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FDA launches health care at home initiative to drive equity in digital medical care 美国食品和药物管理局发起 "在家医疗 "倡议,推动数字医疗的公平性
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-21 DOI: 10.1038/s41746-024-01198-2
Stefanie Brückner, Celia Brightwell, Stephen Gilbert
A highly ambitious FDA initiative will explore, through a hub and ideas lab, how equitable healthcare at home can be delivered, recognizing that this is unlikely to come about without intervention. Market forces, as shaped by current regulations, are leading to digital health tools developed and operating in islands rather than enabling integrated digital care. Can the initiative, which adopts system-level regulatory thinking, solve this issue?
美国食品和药物管理局(FDA)的一项雄心勃勃的倡议将通过一个中心和创意实验室,探索如何在家中提供公平的医疗保健服务,并认识到如果不进行干预,就不可能实现这一目标。现行法规所形成的市场力量正在导致数字医疗工具的开发和运行成为孤岛,而不是实现综合数字医疗。采用系统级监管思维的该倡议能否解决这一问题?
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引用次数: 0
Harnessing the power of longitudinal medical imaging for eye disease prognosis using Transformer-based sequence modeling 利用基于变压器的序列建模技术,将纵向医学成像技术用于眼科疾病的预后分析
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-16 DOI: 10.1038/s41746-024-01207-4
Gregory Holste, Mingquan Lin, Ruiwen Zhou, Fei Wang, Lei Liu, Qi Yan, Sarah H. Van Tassel, Kyle Kovacs, Emily Y. Chew, Zhiyong Lu, Zhangyang Wang, Yifan Peng
Deep learning has enabled breakthroughs in automated diagnosis from medical imaging, with many successful applications in ophthalmology. However, standard medical image classification approaches only assess disease presence at the time of acquisition, neglecting the common clinical setting of longitudinal imaging. For slow, progressive eye diseases like age-related macular degeneration (AMD) and primary open-angle glaucoma (POAG), patients undergo repeated imaging over time to track disease progression and forecasting the future risk of developing a disease is critical to properly plan treatment. Our proposed Longitudinal Transformer for Survival Analysis (LTSA) enables dynamic disease prognosis from longitudinal medical imaging, modeling the time to disease from sequences of fundus photography images captured over long, irregular time periods. Using longitudinal imaging data from the Age-Related Eye Disease Study (AREDS) and Ocular Hypertension Treatment Study (OHTS), LTSA significantly outperformed a single-image baseline in 19/20 head-to-head comparisons on late AMD prognosis and 18/20 comparisons on POAG prognosis. A temporal attention analysis also suggested that, while the most recent image is typically the most influential, prior imaging still provides additional prognostic value.
深度学习在医学影像自动诊断方面取得了突破性进展,在眼科领域有许多成功应用。然而,标准的医学影像分类方法只能评估采集时是否存在疾病,而忽略了纵向成像的常见临床环境。对于年龄相关性黄斑变性(AMD)和原发性开角型青光眼(POAG)等缓慢进展的眼科疾病,患者会随着时间的推移反复接受成像检查,以跟踪疾病的进展情况,而预测未来的患病风险对于制定正确的治疗计划至关重要。我们提出的生存分析纵向变换器(LTSA)可通过纵向医学成像进行动态疾病预后分析,从长期、不规则的眼底摄影图像序列中建立疾病发生时间模型。利用年龄相关眼病研究(AREDS)和眼压升高治疗研究(OHTS)的纵向成像数据,LTSA 在 19/20 次 AMD 晚期预后头对头比较和 18/20 次 POAG 预后比较中的表现明显优于单一图像基线。时间注意力分析还表明,虽然最近的图像通常最有影响力,但之前的成像仍能提供额外的预后价值。
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引用次数: 0
EU-US data transfers: an enduring challenge for health research collaborations 欧盟-美国数据传输:健康研究合作面临的持久挑战
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-16 DOI: 10.1038/s41746-024-01205-6
Teodora Lalova-Spinks, Peggy Valcke, John P. A. Ioannidis, Isabelle Huys
EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence of impeded collaborations is increasing, particularly in the case of sharing data with US public institutions. The adoption of a new EU-US adequacy decision in July 2023 does not hold the promise for a long-lasting solution due to the risks of being challenged and invalidated – yet again – at the Court of Justice of the EU. As the research community is calling for answers, the new proposal for a European Health Data Space regulation may hold a key to solving some of the existing issues. In this paper, we critically discuss the current rules and outline a possible way forward for transfers between public bodies.
鉴于欧盟《通用数据保护条例》(GDPR)的严格规定以及与美国大规模监控计划相关的挑战,特别是美国执法和国家安全机构可以访问源自欧盟的个人数据的方式,欧盟与美国之间的健康研究数据传输仍然是一个特别棘手的问题。自 GDPR 生效以来,合作受阻的证据越来越多,特别是在与美国公共机构共享数据的情况下。2023 年 7 月通过一项新的欧盟-美国充分性决定并不能带来持久的解决方案,因为它有可能再次在欧盟法院受到质疑并被宣布无效。由于研究界正在呼唤答案,欧洲健康数据空间法规的新提案可能是解决某些现有问题的关键。在本文中,我们将对现行规则进行批判性讨论,并为公共机构之间的数据传输勾勒出一条可能的前进之路。
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引用次数: 0
Dose–response relationship between computerized cognitive training and cognitive improvement 计算机化认知训练与认知能力提高之间的剂量-反应关系
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-15 DOI: 10.1038/s41746-024-01210-9
Liyang Liu, Haibo Wang, Yi Xing, Ziheng Zhang, Qingge Zhang, Ming Dong, Zhujiang Ma, Longjun Cai, Xiaoyi Wang, Yi Tang
Although computerized cognitive training (CCT) is an effective digital intervention for cognitive impairment, its dose-response relationship is understudied. This retrospective cohort study explores the association between training dose and cognitive improvement to find the optimal CCT dose. From 2017 to 2022, 8,709 participants with subjective cognitive decline, mild cognitive impairment, and mild dementia were analyzed. CCT exposure varied in daily dose and frequency, with cognitive improvement measured weekly using Cognitive Index. A mixed-effects model revealed significant Cognitive Index increases across most dose groups before reaching the optimal dose. For participants under 60 years, the optimal dose was 25 to <30 min per day for 6 days a week. For those 60 years or older, it was 50 to <55 min per day for 6 days a week. These findings highlight a dose-dependent effect in CCT, suggesting age-specific optimal dosing for cognitive improvement.
尽管计算机化认知训练(CCT)是治疗认知障碍的有效数字干预措施,但其剂量-反应关系却未得到充分研究。这项回顾性队列研究探讨了训练剂量与认知改善之间的关系,以找到最佳的CCT剂量。从2017年到2022年,8709名患有主观认知能力下降、轻度认知障碍和轻度痴呆症的参与者接受了分析。CCT暴露的每日剂量和频率各不相同,每周使用认知指数测量认知改善情况。混合效应模型显示,在达到最佳剂量之前,大多数剂量组的认知指数都有显著提高。对于 60 岁以下的参与者,最佳剂量为每天 25 到 30 分钟,每周 6 天。对于 60 岁或以上的参与者,最佳剂量为每天 50 到 55 分钟,每周 6 天。这些发现凸显了 CCT 的剂量依赖效应,表明针对不同年龄的最佳剂量可改善认知能力。
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引用次数: 0
Robust automated calcification meshing for personalized cardiovascular biomechanics 用于个性化心血管生物力学的稳健自动钙化网格划分。
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-15 DOI: 10.1038/s41746-024-01202-9
Daniel H. Pak, Minliang Liu, Theodore Kim, Caglar Ozturk, Raymond McKay, Ellen T. Roche, Rudolph Gleason, James S. Duncan
Calcification has significant influence over cardiovascular diseases and interventions. Detailed characterization of calcification is thus desired for predictive modeling, but calcium deposits on cardiovascular structures are still often manually reconstructed for physics-driven simulations. This poses a major bottleneck for large-scale adoption of computational simulations for research or clinical use. To address this, we propose an end-to-end automated image-to-mesh algorithm that enables robust incorporation of patient-specific calcification onto a given cardiovascular tissue mesh. The algorithm provides a substantial speed-up from several hours of manual meshing to ~1 min of automated computation, and it solves an important problem that cannot be addressed with recent template-based meshing techniques. We validated our final calcified tissue meshes with extensive simulations, demonstrating our ability to accurately model patient-specific aortic stenosis and Transcatheter Aortic Valve Replacement. Our method may serve as an important tool for accelerating the development and usage of personalized cardiovascular biomechanics.
钙化对心血管疾病和干预措施有重大影响。因此,预测建模需要对钙化进行详细描述,但心血管结构上的钙沉积物通常仍需人工重建,以进行物理驱动模拟。这对大规模采用计算模拟进行研究或临床应用构成了重大瓶颈。为解决这一问题,我们提出了一种端到端自动图像到网格算法,该算法可将患者特异性钙化稳健地整合到给定的心血管组织网格中。该算法大大加快了计算速度,从几小时的手动网格划分缩短到约 1 分钟的自动计算,解决了最近基于模板的网格划分技术无法解决的重要问题。我们通过大量的仿真验证了最终的钙化组织网格,证明了我们有能力准确模拟患者特异性主动脉瓣狭窄和经导管主动脉瓣置换术。我们的方法可作为加速开发和使用个性化心血管生物力学的重要工具。
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引用次数: 0
Lessons learned from an unsuccessful decentralized clinical trial in Oncology 肿瘤学分散临床试验失败的教训。
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-13 DOI: 10.1038/s41746-024-01214-5
Antonis Valachis, Henrik Lindman
Decentralized clinical trials have gained in popularity over the last years due to their advantages related to broadening recruitment strategies and resource saving possibilities. As more clinical trials adopt decentralized strategies, it is essential to share the knowledge about both successful and unsuccessful efforts in the research community. In the present commentary, we explore potential reasons that led to early termination of a decentralized clinical trial in Oncology.
过去几年中,分散型临床试验因其在扩大招募策略和节省资源方面的优势而越来越受欢迎。随着越来越多的临床试验采用分散策略,有必要在研究界分享成功和失败的经验。在本评论中,我们探讨了导致肿瘤学分散临床试验提前终止的潜在原因。
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引用次数: 0
Core elements of national policy for digital health technology evidence and access 数字医疗技术证据与获取国家政策的核心要素。
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-13 DOI: 10.1038/s41746-024-01209-2
Megan Coder, Lacey McBride, Samantha McClenahan
Digital health technologies (DHT) offer the ability to deliver personalized care, lower barriers to access, and positively impact health outcomes. However, DHT utilization is impacted by insufficient market access pathways. A policy “full-stack”—including regulatory authorization, product value assessment, pricing and reimbursement, and patient access infrastructure—offers a framework for DHT integration into national healthcare ecosystems. Consistent clinical evidence requirements across national jurisdictions will further increase DHT scalability.
数字医疗技术(DHT)能够提供个性化医疗服务,降低就医门槛,并对医疗效果产生积极影响。然而,市场准入途径不足影响了数字医疗技术的使用。政策 "全栈"--包括监管授权、产品价值评估、定价和报销以及患者获取基础设施--为 DHT 融入国家医疗保健生态系统提供了一个框架。各国对临床证据的一致要求将进一步提高 DHT 的可扩展性。
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引用次数: 0
Navigating the European Union Artificial Intelligence Act for Healthcare 欧盟人工智能医疗法案导航
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-12 DOI: 10.1038/s41746-024-01213-6
Felix Busch, Jakob Nikolas Kather, Christian Johner, Marina Moser, Daniel Truhn, Lisa C. Adams, Keno K. Bressem
The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the Medical Device Regulation, do not explicitly cover medical AI applications. Given the far-reaching impact of this regulation on the medical AI sector, this commentary provides an overview of the key elements of the AI Act, with easy-to-follow references to the relevant chapters.
欧盟最近通过的《人工智能法案》是首个专门针对人工智能的全面法律框架。这对医疗保健领域尤为重要,因为现有的其他协调立法(如《医疗设备法规》)并未明确涵盖医疗人工智能应用。鉴于该法规对医疗人工智能领域的深远影响,本评论概述了《人工智能法》的主要内容,并提供了相关章节的简明参考。
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引用次数: 0
Biometrics of complete human pregnancy recorded by wearable devices 通过可穿戴设备记录人类怀孕全过程的生物特征
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-12 DOI: 10.1038/s41746-024-01183-9
Lauryn Keeler Bruce, Dalila González, Subhasis Dasgupta, Benjamin L. Smarr
In the United States, normal-risk pregnancies are monitored with the recommended average of 14 prenatal visits. Check-ins every few weeks are the standard of care. This low time resolution and reliance on subjective feedback instead of direct physiological measurement, could be augmented by remote monitoring. To date, continuous physiological measurements have not been characterized across all of pregnancy, so there is little basis of comparison to support the development of the specific monitoring capabilities. Wearables have been shown to enable the detection and prediction of acute illness, often faster than subjective symptom reporting. Wearables have also been used for years to monitor chronic conditions, such as continuous glucose monitors. Here we perform a retrospective analysis on multimodal wearable device data (Oura Ring) generated across pregnancy within 120 individuals. These data reveal clear trajectories of pregnancy from cycling to conception through postpartum recovery. We assessed individuals in whom pregnancy did not progress past the first trimester, and found associated deviations, corroborating that continuous monitoring adds new information that could support decision-making even in the early stages of pregnancy. By contrast, we did not find significant deviations between full-term pregnancies of people younger than 35 and of people with “advanced maternal age”, suggesting that analysis of continuous data within individuals can augment risk assessment beyond standard population comparisons. Our findings demonstrate that low-cost, high-resolution monitoring at all stages of pregnancy in real-world settings is feasible and that many studies into specific demographics, risks, etc., could be carried out using this newer technology.
在美国,正常风险妊娠的监测建议是平均 14 次产前检查。每隔几周检查一次是护理标准。这种低时间分辨率和依赖主观反馈而非直接生理测量的做法,可以通过远程监测来加强。迄今为止,连续的生理测量还没有贯穿整个孕期,因此几乎没有比较的基础来支持特定监测功能的开发。可穿戴设备已被证明能够检测和预测急性疾病,通常比主观症状报告更快。多年来,可穿戴设备还被用于监测慢性疾病,如连续血糖监测仪。在此,我们对 120 人怀孕期间产生的多模态可穿戴设备数据(Oura Ring)进行了回顾性分析。这些数据揭示了从骑自行车到受孕再到产后恢复的清晰怀孕轨迹。我们对怀孕未超过前三个月的孕妇进行了评估,发现了相关的偏差,这证实了持续监测增加了新的信息,即使在怀孕早期也能为决策提供支持。相比之下,我们没有发现 35 岁以下的足月妊娠和 "高龄产妇 "的足月妊娠之间存在明显偏差,这表明对个体内部的连续数据进行分析可以增强风险评估,而不是进行标准的人群比较。我们的研究结果表明,在现实世界中对妊娠各个阶段进行低成本、高分辨率的监测是可行的,而且可以利用这种较新的技术对特定的人口统计学、风险等进行许多研究。
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引用次数: 0
Disparities in clinical studies of AI enabled applications from a global perspective 从全球角度看人工智能应用的临床研究差异。
IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-08-10 DOI: 10.1038/s41746-024-01212-7
Rui Yang, Sabarinath Vinod Nair, Yuhe Ke, Danny D’Agostino, Mingxuan Liu, Yilin Ning, Nan Liu
Artificial intelligence (AI) has been extensively researched in medicine, but its practical application remains limited. Meanwhile, there are various disparities in existing AI-enabled clinical studies, which pose a challenge to global health equity. In this study, we conducted an in-depth analysis of the geo-economic distribution of 159 AI-enabled clinical studies, as well as the gender disparities among these studies. We aim to reveal these disparities from a global literature perspective, thus highlighting the need for equitable access to medical AI technologies.
人工智能(AI)已在医学领域得到广泛研究,但其实际应用仍然有限。同时,现有的人工智能临床研究存在各种差异,这对全球健康公平构成了挑战。在本研究中,我们对 159 项人工智能临床研究的地理经济分布以及这些研究中的性别差异进行了深入分析。我们旨在从全球文献的角度揭示这些差异,从而强调公平获取医疗人工智能技术的必要性。
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引用次数: 0
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NPJ Digital Medicine
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