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Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting

Tonya M Palermo1,2, Gary A Walco2, Unmesha Roy Paladhi3

  • 1Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.

Pain
|February 24, 2021
PubMed

Insights

This study established a core outcome set for pediatric chronic pain interventions. Mandatory domains include pain severity, pain interference, well-being, and adverse events for better clinical trials.

Area of Science:

  • Pediatric Pain Management
  • Clinical Trial Methodology
  • Outcome Measurement

Background:

  • Advancing care for children with chronic pain requires high-quality intervention trials and appropriate outcome measures.
  • A standardized core outcome set is needed for pediatric chronic pain interventions.

Purpose of the Study:

  • To update a core outcome set for pediatric chronic pain interventions.
  • To identify and reach consensus on mandatory and optional outcome domains for clinical trials.

Main Methods:

  • A modified Delphi study involving 3 stakeholder groups: children with chronic pain (n=93), parents (n=90), and healthcare providers (n=52).
  • Two rounds of surveys followed by a virtual consensus conference.
  • Quantitative and qualitative data analysis to identify and rank outcome domains.

Main Results:

  • Ten outcome domains were identified from stakeholder input.
  • Pain severity, pain interference with daily living, overall well-being, and adverse events (including death) were unanimously voted as mandatory domains.
  • Emotional functioning, physical functioning, and sleep were identified as important optional domains.

Conclusions:

  • A consensus-based core outcome set was established for pediatric chronic pain clinical trials.
  • The defined mandatory domains will ensure consistent assessment across interventions.
  • Future research should focus on selecting validated measures for these outcome domains and exploring emerging areas like biomarkers.

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