Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
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.

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

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - January 2020
Funding source(s):
Collaborative Pediatric Critical Care Research Network

Health Area

Disease Category
Child health

Disease Name
Critical illness

Target Population

Age Range
0 - 25

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Consensus conference
Delphi process
Interview
Literature review
Survey

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.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Families
Governmental agencies
Patient/ support group representatives
Policy makers
Researchers
Service providers
Statisticians

Study Type

COS for clinical trials or clinical research

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