteristics, health outcomes, model design, costs, and treatment characteristics. Results: We identified 37 eligible studies for analysis, 19 of which were partial EEs and 18 were full EEs. Study quality, outcomes reported, treatment comparators, and factors included in cost calculations were common influential factors in study results. Vagus nerve stimulation and cannabinoid oil were the most consistently cost-effective, in 6 of 7 and 1 of 2 studies, respectively. Other treatments were inconsistently cost-effective. Conclusions: The cost-effectiveness of treatments for medically refractory pediatric epilepsy was not definitive. Consistency in study design and inputs is necessary for future comparison of epilepsy treatment.

P.024 Sex and gender reporting in clinical trials among neurological US Food and Drug Administration approvals

Background: Sex and gender are related but distinct determinants of disease, treatment response, and research reproducibility whose consideration is increasingly required for research funding. Nevertheless, the quality of sex and gender reporting in neurological randomized controlled trials (RCTs) remains unknown. Methods: This ongoing study of RCTs associated with Food and Drug Administration neurological drug approvals aims to determine the frequency of accurate reporting of RCT participants’ sex and gender. Secondary outcomes include changes in reporting over time and RCT design characteristics. Results: Preliminary analysis included 145 RCTs (153,410 participants) associated with 77 medications approved in 1985-2023, most commonly for epilepsy (19%), migraine (16%), and multiple sclerosis (16%). Sixty-six RCTs (45.5%) used sex-related terms appropriately. Nine RCTs (6.2%) reported gender accurately. Fifty-three RCTs (37%) used sex- or gender-related terms interchangeably. There are no statistically significant differences in the proportions of studies reporting sex and/or gender accurately when comparing those published until versus after 2017. No RCT reported sex or gender collection methods, definitions of sex or gender, or including sex or gender minority participants. Conclusions: Preliminary results suggest shortcomings in reporting sex and, especially, gender accurately and inclusively among neurological drug RCTs and no significant improvement thereof in recent years.

Advancing surgical VQA with scene graph knowledge.

The modern operating room is becoming increasingly complex, requiring innovative intra-operative support systems. While the focus of surgical data science has largely been on video analysis, integrating surgical computer vision with natural language capabilities is emerging as a necessity. Our work aims to advance visual question answering (VQA) in the surgical context with scene graph knowledge, addressing two main challenges in the current surgical VQA systems: removing question-condition bias in the surgical VQA dataset and incorporating scene-aware reasoning in the surgical VQA model design. First, we propose a surgical scene graph-based dataset, SSG-VQA, generated by employing segmentation and detection models on publicly available datasets. We build surgical scene graphs using spatial and action information of instruments and anatomies. These graphs are fed into a question engine, generating diverse QA pairs. We then propose SSG-VQA-Net, a novel surgical VQA model incorporating a lightweight Scene-embedded Interaction Module, which integrates geometric scene knowledge in the VQA model design by employing cross-attention between the textual and the scene features. Our comprehensive analysis shows that our SSG-VQA dataset provides a more complex, diverse, geometrically grounded, unbiased and surgical action-oriented dataset compared to existing surgical VQA datasets and SSG-VQA-Net outperforms existing methods across different question types and complexities. We highlight that the primary limitation in the current surgical VQA systems is the lack of scene knowledge to answer complex queries. We present a novel surgical VQA dataset and model and show that results can be significantly improved by incorporating geometric scene features in the VQA model design. We point out that the bottleneck of the current surgical visual question-answer model lies in learning the encoded representation rather than decoding the sequence. Our SSG-VQA dataset provides a diagnostic benchmark to test the scene understanding and reasoning capabilities of the model. The source code and the dataset will be made publicly available at: https://github.com/CAMMA-public/SSG-VQA .

Layout Characteristics and Design Principles of Atrium Integrated Space

With the development of China's cruise tourism industry, it is necessary to study the design and construction of cruise ships, especially the central atrium, which is an important part of public area design and represents the quality and characteristics of the entire ship's design. However, compared with Europe, China's research foundation for large-scale cruise ship design is still lacking. Therefore, studying the spatial layout characteristics of the central atrium is of great significance for improving China's cruise industry. This article focuses on the design principles and characteristics of integrated space layout in the central atrium of cruise ships. By applying basic theories from architecture, shipbuilding engineering, aesthetics, international maritime safety conventions and technology to analyzing representative central atria from 25 typical domestic and foreign cruise brands through data collection and research methods including mathematical statistics methodology, clustering methodology and cases research methodology. Through comparison and generalization of the cases, the study eventually summarizes six overall principles and four structural principles for designing integrated space in the central atrium of a cruise ship. The six overall principles include safety, rationality, applicability, artistry, coordination and technique-economics. The four structural principles include clear space circulation, natural spatial connection, theme coordination & unification and prominent key levels. This study provides insights into designing integrated space in the central atriums of cruise ships that hopefully can be applied in improving China's cruise design work while also supporting guidance for future related fields. Keywords: central atrium of cruise ship, integrated space, design principles, functional layout, decoration style

Lutetium [177Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective observational (REAL-LU) study.

Gastroenteropancreatic -neuroendocrine tumours (GEP-NETs) are commonly treated with surgical resection or long-term therapies for tumour growth control. Lutetium [177Lu]-DOTA-TATE was approved for the treatment of GEP-NETs after the phase III NETTER 1trial demonstrated improved progression free survival, objective response rates and health-related quality of life (HRQoL) compared to high-dose somatostatin analogues. No real-world data exist on prescribing habits and clinically significant endpoints for [177Lu]Lu-DOTA-TATE treatment in Italy. REAL-LU is a multicentre, long-term observational study in patients with unresectable/metastatic GEP-NETs progressing on standard therapies in Italian clinical practice. A pre-specified interim analysis was performed at the end of the enrolment period, data from which are described herein. Overall duration of REAL-LU will be approximately 48months, with 12- and 36-month recruitment and follow-up periods, respectively. The primary objective is to evaluate [177Lu]Lu-DOTA-TATE effectiveness in terms of progression-free survival. Secondary objectives include safety, impact on HRQoL, and identification of prognostic factors. This pre-specified interim analysis describes patient profiles, at the end of enrollment, of those prescribed [177Lu]Lu-DOTA-TATE for GEP-NETs in Italy. Among 161 evaluable patients, mean age was 64.7 ± 10.3years at study entry, 83.8% presented with no clinical signs of disease at physical examination, and most had minor disease symptoms. All patients had metastatic disease, most commonly in the liver (83.9%) with a median of two metastatic sites. In 90.7% of patients, the disease was stage IV, and 68.3% had ≥ 1 target lesion. [177Lu]Lu-DOTA-TATE was prescribed mainly as second-line therapy (61.6%) and following surgery (58.4%). HRQoL assessments revealed high levels of functioning and low levels of symptoms at baseline; 50.0% of patients were symptom-free at study entry. The characteristics of patients who received [177Lu]Lu-DOTA-TATE in Italy are similar to those of the GEP-NET population of NETTER 1 with trial but with a higher proportion of patients with a grade 2 (71%). With regard to the tumor grade profile, our study cohort appears to be closer to that of NETTER-2 study population which included patients with G2 or G3 advanced GEP-NETs (i.e. Ki-67 ≥ 10% and ≤ 55%). Further analysis of effectiveness and safety can be anticipated as REAL-LU data mature. ClinicalTrials.gov, NCT04727723; Study Registration Date: 25 January, 2021; https://clinicaltrials.gov/study/NCT04727723?cond=NCT04727723&rank=1.

УТОЧНЕННЯ РОЗРАХУНКОВОГО ЗНАЧЕННЯ МОДУЛЯ ПРУЖНОСТІ АСФАЛЬТОБЕТОНІВ

Introduction. One of the most important characteristics of asphalt concrete that characterizes its properties is the elasticity modulus. The elasticity modulus of asphalt concrete is used in the design of pavement structures to calculate its permissible elastic deflection, under the condition of shear resistance of the working subgrade layer and the layers of non-cohesive materials, as well as bending tensile strength. Problem statement. Today, the calculated value of the elasticity modulus of asphalt concrete is taken in accordance with Handbook No. 2 «Design Characteristics of Asphalt Concrete» [2]. In this Handbook, the calculated value of the elasticity modulus of asphalt concrete is given depending on the bitumen grade, temperature, type of asphalt mixture, and time of load action. Numerical design values of the elasticity modulus of asphalt concrete are provided only for asphalt concrete type B; for other types of asphalt concrete, it is proposed to reduce or increase the design value of the elasticity modulus by the value that depends on the type of asphalt concrete and temperature. Since 2020, a new standard on technical requirements for bitumen has been in force in Ukraine, which brings bitumen grades in line with the European classification [4]. At the same time, in the Handbook No. 2 [2], the calculated value of the elasticity modulus of asphalt concrete is given in accordance with the previous bitumen grades, which necessitates their adjustment.

Vitamin D, selenium in type 2 diabetes and Hashimoto's thyroiditis: Is it effective?

The study by Feng et al, explores treatment approaches for these coexisting conditions. It emphasizes the potential advantages of selenium and vitamin D supplementation but also raises methodological and patient selection concerns. Findings indicate a complex interplay between interventions and disease markers, prompting the need for further research. Despite limitations, the study offers valuable insights into managing the intricate relationship between type 2 diabetes mellitus and Hashimoto's thyroiditis. The authors' contributions shed light on potential treatment avenues, although careful consideration of study design and patient characteristics is warranted for future investigations in this domain.

Multifidelity topology design of a maritime survey operation with UUVs

Advances in autonomous systems, maritime communications, and sensing technologies lead to increasing applications of unmanned underwater vehicles (UUVs). In this paper, we study a maritime survey operation topology design problem with UUVs that traverse an ocean environment and collect data from prespecified sensors or locations. This maritime scenario is analyzed via several models and simulation for the purpose of topology design for mission planning. We use a multifidelity approach to examine the trade-offs between different potential topology configurations of assigning UUVs to data collection sensors or locations. We develop three low-fidelity models that make simplifying assumptions. These models provide insight into the design characteristics and allow for sensitivity analysis with low computational cost. They are used to down-select potential configuration designs for further evaluation using a high-fidelity simulation model. A high-fidelity simulation model removes many simplifying assumptions and predicts how a topology design would perform under more realistic conditions. It gathers detailed performance metrics at the expense of higher computational cost. Our study uses this multifidelity approach to demonstrate key trade-offs for topology design. The optimal design of UUVs depends on mission-specific goals.

Measuring protective efficacy and quantifying the impact of drug resistance: A novel malaria chemoprevention trial design and methodology.

Recently revised WHO guidelines on malaria chemoprevention have opened the door to more tailored implementation. Countries face choices on whether to replace old drugs, target additional age groups, and adapt delivery schedules according to local drug resistance levels and malaria transmission patterns. Regular routine assessment of protective efficacy of chemoprevention is key. Here, we apply a novel modelling approach to aid the design and analysis of chemoprevention trials and generate measures of protection that can be applied across a range of transmission settings. We developed a model of genotype-specific drug protection, which accounts for underlying risk of infection and circulating genotypes. Using a Bayesian framework, we fitted the model to multiple simulated scenarios to explore variations in study design, setting, and participant characteristics. We find that a placebo or control group with no drug protection is valuable but not always feasible. An alternative approach is a single-arm trial with an extended follow-up (>42 days), which allows measurement of the underlying infection risk after drug protection wanes, as long as transmission is relatively constant. We show that the currently recommended 28-day follow-up in a single-arm trial results in low precision of estimated 30-day chemoprevention efficacy and low power in determining genotype differences of 12 days in the duration of protection (power = 1.4%). Extending follow-up to 42 days increased precision and power (71.5%) in settings with constant transmission over this time period. However, in settings of unstable transmission, protective efficacy in a single-arm trial was overestimated by 24.3% if recruitment occurred during increasing transmission and underestimated by 15.8% when recruitment occurred during declining transmission. Protective efficacy was estimated with greater precision in high transmission settings, and power to detect differences by resistance genotype was lower in scenarios where the resistant genotype was either rare or too common. These findings have important implications for the current guidelines on chemoprevention efficacy studies and will be valuable for informing where these studies should be optimally placed. The results underscore the need for a comparator group in seasonal settings and provide evidence that the extension of follow-up in single-arm trials improves the accuracy of measures of protective efficacy in settings with more stable transmission. Extension of follow-up may pose logistical challenges to trial feasibility and associated costs. However, these studies may not need to be repeated multiple times, as the estimates of drug protection against different genotypes can be applied to different settings by adjusting for transmission intensity and frequency of resistance.

Scaling analysis of nuclear power plant (APR1400) utilizing ATLAS integral effect test result of A5.1 (Counterpart test for LSTF 1% cold-leg break LOCA)

ATLAS is the thermal hydraulic integral effect test loop that can simulate the same pressure and temperature condition with nuclear power plant. It was designed with a height ratio of 1/2 and a volume ratio of 1/288 with reference to APR1400. The counterpart test against LSTF which was named as A5.1 test was performed within the OECD/NEA ATLAS international joint research project to compare major thermal hydraulic phenomena between two test facilities. The main scenario for the A5.1 test is the LSTF SB-CL-32 test. The SB-CL-32 test is a 1% horizontal small break loss of coolant accident (SBLOCA) at the cold leg with cold leg injection of the emergency core cooling system (ECCS) and accident management (AM) action.From the counterpart test results, the significant differences were found in the viewpoint of the thermal–hydraulic phenomena. It was concluded that the different result were caused by the different design characteristic of each test facility because they referred the different nuclear power plant. Thus, the applicability of the ATLAS test results to its reference nuclear power plant was evaluated by utilizing ATLAS A5.1 test results which was the counterpart test with the LSTF.The transient scenario and initial and boundary conditions of the A5.1 test were adopted to APR1400 after applying scaling ratios of ATLAS. The MARS-KS code was utilized to analyzed thermal hydraulic behaviors of APR1400 and the analysis results were compared with the scaled A5.1 test result. From the result of comparison, it was concluded that the ATLAS test results predicted the thermal hydraulic behavior of the nuclear power plant well. Thus, it was confirmed that ATLAS is a well-designed integral effect test facility which is designed with an appropriate scaling method.

HISTORICAL EVOLUTION AND INNOVATIVE DESIGN OF QIANG COSTUMES

Рurpose. This paper analyzes the evolution process and cultural connotation of Qiang costume form, discusses the application form of Qiang costume elements in modern clothing design, and provides a theoretical basis for the innovative design of national costumes. Methodology. The field research method, literature analysis method, and case study method are used to analyze the evolution process, cultural connotation, and design application of Qiang costumes. Results. By studying the development process and style design changes of the Qiang costumes, it is concluded that its unique cultural connotation and design characteristics are closely related to the social characteristics, production methods and religious beliefs of the Qiang people. It is the materialized expression of the Qiang people's world outlook and national psychology. It reveals the reasons for the change of the Qiang costume modelling and proposes the method of using ethnic elements in modern costume design. Scientific novelty. This paper studies the development process of Qiang costume shape from the perspective of design, history, ethnology and anthropology, and puts forward that Qiang costume is the materialized expression form of local people 's world outlook, values and aesthetics, and clarifies that the change of Qiang costume shape is influenced by religious culture and Han-Tibetan culture. Suggestions are made in the form of integration of national costume elements with modern clothing design. Practical significance. The Qiang costume has been fused with other ethnic cultures in the course of historical changes, which is both inherited and changed, which is very inspiring to modern costume design. Digging deeper into the cultural connotation and design language of Qiang costume, so that it can innovate the design method and explore the design carrier while inheriting the national culture, so as to provide reference for the creation of a costume design that can embody both the traditional Chinese culture and the sense of the times.

PARAMETRIC MODELING AS AN INNOVATIVE APPROACH IN GRAPHIC DESIGN

Purpose. The article focuses on exploring the possibilities and strategies of innovative integration of parametricism into the field of graphic design and analyzing the main problems and potential solutions in using parametric design in creating graphic objects. Methodology. According to the research topic, the methods employed include comparative study, theoretical analysis, and synthesis. Results. The article discusses the definitions and characteristics of parametric design, examines its applications for optimizing design thinking and creating personalized objects. Various levels of innovative implementations are presented, offering several strategies for integrating parametric modeling into graphic design, including visual element generation, layout optimization, design interactivity enhancement, and data visualization in personalized design. Additionally, integration challenges related to the use of artificial intelligence technologies are discussed. Scientific novelty. The article analyzes various levels and effective strategies for applying parametric modeling in the field of graphic design, exploring current aspects of interaction that are innovative and emphasizing the importance of utilizing parametric design methodology, artificial intelligence, and computational design in the paradigm of contemporary graphic design. Practical significance. The materials presented in the article can be utilized for investigating the innovative application of digital design, parametric design, and artificial intelligence in the field of graphic design.

Green with Arrogance: Dominant Brands Benefit from Arrogant Appeals

Consumers increasingly expect brands to contribute positively to the environment. This trend has created a race for brands to establish their “green” credentials. Asserting their superiority—a strategy we refer to as an arrogant appeal—may allow some brands to connect with this consumer preference if perceived as credible; however, when this brand communication lacks credibility, consumers lose trust and suspect brands of greenwashing. Applying expectancy violation theory and signaling theory to green advertising, we find a specific message source (level of brand dominance) influences the effectiveness of an arrogant appeal. Specifically, via the use of two experiments, we demonstrate that consumers use market dominance as a cue to establish the credibility of an arrogant appeal. This research (a) builds on comparative advertising literature to introduce the concept of arrogant appeal to the literature, (b) identifies a new credibility signal—brand dominance—for the effectiveness of green advertising appeals, (c) extends marketing research on arrogance to message design and source characteristics, and (d) discusses the ethical ramifications of consumers inferring credibility based on market dominance. A critical finding is that more dominant brands have earned the right to deploy an arrogant appeal based on a consumer heuristic.

Feasibility of teaching and assessing medical students in the metaverse: design and features for its learning efficiency

The metaverse is known as the hypothetical iteration of the Internet as a single, connected, universal and immersive virtual world that can be accessed via immersive technology devices. One approach to this concept can be achieved through the use of multi-user immersive virtual reality applications.Immersive virtual reality (IVR), which uses gadgets that allow the user to visualize and interact in an enveloping way, is a very attractive technology for teaching purposes. There are many references in the scientific literature about its use for this purpose, including encouraging results in the field of medicine. However, there have not been enough studies assessing how much this type of technology really contributes to learning medicine.This work investigates the feasibility of using the metaverse as an educational tool in medicine. We propose a multi-user immersive virtual reality application for implementing a scene of the metaverse in which medical students are taught. Our work considers that in order to ensure this type of technology is useful in the education of medical students, the technology itself (multi-user IVR) must be designed and implemented for a medical student profile. They usually spend too much time for adapting themselves to use and manage this kind of technology when they are exposed to it for learning. The technology should not be a barrier to acquiring, or disseminating the academic contents themselves. It should act as a catalyst that enhances the speed and capacity for learning medical educational topics. Thus, we present design and user experience specifications that we implemented in an anatomical dissection room in the metaverse, and with which we conducted experiments with 114 sixth-grade medical students. Our results indicate that, based on the design and user experience characteristics that we propose in this paper, the metaverse can indeed serve as a useful and effective educational resource whose technological complexity is no barrier to medical teaching.

Machine learning-assisted effective thermal management of rotor-stator systems

Rotor-stator systems are widely used to facilitate highly effective energy management and process intensification but have complex design characteristics, such as skittish flow and heat transfer. Due to the difficulty in obtaining heat transfer data for thermal management of rotor-stator systems, uneconomical designs with large margins often occur. Here, we propose a comprehensive design process using machine learning guided by convective heat transfer experimental data. We organize domain knowledge involving advection and convective heat transfer using a test rig employing a naphthalene sublimation method on large surfaces. Detailed heat transfer data elucidates that local thermal-fluid characteristics are non-linear as the operating conditions change, which is supported by numerical simulation models. We develop a machine learning-based heat transfer prediction model using pure experimental data and derive the optimal algorithm model. Thermal analysis via 2D thermal circuits provides an effective design process and enables rapid quantified evaluation of critical performance considerations. An improved rotor-stator system simultaneously achieves high heat flux of 1.9 kW/m2 and low thermal resistance of 17.1 K/W to both disks. We expect our experiment-based machine learning-assisted thermal management will serve as a robust and informative indicator for improving the efficiency and feasibility of applications with multivariate thermal-fluid systems.

Cochlear implant electrode design for safe and effective treatment.

The optimal placement of a cochlear implant (CI) electrode inside the scala tympani compartment to create an effective electrode-neural interface is the base for a successful CI treatment. The characteristics of an effective electrode design include (a) electrode matching every possible variation in the inner ear size, shape, and anatomy, (b) electrically covering most of the neuronal elements, and (c) preserving intra-cochlear structures, even in non-hearing preservation surgeries. Flexible electrode arrays of various lengths are required to reach an angular insertion depth of 680° to which neuronal cell bodies are angularly distributed and to minimize the rate of electrode scalar deviation. At the time of writing this article, the current scientific evidence indicates that straight lateral wall electrode outperforms perimodiolar electrode by preventing electrode tip fold-over and scalar deviation. Most of the available literature on electrode insertion depth and hearing outcomes supports the practice of physically placing an electrode to cover both the basal and middle turns of the cochlea. This is only achievable with longer straight lateral wall electrodes as single-sized and pre-shaped perimodiolar electrodes have limitations in reaching beyond the basal turn of the cochlea and in offering consistent modiolar hugging placement in every cochlea. For malformed inner ear anatomies that lack a central modiolar trunk, the perimodiolar electrode is not an effective electrode choice. Most of the literature has failed to demonstrate superiority in hearing outcomes when comparing perimodiolar electrodes with straight lateral wall electrodes from single CI manufacturers. In summary, flexible and straight lateral wall electrode type is reported to be gentle to intra-cochlear structures and has the potential to electrically stimulate most of the neuronal elements, which are necessary in bringing full benefit of the CI device to recipients.

Risk prediction algorithms for prolonged postoperative ileus: A systematic review.

Prolonged postoperative ileus (PPOI) is common and is associated with a significant healthcare burden. Previous studies have attempted to predict PPOI clinically using risk prediction algorithms. The aim of this work was to systematically review and compare risk prediction algorithms for PPOI following colorectal surgery. A systematic literature search was conducted using MEDLINE, Embase, Web of Science and CINAHL Plus. Studies that developed and/or validated a risk prediction algorithm for PPOI in adults following colorectal surgery were included. Data were collected on study design, population and operative characteristics, the definition of PPOI used and risk prediction algorithm design and performance. Quality appraisal was assessed using the PROBAST tool. Eleven studies with 87 549 participants were included in our review. Most were retrospective, single-centre analyses (6/11, 55%) and rates of PPOI varied from 10% to 28%. The most commonly used variables were sex (8/11, 73%), age (6/11, 55%) and surgical approach (5/11, 45%). Area under the curve ranged from 0.68-0.78, and only three models were validated. However, there was significant variation in the definition of PPOI used. No study reported sensitivity, specificity or positive/negative predictive values. Currently available risk prediction algorithms for PPOI appear to discriminate moderately well, although there is a lack of validation data. Future studies should aim to use a standardized definition of PPOI, comprehensively report model performance and validate their findings using internal and external methodologies.

Abstract PO1-06-03: Efficacy of First-line Treatments for Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer: A Systematic Literature Review and Network Meta-analysis Feasibility Assessment

Abstract Background: A comprehensive summary of clinical evidence for first-line (1L) treatments for hormone receptor-positive, human epidermal growth factor receptor 2-positive (HR+/HER2+) advanced or metastatic breast cancer (mBC) is needed to understand which treatments have been evaluated and the outcomes associated with different treatments. Understanding the available clinical evidence for HR+/HER2+ mBC 1L treatments can also inform the feasibility of network meta-analyses (NMAs) to estimate relative treatment effects where head-to-head trials are not available. The objective was to prepare a systematic summary of clinical trials of 1L treatments for HR+/HER2+ mBC and assess the feasibility of NMAs for key efficacy outcomes. Methods: A systematic literature review (SLR) was conducted per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Clinical trials evaluating 1L treatments for adults with HR+/HER2+ mBC published between January 2000 and January 2023 were identified via predefined searches of databases (Embase, MEDLINE, Cochrane Library), relevant congress proceedings, and ClinicalTrials.gov (updating a previous SLR covering January 2000 to December 2020). Study design characteristics, patient characteristics, and efficacy outcomes were extracted from identified trials. An NMA feasibility assessment that considered network connectivity and cross-study heterogeneity was conducted for four efficacy outcomes of interest: progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Results: After screening, 37 records reporting on 23 unique studies (11 randomized controlled trials [RCTs] and 12 single-arm trials; 35 study arms in total) were selected. Included trials were mostly phase II or phase III multi-country studies that evaluated a HR+ or HER2+ population, with outcomes being reported for the subgroup of patients with the HR+/HER2+ subtype. Treatments evaluated included one or two anti-HER2 therapies (AHTs) + endocrine therapy (ET) (5/35 study arms), AHTs + chemotherapy (CT) (20/35), AHTs + ET + CT (2/35), AHTs alone (5/35), and ET alone (3/35). For HR+/HER2+ patients, PFS and OS were reported by 17/23 and 10/23 studies, respectively. Reported median PFS and OS ranged from 2.4-23.7 months and 23.9-66.7 months, respectively. Among the 11 included RCTs, hazard ratios and/or Kaplan-Meier curves, which were considered a requirement for NMAs for time to event outcomes, were reported for PFS and OS by 9 and 6 studies, respectively. Among these studies, reported median PFS and OS ranged from 2.4-19.2 months and 23.9-57.9 months, respectively. For HR+/HER2+ patients, ORR and CBR were reported by 13/23 and 6/23 studies, respectively. Assuming all CTs could be considered equivalent treatments and all ETs could be considered equivalent treatments, NMAs involving networks of 9, 6, 6, and 3 treatments were feasible for PFS, OS, ORR, and CBR, respectively. Some patient characteristics including time since mBC diagnosis and proportion with bone metastases were not reported consistently across trials. However, included studies were broadly comparable based on study design characteristics, outcome definitions and other reported patient characteristics such as age and Eastern Cooperative Oncology Group performance status. Conclusion: Clinical trials in 1L HR+/HER2+ mBC have evaluated various combinations of AHTs, CTs, and ETs, with most study arms being AHTs + CT. Although efficacy outcomes of interest were not consistently reported across trials, NMAs were found to be feasible for PFS, OS, ORR, and CBR based on available data. Citation Format: Priyanka Sharma, Chau Dang, Christopher Drudge, Amrita Debnath, Manvir Rai, Eric Gauthier, Edward Broughton. Efficacy of First-line Treatments for Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer: A Systematic Literature Review and Network Meta-analysis Feasibility Assessment [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-06-03.

Observed seismic performance of buildings and bridges during a major earthquake followed by one other major earthquake in the close vicinity of the first one

AbstractIn the recent 2023 major earthquake triggering one other large earthquake in Anatolia, the poor structural performance of buildings and the satisfactory performance of bridges remained relatively consistent compared to past observed earthquake experiences. Despite numerous building collapses, it is worth noting that no bridges collapsed during the event. Several engineering factors for poor building performance have been identified based on field building inspections in the recent and past earthquakes, such as the misuse of building design software without proper engineering judgment, the utilization of poor-quality construction materials, underestimation of earthquake forces, construction on inadequate soil conditions, design mistakes, and incorrect implementation of high ductility reinforcement details. In the aftermath of the earthquake, it was found that only a small percentage of bridges (1%) were closed, and approximately 50% of them were reopened to traffic within 24 h. Remarkably, no bridge collapses including the modern or old bridges were reported in the affected area. The focus of this paper is to identify the differences in the design philosophy between buildings and bridges and to understand the reasons behind the bridges’ resilience during these rare earthquakes. The study involves analyzing past structural performances of buildings and bridges under different earthquake conditions and design requirements. Analytical results from a survived 90-year-old reinforced concrete arch railroad bridge, highlighting its resilience and design characteristics are also presented.

A Pilot Study Assessing Common Medication Organizers for Child-Resistant Features

IntroductionPrescription and most over-the-counter medicines are required to have child resistant (CR) packaging and/or labeled with instructions “Keep out of reach of children”. Although medication organizers are not required to have such design features or instructions, these could help prevent unsupervised ingestions (UIs) by children. Commonly purchased medication organizers were evaluated for CR design features and instructions for safe use to prevent UIs. MethodsThe 29 best-selling medication organizers on Amazon.com were identified and product identifiers, design characteristics, and safety characteristics recorded using a standardized instrument. ResultsOf the 29 medication organizers, none claimed to be CR. Only 31% provided a specific warning that the organizer was not CR on the packaging; only 41% communicated “Keep out of reach of children”. Most organizers (59%) provided neither a warning that the organizer was not CR nor instructions to store out of reach of children. The majority of organizers (79%) shared the following characteristics: plastic construction, rectangular shape, non-electronic flip-top opening mechanisms, and 7-day usage. ConclusionsOpportunities exist for manufacturers of medication organizers to improve CR product design, provide information to help prevent UIs (directions to keep the device out of the reach of children), and help to reduce UIs.