The Combination of Patient-Reported Clinical Symptoms and an Endoscopic Score Correlates Well with Health-Related Quality of Life in Patients with Ulcerative Colitis.

BACKGROUND AND AIMS

Patient-reported outcomes (PROs) will become increasingly important as primary endpoints in future clinical trials. We aimed to evaluate the relationship between health-related quality of life (HRQoL) and the combination of patient-reported clinical symptoms (ClinPRO2) and Mayo endoscopic subscore (MES) in patients with ulcerative colitis (UC).

METHODS

We conducted a prospective cross-sectional study of 90 consecutive UC patients who were scheduled for sigmoidoscopy or colonoscopy. All patients completed the following questionnaires: (1) self-rated rectal bleeding and stool frequency (ClinPRO2); (2) Short Inflammatory Bowel Disease Questionnaire (SIBDQ); (3) European Quality of Life 5-Dimensions 3-Level (EQ5D3L); (4) Work Productivity and Activity Impairment questionnaire (WPAI); (5) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and (6) Hospital Anxiety and Depression Scale (HADS). The endoscopic images were graded according to the MES. "No symptoms" was defined as a symptom score of 0, and "mucosal healing" was defined as MES score of 0-1. Correlations between the combined ClinPRO2 and MES with HRQoL were assessed using Spearman's correlation coefficients.

RESULTS

The combination of the ClinPRO2 and MES was well correlated to SIBDQ ( = -0.70), EQ5D3L ( = -0.51), WPAI ( = 0.62), FACIT-F ( = -0.58), and HADS-depression ( = 0.45). SIBDQ scores had strong correlations with FACIT-F ( = 0.86), WPAI ( = -0.80), and HADS-depression ( = -0.75) ( < 0.05 for all correlations). Patients with no symptoms reported the greatest all HRQoL scores.

CONCLUSIONS

In patients with ulcerative colitis, the combination of a ClinPRO2 and the MES had good correlation with the SIBDQ. In addition, SIBDQ was well correlated to the various HRQoL.