Document is current

Article History

Accepted: 9 November 2021

First Online: 24 November 2021

Declarations

:

: E. Ammann is currently employed by Johnson & Johnson; the study analyses were completed, and manuscript drafted before his start in this role. C. Leonard serves on the Executive Committee of the University of Pennsylvania's Center for Pharmacoepidemiology Research and Training; the Center receives funds to support education from Pfizer and Sanofi. A. Cuker has served as a consultant for Synergy CRO; his institution has received research support on his behalf from Alexion, Bayer, Novo Nordisk, Pfizer, Sanofi, Spark, and Takeda. J. Robinson reports grants to her institution from Acasti, Amarin, Amgen, Astra-Zeneca, Eli Lilly, Esperion, Medicines Company, Merck, Novartis, Novo-Nordisk, Regeneron, Sanofi, and Takeda, and consulting fees from Amgen, Medicines Company, Merck, Novartis, Novo-Nordisk, Pfizer, Regeneron, and Sanofi. The other authors report no disclosures.

: Data Partners who provided medical records and data used in the analysis: Aetna, a CVS Health company, Blue Bell, PA; Harvard Pilgrim Health Care Institute, Boston, MA; HealthCore, Inc., Translational Research for Affordability and Quality, Alexandria, VA; HealthPartners Institute, Minneapolis, Minnesota; Humana, Inc., Healthcare Research, Miramar, FL; Kaiser Permanente Colorado Institute for Health Research, Denver, CO; Kaiser Permanente Center for Health Research Hawai’i, Honolulu, HI; Kaiser Permanente Northern California, Division of Research, Oakland, CA; Kaiser Permanente Northwest Center for Health Research, Portland, OR; Kaiser Permanente Washington Health Research Institute, Seattle, WA; Meyers Primary Care Institute, Worcester, MA; OptumInsight Life Sciences Inc., Boston, MA; Vanderbilt University Medical Center, Department of Health Policy, Nashville, TN, through the TennCare Division of the Tennessee Department of Finance & Administration which provided data.

: Sentinel uses a distributed data approach in which Data Partners maintain physical and operational control over electronic health data in their existing environments after transforming their data into a common data model. This analysis utilized the Sentinel Distributed Database [and standardized data querying tools. Code for Sentinel standardized data querying tools, query specifications, and related documentation are shared via the Sentinel website, which allows for transparency and potential replicability of this study on other data sources.] To preserve patient privacy, Sentinel generally does not save, maintain, or post individual level datasets. Sentinel Data Partners update data at varying intervals and retain a limited number of iterations of their historical data, which may affect replication of this assessment.

: This Sentinel manuscript is a public health surveillance activity conducted under the authority of the Food and Drug Administration and, accordingly, is not subject to Institutional Review Board oversight.