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Development of a core outcome set for pediatric critical care outcomes research
Ericka L Fink1, Jessica M Jarvis2, Aline B Maddux3
1Division of Pediatric Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, 4401 Penn Avenue, Faculty Pavilion, 2nd floor, Pittsburgh, PA 15224, United States of America.
Insights
Researchers are developing a Pediatric Intensive Care Unit (PICU) Core Outcome Set (COS) to standardize outcome evaluation in critically ill children. This initiative incorporates multi-stakeholder preferences for more comprehensive clinical care research.
Area of Science:
- Pediatric Critical Care Research
- Health Outcomes Research
- Clinical Trial Methodology
Background:
- Critically ill children in Pediatric Intensive Care Units (PICUs) present complex medical and surgical conditions.
- Current research evaluating outcomes for this population often lacks standardized guidance.
- Incorporating multi-stakeholder preferences is crucial for enhancing the evaluation of clinical care.
Purpose of the Study:
- To outline the methodology for developing a Pediatric Intensive Care Unit (PICU) Core Outcome Set (COS).
- To establish a standardized resource for PICU research programs.
- To ensure that research considers outcomes important to all stakeholders.
Main Methods:
- A mixed-methods approach including a scoping review of PICU literature and qualitative interviews with survivors and parents.
- A modified, international Delphi consensus process involving diverse stakeholders (researchers, clinicians, families, funders, etc.).
- Consensus meetings to finalize outcome domains and identify appropriate instruments for future studies.
Main Results:
- The development process aims to derive a minimum set of outcome domains for critically ill children and their families.
- The PICU COS will guide investigators in selecting relevant outcomes for their research.
- The initiative emphasizes broad implementation and dissemination.
Conclusions:
- The PICU COS will serve as a vital guideline for investigators in pediatric critical care research.
- It will ensure that research outcomes reflect the priorities of all stakeholders, not just individual scientists.
- This standardized approach will enhance the quality and relevance of research in PICUs.
Background:
Pediatric Intensive Care Unit (PICU) teams provide care for critically ill children with diverse and often complex medical and surgical conditions. Researchers often lack guidance on an approach to select the best outcomes when evaluating this critically ill population. Studies would be enhanced by incorporating multi-stakeholder preferences to better evaluate clinical care. This manuscript outlines the methodology currently being used to develop a PICU Core Outcome Set (COS). This PICU COS utilizes mixed methods, an inclusive stakeholder approach, and a modified Delphi consensus process that will serve as a resource for PICU research programs.
Methods:
A Scoping Review of the PICU literature evaluating outcomes after pediatric critical illness, a qualitative study interviewing PICU survivors and their parents, and other relevant literature will serve to inform a modified, international Delphi consensus process. The Delphi process will derive a set of minimum domains for evaluation of outcomes of critically ill children and their families. Delphi respondents include researchers, multidisciplinary clinicians, families and former patients, research funding agencies, payors, and advocates. Consensus meetings will refine and finalize the domains of the COS, outline a battery instruments for use in future studies, and prepare for extensive dissemination for broad implementation.
Discussion:
The PICU COS will be a guideline resource for investigators to assure that outcomes most important to all stakeholders are considered in PICU clinical research in addition to those deemed most important to individual scientists.
Trial Registration:
COMET database (http://www.comet-initiative.org/, Record ID 1131, 01/01/18).
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