Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions: A Consensus Statement

Eric R. Coon, Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Corrie E. McDaniel, Division of Hospital Medicine, Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle.
Natalia Paciorkowski, Rochester Regional HealthFollow
Meg Grimshaw, Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Elizabeth Frakes, Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Lilliam Ambroggio, Section of Hospital Medicine, Children's Hospital Colorado, University of Colorado, Aurora.
Katherine A. Auger, Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Eyal Cohen, The Hospital for Sick Children and Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Matthew Garber, Pediatric Hospital Medicine, University of Florida COM-Jacksonville, Jacksonville.
Peter J. Gill, The Hospital for Sick Children and Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Rebecca Jennings, Department of Pediatrics, St Charles Hospital, Bend, Oregon.
Neha Shirish Joshi, Division of Pediatric Hospital Medicine, Stanford University School of Medicine, Stanford, California.
JoAnna K. Leyenaar, Dartmouth Health, Geisel School of Medicine at Dartmouth College, Lebanon, New Hampshire.
Russell McCulloh, Division of Pediatric Hospital Medicine, University of Nebraska Medical Center, Omaha.
Matthew S. Pantell, Division of Pediatric Hospital Medicine, University of California, San Francisco.
Hadley S. Sauers-Ford, Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Alan R. Schroeder, Division of Pediatric Hospital Medicine, Stanford University School of Medicine, Stanford, California.
Raj Srivastava, Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Marie E. Wang, Division of Pediatric Hospital Medicine, Stanford University School of Medicine, Stanford, California.
Karen M. Wilson, Department of Pediatrics, Golisano Children's Hospital, Rochester, New York.
Sunitha V. Kaiser, Division of Pediatric Hospital Medicine, University of California, San Francisco.
RCT conference series group

Department

Pediatrics

Document Type

Article

Publication Title

JAMA Network Open

Abstract

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 statement has 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.

First Page

e2411259

DOI

10.1001/jamanetworkopen.2024.11259

Volume

7

Issue

5

Publication Date

5-1-2024

Medical Subject Headings

Humans; Child; Randomized Controlled Trials as Topic; Delphi Technique; Consensus; Hospitalization (statistics & numerical data); Female; Male; Child, Hospitalized; Child, Preschool; Infant

PubMed ID

38748429

Link to Full Text

Share

COinS