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Pediatric core outcome sets had deficiencies and lacked child and family input: A methodological review
Katherine Goren1, Andrea Monsour1, Emma Stallwood1
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Insights
Most pediatric core outcome sets (COS) developed before 2017 had design gaps. Future COS development needs better child and family involvement and consensus methods for improved pediatric research.
Area of Science:
- Pediatric research methodology
- Health outcomes research
- Core outcome set development
Background:
- The Core Outcome Set-STAndards for Development (COS-STAD) provides criteria for developing core outcome sets (COS).
- Assessing pediatric COS developed before 2017 against these standards is crucial for identifying methodological gaps.
Purpose of the Study:
- To identify and appraise pediatric COS developed prior to the COS-STAD guidelines.
- To evaluate the methods used for involving children and families in the development of these COS.
Main Methods:
- Methodological review of pediatric COS development documents published up to 2017.
- Independent assessment of each COS against COS-STAD criteria.
- Synthesis of child and family involvement methods.
Main Results:
- 56 pediatric COS were identified, meeting a median of five COS-STAD criteria.
- While COS scope was often specified, intervention criteria were met by only 41%.
- Involvement of researchers/health professionals (64%) was more common than patient/family involvement (29%); consensus methods were poorly met (4-23%).
Conclusions:
- Many pediatric COS developed before 2017 exhibit significant methodological deficiencies.
- Future pediatric COS development should prioritize child and family engagement, establish clear consensus criteria, and ensure transparent reporting.
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.
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