Roy, Asim
Bruce, Charles
Schulte, Phillip
Olson, Lyle
Pola, Manasa
Funding for this research was provided by:
Arizona State University (No Award Number)
Article History
Received: 25 February 2020
Accepted: 23 June 2020
First Online: 8 July 2020
Ethics approval and consent to participate
: Subjects in this research study represent one arm of a two-arm randomized clinical trial [CitationRef removed]. Patients assigned to the active intervention and monitoring arm were included. As part of the parent trial, all subjects provided written informed consent that their data collected as part of the parent trial could be used in research. The trial was approved by the Mayo Clinic Institutional Review Board (reference# 15–001448); the IRB also approved sharing of a limited de-identified dataset with Dr. Roy (ASU) as an external partner in this research study.
: Patients provided written informed consent which acknowledges that study results may be made public, but individually identifying information will not be used in any publication.Exact wording on consent document is “If the results of this study are made public, information that identifies you will not be used.” And “If you are enrolled in the study, you will be identified by a study number. Only the study staff will have access to the link between your study number and your identifying information. Your identifying information will not be released outside of Mayo Clinic and any publications will exclude any kind of identifiers that could be linked with you.”
: ASU and Mayo Clinic has filed a nonprovisional patent application on this method titled “<i>Method and Apparatus for Event Prediction for a Physical System Based on Data Solely Collected from the Physical System</i>” on October 18, 2019.