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Table 1 Patient Demographic and Clinical Characteristics: Phase I, Qualitative

From: Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

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%)

  1. Note: Percents may not add to 100 due to rounding
  2. aNot mutually exclusive
  3. bData were only collected for additional concept elicitation and cognitive interview (n = 30)
  4. cResponses are not mutually exclusive
  5. Abbreviations: n Number, SD Standard deviation, SeCDAI Sandler estimated Crohn’s disease Activity Index