Atwater, Brett D.
Guo, Jennifer D.
Keshishian, Allison
Delinger, Rachel
Russ, Cristina
Rosenblatt, Lisa
Jiang, Jenny
Yuce, Huseyin
Ferri, Mauricio
Funding for this research was provided by:
Pfizer
Bristol-Myers Squibb
Article History
Accepted: 24 May 2023
First Online: 2 August 2023
Declarations
:
: Brett D. Atwater has received research grants from Abbott and Boston Scientific and acts as adviser to, Biotronik, Biosense Webster, Pfizer and Medtronic. Lisa Rosenblatt, Jenny Jiang, and Mauricio Ferri are paid employees of Bristol-Myers Squibb. Jennifer D. Guo was a paid employee of Bristol-Myers Squibb at the time of this study. Cristina Russ is a paid employee of Pfizer. Allison Keshishian and Rachel Delinger were a paid employees of STATinMED at the time of this study; STATinMED is a paid consultant to Bristol-Myers Squibb and Pfizer in connection with the development of this manuscript. Huseyin Yuce has no potential conflicts to report.
: This is an observational study. Since this study did not involve the collection, use, or transmittal of individually identifiable data, it was deemed exempt from Institutional Review Board review by Solutions IRB. Both the datasets and the security of the offices where analysis was completed (and where the datasets are kept) meet the requirements of the Health Insurance Portability and Accountability Act of 1996. Solutions IRB determined this study to be EXEMPT from the Office for Human Research Protections (OHRP)’s Regulations for the Protection of Human Subjects (45 CFR 46) under Exemption 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The HIPAA Authorization Waiver was granted in accordance with the specifications of 45 CFR 164.512(i). This project was conducted in full accordance with all applicable laws and regulations, and adhered to the project plan that was reviewed by Solutions Institutional Review Board.
: As this retrospective study utilized deidentified claims data, individual patient consent was not required.
: As this retrospective study utilized deidentified claims data, individual patient consent was not required.