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Conceptual Model for the Integration of Marketing Strategies and Biomedical Innovation in Patient-Centered Care: Mixed Methods Study. 以病人为中心的医疗中行销策略与生物医学创新整合的概念模型:混合方法研究。
Pub Date : 2026-01-06 DOI: 10.2196/77115
Atantra Das Gupta, Yashpal Yadav
<p><strong>Background: </strong>The increasing integration of biomedical technology and digital marketing is quickly transforming how patients engage with health care. The patient as an organization (PAO) model is explored in this study. The PAO model encourages patients to be active participants in health care decisions by leveraging wearables, mobile health (mHealth) apps, artificial intelligence (AI) platforms, and health care marketing strategies.</p><p><strong>Objective: </strong>This study aims to examine how the PAO model is evolving in practice and gain insight into both the opportunities and challenges created by the intersection of biomedical innovation and marketing practices in patient care.</p><p><strong>Methods: </strong>The scoping review was conducted across Scopus, Web of Science, PubMed, and Google Scholar. Selection criteria included articles published from 2014 to 2024. Studies were included if they examined connections among biomedical technologies, marketing strategies, and models of behavior and organizations. Studies lacking interdisciplinary focus or methodological rigor were excluded. Since this work was exploratory, it did not require a strict bias assessment. Additionally, findings derived from qualitative analysis of 18 semistructured interviews with patients, health care professionals, and technologists regarding their experiences with digital technologies and perceptions of trust, autonomy, and engagement were analyzed. Thematic analysis was applied to these interviews using open, axial, and selective coding.</p><p><strong>Results: </strong>From an initial pool of 22,740 records, 45 studies met the inclusion criteria and were analyzed. The review revealed that the integration of AI-based personalization, biosensors, and remote monitoring with marketing strategies, such as segmentation, customer relationship management systems, and behavioral nudging, offers potential to enhance patient autonomy and engagement. However, most studies were descriptive or exploratory, with limited empirical evaluation, particularly regarding ethical risks and digital inequality. Qualitative findings further illustrated how patients are adopting organizational behaviors, such as self-monitoring, real-time decision-making, and strategic management of health data. The following 5 key themes emerged: (1) patients as autonomous digital actors, (2) digital health as a behavioral ecosystem, (3) inequities in digital empowerment, (4) negotiating trust and ethical transparency, and (5) blended care as the preferred future. Although many participants embraced digital tools, concerns about data transparency, algorithmic bias, and loss of human connection highlighted important barriers to equitable adoption.</p><p><strong>Conclusions: </strong>The PAO model shows strong potential for personalizing care and engaging patients in health care. However, it is important to note that, so far, conceptual models have dominated the PAO literature, with littl
背景:生物医学技术和数字营销的日益融合正在迅速改变患者参与医疗保健的方式。本研究探讨病人作为组织(patient as a organization, PAO)模式。PAO模式通过利用可穿戴设备、移动医疗(mHealth)应用程序、人工智能(AI)平台和医疗保健营销策略,鼓励患者积极参与医疗保健决策。目的:本研究旨在研究PAO模式在实践中的演变,并深入了解生物医学创新和患者护理营销实践的交集所带来的机遇和挑战。方法:通过Scopus、Web of Science、PubMed和谷歌Scholar进行范围综述。选择标准包括2014年至2024年发表的文章。如果研究考察了生物医学技术、营销策略、行为模式和组织之间的联系,那么这些研究也被包括在内。缺乏跨学科重点或方法严谨性的研究被排除在外。由于这项工作是探索性的,它不需要严格的偏见评估。此外,对患者、医疗保健专业人员和技术人员进行了18次半结构化访谈,对他们使用数字技术的经历以及对信任、自主和参与的看法进行了定性分析。主题分析应用于这些访谈使用开放,轴向和选择性编码。结果:从最初的22,740份记录中,有45项研究符合纳入标准并进行了分析。该综述显示,将基于人工智能的个性化、生物传感器和远程监控与市场营销策略(如细分、客户关系管理系统和行为推动)相结合,有可能提高患者的自主性和参与度。然而,大多数研究都是描述性或探索性的,经验评估有限,特别是在伦理风险和数字不平等方面。定性研究结果进一步说明了患者如何采用组织行为,如自我监控、实时决策和健康数据的战略管理。出现了以下5个关键主题:(1)患者作为自主的数字行动者;(2)作为行为生态系统的数字健康;(3)数字授权中的不平等;(4)协商信任和道德透明度;(5)混合护理是首选的未来。尽管许多与会者接受了数字工具,但对数据透明度、算法偏见和人际关系缺失的担忧凸显了公平采用数字工具的重要障碍。结论:PAO模型显示出个性化护理和患者参与医疗保健的强大潜力。然而,值得注意的是,到目前为止,概念模型主导了PAO文献,几乎没有经验证据支持它们。因此,随着医疗保健实践越来越多地集成数字技术,为PAO模型制定适当的保障措施至关重要。
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引用次数: 0
Noise-Resilient Bioacoustics Feature Extraction Methods and Their Implications on Audio Classification Performance: Systematic Review. 抗噪声生物声学特征提取方法及其对音频分类性能的影响:系统综述。
Pub Date : 2025-12-16 DOI: 10.2196/80089
Geofrey Owino, Bernard Shibwabo
<p><strong>Background: </strong>Bioacoustics classification plays a crucial role in ecological surveillance and neonatal health monitoring. Infant cry analysis can aid early health diagnostics, while ecological acoustics informs conservation. However, the presence of environmental noise, signal variability, and limited annotated datasets often hinders model reliability and deployment. Robust feature extraction and denoising techniques have become critical for improving model robustness, enabling more accurate interpretation of acoustic events across diverse bioacoustic domains under real-world conditions.</p><p><strong>Objective: </strong>This review systematically evaluates advancements in noise-resilient feature extraction and denoising techniques for bioacoustics classification. Specifically, it explores methodological trends, model types, cross-domain transferability between clinical and ecological applications, and evidence for real-world deployment.</p><p><strong>Methods: </strong>A systematic review was conducted by searching 8 electronic databases, including IEEE Xplore, ScienceDirect, Web of Science, ACM Digital Library, and Scopus, through December 2024. Eligible studies entailed audio-based classification models and applied empirical or computational evaluations of bioacoustics classification using machine learning or deep learning methods. In addition, studies also included explicit or implicit consideration of noise. Two reviewers independently screened studies, extracted data, and assessed quality. Risk of bias was assessed using a customized tool, and reporting quality was evaluated using the TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis) checklist.</p><p><strong>Results: </strong>Of the 5462 records, 132 studies met the eligibility criteria. The majority (112/132, 84.8%) of studies focused on model innovation, with deep learning and hybrid approaches being the most dominant. Feature extraction played a critical role, with 96.2% (127/132) of studies clearly demonstrating feature extraction. Mel frequency cepstral coefficients, spectrograms, and filter bank-based representations were the most common feature representations. Nearly half (62/132, 47%) of the studies incorporated noise-resilient methods, such as adaptive deep models, wavelet transforms, and spectral filtering. However, only 14.4% (19/132) demonstrated real-world deployment across neonatal care and ecological field settings.</p><p><strong>Conclusions: </strong>The integration of noise-resilient techniques has significantly improved classification performance, but real-world deployment and proper use of denoising strategies in various datasets remain limited. Cross-domain synthesis reveals shared challenges, including dataset heterogeneity, inconsistent reporting, and reliance on synthetic noise. Future work should prioritize harmonized benchmarks, cross-domain generalization, and deployment, as well as opportunit
背景:生物声学分类在生态监测和新生儿健康监测中起着至关重要的作用。婴儿哭声分析可以帮助早期健康诊断,而生态声学通知保护。然而,环境噪声、信号可变性和有限的注释数据集的存在往往会阻碍模型的可靠性和部署。鲁棒特征提取和去噪技术已经成为提高模型鲁棒性的关键,能够在现实世界条件下更准确地解释不同生物声学领域的声学事件。目的:综述了生物声学分类中抗噪声特征提取和去噪技术的研究进展。具体来说,它探讨了方法论趋势、模型类型、临床和生态应用之间的跨领域可移植性,以及现实世界部署的证据。方法:通过检索截至2024年12月的IEEE explore、ScienceDirect、Web of Science、ACM Digital Library、Scopus等8个电子数据库进行系统综述。合格的研究包括基于音频的分类模型,以及使用机器学习或深度学习方法应用生物声学分类的经验或计算评估。此外,研究还包括对噪音的显性或隐性考虑。两位审稿人独立筛选研究,提取数据并评估质量。使用定制工具评估偏倚风险,使用TRIPOD(透明报告个体预后或诊断的多变量预测模型)检查表评估报告质量。结果:5462项记录中,132项研究符合入选标准。大多数(112/132,84.8%)的研究集中在模型创新上,其中深度学习和混合方法占主导地位。特征提取发挥了关键作用,96.2%(127/132)的研究清楚地展示了特征提取。Mel频率倒谱系数、谱图和基于滤波器组的表示是最常见的特征表示。近一半(62/ 132,47 %)的研究采用了抗噪声方法,如自适应深度模型、小波变换和频谱滤波。然而,只有14.4%(19/132)在新生儿护理和生态领域环境中展示了实际部署。结论:噪声弹性技术的集成显著提高了分类性能,但在各种数据集上的实际部署和正确使用去噪策略仍然有限。跨域合成揭示了共同的挑战,包括数据集异质性、不一致的报告和对合成噪声的依赖。未来的工作应该优先考虑协调基准、跨领域推广和部署,以及可转移的机会。
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引用次数: 0
Challenges and Solutions in Applying Large Language Models to Guideline-Based Management Planning and Automated Medical Coding in Health Care: Algorithm Development and Validation. 将大型语言模型应用于医疗保健中基于指南的管理计划和自动医疗编码的挑战和解决方案:算法开发和验证。
Pub Date : 2025-11-10 DOI: 10.2196/66691
Peter Sarvari, Zaid Al-Fagih, Alexander Abou-Chedid, Paul Jewell, Rosie Taylor, Arouba Imtiaz

Background: Diagnostic errors and administrative burdens, including medical coding, remain major challenges in health care. Large language models (LLMs) have the potential to alleviate these problems, but their adoption has been limited by concerns regarding reliability, transparency, and clinical safety.

Objective: This study introduces and evaluates 2 LLM-based frameworks, implemented within the Rhazes Clinician platform, designed to address these challenges: generation-assisted retrieval-augmented generation (GARAG) for automated evidence-based treatment planning and generation-assisted vector search (GAVS) for automated medical coding.

Methods: GARAG was evaluated on 21 clinical test cases created by medically qualified authors. Each case was executed 3 times independently, and outputs were assessed using 4 criteria: correctness of references, absence of duplication, adherence to formatting, and clinical appropriateness of the generated management plan. GAVS was evaluated on 958 randomly selected admissions from the Medical Information Mart for Intensive Care (MIMIC)-IV database, in which billed International Classification of Diseases, Tenth Revision (ICD-10) codes served as the ground truth. Two approaches were compared: a direct GPT-4.1 baseline prompted to predict ICD-10 codes without constraints and GAVS, in which GPT-4.1 generated diagnostic entities that were each mapped onto the top 10 matching ICD-10 codes through vector search.

Results: Across the 63 outputs, 62 (98.4%) satisfied all evaluation criteria, with the only exception being a minor ordering inconsistency in one repetition of case 14. For GAVS, the 958 admissions contained 8576 assigned ICD-10 subcategory codes (1610 unique). The vanilla LLM produced 131,329 candidate codes, whereas GAVS produced 136,920. At the subcategory level, the vanilla LLM achieved 17.95% average recall (15.86% weighted), while GAVS achieved 20.63% (18.62% weighted), a statistically significant improvement (P<.001). At the category level, performance converged (32.60% vs 32.58% average weighted recall; P=.99).

Conclusions: GARAG demonstrated a workflow that grounds management plans in diagnosis-specific, peer-reviewed guideline evidence, preserving fine-grained clinical detail during retrieval. GAVS significantly improved fine-grained diagnostic coding recall compared with a direct LLM baseline. Together, these frameworks illustrate how LLM-based methods can enhance clinical decision support and medical coding. Both were subsequently integrated into Rhazes Clinician, a clinician-facing web application that orchestrates LLM agents to call specialized tools, providing a single interface for physician use. Further independent validation and large-scale studies are required to confirm generalizability and assess their impact on patient outcomes.

背景:诊断错误和行政负担,包括医疗编码,仍然是卫生保健的主要挑战。大型语言模型(llm)有可能缓解这些问题,但是它们的采用受到可靠性、透明度和临床安全性的限制。目的:本研究介绍并评估了2个基于法学硕士的框架,这些框架在Rhazes临床医生平台中实施,旨在解决这些挑战:用于自动循证治疗计划的生成辅助检索增强生成(GARAG)和用于自动医学编码的生成辅助载体搜索(GAVS)。方法:对具有医学资格的作者创建的21例临床试验病例进行GARAG评价。每个病例独立执行3次,并使用4个标准评估输出:参考文献的正确性、无重复、遵守格式和生成的管理计划的临床适宜性。GAVS是在重症监护医学信息市场(MIMIC)-IV数据库中随机选择的958例入院患者中进行评估的,其中国际疾病分类第十次修订(ICD-10)代码作为基本事实。比较了两种方法:提示预测ICD-10代码的直接GPT-4.1基线和GAVS,其中GPT-4.1生成诊断实体,每个诊断实体通过矢量搜索映射到前10个匹配ICD-10代码。结果:在63个输出中,62个(98.4%)满足所有评价标准,唯一的例外是在案例14的一个重复中有轻微的顺序不一致。对于GAVS来说,958个录取包含8576个分配的ICD-10子类别代码(1610个唯一的)。香草LLM产生131,329个候选代码,而GAVS产生136,920个。在子类别水平上,香草LLM的平均召回率为17.95%(15.86%加权),而GAVS的平均召回率为20.63%(18.62%加权),在统计学上有显著提高(p结论:GARAG展示了一种基于诊断特异性、同行评审的指南证据的管理计划的工作流程,在检索过程中保留了细粒度的临床细节。与直接LLM基线相比,GAVS显著提高了细粒度诊断编码召回率。总之,这些框架说明了基于法学硕士的方法如何增强临床决策支持和医学编码。随后,两者都被整合到Rhazes Clinician中,这是一个面向临床医生的web应用程序,可以协调LLM代理调用专门的工具,为医生提供一个单一的界面。需要进一步的独立验证和大规模研究来确认其普遍性并评估其对患者预后的影响。
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引用次数: 0
Advancing Brain-Computer Interface Closed-Loop Systems for Neurorehabilitation: Systematic Review of AI and Machine Learning Innovations in Biomedical Engineering. 推进脑机接口闭环系统用于神经康复:生物医学工程中人工智能和机器学习创新的系统综述。
Pub Date : 2025-11-05 DOI: 10.2196/72218
Christopher Williams, Fahim Islam Anik, Md Mehedi Hasan, Juan Rodriguez-Cardenas, Anushka Chowdhury, Shirley Tian, Selena He, Nazmus Sakib
<p><strong>Background: </strong>Brain-computer interface (BCI) closed-loop systems have emerged as a promising tool in health care and wellness monitoring, particularly in neurorehabilitation and cognitive assessment. With the increasing burden of neurological disorders, including Alzheimer disease and related dementias (AD/ADRD), there is a critical need for real-time, noninvasive monitoring technologies. BCIs enable direct communication between the brain and external devices, leveraging artificial intelligence (AI) and machine learning (ML) to interpret neural signals. However, challenges such as signal noise, data processing limitations, and privacy concerns hinder widespread implementation.</p><p><strong>Objective: </strong>The primary objective of this study is to investigate the role of ML and AI in enhancing BCI closed-loop systems for health care applications. Specifically, we aim to analyze the methods and parameters used in these systems, assess the effectiveness of different AI and ML techniques, identify key challenges in their development and implementation, and propose a framework for using BCIs in the longitudinal monitoring of AD/ADRD patients. By addressing these aspects, this study seeks to provide a comprehensive overview of the potential and limitations of AI-driven BCIs in neurological health care.</p><p><strong>Methods: </strong>A systematic literature review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, focusing on studies published between 2019 and 2024. We sourced research articles from PubMed, IEEE, ACM, and Scopus using predefined keywords related to BCIs, AI, and AD/ADRD. A total of 220 papers were initially identified, with 18 meeting the final inclusion criteria. Data extraction followed a structured matrix approach, categorizing studies based on methods, ML algorithms, limitations, and proposed solutions. A comparative analysis was performed to synthesize key findings and trends in AI-enhanced BCI systems for neurorehabilitation and cognitive monitoring.</p><p><strong>Results: </strong>The review identified several ML techniques, including transfer learning (TL), support vector machines (SVMs), and convolutional neural networks (CNNs), that enhance BCI closed-loop performance. These methods improve signal classification, feature extraction, and real-time adaptability, enabling accurate monitoring of cognitive states. However, challenges such as long calibration sessions, computational costs, data security risks, and variability in neural signals were also highlighted. To address these issues, emerging solutions such as improved sensor technology, efficient calibration protocols, and advanced AI-driven decoding models are being explored. In addition, BCIs show potential for real-time alert systems that support caregivers in managing AD/ADRD patients.</p><p><strong>Conclusions: </strong>BCI closed-loop systems, when integrated with AI and ML, offer sign
背景:脑机接口(BCI)闭环系统已成为医疗保健和健康监测,特别是神经康复和认知评估中有前途的工具。随着包括阿尔茨海默病和相关痴呆(AD/ADRD)在内的神经系统疾病负担的增加,迫切需要实时、无创监测技术。脑机接口可以实现大脑和外部设备之间的直接通信,利用人工智能(AI)和机器学习(ML)来解释神经信号。然而,诸如信号噪声、数据处理限制和隐私问题等挑战阻碍了广泛实施。目的:本研究的主要目的是探讨ML和AI在增强BCI闭环系统在医疗保健应用中的作用。具体而言,我们的目标是分析这些系统中使用的方法和参数,评估不同AI和ML技术的有效性,确定其开发和实施中的关键挑战,并提出使用BCIs进行AD/ADRD患者纵向监测的框架。通过解决这些问题,本研究旨在全面概述人工智能驱动的脑机接口在神经保健方面的潜力和局限性。方法:按照PRISMA(首选报告项目用于系统评价和荟萃分析)指南进行系统文献综述,重点关注2019年至2024年间发表的研究。我们使用与bci、AI和AD/ADRD相关的预定义关键字从PubMed、IEEE、ACM和Scopus中获取研究文章。最初共确定了220篇论文,其中18篇符合最终纳入标准。数据提取遵循结构化矩阵方法,根据方法、ML算法、限制和提出的解决方案对研究进行分类。对人工智能增强脑机接口系统用于神经康复和认知监测的主要发现和趋势进行了比较分析。结果:该综述确定了几种ML技术,包括迁移学习(TL),支持向量机(svm)和卷积神经网络(cnn),可以增强脑机接口闭环性能。这些方法改进了信号分类、特征提取和实时适应性,实现了对认知状态的准确监测。然而,校准时间长、计算成本高、数据安全风险和神经信号的可变性等挑战也得到了强调。为了解决这些问题,人们正在探索改进的传感器技术、有效的校准协议和先进的人工智能驱动解码模型等新兴解决方案。此外,脑机接口显示出支持护理人员管理AD/ADRD患者的实时警报系统的潜力。结论:脑机接口闭环系统与人工智能和机器学习相结合,在神经保健方面取得了重大进展,特别是在AD/ADRD监测和神经康复方面。尽管它们具有潜力,但为了广泛的临床应用,必须解决与数据准确性、安全性和可扩展性相关的挑战。未来的研究应侧重于完善人工智能模型,改进实时数据处理,增强用户可访问性。随着技术的不断进步,人工智能驱动的脑机接口可以通过为神经系统疾病患者提供持续、自适应的监测和干预,彻底改变个性化医疗保健。
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引用次数: 0
Thigh-Worn Sensor for Measuring Initial and Final Contact During Gait in a Mobility Impaired Population: Validation Study. 在行动障碍人群中测量初始和最终步态接触的穿戴式传感器:验证研究。
Pub Date : 2025-10-30 DOI: 10.2196/80308
Thomas Johnson, Janeesata Kuntapun, Craig Childs, Andrew Kerr

Background: Adapting physical activity monitors to detect gait events (ie, at initial and final contact) has the potential to build a more personalized approach to gait rehabilitation after stroke. Meeting laboratory standards for detecting these events in impaired populations is challenging, without resorting to a multisensor solution. The Teager-Kaiser energy operator (TKEO) estimates the instantaneous energy of a signal; its enhanced sensitivity has successfully detected gait events from the acceleration signals of individuals with impaired mobility, but has not been applied to stroke.

Objective: This study aimed to test the criterion validity of TKEO gait event detection (and derived spatiotemporal metrics) using data from thigh mounted physical activity monitors compared with concurrent 3D motion capture in chronic survivors of stroke.

Methods: Participants with a history of stroke(n=13, mean age 59, SD 14 years), time since stroke (mean 1.5, SD 0.5 years), walking speed (mean 0.93ms-1 , SD 0.38 m/s) performed two 10m walks at their comfortable speed, while wearing two ActivPAL 4+ (AP4) sensors (anterior of both thighs) and LED cluster markers on the pelvis and ankles which were tracked by a motion capture system. The TKEO signal processing technique was then used to extract gait events (initial and final contact) and calculate stance durations which were compared with motion capture data.

Results: There was very good agreement between the AP4 and motion capture data for stance duration (AP4 0.85s, motion capture system 0.88s, 95% CI of difference -0.07 to 0.13, intraclass correlation coefficient [3,1]=0.79).

Conclusions: The TKEO method for gait event detection using AP4 data provides stance time durations that are comparable with laboratory-based systems in a population with chronic stroke. Providing accurate stance time durations from wearable sensors could extend gait training out of clinical environments. Limitations include ecological and external validity. Future work should confirm findings with a larger sample of participants with a history of stroke.

背景:适应身体活动监测仪来检测步态事件(即在初始和最终接触时)有可能建立一种更加个性化的方法来进行中风后的步态康复。如果不采用多传感器解决方案,在受损人群中达到检测这些事件的实验室标准是具有挑战性的。Teager-Kaiser能量算子(TKEO)估计信号的瞬时能量;其增强的灵敏度已经成功地从行动能力受损的个体的加速信号中检测到步态事件,但尚未应用于中风。目的:本研究旨在测试TKEO步态事件检测(以及衍生的时空指标)的标准有效性,该标准使用大腿上安装的身体活动监测仪的数据,并与并发3D运动捕捉进行比较。方法:有中风病史的参与者(n=13,平均年龄59岁,标准差14岁),中风时间(平均1.5年,标准差0.5年),步行速度(平均0.93ms-1,标准差0.38 m/s),以舒适的速度进行两次10米步行,同时佩戴两个ActivPAL 4+ (AP4)传感器(大腿前部)和骨盆和脚踝上的LED集群标记,由运动捕捉系统跟踪。然后使用TKEO信号处理技术提取步态事件(初始和最终接触)并计算站立时间,并将其与运动捕获数据进行比较。结果:AP4和动作捕捉数据在站立时间上的一致性非常好(AP4为0.85s,动作捕捉系统为0.88s, 95% CI差异为-0.07 ~ 0.13,类内相关系数[3,1]=0.79)。结论:使用AP4数据进行步态事件检测的TKEO方法提供的站立时间持续时间与基于实验室的系统在慢性卒中人群中的可比较。通过可穿戴传感器提供准确的站立时间,可以将步态训练扩展到临床环境之外。限制包括生态有效性和外部有效性。未来的工作应该在有中风史的参与者中进行更大样本的研究,以证实这些发现。
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引用次数: 0
Correction: Can Artificial Intelligence Diagnose Knee Osteoarthritis? 纠正:人工智能能诊断膝关节骨关节炎吗?
Pub Date : 2025-09-12 DOI: 10.2196/82980
Mihir Tandon, Nitin Chetla, Adarsh Mallepally, Botan Zebari, Sai Samayamanthula, Jonathan Silva, Swapna Vaja, John Chen, Matthew Cullen, Kunal Sukhija

[This corrects the article DOI: 10.2196/67481.].

[更正文章DOI: 10.2196/67481]。
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引用次数: 0
Estimation of Brachial-Ankle Pulse Wave Velocity With Hierarchical Regression Model From Wrist Photoplethysmography and Electrocardiographic Signals: Method Design. 用层次回归模型估计腕部光电体积脉搏波和心电图信号的腕部-踝关节脉搏波速度:方法设计。
Pub Date : 2025-08-26 DOI: 10.2196/58756
Chih-I Ho, Chia-Hsiang Yen, Yu-Chuan Li, Chiu-Hua Huang, Jia-Wei Guo, Pei-Yun Tsai, Hung-Ju Lin, Tzung-Dau Wang

Background: Photoplethysmography (PPG) signals captured by wearable devices can provide vascular age information and support pervasive and long-term monitoring of personal health condition.

Objective: In this study, we aimed to estimate brachial-ankle pulse wave velocity (baPWV) from wrist PPG and electrocardiography (ECG) from smartwatch.

Methods: A total of 914 wrist PPG and ECG sequences and 278 baPWV measurements were collected via the smartwatch from 80 men and 82 women with average age of 63.4 (SD 13.4) and 64.3 (SD 11.6) years. Feature extraction and weighted pulse decomposition were applied to identify morphological characteristics regarding blood volume change and component waves in preprocessed PPG and ECG signals. A systematic strategy of feature combination was performed. The hierarchical regression method based on the random forest for classification and extreme gradient boosting (XGBoost) algorithms for regression was used, which first classified the data into subdivisions. The respective regression model for the subdivision was constructed with an overlapping zone.

Results: By using 914 sets of wrist PPG and ECG signals for baPWV estimation, the hierarchical regression model with 2 subdivisions and an overlapping zone of 400 cm per second achieved root-mean-square error of 145.0 cm per second and 141.4 cm per second for 24 men and 26 women, respectively, which is better than the general XGBoost regression model and the multivariable regression model (all P<.001).

Conclusions: We for the first time demonstrated that baPWV could be reliably estimated by the wrist PPG and ECG signals measured by the wearable device. Whether our algorithm could be applied clinically needs further verification.

背景:可穿戴设备捕获的光容积脉搏波(PPG)信号可以提供血管年龄信息,支持对个人健康状况的普遍和长期监测。目的:在本研究中,我们旨在通过手腕PPG和智能手表的心电图(ECG)来估计臂踝脉搏波速度(baPWV)。方法:通过智能手表收集80名男性和82名女性的914个手腕PPG和ECG序列以及278个baPWV测量数据,平均年龄分别为63.4 (SD 13.4)和64.3 (SD 11.6)岁。采用特征提取和加权脉冲分解方法对预处理后的PPG和ECG信号进行血容量变化和分量波的形态学特征识别。采用系统的特征组合策略。采用基于随机森林分类和极端梯度提升(XGBoost)算法的分层回归方法,首先对数据进行细分;用重叠区域构建各细分区域的回归模型。结果:利用914组腕部PPG和心电信号进行baPWV估计,2细分重叠区400 cm / s的层次回归模型分别对24名男性和26名女性实现了145.0 cm / s和141.4 cm / s的均方根误差,优于一般XGBoost回归模型和多变量回归模型(均p < 0.05)。我们首次证明了通过可穿戴设备测量的手腕PPG和心电信号可以可靠地估计baPWV。我们的算法能否在临床上应用还需要进一步验证。
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引用次数: 0
Using Vibration for Secure Pairing With Implantable Medical Devices: Development and Usability Study. 利用振动与植入式医疗器械进行安全配对:开发和可用性研究。
Pub Date : 2025-08-26 DOI: 10.2196/57091
Mo Zhang, Chaofan Wang, Weiwei Jiang, David Oswald, Toby Murray, Eduard Marin, Jing Wei, Mark Ryan, Vassilis Kostakos

Background: Implantable medical devices (IMDs), such as pacemakers, increasingly communicate wirelessly with external devices. To secure this wireless communication channel, a pairing process is needed to bootstrap a secret key between the devices. Previous work has proposed pairing approaches that often adopt a "seamless" design and render the pairing process imperceptible to patients. This lack of user perception can significantly compromise security and pose threats to patients.

Objective: The study aimed to explore the use of highly perceptible vibrations for pairing with IMDs and aim to propose a novel technique that leverages the natural randomness in human motor behavior as a shared source of entropy for pairing, potentially deployable to current IMD products.

Methods: A proof of concept was developed to demonstrate the proposed technique. A wearable prototype was built to simulate an individual acting as an IMD patient (real patients were not involved to avoid potential risks), and signal processing algorithms were devised to use accelerometer readings for facilitating secure pairing with an IMD. The technique was thoroughly evaluated in terms of accuracy, security, and usability through a lab study involving 24 participants.

Results: Our proposed pairing technique achieves high pairing accuracy, with a zero false acceptance rate (indicating low risks from adversaries) and a false rejection rate of only 0.6% (1/192; suggesting that legitimate users will likely experience very few failures). Our approach also offers robust security, which passes the National Institute of Standards and Technology statistical tests (with all P values >.01). Moreover, our technique has high usability, evidenced by an average System Usability Scale questionnaire score of 73.6 (surpassing the standard benchmark of 68 for "good usability") and insights gathered from the interviews. Furthermore, the entire pairing process can be efficiently completed within 5 seconds.

Conclusions: Vibration can be used to realize secure, usable, and deployable pairing in the context of IMDs. Our method also exhibits advantages over previous approaches, for example, lenient requirements on the sensing capabilities of IMDs and the synchronization between the IMD and the external device.

背景:植入式医疗设备(imd),如起搏器,越来越多地与外部设备进行无线通信。为了保护这个无线通信通道,需要一个配对过程来引导设备之间的秘密密钥。以前的工作提出了配对方法,通常采用“无缝”设计,使配对过程对患者难以察觉。这种用户感知的缺乏会严重损害安全性并对患者构成威胁。目的:本研究旨在探索使用高度可感知的振动与IMD配对,并旨在提出一种新技术,利用人类运动行为的自然随机性作为配对的共享熵源,有可能部署到当前的IMD产品中。方法:开发了一个概念验证来演示所提出的技术。设计了一个可穿戴原型来模拟个人作为IMD患者(为了避免潜在风险,没有涉及真实患者),并设计了信号处理算法来使用加速度计读数来促进与IMD的安全配对。通过一项涉及24名参与者的实验室研究,该技术在准确性、安全性和可用性方面进行了全面评估。结果:我们提出的配对技术实现了很高的配对准确率,错误接受率为零(表明对手的风险较低),错误拒绝率仅为0.6%(1/192;表明合法用户可能会遇到很少的失败)。我们的方法还提供了强大的安全性,通过了国家标准与技术研究所的统计测试(所有P值都为>.01)。此外,我们的技术具有很高的可用性,系统可用性量表问卷的平均得分为73.6分(超过了“良好可用性”的标准基准68分)和从访谈中收集的见解证明了这一点。此外,整个配对过程可以在5秒内高效完成。结论:振动可以在imd环境中实现安全、可用和可部署的配对。与以前的方法相比,我们的方法也具有优势,例如,对IMD的传感能力要求较低,并且IMD与外部设备之间的同步要求较低。
{"title":"Using Vibration for Secure Pairing With Implantable Medical Devices: Development and Usability Study.","authors":"Mo Zhang, Chaofan Wang, Weiwei Jiang, David Oswald, Toby Murray, Eduard Marin, Jing Wei, Mark Ryan, Vassilis Kostakos","doi":"10.2196/57091","DOIUrl":"10.2196/57091","url":null,"abstract":"<p><strong>Background: </strong>Implantable medical devices (IMDs), such as pacemakers, increasingly communicate wirelessly with external devices. To secure this wireless communication channel, a pairing process is needed to bootstrap a secret key between the devices. Previous work has proposed pairing approaches that often adopt a \"seamless\" design and render the pairing process imperceptible to patients. This lack of user perception can significantly compromise security and pose threats to patients.</p><p><strong>Objective: </strong>The study aimed to explore the use of highly perceptible vibrations for pairing with IMDs and aim to propose a novel technique that leverages the natural randomness in human motor behavior as a shared source of entropy for pairing, potentially deployable to current IMD products.</p><p><strong>Methods: </strong>A proof of concept was developed to demonstrate the proposed technique. A wearable prototype was built to simulate an individual acting as an IMD patient (real patients were not involved to avoid potential risks), and signal processing algorithms were devised to use accelerometer readings for facilitating secure pairing with an IMD. The technique was thoroughly evaluated in terms of accuracy, security, and usability through a lab study involving 24 participants.</p><p><strong>Results: </strong>Our proposed pairing technique achieves high pairing accuracy, with a zero false acceptance rate (indicating low risks from adversaries) and a false rejection rate of only 0.6% (1/192; suggesting that legitimate users will likely experience very few failures). Our approach also offers robust security, which passes the National Institute of Standards and Technology statistical tests (with all P values >.01). Moreover, our technique has high usability, evidenced by an average System Usability Scale questionnaire score of 73.6 (surpassing the standard benchmark of 68 for \"good usability\") and insights gathered from the interviews. Furthermore, the entire pairing process can be efficiently completed within 5 seconds.</p><p><strong>Conclusions: </strong>Vibration can be used to realize secure, usable, and deployable pairing in the context of IMDs. Our method also exhibits advantages over previous approaches, for example, lenient requirements on the sensing capabilities of IMDs and the synchronization between the IMD and the external device.</p>","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":"10 ","pages":"e57091"},"PeriodicalIF":0.0,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12379749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144982053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Influence of Pre-Existing Pain on the Body's Response to External Pain Stimuli: Experimental Study. 预先存在的疼痛对身体对外部疼痛刺激反应的影响:实验研究。
Pub Date : 2025-08-20 DOI: 10.2196/70938
Burcu Ozek, Zhenyuan Lu, Srinivasan Radhakrishnan, Sagar Kamarthi

Background: Accurately assessing pain severity is essential for effective pain treatment and desirable patient outcomes. In clinical settings, pain intensity assessment relies on self-reporting methods, which are subjective to individuals and impractical for noncommunicative or critically ill patients. Previous studies have attempted to measure pain objectively using physiological responses to an external pain stimulus, assuming that the participant is free of internal body pain. However, this approach does not reflect the situation in a clinical setting, where a patient subjected to an external pain stimulus may already be experiencing internal body pain.

Objective: This study investigates the hypothesis that an individual's physiological response to external pain varies in the presence of preexisting pain.

Methods: We recruited 39 healthy participants aged 22-37 years, including 23 female and 16 male participants. Physiological signals, electrodermal activity, and electromyography were recorded while participants were subject to a combination of preexisting heat pain and cold pain stimuli. Feature engineering methods were applied to extract time-series features, and statistical analysis using ANOVA was conducted to assess significance.

Results: We found that the preexisting pain influences the body's physiological responses to an external pain stimulus. Several features-particularly those related to temporal statistics, successive differences, and distributions-showed statistically significant variation across varying preexisting pain conditions, with P values <.05 depending on the feature and stimulus.

Conclusions: Our findings suggest that preexisting pain alters the body's physiological response to new pain stimuli, highlighting the importance of considering pain history in objective pain assessment models.

背景:准确评估疼痛严重程度对于有效的疼痛治疗和理想的患者预后至关重要。在临床环境中,疼痛强度评估依赖于自我报告方法,这对个人来说是主观的,对于非交流或危重患者来说是不切实际的。先前的研究试图通过对外部疼痛刺激的生理反应来客观地测量疼痛,假设参与者没有身体内部疼痛。然而,这种方法并不能反映临床环境中的情况,在这种情况下,受到外部疼痛刺激的患者可能已经经历了身体内部的疼痛。目的:本研究探讨了个体对外部疼痛的生理反应在先前存在的疼痛中发生变化的假设。方法:招募年龄22 ~ 37岁的健康受试者39例,其中女性23例,男性16例。当参与者受到预先存在的热痛和冷痛刺激时,记录了生理信号、皮电活动和肌电图。采用特征工程方法提取时间序列特征,并采用方差分析进行统计分析以评估显著性。结果:我们发现先前存在的疼痛会影响身体对外部疼痛刺激的生理反应。结论:我们的研究结果表明,已存在的疼痛会改变身体对新的疼痛刺激的生理反应,这突出了在客观疼痛评估模型中考虑疼痛史的重要性。
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引用次数: 0
Optimizing Voice Sample Quantity and Recording Settings for the Prediction of Type 2 Diabetes Mellitus: Retrospective Study. 优化语音样本量和录音设置预测2型糖尿病:回顾性研究。
Pub Date : 2025-06-26 DOI: 10.2196/64357
Atousa Assadi, Jessica Oreskovic, Jaycee Kaufman, Yan Fossat

Background: The use of acoustic biomarkers derived from speech signals is a promising non-invasive technique for diagnosing type 2 diabetes mellitus (T2DM). Despite its potential, there remains a critical gap in knowledge regarding the optimal number of voice recordings and recording schedule necessary to achieve effective diagnostic accuracy.

Objective: This study aimed to determine the optimal number of voice samples and the ideal recording schedule (frequency and timing), required to maintain the T2DM diagnostic efficacy while reducing patient burden.

Methods: We analyzed voice recordings from 78 adults (22 women), including 39 individuals diagnosed with T2DM. Participants had a mean (SD) age of 45.26 (10.63) years and mean (SD) BMI of 28.07 (4.59) kg/m². In total, 5035 voice recordings were collected, with a mean (SD) of 4.91 (1.45) recordings per day; higher adherence was observed among women (5.13 [1.38] vs 4.82 [1.46] in men). We evaluated the diagnostic accuracy of a previously developed voice-based model under different recording conditions. Segmented linear regression analysis was used to assess model accuracy across varying numbers of voice recordings, and the Kendall tau correlation was used to measure the relationship between recording settings and accuracy. A significance threshold of P<.05 was applied.

Results: Our results showed that including up to 6 voice recordings notably improved the model accuracy for T2DM compared to using only one recording, with accuracy increasing from 59.61 to 65.02 for men and from 65.55 to 69.43 for women. Additionally, the day on which voice recordings were collected did not significantly affect model accuracy (P>.05). However, adhering to recording within a single day demonstrated higher accuracy, with accuracy of 73.95% for women and 85.48% for men when all recordings were from the first and second days.

Conclusions: This study underscores the optimal voice recording settings to reduce patient burden while maintaining diagnostic efficacy.

背景:使用来自语音信号的声学生物标志物是诊断2型糖尿病(T2DM)的一种很有前途的非侵入性技术。尽管有潜力,但在实现有效诊断准确性所需的最佳录音数量和录音时间表方面,知识仍然存在重大差距。目的:本研究旨在确定维持T2DM诊断疗效同时减轻患者负担所需的最佳语音样本数量和理想录音时间表(频率和时间)。方法:我们分析了78名成年人(22名女性)的录音,其中包括39名诊断为T2DM的人。参与者的平均(SD)年龄为45.26(10.63)岁,平均(SD) BMI为28.07 (4.59)kg/m²。共收集到5035份录音,平均(SD)为4.91(1.45)份/天;女性患者的依从性更高(5.13 [1.38]vs 4.82[1.46])。我们评估了先前开发的基于语音的模型在不同录音条件下的诊断准确性。使用分段线性回归分析来评估不同数量录音的模型准确性,并使用肯德尔tau相关来衡量录音设置与准确性之间的关系。结果的显著性阈值:我们的结果表明,与只使用一个录音相比,包含多达6个录音的T2DM模型的准确性显着提高,男性的准确性从59.61提高到65.02,女性的准确性从65.55提高到69.43。此外,收集录音的日期对模型的准确性没有显著影响(P < 0.05)。然而,坚持在一天内记录的准确率更高,当所有记录都在第一天和第二天时,女性的准确率为73.95%,男性的准确率为85.48%。结论:本研究强调了最佳的录音设置,以减轻患者负担,同时保持诊断疗效。
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引用次数: 0
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