Pub Date : 2024-06-12eCollection Date: 2024-01-01DOI: 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。
{"title":"Changes in Exhaled Carbon Dioxide during the Menstrual Cycle and Menopause.","authors":"Tomer Cramer, Shlomo Yeshurun, Merav Mor","doi":"10.1159/000539126","DOIUrl":"10.1159/000539126","url":null,"abstract":"<p><strong>Introduction: </strong>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 (CO<sub>2</sub>). Lumen is a small handheld device that measures metabolic fuel usage via exhaled CO<sub>2</sub>. This study leverages exhaled CO<sub>2</sub> patterns measured by the Lumen device to elucidate metabolic variations during the MC, which may hold significance for fertility management. Additionally, CO<sub>2</sub> changes are explored in menopausal women with and without hormonal replacement therapy (HRT).</p><p><strong>Methods: </strong>This retrospective cohort study analyzed exhaled CO<sub>2</sub> data from 3,981 Lumen users, including eumenorrheal women and menopausal women with and without HRT. Linear mixed models assessed both CO<sub>2</sub> changes of eumenorrheal women during the MC phases and compared between menopausal women with or without HRT.</p><p><strong>Results: </strong>Eumenorrheic women displayed cyclical CO<sub>2</sub> 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 CO<sub>2</sub> levels within a cycle, the overall pattern remained consistent. Furthermore, CO<sub>2</sub> levels in menopausal women without HRT differed significantly from those with HRT, which showed lower levels.</p><p><strong>Conclusion: </strong>This study reveals distinct CO<sub>2</sub> patterns across MC phases, providing insights into hormonal influences on metabolic activity. Menopausal women exhibit altered CO<sub>2</sub> profiles in relation to the use or absence of HRT. CO<sub>2</sub> monitoring emerges as a potential tool for tracking the MC and understanding metabolic changes during menopause.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"102-110"},"PeriodicalIF":0.0,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626280","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}
Pub Date : 2024-05-08eCollection Date: 2024-01-01DOI: 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.
{"title":"Clustering Approaches for Gait Analysis within Neurological Disorders: A Narrative Review.","authors":"Jonas Hummel, Michael Schwenk, Daniel Seebacher, Philipp Barzyk, Joachim Liepert, Manuel Stein","doi":"10.1159/000538270","DOIUrl":"10.1159/000538270","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"93-101"},"PeriodicalIF":0.0,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11078540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140890552","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}
Pub Date : 2024-04-26eCollection Date: 2024-01-01DOI: 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.
{"title":"A Study of Pupil Response to Light as a Digital Biomarker of Recent Cannabis Use.","authors":"Suneeta Godbole, Andrew Leroux, Ashley Brooks-Russell, Prem S Subramanian, Michael J Kosnett, Julia Wrobel","doi":"10.1159/000538561","DOIUrl":"https://doi.org/10.1159/000538561","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>These analyses show the promise of pairing pupillary light response and functional data analysis methods to assess recent cannabis use.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"83-92"},"PeriodicalIF":0.0,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11052563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140853275","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}
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。
{"title":"Toward Personalized Orthopedic Care: Validation of a Smart Knee Brace","authors":"Annah McPherson, Andrew J. McDaid, Sarah Ward","doi":"10.1159/000538487","DOIUrl":"https://doi.org/10.1159/000538487","url":null,"abstract":"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.","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"26 5","pages":"75 - 82"},"PeriodicalIF":0.0,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140672249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Feature Importance Analysis and Machine Learning for Alzheimer’s Disease Early Detection: Feature Fusion of the Hippocampus, Entorhinal Cortex, and Standardized Uptake Value Ratio","authors":"Aya Hassouneh, Bradley Bazuin, A. Danna-dos-Santos, Ilgin Acar, I. Abdel-Qader","doi":"10.1159/000538486","DOIUrl":"https://doi.org/10.1159/000538486","url":null,"abstract":"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.","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"46 5","pages":"59 - 74"},"PeriodicalIF":0.0,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140677533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Vestibulo-Ocular Reflex Suppression: Clinical Relevance and Assessment in the Digital Age","authors":"Patrik Theodor Nerdal, Florin Gandor, Maximilian Uwe Friedrich, Laurin Schappe, Georg Ebersbach, Walter Maetzler","doi":"10.1159/000537842","DOIUrl":"https://doi.org/10.1159/000537842","url":null,"abstract":"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.","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 2","pages":"52 - 58"},"PeriodicalIF":0.0,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140710449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"A Novel Method for Tracking Neck Motions Using a Skin-Conformable Wireless Accelerometer: A Pilot Study","authors":"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","doi":"10.1159/000536473","DOIUrl":"https://doi.org/10.1159/000536473","url":null,"abstract":"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.","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"31 1","pages":"40 - 51"},"PeriodicalIF":0.0,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140717400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-20eCollection Date: 2024-01-01DOI: 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.
{"title":"Fatigue-Related Changes of Daily Function: Most Promising Measures for the Digital Age.","authors":"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","doi":"10.1159/000536568","DOIUrl":"10.1159/000536568","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"30-39"},"PeriodicalIF":0.0,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10954320/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174078","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}
Pub Date : 2024-03-04eCollection Date: 2024-01-01DOI: 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。
{"title":"Deep Learning-Based Psoriasis Assessment: Harnessing Clinical Trial Imaging for Accurate Psoriasis Area Severity Index Prediction.","authors":"Yunzhao Xing, Sheng Zhong, Samuel L Aronson, Francisco M Rausa, Dan E Webster, Michelle H Crouthamel, Li Wang","doi":"10.1159/000536499","DOIUrl":"10.1159/000536499","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"13-21"},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10911790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027681","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}
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.
{"title":"Why Language Matters in Digital Endpoint Development: Harmonized Terminology as a Key Prerequisite for Evidence Generation","authors":"Lada Leyens, Carrie A. Northcott, Lesley Maloney, Marie McCarthy, Nona Dokuzova, Thomas Pfister","doi":"10.1159/000534954","DOIUrl":"https://doi.org/10.1159/000534954","url":null,"abstract":"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.","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 5","pages":"1 - 12"},"PeriodicalIF":0.0,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139438175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}