Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases

Aug 31, 2017The American journal of gastroenterology

Assessment of Patient-Reported Digestive Symptom Scales in People with Inflammatory Bowel Diseases

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Abstract

The study included 2,378 Crohn's Disease and 1,455 ulcerative colitis respondents.

Participants had a median age of 41 years, with disease durations of 11 years for Crohn's Disease and 8 years for ulcerative colitis.
57% of Crohn's Disease subjects and 42% of ulcerative colitis subjects were in remission.
Symptomatic Crohn's Disease subjects with active disease reported significantly worse symptoms across all 8 gastrointestinal PROMIS domains compared to those in remission.
Ulcerative colitis subjects showed similar trends, with the exception of disrupted swallowing.
IBD subjects with poorer quality of life reported significantly worse symptoms on all 8 domains compared to those with better quality of life.

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OBJECTIVES: Patient reported outcomes (PROs) are important treatment endpoints in inflammatory bowel diseases (IBD). We evaluated the gastrointestinal (GI) PRO Measurement Information System (PROMIS) in IBD subjects.

METHODS: Crohn's and Colitis Foundation of America's Partners is an Internet-based cohort of IBD subjects. Participants complete surveys, including demographics, disease characteristics, PROMIS domains, disease activity (short Crohn's disease activity index or simple clinical colitis activity index) and quality of life (QoL) indices. In a nested cross-sectional study, we used univariate and bivariate analyses to assess associations between 8 GI-PROMIS domains (reflux, swallowing, diarrhea, nausea, belly pain, gas, incontinence, and constipation) and QoL and disease activity indices.

RESULTS: The study included 2,378 Crohn's Disease (CD) and 1,455 ulcerative colitis (UC) respondents with a median age of 41 years. Median disease duration was 11 years for CD subjects and 8 years for UC subjects; 57% of CD subjects and 42% of UC subjects were in remission. Among symptomatic CD subjects, those with active CD reported significantly worse symptoms on all 8 domains than those in remission. The same was observed for UC subjects with the exception of disrupted swallowing. IBD subjects with worse QoL reported significantly worse symptoms on all 8 domains compared to those with better QoL.

CONCLUSIONS: In IBD subjects experiencing GI symptoms, GI-PROMIS domains were strongly associated with disease activity and QoL indices. GI-PROMIS holds potential as PRO measures in IBD and correlates with other validated indices in this population.

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Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases

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