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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Dec 21, 2021
Date Accepted: Apr 18, 2022

The final, peer-reviewed published version of this preprint can be found here:

StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials

Konigorski S, Wernicke S, Slosarek T, Zenner AM, Strelow N, Ruether FD, Henschel F, Manaswini M, Pottbäcker F, Edelman JA, Owoyele B, Danieletto M, Golden E, Zweig M, Nadkarni G, Böttinger E

StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials

J Med Internet Res 2022;24(7):e35884

DOI: 10.2196/35884

PMID: 35787512

PMCID: 9297132

StudyU: a platform for designing and conducting innovative digital N-of-1 trials

  • Stefan Konigorski; 
  • Sarah Wernicke; 
  • Tamara Slosarek; 
  • Alexander M. Zenner; 
  • Nils Strelow; 
  • Ferenc D. Ruether; 
  • Florian Henschel; 
  • Manisha Manaswini; 
  • Fabian Pottbäcker; 
  • Jonathan A. Edelman; 
  • Babajide Owoyele; 
  • Matteo Danieletto; 
  • Eddye Golden; 
  • Micol Zweig; 
  • Girish Nadkarni; 
  • Erwin Böttinger

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 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.


 Citation

Please cite as:

Konigorski S, Wernicke S, Slosarek T, Zenner AM, Strelow N, Ruether FD, Henschel F, Manaswini M, Pottbäcker F, Edelman JA, Owoyele B, Danieletto M, Golden E, Zweig M, Nadkarni G, Böttinger E

StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials

J Med Internet Res 2022;24(7):e35884

DOI: 10.2196/35884

PMID: 35787512

PMCID: 9297132

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