Disclosure of Interest:LC is now employed by Genentech. ZBC is now employed by Roche
Pharmaceuticals. TRE has consulted for Alnylam Pharmaceuticals,
DiabetOmics, and Ferring Pharmaceuticals. SMS has received grant funding
through her institutions from Syneos Health, LAA received funding
through her institution from Bausch Health Companies, KR from Novartis
and Merck & Co., and SD from GSK. Other authors report no conflict of
interest.
Contributions to Authorship: SD, LAA, TCC, TRE, LC, VLH, RSN,
SEB, and SMS contributed to the conception and design of the study. SD,
TCC and LAA obtained funding. NN and ZBC extracted study data. MA
performed statistical analyses with guidance from SMS. SD, SMS, TCC, LAA
and KR provided supervision. All authors participated in interpretation
of results; SD, MA and SMS drafted the manuscript; and all authors
participated in revision of the manuscript. All authors accept
responsibility for the paper as submitted.
Details of Ethics
Approval: Study procedures were approved by the regions’ institutional
review boards and those of Washington State and California, with a
waiver of consent. The study received initial approval from the Kaiser
Permanente Washington Institutional Review Board on October 8, 2015
under file number 806302; from the KP Southern California Institutional
Review Board on January 12, 2016 (file number 10913), and from the KP
Northern California Institutional Review Board on 8/24/2015under file
number CN-15-2337-H/1277850. At KP Northern California, it was
subsequently considered exempt beginning in 2019 due to changes to the
US Common Rule. This work was also approved by the Washington State
Institutional Review Board on July 21, 2015, under file number
D-082213-H14.01 and by the California State Institutional Review Board
on 1/19/2016 under file number 15-07-2118.
Funding: This study was funded by National Institute on Child
Health and Human Development grant R01HD082141. Dr. Chen received a
fellowship from the Group Health Foundation. The sponsors did not play a
role in the study design; in the collection, analysis, and
interpretation of data; in writing the report; nor in the decision to
submit the article for publication.
Prior presentation: Results were presented as an oral
presentation at the International Conference on Pharmacoepidemiology,
35th annual meeting, in Philadelphia, Pennsylvania,
from August 24-28, 2019 and additional results at the virtual
International Conference on Pharmacoepidemiology, 36thannual meeting, September 16-17, 2020.