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Validation of Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric Measures for Children
Mary M Eckert1,2, Eveline Y Wu3, Melissa Oliver4
1Western University of Health Sciences, Lebanon, United States of America.
Objectives:
To assess the validity of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric measures in patients with chronic nonbacterial osteomyelitis (CNO).
Methods:
Within the longitudinal patient registry of CNO, English-speaking patients aged 8 years and older self-reported PROMIS Pediatric measures of fatigue, pain interference (PI), pain behavior (PB), mobility, upper extremity (UE), physical activity (PA) and strength impact (SI), and external validation measures. Log-transformed linear mixed-effects models with random patient intercepts were used to assess PROMIS T-score changes. Wilcoxon signed-rank test was performed to determine the PROMIS T-score changes among the improved, worsened, and unchanged groups. Spearman rank correlation test determined the relationship of PROMIS T-scores with disease status reported by patients/families.
Results:
More than 1,000 clinical visits from 184 patients included PROMIS Pediatric measures entries. All PROMIS T-scores correlated significantly (p<0.01) with patient-reported variables and physician global assessment (PHGA). The correlation between function and mobility, PB, and PI was good (r=0.4-0.6). The correlation of patient-reported disease status was strong with PHGA (r=0.75), moderate with mobility, PB, PI, and weak with Fatigue, SI, UE, and PA. The changes of PROMIS T-scores over time for mobility, PB, PA, and PI compared to the self-reported status change were significant (p<0.05). After effective treatment, when clinical disease activity score improved by at least 3 points (n=18), the change of PROMIS T-scores for mobility, PB, PI, UE were significant (p<0.05).
Conclusion:
This study provided evidence supporting the use of PROMIS Pediatric mobility, pain behavior, and pain interference measures for CNO clinical disease monitoring.
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