tetano
Editor, Senior Moderator
J Pediatric Infect Dis Soc. 2019 Nov 14. pii: piz075. doi: 10.1093/jpids/piz075. [Epub ahead of print] [h=1]Evaluation of a New Clinical Endpoint for Moderate to Severe Influenza Disease in Children: A Prospective Cohort Study.[/h]
Rao S[SUP]1[/SUP], Yanni E[SUP]2[/SUP], Moss A[SUP]3[/SUP], Lamb MM[SUP]4[/SUP], Schuind A[SUP]2[/SUP], Bekkat-Berkani R[SUP]5[/SUP], Innis BL[SUP]2[/SUP], Cotter J[SUP]6[/SUP], Mistry RD[SUP]7[/SUP], Asturias EJ[SUP]8[/SUP].
[h=3]Author information[/h] 1 Department of Pediatrics (Infectious Diseases, Hospital Medicine and Epidemiology), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 2 GSK, Rockville, Maryland, USA. 3 Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado and Adult and Child Center for Health Outcomes Research and Delivery Science, Aurora, Colorado, USA. 4 Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA. 5 GSK, Philadelphia, Pennsylvania, USA. 6 Department of Pediatrics (Hospital Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 7 Department of Pediatrics (Emergency Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 8 Department of Pediatrics, University of Colorado School of Medicine, Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A moderate to severe (M/S) influenza clinical endpoint has been proposed in children, defined as fever >39?C, otitis media, lower respiratory tract infection, or serious extrapulmonary manifestations. The objective of the study was to evaluate the M/S measure against clinically relevant outcomes including hospitalization, emergency room visits, antimicrobial use, and child/parental absenteeism.
[h=4]METHODS:[/h] We conducted a prospective observational study of children aged 6 months-8 years at the Children's Hospital Colorado emergency department (ED) and urgent care site during 2016-2017 and 2017-2018. Children with influenza-like illness (ILI) underwent influenza testing by polymerase chain reaction (PCR); children who tested positive and a subset of matched test-negative controls underwent follow-up at 2 weeks. The primary outcome was the proportion of children who were hospitalized. Secondary outcomes included recurrent ED visits, antimicrobial use, hospital charges, and child/parental absenteeism within 14 days.
[h=4]RESULTS:[/h] Among 1478 children enrolled with ILI, 411 (28%) tested positive for influenza by PCR. Of children with influenza illness, 313 (76%) met the M/S definition. Children with M/S influenza were younger (3.8 years vs 4.8 years), infected with influenza A (59% vs 44%), and more frequently hospitalized (unadjusted risk difference [RD], 6.3%; 95% confidence interval [CI], 2.1-10.4; P = .03) and treated with antibiotics (unadjusted RD, 13.3%; 95% CI, 4.3-22.4; P < .01) compared to those with mild disease.
[h=4]CONCLUSIONS:[/h] Children with M/S influenza have a higher risk of hospitalization and antibiotic use compared with mild disease. This proposed definition may be a useful clinical endpoint to study the public health and clinical impact of influenza interventions in children.
[h=4]CLINICAL TRIALS REGISTRATION:[/h] NCT02979626.
? The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
[h=4]KEYWORDS:[/h] absenteeism; antibiotics; clinical endpoint; hospitalization; influenza; influenza-like illness; severity
PMID: 31724050 DOI: 10.1093/jpids/piz075
Rao S[SUP]1[/SUP], Yanni E[SUP]2[/SUP], Moss A[SUP]3[/SUP], Lamb MM[SUP]4[/SUP], Schuind A[SUP]2[/SUP], Bekkat-Berkani R[SUP]5[/SUP], Innis BL[SUP]2[/SUP], Cotter J[SUP]6[/SUP], Mistry RD[SUP]7[/SUP], Asturias EJ[SUP]8[/SUP].
[h=3]Author information[/h] 1 Department of Pediatrics (Infectious Diseases, Hospital Medicine and Epidemiology), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 2 GSK, Rockville, Maryland, USA. 3 Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado and Adult and Child Center for Health Outcomes Research and Delivery Science, Aurora, Colorado, USA. 4 Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA. 5 GSK, Philadelphia, Pennsylvania, USA. 6 Department of Pediatrics (Hospital Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 7 Department of Pediatrics (Emergency Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 8 Department of Pediatrics, University of Colorado School of Medicine, Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A moderate to severe (M/S) influenza clinical endpoint has been proposed in children, defined as fever >39?C, otitis media, lower respiratory tract infection, or serious extrapulmonary manifestations. The objective of the study was to evaluate the M/S measure against clinically relevant outcomes including hospitalization, emergency room visits, antimicrobial use, and child/parental absenteeism.
[h=4]METHODS:[/h] We conducted a prospective observational study of children aged 6 months-8 years at the Children's Hospital Colorado emergency department (ED) and urgent care site during 2016-2017 and 2017-2018. Children with influenza-like illness (ILI) underwent influenza testing by polymerase chain reaction (PCR); children who tested positive and a subset of matched test-negative controls underwent follow-up at 2 weeks. The primary outcome was the proportion of children who were hospitalized. Secondary outcomes included recurrent ED visits, antimicrobial use, hospital charges, and child/parental absenteeism within 14 days.
[h=4]RESULTS:[/h] Among 1478 children enrolled with ILI, 411 (28%) tested positive for influenza by PCR. Of children with influenza illness, 313 (76%) met the M/S definition. Children with M/S influenza were younger (3.8 years vs 4.8 years), infected with influenza A (59% vs 44%), and more frequently hospitalized (unadjusted risk difference [RD], 6.3%; 95% confidence interval [CI], 2.1-10.4; P = .03) and treated with antibiotics (unadjusted RD, 13.3%; 95% CI, 4.3-22.4; P < .01) compared to those with mild disease.
[h=4]CONCLUSIONS:[/h] Children with M/S influenza have a higher risk of hospitalization and antibiotic use compared with mild disease. This proposed definition may be a useful clinical endpoint to study the public health and clinical impact of influenza interventions in children.
[h=4]CLINICAL TRIALS REGISTRATION:[/h] NCT02979626.
? The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
[h=4]KEYWORDS:[/h] absenteeism; antibiotics; clinical endpoint; hospitalization; influenza; influenza-like illness; severity
PMID: 31724050 DOI: 10.1093/jpids/piz075