Atwater, Brett D.
Di Fusco, Manuela
Keshishian, Allison
Delinger, Rachel
Ferri, Mauricio
Jiang, Jenny
Seigel, Lauren
Yuce, Huseyin
Guo, Jennifer D.
Funding for this research was provided by:
Pfizer
Bristol-Myers Squibb
Article History
Accepted: 15 June 2023
First Online: 2 August 2023
Declarations
:
: BDA reported receiving research grants from Abbott and acting as adviser to Abbott, Biotronik, Pfizer and Medtronic. Jennifer D. Guo, Jenny Jiang, Lauren Seigel, and Mauricio Ferri are paid employees of Bristol Myers Squibb. Allison Keshishian and Rachel Delinger are paid employees of STATinMED Research which is a paid consultant to Pfizer and Bristol Myers Squibb in connection with the development of this manuscript. Manuela Di Fusco is a paid employee of Pfizer.
: 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.