Appropriate outcome measures as part of high-quality intervention trials are critical to advancing hospital-to-home transitions for Children with Medical Complexity (CMC). Our aim was to conduct a Delphi study and focus groups to identify a Core Outcome Set (COS) that healthcare professionals and parents consider essential outcomes for future intervention research. The development process consisted of two phases: (1) a three-round Delphi study in which different professionals rated outcomes, previously described in a systematic review, for inclusion in the COS and (2) focus groups with parents of CMC to validate the results of the Delphi study. Forty-five professionals participated in the Delphi study. The response rates were 55%, 57%, and 58% in the three rounds, respectively. In addition to the 24 outcomes from the literature, the participants suggested 12 additional outcomes. The Delphi rounds resulted in the following core outcomes: (1) disease management, (2) child’s quality of life, and (3) impact on the life of families. Two focus groups with seven parents highlighted another core outcome: (4) self-efficacy of parents.
Conclusion: An evidence-informed COS has been developed based on consensus among healthcare professionals and parents. These core outcomes could facilitate standard reporting in future CMC hospital to home transition research. This study facilitated the next step of COS development: selecting the appropriate measurement instruments for every outcome.
This study aimed to reach a consensus on a set of core outcomes informed by healthcare
professionals and parents
Heleen N. Haspels, Annemieke A. de Lange, Mattijs W. Alsem, Bettina Sandbergen, Karolijn Dulfer, Matthijs de Hoog, Koen F. M. Joosten, Clara D. van Karnebeek, Job B. M. van Woensel, Jolanda M. Maaskant
Disease Category: Child health, Effective practice/health systems
Disease Name: Complex medical needs
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Management of care
- Clinical experts
- Consumers (caregivers)
- Families
- Patient/ support group representatives
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
The development process consisted of two phases: (1) a three-round Delphi study in which diferent professionals rated outcomes, previously described in a systematic review, for inclusion in the COS and (2) focus groups with parents of
CMC to validate the results of the Delphi study.