Table 1.
Patient Demographic and Clinical Characteristics: Phase I, Qualitative
| Demographic and Clinical Characteristics | Total (n = 49) |
|---|---|
| Age | |
| Mean (SD) | 43.3 (15.43) |
| Range | (19–72) |
| Gender, n (%) | |
| Male | 15 (30.6%) |
| Female | 34 (69.4%) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 2 (4.1%) |
| Not Hispanic or Latino | 46 (93.9%) |
| Missing | 1 (2.0%) |
| Race,a n (%) | |
| American Indian or Alaska Native | 0 (0.0%) |
| Asian | 1 (2.0%) |
| Black or African American | 5 (10.2%) |
| Native Hawaiian or other Pacific Islander | 0 (0.0%) |
| White | 40 (81.6%) |
| Other | 3 (6.1%) |
| SeCDAI score | |
| Mean (SD) | 470.8 (262.82) |
| Range | (42–1078) |
| Remission (< 150) | 5 (10.2%) |
| Mild (150–220) | 3 (6.1%) |
| Moderate (≥ 220) | 41 (83.7%) |
| Extent of disease, n (%) | |
| Affecting only the colon (large intestine) | 14 (28.6%) |
| Affecting only the lower small intestine (ileum and jejunum) | 6 (12.2%) |
| Affecting only the upper GI tract (stomach, esophagus, and duodenum) | 0 (0.0%) |
| Affecting the colon (large intestine) and lower small intestine | 22 (44.9%) |
| Affecting the lower small intestine and upper GI tract | 3 (6.1%) |
| Affecting the colon (large intestine), and the lower small intestine, and the upper GI tract (stomach, esophagus, and duodenum) | 4 (8.2%) |
| Disease location,b n (%) | |
| L1, ileal only | 4 (13%) |
| L2, colonic only | 13 (43%) |
| L3, ileocolonic | 12 (40%) |
| L4, isolated upper disease | – |
| Missing | 1 (3%) |
| Disease behavior,b,c n (%) | |
| B1, non-stricturing non-penetrating | 14 (47%) |
| B2, stricturine | 11 (37%) |
| B3, penetrating (not including abscess) | 6 (20%) |
Note: Percents may not add to 100 due to rounding
aNot mutually exclusive
bData were only collected for additional concept elicitation and cognitive interview (n = 30)
cResponses are not mutually exclusive
Abbreviations: n Number, SD Standard deviation, SeCDAI Sandler estimated Crohn’s disease Activity Index