The utility and impact of digital endpoints for improving breast cancer outcomes.

IF 1.8 4区医学 Q3 HEALTH CARE SCIENCES & SERVICES

Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-08-11 DOI:10.1080/14737167.2024.2390056

Ismail Jatoi, Jonathan A L Gelfond

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引用次数: 0

Abstract

Introduction: In breast cancer clinical trials utilizing digital endpoints, wearable sensors record participants' health information during activities of daily living. These sensors are worn on the wrist or finger, placed as a skin patch or headband, or embedded on clothing. Data collected from wearable sensors form the basis of a digital endpoint, useful for determining effects of novel treatments on health outcomes, particularly quality-of-life outcomes.

Areas covered: References for this article were selected from a PubMed search spanning from 1 January 2017,to 1 July 2024, using the terms 'wearable sensors,' 'digital endpoints,' 'virtualtrials,' 'breast cancer.' Additional articles from the authors' personal collection of papers and reviewers suggestions were also used.

Expert opinion: Digital endpoints must be validated as proper surrogate measures for healthcare outcomes, prior to their use in breast cancer trials. Wearable sensors may introduce biases, such as 'missing not-at-random bias,' and perhaps even exacerbate disparities in healthcare outcomes if patients not comfortable with their use are excluded from clinical trials, or if the accuracy of sensors varies between racial and ethnic groups. Therefore, before embarking on trials with digital endpoints, validation studies are required, and limitations and risks of such trials need to be addressed.

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数字终点对改善乳腺癌预后的作用和影响。

简介：乳腺癌临床试验利用数字终点、可穿戴传感器记录参与者在日常生活活动中的健康信息：在使用数字终点的乳腺癌临床试验中，可穿戴传感器记录了参与者在日常生活中的健康信息。这些传感器可佩戴在手腕或手指上，或作为皮肤贴片或头带，或嵌入衣物。可穿戴传感器收集的数据构成了数字终点的基础，有助于确定新型疗法对健康结果的影响，尤其是对生活质量的影响：本文的参考文献选自PubMed搜索，时间跨度为2017年1月1日至2024年7月1日，使用的术语为 "可穿戴传感器"、"数字终点"、"虚拟试验"、"乳腺癌"。此外，还采用了作者个人收集的其他文章和审稿人的建议：数字终点在用于乳腺癌试验之前必须经过验证，以作为医疗保健结果的适当替代指标。可穿戴传感器可能会带来一些偏差，如 "随机缺失偏差"，如果不习惯使用传感器的患者被排除在临床试验之外，或者传感器的准确性在不同种族和民族群体之间存在差异，那么这些偏差甚至可能会加剧医疗结果的差异。因此，在开展数字终点试验之前，需要进行验证研究，并解决此类试验的局限性和风险问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Pharmacoeconomics & Outcomes Research HEALTH CARE SCIENCES & SERVICES-PHARMACOLOGY & PHARMACY

CiteScore

4.00

自引率

4.30%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Review of Pharmacoeconomics & Outcomes Research (ISSN 1473-7167) provides expert reviews on cost-benefit and pharmacoeconomic issues relating to the clinical use of drugs and therapeutic approaches. Coverage includes pharmacoeconomics and quality-of-life research, therapeutic outcomes, evidence-based medicine and cost-benefit research. All articles are subject to rigorous peer-review. The journal adopts the unique Expert Review article format, offering a complete overview of current thinking in a key technology area, research or clinical practice, augmented by the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results Article Highlights – an executive summary of the author’s most critical points.