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利用患者生成数据进行真实世界临床结局测量的数字健康技术:系统范围界定综述。

Digital Health Technology for Real-World Clinical Outcome Measurement Using Patient-Generated Data: Systematic Scoping Review.

机构信息

Department for Continuing Education, University of Oxford, Oxford, United Kingdom.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.

出版信息

J Med Internet Res. 2023 Oct 11;25:e46992. doi: 10.2196/46992.


DOI:10.2196/46992
PMID:37819698
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10600647/
Abstract

BACKGROUND: Digital health technologies (DHTs) play an ever-expanding role in health care management and delivery. Beyond their use as interventions, DHTs also serve as a vehicle for real-world data collection to characterize patients, their care journeys, and their responses to other clinical interventions. There is a need to comprehensively map the evidence-across all conditions and technology types-on DHT measurement of patient outcomes in the real world. OBJECTIVE: We aimed to investigate the use of DHTs to measure real-world clinical outcomes using patient-generated data. METHODS: We conducted this systematic scoping review in accordance with the Joanna Briggs Institute methodology. Detailed eligibility criteria documented in a preregistered protocol informed a search strategy for the following databases: MEDLINE (Ovid), CINAHL, Cochrane (CENTRAL), Embase, PsycINFO, ClinicalTrials.gov, and the EU Clinical Trials Register. We considered studies published between 2000 and 2022 wherein digital health data were collected, passively or actively, from patients with any specified health condition outside of clinical visits. Categories for key concepts, such as DHT type and analytical applications, were established where needed. Following screening and full-text review, data were extracted and analyzed using predefined fields, and findings were reported in accordance with established guidelines. RESULTS: The search strategy identified 11,015 publications, with 7308 records after duplicates and reviews were removed. After screening and full-text review, 510 studies were included for extraction. These studies encompassed 169 different conditions in over 20 therapeutic areas and 44 countries. The DHTs used for mental health and addictions research (111/510, 21.8%) were the most prevalent. The most common type of DHT, mobile apps, was observed in approximately half of the studies (250/510, 49%). Most studies used only 1 DHT (346/510, 67.8%); however, the majority of technologies used were able to collect more than 1 type of data, with the most common being physiological data (189/510, 37.1%), clinical symptoms data (188/510, 36.9%), and behavioral data (171/510, 33.5%). Overall, there has been real growth in the depth and breadth of evidence, number of DHT types, and use of artificial intelligence and advanced analytics over time. CONCLUSIONS: This scoping review offers a comprehensive view of the variety of types of technology, data, collection methods, analytical approaches, and therapeutic applications within this growing body of evidence. To unlock the full potential of DHT for measuring health outcomes and capturing digital biomarkers, there is a need for more rigorous research that goes beyond technology validation to demonstrate whether robust real-world data can be reliably captured from patients in their daily life and whether its capture improves patient outcomes. This study provides a valuable repository of DHT studies to inform subsequent research by health care providers, policy makers, and the life sciences industry. TRIAL REGISTRATION: Open Science Framework 5TMKY; https://osf.io/5tmky/.

摘要

背景:数字健康技术(DHT)在医疗保健管理和提供方面发挥着越来越重要的作用。除了作为干预措施的应用外,DHT 还可作为收集真实世界数据的工具,用于描述患者、他们的护理旅程以及他们对其他临床干预措施的反应。因此,我们需要全面地了解所有条件和技术类型的 DHT 在真实世界中对患者结局的测量证据。

目的:我们旨在研究使用 DHT 测量真实世界的临床结局。

方法:我们按照乔纳森·布利格研究所(Joanna Briggs Institute)的方法进行了本次系统范围的综述。预注册方案中详细记录的详细纳入标准为以下数据库制定了搜索策略:MEDLINE(Ovid)、CINAHL、Cochrane(CENTRAL)、Embase、PsycINFO、ClinicalTrials.gov 和欧盟临床试验注册中心。我们考虑了在 2000 年至 2022 年期间发表的研究,其中从任何特定健康状况的患者处收集了数字健康数据,无论是在临床访问之外被动收集还是主动收集。在需要的情况下,为 DHT 类型和分析应用等关键概念建立了类别。在进行筛选和全文审查后,使用预定义字段提取和分析数据,并根据既定指南报告研究结果。

结果:搜索策略确定了 11015 篇出版物,在去除重复项和审查后,剩余 7308 篇记录。经过筛选和全文审查,共纳入 510 项研究。这些研究涵盖了 20 多个治疗领域和 44 个国家的 169 种不同疾病。用于精神健康和成瘾研究的 DHT(111/510,21.8%)最为常见。观察到最常见的 DHT,即移动应用程序,在大约一半的研究中(250/510,49%)。大多数研究仅使用了 1 种 DHT(346/510,67.8%);然而,大多数技术都能够收集超过 1 种类型的数据,最常见的是生理数据(189/510,37.1%)、临床症状数据(188/510,36.9%)和行为数据(171/510,33.5%)。总体而言,随着时间的推移,证据的深度和广度、DHT 类型数量以及人工智能和高级分析的使用都在不断增加。

结论:本范围综述全面展示了这一快速发展领域中各种技术、数据、收集方法、分析方法和治疗应用的情况。为了充分发挥 DHT 在测量健康结局和捕捉数字生物标志物方面的潜力,需要开展更严格的研究,不仅仅验证技术,还要证明是否能够从患者的日常生活中可靠地获取稳健的真实世界数据,以及获取这些数据是否能够改善患者结局。本研究提供了一个有价值的 DHT 研究资料库,为医疗保健提供者、政策制定者和生命科学行业的后续研究提供信息。

试验注册:Open Science Framework 5TMKY;https://osf.io/5tmky/。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/81e04ec5de42/jmir_v25i1e46992_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/7689d9529688/jmir_v25i1e46992_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/671e2d1c6102/jmir_v25i1e46992_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/56d34062fb57/jmir_v25i1e46992_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/cf71f82d8a6b/jmir_v25i1e46992_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/15aadfde9c54/jmir_v25i1e46992_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/f49570c1a92f/jmir_v25i1e46992_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/81e04ec5de42/jmir_v25i1e46992_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/7689d9529688/jmir_v25i1e46992_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/671e2d1c6102/jmir_v25i1e46992_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/56d34062fb57/jmir_v25i1e46992_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/cf71f82d8a6b/jmir_v25i1e46992_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/15aadfde9c54/jmir_v25i1e46992_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/f49570c1a92f/jmir_v25i1e46992_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e04d/10600647/81e04ec5de42/jmir_v25i1e46992_fig7.jpg

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