The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England
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The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England. / Nealon, Joshua; Modin, Daniel; Ghosh, Rebecca E.; Rudin, Deborah; Gislason, Gunnar; Booth, Helen P.; Jensen, Jens Ulrik Stæhr; Williams, Rachael; Shepherd, Hilary; Yelland, Eleanor; Bricout, Helene; Chaves, Sandra S.; Biering-Sørensen, Tor.
In: npj Vaccines, Vol. 7, No. 1, 25, 2022, p. 1-9.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England
AU - Nealon, Joshua
AU - Modin, Daniel
AU - Ghosh, Rebecca E.
AU - Rudin, Deborah
AU - Gislason, Gunnar
AU - Booth, Helen P.
AU - Jensen, Jens Ulrik Stæhr
AU - Williams, Rachael
AU - Shepherd, Hilary
AU - Yelland, Eleanor
AU - Bricout, Helene
AU - Chaves, Sandra S.
AU - Biering-Sørensen, Tor
N1 - Publisher Copyright: © 2022, The Author(s).
PY - 2022
Y1 - 2022
N2 - We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England’s electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40–50-fold and 2–10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency.
AB - We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England’s electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40–50-fold and 2–10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency.
UR - http://www.scopus.com/inward/record.url?scp=85125441713&partnerID=8YFLogxK
U2 - 10.1038/s41541-022-00444-6
DO - 10.1038/s41541-022-00444-6
M3 - Journal article
C2 - 35197469
AN - SCOPUS:85125441713
VL - 7
SP - 1
EP - 9
JO - npj Vaccines
JF - npj Vaccines
SN - 2059-0105
IS - 1
M1 - 25
ER -
ID: 311115576