Abstract
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.
Keywords
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Article info
Publication history
Published online: December 16, 2022
Accepted:
December 12,
2022
Footnotes
Conflict of interest: KG, AM, ES, and MO have no financial conflict of interest to declare. NJB has received personal consulting fees from Nobias Therapeutics, Inc., unrelated to this work.
Ethics and dissemination: This methodological review did not require ethics approval.
Declaration of interests: AM, MO, and NJB are pediatric core outcome set developers.
Author Contributions: Katherine Goren contributed to conceptualization, methodology, investigation, and data curation, formal analysis, visualization, writing–original draft, and writing–review and editing. Andrea Monsour contributed to conceptualization, methodology, investigation, visualization, project administration, supervision, and writing–review and editing. Emma Stallwood contributed to conceptualization, methodology, investigation, and writing–review and editing. Martin Offringa contributed to conceptualization, methodology, resources, supervision, and writing–review and editing. Nancy J. Butcher contributed to conceptualization, methodology, supervision, visualization, and writing–original draft, and writing–review and editing.
Identification
Copyright
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