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Updated recommendations on measures for clinical trials in pediatric chronic pain: a multiphase approach from the

Tonya M Palermo1,2, Rui Li1, Kathryn A Birnie3

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

Pain
|December 19, 2023
PubMed

Insights

This study recommends 9 patient-reported measures for assessing pediatric chronic pain, aiming to improve treatment effectiveness and accessibility for youth. These validated tools address key domains like pain severity and daily life interference.

Area of Science:

  • Pediatric Pain Research
  • Clinical Trial Methodology
  • Patient-Reported Outcomes

Background:

  • Significant challenges persist in developing effective, safe, and equitable chronic pain treatments for children and adolescents.
  • Improving pain assessment is a primary objective in pediatric pain research.
  • Validated patient-reported outcome measures are crucial for advancing clinical interventions in pediatric chronic pain.

Purpose of the Study:

  • To recommend specific patient-reported measures for a newly updated core outcome set (COS) in pediatric chronic pain clinical trials.
  • To identify validated instruments for 7 domains: pain severity, pain interference, adverse events, well-being, emotional functioning, physical functioning, and sleep quality.
  • To provide guidance on the strengths and limitations of recommended measurement tools.

Main Methods:

  • A multiphased approach involving a Delphi study with experts to identify candidate measures.
  • A systematic review to gather evidence on the measurement properties of candidate instruments.
  • An expert consensus conference to finalize recommendations for specific measures.

Main Results:

  • The study recommends 9 specific patient-reported measures for the core outcome set in pediatric chronic pain.
  • Recommendations cover mandatory domains (pain severity, interference, adverse events) and optional domains (well-being, emotional, physical functioning, sleep).
  • Contextual considerations, strengths, and limitations of the recommended measures are discussed.

Conclusions:

  • The recommended patient-reported measures provide a standardized approach to assessing pediatric chronic pain.
  • Widespread dissemination and accessibility of these tools can enhance their implementation in clinical trials.
  • These recommendations aim to advance the field of pediatric chronic pain research and treatment.

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