Pediatric core outcome sets had deficiencies and lacked child and family input: A methodological review
Journal of clinical epidemiology(2023)
摘要
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. (c) 2022 Elsevier Inc. All rights reserved.
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关键词
Core outcome set,Pediatrics,COS-STAD,Clinical trial,Patient and public involvement,Family engagement
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