Cai, Qian
Ding, Zhijie
Fu, Alex Z.
Patel, Aarti A.
Funding for this research was provided by:
Janssen Scientific Affairs
Article History
Received: 5 January 2022
Accepted: 29 October 2022
First Online: 29 December 2022
Declarations
:
: The use of OPTUM data was reviewed by the New England Institutional Review Board (IRB) and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. Administrative permissions were not required to access the raw data. This is because our claims database is de-identified under the Expert Determination method consistent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) standards. The Ethical Guidelines of the Declaration of Helsinki were strictly followed. All study data were accessed with protocols compliant with US patient confidentiality requirements, including the HIPAA. As this study consisted of secondary data analyses of de-identified patient records, it does not constitute human subjects research and was exempt from Institutional Review Board registration and review requirements per US Federal Policy 45 CFR 46.102(f)(2). Furthermore, since this study used existing fully de-identified data and the investigators cannot be identified, directly or through identifiers linked to subjects, it is exempt from all 45 CFR part 46 requirements. In this manuscript, we also report only aggregate-level statistics to ensure patient confidentiality.
: Not applicable.
: ZD, QC, ZF, and AP are employees of Janssen Scientific Affairs (a Johnson & Johnson company) and hold stock in Johnson & Johnson.