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VIDEO: Novel patient-reported QOL tool may improve clinical trial outcomes in IBD
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In this exclusive video from the Congress of the European Crohn’s and Colitis Organisation, Peter D.R. Higgins, MD, PhD, director of the IBD program at the University of Michigan, discusses a new patient-reported outcome tool that was developed and used to assess experience and quality of life in patients with ulcerative colitis.
“This [tool] was developed based on an FDA-guidance based on input from focus groups from patients with ulcerative colitis and asking them what was important to them and how they knew they were improved or worsened by their symptoms and this led to a focus on symptoms that aren’t normally measured and standard measures of ulcerative colitis,” Higgins told Healio Gastroenterology and Liver Disease.
Standard assessment tools mainly focus on items such as abdominal pain and bleeding, according to Higgins. However, the researchers identified that urgency, incontinence, bloating and abdominal and rectal pain were important to patients.
“One of the challenges of this kind of measurement is that it incorporates all kinds of things, some of which can be directly related to inflammation in ulcerative colitis and others that are more about the function of the bowels, or what we call functional symptoms,” Higgins said.
Functional symptoms, according to Higgins, include pain, bloating and passing gas, whereas bowel symptoms associated with inflammation include bloody stools, urgent bowel movements and mucus in a stool.
“What we found when we developed these items and started testing them, and in this case, that we were testing them in a setting of a clinical trial where patients come in with very active inflammation and in response to a medication, get better,” he said. “We found that there were correlations among the items that actually separate into two domains, a functional domain and a bowel symptom domain. The benefit of this, as these distinct domains, allow someone designing a clinical trial to focus on either the functional aspects for a medication designed to help those functional symptoms, or on the inflammatory components of the bowel domain and focus exclusively on that and by picking one area and not the other, you can separate them and have less noise in your outcome in your study, which is an advantage of this measure.”
Reference:
Higgins PDR, et al. P224. Presented at: Congress of the European Crohn’s and Colitis Organisation; March 7-9, 2019; Copenhagen, Denmark.
Disclosure: Higgins reports consulting for AbbVie, Arena Pharmaceuticals, Eli Lilly, Janssen, Lycera, PRIME Medical Education, Takeda and UCB; as well as serving on advisory committees or review panels for Janssen.