Developing Consensus on Clinical Outcomes for Children with Mild Pneumonia: A Delphi Study

Authors

Todd A Florin
Joy Melnikow
Melissa Gosdin
Ryan Ciuffetelli
Jillian Benedetti
Dustin Ballard
Marianne Gausche-Hill
Matthew P Kronman
Lisa A Martin
Rakesh D Mistry
Mark I Neuman
Debra L Palazzi
Sameer J Patel
Wesley H Self
Samir S Shah
Sonal N Shah
Susan Sirota
Andrea T Cruz
Richard Ruddy
Jeffrey S Gerber
Nathan Kuppermann

Publication Date

2-27-2023

Journal

Journal of the Pediatric Infectious Diseases Society

DOI

10.1093/jpids/piac123

PMID

36625856

PMCID

PMC9969329

PubMedCentral® Posted Date

1-10-2023

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Humans, Child, Consensus, Delphi Technique, Pneumonia, Dyspnea, Community-Acquired Infections, Anti-Bacterial Agents, Oxygen, antibiotics, clinical trials, Delphi, outcomes, pneumonia

Abstract

BACKGROUND: The absence of consensus for outcomes in pediatric antibiotic trials is a major barrier to research harmonization and clinical translation. We sought to develop expert consensus on study outcomes for clinical trials of children with mild community-acquired pneumonia (CAP).

METHODS: Applying the Delphi method, a multispecialty expert panel ranked the importance of various components of clinical response and treatment failure outcomes in children with mild CAP for use in research. During Round 1, panelists suggested additional outcomes in open-ended responses that were added to subsequent rounds of consensus building. For Rounds 2 and 3, panelists were provided their own prior responses and summary statistics for each item in the previous round. The consensus was defined by >70% agreement.

RESULTS: The expert panel determined that response to and failure of treatment should be addressed at a median of 3 days after initiation. Complete or substantial improvement in fever, work of breathing, dyspnea, tachypnea when afebrile, oral intake, and activity should be included as components of adequate clinical response outcomes. Clinical signs and symptoms including persistent or worsening fever, work of breathing, and reduced oral intake should be included in treatment failure outcomes. Interventions including receipt of parenteral fluids, supplemental oxygen, need for high-flow nasal cannula oxygen therapy, and change in prescription of antibiotics should also be considered in treatment failure outcomes.

CONCLUSIONS: Clinical response and treatment failure outcomes determined by the consensus of this multidisciplinary expert panel can be used for pediatric CAP studies to provide objective data translatable to clinical practice.