Chiorean, Michael V.
Allegretti, Jessica R.
Sharma, Puza P.
Chastek, Benjamin
Salese, Leonardo
Bell, Elizabeth J.
Peterson-Brandt, Jesse
Cappelleri, Joseph C.
Guo, Xiang
Khan, Nabeel
Article History
Received: 17 September 2021
Accepted: 8 March 2022
First Online: 9 April 2022
Change Date: 26 July 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12876-022-02298-7
Declarations
:
: The study only used data from the Optum Research Database which have been de-identified in compliance with 45 Code of Federal Regulations 164.514(a)-(c). The de-identified data in the Optum Research Database were obtained from Covered Entities that permitted de-identification of protected health information for use in research studies conducted by Optum. In the United States, research involving human subjects is subject to the United States Department of Health and Human Services (HHS) “Common Rule”, codified at 45 C.F.R. Part 46, which includes requirements for IRB review to ensure adequate protections of those human subjects. However, in this case, the research has been conducted with de-identified Protected Health Information (PHI). The PHI has been de-identified in accordance with the HHS Privacy Rule’s requirements for de-identification codified at 45 C.F.R. § 164.514(b). Therefore, the research is not subject to the Common Rule requirements and an IRB review. Throughout the process, patient privacy was preserved, and researchers complied strictly with all applicable Health Insurance Portability and Accountability Act data management rules and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Patient consent was not required for this retrospective study.
: Not applicable.
: MVC has served as a speaker for AbbVie, Bristol-Myers Squibb, Janssen, Medtronic, Pfizer Inc and Takeda; and has served as a consultant for AbbVie, Arena, Bristol-Myers Squibb, Medtronic, Pfizer Inc, Prometheus and Takeda. JRA is a consultant for Artugen Therapeutics, Baccarin, Bristol-Myers Squibb, Celgene, Finch Therapeutics, Iterative Scopes, Janssen, Morphic, Pandion Therapeutics and Pfizer Inc; and has received research support from Merck. PPS, LS, JCC and XG are employees and stockholders of Pfizer Inc. BC, EJB and JP-B are employees of Optum Life Sciences, which was a paid consultant to Pfizer in connection with the development of this manuscript. NK has received an unrestricted research grant from Luitpold Pharmaceuticals Inc, Pfizer Inc, Samsung BioEpis and Takeda Pharmaceuticals.