Core Outcomes Set (COS) for Pediatric Critical Care Medicine (PCCM) Research

Purpose of the Study
To develop a collaborative, stakeholder-informed Core Outcomes Set (COS) for pediatric critical care medicine (PCCM) research programs. A core outcome is defined as “a patient outcome, health-related condition, or aspects of health that relevant stakeholders agree are essential to assess in all clinical research studies evaluating outcomes”1. The COS will serve as a guideline resource for investigators to assure that outcomes most important to all stakeholders are considered in PCCM clinical research programs.

Specific Aims
Aim 1. Create a comprehensive list of outcomes for consideration by stakeholders for inclusion in the COS for PCCM research.
a. Conduct a Scoping Review of PICU outcomes. Review to be led by the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Outcomes subgroup, highlighting outcomes that have been of interest to health care providers, researchers, and families.
b. Conduct a qualitative study by interviewing 21 families with children who experienced critical illness to explore outcomes important to them for consideration in the Delphi process.
c. Analyze and summarize findings from Aims 1a-c to inform the Delphi variables.
Aim 2. Identify a minimum COS for PCCM clinical research using a multi-stakeholder Delphi process.
Aim 3: COS Dissemination and implementation.

PI, Ericka L. Fink, MD, MS; Children's Hospital of Pittsburgh of UPMC
Co-I, Lenora Olson, PhD; University of Utah