Intended Audiences: Clinical Research 

Background and Aims: The Patient-Reported Outcome Measurement Information System (PROMIS®) pediatric measures assess multifaceted aspects of physical, social, and emotional health among children and adolescents. However, their measurement properties have not been systematically examined in youth with chronic pain, resulting in a lack of evidence to guide the selection of specific measures for use in clinical and research contexts. Our aim was to thoroughly assess a comprehensive set of measurement properties of existing self-reported PROMIS® pediatric measures and provide evidence-based recommendations for their use in clinical trials and observational studies involving youth with chronic pain. 

 

Methods: We conducted a pre-registered (PROSPERO CRD42021289059) systematic review employing the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Peer-reviewed articles focusing on various measurement properties, interpretability, or feasibility of self-reported PROMIS® pediatric measures in chronic pain populations aged 5-19 years, along with the original measure development and validation studies, were included. Based on the adapted COSMIN criteria for good measurement, we evaluated 9 measurement properties related to validity, reliability, and responsiveness across all measurement versions (item bank, short form, computer adaptive testing). The COSMIN Risk of Bias checklist and a modified GRADE approach were used to evaluate study quality and evidence. Recommendations were made for the use of each measure in clinical trials and observational studies in pediatric chronic pain. 

 

Results: This review included 63 articles covering 25 PROMIS® pediatric measures. Of these, 30 articles published between 2013 and 2022 included youth aged 8-20 years with a range of chronic pain conditions. Overall, 54% of PROMIS® pediatric measures (typically 8-item measures) showed moderate or high-quality evidence for sufficient content validity. We also found moderate or high-quality evidence for sufficient structural validity in 73% of measures, internal consistency in 65% of measures, construct validity in 69% of measures, and responsiveness to change in 46% of measures. Despite generally sufficient ratings for cross-cultural validity/measurement invariance and test-retest reliability, the quality of evidence was low to very low, and evidence for measurement errors was lacking. Administering PROMIS® pediatric measures in clinical settings was highly feasible, and minimal important differences were available for several domains in youth with chronic pain. Based on predefined criteria, four short form PROMIS® pediatric measures (mobility, anxiety, depressive symptoms, and physical stress experiences) achieved recommendation for use in pediatric chronic pain clinical trials. Seven measures approached recommendation, and 14 would be recommended with further evidence. In observational studies, 9 short form measures achieved recommendation, 2 approached recommendation, and 14 would be recommended with further evidence. 

 

Conclusions: Eleven self-reported PROMIS® pediatric short form measures spanning physical, psychological, and social domains are recommended or approached recommendation for use in youth ages 8-19 years with chronic pain based on existing evidence. More research is required to establish the test-retest reliability, measurement errors, cross-cultural validity, and responsiveness of these measures. Additionally, our results highlight a critical need to expand the evaluation of PROMIS® pediatric measures in specific subpopulations of youth with chronic pain, particularly young children and youth with neurodevelopmental disabilities.

Relevance for Patient Care: Patient-reported outcomes (PROs) are important in understanding the subjective and complex experience of chronic pain that varies greatly among individuals. The PROMIS® pediatric measures offer several advantages, including efficiency, flexibility, interpretability, and ease of use. Our systematic review helps providers and researchers make informed decisions regarding the use of PROMIS® pediatric measures in youth with chronic pain and serves as evidence for recommending measurement instruments for the updated core outcome set for pediatric chronic pain clinical trials, incorporating the important PROMIS® measurement advances from the past two decades.