A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease

Abstract

Objectives: There is increased interest in measuring patient reported outcomes (PROs) such as quality of life (QoL) among patients with inflammatory bowel disease (IBD). We aimed to create and validate a new measure of QoL to assess the psychosocial burden of IBD, using publicly available assessment tools. Methods: Using the Crohn's & Colitis Foundation's IBD Partners cohort, we performed several cross-sectional and longitudinal analyses to create a new PRO-based evaluation (PROBE) of QoL among patients with Crohn's disease (CD) and ulcerative colitis (UC). We used factor analysis and Pearson correlation testing to identify candidate questions for inclusion, Wilcoxon rank sum testing to examine responsiveness of the PROBE to changes in disease activity, and test-retest reliability assessments in patients with stable disease activity. We also compared the PROBE to the Short Inflammatory Bowel Disease Questionnaire to assess construct validity. Results: A total of 4,854 patients (64% CD, 36% UC) completed surveys with 6 items included in the final PROBE. Compared to baseline, there was a significant decrease in PROBE scores at follow-up among patients who experienced a flare for UC (25.0 vs. 22.2, p=0.001) and CD (23.1

Systematic Review of Development and Content Validity of Patient-reported Outcome Measures in Inflammatory Bowel Disease: Do We Measure What We Measure?

“…75–79 Some of the Hr-QoL instruments are validated for UC patients, two measuring health status 80 , 81 and one Hr-QoL, 82 and three PROMs are CD-specific and report to measure health status, 80 HR-QoL, 83 and disease burden. 84 …”

Adaptation of TECCU App Based on Patients´ Perceptions for the Telemonitoring of Inflammatory Bowel Disease: A Qualitative Study Using Focus Groups

“…They were reluctant to answer excessive close-ended questionnaires, and they preferred to receive continuous follow-up and personalized feedback adapted to their particular evolution, which is similar to patients in other studies [30,45]. In this sense, we maintained the questionnaires to classify the patients' health status, but we also adapted simple and validated PROs previously used for telemonitoring of IBD patients [17,18,[40][41][42][43][44]. Additionally, some specific terms were presented through text and images so that they were more easily understood.…”

“…Moreover, they missed some feedback from the questionnaires and they did not understand the meaning of some of the specific terms. To address these comments, we reassessed the readability of the platform's components and adapted the patient-reported outcomes (PROs) [40][41][42][43][44]. Beyond the adaptation of the self-testing frequency, we also incorporated the option to self-evaluate disease activity, quality of life, and issues related to medication to a conversation format (Figure 3).…”

“…Yet, they also indicated that it was important to make the information included in the questionnaires more comprehensible and practical. In this sense, we adapted simple and validated patient-reported outcomes (PROs) [40][41][42][43][44], and included some information to illustrate in text and images the meaning of specific terms like aphtha, arthralgia, etc. Moreover, the app was redesigned to include a section that contained a summary of the patients' disease evolution and the medications prescribed ( Figure 5).…”

Biopsychosocial Correlates of Presence and Intensity of Pain in Adolescents With Inflammatory Bowel Disease

“…Adolescents self-reported IBD diagnosis (Crohn's Disease or Ulcerative Colitis/IBD-unclassified), duration (from time of diagnosis) of illness, current medications (checked and confirmed by a nurse), presence of ostomy, and current stool frequency and characteristics. IBD disease activity was measured using the disease activity item from the Patient-Reported Outcome-Based Evaluation [PROBE (31)], which is a 5-point Likert Scale that assessed IBD activity over the past week (0 = remission, 1 = minimal symptoms, 2 = mildly active, 3 = moderately active, 4 = severely active). In addition, to support the face validity of this measure, we examined how stool characteristics (frequency, consistency, blood) varied with changes in this self-reported activity score.…”