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

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 on 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 3 mandatory domains: pain severity, pain-related interference with daily living, and adverse events and 4 optional domains: overall well-being, emotional functioning, physical functioning, and sleep quality. The aim of this study was to use a multiphased approach to recommend specific measures for each of the 7 domains identified in our new COS for pediatric chronic pain. We synthesized evidence through conducting the following: (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.

Contributors

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

Publication

Journal: PAIN
Volume: 165
Issue:
Pages: 1086 - 1100
Year: 2024
DOI: 10.1097/j.pain.0000000000003105

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Research reported in this publication was supported by the Mayday Foundation. A.L.S. was supported by NIH K23 HD104183.


Health Area

Disease Category: Anaesthesia & pain control, Child health

Disease Name: Chronic pain

Target Population

Age Range: 0 - 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus conference
- Delphi process
- Systematic review

Work was conducted in 3 phases: (1) a Delphi study of experts to identify candidate measures, (2) a review phase to gather evidence for measurement properties of the candidate measures, and (3) a consensus conference among our Core-OPPP steering commitee to make final recommendations.