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A Holistic Approach to the Measurement of Physical Function in Clinical Research. 临床研究中身体功能测量的整体方法。
Q1 Computer Science Pub Date : 2025-01-03 eCollection Date: 2025-01-01 DOI: 10.1159/000542364
Jennifer C Richards, Shelby L Bachman, Krista Leonard-Corzo, Suvekshya Aryal, Jennifer M Blankenship, Ieuan Clay, Kate Lyden

Background: This commentary highlights the evolution of our understanding of physical function (PF) and key models/frameworks that have contributed to the current holistic understanding of PF, which encompasses not only a person's performance but also the environment and any adaptations an individual utilizes. This commentary also addresses how digital health tools can facilitate and complement the assessment of holistic PF and enable both objective and subjective input from the participant in their real-world environment. Lastly, we discuss how successful implementation of digital tools within clinical research requires patient input.

Summary: This commentary highlights how our understanding of PF has evolved to be more holistic.

Key messages: Inclusion of digital tools within clinical research can provide a path forward to holistically assess PF in a patient-focused manner.

背景:这篇评论强调了我们对身体机能(PF)和关键模型/框架的理解的演变,这些模型/框架有助于当前对PF的整体理解,这不仅包括一个人的表现,还包括环境和个人利用的任何适应。本评论还讨论了数字卫生工具如何促进和补充对整体PF的评估,并使参与者能够在其现实环境中提供客观和主观的投入。最后,我们讨论了在临床研究中成功实施数字工具如何需要患者的输入。摘要:这篇评论强调了我们对PF的理解是如何变得更加全面的。关键信息:在临床研究中纳入数字工具可以为以患者为中心的方式全面评估PF提供一条前进的道路。
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引用次数: 0
Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. 腕式设备上机器学习连续脉搏率算法的多中心评估。
Q1 Computer Science Pub Date : 2024-12-12 eCollection Date: 2024-01-01 DOI: 10.1159/000542615
Weixuan Chen, Rafael Cordero, Jessie Lever Taylor, Domenico R Pangallo, Rosalind W Picard, Marisa Cruz, Giulia Regalia
<p><strong>Introduction: </strong>Though wrist-worn photoplethysmography (PPG) sensors play an important role in long-term and continuous heart rhythm monitoring, signals measured at the wrist are contaminated by more intense motion artifacts compared to other body locations. Machine learning (ML)-based algorithms can improve long-term pulse rate (PR) tracking but are associated with more stringent regulatory requirements when intended for clinical use. This study aimed to evaluate the accuracy of a digital health technology using wrist-worn PPG sensors and an ML-based algorithm to measure PR continuously.</p><p><strong>Methods: </strong>Volunteers were enrolled in three independent clinical trials and concurrently monitored with the investigational device and FDA-cleared electrocardiography (ECG) devices during supervised protocols representative of real-life activities. The primary acceptance threshold was an accuracy root-mean-square (ARMS) ≤3 beats per minute (bpm) or 5 bpm under no-motion and motion conditions, respectively. Bias, mean absolute error (MAE), mean absolute percentage error (MAPE), limits of agreement (LoA), and Pearson and Lin's concordance correlation coefficients (⍴ and CCC) were also computed. Subgroup and outlier analyses were conducted to examine the effect of site, skin tone, age, sex, body mass index (BMI), and health status on PR accuracy.</p><p><strong>Results: </strong>Collectively, 16,915 paired observations between the device and the reference ECG were analyzed from 157 subjects (male: 49.04%, age mean: 43 years, age range: 19-83 years, BMI mean: 26.4, BMI range: 17.5-52, Fitzpatrick class V-IV: 22.9%, cardiovascular condition: 24%). The PR output attained an accuracy of 1.67 bpm under no-motion (<i>n</i> = 5,621 min) and 4.39 bpm under motion (<i>n</i> = 11,294 min), satisfying the acceptance thresholds. Bias and LoA (lower, upper LoA) were -0.09 (-3.36, 3.17) bpm under no-motion and 0.51 (-8.05, 9.06) bpm under motion. MAE was 0.6 bpm in no-motion and 1.77 bpm in motion, and MAPE was 0.86% in no-motion and 2.05% in motion, with ⍴ and CCC >0.98 in both conditions. ARMS values met the clinical acceptance threshold in all relevant subgroups at each clinical site separately, excluding male subjects under motion conditions (ARMS = 5.41 bpm), with more frequent and larger outliers due to stronger forearm contractions. However, these mostly occurred in isolation and, therefore would not impact the clinical utility or usability of the device for its intended use of retrospective review and trend analysis (⍴ and CCC >0.97 and MAPE = 2.61%).</p><p><strong>Conclusion: </strong>The analytical validation conducted in this study demonstrated clinical-grade accuracy and generalizability of ML-based continuous PR estimations across a full range of physical motions, health conditions, and demographic variables known to confound PPG signals, paving the way for device usage by populations most likely to benefit from continuous PR m
导读:虽然腕戴式光电容积脉搏波(PPG)传感器在长期和连续的心律监测中发挥着重要作用,但与身体其他部位相比,腕部测量的信号受到更强烈的运动干扰。基于机器学习(ML)的算法可以改善长期脉搏率(PR)跟踪,但在临床使用时需要更严格的监管要求。本研究旨在评估使用腕带PPG传感器和基于ml的算法连续测量PR的数字健康技术的准确性。方法:志愿者参加了三个独立的临床试验,并在具有现实生活活动代表的监督方案中同时使用研究设备和fda批准的心电图(ECG)设备进行监测。主要的接受阈值是在静止和运动条件下,准确率均方根(ARMS)分别≤3次/分钟(bpm)或5次/分钟。并计算偏倚、平均绝对误差(MAE)、平均绝对百分比误差(MAPE)、一致限(LoA)以及Pearson和Lin’s一致性相关系数(CCC)。进行亚组分析和离群分析,以检验部位、肤色、年龄、性别、体重指数(BMI)和健康状况对PR准确性的影响。结果:总共分析了157名受试者(男性:49.04%,平均年龄:43岁,年龄范围:19-83岁,BMI平均值:26.4,BMI范围:17.5-52,Fitzpatrick V-IV级:22.9%,心血管疾病:24%)的设备与参考心电图之间的16,915对配对观察结果。在无运动(n = 5,621 min)和运动(n = 11,294 min)下,PR输出的精度分别为1.67 bpm和4.39 bpm,满足接受阈值。无运动时Bias和LoA(上、下LoA)分别为-0.09 (-3.36,3.17)bpm和0.51 (-8.05,9.06)bpm。无运动时MAE为0.6 bpm,运动时为1.77 bpm,无运动时MAPE为0.86%,运动时为2.05%,两种情况下CCC >为0.98。在每个临床部位的所有相关亚组中,ARMS值分别满足临床接受阈值,但不包括运动条件下的男性受试者(ARMS = 5.41 bpm),由于前臂收缩更强,异常值更频繁,更大。然而,这些大多是孤立发生的,因此不会影响器械的临床效用或可用性,用于回顾性审查和趋势分析(CCC >0.97和MAPE = 2.61%)。结论:在本研究中进行的分析验证证明了基于ml的连续PR估计的临床级准确性和通用性,该估计跨越了所有已知的混淆PPG信号的身体运动、健康状况和人口变量,为最有可能从连续PR监测中受益的人群使用设备铺平了道路。
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引用次数: 0
The State of Digital Biomarkers in Mental Health. 心理健康数字生物标志物的现状。
Q1 Computer Science Pub Date : 2024-11-22 eCollection Date: 2024-01-01 DOI: 10.1159/000542320
Ellen W McGinnis, Josh Cherian, Ryan S McGinnis
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引用次数: 0
The Imperative of Voice Data Collection in Clinical Trials. 在临床试验中收集语音数据的必要性
Q1 Computer Science Pub Date : 2024-11-13 eCollection Date: 2024-01-01 DOI: 10.1159/000541456
Guy Fagherazzi, Yaël Bensoussan
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引用次数: 0
eHealth and mHealth in Antimicrobial Stewardship Programs. 抗菌药物管理计划中的电子健康和移动健康。
Q1 Computer Science Pub Date : 2024-09-20 eCollection Date: 2024-01-01 DOI: 10.1159/000541120
Felipe Francisco Tuon, Tiago Zequinao, Marcelo Silva da Silva, Kleber Oliveira Silva

Background: The global need for rapid diagnostic methods for pathogen identification and antimicrobial susceptibility testing (AST) is underscored by the increasing bacterial resistance and limited therapeutic options, especially critical in sepsis management.

Summary: This review examines the aspects of the eHealth and mHealth in Antimicrobial Stewardship Programs (ASPs) to improve the treatment of infections and rational use of antimicrobials.

Key messages: The evolution from traditional phenotype-based methods to rapid molecular and mass spectrometry techniques has significantly decreased result turnaround times, improving patient outcomes. Despite advancements, the complex decision-making in antimicrobial therapy often exceeds the capacity of many clinicians, highlighting the importance of ASPs. These programs, integrating mHealth and eHealth, leverage technology to enhance healthcare services and patient outcomes, particularly in remote or resource-limited settings. However, the application of such technologies in antimicrobial management remains underexplored in hospitals. The development of platforms combining antimicrobial prescription data with pharmacotherapeutic algorithms and laboratory integration can significantly reduce costs and improve hospitalization times and mortality rates.

背景:摘要:本综述探讨了抗菌药物管理计划(ASPs)中电子医疗和移动医疗的各个方面,以改善感染治疗和抗菌药物的合理使用:从传统的基于表型的方法发展到快速分子和质谱技术,大大缩短了结果的周转时间,改善了患者的治疗效果。尽管取得了进步,但抗菌治疗决策的复杂性往往超出了许多临床医生的能力范围,这就凸显了 ASP 的重要性。这些计划整合了移动医疗和电子医疗,利用技术提高医疗服务和患者疗效,尤其是在偏远或资源有限的环境中。然而,这些技术在医院抗菌药物管理中的应用仍未得到充分探索。开发将抗菌药物处方数据与药物治疗算法和实验室集成相结合的平台,可以大大降低成本,缩短住院时间,提高死亡率。
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引用次数: 0
Detecting Longitudinal Trends between Passively Collected Phone Use and Anxiety among College Students. 检测大学生被动收集手机使用情况与焦虑之间的纵向趋势。
Q1 Computer Science Pub Date : 2024-09-05 eCollection Date: 2024-01-01 DOI: 10.1159/000540546
Joseph A Gyorda, Damien Lekkas, Nicholas C Jacobson

Introduction: Existing theories and empirical works link phone use with anxiety; however, most leverage subjective self-reports of phone use (e.g., validated questionnaires) that may not correspond well with true behavior. Moreover, most works linking phone use with anxiety do not interrogate associations within a temporal framework. Accordingly, the present study sought to investigate the utility of passively sensed phone use as a longitudinal predictor of anxiety symptomatology within a population particularly vulnerable to experiencing anxiety.

Methods: Using data from the GLOBEM study, which continuously collected longitudinal behavioral data from a college cohort of N = 330 students, weekly PHQ-4 anxiety subscale scores across 3 years (2019-2021) were paired with median daily phone use records from the 2 weeks prior to anxiety self-report completion. Phone use was operationalized through unlock duration which was passively curated via Apple's "Screen Time" feature. GPS-tracked location data was further utilized to specify whether an individual's phone use was at home or away from home. Within-individual and temporal associations between phone use and anxiety were modeled within an ordinal mixed-effects logistic regression framework.

Results: While there was no significant association between anxiety levels and either median total phone use or median phone use at home, participants in the top quartile of median phone use away from home were predicted to exhibit clinically significant anxiety levels 20% more frequently than participants in the bottom quartile during the first study year; however, this association weakened across successive years. Importantly, these associations remained after controlling for age, physical activity, sleep, and baseline anxiety levels and were not recapitulated when operationalizing phone use with unlock frequency.

Conclusions: These findings suggest that phone use may be leveraged as a means of mitigating or coping with anxiety in social situations outside the home, while pandemic-related developments may also have attenuated this behavior later in the study. Nevertheless, the present results suggest promise in interrogating a larger suite of objectively measured phone use behaviors within the context of social anxiety.

导言:现有的理论和实证研究将手机使用与焦虑联系在一起;然而,大多数研究利用的是对手机使用的主观自我报告(如有效问卷),这些报告可能与真实行为并不相符。此外,大多数将手机使用与焦虑联系起来的研究都没有在时间框架内对两者的关联进行分析。因此,本研究试图调查被动感知的手机使用情况作为焦虑症状纵向预测指标在焦虑症高发人群中的实用性:GLOBEM 研究持续收集了 N = 330 名大学生的纵向行为数据,利用该研究的数据,将 3 年内(2019-2021 年)每周的 PHQ-4 焦虑子量表得分与完成焦虑自我报告前 2 周的每日手机使用记录中位数配对。通过苹果公司的 "屏幕时间 "功能被动整理出的解锁时长对手机使用情况进行操作。此外,还利用 GPS 跟踪位置数据来确定个人的手机使用是在家里还是在外面。在一个序数混合效应逻辑回归框架内,对手机使用与焦虑之间的个体内部和时间关联进行了建模:虽然焦虑水平与手机总使用量中位数或在家使用量中位数之间没有明显关联,但在第一个研究年度,手机离家使用量中位数排名前四分位数的参与者比排名后四分位数的参与者在临床上表现出明显焦虑水平的频率要高出 20%;然而,这种关联在连续几年中逐渐减弱。重要的是,在控制了年龄、体力活动、睡眠和基线焦虑水平后,这些关联依然存在,而且在用解锁频率操作手机使用时,这些关联也没有再现:这些研究结果表明,在家庭以外的社交场合,使用手机可能是减轻或应对焦虑的一种手段,而在研究后期,与大流行病相关的发展也可能会削弱这种行为。尽管如此,本研究结果表明,在社交焦虑的背景下,对更多客观测量的手机使用行为进行研究是有前景的。
{"title":"Detecting Longitudinal Trends between Passively Collected Phone Use and Anxiety among College Students.","authors":"Joseph A Gyorda, Damien Lekkas, Nicholas C Jacobson","doi":"10.1159/000540546","DOIUrl":"https://doi.org/10.1159/000540546","url":null,"abstract":"<p><strong>Introduction: </strong>Existing theories and empirical works link phone use with anxiety; however, most leverage subjective self-reports of phone use (e.g., validated questionnaires) that may not correspond well with true behavior. Moreover, most works linking phone use with anxiety do not interrogate associations within a temporal framework. Accordingly, the present study sought to investigate the utility of passively sensed phone use as a longitudinal predictor of anxiety symptomatology within a population particularly vulnerable to experiencing anxiety.</p><p><strong>Methods: </strong>Using data from the GLOBEM study, which continuously collected longitudinal behavioral data from a college cohort of <i>N</i> = 330 students, weekly PHQ-4 anxiety subscale scores across 3 years (2019-2021) were paired with median daily phone use records from the 2 weeks prior to anxiety self-report completion. Phone use was operationalized through unlock duration which was passively curated via Apple's \"Screen Time\" feature. GPS-tracked location data was further utilized to specify whether an individual's phone use was at home or away from home. Within-individual and temporal associations between phone use and anxiety were modeled within an ordinal mixed-effects logistic regression framework.</p><p><strong>Results: </strong>While there was no significant association between anxiety levels and either median total phone use or median phone use at home, participants in the top quartile of median phone use away from home were predicted to exhibit clinically significant anxiety levels 20% more frequently than participants in the bottom quartile during the first study year; however, this association weakened across successive years. Importantly, these associations remained after controlling for age, physical activity, sleep, and baseline anxiety levels and were not recapitulated when operationalizing phone use with unlock frequency.</p><p><strong>Conclusions: </strong>These findings suggest that phone use may be leveraged as a means of mitigating or coping with anxiety in social situations outside the home, while pandemic-related developments may also have attenuated this behavior later in the study. Nevertheless, the present results suggest promise in interrogating a larger suite of objectively measured phone use behaviors within the context of social anxiety.</p>","PeriodicalId":11242,"journal":{"name":"Digital Biomarkers","volume":"8 1","pages":"181-193"},"PeriodicalIF":0.0,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11521436/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544330","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
Video Assessment to Detect Amyotrophic Lateral Sclerosis. 通过视频评估检测肌萎缩性脊髓侧索硬化症
Q1 Computer Science Pub Date : 2024-08-29 eCollection Date: 2024-01-01 DOI: 10.1159/000540547
Guilherme Camargo Oliveira, Quoc Cuong Ngo, Leandro Aparecido Passos, Leonardo Silva Oliveira, Stella Stylianou, João Paulo Papa, Dinesh Kumar

Introduction: Weakened facial movements are early-stage symptoms of amyotrophic lateral sclerosis (ALS). ALS is generally detected based on changes in facial expressions, but large differences between individuals can lead to subjectivity in the diagnosis. We have proposed a computerized analysis of facial expression videos to detect ALS.

Methods: This study investigated the action units obtained from facial expression videos to differentiate between ALS patients and healthy individuals, identifying the specific action units and facial expressions that give the best results. We utilized the Toronto NeuroFace Dataset, which includes nine facial expression tasks for healthy individuals and ALS patients.

Results: The best classification accuracy was 0.91 obtained for the pretending to smile with tight lips expression.

Conclusion: This pilot study shows the potential of using computerized facial expression analysis based on action units to identify facial weakness symptoms in ALS.

简介面部动作减弱是肌萎缩性脊髓侧索硬化症(ALS)的早期症状。一般根据面部表情的变化来检测 ALS,但个体之间的巨大差异会导致诊断的主观性。我们提出了一种通过计算机分析面部表情视频来检测 ALS 的方法:本研究调查了从面部表情视频中获得的动作单元,以区分 ALS 患者和健康人,并确定了效果最佳的特定动作单元和面部表情。我们使用了多伦多神经脸部数据集,其中包括针对健康人和 ALS 患者的九项面部表情任务:结果:"紧闭嘴唇假装微笑 "表情的最佳分类准确率为 0.91:这项试验研究表明,基于动作单元的计算机化面部表情分析具有识别 ALS 患者面部无力症状的潜力。
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引用次数: 0
Digital Vocal Biomarker of Smoking Status Using Ecological Audio Recordings: Results from the Colive Voice Study. 使用生态录音的数字嗓音生物标记吸烟状况:Colive Voice 研究的结果
Q1 Computer Science Pub Date : 2024-08-28 eCollection Date: 2024-01-01 DOI: 10.1159/000540327
Hanin Ayadi, Abir Elbéji, Vladimir Despotovic, Guy Fagherazzi

Introduction: The complex health, social, and economic consequences of tobacco smoking underscore the importance of incorporating reliable and scalable data collection on smoking status and habits into research across various disciplines. Given that smoking impacts voice production, we aimed to develop a gender and language-specific vocal biomarker of smoking status.

Methods: Leveraging data from the Colive Voice study, we used statistical analysis methods to quantify the effects of smoking on voice characteristics. Various voice feature extraction methods combined with machine learning algorithms were then used to produce a gender and language-specific (English and French) digital vocal biomarker to differentiate smokers from never-smokers.

Results: A total of 1,332‬ participants were included after propensity score matching (mean age = 43.6 [13.65], 64.41% are female, 56.68% are English speakers, 50% are smokers and 50% are never-smokers). We observed differences in voice features distribution: for women, the fundamental frequency F0, the formants F1, F2, and F3 frequencies and the harmonics-to-noise ratio were lower in smokers compared to never-smokers (p < 0.05) while for men no significant disparities were noted between the two groups. The accuracy and AUC of smoking status prediction reached 0.71 and 0.76, respectively, for the female participants, and 0.65 and 0.68, respectively, for the male participants.

Conclusion: We have shown that voice features are impacted by smoking. We have developed a novel digital vocal biomarker that can be used in clinical and epidemiological research to assess smoking status in a rapid, scalable, and accurate manner using ecological audio recordings.

导言:吸烟对健康、社会和经济造成的复杂后果凸显了将可靠、可扩展的吸烟状况和习惯数据收集纳入各学科研究的重要性。鉴于吸烟会影响嗓音的产生,我们旨在开发一种针对不同性别和语言的吸烟状况嗓音生物标志物:我们利用 Colive Voice 研究的数据,采用统计分析方法量化吸烟对嗓音特征的影响。然后利用各种语音特征提取方法与机器学习算法相结合,生成了一种针对不同性别和语言(英语和法语)的数字语音生物标记,用于区分吸烟者和从不吸烟者:经过倾向得分匹配后,共纳入了 1332 名参与者(平均年龄 = 43.6 [13.65],64.41% 为女性,56.68% 为英语使用者,50% 为吸烟者,50% 为从不吸烟者)。我们观察到语音特征分布的差异:对于女性而言,吸烟者的基频 F0、声母 F1、F2 和 F3 频率以及谐波噪声比均低于从不吸烟者(P < 0.05),而对于男性而言,两组之间没有明显差异。女性参与者的吸烟状态预测准确率和 AUC 分别达到 0.71 和 0.76,男性参与者的准确率和 AUC 分别达到 0.65 和 0.68:结论:我们的研究表明,嗓音特征会受到吸烟的影响。我们开发了一种新型数字声音生物标记,可用于临床和流行病学研究,利用生态录音以快速、可扩展和准确的方式评估吸烟状况。
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引用次数: 0
Automate, Illuminate, Predict: A Universal Framework for Integrating Wearable Sensors in Healthcare. 自动化、照明、预测:将可穿戴传感器整合到医疗保健领域的通用框架。
Q1 Computer Science Pub Date : 2024-08-26 eCollection Date: 2024-01-01 DOI: 10.1159/000540492
Megan K O'Brien, Kristen Hohl, Richard L Lieber, Arun Jayaraman

Background: Wearable sensors have been heralded as revolutionary tools for healthcare. However, while data are easily acquired from sensors, users still grapple with questions about how sensors can meaningfully inform everyday clinical practice and research.

Summary: We propose a simple, comprehensive framework for utilizing sensor data in healthcare. The framework includes three key processes that are applied together or separately to (1) automate traditional clinical measures, (2) illuminate novel correlates of disease and impairment, and (3) predict current and future outcomes. We demonstrate applications of the Automate-Illuminate-Predict framework using examples from rehabilitation medicine.

Key messages: Automate-Illuminate-Predict provides a universal approach to extract clinically meaningful data from wearable sensors. This framework can be applied across the care continuum to enhance patient care and inform personalized medicine through accessible, noninvasive technology.

背景:可穿戴传感器被誉为医疗保健领域的革命性工具。然而,虽然从传感器上获取数据很容易,但用户仍在为传感器如何为日常临床实践和研究提供有意义的信息而苦恼。摘要:我们提出了一个在医疗保健领域利用传感器数据的简单而全面的框架。该框架包括三个关键过程,它们可一起或单独应用于:(1)传统临床测量的自动化;(2)阐明疾病和损伤的新型相关性;以及(3)预测当前和未来的结果。我们以康复医学为例,展示了自动-启示-预测框架的应用:Automate-Illuminate-Predict 提供了一种通用方法,可从可穿戴传感器中提取有临床意义的数据。该框架可应用于整个护理过程,通过可获取的无创技术加强对患者的护理并为个性化医疗提供信息。
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引用次数: 0
An Algorithm for Automated Measurement of Kinetic Tremor Magnitude Using Digital Spiral Drawings. 使用数字螺旋绘图自动测量动力震颤幅度的算法。
Q1 Computer Science Pub Date : 2024-07-20 eCollection Date: 2024-01-01 DOI: 10.1159/000539529
Katherine Longardner, Qian Shen, Bin Tang, Brenton A Wright, Prantik Kundu, Fatta B Nahab

Introduction: Essential tremor is a common movement disorder. Numerous validated clinical rating scales exist to quantify essential tremor severity by employing rater-dependent visual observation but have limitations, including the need for trained human raters and the lack of precision and sensitivity compared to technology-based objective measures. Other continuous objective methods to quantify tremor amplitude have been developed, but frequently provide unitless measures (e.g., tremor power), limiting real-world interpretability. We propose a novel algorithm to measure kinetic tremor amplitude using digital spiral drawings, applying the V3 framework (sensor verification, analytical validation, and clinical validation) to establish reliability and clinical utility.

Methods: Archimedes spiral drawings were recorded on a digitizing tablet from participants (n = 7) enrolled in a randomized placebo control double-blinded crossover pilot trial evaluating the efficacy of oral cannabinoids in reducing essential tremor. We developed an algorithm to calculate the mean and maximum tremor amplitude derived from the spiral tracings. We compared the digitally measured tremor amplitudes to manual measurement to evaluate sensor reliability, determined the test-retest reliability of the digital output across two short-interval repeated measures, and compared the digital measure to kinetic tremor severity graded using The Essential Tremor Rating Assessment Scale (TETRAS) score for spiral drawings.

Results: This algorithm for automated assessment of kinetic tremor amplitude from digital spiral tracings demonstrated a high correlation with manual spot measures of tremor amplitude, excellent test-retest reliability, and a high correlation with human ratings of the TETRAS score for spiral drawing severity when the tremor severity was rated "slight tremor" or worse.

Discussion: This digital measure provides a simple and clinically relevant evaluation of kinetic tremor amplitude that shows promise as a potential future endpoint for use in clinical trials of essential tremor.

简介本质性震颤是一种常见的运动障碍。目前有许多经过验证的临床评分量表,可通过依赖于评分者的视觉观察来量化本质性震颤的严重程度,但这些量表都存在局限性,包括需要训练有素的人类评分者,以及与基于技术的客观测量相比缺乏精确性和灵敏度。其他量化震颤振幅的连续客观方法也已开发出来,但经常提供无单位的测量值(如震颤功率),限制了对现实世界的解释能力。我们提出了一种利用数字螺旋图测量运动性震颤振幅的新型算法,并应用 V3 框架(传感器验证、分析验证和临床验证)来确定其可靠性和临床实用性:参加随机安慰剂对照双盲交叉试验的参与者(n = 7)用数字化平板电脑记录了阿基米德螺旋图,该试验评估了口服大麻素对减轻本质性震颤的疗效。我们开发了一种算法,用于计算从螺旋轨迹中得出的平均和最大震颤幅度。我们将数字测量的震颤振幅与人工测量的震颤振幅进行了比较,以评估传感器的可靠性,确定了两次短间隔重复测量中数字输出的测试-再测试可靠性,并将数字测量结果与使用本质性震颤分级评估量表(TETRAS)对螺旋描记图进行评分的本质性震颤严重程度进行了比较:这种通过数字螺旋描记图自动评估运动性震颤振幅的算法与震颤振幅的人工定点测量结果具有很高的相关性、极好的测试-再测可靠性,并且在震颤严重程度被评为 "轻微震颤 "或更严重时,与螺旋描记图严重程度的 TETRAS 评分的人工评分具有很高的相关性:讨论:这种数字测量方法提供了一种简单且与临床相关的运动性震颤振幅评估,有望成为未来用于本质性震颤临床试验的潜在终点。
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引用次数: 0
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Digital Biomarkers
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