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Quality and readability of chatbot responses to patient questions: A systematic cross-sectional meta-synthesis. 聊天机器人回答病人问题的质量和可读性:一个系统的横断面综合。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.1177/14604582251388879
Peter Whittaker, Mengyan Sun

Introduction: Patients increasingly use chatbots to obtain medical information, a trend that has provoked both optimism and pessimism. Numerous studies have evaluated the quality and readability of these outputs. This study synthesizes these findings through a cross-sectional meta-synthesis. Methods: We identified studies that evaluated responses using the DISCERN instrument, designed to assess the quality of written material. Additionally, we only included studies that also evaluated readability. We recorded the chatbot used, DISCERN scores, the number of words in each question, the number of questions asked, the number of DISCERN evaluators, the readability of responses, and the year the study was conducted. We also assessed the influence of each publication's journal ranking using the Journal Citation Indicator. Results: We identified 42 studies that conducted 86 tests. Chatbot response readability decreased as response quality increased. Forty-nine tests produced responses ranked "good" or better, and only 10 scored below college-level readability. We significantly increased readability by adding the phrase "write responses at sixth-grade reading level" to prompts that previously produced post-graduate reading level responses in published studies. Discussion: Variable quality and poor readability of chatbot responses reinforce pessimism about their utility. Nevertheless, appropriate "prompt engineering" provides scope to enhance response quality and readability.

导读:越来越多的患者使用聊天机器人来获取医疗信息,这一趋势引发了乐观和悲观。许多研究评估了这些产出的质量和可读性。本研究通过横断面综合研究综合了这些发现。方法:我们确定了使用DISCERN工具评估反应的研究,该工具旨在评估书面材料的质量。此外,我们只纳入了评估可读性的研究。我们记录了使用的聊天机器人、DISCERN得分、每个问题的字数、提出的问题数量、DISCERN评估人员的数量、回答的可读性以及研究进行的年份。我们还使用期刊引用指标评估了每个出版物的期刊排名的影响。结果:我们确定了42项研究,进行了86项测试。聊天机器人响应的可读性随着响应质量的提高而下降。49项测试的结果被评为“好”或更好,只有10项测试的得分低于大学水平的可读性。我们通过在先前发表的研究中产生的研究生阅读水平的回答提示中添加“写出六年级阅读水平的回答”这一短语,显著提高了可读性。讨论:聊天机器人响应的质量不稳定和可读性差,加剧了人们对其效用的悲观情绪。然而,适当的“即时工程”提供了提高响应质量和可读性的范围。
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引用次数: 0
An assessment of patient readiness to engage in digital patient reported outcomes in an Australian inflammatory bowel disease cohort. 在澳大利亚炎症性肠病队列中评估患者参与数字患者报告结果的准备情况。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-31 DOI: 10.1177/14604582251383804
Tsz Hong Yiu, Sarah Rouse, Caitlin Hausler, Kerrie Curin, Nicola McGuinn, Joanna Petrunic, Amalie Søgaard Nielsen, Bodil Rasmussen, Christopher F D Li Wai Suen, Elizabeth Chow

Objectives: Digital patient-reported outcome (PRO) tools, though beneficial for managing inflammatory bowel disease (IBD), remain underutilized in Australia. This study aimed to investigate a group of Australian patients' readiness to engage with digital PRO tools and identify potential barriers to their implementation. Methods: We assessed 58 patients from a tertiary IBD clinic in Melbourne, Australia, using the Readiness and Enablement Index for Health Technology (ReadHy) tool, and compared the results to those from a Danish study. Results: Compared to the Danish cohort, our patients were younger with more frequent users of electronic devices, showed higher readiness across most ReadHy dimensions, except in the "heiQ8 Emotional Distress" dimension. Conclusion: These findings suggest a generally favourable environment for implementing digital PRO tools at an Australian tertiary IBD clinic, though attention should be paid to emotional well-being to improve adoption. This study also provides a framework for other centres to evaluate their patients' readiness for digital PRO engagement.

目的:数字化患者报告结果(PRO)工具,虽然有利于治疗炎症性肠病(IBD),但在澳大利亚仍未得到充分利用。本研究旨在调查一组澳大利亚患者是否愿意使用数字PRO工具,并确定其实施的潜在障碍。方法:我们评估了来自澳大利亚墨尔本一家三级IBD诊所的58名患者,使用健康技术准备和实现指数(ReadHy)工具,并将结果与丹麦的一项研究进行了比较。结果:与丹麦队列相比,我们的患者更年轻,更频繁地使用电子设备,在大多数ReadHy维度上表现出更高的准备程度,除了“heiQ8情绪困扰”维度。结论:这些发现表明,在澳大利亚三级IBD诊所实施数字PRO工具的环境总体上是有利的,尽管应该注意情绪健康以提高采用率。这项研究也为其他中心提供了一个框架,以评估他们的患者对数字PRO参与的准备情况。
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引用次数: 0
Performance and security analysis of fully homomorphic encryption in cloud-based healthcare blockchain. 基于云的医疗保健区块链中全同态加密的性能和安全性分析。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-11-10 DOI: 10.1177/14604582251394616
Salah ElDin Zaher Olaymi

Objective: This study evaluates the feasibility and performance of a cloud-based healthcare blockchain framework that integrates Fully Homomorphic Encryption (FHE), Extended Secure Searchable Encryption (ESSE), and Attribute-Based Signature (ABS) for managing encrypted Personal Health Records (PHRs). Methods: A synthetic dataset of 1,000 anonymized health records, modeled after the publicly available Cell-Phone Brain Tumour dataset (Kaggle), was generated in MATLAB. The dataset emulated attributes typically collected by IoT-enabled or mobile health devices (e.g., usage duration, radiation exposure), although no physical IoT integration was implemented. The cryptographic modules-FHE, ESSE, and ABS-were implemented and simulated in a MATLAB-based cloud environment. System evaluation focused on encryption latency, query throughput, access control accuracy, and overall operational efficiency. Results: The FHE module achieved an average encryption time of 2.5 s and a computation time of 4.8 s per 1 KB record. ESSE sustained 20 encrypted queries per second with an 85% success rate. ABS enforced decentralized access with 97% accuracy and a false positive rate of 0.002%. When integrated, the system reached 94% operational efficiency across simulated healthcare workloads. Conclusion: The proposed FHE-ESSE-ABS framework advances existing healthcare blockchain solutions by enabling encrypted computation, privacy-preserving search, and fine-grained access control. These findings confirm its feasibility for secure cloud-based healthcare data management and establish a foundation for future real-world deployment in health informatics.

目的:本研究评估了基于云的医疗保健区块链框架的可行性和性能,该框架集成了完全同态加密(FHE)、扩展安全可搜索加密(ESSE)和基于属性的签名(ABS),用于管理加密的个人健康记录(PHRs)。方法:以公开的手机脑肿瘤数据集(Kaggle)为模型,在MATLAB中生成1000个匿名健康记录的合成数据集。该数据集模拟了通常由支持物联网或移动医疗设备收集的属性(例如,使用持续时间、辐射暴露),尽管没有实现物理物联网集成。加密模块fhe、ESSE和abs在基于matlab的云环境中实现和模拟。系统评估侧重于加密延迟、查询吞吐量、访问控制准确性和整体操作效率。结果:FHE模块的平均加密时间为2.5 s,每1kb记录的计算时间为4.8 s。ESSE每秒支持20个加密查询,成功率为85%。ABS强制分散访问,准确率为97%,假阳性率为0.002%。集成后,系统在模拟医疗保健工作负载中达到94%的操作效率。结论:提出的FHE-ESSE-ABS框架通过启用加密计算、隐私保护搜索和细粒度访问控制,推进了现有的医疗保健区块链解决方案。这些发现证实了安全的基于云的医疗保健数据管理的可行性,并为未来在健康信息学中的实际部署奠定了基础。
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引用次数: 0
A scoping review of electronic health records interoperability levels, expectations, approaches, and problems. 对电子健康记录互操作性级别、期望、方法和问题的范围审查。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-24 DOI: 10.1177/14604582251385986
Raghid El-Yafouri, Leslie Klieb

To achieve useful interoperability between electronic health record (EHR) systems, many approaches have been proposed. To date, none has prevailed as a clear solution. This scoping review studies 24 publications from 2014 to 2023. The aim is to streamline the understanding of current EHR interoperability expectations, practices, and problems, highlight learnings from the Levels of Conceptual Interoperability Model (LCIM), and suggest means for expediting EHR interoperability. Four interoperability levels are visible in EHR compared to seven in the LCIM: technical/foundational, syntactic/structural, semantic, and process/organization. Semantic interoperability-preserving meaning of exchanged data-is the main focus and the problem to solve. Its many expectations cause implementation difficulty. Standardization of data structures, transfer protocols, terminologies, vocabularies, and ontologies are the most common approach, but there is a lack of consensus on standards. Emerging approaches include fuzzy ontologies, natural language processing, and bidirectional transformation. Standardized data structure is not a prerequisite to useful EHR interoperability. Focusing on the state of health records rather than full system integration can expedite interoperability. Different use cases can benefit from various approaches. Artificial intelligence shows promise for handling semi-structured or unstructured data. Stronger regulations may be necessary to guide ongoing integrations.

为了实现电子健康记录(EHR)系统之间有效的互操作性,人们提出了许多方法。迄今为止,没有一种明确的解决方案占了上风。本范围综述研究了2014年至2023年的24篇出版物。目的是简化对当前EHR互操作性期望、实践和问题的理解,强调从概念互操作性模型(LCIM)的层次中学习,并提出加快EHR互操作性的方法。与LCIM中的七个互操作性级别相比,EHR中可见四个互操作性级别:技术/基础、语法/结构、语义和过程/组织。语义互操作性——保持交换数据的意义——是主要的焦点和需要解决的问题。它的许多期望造成了实施困难。数据结构、传输协议、术语、词汇表和本体的标准化是最常见的方法,但在标准方面缺乏共识。新兴的方法包括模糊本体、自然语言处理和双向转换。标准化的数据结构并不是有用的EHR互操作性的先决条件。关注健康记录的状态而不是完整的系统集成可以加快互操作性。不同的用例可以从不同的方法中获益。人工智能有望处理半结构化或非结构化数据。可能需要更强有力的法规来指导正在进行的整合。
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引用次数: 0
Using machine learning models to predict coronary artery calcium scores in firefighters. 使用机器学习模型预测消防员冠状动脉钙评分。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.1177/14604582251381274
Mingyue Li, Jiali Han, Carolyn Muegge, Terrell Zollinger, Yixi Xu, Laura Y Zhou, Patrick Monahan, Jennifer Wessel, Vanessa Kleinschmidt, Steven Moffatt, Hongmei Nan

Objective: To develop and compare the predictive accuracy of machine learning (ML) models for coronary artery calcium (CAC) prediction among firefighters and to evaluate their cross-validated performance against traditional binary logistic regression (BLR). Methods: This study utilized health records from 416 firefighters who underwent comprehensive health screenings at Ascension Public Safety Medical. CAC was assessed using cardiac computed tomography scans. The degree of CAC was measured using the Agatston scores. 17 clinical and lifestyle related risk variables were collected. Machine learning models, including XGBoost, Random Forest (RF), Support Vector Machine (SVM), Naïve Bayes (NB), and K Nearest Neighbor (KNN), were developed and compared. Additionally, the performance of these ML models was evaluated against traditional binary logistic regression (BLR). Results: Among the 416 firefighters, age (r = 0.28, p < 0.0001), glucose levels (r = 0.13, p = 0.001), monocyte percentages (r = 0.13, p = 0.001), and resting systolic blood pressure (r = 0.13, p = 0.009) were positively associated with CAC. While sodium levels (r = -0.11, p = 0.038), GFR (r = -0.17, p = 0.021), and maximum oxygen volumes (r = -0.19, p = 0.0002) were inversely associated with CAC. XGBoost achieved the highest cross-validated area under the curve (AUC) of 0.770, outperforming NB (0.768), SVM (0.765), RF (0.749), KNN (0.671), and BLR (0.658). Conclusion: Our research demonstrates the efficacy of ML algorithms, particularly XGBoost, in enhancing early detection and preventive strategies for CAC among firefighters. These advancements are crucial for proactive health management in this high-risk group, potentially mitigating risks associated with their demanding profession.

目的:建立和比较机器学习(ML)模型对消防员冠状动脉钙(CAC)预测的准确性,并评估其与传统二元逻辑回归(BLR)交叉验证的性能。方法:本研究利用了在阿森松公共安全医疗中心接受全面健康检查的416名消防员的健康记录。通过心脏计算机断层扫描评估CAC。CAC的程度用Agatston评分来衡量。收集了17个与临床和生活方式相关的风险变量。开发并比较了XGBoost、随机森林(RF)、支持向量机(SVM)、Naïve贝叶斯(NB)和K近邻(KNN)等机器学习模型。此外,根据传统的二元逻辑回归(BLR)对这些ML模型的性能进行了评估。结果:在416名消防员中,年龄(r = 0.28, p < 0.0001)、血糖水平(r = 0.13, p = 0.001)、单核细胞百分比(r = 0.13, p = 0.001)和静息收缩压(r = 0.13, p = 0.009)与CAC呈正相关。而钠水平(r = -0.11, p = 0.038)、GFR (r = -0.17, p = 0.021)和最大氧容量(r = -0.19, p = 0.0002)与CAC呈负相关。XGBoost实现了最高的交叉验证曲线下面积(AUC)为0.770,优于NB(0.768)、SVM(0.765)、RF(0.749)、KNN(0.671)和BLR(0.658)。结论:我们的研究证明了ML算法,特别是XGBoost,在加强消防员CAC的早期发现和预防策略方面的有效性。这些进步对于这一高风险群体的主动健康管理至关重要,可能会减轻与他们苛刻的职业相关的风险。
{"title":"Using machine learning models to predict coronary artery calcium scores in firefighters.","authors":"Mingyue Li, Jiali Han, Carolyn Muegge, Terrell Zollinger, Yixi Xu, Laura Y Zhou, Patrick Monahan, Jennifer Wessel, Vanessa Kleinschmidt, Steven Moffatt, Hongmei Nan","doi":"10.1177/14604582251381274","DOIUrl":"https://doi.org/10.1177/14604582251381274","url":null,"abstract":"<p><p><b>Objective:</b> To develop and compare the predictive accuracy of machine learning (ML) models for coronary artery calcium (CAC) prediction among firefighters and to evaluate their cross-validated performance against traditional binary logistic regression (BLR). <b>Methods:</b> This study utilized health records from 416 firefighters who underwent comprehensive health screenings at Ascension Public Safety Medical. CAC was assessed using cardiac computed tomography scans. The degree of CAC was measured using the Agatston scores. 17 clinical and lifestyle related risk variables were collected. Machine learning models, including XGBoost, Random Forest (RF), Support Vector Machine (SVM), Naïve Bayes (NB), and K Nearest Neighbor (KNN), were developed and compared. Additionally, the performance of these ML models was evaluated against traditional binary logistic regression (BLR). <b>Results:</b> Among the 416 firefighters, age (r = 0.28, <i>p</i> < 0.0001), glucose levels (r = 0.13, <i>p</i> = 0.001), monocyte percentages (r = 0.13, <i>p</i> = 0.001), and resting systolic blood pressure (r = 0.13, <i>p</i> = 0.009) were positively associated with CAC. While sodium levels (r = -0.11, <i>p</i> = 0.038), GFR (r = -0.17, <i>p</i> = 0.021), and maximum oxygen volumes (r = -0.19, <i>p</i> = 0.0002) were inversely associated with CAC. XGBoost achieved the highest cross-validated area under the curve (AUC) of 0.770, outperforming NB (0.768), SVM (0.765), RF (0.749), KNN (0.671), and BLR (0.658). <b>Conclusion:</b> Our research demonstrates the efficacy of ML algorithms, particularly XGBoost, in enhancing early detection and preventive strategies for CAC among firefighters. These advancements are crucial for proactive health management in this high-risk group, potentially mitigating risks associated with their demanding profession.</p>","PeriodicalId":55069,"journal":{"name":"Health Informatics Journal","volume":"31 4","pages":"14604582251381274"},"PeriodicalIF":2.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145310059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predictors of and reasons for refusal to participate in a digitally supported remote maintenance pulmonary rehabilitation programme. 拒绝参加数字支持的远程维持肺康复计划的预测因素和原因。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.1177/14604582251345329
François Alexandre, Virginie Molinier, Espérance Moine, Sébastien Kuss, François Bughin, Antonin Vernet, Guillaume Coste, Amandine Calvat, Virginie Guerre, Nicolas Oliver, Maurice Hayot, Nelly Heraud

Objective: The study aimed to assess the predictors and the reasons for refusal to participate in a digitally supported remote maintenance pulmonary rehabilitation programme (M-PRP). Methods: Patients contacted to integrate a 12-month M-PRP were assessed for clinical and sociodemographic characteristics and completed a series of 11 questionnaires including digital literacy (MDPQ-16), personality traits (BFI-10) and reasons for refusal. Results: Of the 136 patients included, 78 accepted the M-PRP and 58 refused (43%). The likelihood of refusal was associated with low forced expiratory volume in 1s (FEV1), body mass index, neuroticism (BFI-10) and MDPQ-16. Main reasons for refusal were programme constraints (47%), intention to continue physical activity alone (45%), and lack of information technologies (IT) equipment (29%). Conclusion: Digital M-PRP rejection is a common problem. Disease severity and technology issues are main barriers. Particular attention should be paid to patients who state they intend to continue on their own, given conflicting literature data.

目的:本研究旨在评估拒绝参加数字支持的远程维持肺康复计划(M-PRP)的预测因素和原因。方法:对参与12个月M-PRP的患者进行临床和社会人口学特征评估,并完成包括数字素养(MDPQ-16)、人格特征(BFI-10)和拒绝原因在内的一系列11份问卷。结果:136例患者中,78例接受M-PRP, 58例拒绝(43%)。拒绝的可能性与低用力呼气量(FEV1)、体重指数、神经质(BFI-10)和MDPQ-16有关。拒绝的主要原因是项目限制(47%)、打算单独继续体育活动(45%)和缺乏信息技术(IT)设备(29%)。结论:数字M-PRP排斥是常见问题。疾病严重程度和技术问题是主要障碍。鉴于文献资料相互矛盾,应特别注意那些表示打算继续自行治疗的患者。
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引用次数: 0
Advanced monitoring, alerting and feedback in early risk mitigation for pancreatic cancer. 胰腺癌早期风险缓解的先进监测、预警和反馈
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-15 DOI: 10.1177/14604582251387969
George Manias, Nelina Angelova, Diana Kirova, Aristodemos Pnevmatikakis, Pencho Stefanov, Fabio Melillo, Oscar Garcia Perales, Konstantina Kostopoulou, Sofoklis Kyriazakos, Dimosthenis Kyriazis

A novel patient monitoring system is introduced, designed to support early risk mitigation in pancreatic cancer through personalized health interventions. The system aims to strengthen patient engagement and proactive care by enabling healthcare practitioners (HCP) to assign dynamic, data-driven and personalized mitigation plans. Central to this system is a user interface that allows HCP to review and assign tailored mitigation plans to patients. These plans are formulated based on primary clinical data and enriched with secondary behavioral data, such as wearable-derived metrics and self-reported inputs. These inputs are continuously collected, transformed into Holistic Health Records (HHRs), and stored in a scalable platform for integration with ML-based trend analysis and visualization. The article outlines the system's technical architecture, patient data evaluation logic, and user experience across both the HCP interface and patient app. Evaluation by end users via questionnaires demonstrated improved adherence to plans and higher-quality behavioral data. This monitoring platform offers a promising tool for facilitating early risk intervention in pancreatic cancer care. By integrating multi-source patient data into actionable strategies and fostering bidirectional engagement, it bridges the gap between clinical insight and patient participation, contributing to holistic health management.

介绍了一种新的患者监测系统,旨在通过个性化的健康干预来支持胰腺癌的早期风险缓解。该系统旨在通过使医疗保健从业者(HCP)分配动态的、数据驱动的和个性化的缓解计划,加强患者的参与和主动护理。该系统的核心是一个用户界面,允许HCP审查并为患者分配量身定制的缓解计划。这些计划是根据主要临床数据制定的,并辅以次要行为数据,如可穿戴设备衍生指标和自我报告输入。不断收集这些输入,将其转换为整体健康记录(hhr),并存储在可扩展的平台中,以便与基于ml的趋势分析和可视化集成。本文概述了系统的技术架构、患者数据评估逻辑以及HCP界面和患者应用程序的用户体验。最终用户通过问卷调查进行的评估表明,计划的依从性得到了提高,行为数据的质量也得到了提高。该监测平台为促进胰腺癌早期风险干预提供了一个有前途的工具。通过将多源患者数据集成到可操作的策略中并促进双向参与,它弥合了临床洞察和患者参与之间的差距,有助于整体健康管理。
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引用次数: 0
Human Digital Twins for pervasive healthcare: A scoping review. 普及医疗保健的人类数字孪生:范围审查。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-30 DOI: 10.1177/14604582251392455
Joonyoung Park, Eunji Park, Duri Lee, Soowon Kang, Takyeon Lee, Hwajung Hong, Sung-Ju Lee, Heepyung Kim, Yu Rang Park, Uichin Lee

Background: Human Digital Twins (HDTs) have recently emerged, especially in the context of healthcare. With the growing emphasis on preventive healthcare beyond diagnosis, pervasive sensing has become essential which enables continuous monitoring through real-world data captured from wearables and/or mobile devices. Objective: This scoping review investigates how pervasive sensing technologies have been utilized in the implementation of HDTs for healthcare, with a focus on understanding the twinning methods, identifying their advantages and limitations, and uncovering key challenges encountered in real-world applications. Methods: We proposed an analytical framework to examine how pervasive sensing technologies are utilized in the implementation of HDTs for personal health management. Using this framework, we conducted a comprehensive literature search across PubMed, Scopus, IEEE Xplore, Web of Science, and Google Scholar. Results: A total of 39 eligible papers were reviewed. We present an analysis of these studies and provide a discussion on the potential and limitations of HDTs in the context of pervasive healthcare. Conclusions: The key takeaway is that the integration of HDTs and pervasive sensing provides a foundation for realizing pervasive healthcare by enabling not one-time digital replication, but continuous and comprehensive monitoring of individuals, including their surrounding environments and behavioral changes.

背景:人类数字双胞胎(HDTs)最近出现了,特别是在医疗保健领域。随着对诊断之外的预防性医疗保健的日益重视,普适传感变得至关重要,它可以通过从可穿戴设备和/或移动设备捕获的真实世界数据进行持续监测。目的:本综述调查了普适传感技术在医疗保健HDTs实施中的应用情况,重点是了解孪生方法,确定其优点和局限性,并揭示在实际应用中遇到的关键挑战。方法:我们提出了一个分析框架来研究如何利用普适传感技术实施HDTs进行个人健康管理。利用这个框架,我们在PubMed、Scopus、IEEE explore、Web of Science和b谷歌Scholar上进行了全面的文献检索。结果:共筛选到39篇符合条件的论文。我们对这些研究进行了分析,并就HDTs在普及医疗保健背景下的潜力和局限性进行了讨论。结论:关键的结论是,HDTs和普适传感的集成为实现普适医疗奠定了基础,实现了对个体(包括其周围环境和行为变化)的持续和全面监测,而不是一次性的数字复制。
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引用次数: 0
Using cognitive behavioral therapy-based chatbots to alleviate symptoms of insomnia, depression, and anxiety: A randomized controlled trial. 使用基于认知行为疗法的聊天机器人来缓解失眠、抑郁和焦虑的症状:一项随机对照试验。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-11-26 DOI: 10.1177/14604582251396428
Yi-Hang Chiu, Yen-Fen Lee, Huang-Li Lin, Li-Chen Cheng

Background: Insomnia is common among psychiatric outpatients in Taiwan and often coexists with anxiety and depression. Early insomnia changes may predict long-term depression. Although CBT-I is effective, face-to-face therapy requires many resources. This study evaluated the effectiveness of a chatbot to enhance access to sleep training. Methods: This study recruited 80 patients from a psychosomatic outpatient clinic in Taiwan and randomly assigned them 1:1 to the intervention or control group. Due to withdrawals or incomplete assessments, 35 in the intervention group and 31 in the control group completed all procedures. The intervention group used a CBT-I chatbot for 4 weeks, while the control group received basic sleep education via a website. Sleep quality and mental health were assessed using the PSQI, BSRS-5, PHQ-9, BDI, and BAI. Results: The intervention group showed significant PSQI improvement (t (34) = 3.80, p < .001) and reduced BSRS-5, PHQ-9, BDI, and BAI scores (p < .05). The control group showed no significant changes. Conclusions: A CBT-I chatbot significantly enhances sleep and mental health, offering accessible, effective support with broad clinical potential.

背景:失眠在台湾精神科门诊病人中很常见,且常与焦虑、抑郁并存。早期失眠的变化可能预示着长期的抑郁。虽然CBT-I是有效的,但面对面治疗需要很多资源。这项研究评估了聊天机器人在增强睡眠训练方面的有效性。方法:本研究在台湾某心身门诊招募80例患者,按1:1的比例随机分为干预组和对照组。干预组35例,对照组31例,由于退出或评估不完整,完成了所有程序。干预组使用CBT-I聊天机器人4周,对照组通过网站接受基础睡眠教育。采用PSQI、brs -5、PHQ-9、BDI和BAI对睡眠质量和心理健康进行评估。结果:干预组患者PSQI明显改善(t (34) = 3.80, p < 0.001), bsr -5、PHQ-9、BDI、BAI评分明显降低(p < 0.05)。对照组无明显变化。结论:CBT-I聊天机器人可显著改善睡眠和心理健康,提供方便、有效的支持,具有广泛的临床潜力。
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引用次数: 0
Navigating through regulatory frameworks for digital therapeutics and biomarkers. 浏览数字疗法和生物标志物的监管框架。
IF 2.3 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-10-01 Epub Date: 2025-10-09 DOI: 10.1177/14604582251387656
Cinja Koller, Marc Blanchard, Thomas Hügle

Background: Digital health technologies are often subject to regulatory requirements. Regulatory auditing processes are complex but necessary to guarantee quality, efficacy and safety of patients. Evolvements such as digitalized clinical trials, and digital biomarkers require a constant adaption of regulatory frameworks. Objective: This review aims to provide an overview on current regulations and standards for digital therapeutics and digital biomarkers, from technical development to market access. Methods: We conducted an unstructured literature review to identify the relevant guidelines, policies and standards for software based digital therapeutics and digital biomarkers. Results: The principal regulations governing software as a medical device are outlined in Chapter 21 of the Code of Federal Regulations by the US Food and Drug Administration, as well as the European Medical Device Regulation 2017/745. Regulatory pathways, such as the DiGA, are in the process of development, particularly for digital therapeutics, which fall within the purview of software as a medical device. Qualification of (digital) biomarkers is typically voluntary but can play a significant role in the development and approval of digital therapeutics. Conclusions: Fragmented, lacking and diverse regulations around digital biomarkers and digital therapeutics highlight the urge to harmonize and foster regulatory frameworks on an international level.

背景:数字卫生技术经常受到监管要求的制约。监管审计过程很复杂,但对于保证患者的质量、疗效和安全是必要的。数字化临床试验和数字生物标志物等发展需要不断适应监管框架。目的:综述了数字疗法和数字生物标志物从技术开发到市场准入的现行法规和标准。方法:我们进行了一项非结构化的文献综述,以确定基于软件的数字治疗和数字生物标志物的相关指南、政策和标准。结果:美国食品和药物管理局在联邦法规第21章以及欧洲医疗器械法规2017/745中概述了将软件作为医疗器械的主要法规。监管途径,如DiGA,正处于发展过程中,特别是数字疗法,它属于软件作为医疗设备的范围。(数字)生物标志物的鉴定通常是自愿的,但在数字治疗的开发和批准中可以发挥重要作用。结论:围绕数字生物标志物和数字疗法的支离破碎、缺乏和多样化的监管,突显了在国际层面协调和促进监管框架的紧迫性。
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Health Informatics Journal
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