Patient-Reported Outcomes Informative, Valid Measures of Pediatric UC

Boy having a stomachache holding his belly tightly with two hands with red pain coloring around his stomach
Investigators conducted a longitudinal cohort study of patients with UC to evaluate how PROMIS Pediatric measures relate to disease activity and health-related quality of life.

Study data published in the Journal of Pediatric Gastroenterology and Nutrition support the use of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in clinical care and research. In a cohort study of children and adolescents with ulcerative colitis (UC), the PROMIS Pediatric measures had high construct validity and responsiveness over time.

The PROMIS consists of a set of patient-reported outcome measures designed to capture “physical, emotional, and social health.” The reliability and validity of the PROMIS Pediatric measures have been established in pediatric Crohn disease and other chronic conditions. However, its utility in pediatric UC has yet to be established.

To better evaluate how PROMIS Pediatric measures relate to disease activity and health-related quality of life (HRQOL), investigators conducted a longitudinal cohort study of patients with UC aged 9 to 17 years. Enrollees in the Inflammatory Bowel Disease Partners Kids & Teens internet-based cohort were invited to complete online surveys between 2013 and 2019.

The Pediatric Ulcerative Colitis Activity Index (PUCAI) and IMPACT-III surveys were used to measure UC disease activity and HRQOL. Participants also completed 5 PROMIS Pediatric measures, which assessed anxiety, depressive symptoms, pain levels, fatigue, and relationships with peers. Investigators conducted cross-sectional and longitudinal analyses to evaluate the correlation between PROMIS scores, disease activity, and HRQOL.

The study cohort included 91 patients with UC of mean age 13.3±3.0 years, among whom 57% were girls. Mean disease duration was 3.5±3.1 years. A total of 43 participants completed more than 1 survey round, allowing for longitudinal analyses.

In both cross-sectional and longitudinal analyses, better PROMIS Pediatric scores were associated with lower disease activity. Similarly, worse PUCAI scores predicted poorer PROMIS scores for anxiety, depression, pain, fatigue, and peer relationships (P <.0001 in all domains).

Changes in disease activity were also found to impact PROMIS scores over time. Specifically, a change from moderate/severe disease activity to remission on PUCAI had an estimated effect size of -5.1 points for anxiety, -5.0 points for depression, -14.7 points for pain interference, and +5.3 points for peer relationships.

As with disease activity, PROMIS Pediatric scores were poorer among patients that reported worse HRQOL (P <.0001 for all domains). Similarly, changes in PROMIS Pediatric scores over time were moderately correlated with changes in IMPACT-III scores (P <.01 for all domains).

This study was not without limitations. Investigators noted that the cohort enrolled only online volunteers, which may limit data generalizability. In addition, disease activity was measured only through surveys; validation in a cohort which involves histological endpoints may be warranted.

These data provide evidence for the validity and responsiveness of the PROMIS Pediatric measures for patients with UC. PROMIS measures were closely correlated with disease activity levels and HRQOL in both cross-sectional and longitudinal analyses.

 “These findings support the use of PROMIS Pediatric in clinical research involving children and adolescents with UC,” investigators wrote.


Brenner EJ, Long MD, Mann CM, et al. Validity and responsiveness of the patient-reported outcomes measurement information system in children with ulcerative colitis. J Pediatr Gastroenterol Nutr. 2021;73(1):67-72. doi:10.1097/MPG.0000000000003101