@article{8d69b60c714a44a2bf19ce82f40bc98c,
title = "StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials",
abstract = "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 app with innovative user-centric elements for participants to partake in trials published through the StudyU Designer to 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.",
keywords = "N-of-1 trial, SCED, app, digital health, digital interventions, mobile application, single-case experimental design, web application",
author = "Stefan Konigorski and Sarah Wernicke and Tamara Slosarek and Zenner, {Alexander M.} and Nils Strelow and Ruether, {Darius F.} and Florian Henschel and Manisha Manaswini and Fabian Pottb{\"a}cker and Edelman, {Jonathan A.} and Babajide Owoyele and Matteo Danieletto and Eddye Golden and Micol Zweig and Nadkarni, {Girish N.} and Erwin B{\"o}ttinger",
note = "Funding Information: This work has received funding from the European Union's Horizon 2020 research and innovation program under the grant agreement 826117 Smart4Health, building a citizen-centered EU-electronic health record exchange for personalized health, and from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation; project 491466077). Funding Information: This work has received funding from the European Union{\textquoteright}s Horizon 2020 research and innovation program under the grant agreement 826117 Smart4Health, building a citizen-centered EU–electronic health record exchange for personalized health, and from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation; project 491466077). Publisher Copyright: {\textcopyright} Stefan Konigorski, Sarah Wernicke, Tamara Slosarek, Alexander M Zenner, Nils Strelow, Darius F Ruether, Florian Henschel, Manisha Manaswini, Fabian Pottb{\"a}cker, Jonathan A Edelman, Babajide Owoyele, Matteo Danieletto, Eddye Golden, Micol Zweig, Girish N Nadkarni, Erwin B{\"o}ttinger.",
year = "2022",
month = jul,
day = "1",
doi = "10.2196/35884",
language = "English",
volume = "24",
journal = "Journal of Medical Internet Research",
issn = "1439-4456",
publisher = "JMIR Publications Inc.",
number = "7",
}