What Is a Flare? The Manitoba Living With IBD Study
Kelcie Witges, Kathryn A. Sexton, Lesley A. Graff, Laura E. Targownik, Lisa M. Lix, Clove Haviva, James Stone, Leigh Anne Shafer, Kathy Vagianos, Çharles N. Bernstein
Abstract
BACKGROUND: Flare is a poorly defined term used by patients and clinicians to indicate inflammatory bowel disease (IBD) status. This study aimed to evaluate the validity of a single-item 7-point flare indicator relative to other measures of disease flare. METHODS: The longitudinal Manitoba Living with IBD Study followed persons with IBD for 1 year; they completed biweekly online surveys and provided 3 stool samples. Disease flare on a single-item flare indicator with 7 possible responses developed for the study was defined by report of symptoms as "moderately" or "much" worse. The flare indicator was evaluated against 5 measures of disease activity: fecal calprotectin score (FCAL), a 2-point disease status indicator, a 4-point flare certainty indicator, the IBD Symptom Index short form (SIBDSI), and the short form IBD Questionnaire (SIBDQ). Participants in a flare, based on the 7-point measure, were matched to a nonflaring participant, and a stool sample was collected. RESULTS: Of the 155 IBD participants, almost half (n = 74) experienced a flare. Of those who flared, 97.0% endorsed active IBD on the 2-point indicator (controls 42.5%; P < .001); 91.9% endorsed active IBD on the 4-point certainty indicator (controls 32.9%; P < .001); 90.5% endorsed active disease on the SIBDSI (controls 34.2%; P < .001); and 48.5% had an elevated FCAL (controls 34.3%; P < .05). The mean SIBDQ was lower for the flare group compared with controls (43.9 [SD 11.1] vs 58.3 [SD 8.5]; P < .001), indicating worse disease. CONCLUSIONS: The 7-point flare indicator robustly identified symptomatic flares. This patient self-report indicator reflected meaningful changes in more complex clinical indices and had only weak concordance with the presence of inflammation.