论文标题
研究u:设计和进行创新的数字N-1-1-1试验平台
StudyU: a platform for designing and conducting innovative digital N-of-1 trials
论文作者
论文摘要
N-1-1试验是评估个体治疗效果并得出个性化治疗策略的黄金标准研究设计。数字工具有可能在规模和范围方面启动N-OF-1试验的新时代,但尚无功能功能的平台。在这里,我们介绍了包括研究工设计师和研究U应用在内的开源研究U平台。与研究U的设计师一起,为科学家提供了一个协作的Web应用程序,以数字方式指定,发布和进行N-OF-1试验。该研究U应用程序是一种智能手机应用程序,具有创新的以用户为中心的元素,供参与者参加已发表的试验,并评估不同干预措施对其健康的影响。因此,研究U平台允许全世界的临床医生和研究人员以安全的方式轻松设计和进行数字N-OF-1试验。我们设想,研究u可以改变针对患者和健康个体的个性化疗法的景观,使自我优化和医学的证据生成和个性化证据,并可以融入临床实践中。
N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully-functional platforms are not yet available. Here, we present the open source StudyU platform which includes the StudyU designer and StudyU app. With the StudyU designer, scientists are given a collaborative web application to digitally specify, publish, and conduct N-of-1 trials. The StudyU app is a smartphone application with innovative user-centric elements for participants to partake in the published trials and assess the effects of different interventions on their health. Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner. We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, democratize and personalize evidence generation for self-optimization and medicine, and can be integrated in clinical practice.