@misc{KonigorskiWernickeSlosareketal.2022,
  author    = {Konigorski, Stefan and Wernicke, Sarah and Slosarek, Tamara and Zenner, Alexander M. and Strelow, Nils and Ruether, Darius F. and Henschel, Florian and Manaswini, Manisha and Pottb{\"a}cker, Fabian and Edelman, Jonathan A. and Owoyele, Babajide and Danieletto, Matteo and Golden, Eddye and Zweig, Micol and Nadkarni, Girish N. and B{\"o}ttinger, Erwin},
  title     = {StudyU: a platform for designing and conducting innovative digital N-of-1 trials},
  series = {Journal of medical internet research},
  volume    = {24},
  journal   = {Journal of medical internet research},
  number    = {7},
  publisher = {Healthcare World},
  address   = {Richmond, Va.},
  issn      = {1439-4456},
  doi       = {10.2196/35884},
  pages     = {12},
  year      = {2022},
  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.},
  language  = {en}
}
@article{WetzelKochPreiseretal.2022,
  author    = {Wetzel, Anna-Jasmin and Koch, Roland and Preiser, Christine and M{\"u}ller, Regina and Klemmt, Malte and Ranisch, Robert and Ehni, Hans-J{\"o}rg and Wiesing, Urban and Rieger, Monika A. and Henking, Tanja and Joos, Stefanie},
  title     = {Ethical, legal, and social implications of symptom checker Apps in primary Health Care (CHECK.APP)},
  series = {JMIR Research Protocols},
  volume    = {11},
  journal   = {JMIR Research Protocols},
  number    = {5},
  publisher = {JMIR Research Protocols},
  address   = {Toronto},
  issn      = {1929-0748},
  doi       = {10.2196/34026},
  pages     = {11},
  year      = {2022},
  abstract  = {Background: Symptom checker apps (SCAs) are accessible tools that provide early symptom assessment for users. The ethical, legal, and social implications of SCAs and their impact on the patient-physician relationship, the health care providers, and the health care system have sparsely been examined. This study protocol describes an approach to investigate the possible impacts and implications of SCAs on different levels of health care provision. It considers the perspectives of the users, nonusers, general practitioners (GPs), and health care experts. Objective: We aim to assess a comprehensive overview of the use of SCAs and address problematic issues, if any. The primary outcomes of this study are empirically informed multi-perspective recommendations for different stakeholders on the ethical, legal, and social implications of SCAs. Methods: Quantitative and qualitative methods will be used in several overlapping and interconnected study phases. In study phase 1, a comprehensive literature review will be conducted to assess the ethical, legal, social, and systemic impacts of SCAs. Study phase 2 comprises a survey that will be analyzed with a logistic regression. It aims to assess the user degree of SCAs in Germany as well as the predictors for SCA usage. Study phase 3 will investigate self-observational diaries and user interviews, which will be analyzed as integrated cases to assess user perspectives, usage pattern, and arising problems. Study phase 4 will comprise GP interviews to assess their experiences, perspectives, self-image, and concepts and will be analyzed with the basic procedure by Kruse. Moreover, interviews with health care experts will be conducted in study phase 3 and will be analyzed by using the reflexive thematical analysis approach of Braun and Clark. Results: Study phase 1 will be completed in November 2021. We expect the results of study phase 2 in December 2021 and February 2022. In study phase 3, interviews are currently being conducted. The final study endpoint will be in February 2023. Conclusions: The possible ethical, legal, social, and systemic impacts of a widespread use of SCAs that affect stakeholders and stakeholder groups on different levels of health care will be identified. The proposed methodological approach provides a multifaceted and diverse empirical basis for a broad discussion on these implications.},
  language  = {en}
}
@misc{KonigorskiWernickeSlosareketal.2021,
  author    = {Konigorski, Stefan and Wernicke, Sarah and Slosarek, Tamara and Zenner, Alexander Maximilian and Strelow, Nils and Ruether, Darius Ferenc and Henschel, Florian and Manaswini, Manisha and Pottb{\"a}cker, Fabian and Edelman, Jonathan Antonio and Owoyele, Babajide and Danieletto, Matteo and Golden, Eddye and Zweig, Micol and Nadkarni, Girish N. and Bottinger, Erwin},
  title     = {StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials},
  series = {Zweitver{\"o}ffentlichungen der Universit{\"a}t Potsdam : Reihe der Digital Engineering Fakult{\"a}t},
  journal   = {Zweitver{\"o}ffentlichungen der Universit{\"a}t Potsdam : Reihe der Digital Engineering Fakult{\"a}t},
  number    = {12},
  doi       = {10.25932/publishup-58037},
  url       = {http://nbn-resolving.de/urn:nbn:de:kobv:517-opus4-580370},
  pages     = {12},
  year      = {2021},
  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.},
  language  = {en}
}
@article{KonigorskiWernickeSlosareketal.2021,
  author    = {Konigorski, Stefan and Wernicke, Sarah and Slosarek, Tamara and Zenner, Alexander Maximilian and Strelow, Nils and Ruether, Darius Ferenc Ruether and Henschel, Florian and Manaswini, Manisha and Pottb{\"a}cker, Fabian and Edelman, Jonathan Antonio and Owoyele, Babajide and Danieletto, Matteo and Golden, Eddye and Zweig, Micol and Nadkarni, Girish N. and Bottinger, Erwin},
  title     = {StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials},
  series = {Journal of Medical Internet Research},
  volume    = {24},
  journal   = {Journal of Medical Internet Research},
  edition   = {7},
  publisher = {JMIR Publications},
  address   = {Richmond, Virginia, USA},
  issn      = {1438-8871},
  doi       = {10.2196/35884},
  pages     = {12},
  year      = {2021},
  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.},
  language  = {en}
}