Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children"

Research output: Contribution to journalReview articleContributedpeer-review

Contributors

  • PC-COS Children Study Group - (Author)
  • Center for Evidence-Based Healthcare
  • Sechenov First Moscow State Medical University
  • National Medical Research Center for Children's Health
  • University of Birmingham
  • Royal Liverpool Children's NHS Trust:
  • Otto von Guericke University Magdeburg
  • Shiraz University of Medical Sciences
  • Thomas Jefferson University
  • Schneider Childrens Medical Center Israel
  • University of Amsterdam
  • Tergooi Hospital
  • Catholic University of the Sacred Heart
  • World Health Organization
  • University of Padua
  • University College Cork
  • Leipzig University
  • University of Surrey
  • Kennedy Krieger Institute
  • Johns Hopkins University
  • University of Washington
  • King's College London (KCL)
  • Yale University
  • Yale New Haven Health System
  • University College London Hospitals NHS Foundation Trust
  • University of Oxford
  • University College London
  • Amsterdam University Medical Centers (UMC)
  • Imperial College London
  • University of Liverpool (UOL)
  • Research and Clinical Center for Neuropsychiatry

Abstract

The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

Details

Original languageEnglish
Article number2301761
JournalThe European respiratory journal
Volume63
Issue number3
Publication statusPublished - Mar 2024
Peer-reviewedYes

External IDs

PubMedCentral PMC10938351
Scopus 85183355776

Keywords

Keywords

  • Adolescent, Child, Humans, COVID-19, Delphi Technique, Outcome Assessment, Health Care, Post-Acute COVID-19 Syndrome, Research Design, Treatment Outcome