Core Outcomes in Pediatric Persistent Pain (Core-OPPP) Workgroup
Embedded Files
Pediatric Chronic Pain Clinical Trials
Core Outcome Set (COS) and Measurement Instruments
Improve pediatric chronic pain clinical trials by making stakeholder-informed and evidence-based recommendations for outcome measures
Identifying core outcome set
OMERACT 2.0 Domain Framework Link
Selecting measurement instruments
Core outcome set - Mandatory domains
Core outcome set - Mandatory domains
Pain severity
Pain severity
Perception of the severity of pain including how intense pain is and how frequently it occurs
Pain-related interference with daily living
Pain-related interference with daily living
How much pain interferes with engagement in social, physical, and recreational activities
Functional Disability Inventory (FDI)
Spanish translation* (translations available in 32 languages)
Child's Activity Limitations Interview Short Version (CALI-9)
Overall (global) well-being
Overall (global) well-being
Perception of overall (global) well-being
Adverse events
Adverse events
An unwanted symptom or reaction from a treatment
* No specific measure recommended at this point. Consider using symptom checklist and serious adverse events assessment. (click here for more information)
Core outcome set - Optional domains
Emotional functioning
Emotional functioning
Psychological and emotional well-being
PROMIS® Pediatric Depressive Symptoms 8a
PROMIS® Pediatric Anxiety 8a
Find the English and Spanish measures in HealthMeasures
Children's Depression Inventory Short Version (CDI-S)
Refer to: Kovacs M. Children's Depression Inventory (CDI). Technical manual update. North Tonawanda, NY: Multi-Health Systems; 2003.
Physical functioning
Physical functioning
Ability to perform physical activities
Bath Adolescent Pain Questionnaire (BAPQ) - Physical Functioning Scale
Sleep
Sleep
Quantity and quality of sleep
*It should be noted that the Spanish translations of the recommended measures have not been formally validated in youth of Spanish cultures.
References:
[1] McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L, PedImmpact. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain 2008;9(9):771-783.
[2] Palermo TM, Walco GA, Paladhi UR, Birnie KA, Crombez G, de la Vega R, Eccleston C, Kashikar-Zuck S, Stone AL. Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting. Pain 2021;162(10):2539-2547.
[3] Palermo TM, Slack K, Loren D, Eccleston C, Jamison RN. Measuring and reporting adverse events in clinical trials of psychological treatments for chronic pain. Pain. 2020 Apr;161(4):713-717.
[4] Palermo TM, Li R, Birnie KA, Crombez G, Eccleston C, Kashikar-Zuck S, Stone AL, Walco GA. 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. Pain. 2023 Dec 15.
[5] Li R, Gibler RC, Rheel E, Slack K, Palermo TM. Recommendations for Patient-Reported Outcomes Measurement Information System pediatric measures in youth with chronic pain: a COnsensus-based Standards for the selection of health Measurement INstruments systematic review of measurement properties. Pain. 2024 Feb 1;165(2):258-295.
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