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Core Outcome Sets in Child Health: A Systematic Review
Ruobing Lei1,2,3,4,5, Quan Shen1,2,3,4,5, Bo Yang6
1Chevidence Lab of Child and Adolescent Health, Children's Hospital of Chongqing Medical University, Chongqing, China.
Insights
Developing core outcome sets for children is crucial for comparable clinical trial results. This study found 77 pediatric core outcome sets, but most lacked methodological quality and stakeholder diversity, highlighting a need for improved standards.
Area of Science:
- Pediatric Health Research
- Clinical Trial Methodology
- Outcome Measurement
Background:
- Core outcome sets (COS) are vital for standardizing clinical trial results in pediatrics.
- A comprehensive understanding of existing pediatric COS, their development, and quality is lacking.
Approach:
- Systematically identified pediatric COS across multiple databases (MEDLINE, SCOPUS, etc.) and relevant websites.
- Extracted data on diseases addressed, development methods, stakeholder involvement, and methodological quality using COS-STAD criteria.
- Evaluated 77 identified pediatric COS for their development and reporting standards.
Key Points:
- 77 pediatric COS were identified, primarily from Europe, North America, and Australia.
- Diseases of the digestive system were most frequently addressed.
- Most COS lacked methodological rigor (only 8% met COS-STAD criteria) and had limited stakeholder diversity (industry rarely involved).
Conclusions:
- Significant improvements in the quality and methodology of pediatric COS are needed.
- Adherence to standards like those from the COMET initiative is recommended.
- Development of pediatric-specific outcome taxonomies is essential for advancing child health research.
Importance:
Developing core outcome sets is essential to ensure that results of clinical trials are comparable and useful. A number of core outcome sets in pediatrics have been published, but a comprehensive in-depth understanding of core outcome sets in this field is lacking.
Objective:
To systematically identify core outcome sets in child health, collate the diseases to which core outcome sets have been applied, describe the methods used for development and stakeholder participation, and evaluate the methodological quality of existing core outcome sets.
Evidence Review:
MEDLINE, SCOPUS, Cochrane Library, and CINAHL were searched using relevant search terms, such as clinical trials, core outcome, and children, along with relevant websites, such as Core Outcome Measures in Effectiveness Trials (COMET). Four researchers worked in teams of 2, performed literature screening and data extraction, and evaluated the methodological quality of core outcome sets using the Core Outcome Set-Standards for Development (COS-STAD).
Findings:
A total of 77 pediatric core outcome sets were identified, mainly developed by organizations or researchers in Europe, North America, and Australia and mostly from the UK (22 [29%]) and the US (22 [29%]). A total of 77 conditions were addressed; the most frequent International Classification of Diseases, 11th Revision category was diseases of the digestive system (14 [18%]). Most of the outcomes in pediatric core outcome sets were unordered (34 [44%]) or presented in custom classifications (29 [38%]). Core outcome sets used 1 or more of 8 development methods; the most frequent combination of methods was systematic review/literature review/scoping review, together with the Delphi approach and consensus for decision-making (10 [14%]). Among the 6 main types of stakeholders, clinical experts were the most frequently involved (74 [100%]), while industry representatives were rarely involved (4 [5%]). Only 6 core outcome sets (8%) met the 12 criteria of COS-STAD.
Conclusions And Relevance:
Future quality of pediatric core outcome sets should be improved based on the standards proposed by the COMET initiative, while core outcome sets methodology and reporting standards should be extended to pediatric populations to help improve the quality of core outcome sets in child health. In addition, the COMET outcome taxonomy should also add items applicable to children.
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