scholarly journals Correction:Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023118corr1
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
High Risk ◽  
Influenza Vaccine ◽  
Children And Adolescents ◽  
Prospective Cohort ◽  
Population Based ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Live Attenuated Influenza Vaccine

scholarly journals Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023118 ◽  
Author(s):  
Herve Caspard ◽  
Amy Steffey ◽  
Raburn M Mallory ◽  
Christopher S Ambrose
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
High Risk ◽  
Influenza Vaccine ◽  
Children And Adolescents ◽  
Influenza Season ◽  
Risk Groups ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Live Attenuated Influenza Vaccine

ObjectivesTo assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.DesignNon-interventional cohort study.SettingEngland during 2013–2014 and 2014–2015 influenza seasons.ParticipantsLAIV recipients identified from the Clinical Practice Research Datalink, aged 2–17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls.Primary outcome measuresPrimary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.Results11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013–2014 influenza season and 6745 received the quadrivalent formulation during the 2014–2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013–2014 and 231 (95% CI 198 to 267) in season 2014–2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013–2014, 0.90 (95% CI 0.76 to 1.07) in season 2014–2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013–2014, 0.42 (95% CI 0.35 to 0.51) in season 2014–2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration.ConclusionsThis study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline.Trial registration numberEUPAS18527.

scholarly journals Examining the risk of depression or self-harm associated with incretin-based therapies used to manage hyperglycaemia in patients with type 2 diabetes: a cohort study using the UK Clinical Practice Research Datalink

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023830 ◽  
Author(s):  
John-Michael Gamble ◽  
Eugene Chibrikov ◽  
William K Midodzi ◽  
Laurie K Twells ◽  
Sumit R Majumdar
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Population Based ◽  
Practice Research ◽  
Primary Study ◽  
Clinical Practice Research Datalink ◽  
Glucose Lowering ◽  
Self Harm ◽  
The Uk ◽  
New Onset

ObjectivesTo compare population-based incidence rates of new-onset depression or self-harm in patients initiating incretin-based therapies with that of sulfonylureas (SU) and other glucose-lowering agents.DesignPopulation-based cohort study.SettingPatients attending primary care practices registered with the UK-based Clinical Practice Research Datalink (CPRD).ParticipantsUsing the UK-based CPRD, we identified two incretin-based therapies cohorts: (1) dipeptidyl peptidase-4 inhibitor (DPP-4i)-cohort, consisting of new users of DPP-4i and SU and (2) glucagon-like peptide-1 receptor agonists (GLP-1RA)-cohort, consisting of new users of GLP-1RA and SU, between January 2007 and January 2016. Patients with a prior history of depression, self-harm and other serious psychiatric conditions were excluded.Main outcome measuresThe primary study outcome comprised a composite of new-onset depression or self-harm. Unadjusted and adjusted Cox proportional hazards regression was used to quantify the association between incretin-based therapies and depression or self-harm. Deciles of High-Dimensional Propensity Scores and concurrent number of glucose-lowering agents were used to adjust for potential confounding.ResultsWe identified new users of 6206 DPP-4i and 22 128 SU in the DPP-4i-cohort, and 501 GLP-1RA and 16 409 SU new users in the GLP-1RA-cohort. The incidence of depression or self-harm was 8.2 vs 11.7 events/1000 person-years in the DPP-4i-cohort and 18.2 vs 13.6 events/1000 person-years in the GLP-1RA-cohort for incretin-based therapies versus SU, respectively. Incretin-based therapies were not associated with an increased or decreased incidence of depression or self-harm compared with SU (DPP-4i-cohort: unadjusted HR 0.70, 95% CI 0.51 to 0.96; adjusted HR 0.80, 95% CI 0.57 to 1.13; GLP-1RA-cohort: unadjusted HR 1.36, 95% CI 0.72 to 2.58; adjusted HR 1.25, 95% CI 0.63 to 2.50). Consistent results were observed for other glucose-lowering comparators including insulin and thiazolidinediones.ConclusionsOur findings suggest that the two incretin-based therapies are not associated with an increased or decreased risk of depression or self-harm.

scholarly journals Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England

Drug Safety ◽  
2016 ◽  
Vol 39 (4) ◽  
pp. 323-333 ◽  
Author(s):  
Rhian McNaughton ◽  
Elizabeth Lynn ◽  
Vicki Osborne ◽  
Abigail Coughtrie ◽  
Deborah Layton ◽  
...  
Keyword(s):  
Cohort Study ◽  
Influenza Vaccine ◽  
Children And Adolescents ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Live Attenuated Influenza Vaccine
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