TY - JOUR
T1 - Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccine Among Patients Receiving Maintenance Hemodialysis
AU - Butler, Anne M.
AU - Layton, J. Bradley
AU - Dharnidharka, Vikas R.
AU - Sahrmann, John M.
AU - Seamans, Marissa J.
AU - Weber, David J.
AU - McGrath, Leah J.
N1 - Funding Information:
Anne M. Butler, PhD, J. Bradley Layton, PhD, Vikas R. Dharnidharka, MD, MPH, John M. Sahrmann, MA, Marissa J. Seamans, PhD, David J. Weber, MD, MPH, and Leah J. McGrath, PhD. Research idea and study design: AMB, JBL, LJM; data acquisition: AMB; data analysis/interpretation: AMB, JBL, VRD, JMS, MJS, DJW, LJM; statistical analysis: AMB, JMS, MJS; supervision or mentorship: AMB, JBL, VRD, LJM. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. This project was supported by the US National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), through grant award number 1R21AI138385. Dr Butler is supported by a grant from the National Center for Advancing Translational Sciences (NCATS), NIH, under award number KL2 TR002346. Dr Seamans is supported by a grant from the National Institute on Drug Abuse, NIH, under award number T32DA007292. Data programming for this study was conducted by the Center for Administrative Data Research, which is supported in part by the Washington University Institute of Clinical and Translational Sciences grant UL1 TR002345 from NCATS of the NIH, grant number R24 HS19455 through the Agency for Healthcare Research and Quality. The study sponsors did not have any role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication. Dr Butler has received investigator-initiated support from Amgen. Dr Layton is an employee of RTI International, an independent, nonprofit research organization that performs research on behalf of government and commercial clients, including pharmaceutical companies. Dr McGrath is an employee of NoviSci, a data sciences company, and previously was an employee of RTI Health Solutions. The remaining authors declare that they have no relevant financial interests. The authors acknowledge Amber Salter from Washington University for biostatistical advice and Carrie O'Neil from Washington University for editorial assistance. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The data reported here have been supplied by the USRDS. The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy or interpretation of the US government. Received January 8, 2019. Evaluated by 2 external peer reviewers, with direct editorial input from a Statistics/Methods Editor, an Associate Editor, and the Editor-in-Chief. Accepted in revised form May 23, 2019.
Funding Information:
This project was supported by the US National Institute of Allergy and Infectious Diseases , National Institutes of Health (NIH), through grant award number 1R21AI138385 . Dr Butler is supported by a grant from the National Center for Advancing Translational Sciences (NCATS), NIH , under award number KL2 TR002346 . Dr Seamans is supported by a grant from the National Institute on Drug Abuse , NIH , under award number T32DA007292 . Data programming for this study was conducted by the Center for Administrative Data Research, which is supported in part by the Washington University Institute of Clinical and Translational Sciences grant UL1 TR002345 from NCATS of the NIH , grant number R24 HS19455 through the Agency for Healthcare Research and Quality . The study sponsors did not have any role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication.
Publisher Copyright:
© 2019 National Kidney Foundation, Inc.
PY - 2020/1
Y1 - 2020/1
N2 - Rationale & Objective: Studies of patients on maintenance dialysis therapy suggest that standard-dose influenza vaccine (SDV) may not prevent influenza-related outcomes. Little is known about the comparative effectiveness of SDV versus high-dose influenza vaccine (HDV) in this population. Study Design: Cohort study using data from the US Renal Data System. Setting & Participants: 507,552 adults undergoing in-center maintenance hemodialysis between the 2010 to 2011 and 2014 to 2015 influenza seasons. Exposures: SDV and HDV. Outcomes: All-cause mortality, hospitalization due to influenza or pneumonia, and influenza-like illness during the influenza season. Analytic Approach: Patients were eligible for inclusion in multiple yearly cohorts; thus, our unit of analysis was the influenza patient-season. To examine the relationship between vaccine dose and effectiveness outcomes, we estimated risk differences and risk ratios using propensity score weighting of Kaplan-Meier functions, accounting for a wide range of patient- and facility-level characteristics. For nonmortality outcomes, we used competing-risk methods to account for the high mortality rate in the dialysis population. Results: Within 225,215 influenza patient-seasons among adults 65 years and older, 97.4% received SDV and 2.6% received HDV. We observed similar risk estimates for HDV and SDV recipients for mortality (risk difference, −0.08%; 95% CI, −0.85% to 0.80%), hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI, −0.69% to 0.93%), and influenza-like illness (risk difference, 0.00%; 95% CI, −1.50% to 1.08%). Our findings were similar among adults younger than 65 years, as well as within other subgroups defined by influenza season, age group, dialysis vintage, month of influenza vaccination, and vaccine valence. Limitations: Residual confounding and outcome misclassification. Conclusions: The HDV does not appear to provide additional protection beyond the SDV against all-cause mortality or influenza-related outcomes for adults undergoing hemodialysis. The additional cost and side effects associated with HDV should be considered when offering this vaccine. Future studies of HDV and other influenza vaccine strategies are warranted.
AB - Rationale & Objective: Studies of patients on maintenance dialysis therapy suggest that standard-dose influenza vaccine (SDV) may not prevent influenza-related outcomes. Little is known about the comparative effectiveness of SDV versus high-dose influenza vaccine (HDV) in this population. Study Design: Cohort study using data from the US Renal Data System. Setting & Participants: 507,552 adults undergoing in-center maintenance hemodialysis between the 2010 to 2011 and 2014 to 2015 influenza seasons. Exposures: SDV and HDV. Outcomes: All-cause mortality, hospitalization due to influenza or pneumonia, and influenza-like illness during the influenza season. Analytic Approach: Patients were eligible for inclusion in multiple yearly cohorts; thus, our unit of analysis was the influenza patient-season. To examine the relationship between vaccine dose and effectiveness outcomes, we estimated risk differences and risk ratios using propensity score weighting of Kaplan-Meier functions, accounting for a wide range of patient- and facility-level characteristics. For nonmortality outcomes, we used competing-risk methods to account for the high mortality rate in the dialysis population. Results: Within 225,215 influenza patient-seasons among adults 65 years and older, 97.4% received SDV and 2.6% received HDV. We observed similar risk estimates for HDV and SDV recipients for mortality (risk difference, −0.08%; 95% CI, −0.85% to 0.80%), hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI, −0.69% to 0.93%), and influenza-like illness (risk difference, 0.00%; 95% CI, −1.50% to 1.08%). Our findings were similar among adults younger than 65 years, as well as within other subgroups defined by influenza season, age group, dialysis vintage, month of influenza vaccination, and vaccine valence. Limitations: Residual confounding and outcome misclassification. Conclusions: The HDV does not appear to provide additional protection beyond the SDV against all-cause mortality or influenza-related outcomes for adults undergoing hemodialysis. The additional cost and side effects associated with HDV should be considered when offering this vaccine. Future studies of HDV and other influenza vaccine strategies are warranted.
KW - Comparative effectiveness
KW - end-stage renal disease (ESRD)
KW - hemodialysis
KW - high-dose influenza vaccine
KW - hospitalization
KW - hospitalization
KW - immunization
KW - infection
KW - influenza
KW - influenza-like illness (ILI)
KW - mortality
KW - renal dialysis
KW - standard-dose influenza vaccine
KW - vaccination
KW - vaccine effectiveness
UR - http://www.scopus.com/inward/record.url?scp=85069952993&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2019.05.018
DO - 10.1053/j.ajkd.2019.05.018
M3 - Article
C2 - 31378646
AN - SCOPUS:85069952993
SN - 0272-6386
VL - 75
SP - 72
EP - 83
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 1
ER -