Background Information Research Articles

An undrained dynamic strain-pore pressure model for deep-water soft clays from the South China Sea

With the increasing use of oceans for engineering purposes, such as the installation of suction anchors and pipelines, the stability of seabed structures has become a pivotal concern and is intricately linked to the characteristics of seabed soils. This study focuses specifically on deep-sea soft clay, a predominant seabed soil type distinguished by its high water content, thixotropy, and low permeability. These clays are vulnerable to destabilization and damage when disturbed, thereby posing threats to seabed installations. While the existing literature extensively examines the cyclic behavior of clay, considering factors such as the pore pressure response and strain and deformation characteristics, there is a notable gap in research addressing the behavior of deep-sea soft clay under comprehensive stress levels and prolonged cyclic loading. In this study, cyclic shear tests of the natural marine clay of the South China Sea were conducted, and the cyclic stress ratio (CSR), overpressure consolidation ratio (OCR), consolidation ratio (Kc), and loading frequency were varied. It was found that the CSR, OCR, and Kc significantly impact the cumulative dynamic strain in deep-sea soft clay during undrained cyclic dynamic tests. Higher CSR values lead to increased dynamic strain and structural failure risk. Subsequently, a dynamic strain-dynamic pore pressure development model was proposed. This model effectively captures the cumulative plastic deformation and dynamic pore pressure development, showing correlations with the CSR, OCR, and Kc, thus providing insights into the deformation and pore pressure trends in deep-sea clay under high cyclic dynamic loading conditions. This research not only furnishes essential background information but also addresses a critical gap in understanding the behavior of deep-sea soft clay under cyclic loading, thereby enhancing the safety and stability of seabed structures.

User-centred collecting for emerging formats

ABSTRACT Since 2013, the UK legal deposit libraries have worked collaboratively to develop systems to manage born-digital publications, including a more experimental approach to content management for emerging formats. Within the content management lifecycle, access was identified as a key challenge. This paper provides an overview of the work conducted at legal deposit libraries to better understand access requirements for emerging formats, from a user's perspective and with a focus on web-based interactive narratives. It includes background information on UK non-print legal deposit and the characteristics that distinguish emerging formats from other collection items. It explores the findings from different workshops discussing user's needs and expectations when accessing born-digital collections in a library environment. It also considers how existing tools and methodologies, such as web archiving, can be adapted and built to support the collection of emerging formats. Finally, it delves into different research projects conducted at the British Library around archiving and performing quality assurance for interactive narratives, collecting contextual information, and lessons learnt from exhibiting born-digital content in a physical space.

A comparative study on dietary diversity and gut microbial diversity in children with autism spectrum disorder, attention-deficit hyperactivity disorder, their neurotypical siblings, and non-related neurotypical volunteers: a cross-sectional study.

Previous research has shown a significant link between gut microbiota in children with autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD). However, much remains unknown because of the heterogeneity of disorders and the potential confounders such as dietary patterns and control group variations. Children aged 6-12 years who had been clinically diagnosed with ASD and/or ADHD, their unaffected neurotypical siblings, and non-related neurotypical volunteers were recruited cross-sectionally. The ASD diagnosis was confirmed using the Autism Diagnostic Observation Schedule-2 (ADOS-2) in all patients, including those with ADHD. Standardized DNA extraction and sequencing methods were used to compare gut microbial alpha-diversity among the groups. Dietary diversity was calculated from a standardized dietary questionnaire form. We compared the difference in gut microbiome between patients with ASD and/or ADHD with neurotypical siblings and non-related neurotypical controls. Ninety-eight subjects were included in the study (18 with ASD, 19 with ADHD, 20 with both ASD and ADHD, 13 neurotypical siblings, and 28 non-related neurotypical controls). The alpha-diversity indices, such as Chao 1 and Shannon index, showed a significant difference between the groups in a Linear mixed-effect model (F(4, 93) = 4.539, p = .02), (F(4, 93) = 3.185, p = .017), respectively. In a post-hoc pairwise comparison, patients with ASD had lower alpha-diversity compared with non-related controls after Bonferroni correction. Dietary diversity shown in Shannon index did not differ among the groups (F(4, 84) = 1.494, p = .211). Our study indicates disorder-specific microbiome differences in patients with ASD. In future research on gut microbiota in neurodevelopmental disorders, it is necessary to consider the impact of ASD and ADHD co-occurrence, and strictly control for background information such as diet, to elucidate the gut-microbiota interaction in ASD and ADHD for exploring the potential of therapeutic interventions.

New use of an old discourse marker: The rise of prefacing answers to questions with so

This study investigates a previously unresearched use of the discourse marker so: prefacing answers to questions from an interlocutor, informally coined “backstory so” and found to signal that the answer necessitates background information, or more complexity or length than the asker assumes the questioner expects, a function known to be carried out by well. This investigation was motivated by (i) negative attitudes toward this use of so, describing the speakers with attributes like annoying, condescending, confusing, and wrong; (ii) layperson claims that it is new; and (iii) non-scholarly writings by linguists reporting controversy over whether answering questions with so is actually new or a Zwickian Recency Illusion. This paper draws on spoken data from the Corpus of Contemporary American English from 1990 to 2016, and presents findings of 774 target tokens by 544 unique speakers starting in 1992. Results of a logistic regression show a statistically significant increase in the rate of this form over that time. I tentatively suggest that previous constraints against the discourse marker so prefacing answers to mark added information seem to have undergone a rapid language shift, competing with the older use of well, and supporting the layperson intuitions of newness.

Strength and Conditioning (S&C) Practices of Judo Athletes and S&C Coaches: A Survey-Based Investigation.

Weldon, A, Cloak, R, Kirk, C, Ruddock, A, Langan-Evans, C, Detanico, D, Loturco, I, and Kons, R. Strength and conditioning (S&C) practices of judo athletes and S&C coaches: A survey-based investigation. J Strength Cond Res 38(4): e160-e173, 2024-The benefits of strength and conditioning (S&C) for improving judo performance and reducing injuries have been widely studied. However, the S&C practices used and perspectives held by those delivering S&C have yet to be elucidated. Therefore, this study investigated the S&C practices and perspectives of judokas and S&C coaches working within judo. Forty-two judokas and 9 S&C coaches completed an online survey comprising 6 sections: (a) written informed consent; (b) background information; (c) education, qualifications, and prescription; (d) views on S&C; (e) exercise selection; and (f) issues and improvements. Frequency analysis was used to report responses to fixed-response questions and thematic analysis for open-ended questions. Results indicated that S&C coaches were primarily responsible for delivering S&C programs (60%), and S&C information was predominantly sourced from S&C coaches (43%). Strength and conditioning was deemed very important for randori (78-88%), overall judo performance (67-79%), and judo fitness (62-78%). Similarly, S&C was considered very important for the development of speed and power (76-89%), strength (71-89%), and injury reduction (69-78%). Novel findings were also observed, such as integrating judo-specific training within S&C practice, which may be partly explained by more S&C coaches holding judo belts (67%) than S&C qualifications (11%). This study supports practitioners delivering S&C in judo by offering a base of information to critique or align with their existing S&C practices and perspectives. Furthermore, our results may help identify potential gaps between methods used, proposed guidelines, and actual practice, facilitating the development of research and education resources tailored to the current climate.

Flow-Edge-Net: Video Saliency Detection Based on Optical Flow and Edge-Weighted Balance Loss

Optical flow networks have been widely utilized for video saliency detection (VSD) due to their effective performance in capturing the motion of objects. However, the use of optical flow blurs the edges of salient objects and leads to the problems of poorly defined object boundaries. To address this issue, we propose an optical flow-based edge-weighted loss function, to train a network called Flow-Edge-Net, which can balance the weights of the foreground and background information at the edges of video frames. It has achieved superior performance in detecting salient boundaries. Specifically, we propose two complementary encoding and decoding networks based on the concept of decoupling. That is, the optical flow network focuses on moving objects, while the edge network, based on the encoder-decoder structure, focuses on edge information. As the two networks output features of the same dimension and are from the same input, our proposed self-designed adaptive weighted feature fusion module can compare and integrate the edge information and location information from the two networks through adaptive weighting. The proposed method has been evaluated on five widely used databases. Experiment results demonstrate the superior performance of the proposed Flow-Edge-Net in locating salient objects, with accurate and refined edges. The proposed method achieves superior performance over the state-of-the-art methods in detecting salient objects in videos.

Explainable Early Prediction of Gestational Diabetes Biomarkers by Combining Medical Background and Wearable Devices: A Pilot Study with a Cohort Group in South Africa.

This study aims to explore the potential of Internet of Things (IoT) devices and explainable Artificial Intelligence (AI) techniques in predicting biomarker values associated with GDM when measured 13 - 16 weeks prior to diagnosis. We developed a system that forecasts biomarkers such as LDL, HDL, triglycerides, cholesterol, HbA1c, and results from the Oral Glucose Tolerance Test (OGTT) including fasting glucose, 1-hour, and 2-hour post-load glucose values. These biomarker values are predicted based on sensory measurements collected around week 12 of pregnancy, including continuous glucose levels, short physical movement recordings, and medical background information. To the best of our knowledge, this is the first study to forecast GDM-associated biomarker values 13 to 16 weeks prior to the GDM screening test, using continuous glucose monitoring devices, a wristband for activity detection, and medical background data. We applied machine learning models, specifically Decision Tree and Random Forest Regressors, along with Coupled-Matrix Tensor Factorisation (CMTF) and Elastic Net techniques, examining all possible combinations of these methods across different data modalities. The results demonstrated good performance for most biomarkers. On average, the models achieved Mean Squared Error (MSE) between 0.29 and 0.42 and Mean Absolute Error (MAE) between 0.23 and 0.45 for biomarkers like HDL, LDL, cholesterol, and HbA1c. For the OGTT glucose values, the average MSE ranged from 0.95 to 2.44, and the average MAE ranged from 0.72 to 0.91. Additionally, the utilisation of CMTF with Alternating Least Squares technique yielded slightly better results (0.16 MSE and 0.07 MAE on average) compared to the well-known Elastic Net feature selection technique. While our study was conducted with a limited cohort in South Africa, our findings offer promising indications regarding the potential for predicting biomarker values in pregnant women through the integration of wearable devices and medical background data in the analysis. Nevertheless, further validation on a larger, more diverse cohort is imperative to substantiate these encouraging results.

Flying high for conservation: Opportunities and challenges of operating drones within the oldest National Park in the Alps

Abstract Drones have emerged as an essential tool in various conservation applications. Despite the great potential, drone use by protected area managers is still scarce or accompanied by scepticism. The ongoing debate revolves around whether drones are fancy gadgets or if they can effectively guide management strategies and align with the overarching goals of protected areas. Here, we present a practical overview of how novel drone applications contribute to the goals of the oldest national park in the Alps, along with the associated challenges. To do so, we review our seven‐year experience as park employees flying drones within the park and its surroundings. First, we provide background information receiving limited attention in the existing literature such as our motivation behind a drone purchase, costs and an overview of our flight operations. Second, we show three examples that demonstrate the potential of drones as a valuable tool in addressing the goals of the park: managing the area, researching natural processes and facilitating communication. Third, we reflect on operational challenges and provide valuable lessons for addressing the specific challenges of flying drones in an alpine and protected environment. Practical implication: Our experience supports the benefits of drones for protected area management, but it also highlights the need for certain precautions, increased focus on operational challenges and further research on wildlife‐drone interactions.

COVID-19 Vaccine Hesitancy Among Healthcare Workers: A Phenomenological Study of Skepticism.

Despite the prioritizing the healthcare workers (HCWs) for COVID-19 in a systematized manner the phenomenon of vaccine hesitancy was observed in them. HCWs are presumed to be pre-emptive in up-taking the vaccine due to their closest association and having reasonable background information. Hence, we intended to explore and investigate the phenomenology of skepticism and hesitancy toward the COVID-19 vaccine among HCWs. A sequential explanatory mixed methods study design incorporating a baseline cross-sectional survey followed by qualitative and semiquantitative text-mining approach was adopted in a tertiary care center in Madhya Pradesh, India. Six hundred seventy-nine HCWs for quantitative data and 30 HCWs for qualitative interviews were surveyed. After determining the quantum and baseline traits of hesitant HCWs, 30 participants were purposively selected for in-depth qualitative analysis based on grounded theory using a framework approach and consolidated from the psychological and philosophical plane of skepticism. This was complementedby a semiquantitative text-mining approach using mono/bigram analysis and network plotting. Approximately one-fifth of participants (18%,122 out of 679) were initially, and one-tenth of initially hesitant (10 out of 122) were terminally hesitant. Hesitant and non-hesitant participants were similar except for comorbidity status.Five themes emerged namely individual, vaccine-related, social, system, and contextual after thematic consolidation. Words/phrases indicating individualistic desire to knowing more, internal conflicts, and conjecture were mined further. The network plot showed diversified expressionsof participants. There seems to be a requirement to prime HCWs by offering objective information beforehand and removing diffidence using a systematic approach addressing the psychology and prevalent partisan belief in similar circumstances in the future.

CERN生物长期样地背景和植被分类特征本底数据集

This dataset is a comprehensive integration of 95 long-term plots from 22 natural ecosystem stations. We first sorted out the background information such as the geographical location, establishment time, area and representativeness of the long-term plot of ecological station. Drawing from the survey data of plant communities at the beginning of the plot establishment and adhering to the latest Chinese vegetation classification system, we then meticulously delineated the vegetation formation group, vegetation formation and vegetation subformation of each sample plot’s plant community. Based on the list of dominant species found in each sample plot, we identified and named the alliance and association of the vegetation in the plot. The construction of this dataset went through multiple rounds of expert review-station verification-expert review-station acceptance, etc. The dataset comprises station code, station name, plot code, plot name, plot type, plot representativeness, geographical location, altitude, plot area and shape, plot establishment time and design service life, vegetation formation group, vegetation formation, vegetation subformation, alliance, association, dominant species and remarks. It is expected to provide data support for the studies on flora, vegetation resource distribution, and biodiversity conservation.

2011–2015年东洞庭湖洲滩典型植物群落样方调查数据集

The fixed sample plot investigation obtains the dynamic characteristics of ecosystem through long-term data accumulation and accurate space-time comparison, which provides a solid basis for long-term ecosystem research. In accordance with the unified monitoring specifications set forth by the Chinese Ecosystem Research Network (CERN), Dongting Lake Wetland Ecosystem Research Station conducts long-term positioning monitoring on the species composition and community characteristics of typical beach vegetation in the wetland ecosystem in response to the changing hydrological conditions of Dongting Lake. We processed the data of long-term monitoring sample plots of three typical wetland plant communities (Carex sp, Miscanthus lutarioriparius and Polygonum hydropiper) in Dongting Lake to obtain the dataset of sample survey of typical plant communities on East Dongting Lake beach from 2011 to 2015. This dataset covers a total of 14 indicators, including species name, Latin name, number of plants (clusters) (plants or clusters/quadrats), average height of leaf layer (cm), average height of reproductive branches (cm), coverage (%), phenological period, dominant species, number of plant species, density (plants or clusters/m2), leaf layer height (cm) of dominant species, reproductive branch height (cm) of dominant species, total coverage (%), and total dry weight of aboveground green parts (g/m2). This dataset comes with detailed background information to ensure its consistency across both spatial and temporal dimensions. Moreover, to ensure data accuracy and reliability, the dataset underwent comprehensive quality control throughout the entire process and is subject to expert review and verification. It can serve as an important source of background data for studying the process and succession trends of the beach wetland ecosystem in response to the hydrological conditions of Dongting Lake, and provide data support for vegetation remote sensing monitoring, biodiversity protection, wetland ecological restoration and adaptive management of Dongting Lake.

2011–2015年洞庭湖洲滩群落植物生态型、生活型和生长型组成数据集

Analyzing plant life-forms and ecotypes can provide deep insights into the relationship between plant community structure and environmental conditions, and plant life-forms play an important role in understanding the emergence, development, and succession laws of plant community. An investigation was made on the species life-forms and ecotypes of wetland plants in Dongting lake wetland. In accordance with the unified monitoring specifications of the Chinese Ecosystem Research Network (CERN), the Dongting Lake Wetland Ecosystem Observation and Research Station conducts long-term positioning monitoring on the species composition, species life-forms, growth forms and ecotypes of typical beach vegetation in the wetland ecosystem in response to the changing hydrological conditions of Dongting Lake. The dataset of long-term monitoring conducted on three typical plant communities (Carex sp., Miscanthus lutarioriparius and Polygonum hydropiper) in Dongting Lake wetland has been verified by experts to ensure the accuracy of the data. We then classified and processed the data to obtain the dataset of community composition of plant life-forms, growth forms and ecotypes on Dongting Lake beach (2011–2015). The dataset covers a total of 8 indicators, namely species name, Latin name, life-form, growth form, ecotype according to light intensity, ecotype according to water requirement, ecotype based on soil pH and ecotype according to responses sediment burial. This dataset comes with detailed background information to ensure its consistency across both spatial and temporal dimensions. This dataset comes with detailed background information about site information and site management records to ensure its consistency across both spatial and temporal dimensions. This dataset can provide support for the analysis of the classification of plant life forms and the composition and structure of ecotypes, and serve as valuable reference for further study of vegetation succession in Dongting Lake wetland.

Dynamic region-aware transformer backbone network for visual tracking

In visual tracking, the Transformer architecture is widely used because it can capture the global dependencies of sequence data without inductive bias. However, the attention mechanism of Transformer will bring ultra-high computational complexity and space occupancy, so that the tracking task cannot meet the real-time requirements. In this paper, we explore a sparsity region-aware attention mechanism. The sparse attention mechanism retains the regions with semantic relevance, and performs fine-grained attention calculation in this region. In the region-aware attention mechanism, a DropKey technique is introduced to reduce model over-fitting and improve the generalization ability of the model. Using region-aware attention as the basic building block, we design a dynamic region-aware Transformer backbone for visual tracking. This backbone network can effectively reduce the computational complexity while exploring global context dependencies. Based on the region-aware Transformer backbone network, this paper proposes a dynamic region-aware Transformer backbone visual tracking algorithm, which uses an optimization based model predictor to fully fuse object appearance and background information, so as to achieve more robust object tracking. The proposed tracker is trained in an end-to-end manner and experimentally evaluated on eight tracking benchmarks. Experimental results show that the algorithm has good tracking performance, especially in the application of unmanned aerial vehicle (UAV) tracking, our proposed tracker achieves an area under curve (AUC) score of 66.5% on the UAV123 dataset. Code is available at https://github.com/YSGFF/RTDiMP.

Services Integration in Tanzania e-Government Systems

The interoperability of information systems for public organizations is a significant opportunity for improved delivery of e-government services. However, the lack of e-government services integration is one of the issues preventing services from effectively reaching citizens in many developing nations, especially in this era of information technology advancement. Consequently, this paper aims to provide background information and a framework for comprehending the relevance of Tanzania's integration of e-government services. To understand the current state of the art and the prospects for system integration in government procedures, a thorough government institution Information Systems analysis was done to understand the magnitude of the problem. The survey revealed that the absence of electronic data exchange between public information systems leads to information system silos, which hinder efficiency and synergy in the provision of electronic services. A framework for e-government service integration is proposed utilizing a design science research approach to explain the possibilities of service integration in the public sector. The framework suggests harmonizing public institutions in e-government project plans, communicating e-government systems through a unified network, and establishing the e-government service catalog.

Definite example of negative entropy production in the Rolie Poly model

While it is known that the Rolie Poly model is not guaranteed to be thermodynamically consistent, definite examples of a thermodynamically inconsistent prediction have not yet been published. Additionally, the source of the problem (and its historical context) may not be widely known. This work provides additional background information and a definite example of negative entropy production in an experimentally relevant flow, including a discussion of the implications in terms of an experimentally measurable quantity like recoverable strain.

Listening to / in Public Space

As an artist working often with audio walks I often have the nagging thought: does using headphones to present sound in public space immerse the listener in a bubble, separating them from their surroundings? This research looks at the form of the audio walk and the possibilities of using binaural recording, narrative devices and locative media to prioritise engagement with the environment. In addition it documents the re-activation of an older work of mine in a app using geo-location and it collects documentation of a number of walk-pieces including scripts, audio files, maps and other background information. Lectorate Music, Education and Society, Koninklijk Conservatorium, Den Haag. 2023-24

Using simulation to teach nursing students how to deal with a euthanasia request.

Nursing students are confronted with euthanasia during their internship and certainly during their later career but they feel inadequately prepared in dealing with a euthanasia request. This study presents a simulation module focused on euthanasia and evaluates nursing students' perceptions after they have completed the simulation practice. The 'euthanasia module' consisted of a preparatory online learning module, a good-practice video, an in-vivo simulation scenario, and a debriefing session. The module's content was validated by four experts in end-of-life care. The module was completed by three groups of students from two different University Colleges (n = 17 in total). The students were divided into three groups: one with no previous simulation education experience, one with all students having previous experience, and another with a mix of experiences. After completing the entire module, each group had a discussion regarding their perceptions and expectations concerning this simulation module. Thematic content analysis was conducted on audio-recorded group interviews using NVIVO® software, involving initial open coding, transformation into specific themes and subthemes through axial coding, and defining core themes through selective coding, with data analysis continuing until data saturation was reached. Students generally found the online learning module valuable for background information, had mixed perceptions of the good-practice video, and appreciated the well-crafted scenarios with the taboo of euthanasia emerging during simulations, while the debriefing process was seen as enhancing clinical reasoning abilities. Students considered the simulation module a valuable addition to their education and nursing careers, expressing their satisfaction with the comprehensive coverage of the sensitive topic presented without sensationalism or taboos. This subject holds significance for nations with established euthanasia laws and those lacking such legal frameworks. The findings of this study can aid teachers in developing and accessing euthanasia simulation training programs, contributing to broader education's emphasis on integrating euthanasia-related knowledge and skills.

Organic Petrologic Characterization and Paleoenvironmental Analysis of Permian Shale in Northeast Sichuan Province, China

The Permian shale in Northeast Sichuan is an important shale oil and gas resource potential area, and the study of its organic matter characteristics and paleoenvironmental analysis is of great significance for revealing the shale oil and gas formation mechanism and resource evaluation. In this study, the organic matter of Permian shales in northeast Sichuan was carefully studied based on various analytical tools, such as petrology, laser Raman, microscopy, and principal trace elements, and the paleoenvironmental parameters of the shales were comprehensively analysed. A detailed study of the organic matter characteristics of Permian shales in northeast Sichuan reveals important features such as organic matter fractions, structural characteristics, maturity and sources. The results show that the organic matter of the shale consists mainly of solid bitumen, putrescine group, specular group and multicellular planktonic algae. Petrological observations and laser Raman analyses indicate a high maturity of the organic matter and a high content of organic carbon (TOC), showing good hydrocarbon potential. In this study, we reconstructed the palaeoenvironmental parameters and inferred the palaeoenvironmental evolution through palaeoenvironmental analyses of Permian shales in northeast Sichuan. The results of the comprehensive multi-indicator study show that the type of palaeoenvironment at the time of shale deposition was mainly an anoxic-reducing environment, and the depositional conditions were favourable to the enrichment and preservation of organic matter. In summary, the organic matter characteristics and paleoenvironmental analyses of the Permian shales in Northeast Sichuan provide important geological background information for an in-depth understanding of the formation mechanism, exploration potential and development prospect of shale hydrocarbons in this area. The results of this study can provide a scientific basis for the evaluation and development of shale oil and gas resources in this area, which is of great significance to geologists and the energy industry.

A false emotion opinion target extraction model with two stage BERT and background information fusion

As social media has gradually become an indispensable part of people’s life, more and more users begin to express their opinions on social media. These opinions contain rich emotional information, as well as many abnormal false emotion. And the opinion target rich in false emotion will have great potential value in the field of movie box office prediction, public opinion guidance and so on. Therefore, we propose a false emotion opinion target extraction task and two stage BERT+CRF model based on the concept of false emotion. Firstly, two stage BERT network includes C-BERT and W-BERT. We use C-BERT to learn the users comment feature, and W-BERT to learn the background content features of microblog. Then, we design five feature interaction fusion methods to fuse the features learned by C-BERT and W-BERT. At last, we transform the false emotion opinion target extraction task into a sequence labeling task, and use the CRF method to learn the label dependency of the context and output the optimal sequence among all candidate sequences. Due to the lack of false emotion opinion target datasets, we collate a false emotion opinion target dataset Weibo23. Comparing with the advanced models used in related research, including some sequence labeling models and named entity recognition models, two stage BERT+CRF model achieves an F1 score of 0.8834, which is about 10%–20% higher.

Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN‐ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study

AbstractBackgroundDespite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients.MethodsWe are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.ResultsNot applicable.ConclusionThis study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.