Updated recommendations on measures for clinical trials in pediatric chronic pain: A multi-phase approach from the Core Outcomes in Pediatric Persistent Pain (Core-OPPP) Workgroup

Tonya M. Palermo, Rui Li, Kathryn A. Birnie, Geert Crombez, Christopher Eccleston, Susmita Kashikar-Zuck, Amanda L. Stone, Gary A. Walco

Research output: Contribution to journalArticlepeer-review

7 Citations (SciVal)

Abstract

Many gaps remain in finding effective, safe, and equitable treatments for children and adolescents with chronic pain and in accessing treatments in different settings. A major goal of the field is to improve assessment of pain and related experience. Valid and reliable patient-reported outcome measures are critical for advancing knowledge of clinical interventions for pediatric chronic pain. Building upon the work of the Ped-IMMPACT group, we previously updated a core outcome set (COS) for pediatric chronic pain clinical trials using stakeholder feedback from providers, youth, and parents. The new COS includes three mandatory domains: pain severity, pain-related interference with daily living, and adverse events, and four optional domains: overall well-being, emotional functioning, physical functioning, and sleep quality. The aim of the current study was to use a multi-phased approach to recommend specific measures for each of the seven domains identified in our new COS for pediatric chronic pain. We synthesized evidence through conducting: (1) a Delphi study of experts to identify candidate measures for the new COS domains, (2) a review phase to gather evidence for measurement properties for candidate measures, and (3) an expert consensus conference to reach agreement on measurement recommendations. Final recommendations included 9 patient-reported measures. Important contextual considerations are discussed, and guidance is provided regarding strengths and limitations of the recommendations. Implementation of these recommendations may be enhanced by widespread dissemination and ease of access to measurement tools.
Original languageEnglish
Pages (from-to)1086-1100
Number of pages15
JournalPain
Volume165
Issue number5
Early online date15 Dec 2023
DOIs
Publication statusPublished - 1 May 2024

Bibliographical note

Funding:
Research reported in this publication was supported by the Mayday Foundation. ALS was supported by NIH K23 HD104183.

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