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Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions: A Consensus
Eric R Coon1,2, Corrie E McDaniel3, Natalia Paciorkowski4
1Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Insights
This study identified key research questions for hospitalized children, focusing on common conditions lacking randomized clinical trial (RCT) data. The findings prioritize crucial areas for future research to improve pediatric care.
Area of Science:
- Pediatric Hospital Medicine
- Clinical Trial Design
- Evidence-Based Practice
Background:
- Limited randomized clinical trial (RCT) data exists for routine care decisions in hospitalized children with common conditions.
- A critical need exists to identify high-priority RCT questions for this vulnerable population.
Purpose of the Study:
- To identify and prioritize the most important and feasible randomized clinical trial (RCT) questions for common pediatric hospitalizations.
- To guide future research endeavors and funding for pediatric clinical trials.
Main Methods:
- A 3-stage modified Delphi process was conducted virtually from January to September 2022.
- Forty-six participants from 30 institutions, including pediatricians and parents, developed and scored RCT questions for 10 common pediatric conditions.
- Questions were framed in PICO format and ranked by importance and feasibility.
Main Results:
- 62 unique, pragmatic RCT questions were generated, addressing interventions with limited effectiveness data.
- The top-ranked questions focused on optimizing antibiotic regimens for pneumonia, urinary tract infections, and cellulitis.
- Overall importance and feasibility scores ranged from 1 to 9, with a median of 5.
Conclusions:
- This consensus statement highlights the most critical and achievable RCT questions for hospitalized children.
- The identified research priorities can direct investigators and funders toward impactful trials.
- Improving the evidence base for pediatric hospital care is essential for better patient outcomes.
Importance:
There is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions.
Objective:
To identify the most important and feasible RCT questions for children hospitalized with common conditions.
Design, Setting, And Participants:
For this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to September 29, 2022. Forty-six individuals from 30 different institutions participated in the process. Stage 1 involved construction of RCT questions for the 10 most common pediatric conditions leading to hospitalization. Participants used condition-specific guidelines and reviews from a structured literature search to inform their development of RCT questions. During stage 2, RCT questions were refined and scored according to importance. Stage 3 incorporated public comment and feasibility with the prioritization of RCT questions.
Main Outcomes And Measures:
The main outcome was RCT questions framed in a PICO (population, intervention, control, and outcome) format and ranked according to importance and feasibility; score choices ranged from 1 to 9, with higher scores indicating greater importance and feasibility.
Results:
Forty-six individuals (38 who shared demographic data; 24 women [63%]) from 30 different institutions participated in our modified Delphi process. Participants included children's hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (n = 2), biostatisticians (n = 2), and other researchers (n = 11). The process yielded 62 unique RCT questions, most of which are pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Overall scores for importance and feasibility of the RCT questions ranged from 1 to 9, with a median of 5 (IQR, 4-7). Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis).
Conclusions And Relevance:
This consensus statementhas identified the most important and feasible RCT questions for children hospitalized with common conditions. This list of RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for hospitalized children.
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