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Changes in Exhaled Carbon Dioxide during the Menstrual Cycle and Menopause. 月经周期和更年期期间呼出二氧化碳的变化。
Q1 Computer Science Pub Date : 2024-06-12 eCollection Date: 2024-01-01 DOI: 10.1159/000539126
Tomer Cramer, Shlomo Yeshurun, Merav Mor

Introduction: The menstrual cycle (MC) reflects multifaceted hormonal changes influencing women's metabolism, making it a key aspect of women's health. Changes in hormonal levels throughout the MC have been demonstrated to influence various physiological parameters, including exhaled carbon dioxide (CO2). Lumen is a small handheld device that measures metabolic fuel usage via exhaled CO2. This study leverages exhaled CO2 patterns measured by the Lumen device to elucidate metabolic variations during the MC, which may hold significance for fertility management. Additionally, CO2 changes are explored in menopausal women with and without hormonal replacement therapy (HRT).

Methods: This retrospective cohort study analyzed exhaled CO2 data from 3,981 Lumen users, including eumenorrheal women and menopausal women with and without HRT. Linear mixed models assessed both CO2 changes of eumenorrheal women during the MC phases and compared between menopausal women with or without HRT.

Results: Eumenorrheic women displayed cyclical CO2 patterns during the MC, characterized by elevated levels during the menstrual, estrogenic and ovulation phases and decreased levels during post-ovulation and pre-menstrual phases. Notably, despite variations in cycle length affecting the timing of maximum and minimum CO2 levels within a cycle, the overall pattern remained consistent. Furthermore, CO2 levels in menopausal women without HRT differed significantly from those with HRT, which showed lower levels.

Conclusion: This study reveals distinct CO2 patterns across MC phases, providing insights into hormonal influences on metabolic activity. Menopausal women exhibit altered CO2 profiles in relation to the use or absence of HRT. CO2 monitoring emerges as a potential tool for tracking the MC and understanding metabolic changes during menopause.

简介月经周期(MC)反映了影响女性新陈代谢的多方面激素变化,因此是女性健康的一个重要方面。事实证明,整个月经周期中激素水平的变化会影响各种生理参数,包括呼出的二氧化碳(CO2)。Lumen 是一种小型手持设备,可通过呼出的二氧化碳测量代谢燃料的使用情况。本研究利用 Lumen 设备测量的呼出二氧化碳模式来阐明 MC 期间的代谢变化,这可能对生育管理具有重要意义。此外,还探讨了接受和未接受激素替代疗法(HRT)的更年期女性的二氧化碳变化:这项回顾性队列研究分析了 3981 名 Lumen 用户的呼出二氧化碳数据,其中包括闭经妇女和接受或未接受激素替代疗法的更年期妇女。线性混合模型评估了更年期女性在 MC 阶段呼出的二氧化碳变化,并对使用或未使用 HRT 的更年期女性进行了比较:结果:月经过多妇女在 MC 期间表现出周期性二氧化碳模式,其特点是月经期、雌激素期和排卵期二氧化碳水平升高,排卵后和月经前二氧化碳水平降低。值得注意的是,尽管周期长度的变化会影响周期内二氧化碳水平最高和最低的时间,但总体模式保持一致。此外,未接受激素治疗的更年期女性与接受激素治疗的更年期女性的二氧化碳水平差异显著,后者的二氧化碳水平更低:这项研究揭示了各 MC 阶段不同的二氧化碳模式,为了解激素对代谢活动的影响提供了见解。更年期妇女的二氧化碳特征与使用或不使用 HRT 有关。二氧化碳监测是跟踪 MC 和了解更年期代谢变化的潜在工具。
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引用次数: 0
Clustering Approaches for Gait Analysis within Neurological Disorders: A Narrative Review. 神经系统疾病步态分析的聚类方法:叙述性综述。
Q1 Computer Science Pub Date : 2024-05-08 eCollection Date: 2024-01-01 DOI: 10.1159/000538270
Jonas Hummel, Michael Schwenk, Daniel Seebacher, Philipp Barzyk, Joachim Liepert, Manuel Stein

Background: The prevalence of neurological disorders is increasing, underscoring the importance of objective gait analysis to help clinicians identify specific deficits. Nevertheless, existing technological solutions for gait analysis often suffer from impracticality in daily clinical use, including excessive cost, time constraints, and limited processing capabilities.

Summary: This review aims to evaluate existing techniques for clustering patients with the same neurological disorder to assist clinicians in optimizing treatment options. A narrative review of thirteen relevant studies was conducted, characterizing their methods, and evaluating them against seven criteria. Additionally, the results are summarized in two comprehensive tables. Recent approaches show promise; however, our results indicate that, overall, only three approaches display medium or high process maturity, and only two show high clinical applicability.

Key messages: Our findings highlight the necessity for advancements, specifically regarding the use of markerless optical tracking systems, the optimization of experimental plans, and the external validation of results. This narrative review provides a comprehensive overview of existing clustering techniques, bridging the gap between instrumented gait analysis and its real-world clinical utility. We encourage researchers to use our findings and those from other medical fields to enhance clustering techniques for patients with neurological disorders, facilitating the identification of disparities within groups and their extent, ultimately improving patient outcomes.

背景:神经系统疾病的发病率正在不断上升,这凸显了客观步态分析在帮助临床医生识别特定缺陷方面的重要性。然而,现有的步态分析技术解决方案在日常临床使用中往往存在不切实际的问题,包括成本过高、时间限制和处理能力有限。摘要:本综述旨在评估将患有相同神经系统疾病的患者聚类的现有技术,以帮助临床医生优化治疗方案。我们对 13 项相关研究进行了叙述性综述,分析了这些研究的方法特点,并根据七项标准对其进行了评估。此外,我们还在两张综合表格中对研究结果进行了总结。最近的方法显示出了前景;然而,我们的结果表明,总体而言,只有三种方法显示出了中等或较高的流程成熟度,只有两种方法显示出了较高的临床适用性:我们的研究结果凸显了进步的必要性,特别是在无标记光学跟踪系统的使用、实验计划的优化以及结果的外部验证方面。这篇叙述性综述全面概述了现有的聚类技术,弥补了仪器步态分析与实际临床应用之间的差距。我们鼓励研究人员利用我们的研究成果和其他医学领域的研究成果,加强神经系统疾病患者的聚类技术,促进识别群体内的差异及其程度,最终改善患者的预后。
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引用次数: 0
A Study of Pupil Response to Light as a Digital Biomarker of Recent Cannabis Use. 将瞳孔对光的反应作为近期吸食大麻的数字生物标记的研究。
Q1 Computer Science Pub Date : 2024-04-26 eCollection Date: 2024-01-01 DOI: 10.1159/000538561
Suneeta Godbole, Andrew Leroux, Ashley Brooks-Russell, Prem S Subramanian, Michael J Kosnett, Julia Wrobel

Introduction: Given the traffic safety and occupational injury prevention implications associated with cannabis impairment, there is a need for objective and validated measures of recent cannabis use. Pupillary light response may offer an approach for detection.

Method: Eighty-four participants (mean age: 32, 42% female) with daily, occasional, and no-use cannabis use histories participated in pupillary light response tests before and after smoking cannabis ad libitum or relaxing for 15 min (no use). The impact of recent cannabis consumption on trajectories of the pupillary light response was modeled using functional data analysis tools. Logistic regression models for detecting recent cannabis use were compared, and average pupil trajectories across cannabis use groups and times since light test administration were estimated.

Results: Models revealed small, significant differences in pupil response to light after cannabis use comparing the occasional use group to the no-use control group, and similar statistically significant differences in pupil response patterns comparing the daily use group to the no-use comparison group. Trajectories of pupillary light response estimated using functional data analysis found that acute cannabis smoking was associated with less initial and sustained pupil constriction compared to no cannabis smoking.

Conclusion: These analyses show the promise of pairing pupillary light response and functional data analysis methods to assess recent cannabis use.

简介:鉴于大麻损害对交通安全和工伤预防的影响,需要对近期使用大麻的情况进行客观、有效的测量。瞳孔光反应可能是一种检测方法:84名有每天吸食、偶尔吸食和不吸食大麻史的参与者(平均年龄:32岁,42%为女性)在自由吸食大麻或放松15分钟(不吸食)前后参加了瞳孔光反应测试。使用功能数据分析工具模拟了近期吸食大麻对瞳孔光反应轨迹的影响。对检测近期吸食大麻的逻辑回归模型进行了比较,并估算了不同吸食大麻组和进行光照测试后不同时间的平均瞳孔轨迹:结果:模型显示,偶尔吸食大麻组与不吸食对照组相比,吸食大麻后瞳孔对光线的反应存在微小而显著的差异,而每天吸食大麻组与不吸食对照组相比,瞳孔反应模式也存在类似的统计意义上的显著差异。使用功能数据分析估算的瞳孔光反应轨迹发现,与不吸食大麻相比,急性吸食大麻与较少的初始和持续瞳孔收缩有关:这些分析表明,将瞳孔光反应和功能数据分析方法结合起来评估近期使用大麻的情况大有可为。
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引用次数: 0
Toward Personalized Orthopedic Care: Validation of a Smart Knee Brace 实现个性化矫形护理:智能膝关节护套的验证
Q1 Computer Science Pub Date : 2024-04-23 DOI: 10.1159/000538487
Annah McPherson, Andrew J. McDaid, Sarah Ward
Abstract Introduction Wearable technology offers a promising solution to advance current rehabilitation strategies for post-operative orthopedic care. The aim of this study was to determine the level of agreement and concurrent validity of a smart knee brace compared to the gold standard measurement system GAITRite® for assessing lower limb gait parameters. Methods Thirty-four healthy participants were fitted with the smart knee brace (Digital Knee®) on their dominant limb. Gait parameters (stride length, stride time, and gait velocity) were measured simultaneously using the Digital Knee® and the GAITRite® electronic walkway. Two walks were performed at a comfortable speed and two at a fast-walking speed. Results At a comfortable walking speed, stride time was moderately valid (ICC2,1 = 0.66 s), and stride length and gait velocity demonstrated poor validity (ICC2,1 = 0.29; ICC2,1 = 0.41). All gait parameters demonstrated poor validity at a fast-walking speed (ICC2,1 = −0.16 to −0.01). Bias ranged from −0.08 to 0.28, with more clinically acceptable percentage errors at a comfortable walking speed (14.1–30%) versus at a fast-walking speed (26.4–42.6%). Gait velocity and stride length had substantially higher biases in the fast-walking speed compared to the comfortable walking speed (0.28 ± 0.39 m s−1 vs. 0.02 ± 0.21 m s−1; 0.15 ± 0.23 m vs. −0.04 ± 0.17 m). Limits of agreement were considered narrower for stride time compared to stride length and gait velocity. Conclusion The Digital Knee® is a promising approach to improving post-operative rehabilitation outcomes in patients with osteoarthritis. The Digital Knee® demonstrated good agreement and moderate concurrent validity for measuring gait metrics at a comfortable walking speed. These findings highlight the opportunity of the wearable sensor as an intervention for post-operative orthopedic care. This was a laboratory-based study; thus, further research is required to validate the wearable sensor in real-world contexts and in patients with knee pathologies. Further, refinement of the algorithm for measuring gait metrics at slow- and fast-walking speed with the Digital Knee® is warranted.
摘要 引言 可穿戴技术为推进当前骨科术后护理的康复策略提供了一种前景广阔的解决方案。本研究旨在确定智能膝关节护套与黄金标准测量系统 GAITRite® 在评估下肢步态参数方面的一致性和并发有效性。方法 为 34 名健康参与者的优势肢体安装智能膝关节护套(Digital Knee®)。使用 Digital Knee® 和 GAITRite® 电子步道同时测量步态参数(步长、步幅和步速)。两次以舒适速度行走,两次以快速行走。结果 在舒适步行速度下,步幅时间的有效性为中等(ICC2,1 = 0.66 秒),步幅长度和步速的有效性较差(ICC2,1 = 0.29;ICC2,1 = 0.41)。在快速行走时,所有步态参数的有效性都很差(ICC2,1 = -0.16 至 -0.01)。偏差范围为-0.08至0.28,舒适行走速度(14.1%-30%)与快速行走速度(26.4%-42.6%)相比,临床上可接受的误差百分比更高。与舒适行走速度相比,快速行走速度下步速和步幅的偏差要大得多(0.28 ± 0.39 m s-1 vs. 0.02 ± 0.21 m s-1;0.15 ± 0.23 m vs. -0.04 ± 0.17 m)。与步长和步速相比,步幅时间的一致性范围较窄。结论 数字膝关节 (Digital Knee®) 是改善骨关节炎患者术后康复效果的有效方法。在以舒适的步行速度测量步态指标时,数字膝关节®表现出良好的一致性和适度的并发有效性。这些发现凸显了可穿戴传感器作为骨科术后护理干预措施的机遇。这只是一项基于实验室的研究,因此还需要进一步的研究来验证可穿戴传感器在实际环境和膝关节病患者中的有效性。此外,还需要对数字膝关节®在慢速和快速行走时测量步态指标的算法进行改进。
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引用次数: 0
Feature Importance Analysis and Machine Learning for Alzheimer’s Disease Early Detection: Feature Fusion of the Hippocampus, Entorhinal Cortex, and Standardized Uptake Value Ratio 用于阿尔茨海默病早期检测的特征重要性分析和机器学习:海马、内皮层和标准化摄取值比率的特征融合
Q1 Computer Science Pub Date : 2024-04-22 DOI: 10.1159/000538486
Aya Hassouneh, Bradley Bazuin, A. Danna-dos-Santos, Ilgin Acar, I. Abdel-Qader
Abstract Introduction Alzheimer’s disease (AD) is a progressive neurological disorder characterized by mild memory loss and ranks as a leading cause of mortality in the USA, accounting for approximately 120,000 deaths per year. It is also the primary form of dementia. Early detection is critical for timely intervention as the neurodegenerative process often starts 15–20 years before cognitive symptoms manifest. This study focuses on determining feature importance in AD classification using fused texture features from 3D magnetic resonance imaging hippocampal and entorhinal cortex and standardized uptake value ratio (SUVR) derived from positron emission tomography (PET) images. Methods To achieve this objective, we employed four distinct classifiers (Linear Support Vector Classification, Linear Discriminant Analysis, Logistic Regression, and Logistic Regression Classifier with Stochastic Gradient Descent Learning). These classifiers were used to derive both average and top-ranked importance scores for each feature based on their outputs. Our framework is designed to distinguish between two classes, AD-negative (or mild cognitive impairment stable [MCIs]) and AD-positive (or MCI conversion [MCIc]), using a probabilistic neural network classifier and the Alzheimer’s Disease Neuroimaging Initiative (ADNI) database. Results The findings from the feature importance highlight the crucial role of the GLCM texture features extracted from the hippocampus and entorhinal cortex, demonstrating their superior performance compared to the volume and SUVR. GLCM texture AD classification achieved approximately 90% sensitivity in identifying MCIc cases while maintaining low false positives (below 30%) when fused with other features. Moreover, the receiver operating characteristic curves validate the GLCMs’ superior performance in distinguishing between MCIs and MCIc. Additionally, fusing different types of features improved classification performance compared to relying solely on any single feature category. Conclusion Our study emphasizes the pivotal role of GLCM texture features in early Alzheimer’s detection.
摘要 引言 阿尔茨海默病(AD)是一种以轻度失忆为特征的进行性神经系统疾病,在美国是导致死亡的主要原因之一,每年约有 12 万人死于此病。它也是痴呆症的主要形式。由于神经退行性过程通常在认知症状出现前 15-20 年就已开始,因此早期发现对于及时干预至关重要。本研究的重点是利用三维磁共振成像海马和内侧皮层的融合纹理特征以及正电子发射断层扫描(PET)图像得出的标准化摄取值比(SUVR),确定特征在老年痴呆症分类中的重要性。方法 为了实现这一目标,我们采用了四种不同的分类器(线性支持向量分类、线性判别分析、逻辑回归和逻辑回归分类器与随机梯度下降学习)。这些分类器根据其输出结果为每个特征得出平均重要度分数和最高重要度分数。我们的框架旨在利用概率神经网络分类器和阿尔茨海默病神经影像倡议(ADNI)数据库区分两类患者,即 AD 阴性患者(或轻度认知障碍稳定型患者 [MCIs])和 AD 阳性患者(或 MCI 转换型患者 [MCIc])。结果 从特征重要性中得出的结论强调了从海马和内侧皮层中提取的 GLCM 纹理特征的关键作用,显示出其优于体积和 SUVR 的性能。GLCM 纹理 AD 分类在识别 MCIc 病例方面达到了约 90% 的灵敏度,同时在与其他特征融合时保持了较低的误报率(低于 30%)。此外,接收者操作特征曲线验证了 GLCM 在区分 MCIs 和 MCIc 方面的卓越性能。此外,与仅依赖单一特征类别相比,融合不同类型的特征可提高分类性能。结论 我们的研究强调了 GLCM 纹理特征在早期阿尔茨海默氏症检测中的关键作用。
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引用次数: 0
Vestibulo-Ocular Reflex Suppression: Clinical Relevance and Assessment in the Digital Age 前庭-眼球反射抑制:数字时代的临床意义与评估
Q1 Computer Science Pub Date : 2024-04-12 DOI: 10.1159/000537842
Patrik Theodor Nerdal, Florin Gandor, Maximilian Uwe Friedrich, Laurin Schappe, Georg Ebersbach, Walter Maetzler
Abstract Background Visual acuity and image stability are crucial for daily activities, particularly during head motion. The vestibulo-ocular reflex (VOR) and its suppression (VORS) support stable fixation of objects of interest. The VOR drives a reflexive eye movement to counter retinal slip of a stable target during head motion. In contrast, VORS inhibits this countermovement when the target stimulus is in motion. The VORS allows for object fixation when it aligns with the direction of the head’s movement, or when an object within or outside the peripheral vision needs to be focused upon. Summary Deficits of the VORS have been linked to age-related diseases such as balance deficits associated with an increased fall risk. Therefore, the accurate assessment of the VORS is of particular clinical relevance. However, current clinical assessment methods for VORS are mainly qualitative and not sufficiently standardised. Recent advances in digital health technology, such as smartphone-based videooculography, offer a promising alternative for assessing VORS in a more accessible, efficient, and quantitative manner. Moreover, integrating mobile eye-tracking technology with virtual reality environments allows for the implementation of controlled VORS assessments with different visual inputs. These assessment approaches allow the extraction of novel parameters with potential pathomechanistic and clinical relevance. Key Messages We argue that researchers and clinicians can obtain a more nuanced understanding of this ocular stabilisation reflex and its associated pathologies by harnessing digital health technology for VORS assessment. Further research is warranted to explore the technologies’ full potential and utility in clinical practice.
摘要 背景 视觉敏锐度和图像稳定性对日常活动至关重要,尤其是在头部运动时。前庭眼反射(VOR)及其抑制(VORS)有助于稳定地固定感兴趣的目标。VOR 驱动眼球反射性运动,以对抗头部运动时稳定目标的视网膜滑动。相反,当目标刺激物处于运动状态时,VORS 会抑制这种反运动。当目标与头部运动方向一致时,或当需要聚焦于周边视线内外的目标时,VORS 可使目标固定。小结 VORS 的缺陷与年龄相关疾病有关,如与增加跌倒风险相关的平衡缺陷。因此,准确评估 VORS 具有特殊的临床意义。然而,目前对 VORS 的临床评估方法主要是定性评估,标准化程度不够。数字健康技术的最新进展,如基于智能手机的视频眼动图,为以更便捷、高效和定量的方式评估 VORS 提供了一种很有前景的替代方法。此外,将移动眼动跟踪技术与虚拟现实环境相结合,可以在不同的视觉输入下实施可控的 VORS 评估。这些评估方法可以提取具有潜在病理机制和临床相关性的新参数。关键信息 我们认为,研究人员和临床医生可以通过利用数字健康技术进行 VORS 评估,对这种眼球稳定反射及其相关病理有更细致的了解。我们需要进一步开展研究,探索这些技术在临床实践中的全部潜力和效用。
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引用次数: 0
A Novel Method for Tracking Neck Motions Using a Skin-Conformable Wireless Accelerometer: A Pilot Study 使用可贴合皮肤的无线加速度计追踪颈部运动的新方法:试点研究
Q1 Computer Science Pub Date : 2024-04-10 DOI: 10.1159/000536473
Le Huang, K. Chun, Lian Yu, Jong Yoon Lee, Alan Soetikno, Hope Chen, Hyoyoung Jeong, Joshua Barrett, Knute L. Martell, Youn Kang, Alpesh A. Patel, Shuai Xu
Abstract Introduction Cervical spine disease is a leading cause of pain and disability. Degenerative conditions of the spine can result in neurologic compression of the cervical spinal cord or nerve roots and may be surgically treated with an anterior cervical discectomy and fusion (ACDF) in up to 137,000 people per year in the United States. A common sequelae of ACDF is reduced cervical range of motion (CROM) with patient-based complaints of stiffness and neck pain. Currently, tools for assessment of CROM are manual, subjective, and only intermittently utilized during doctor or physical therapy visits. We propose a skin-mountable acousto-mechanic sensor (ADvanced Acousto-Mechanic sensor; ADAM) as a tool for continuous neck motion monitoring in postoperative ACDF patients. We have developed and validated a machine learning neck motion classification algorithm to differentiate between eight neck motions (right/left rotation, right/left lateral bending, flexion, extension, retraction, protraction) in healthy normal subjects and patients. Methods Sensor data from 12 healthy normal subjects and 5 patients were used to develop and validate a Convolutional Neural Network (CNN). Results An average algorithm accuracy of 80.0 ± 3.8% was obtained for healthy normal subjects (94% for right rotation, 98% for left rotation, 65% for right lateral bending, 87% for left lateral bending, 89% for flexion, 77% for extension, 50% for retraction, 84% for protraction). An average accuracy of 67.5 ± 5.8% was obtained for patients. Discussion ADAM, with our algorithm, may serve as a rehabilitation tool for neck motion monitoring in postoperative ACDF patients. Sensor-captured vital signs and other events (extubation, vocalization, physical therapy, walking) are potential metrics to be incorporated into our algorithm to offer more holistic monitoring of patients after cervical spine surgery.
摘要 引言 颈椎病是导致疼痛和残疾的主要原因。脊柱退行性病变可导致颈椎脊髓或神经根的神经压迫,在美国,每年有多达 13.7 万人接受颈椎前路椎间盘切除和融合术(ACDF)手术治疗。ACDF 常见的后遗症是颈椎活动范围减小 (CROM),患者会抱怨颈部僵硬和疼痛。目前,用于评估 CROM 的工具都是手动的、主观的,而且只能在看医生或物理治疗时间歇使用。我们提出了一种可安装在皮肤上的声力学传感器(ADvanced Acousto-Mechanic sensor; ADAM),作为对 ACDF 术后患者颈部运动进行连续监测的工具。我们开发并验证了一种机器学习颈部运动分类算法,可区分健康正常人和患者的八种颈部运动(右/左旋转、右/左侧弯、屈曲、伸展、后缩、前伸)。方法 利用 12 名健康正常人和 5 名患者的传感器数据开发并验证了卷积神经网络(CNN)。结果 健康正常人的平均算法准确率为 80.0 ± 3.8%(右旋转 94%、左旋转 98%、右侧屈 65%、左侧屈 87%、屈 89%、伸 77%、缩 50%、伸 84%)。患者的平均准确率为 67.5 ± 5.8%。讨论 ADAM 和我们的算法可作为 ACDF 术后患者颈部运动监测的康复工具。传感器捕获的生命体征和其他事件(拔管、发声、理疗、行走)都是潜在的指标,可纳入我们的算法,为颈椎手术后的患者提供更全面的监测。
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引用次数: 0
Fatigue-Related Changes of Daily Function: Most Promising Measures for the Digital Age. 与疲劳有关的日常功能变化:数字时代最有前途的措施。
Q1 Computer Science Pub Date : 2024-03-20 eCollection Date: 2024-01-01 DOI: 10.1159/000536568
Walter Maetzler, Leonor Correia Guedes, Kirsten Nele Emmert, Jennifer Kudelka, Hanna Luise Hildesheim, Emma Paulides, Hayley Connolly, Kristen Davies, Valentina Dilda, Teemu Ahmaniemi, Luisa Avedano, Raquel Bouça-Machado, Michael Chambers, Meenakshi Chatterjee, Peter Gallagher, Johanna Graeber, Corina Maetzler, Hanna Kaduszkiewicz, Norelee Kennedy, Victoria Macrae, Laura Carrasco Marin, Anusha Moses, Alessandro Padovani, Andrea Pilotto, Natasha Ratcliffe, Ralf Reilmann, Madalena Rosario, Stefan Schreiber, Dina De Sousa, Geert Van Gassen, Lori Ann Warring, Klaus Seppi, C Janneke van der Woude, Joaquim J Ferreira, Wan-Fai Ng

Background: Fatigue is a prominent symptom in many diseases and is strongly associated with impaired daily function. The measurement of daily function is currently almost always done with questionnaires, which are subjective and imprecise. With the recent advances of digital wearable technologies, novel approaches to evaluate daily function quantitatively and objectively in real-life conditions are increasingly possible. This also creates new possibilities to measure fatigue-related changes of daily function using such technologies.

Summary: This review examines which digitally assessable parameters in immune-mediated inflammatory and neurodegenerative diseases may have the greatest potential to reflect fatigue-related changes of daily function.

Key messages: Results of a standardized analysis of the literature reporting about perception-, capacity-, and performance-evaluating assessment tools indicate that changes of the following parameters: physical activity, independence of daily living, social participation, working life, mental status, cognitive and aerobic capacity, and supervised and unsupervised mobility performance have the highest potential to reflect fatigue-related changes of daily function. These parameters thus hold the greatest potential for quantitatively measuring fatigue in representative diseases in real-life conditions, e.g., with digital wearable technologies. Furthermore, to the best of our knowledge, this is a new approach to analysing evidence for the design of performance-based digital assessment protocols in human research, which may stimulate further systematic research in this area.

背景:疲劳是许多疾病的突出症状,与日常功能受损密切相关。目前,对日常功能的测量几乎都是通过问卷进行的,这种方法既主观又不精确。随着最近数字可穿戴技术的发展,越来越多的新方法可以在现实生活中对日常功能进行客观的定量评估。摘要:本综述探讨了在免疫介导的炎症和神经退行性疾病中,哪些数字可评估参数最有可能反映与疲劳相关的日常功能变化:对报告感知、能力和表现评估工具的文献进行标准化分析的结果表明,以下参数的变化最有可能反映与疲劳相关的日常功能变化:体力活动、日常生活独立性、社会参与、工作生活、精神状态、认知和有氧能力,以及有监督和无监督的移动表现。因此,这些参数最有可能用于在现实生活条件下(如使用数字可穿戴技术)定量测量代表性疾病的疲劳程度。此外,据我们所知,这是一种分析证据的新方法,可用于在人类研究中设计基于性能的数字评估方案,这可能会促进该领域的进一步系统研究。
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引用次数: 0
Deep Learning-Based Psoriasis Assessment: Harnessing Clinical Trial Imaging for Accurate Psoriasis Area Severity Index Prediction. 基于深度学习的牛皮癣评估:利用临床试验成像准确预测牛皮癣面积严重指数。
Q1 Computer Science Pub Date : 2024-03-04 eCollection Date: 2024-01-01 DOI: 10.1159/000536499
Yunzhao Xing, Sheng Zhong, Samuel L Aronson, Francisco M Rausa, Dan E Webster, Michelle H Crouthamel, Li Wang

Introduction: Image-based machine learning holds great promise for facilitating clinical care; however, the datasets often used for model training differ from the interventional clinical trial-based findings frequently used to inform treatment guidelines. Here, we draw on longitudinal imaging of psoriasis patients undergoing treatment in the Ultima 2 clinical trial (NCT02684357), including 2,700 body images with psoriasis area severity index (PASI) annotations by uniformly trained dermatologists.

Methods: An image-processing workflow integrating clinical photos of multiple body regions into one model pipeline was developed, which we refer to as the "One-Step PASI" framework due to its simultaneous body detection, lesion detection, and lesion severity classification. Group-stratified cross-validation was performed with 145 deep convolutional neural network models combined in an ensemble learning architecture.

Results: The highest-performing model demonstrated a mean absolute error of 3.3, Lin's concordance correlation coefficient of 0.86, and Pearson correlation coefficient of 0.90 across a wide range of PASI scores comprising disease classifications of clear skin, mild, and moderate-to-severe disease. Within-person, time-series analysis of model performance demonstrated that PASI predictions closely tracked the trajectory of physician scores from severe to clear skin without systematically over- or underestimating PASI scores or percent changes from baseline.

Conclusion: This study demonstrates the potential of image processing and deep learning to translate otherwise inaccessible clinical trial data into accurate, extensible machine learning models to assess therapeutic efficacy.

简介基于图像的机器学习在促进临床护理方面大有可为;然而,通常用于模型训练的数据集不同于经常用于指导治疗指南的基于干预性临床试验的结果。在此,我们借鉴了Ultima 2临床试验(NCT02684357)中接受治疗的银屑病患者的纵向图像,包括2700张由经过统一培训的皮肤科医生标注了银屑病面积严重程度指数(PASI)的身体图像:我们开发了一种图像处理工作流程,将多个身体区域的临床照片整合到一个模型管道中,我们将其称为 "一步式 PASI "框架,因为它能同时进行身体检测、皮损检测和皮损严重程度分类。我们使用 145 个深度卷积神经网络模型在一个集合学习架构中进行了分组分层交叉验证:结果:表现最好的模型的平均绝对误差为 3.3,Lin's concordance 相关系数为 0.86,Pearson 相关系数为 0.90,适用于广泛的 PASI 分数范围,包括皮肤透明、轻度和中重度疾病分类。对模型性能进行的人内时间序列分析表明,PASI 预测值密切跟踪了从重度到皮肤透明的医生评分轨迹,没有系统性地高估或低估 PASI 评分或与基线相比的百分比变化:这项研究证明了图像处理和深度学习的潜力,可将原本无法获取的临床试验数据转化为准确、可扩展的机器学习模型,以评估疗效。
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引用次数: 0
Why Language Matters in Digital Endpoint Development: Harmonized Terminology as a Key Prerequisite for Evidence Generation 数字终端开发中的语言问题:统一术语是生成证据的关键前提
Q1 Computer Science Pub Date : 2024-01-11 DOI: 10.1159/000534954
Lada Leyens, Carrie A. Northcott, Lesley Maloney, Marie McCarthy, Nona Dokuzova, Thomas Pfister
Abstract Background Developments in the field of digital measures and digitally derived endpoints demand greater attention on globally aligned approaches to enhance digital measure acceptance by regulatory authorities and health technology assessment (HTA) bodies for decision-making. In order to maximize the value of digital measures in global drug development programs and to ensure study teams and regulators are referring to the same items, greater alignment of concepts, definitions, and terminology is required. This is a fast-moving complex field; every day brings new technologies, algorithms, and possibilities. A common language is particularly important when working in multifunctional teams to ensure that there is a clear understanding of what is meant and understood. Summary In the paper, the EFPIA digital endpoint joint subgroup reviews the challenges facing teams working to advance digital endpoints, where different terms are used to describe the same things, where common terms such as “monitoring” have significantly different meaning for different regulatory agencies, where the preface “e” to denote electronic is still used in some contexts, but the term “digital” is used in other, and where there is significant confusion as to what is understood by “raw” when it comes to data derived from digital health technologies. Key Message The EFPIA subgroup is calling for an aligned lexicon. Alignment provides a more predictable path for development, validation, and use of the tools and measures used to collect digital endpoints supporting standardization and consistency in this new field of research, with the goal of increasing regulatory and payer harmonization and acceptance.
摘要 背景 数字测量和数字衍生终点领域的发展要求我们更加关注全球统一的方法,以提高监管机构和卫生技术评估(HTA)机构在决策时对数字测量的接受程度。为了最大限度地发挥数字测量在全球药物开发项目中的价值,并确保研究团队和监管机构参照相同的项目,需要进一步统一概念、定义和术语。这是一个快速发展的复杂领域;每天都有新的技术、算法和可能性。在多功能团队中开展工作时,共同语言尤为重要,它可确保大家清楚地理解和掌握所表达的意思。摘要 在本文中,EFPIA 数字终点联合分组回顾了致力于推进数字终点的团队所面临的挑战,在这些挑战中,不同的术语被用于描述相同的事物,"监测 "等常用术语对于不同的监管机构具有明显不同的含义,在某些情况下,表示电子的前缀 "e "仍被使用,但在其他情况下,术语 "数字 "却被使用,而且在涉及到从数字健康技术中获取的数据时,对于 "原始 "的理解存在严重混淆。关键信息 EFPIA 分组呼吁统一词汇。统一为开发、验证和使用用于收集数字终点的工具和措施提供了更可预测的途径,支持这一新研究领域的标准化和一致性,目的是提高监管和支付方的协调性和接受度。
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引用次数: 0
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Digital Biomarkers
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