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基于应用程序的医疗设备评估个体身体能力的有效性和可靠性。

Validity and reliability of an app-based medical device to empower individuals in evaluating their physical capacities.

机构信息

SENS, Univ. Grenoble Alpes, Grenoble, France.

INRAE, UNH, CRNH Auvergne, Clermont Auvergne University, Clermont-Ferrand, France.

出版信息

PLoS One. 2023 Aug 10;18(8):e0289874. doi: 10.1371/journal.pone.0289874. eCollection 2023.

Abstract

BACKGROUND

Cardiorespiratory fitness and muscle strength are valid markers of health and strong predictors of mortality and morbidity. The tests used to measure these variables require in-person visits with specialized equipment and trained personnel-leading to organizational constraints both for patients and hospitals, and making them difficult to implement at a large scale. In this context, technologies embedded in smartphones offer new opportunities to develop remote tests.

OBJECTIVES

This study aimed to test the validity and reliability of MediEval, a newly developed app-based medical device that allows individuals to perform the 6-minute walk test (6MWT) and the 30-second sit-to-stand (30s-STS) test on their own using GPS signal and camera detection with a skeleton extraction algorithm.

METHODS

A total of 53 healthy adults performed the two tests in three different sessions to determine the intra- and inter-day reproducibility. Test validity was assessed by comparing the results obtained from the app to gold standard measures. Pearson correlations and concordance correlation coefficients, the relative measurement error, intraclass correlation coefficients, the standard error of measure and the minimal detectable change were computed for each test.s.

RESULTS

The results revealed high to excellent validity of the app in comparison to gold standards (ρ = 0.84 for the 6MWT and ρ = 0.99 for the 30s-STS test) with low relative measurement error. The mean differences between the app and the gold standard measures were 8.96m for the 6MWT and 0.28 repetition for the 30s-STS test. Both tests had good test-retest reliability (ICCs = 0.77). The minimal detectable changes were respectively 97.56 meters for the 6MWT and 7.37 repetitions for the 30s-STS test.

CONCLUSION

The MediEval medical device proposes valid and reproducible measures of the 6MWT and the 30s-STS test. This device holds promise for monitoring the physical activity of large epidemiologic cohorts while refining patient experience and improving the scalability of the healthcare system. Considering minimal detectable change values, it may be important to ask participants to perform several tests and average them to improve accuracy. Future studies in clinical context are needed to evaluate the responsiveness and the smallest detectable changes of the device for specific populations with chronic diseases.

摘要

背景

心肺适能和肌肉力量是健康的有效指标,也是死亡率和发病率的强有力预测指标。用于测量这些变量的测试需要使用专门的设备和经过培训的人员进行现场访问,这对患者和医院都带来了组织上的限制,使其难以大规模实施。在这种情况下,智能手机中嵌入的技术为开发远程测试提供了新的机会。

目的

本研究旨在测试 MediEval 的有效性和可靠性,MediEval 是一种新开发的基于应用程序的医疗设备,允许个人使用 GPS 信号和相机检测以及骨骼提取算法自行进行 6 分钟步行测试(6MWT)和 30 秒坐站测试(30s-STS)。

方法

共有 53 名健康成年人在三个不同的时段进行了这两项测试,以确定日内和日间的可重复性。通过将应用程序获得的结果与金标准测量值进行比较,评估测试的有效性。计算了每个测试的 Pearson 相关系数和一致性相关系数、相对测量误差、组内相关系数、测量标准误差和最小可检测变化。

结果

与金标准相比,该应用程序在 6MWT 中具有高到极好的有效性(ρ=0.84),在 30s-STS 测试中具有极好的有效性(ρ=0.99),相对测量误差较低。应用程序与金标准测量值之间的平均差异为 6MWT 为 8.96m,30s-STS 测试为 0.28 次重复。两项测试的测试重测信度均较好(ICC=0.77)。6MWT 的最小可检测变化分别为 97.56 米,30s-STS 测试为 7.37 次重复。

结论

MediEval 医疗设备可提供有效且可重复的 6MWT 和 30s-STS 测试结果。该设备有望在监测大型流行病学队列的身体活动的同时,改善患者体验并提高医疗保健系统的可扩展性。考虑到最小可检测变化值,要求参与者进行多次测试并对其进行平均以提高准确性可能很重要。需要在临床环境中进行未来的研究,以评估该设备对患有慢性疾病的特定人群的反应性和最小可检测变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/256d/10414674/281d1670211b/pone.0289874.g001.jpg

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