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. 2024 Dec 31;22(1):112.
doi: 10.1186/s12955-024-02330-2.

Clinical usefulness of patient-reported-outcome-measurement information system in Pediatric Crohn's Disease: a cross-sectional study

Sara Azevedo  1   2 , Maria Miguel Oliveira  3   4   5 , Paulo Nogueira  3   4   5   6 , Ana Isabel Lopes  7   3
Affiliations

Clinical usefulness of patient-reported-outcome-measurement information system in Pediatric Crohn's Disease: a cross-sectional study

Sara Azevedo et al. Health Qual Life Outcomes. .

Abstract

Objectives: This study evaluated the clinical utility of the Patient-Reported Outcomes Measurement Information System (PROMIS®) by comparing it with objective clinical data and validated health-related quality of life (HRQOL) measures in pediatric Crohn's disease (CD) patients.

Study design: Cross-sectional study. Pediatric CD patients (aged 8-17 years) were enrolled prospectively over eight months from an outpatient pediatric gastroenterology center. We assessed the associations between PROMIS® Pediatric short-form measures, demographic and disease-related data, global clinical assessments, and HRQOL measures. A subanalysis according to the PCDAI (remission versus active disease) was also conducted.

Results: Thirty-one patients (mean age: 15.3; 58% female) with a mean disease duration of 2.7 years were included; 80.6% were in remission or had mild disease. The PROMIS® score was significantly correlated with several factors: age was negatively correlated with the PROMIS® Global Health Scale (r=-0.399; p = 0.026) and Life Satisfaction (r=-0.359; p = 0.047); sex was associated with the PROMIS® Cognitive Function Scale (t = 2.20; p = 0.038), favoring males; and school level was inversely related to the PROMIS® Peer Relationships (F = 3.90; p = 0.003). Clinical assessments also revealed significant correlations between hemoglobin and PROMIS® Global Health (r = 0.356; p = 0.049) and pain interference (r=-0.360; p = 0.046) and between ferritin and PROMIS® Meaning and Purpose (r = 0.435; p = 0.016) and cognitive function (r = 0.450; p = 0.011). Disease activity assessments correlated significantly with multiple PROMIS® measures, with better scores in patients in remission. Treatment changes, particularly corticosteroid treatment, negatively impacted the PROMIS® Anxiety and Life Satisfaction scores. IMPACT-III scores correlated positively with PROMIS® Global Health, Meaning and Purpose, Life Satisfaction, and peer relationships scores and negatively with Depression, Anxiety, Pain interference, and Fatigue scores. Group analysis indicated better PROMIS® scores and HRQOL scores in remission than in active disease remission.

Conclusion: Consistent with recent evidence, PROMIS® scores reliably reflect disease activity and HRQOL. 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.

Keywords: Children; Crohn’s disease; Health-related quality of life; Inflammatory bowel disease; Patient-reported outcomes measurement information system (PROMI); Pediatric chronic diseases; Pediatrics.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethics approval and consent to participate: The study was conducted in accordance with the ethical principles set forth in the Declaration of Helsinki of the World Medical Association and in accordance with the additional requirements set forth in the national legislation. Prior to the commencement of the study, ethical approval was obtained from the Ethical Committee of Santa Maria University Hospital - CHLN, Academic Medical Centre of Lisbon, Portugal. Consent for publication: Informed consent to participate in the study and for publication was obtain prior to enrollment. All pediatric CD patients with 8–17 years of age signed an informed assent (< 16 years) and consent (patients with16 years). Informed consent was also obtain from all caregivers of all pediatric patients. Competing interests: The authors declare no competing interests.

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