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Validity and Responsiveness of the Patient-reported Outcomes Measurement Information System in Children With
Erica J Brenner1, Millie D Long2, Courtney M Mann3
1Department of Pediatric Gastroenterology.
Insights
Patient-reported outcome measures (PROMIS) effectively assess health in pediatric ulcerative colitis (UC) patients. PROMIS scores correlate with disease activity and quality of life, supporting their clinical use.
Area of Science:
- Pediatric gastroenterology
- Health outcomes research
- Psychometrics
Background:
- Patient-reported outcome measures (PROMIS) enable children to report their health status.
- Ulcerative colitis (UC) significantly impacts pediatric patients' well-being.
- Validating PROMIS Pediatric measures is crucial for assessing health in pediatric UC.
Purpose of the Study:
- To assess the construct validity and responsiveness of PROMIS Pediatric measures in children and adolescents with UC.
- To determine the association between PROMIS scores and disease activity/quality of life.
- To evaluate the longitudinal responsiveness of PROMIS measures to clinical changes.
Main Methods:
- Utilized data from the Inflammatory Bowel Disease Partners Kids & Teens cohort.
- Included 91 pediatric UC patients (ages 9-17).
- Employed cross-sectional and longitudinal mixed-linear regression analyses correlating PROMIS scores with disease activity (PUCAI) and quality of life (IMPACT-III).
Main Results:
- PROMIS Pediatric scores demonstrated construct validity, correlating with lower disease activity and improved quality of life.
- Significant improvements in PROMIS scores were observed with disease remission.
- PROMIS scores showed moderate correlation with changes in IMPACT-III over time.
Conclusions:
- The PROMIS Pediatric measures are valid and responsive for assessing pediatric patients with UC.
- Findings support the use of PROMIS Pediatric measures in clinical research and patient care for pediatric UC.
- This validation enhances the utility of patient-reported outcomes in pediatric inflammatory bowel disease.
Objectives:
Patient-reported outcome measures allow children to directly report on their health and well-being. We assessed the construct validity and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in children and adolescents with ulcerative colitis (UC).
Methods:
Through the Inflammatory Bowel Disease Partners Kids & Teens' Internet-based cohort, children with UC reported symptoms related to disease activity (Pediatric Ulcerative Colitis Activity Index), IMPACT-III health-related quality of life measure, and 5 PROMIS Pediatric measures (anxiety, depressive symptoms, pain interference, fatigue, and peer relationships). We included participants aged 9 to 17 years and conducted cross-sectional and longitudinal, mixed-linear regression analyses to examine the extent to which PROMIS Pediatric scores are associated with and respond to changes in Pediatric Ulcerative Colitis Activity Index and IMPACT-III.
Results:
We evaluated 91 participants with UC (mean age 13 years, 57% girls). Better PROMIS Pediatric scores were associated with lower disease activity, in both cross-sectional and longitudinal analyses. For a change from moderate/severe to remission, observed effect estimates were -5.1 points for anxiety, -5.0 for depressive symptoms, -14.7 for pain interference, -13.7 for fatigue, and 5.3 for peer relationships (P < 0.05 for all domains). Better PROMIS Pediatric scores were associated with improved IMPACT-III scores (P values <0.01), and changes in scores were moderately correlated with changes in IMPACT-III over time (adjusted P values <0.01).
Conclusions:
This study provides evidence for the construct validity and longitudinal responsiveness of the PROMIS Pediatric measures in pediatric patients with UC, thus supporting their use in clinical research and patient care.
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