PROMIS Scores Accurately Reflect Pediatric Crohn’s Disease Activity

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Among a group of pediatric patients with Crohn’s disease, Patient-Reported Outcomes Measurement Information System (PROMIS) scores correlated with disease activity, demographic factors and health-related quality of life (HRQoL), confirming their reliability in reflecting disease status and treatment outcomes, particularly for children in remission.

Approximately 10% to 25% of patients with inflammatory bowel disease (IBD) are diagnosed during childhood or adolescence, with early onset — defined as diagnosis younger than 10 years — connected with a more complicated and extensive disease course than that of patients diagnosed in adulthood.

Patient-reported outcome (PRO) measures, such as PROMIS, have been shown to be instrumental in clinical practice, research and healthcare management. They are given to patients and/or caregivers and are designed to determine health experiences.

PROMIS has several pediatric self-reported item banks that evaluate five general health domains: physical function, emotional health, social health, pain and fatigue. According to preliminary data, these scores are significantly linked to Crohn’s disease and ulcerative colitis in a linear and clinically meaningful way, although much of this research was performed in internet-based groups and not a real clinical setting.

“Healthcare recommendations for improving care in pediatric IBD patients are increasingly comprehensive, with a focus on patient-reported data to assess physical and psychosocial functioning and well-being,” wrote a team of investigators from the University of Lisbon in Portugal.

To evaluate the clinical utility of PROMIS among this patient population, investigators compared patient-reported outcomes with HRQoL measures and clinical data. Eligible patients were aged 8 to 17 years and visited an outpatient pediatric gastroenterology center in Portugal.

Connections between PROMIS pediatric short-form measures, disease-related information, demographics, global clinical assessments and HRQoL measures were analyzed. An additional subanalysis of those in remission compared with active disease was also performed.

In total, 31 children were enrolled in the cross-sectional study with a mean age of 15.3 years and a mean disease duration of 2.7 years, and 58% were female. Among the cohort, most (80.6%) were either in remission or had mild disease.

Overall, patients in remission had significantly better PROMIS and HRQoL scores than those with active disease. Scores were found to be influenced by several factors. Older children experienced lower overall health and life satisfaction scores, boys had slightly better scores in cognitive function than girls, and children at higher grade levels reported weaker peer relationships.

According to the clinical evaluations, higher hemoglobin levels were linked to better overall health and less pain, and higher ferritin levels were linked to greater meaning and purpose in life and better cognitive function.

The IMPACT-III scores, which measure quality of life, showed positive associations with better overall health, meaning and purpose, life satisfaction, and peer relationships. There were negative associations with depression, anxiety, pain and fatigue. Treatment changes, especially with corticosteroids, negatively affected scores for anxiety and life satisfaction.

Investigators mentioned several limitations, including the small sample size comprised of patients with low disease activity and remission, which hindered generalizability. Additionally, the cross-sectional study design could not assess disease course and its impact on patient health as well as a prospective analysis may have.

“The meaningful associations with clinical assessment and treatment efficacy reinforce the clinical relevance and utility of PROs in the patient-centered management of pediatric IBD and highlight the importance of self-reports as a gold standard tool for assessing health status,” investigators concluded.