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

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. GerberNathan Kuppermann

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)83-88
Number of pages6
JournalJournal of the Pediatric Infectious Diseases Society
Issue number2
StatePublished - Feb 27 2023


  • antibiotics
  • clinical trials
  • Delphi
  • outcomes
  • pneumonia

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases


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