Objectives
The Core Outcome Set-STAndards for Development (COS-STAD), published in 2017, contains 11 standards (12 criteria) describing minimum design criteria for core outcome set (COS) development. We aimed to identify and appraise all pediatric COS published prior to COS-STAD, and assess methods of child and family involvement in their development.
Study Design and Setting
This methodological review included documents that described the development of pediatric COS up to and including 2017. Reviewers independently assessed each COS against COS-STAD criteria, and methods of involvement were synthesized.
Results
A total of 56 pediatric COS were identified, meeting a median of five COS-STAD criteria. Nearly all met criteria on COS scope specification for setting, health condition, and population; 41% met criteria for intervention. Standards were more often met for the involvement of researchers/health professionals (64%) than for patients or their representatives (29%). Few met standards for achieving COS consensus (4–23%). Methods of child and family engagement varied and were limited.
Conclusion
A large proportion of pediatric COS developed prior to COS-STAD recommendations show gaps in design methodology. Updated and newly developed pediatric COS would benefit from the inclusion of the child and family voice, implementing a priori criteria for COS consensus, and clear reporting.
Principal Investigators:
Nancy J. Butcher, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Martin Offringa, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Research Team:
Katherine Goren, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada (Medical Student)
Andrea Monsour, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Emma Stallwood, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
Disease Category: Child health
Disease Name: N/A
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Any
- None
- COS methods research
- Systematic review
- Literature review
Two groups of two reviewers will independently and in duplicate assess each COS against the 11 COS-STAD standards (12 criteria). Pediatric COS published prior to 2017 identified via systematic reviews performed by the COMET Initiative and supplementary searching will be eligible for inclusion. Percentages will be used to describe the frequency of studies meeting each COS-STAD standard.