Children with Medical Complexity (CMC) experience multiple chronic conditions and functional limitations that require high levels of care. They are among the highest utilizers of pediatric health services, with a large proportion of resources directed toward inpatient care. Improving care and reducing costs for this population requires the development of innovative care interventions and evaluation frameworks that reflect the priorities of patients, families, health care professionals (HCPs), and health system leaders.
This study aims to develop a stakeholder-driven, person-centered, and prioritized Core Outcome Set (COS) for evaluating inpatient care for CMC and their families. A steering committee, including parent-partners, multi-disciplinary healthcare professionals, and researchers, will be created to guide the study. The first step will be a rapid review of existing COS for CMC and children with chronic conditions to compile a comprehensive list of candidate outcomes. This list will be reviewed by the research team—including parent-partners and multidisciplinary HCPs—with opportunities to add outcomes considered important. Outcomes irrelevant to the inpatient setting will be excluded, and the remaining outcomes will be grouped into key domains with definitions added.
Two rounds of a Delphi process will follow. In Round 1, the candidate outcomes will be presented in an electronic survey, and stakeholders (CMC, caregivers, HCPs, and researchers) will rate each outcome using a 9-point GRADE Likert scale. A text box will allow participants to provide comments within each domain. In Round 2, the research team will review any new outcomes suggested in Round 1 for relevance to the COS. Participants will then receive both (a) a summary of Round 1 results and (b) their own previous responses, after which they will re-score retained outcomes and rate any new items.
Items not reaching consensus will be discussed during consultation meetings with the research team, where final inclusion will be determined. Additional consensus meetings with stakeholders will be held as needed. The final COS will be established based on the Delphi results and subsequent team discussions.
Dr. Lyndsay MacKay
Dr. Tammie Dewan
Dr. David Nicols
Dr. Maria Santana
Dr. Jennifer Swicker
Dr. Rick Sawatzky
Dr. Peter Gill
Dr. Angela Wolff
Elisha Comeau
Kristina McGuire
Rayna Anderson
Disease Category: Child health
Disease Name: Complex medical needs
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Management of care
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Survey
- Systematic review
The first step will be a rapid review of existing COS for CMC and children with chronic conditions to compile a comprehensive list of candidate outcomes. This list will be reviewed by the research team—including parent-partners and multidisciplinary HCPs—with opportunities to add outcomes considered important. Outcomes irrelevant to the inpatient setting will be excluded, and the remaining outcomes will be grouped into key domains with definitions added.
Two rounds of a Delphi process will follow. In Round 1, the candidate outcomes will be presented in an electronic survey, and stakeholders (CMC, caregivers, HCPs, and researchers from Canada) will rate each outcome using a 9-point GRADE Likert scale. A text box will allow participants to provide comments within each domain. In Round 2, the research team will review any new outcomes suggested in Round 1 for relevance to the COS. Participants will then receive both (a) a summary of Round 1 results and (b) their own previous responses, after which they will re-score retained outcomes and rate any new items.