医学考博英语2025年真题精讲 | 阅读理解 (4/6)

Passage Four

The increasing digitisation of health‑care has led to wearable devices becoming a frequent contributor to health‑care decisions. Wearable devices are a developing group of health‑care technologies that include smartwatches and fitness trackers. These technologies have a substantial number of users, with a fifth of adults in the USA now using a wearable device. These devices provide objective data that can enhance the doctor‑patient relationship and improve the overall quality of clinical encounters. Unfortunately, survey data from six federally qualified health centres in the USA published in 2022 show that wearable devices and other digital technologies are not used as widely in low‑income and minority populations, with cost and education being issues that substantially affect use. In this comment, we attempt to bring attention to the increasing issues in generalisability for wearable devices driven by the non‑inclusion of these populations in ongoing research studies.

Historically, the implementation of any high‑risk medical device or drug therapy requires thorough validation in a representative population. Digital technology companies have avoided traditional approval processes by originally marketing consumer products as low‑risk wellness tools. The increase in the number of wearable devices approved by the US Food and Drug Administration(FDA) requires the conversation on bias and equity within the wearable device industry to be broadened, especially as these consumer devices ( e. g. smartwatches ) are increasingly applied to medical indications, such as arrhythmia detection and at‑home pulse oximetry. The FDA 510(k) clearance process, which is the way to FDA approval for most wearable devices, only requires equivalent safety and efficacy to products that are already available. With initial wearable device studies not being proactive in setting requirements for equity, the deficits in the representation of people of colour, rural communities, and populations with low digital literacy have continued.

The future of chronic disease management relies on collaboration between telemedicine, sensor technology, and artificial intelligence. Extensive research on incorporating artificial intelligence into wearable devices has already produced positive results in arrhythmia detection and physical fitness. Nonetheless, the continued lack of diversity in study populations has increased the risk of poorly generalisable model of artificial intelligence. The Apple Heart Study with 419,297 participants, is the most comprehensive study to evaluate the accuracy of an irregular pulse detection algorithm in a general population. The high positive predictive value of an initial irregular pulse notification for subsequent electrocardiogram‑confirmed atrial fibrillation allowed for FDA clearance of the feature. However, the requirement to own an Apple product biased the study with a young, wealthy, and technology‑proficient population. Since 2020, other companies( e. g. Fitbit and Samsung) have obtained similar FDA clearance for passive arrhythmia monitoring. However, each independent algorithm will require extensive clinical validation, highlighting how equity issues will persist as wearable device use continues.

【参考译文】

医疗保健领域数字化水平不断提升，可穿戴设备日益成为医疗决策的重要依据。可穿戴设备是一类仍在发展的医疗技术，包括智能手表和运动健康手环。该类技术拥有庞大用户群体，如今美国五分之一的成年人都在使用可穿戴设备。这些设备可提供客观数据，有助于改善医患关系，提升临床问诊的整体质量。但遗憾的是，2022 年发布的、来自美国六家联邦合格医疗中心的调查数据显示，可穿戴设备及其他数字技术在低收入群体与少数族裔群体中的普及度并不高，成本与认知水平是制约其使用的两大关键因素。本文旨在提醒业界注意：现有研究未纳入上述人群，正造成可穿戴设备普适性方面愈发突出的问题。

从过往经验来看，任何高风险医疗器械或药物疗法投入应用前，都必须在具有代表性的人群中完成充分验证。数字科技企业最初将产品定位为低风险健康消费工具，借此规避了传统审批流程。如今美国食品药品监督管理局（FDA）批准的可穿戴设备数量不断增多，这就需要我们进一步探讨可穿戴设备行业存在的偏见与公平性问题；尤其当下这类消费级设备（例如智能手表）越来越多地用于心律失常检测、居家脉搏血氧监测等医疗用途。绝大多数可穿戴设备通过 FDA 的 510 (k) 许可流程获得审批，该流程仅要求产品的安全性与有效性和已上市同类产品相当。早期可穿戴设备相关研究并未主动设立公平性相关要求，因此有色人种、农村群体以及数字素养较低人群样本不足的问题始终存在。

慢性病管理的未来，离不开远程医疗、传感器技术与人工智能三者的协同。大量将人工智能融入可穿戴设备的研究，已经在心律失常识别、体能监测方面取得不错成果。尽管如此，研究受试人群多样性持续缺失，会加大人工智能模型通用性不足的风险。苹果心脏研究共计 419297 名受试者，是评估脉搏不规则检测算法在普通人群中准确度的规模最大的研究。该设备初次提示脉搏异常后，后续经心电图确诊房颤的阳性预测值很高，这项结果让该功能拿到了 FDA 许可。但该研究要求受试者必须拥有苹果产品，使得受试人群偏向年轻、富裕、精通科技的群体，带来样本偏差。2020 年以来，Fitbit、三星等其他企业也取得心律失常被动监测功能的同类 FDA 许可。但每一套独立算法都需要充分的临床验证，这也表明：随着可穿戴设备持续普及，公平性相关问题仍会长期存在。

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