Children with complex chronic conditions (CCCs) often require specialty pediatric care due to the complexity in treatment. This challenging treatment process not only has significant impact on the child, but also on the child’s primary caregiver and other family members. These effects, known as family spillover effects, include challenges such as paying out-of-pocket for the child’s treatment and care, spending additional time taking care of the child, and their well-being being affected. While these spillover effects are important and recommended to be included in studies, they are usually partially included or not included at all. This would potentially underestimate the impact of the condition, such as the long-term family spillover effect that the family of children with CCCs face. Therefore, the objective of this study is to develop a core outcome set for measuring family spillover effects for children with complex chronic illness, following the methodology developed by the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. This methodology is used to develop a standardized set of outcomes that is recommended to be included at minimum in measuring the topic of interest. This standardized core outcomes set would provide a framework for incorporating family spillover effects into studies, such as in clinical trials or registries, as well as in economic evaluation studies.Contributors
Huey-Fen Chen, M.H.A. (Principal investigator)
Lisa A. Prosser, Ph.D., M.S. (Principal investigator and supervisor)
Angela M. Rose, M.S., M.P.H.
Jeremy Adler, M.D., M.Sc.
Ryan Barbaro, M.D., M.S.
Samir Gadepalli, M.D., M.S., M.B.A.
Folafoluwa Olutobi Odetola, M.D., M.P.H.
David E. Sandberg, Ph.D.
Courtney Streur, M.D., M.S.
Affiliations: The Susan B. Meister Child Health Evaluation and Research (CHEAR) Center at the University of Michigan
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Literature review
- Systematic review