Core Outcomes and Measurement Set (COS and COMS) for Pediatric Critical Care Medicine (PCCM)

Purpose of the study
To develop a collaborative, stakeholder-informed Core Outcomes Set (COS) for pediatric critical care medicine (PCCM) clinical and 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”.

The COS will serve as a guideline resource for clinicians and investigators to assure that outcomes most important to all stakeholders are considered in PCCM clinical and research programs.

PCCM programs utilize a heterogeneous set of measures to evaluate post-pediatric intensive care unit (PICU) outcomes, limiting the ability to aggregate and synthesize data.

Aim

To identify a COS and COMS that are essential to include in all clinical and research studies evaluating PICU survivors and families after discharge.

Contributors

Overall PI, Ericka L. Fink, MD, MS; UPMC Children's Hospital of Pittsburgh
Co-I, Lenora Olson, PhD; University of Utah
COMS Co-PI, Aline Maddux, MD, MSCS, University of Colorado School of Medicine, Children’s Hospital of Colorado
COMS Co-PI, Neethi Pinto, MD, MS, Children’s Hospital of Philadelphia
R. Scott Watson, MD, MPH, University of Washington School of Medicine, Seattle Children’s Research Institute
Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network POST-PICU Investigators
PICU-COS Investigators of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network

Further Study Information

Current Stage: Ongoing
Date: January 2018 - November 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 of Intervention:

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
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus conference
- Delphi process
- Interview
- Literature review
- Survey


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.
Aim 4: Establish and disseminate a COMS for PCCM clinical and research programs using an expert consensus panel.