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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.
SUBMITTER: Florin TA
PROVIDER: S-EPMC9969329 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Florin Todd A TA Melnikow Joy J Gosdin Melissa M Ciuffetelli Ryan R Benedetti Jillian J Ballard Dustin D Gausche-Hill Marianne M Kronman Matthew P MP Martin Lisa A LA Mistry Rakesh D RD Neuman Mark I MI Palazzi Debra L DL Patel Sameer J SJ Self Wesley H WH Shah Samir S SS Shah Sonal N SN Sirota Susan S Cruz Andrea T AT Ruddy Richard R Gerber Jeffrey S JS Kuppermann Nathan N
Journal of the Pediatric Infectious Diseases Society 20230201 2
<h4>Background</h4>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).<h4>Methods</h4>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 r ...[more]