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Pediatric core outcome sets had deficiencies and lacked child and family input: A methodological review

  • Katherine Goren
    Affiliations
    Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
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  • Andrea Monsour
    Affiliations
    Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
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  • Emma Stallwood
    Affiliations
    Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
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  • Martin Offringa
    Affiliations
    Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada

    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Division of Neonatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
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  • Nancy J. Butcher
    Correspondence
    Corresponding author. The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, 11th floor, 11.9.712, South 16, Toronto, Ontario, Canada M5G 0A4. Tel.: +1-416-813-7654; fax: +1-416-813-5245.
    Affiliations
    Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada

    Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
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Published:December 16, 2022DOI:https://doi.org/10.1016/j.jclinepi.2022.12.009

      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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