背景:数字健康技术(DHT)在医疗保健管理和交付中发挥着越来越大的作用。除了它们作为干预措施,DHT还可以作为真实世界数据收集的载体,以表征患者的特征。他们的护理旅程,以及他们对其他临床干预措施的反应。需要在现实世界中对患者结果的DHT测量上全面映射所有条件和技术类型的证据。
目的:我们的目的是利用患者产生的数据研究使用DHT来衡量真实世界的临床结果。
方法:我们根据JoannaBriggs研究所的方法进行了系统的范围审查。预先注册的方案中记录的详细资格标准为以下数据库提供了搜索策略:MEDLINE(Ovid),CINAHL,科克伦(中部),Embase,PsycINFO,ClinicalTrials.gov,和欧盟临床试验注册。我们考虑了2000年至2022年之间发表的数字健康数据收集研究,被动或主动,来自临床就诊以外的任何特定健康状况的患者。关键概念的类别,如DHT类型和分析应用,在需要的地方建立。经过筛选和全文审查,使用预定义的字段提取和分析数据,并按照既定指南报告调查结果。
结果:搜索策略确定了11,015种出版物,删除了重复和评论后的7308条记录。经过筛选和全文审查,包括510项研究进行提取。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。用于心理健康和成瘾研究的DHT(111/510,21.8%)最为普遍。最常见的DHT类型,移动应用程序,在大约一半的研究中观察到(250/510,49%)。大多数研究仅使用1DHT(346/510,67.8%);然而,使用的大多数技术都能够收集多种类型的数据,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%)。总的来说,证据的深度和广度都有了真正的增长,DHT类型的数量,随着时间的推移,人工智能和高级分析的使用。
结论:本范围审查提供了各种技术类型的全面视图,数据,收集方法,分析方法,以及越来越多的证据中的治疗应用。为了释放DHT在测量健康结果和捕获数字生物标志物方面的全部潜力,有必要进行更严格的研究,超越技术验证,以证明是否可以在患者日常生活中可靠地捕获稳健的现实世界数据,以及其捕获是否可以改善患者预后.这项研究提供了一个有价值的DHT研究库,为医疗保健提供者的后续研究提供信息。政策制定者,和生命科学产业。
背景:开放科学框架5TMKY;https://osf.io/5tmky/。
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.
We aimed to investigate the use of DHTs to measure real-world clinical outcomes using patient-generated data.
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.
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.
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.
Open Science Framework 5TMKY; https://osf.io/5tmky/.