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Trends in South Korean Medical Device Development for Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder: Narrative Review. 韩国针对注意力缺陷/多动症和自闭症谱系障碍的医疗器械开发趋势:叙述性评论。
Pub Date : 2024-10-15 DOI: 10.2196/60399
Yunah Cho, Sharon L Talboys
<p><strong>Background: </strong>Attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) are among the most prevalent mental disorders among school-aged youth in South Korea and may play a role in the increasing pressures on teachers and school-based special education programming. A lack of support for special education; tensions between teachers, students, and parents; and limited backup for teacher absences are common complaints among Korean educators. New innovations in technology to screen and treat ADHD and ASD may offer relief to students, parents, and teachers through earlier and efficient diagnosis; access to treatment options; and ultimately, better-managed care and expectations.</p><p><strong>Objective: </strong>This narrative literature review provides an account of medical device use and development in South Korea for the diagnosis and management of ADHD and ASD and highlights research gaps.</p><p><strong>Methods: </strong>A narrative review was conducted across 4 databases (PubMed, Korean National Assembly Library, Scopus, and PsycINFO). Journal articles, dissertations, and government research and development reports were included if they discussed medical devices for ADHD and ASD. Only Korean or English papers were included. Resources were excluded if they did not correspond to the research objective or did not discuss at least 1 topic about medical devices for ADHD and ASD. Journal articles were excluded if they were not peer reviewed. Resources were limited to publications between 2013 and July 22, 2024.</p><p><strong>Results: </strong>A total of 1794 records about trends in Korean medical device development were categorized into 2 major groups: digital therapeutics and traditional therapy. Digital therapeutics resulted in 5 subgroups: virtual reality and artificial intelligence, machine learning and robot, gaming and visual contents, eye-feedback and movement intervention, and electroencephalography and neurofeedback. Traditional therapy resulted in 3 subgroups: cognitive behavioral therapy and working memory; diagnosis and rating scale; and musical, literary therapy, and mindfulness-based stress reduction. Digital therapeutics using artificial intelligence, machine learning, and electroencephalography technologies account for the biggest portions of development in South Korea, rather than traditional therapies. Most resources, 94.15% (1689/1794), were from the Korean National Assembly Library.</p><p><strong>Conclusions: </strong>Limitations include small sizes of populations to conclude findings in many articles, a lower number of articles discussing medical devices for ASD, and a majority of articles being dissertations. Emerging digital medical devices and those integrated with traditional therapies are important solutions to reducing the prevalence rates of ADHD and ASD in South Korea by promoting early diagnosis and intervention. Furthermore, their application will relieve pressures on teachers and
背景:注意缺陷/多动障碍(ADHD)和自闭症谱系障碍(ASD)是韩国学龄青少年中最常见的精神障碍,这可能是教师和学校特殊教育课程压力不断增加的原因之一。韩国教育工作者普遍抱怨特殊教育缺乏支持,教师、学生和家长之间关系紧张,教师缺勤的后备力量有限。筛查和治疗多动症和自闭症的新技术创新可以通过更早和更有效的诊断、获得治疗方案以及最终更好地管理护理和期望,为学生、家长和教师提供帮助:本叙事性文献综述介绍了韩国在诊断和管理多动症和 ASD 方面使用和开发医疗设备的情况,并强调了研究缺口:在 4 个数据库(PubMed、韩国国会图书馆、Scopus 和 PsycINFO)中进行了叙述性综述。如果期刊论文、学位论文和政府研发报告中讨论了治疗 ADHD 和 ASD 的医疗设备,则将其纳入其中。只收录韩文或英文论文。如果资源与研究目标不符,或没有讨论至少一个有关 ADHD 和 ASD 医疗设备的主题,则将其排除在外。期刊论文如果未经同行评审,则排除在外。资源仅限于 2013 年至 2024 年 7 月 22 日期间发表的文章:共有 1794 条关于韩国医疗器械发展动向的记录被分为两大类:数字疗法和传统疗法。数字疗法分为 5 个分组:虚拟现实与人工智能、机器学习与机器人、游戏与视觉内容、眼动反馈与运动干预、脑电图与神经反馈。传统疗法产生了 3 个分组:认知行为疗法和工作记忆;诊断和评分表;音乐、文学疗法和正念减压。在韩国,使用人工智能、机器学习和脑电图技术的数字疗法比传统疗法占了最大的发展份额。大多数资源(94.15%(1689/1794))来自韩国国会图书馆:研究的局限性包括:许多文章的研究对象规模较小,无法得出结论;讨论 ASD 医疗设备的文章数量较少;大多数文章为论文。通过促进早期诊断和干预,新兴的数字医疗设备以及与传统疗法相结合的医疗设备是降低韩国多动症和自闭症患病率的重要解决方案。此外,这些设备的应用将为患有多动症或自闭症的学生提供直接的支持资源,从而减轻教师和学校特殊教育课程的压力。据预测,未来多动症和自闭症医疗设备的发展将在很大程度上依赖于数字技术,如那些能感知人们行为、眼球运动和脑电波的技术。
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引用次数: 0
Classifying Residual Stroke Severity Using Robotics-Assisted Stroke Rehabilitation: Machine Learning Approach. 利用机器人辅助脑卒中康复对残余脑卒中严重程度进行分类:机器学习方法。
Pub Date : 2024-10-07 DOI: 10.2196/56980
Russell Jeter, Raymond Greenfield, Stephen N Housley, Igor Belykh

Background: Stroke therapy is essential to reduce impairments and improve motor movements by engaging autogenous neuroplasticity. Traditionally, stroke rehabilitation occurs in inpatient and outpatient rehabilitation facilities. However, recent literature increasingly explores moving the recovery process into the home and integrating technology-based interventions. This study advances this goal by promoting in-home, autonomous recovery for patients who experienced a stroke through robotics-assisted rehabilitation and classifying stroke residual severity using machine learning methods.

Objective: Our main objective is to use kinematics data collected during in-home, self-guided therapy sessions to develop supervised machine learning methods, to address a clinician's autonomous classification of stroke residual severity-labeled data toward improving in-home, robotics-assisted stroke rehabilitation.

Methods: In total, 33 patients who experienced a stroke participated in in-home therapy sessions using Motus Nova robotics rehabilitation technology to capture upper and lower body motion. During each therapy session, the Motus Hand and Motus Foot devices collected movement data, assistance data, and activity-specific data. We then synthesized, processed, and summarized these data. Next, the therapy session data were paired with clinician-informed, discrete stroke residual severity labels: "no range of motion (ROM)," "low ROM," and "high ROM." Afterward, an 80%:20% split was performed to divide the dataset into a training set and a holdout test set. We used 4 machine learning algorithms to classify stroke residual severity: light gradient boosting (LGB), extra trees classifier, deep feed-forward neural network, and classical logistic regression. We selected models based on 10-fold cross-validation and measured their performance on a holdout test dataset using F1-score to identify which model maximizes stroke residual severity classification accuracy.

Results: We demonstrated that the LGB method provides the most reliable autonomous detection of stroke severity. The trained model is a consensus model that consists of 139 decision trees with up to 115 leaves each. This LGB model boasts a 96.70% F1-score compared to logistic regression (55.82%), extra trees classifier (94.81%), and deep feed-forward neural network (70.11%).

Conclusions: We showed how objectively measured rehabilitation training paired with machine learning methods can be used to identify the residual stroke severity class, with efforts to enhance in-home self-guided, individualized stroke rehabilitation. The model we trained relies only on session summary statistics, meaning it can potentially be integrated into similar settings for real-time classification, such as outpatient rehabilitation facilities.

背景:脑卒中治疗对于通过调动自体神经可塑性来减少运动障碍和改善运动能力至关重要。传统上,脑卒中康复需要在住院和门诊康复设施中进行。然而,最近有越来越多的文献探讨将康复过程搬到家中,并整合基于技术的干预措施。本研究通过机器人辅助康复以及使用机器学习方法对中风残余严重程度进行分类,促进中风患者在家自主康复,从而推进这一目标的实现:我们的主要目标是利用在居家自我指导治疗过程中收集的运动学数据开发有监督的机器学习方法,解决临床医生对中风残余严重程度标记数据进行自主分类的问题,从而改善居家机器人辅助中风康复:共有 33 名中风患者参加了居家治疗课程,他们使用 Motus Nova 机器人康复技术来捕捉上半身和下半身的运动。在每次治疗过程中,Motus 手部和脚部设备都会收集运动数据、辅助数据和特定活动数据。然后,我们对这些数据进行综合、处理和总结。接下来,我们将治疗过程数据与临床医生提供的离散中风残余严重程度标签进行配对:"无活动范围 (ROM)"、"低活动范围 "和 "高活动范围"。然后,按 80%:20% 的比例将数据集分为训练集和保留测试集。我们使用了四种机器学习算法对中风残余严重程度进行分类:轻梯度提升(LGB)、额外树分类器、深度前馈神经网络和经典逻辑回归。我们在 10 倍交叉验证的基础上选择模型,并使用 F1 分数衡量它们在保留测试数据集上的性能,以确定哪个模型能最大限度地提高中风残余严重程度分类的准确性:结果:我们证明 LGB 方法能提供最可靠的中风严重程度自主检测。训练出的模型是一个共识模型,由 139 棵决策树组成,每棵决策树最多有 115 个树叶。与逻辑回归(55.82%)、额外树分类器(94.81%)和深度前馈神经网络(70.11%)相比,LGB 模型的 F1 分数高达 96.70%:我们展示了如何将客观测量的康复训练与机器学习方法相结合,用于识别残余中风严重程度等级,从而提高居家自我指导的个性化中风康复水平。我们训练的模型仅依赖于会话摘要统计,这意味着它有可能被整合到类似的环境中进行实时分类,如门诊康复设施。
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引用次数: 0
Assessing the Accuracy of Smartwatch-Based Estimation of Maximum Oxygen Uptake Using the Apple Watch Series 7: Validation Study. 使用 Apple Watch Series 7 评估基于智能手表的最大摄氧量估算的准确性:验证研究。
Pub Date : 2024-07-31 DOI: 10.2196/59459
Polona Caserman, Sungsoo Yum, Stefan Göbel, Andreas Reif, Silke Matura

Background: Determining maximum oxygen uptake (VO2max) is essential for evaluating cardiorespiratory fitness. While laboratory-based testing is considered the gold standard, sports watches or fitness trackers offer a convenient alternative. However, despite the high number of wrist-worn devices, there is a lack of scientific validation for VO2max estimation outside the laboratory setting.

Objective: This study aims to compare the Apple Watch Series 7's performance against the gold standard in VO2max estimation and Apple's validation findings.

Methods: A total of 19 participants (7 female and 12 male), aged 18 to 63 (mean 28.42, SD 11.43) years were included in the validation study. VO2max for all participants was determined in a controlled laboratory environment using a metabolic gas analyzer. Thereby, they completed a graded exercise test on a cycle ergometer until reaching subjective exhaustion. This value was then compared with the estimated VO2max value from the Apple Watch, which was calculated after wearing the watch for at least 2 consecutive days and measured directly after an outdoor running test.

Results: The measured VO2max (mean 45.88, SD 9.42 mL/kg/minute) in the laboratory setting was significantly higher than the predicted VO2max (mean 41.37, SD 6.5 mL/kg/minute) from the Apple Watch (t18=2.51; P=.01) with a medium effect size (Hedges g=0.53). The Bland-Altman analysis revealed a good overall agreement between both measurements. However, the intraclass correlation coefficient ICC(2,1)=0.47 (95% CI 0.06-0.75) indicated poor reliability. The mean absolute percentage error between the predicted and the actual VO2max was 15.79%, while the root mean square error was 8.85 mL/kg/minute. The analysis further revealed higher accuracy when focusing on participants with good fitness levels (mean absolute percentage error=14.59%; root-mean-square error=7.22 ml/kg/minute; ICC(2,1)=0.60 95% CI 0.09-0.87).

Conclusions: Similar to other smartwatches, the Apple Watch also overestimates or underestimates the VO2max in individuals with poor or excellent fitness levels, respectively. Assessing the accuracy and reliability of the Apple Watch's VO2max estimation is crucial for determining its suitability as an alternative to laboratory testing. The findings of this study will apprise researchers, physical training professionals, and end users of wearable technology, thereby enhancing the knowledge base and practical application of such devices in assessing cardiorespiratory fitness parameters.

背景:测定最大摄氧量(VO2max)对于评估心肺功能至关重要。虽然实验室测试被认为是黄金标准,但运动手表或健身追踪器提供了一种方便的替代方法。然而,尽管腕戴式设备的数量很多,但在实验室以外的环境中,VO2max 的估算还缺乏科学验证:本研究旨在将 Apple Watch Series 7 的性能与 VO2max 估测的黄金标准和苹果公司的验证结果进行比较:方法:共有 19 名参与者(7 名女性和 12 名男性)参加了验证研究,他们的年龄在 18 岁至 63 岁之间(平均 28.42 岁,标准差 11.43 岁)。所有参与者的最大氧饱和度都是在受控实验室环境中使用代谢气体分析仪测定的。然后,他们在自行车测力计上完成分级运动测试,直至达到主观力竭。该值是在连续佩戴手表至少两天后计算得出的,并在户外跑步测试后直接测量:在实验室环境中测得的 VO2max 值(平均值 45.88,标定值 9.42 毫升/千克/分钟)显著高于 Apple Watch 预测的 VO2max 值(平均值 41.37,标定值 6.5 毫升/千克/分钟)(t18=2.51;P=.01),两者的效应大小为中等(Hedges g=0.53)。Bland-Altman 分析显示,两种测量结果的总体一致性良好。然而,类内相关系数 ICC(2,1)=0.47 (95% CI 0.06-0.75)表明可靠性较差。预测 VO2max 与实际 VO2max 之间的平均绝对百分比误差为 15.79%,均方根误差为 8.85 毫升/千克/分钟。分析进一步显示,体能水平较好的参与者的准确性更高(平均绝对百分比误差=14.59%;均方根误差=7.22 毫升/千克/分钟;ICC(2,1)=0.60 95% CI 0.09-0.87):与其他智能手表类似,Apple Watch也会分别高估或低估体能水平较差或较好的人的最大氧饱和度。评估 Apple Watch VO2max 估算值的准确性和可靠性对于确定其是否适合替代实验室测试至关重要。这项研究的结果将为研究人员、体能训练专业人员和可穿戴技术的最终用户提供参考,从而增强此类设备在评估心肺功能参数方面的知识基础和实际应用。
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引用次数: 0
Agreement Between Apple Watch and Actical Step Counts in a Community Setting: Cross-Sectional Investigation From the Framingham Heart Study. 社区环境中 Apple Watch 和 Actical 步数的一致性:来自弗雷明汉心脏研究的横断面调查
Pub Date : 2024-07-24 DOI: 10.2196/54631
Nicole L Spartano, Yuankai Zhang, Chunyu Liu, Ariel Chernofsky, Honghuang Lin, Ludovic Trinquart, Belinda Borrelli, Chathurangi H Pathiravasan, Vik Kheterpal, Christopher Nowak, Ramachandran S Vasan, Emelia J Benjamin, David D McManus, Joanne M Murabito

Background: Step counting is comparable among many research-grade and consumer-grade accelerometers in laboratory settings.

Objective: The purpose of this study was to compare the agreement between Actical and Apple Watch step-counting in a community setting.

Methods: Among Third Generation Framingham Heart Study participants (N=3486), we examined the agreement of step-counting between those who wore a consumer-grade accelerometer (Apple Watch Series 0) and a research-grade accelerometer (Actical) on the same days. Secondarily, we examined the agreement during each hour when both devices were worn to account for differences in wear time between devices.

Results: We studied 523 participants (n=3223 person-days, mean age 51.7, SD 8.9 years; women: n=298, 57.0%). Between devices, we observed modest correlation (intraclass correlation [ICC] 0.56, 95% CI 0.54-0.59), poor continuous agreement (29.7%, n=957 of days having steps counts with ≤15% difference), a mean difference of 499 steps per day higher count by Actical, and wide limits of agreement, roughly ±9000 steps per day. However, devices showed stronger agreement in identifying who meets various steps per day thresholds (eg, at 8000 steps per day, kappa coefficient=0.49), for which devices were concordant for 74.8% (n=391) of participants. In secondary analyses, in the hours during which both devices were worn (n=456 participants, n=18,760 person-hours), the correlation was much stronger (ICC 0.86, 95% CI 0.85-0.86), but continuous agreement remained poor (27.3%, n=5115 of hours having step counts with ≤15% difference) between devices and was slightly worse for those with mobility limitations or obesity.

Conclusions: Our investigation suggests poor overall agreement between steps counted by the Actical device and those counted by the Apple Watch device, with stronger agreement in discriminating who meets certain step thresholds. The impact of these challenges may be minimized if accelerometers are used by individuals to determine whether they are meeting physical activity guidelines or tracking step counts. It is also possible that some of the limitations of these older accelerometers may be improved in newer devices.

背景:在实验室环境中,许多研究级和消费级加速度计的计步性能相当:在实验室环境中,许多研究级和消费级加速度计的计步结果具有可比性:本研究旨在比较 Actical 和 Apple Watch 在社区环境中计步的一致性:在第三代弗雷明汉心脏研究参与者(N=3486)中,我们检查了在同一天佩戴消费级加速度计(Apple Watch Series 0)和研究级加速度计(Actical)的参与者的计步一致性。其次,我们还考察了在佩戴两种设备的每个小时内的一致性,以考虑设备之间佩戴时间的差异:我们研究了 523 名参与者(n=3223 人天,平均年龄 51.7 岁,SD 8.9 岁;女性:n=298,57.0%)。在不同设备之间,我们观察到了适度的相关性(类内相关性 [ICC] 0.56,95% CI 0.54-0.59)、较差的连续一致性(29.7%,n=957 天的步数差异≤15%)、Actical 每天平均高出 499 步的差异以及较宽的一致性范围(大约为每天 ±9000 步)。不过,设备在识别哪些人达到了不同的日步数阈值(例如,在日步数为 8000 步时,卡帕系数=0.49)时表现出了更强的一致性,在这一点上,74.8% 的参与者(人数=391)的设备是一致的。在二次分析中,在佩戴两种设备的小时数中(456 名参与者,18760 人时),设备间的相关性更强(ICC 0.86,95% CI 0.85-0.86),但设备间的连续一致性仍然较差(27.3%,5115 个小时的步数差异≤15%),对于行动不便或肥胖者,设备间的一致性略差:我们的调查表明,Actical 设备计算的步数与 Apple Watch 设备计算的步数之间的整体一致性较差,而在区分哪些人达到特定步数阈值方面的一致性较强。如果个人使用加速度计来确定自己是否符合体育锻炼指南或跟踪步数,这些挑战的影响可能会降到最低。此外,这些老式加速度计的一些局限性也有可能在更新的设备中得到改善。
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引用次数: 0
Stroke Survivors' Interaction With Hand Rehabilitation Devices: Observational Study. 中风幸存者与手部康复设备的互动:观察研究。
Pub Date : 2024-06-26 DOI: 10.2196/54159
Chioma Obinuchi Wodu, Gillian Sweeney, Milena Slachetka, Andrew Kerr

Background: The hand is crucial for carrying out activities of daily living as well as social interaction. Functional use of the upper limb is affected in up to 55% to 75% of stroke survivors 3 to 6 months after stroke. Rehabilitation can help restore function, and several rehabilitation devices have been designed to improve hand function. However, access to these devices is compromised in people with more severe loss of function.

Objective: In this study, we aimed to observe stroke survivors with poor hand function interacting with a range of commonly used hand rehabilitation devices.

Methods: Participants were engaged in an 8-week rehabilitation intervention at a technology-enriched rehabilitation gym. The participants spent 50-60 minutes of the 2-hour session in the upper limb section at least twice a week. Each participant communicated their rehabilitation goals, and an Action Research Arm Test (ARAT) was used to measure and categorize hand function as poor (scores of 0-9), moderate (scores of 10-56), or good (score of 57). Participants were observed during their interactions with 3 hand-based rehabilitation devices that focused on hand rehabilitation: the GripAble, NeuroBall, and Semi-Circular Peg Board. Observations of device interactions were recorded for each session.

Results: A total of 29 participants were included in this study, of whom 10 (34%) had poor hand function, 17 (59%) had moderate hand function, and 2 (7%) had good hand function. There were no differences in the age and years after stroke among participants with poor hand function and those with moderate (P=.06 and P=.09, respectively) and good (P=.37 and P=.99, respectively) hand function. Regarding the ability of the 10 participants with poor hand function to interact with the 3 hand-based rehabilitation devices, 2 (20%) participants with an ARAT score greater than 0 were able to interact with the devices, whereas the other 8 (80%) who had an ARAT score of 0 could not. Their inability to interact with these devices was clinically examined, and the reason was determined to be a result of either the presence of (1) muscle tone or stiffness or (2) muscle weakness.

Conclusions: Not all stroke survivors with impairments in their hands can make use of currently available rehabilitation technologies. Those with an ARAT score of 0 cannot actively interact with hand rehabilitation devices, as they cannot carry out the hand movement necessary for such interaction. The design of devices for hand rehabilitation should consider the accessibility needs of those with poor hand function.

背景:手对于日常生活活动和社会交往至关重要。多达 55% 至 75% 的中风幸存者在中风 3 至 6 个月后上肢功能会受到影响。康复训练可以帮助恢复手部功能,目前已设计出多种康复设备来改善手部功能。然而,对于功能丧失较严重的人来说,使用这些设备的机会受到了影响:在这项研究中,我们旨在观察手部功能较差的中风幸存者与一系列常用手部康复设备的互动情况:方法:参与者在一家科技含量较高的康复健身房进行为期 8 周的康复干预。每周至少两次,每次 2 小时,每次 50-60 分钟。每位参与者都会告知自己的康复目标,并使用行动研究手臂测试(ARAT)来测量手部功能并将其分为较差(0-9 分)、中等(10-56 分)或良好(57 分)。在参与者与三种手部康复设备(GripAble、NeuroBall 和 Semi-Circular Peg Board)互动的过程中,对他们进行了观察。每节课都对设备互动情况进行了观察记录:本研究共纳入 29 名参与者,其中 10 人(34%)手部功能较差,17 人(59%)手部功能中等,2 人(7%)手部功能良好。手部功能差的参与者与手部功能中等(分别为 P=.06 和 P=.09)和手部功能良好(分别为 P=.37 和 P=.99)的参与者在年龄和卒中后年数上没有差异。关于 10 名手部功能较差的参与者与 3 种手部康复设备的互动能力,2 名(20%)ARAT 得分大于 0 的参与者能够与设备互动,而其他 8 名(80%)ARAT 得分为 0 的参与者则不能。经临床检查,他们无法与这些设备互动的原因是:(1)肌肉张力或僵硬或(2)肌肉无力:结论:并非所有手部受损的中风幸存者都能使用现有的康复技术。ARAT评分为0分的患者无法与手部康复设备积极互动,因为他们无法进行互动所需的手部运动。手部康复设备的设计应考虑手部功能不良者的无障碍需求。
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引用次数: 0
An Engineering Alternative to Lockdown During COVID-19 and Other Airborne Infectious Disease Pandemics: Feasibility Study. COVID-19 和其他空气传播传染病大流行期间封锁的工程替代方案:可行性研究。
Pub Date : 2024-05-14 DOI: 10.2196/54666
Yusaku Fujii

Background: Now and in the future, airborne diseases such as COVID-19 could become uncontrollable and lead the world into lockdowns. Finding alternatives to lockdowns, which limit individual freedoms and cause enormous economic losses, is critical.

Objective: The purpose of this study was to assess the feasibility of achieving a society or a nation that does not require lockdown during a pandemic due to airborne infectious diseases through the mass production and distribution of high-performance, low-cost, and comfortable powered air purifying respirators (PAPRs).

Methods: The feasibility of a social system using PAPR as an alternative to lockdown was examined from the following perspectives: first, what PAPRs can do as an alternative to lockdown; second, how to operate a social system utilizing PAPR; third, directions of improvement of PAPR as an alternative to lockdown; and finally, balancing between efficiency of infection control and personal freedom through the use of Internet of Things (IoT).

Results: PAPR was shown to be a possible alternative to lockdown through the reduction of airborne and droplet transmissions and through a temporary reduction of infection probability per contact. A social system in which individual constraints imposed by lockdown are replaced by PAPRs was proposed, and an example of its operation is presented in this paper. For example, the government determines the type and intensity of the lockdown and activates it. At that time, the government will also indicate how PAPR can be substituted for the different activity and movement restrictions imposed during a lockdown, for example, a curfew order may be replaced with the permission to go outside if wearing a PAPR. The following 7 points were raised as directions for improvement of PAPR as an alternative method to lockdown: flow optimization, precise differential pressure control, design improvement, maintenance method, variation development such as booth type, information terminal function, and performance evaluation method. In order to achieve the effectiveness and efficiency in controlling the spread of infection and the individual freedom at a high level in a social system that uses PAPRs as an alternative to lockdown, it was considered effective to develop a PAPR wearing rate network management system utilizing IoT.

Conclusions: This study shows that using PAPR with infection control ability and with less economic and social damage as an alternative to nationwide lockdown is possible during a pandemic due to airborne infectious diseases. Further, the efficiency of the government's infection control and each citizen's freedom can be balanced by using the PAPR wearing rate network management system utilizing an IoT system.

背景:现在和将来,COVID-19 等空气传播疾病可能变得无法控制,并导致世界陷入封锁。封锁会限制个人自由并造成巨大的经济损失,因此寻找封锁的替代方案至关重要:本研究的目的是评估通过大规模生产和分发高性能、低成本和舒适的动力空气净化呼吸器(PAPRs),实现社会或国家在空气传播传染病大流行期间无需封锁的可行性:方法:从以下几个方面研究了使用 PAPR 替代封锁的社会系统的可行性:首先,PAPR 作为封锁的替代品能做什么;其次,如何操作使用 PAPR 的社会系统;第三,PAPR 作为封锁的替代品的改进方向;最后,通过使用物联网(IoT)在感染控制的效率和个人自由之间取得平衡:结果表明,通过减少空气传播和飞沫传播,并通过暂时降低每次接触的感染概率,PAPR 可以替代封锁。本文提出了一个社会系统,在该系统中,PAPR 取代了封锁所施加的个人限制,并介绍了该系统的一个运行实例。例如,政府决定封锁的类型和强度并启动封锁。政府届时还将说明如何用 PAPR 代替封锁期间实施的不同活动和行动限制,例如,如果佩戴 PAPR,宵禁令可能会被允许外出所取代。作为封锁的替代方法,PAPR 的改进方向有以下 7 点:流量优化、精确压差控制、设计改进、维护方法、岗亭类型等差异化开发、信息终端功能和性能评估方法。为了在使用 PAPR 作为封锁替代方法的社会系统中实现控制感染传播的有效性和高效性以及个人的高度自由,利用物联网开发 PAPR 穿戴率网络管理系统被认为是有效的:本研究表明,在空气传播传染病大流行期间,使用具有感染控制能力且经济和社会损失较小的空气呼吸器替代全国范围的封锁是可行的。此外,通过利用物联网系统的 PAPR 佩戴率网络管理系统,可以平衡政府的感染控制效率和每个公民的自由。
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引用次数: 0
Preliminary Assessment of an Ambulatory Device Dedicated to Upper Airway Muscle Training in Patients With Sleep Apnea: Proof-of-Concept Study. 睡眠呼吸暂停患者上气道肌肉训练专用可移动设备的初步评估:概念验证研究
Pub Date : 2024-04-15 DOI: 10.2196/51901
Patrice Roberge, Jean Ruel, André Bégin-Drolet, Jean Lemay, Simon Gakwaya, Jean-François Masse, Frédéric Sériès

Background: Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a prevalent condition affecting a substantial portion of the global population, with its prevalence increasing over the past 2 decades. OSAHS is characterized by recurrent upper airway (UA) closure during sleep, leading to significant impacts on quality of life and heightened cardiovascular and metabolic morbidity. Despite continuous positive airway pressure (CPAP) being the gold standard treatment, patient adherence remains suboptimal due to various factors, such as discomfort, side effects, and treatment unacceptability.

Objective: Considering the challenges associated with CPAP adherence, an alternative approach targeting the UA muscles through myofunctional therapy was explored. This noninvasive intervention involves exercises of the lips, tongue, or both to improve oropharyngeal functions and mitigate the severity of OSAHS. With the goal of developing a portable device for home-based myofunctional therapy with continuous monitoring of exercise performance and adherence, the primary outcome of this study was the degree of completion and adherence to a 4-week training session.

Methods: This proof-of-concept study focused on a portable device that was designed to facilitate tongue and lip myofunctional therapy and enable precise monitoring of exercise performance and adherence. A clinical study was conducted to assess the effectiveness of this program in improving sleep-disordered breathing. Participants were instructed to perform tongue protrusion, lip pressure, and controlled breathing as part of various tasks 6 times a week for 4 weeks, with each session lasting approximately 35 minutes.

Results: Ten participants were enrolled in the study (n=8 male; mean age 48, SD 22 years; mean BMI 29.3, SD 3.5 kg/m2; mean apnea-hypopnea index [AHI] 20.7, SD 17.8/hour). Among the 8 participants who completed the 4-week program, the overall compliance rate was 91% (175/192 sessions). For the tongue exercise, the success rate increased from 66% (211/320 exercises; SD 18%) on the first day to 85% (272/320 exercises; SD 17%) on the last day (P=.05). AHI did not change significantly after completion of training but a noteworthy correlation between successful lip exercise improvement and AHI reduction in the supine position was observed (Rs=-0.76; P=.03). These findings demonstrate the potential of the device for accurately monitoring participants' performance in lip and tongue pressure exercises during myofunctional therapy. The diversity of the training program (it mixed exercises mixed training games), its ability to provide direct feedback for each exercise to the participants, and the easy measurement of treatment adherence are major strengths of our training program.

Conclusions: The study's portable device for home-based myofunctional therapy shows promise as

背景:阻塞性睡眠呼吸暂停/低通气综合征(OSAHS)是一种影响全球大部分人口的普遍病症,其发病率在过去 20 年中不断上升。OSAHS 的特点是睡眠时反复出现上气道(UA)关闭,严重影响生活质量,并增加心血管和代谢疾病的发病率。尽管持续气道正压(CPAP)是金标准治疗方法,但由于不适、副作用和治疗不可接受性等各种因素,患者的依从性仍不理想:考虑到坚持使用 CPAP 所面临的挑战,我们探索了一种通过肌肉功能疗法来治疗 UA 肌肉的替代方法。这种非侵入性干预包括嘴唇、舌头或两者的锻炼,以改善口咽功能,减轻 OSAHS 的严重程度。本研究的目标是开发一种用于家庭肌肉功能治疗的便携式设备,并对锻炼效果和坚持情况进行持续监测,研究的主要结果是完成和坚持4周训练课程的程度:这项概念验证研究的重点是一种便携式设备,该设备旨在促进舌唇肌功能治疗,并能精确监测运动表现和坚持情况。我们进行了一项临床研究,以评估该项目在改善睡眠呼吸障碍方面的效果。研究人员指导参与者进行伸舌、压唇和控制呼吸等各种训练,每周 6 次,持续 4 周,每次训练约 35 分钟:10 名参与者参加了研究(男性 8 人;平均年龄 48 岁,标准差 22 岁;平均体重指数 29.3,标准差 3.5 千克/平方米;平均呼吸暂停-低通气指数 [AHI] 20.7,标准差 17.8/小时)。8 名参与者完成了为期 4 周的计划,总体达标率为 91%(175/192 次)。舌部运动的成功率从第一天的 66%(211/320 次运动;SD 18%)上升到最后一天的 85%(272/320 次运动;SD 17%)(P=.05)。训练完成后,AHI 没有明显变化,但在成功改善唇部运动和仰卧位 AHI 降低之间观察到显著的相关性(Rs=-0.76;P=.03)。这些研究结果表明,在肌肉功能治疗过程中,该设备具有准确监测参与者唇压和舌压练习表现的潜力。训练项目的多样性(混合练习混合训练游戏)、为参与者的每次练习提供直接反馈的能力以及易于测量治疗依从性是我们训练项目的主要优势:本研究的便携式家用肌功能治疗设备有望成为降低 OSAHS 严重程度的非侵入性替代方法,成功改善唇部运动与降低 AHI 之间存在显著相关性,值得进一步开发和研究。
{"title":"Preliminary Assessment of an Ambulatory Device Dedicated to Upper Airway Muscle Training in Patients With Sleep Apnea: Proof-of-Concept Study.","authors":"Patrice Roberge, Jean Ruel, André Bégin-Drolet, Jean Lemay, Simon Gakwaya, Jean-François Masse, Frédéric Sériès","doi":"10.2196/51901","DOIUrl":"10.2196/51901","url":null,"abstract":"<p><strong>Background: </strong>Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a prevalent condition affecting a substantial portion of the global population, with its prevalence increasing over the past 2 decades. OSAHS is characterized by recurrent upper airway (UA) closure during sleep, leading to significant impacts on quality of life and heightened cardiovascular and metabolic morbidity. Despite continuous positive airway pressure (CPAP) being the gold standard treatment, patient adherence remains suboptimal due to various factors, such as discomfort, side effects, and treatment unacceptability.</p><p><strong>Objective: </strong>Considering the challenges associated with CPAP adherence, an alternative approach targeting the UA muscles through myofunctional therapy was explored. This noninvasive intervention involves exercises of the lips, tongue, or both to improve oropharyngeal functions and mitigate the severity of OSAHS. With the goal of developing a portable device for home-based myofunctional therapy with continuous monitoring of exercise performance and adherence, the primary outcome of this study was the degree of completion and adherence to a 4-week training session.</p><p><strong>Methods: </strong>This proof-of-concept study focused on a portable device that was designed to facilitate tongue and lip myofunctional therapy and enable precise monitoring of exercise performance and adherence. A clinical study was conducted to assess the effectiveness of this program in improving sleep-disordered breathing. Participants were instructed to perform tongue protrusion, lip pressure, and controlled breathing as part of various tasks 6 times a week for 4 weeks, with each session lasting approximately 35 minutes.</p><p><strong>Results: </strong>Ten participants were enrolled in the study (n=8 male; mean age 48, SD 22 years; mean BMI 29.3, SD 3.5 kg/m<sup>2</sup>; mean apnea-hypopnea index [AHI] 20.7, SD 17.8/hour). Among the 8 participants who completed the 4-week program, the overall compliance rate was 91% (175/192 sessions). For the tongue exercise, the success rate increased from 66% (211/320 exercises; SD 18%) on the first day to 85% (272/320 exercises; SD 17%) on the last day (P=.05). AHI did not change significantly after completion of training but a noteworthy correlation between successful lip exercise improvement and AHI reduction in the supine position was observed (R<sub>s</sub>=-0.76; P=.03). These findings demonstrate the potential of the device for accurately monitoring participants' performance in lip and tongue pressure exercises during myofunctional therapy. The diversity of the training program (it mixed exercises mixed training games), its ability to provide direct feedback for each exercise to the participants, and the easy measurement of treatment adherence are major strengths of our training program.</p><p><strong>Conclusions: </strong>The study's portable device for home-based myofunctional therapy shows promise as","PeriodicalId":87288,"journal":{"name":"JMIR biomedical engineering","volume":"9 ","pages":"e51901"},"PeriodicalIF":0.0,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141322167","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
Finite Element Analysis for Degenerative Cervical Myelopathy: Scoping Review of the Current Findings and Design Approaches, Including Recommendations on the Choice of Material Properties. 颈椎退行性病变的有限元分析:当前研究结果和设计方法的范围审查,包括材料特性选择建议。
Pub Date : 2024-03-28 DOI: 10.2196/48146
Benjamin Davies, Samuel Schaefer, Amir Rafati Fard, Virginia Newcombe, Michael Sutcliffe

Background: Degenerative cervical myelopathy (DCM) is a slow-motion spinal cord injury caused via chronic mechanical loading by spinal degenerative changes. A range of different degenerative changes can occur. Finite element analysis (FEA) can predict the distribution of mechanical stress and strain on the spinal cord to help understand the implications of any mechanical loading. One of the critical assumptions for FEA is the behavior of each anatomical element under loading (ie, its material properties).

Objective: This scoping review aims to undertake a structured process to select the most appropriate material properties for use in DCM FEA. In doing so, it also provides an overview of existing modeling approaches in spinal cord disease and clinical insights into DCM.

Methods: We conducted a scoping review using qualitative synthesis. Observational studies that discussed the use of FEA models involving the spinal cord in either health or disease (including DCM) were eligible for inclusion in the review. We followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The MEDLINE and Embase databases were searched to September 1, 2021. This was supplemented with citation searching to retrieve the literature used to define material properties. Duplicate title and abstract screening and data extraction were performed. The quality of evidence was appraised using the quality assessment tool we developed, adapted from the Newcastle-Ottawa Scale, and shortlisted with respect to DCM material properties, with a final recommendation provided. A qualitative synthesis of the literature is presented according to the Synthesis Without Meta-Analysis reporting guidelines.

Results: A total of 60 papers were included: 41 (68%) "FEA articles" and 19 (32%) "source articles." Most FEA articles (33/41, 80%) modeled the gray matter and white matter separately, with models typically based on tabulated data or, less frequently, a hyperelastic Ogden variant or linear elastic function. Of the 19 source articles, 14 (74%) were identified as describing the material properties of the spinal cord, of which 3 (21%) were considered most relevant to DCM. Of the 41 FEA articles, 15 (37%) focused on DCM, of which 9 (60%) focused on ossification of the posterior longitudinal ligament. Our aggregated results of DCM FEA indicate that spinal cord loading is influenced by the pattern of degenerative changes, with decompression alone (eg, laminectomy) sufficient to address this as opposed to decompression combined with other procedures (eg, laminectomy and fusion).

Conclusions: FEA is a promising technique for exploring the pathobiology of DCM and informing clinical care. This review describes a structured approach to help future investigators deploy FEA for DCM. However, there are limitations to these r

背景:颈椎退行性脊髓病(DCM)是一种慢动作脊髓损伤,由脊髓退行性病变造成的慢性机械负荷引起。可发生一系列不同的退行性病变。有限元分析(FEA)可以预测脊髓上机械应力和应变的分布,帮助了解任何机械负荷的影响。有限元分析的关键假设之一是每个解剖元素在负荷下的行为(即其材料特性):本范围审查旨在采用结构化流程来选择最适合用于 DCM 有限元分析的材料特性。在此过程中,它还概述了脊髓疾病的现有建模方法以及对 DCM 的临床见解:我们采用定性综述的方法进行了范围界定综述。讨论脊髓在健康或疾病(包括 DCM)中使用有限元分析模型的观察性研究均可纳入综述。我们遵循了 PRISMA-ScR(系统综述和荟萃分析的首选报告项目扩展至范围综述)指南。我们对 MEDLINE 和 Embase 数据库进行了检索,检索期至 2021 年 9 月 1 日。此外,还进行了引文检索,以检索用于定义材料特性的文献。对重复的标题和摘要进行筛选并提取数据。使用我们开发的质量评估工具(改编自纽卡斯尔-渥太华量表)对证据质量进行评估,并针对 DCM 材料特性进行筛选,最后提出建议。根据无元分析综合报告指南,对文献进行了定性综合:结果:共收录了 60 篇论文:41篇(68%)为 "有限元分析文章",19篇(32%)为 "资料来源文章"。大多数有限元分析文章(33/41,80%)分别对灰质和白质进行了建模,模型通常基于表格数据或较少见的高弹性奥格登变体或线性弹性函数。在 19 篇来源文章中,有 14 篇(74%)被确定为描述脊髓的材料特性,其中 3 篇(21%)被认为与 DCM 最为相关。在 41 篇有限元分析文章中,15 篇(37%)侧重于 DCM,其中 9 篇(60%)侧重于后纵韧带骨化。我们对 DCM FEA 的汇总结果表明,脊髓负荷受退行性病变模式的影响,单纯减压(如椎板切除术)足以解决这一问题,而减压结合其他手术(如椎板切除术和融合术)则无法解决这一问题:结论:FEA 是一种很有前途的技术,可用于探索 DCM 的病理生物学并为临床治疗提供依据。本综述介绍了一种结构化方法,可帮助未来的研究人员将 FEA 用于 DCM。然而,这些建议还存在局限性和更广泛的不确定性。要将 FEA 应用于 DCM 的临床治疗,很可能需要克服这些限制因素。
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引用次数: 0
Validation of a Novel Noninvasive Technology to Estimate Blood Oxygen Saturation Using Green Light: Observational Study 利用绿光估算血氧饱和度的新型无创技术的验证:观察研究
Pub Date : 2024-03-27 DOI: 10.2196/46974
Sanjay Gokhale, V. Daggubati, Georgios Alexandrakis
Pulse oximeters work within the red-infrared wavelengths. Therefore, these oximeters produce erratic results in dark-skinned subjects and in subjects with cold extremities. Pulse oximetry is routinely performed in patients with fever; however, an elevation in body temperature decreases the affinity of hemoglobin for oxygen, causing a drop in oxygen saturation or oxyhemoglobin concentrations. We aimed to determine whether our new investigational device, the Shani device or SH1 (US Patent 11191460), detects a drop in oxygen saturation or a decrease in oxyhemoglobin concentrations. An observational study (phase 1) was performed in two separate groups to validate measurements of hemoglobin and oxygen concentrations, including 39 participants recruited among current university students and staff aged 20-40 years. All volunteers completed baseline readings using the SH1 device and the commercially available Food and Drug Administration–approved pulse oximeter Masimo. SH1 uses two light-emitting diodes in which the emitted wavelengths match with absorption peaks of oxyhemoglobin (hemoglobin combined with oxygen) and deoxyhemoglobin (hemoglobin without oxygen or reduced hemoglobin). Total hemoglobin was calculated as the sum of oxyhemoglobin and deoxyhemoglobin. Subsequently, 16 subjects completed the “heat jacket study” and the others completed the “blood donation study.” Masimo was consistently used on the finger for comparison. The melanin level was accounted for using the von Luschan skin color scale (VLS) and a specifically designed algorithm. We here focus on the results of the heat jacket study, in which the subject wore a double-layered heated jacket and pair of trousers including a network of polythene tubules along with an inlet and outlet. Warm water was circulated to increase the body temperature by 0.5-0.8 °C above the baseline body temperature. We expected a slight drop in oxyhemoglobin concentrations in the heating phase at the tissue level. The mean age of the participants was 24.1 (SD 0.8) years. The skin tone varied from 12 to 36 on the VLS, representing a uniform distribution with one-third of the participants having fair skin, brown skin, and dark skin, respectively. Using a specific algorithm and software, the reflection ratio for oxyhemoglobin was displayed on the screen of the device along with direct hemoglobin values. The SH1 device picked up more minor changes in oxyhemoglobin levels after a change in body temperature compared to the pulse oximeter, with a maximum drop in oxyhemoglobin concentration detected of 6.5% and 2.54%, respectively. Our new investigational device SH1 measures oxygen saturation at the tissue level by reflectance spectroscopy using green wavelengths. This device fared well regardless of skin color. This device can thus eliminate racial disparity in these key biomarker assessments. Moreover, since the light is shone on the wrist, SH1 can be readily miniaturized into a wearabl
脉冲血氧仪的工作波长为红外线。因此,这些血氧仪对深肤色受试者和四肢冰冷的受试者产生的结果不稳定。脉搏血氧仪是发热患者的常规检测仪器,但体温升高会降低血红蛋白对氧气的亲和力,导致血氧饱和度或氧血红蛋白浓度下降。 我们的目的是确定我们的新型研究设备--Shani 设备或 SH1(美国专利 11191460)是否能检测到血氧饱和度下降或氧血红蛋白浓度降低。 为了验证血红蛋白和氧浓度的测量结果,我们在两个不同的小组中分别进行了观察研究(第 1 阶段),其中包括从 20-40 岁的在校大学生和教职员工中招募的 39 名参与者。所有志愿者都使用 SH1 设备和经美国食品和药物管理局批准的商用脉搏血氧仪 Masimo 完成了基线读数。SH1 使用两个发光二极管,其发射波长与氧合血红蛋白(含氧血红蛋白)和脱氧血红蛋白(不含氧血红蛋白或还原血红蛋白)的吸收峰相匹配。总血红蛋白的计算是氧合血红蛋白和脱氧血红蛋白之和。随后,16 名受试者完成了 "热夹克研究",其他受试者完成了 "献血研究"。始终使用 Masimo 对手指进行比较。黑色素水平是通过 von Luschan 皮肤色标(VLS)和专门设计的算法计算得出的。在这项研究中,受试者穿着双层加热夹克和裤子,其中包括一个聚乙烯管网和一个进出口。通过循环温水,使体温比基准体温高出 0.5-0.8 °C。我们预计在加热阶段,氧合血红蛋白在组织水平的浓度会略有下降。 参与者的平均年龄为 24.1 岁(标准差为 0.8 岁)。在 VLS 上,肤色从 12 到 36 不等,分布均匀,三分之一的参与者分别为白皙皮肤、棕色皮肤和深色皮肤。通过特定的算法和软件,氧合血红蛋白的反射比值与直接血红蛋白值一起显示在设备屏幕上。与脉搏血氧仪相比,SH1 设备在体温变化后能捕捉到更多的氧合血红蛋白水平的微小变化,检测到的氧合血红蛋白浓度的最大降幅分别为 6.5% 和 2.54%。 我们的新型研究设备 SH1 通过使用绿色波长的反射光谱法测量组织水平的血氧饱和度。无论肤色如何,该设备都表现良好。因此,该设备可以消除这些关键生物标志物评估中的种族差异。此外,由于光照在手腕上,SH1 可以很容易地微型化,成为一种可穿戴设备。
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引用次数: 0
Enhancing Energy Efficiency in Telehealth Internet of Things Systems Through Fog and Cloud Computing Integration: Simulation Study. 通过雾和云计算集成提高远程医疗物联网系统的能效:模拟研究。
Pub Date : 2024-03-06 DOI: 10.2196/50175
Yunyong Guo, Sudhakar Ganti, Yi Wu

Background: The increasing adoption of telehealth Internet of Things (IoT) devices in health care informatics has led to concerns about energy use and data processing efficiency.

Objective: This paper introduces an innovative model that integrates telehealth IoT devices with a fog and cloud computing-based platform, aiming to enhance energy efficiency in telehealth IoT systems.

Methods: The proposed model incorporates adaptive energy-saving strategies, localized fog nodes, and a hybrid cloud infrastructure. Simulation analyses were conducted to assess the model's effectiveness in reducing energy consumption and enhancing data processing efficiency.

Results: Simulation results demonstrated significant energy savings, with a 2% reduction in energy consumption achieved through adaptive energy-saving strategies. The sample size for the simulation was 10-40, providing statistical robustness to the findings.

Conclusions: The proposed model successfully addresses energy and data processing challenges in telehealth IoT scenarios. By integrating fog computing for local processing and a hybrid cloud infrastructure, substantial energy savings are achieved. Ongoing research will focus on refining the energy conservation model and exploring additional functional enhancements for broader applicability in health care and industrial contexts.

背景随着远程医疗物联网(IoT)设备在医疗信息学中的应用日益广泛,人们开始关注能源使用和数据处理效率问题:本文介绍了一种将远程医疗物联网设备与基于雾和云计算的平台相结合的创新模式,旨在提高远程医疗物联网系统的能效:所提出的模型结合了自适应节能策略、本地化雾节点和混合云基础设施。我们进行了仿真分析,以评估该模型在降低能耗和提高数据处理效率方面的有效性:仿真结果表明节能效果显著,通过自适应节能策略,能耗降低了 2%。模拟的样本量为 10-40 个,为研究结果提供了统计稳健性:所提出的模型成功地解决了远程医疗物联网场景中的能源和数据处理难题。通过整合用于本地处理的雾计算和混合云基础设施,实现了大幅节能。正在进行的研究将侧重于完善节能模型,并探索更多的功能改进,以便在医疗保健和工业环境中更广泛地应用。
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JMIR biomedical engineering
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