TABLE 1.
Baseline demographic and clinical characteristics of participants included in the concept elicitation interviews
| Characteristic | CD | UC | |||
|---|---|---|---|---|---|
| Total (N = 54) | Without complications (N = 36) | With complications | Total (N = 53) | ||
| Ostomy (N = 12) | Perianal fistula (N = 6) | ||||
| Age (years) | |||||
| Mean (SD) | 46.2 (15.3) | 45.8 (15.3) | 51.3 (14.5) | 38.0 (15.7) | 41.4 (14.3) |
| Range | 19‐77 | 19‐77 | 32‐70 | 20‐67 | 19‐79 |
| Gender | |||||
| Male | 18 (33.3%) | 12 (33.3%) | 2 (16.7%) | 4 (66.7%) | 27 (50.9%) |
| Female | 36 (66.7%) | 24 (66.7%) | 10 (83.3%) | 2 (33.3%) | 26 (49.1%) |
| Marital status | |||||
| Married or living as married | 27 (50.0%) | 20 (55.6%) | 5 (41.7%) | 2 (33.3%) | 32 (60.4%) |
| Widowed | 3 (5.6%) | 2 (5.6%) | 1 (8.3%) | 0 | 1 (1.9%) |
| Separated or divorced | 11 (20.4%) | 5 (13.9%) | 4 (33.3%) | 2 (33.3%) | 3 (5.7%) |
| Never married | 13 (24.1%) | 9 (25.0%) | 2 (16.7%) | 2 (33.3%) | 17 (32/1%) |
| Highest level of education completed | |||||
| High school | 18 (33.3%) | 14 (38.9%) | 2 (16.7%) | 2 (33.3%) | 7 (13.2%) |
| Some college | 14 (25.9%) | 7 (19.4%) | 5 (41.7%) | 2 (33.3%) | 17 (32.1%) |
| Bachelor's degree | 15 (27.8%) | 13 (36.1%) | 2 (16.7%) | 0 | 14 (26.4%) |
| Graduate/professional school | 6 (11.1%) | 2 (5.6%) | 3 (25.0%) | 1 (16.7%) | 15 (28.3%) |
| Missing/refused to answer | 1 (1.9%) | 0 | 0 | 1 (16.7%) | 0 |
| Employment | |||||
| Employed full‐time for wages | 19 (35.2%) | 15 (41.7%) | 1 (8.3%) | 3 (50.0%) | 29 (54.7%) |
| Employed part‐time for wages | 0 | 0 | 0 | 0 | 6 (11.3%) |
| Self‐employed | 1 (1.9%) | 0 | 0 | 1 (16.7%) | 3 (5.7%) |
| Out of work | 2 (3.7%) | 2 (5.6%) | 0 | 0 | 2 (3.8%) |
| Homemaker | 5 (9.3%) | 3 (8.3%) | 2 (16.7%) | 0 | 1 (1.9%) |
| Student | 3 (5.6%) | 2 (5.6%) | 0 | 1 (16.7%) | 5 (9.4%) |
| Retired | 10 (18.5%) | 6 (16.7%) | 4 (33.3%) | 0 | 3 (5.7%) |
| Unable to work | 13 (24.1%) | 8 (22.2%) | 5 (41.7%) | 0 | 4 (7.5%) |
| Missing/refused to answer | 1 (1.9%) | 0 | 0 | 1 (16.7%) | 0 |
| Hispanic or Latino origin | |||||
| Non‐Hispanic or Latino | 54 (100%) | 36 (100%) | 12 (100%) | 6 (100%) | 46 (86.8%) |
| Hispanic or Latino | 0 | 0 | 0 | 0 | 7 (13.2%) |
| Race | |||||
| Black or African American | 6 (11.1%) | 6 (16.7%) | 0 | 0 | 2 (3.8%) |
| White | 46 (85.2%) | 29 (80.6%) | 11 (91.7%) | 6 (100%) | 45 (84.9%) |
| Other | 1 (1.9%) | 1 (2.8%) | 0 | 0 | 6 (11.3%) |
| Missing/refused to answer | 1 (1.9%) | 0 | 1 (8.3%) | 0 | 0 |
| Time since diagnosis (years) | |||||
| Mean (SD) | 15.5 (12.2) | 12.7 (10.9) | 23.8 (6.3) | 14.8 (12.5) | 8.7 (6.9) |
| Range | 0‐43 | 0‐35 | 2‐43 | 2‐29 | 1‐33 |
| HBI score | |||||
| Mean (SD) | 7.8 (5.6) | 6.4 (4.8) | 12.3 (5.5) | 8.0 (5.6) | — |
| Range (0‐18 a ) | 0‐23 | 0‐20 | 4‐23 | 3‐18 | — |
| HBI score category | |||||
| <5 | 16 (29.6%) | 13 (36.1%) | 1 (8.3%) | 2 (33.3%) | — |
| 5‐8 | 18 (33.3%) | 14 (38.9%) | 3 (25.0%) | 1 (16.7%) | — |
| >8 | 20 (37.0%) | 9 (25.0%) | 8 (66.7%) | 3 (50.0%) | — |
| SCCAI score | |||||
| Mean (SD) | — | — | — | — | 3.6 (3.5) |
| Range (0‐19) | — | — | — | — | 0‐14 |
| SCCAI score category | |||||
| <3 | — | — | — | — | 26 |
| 3‐5 | — | — | — | — | 10 |
| 6‐11 | — | — | — | — | 16 |
| >11 | — | — | — | — | 1 |
| SES‐CD (N = 34) b , c | |||||
| Median (IQR) | — | 3.5 (0‐7) | — | 6.0 (4‐14) | — |
| Range (0‐56) | — | 0‐19 | — | 3‐15 | — |
| SES‐CD category (N = 34) b , c | |||||
| 0‐2 | — | 12 | — | 0 | — |
| 3‐6 | — | 13 | — | 4 | — |
| >7 | — | 9 | — | 2 | — |
| MCES category | |||||
| 0 | — | — | — | — | 6 (11.3%) |
| 1 | — | — | — | — | 19 (35.8%) |
| 2 | — | — | — | — | 12 (22.6%) |
| 3 | — | — | — | — | 16 (30.2%) |
| UCEIS score | |||||
| Mean (SD) | — | — | — | — | 2.5 (1.9) |
| Range (0‐8) | — | — | — | — | 0‐8 |
| Disease extent | |||||
| E1 (proctitis) | — | — | — | — | 17 (32.1%) |
| E2 (distal to splenic flexure) | — | — | — | — | 17 (32.1%) |
| E3 (proximal to splenic flexure) | — | — | — | — | 19 (35.8%) |
| Comorbidities/extraintestinal manifestations | |||||
| Allergies | 25 (47.2%) | ||||
| Arthritis/rheumatism | 8 (15.1%) | ||||
| Bile acid diarrhoea | 4 (7.4%) | 4 (11.1%) | 0 | 0 | — |
| Back problems | — | — | — | — | 6 (11.3%) |
| Depression | — | — | — | — | 12 (22.6%) |
| Diabetes or high blood pressure | — | — | — | — | 7 (13.2%) |
| Headache or migraine | — | — | — | — | 11 (20.8%) |
| Heart trouble | — | — | — | — | 2 (3.8%) |
| High blood pressure or hypertension | — | — | — | — | 7 (13.2%) |
| Intestinal bacterial overgrowth | 1 (1.9%) | 1 (2.8%) | 0 | 0 | — |
| Liver problems | — | — | — | — | 4 (7.5%) |
| Nervousness or anxiety disorder | — | — | — | — | 14 (26.4%) |
| Primary sclerosing cholangitis | — | — | — | — | 2 (3.8%) |
| Thyroid problems | — | — | — | — | 3 (5.7%) |
| Trouble hearing (even with hearing aid) | — | — | — | — | 3 (5.7%) |
| Trouble seeing (even with glasses/contacts) | — | — | — | — | 8 (15.1%) |
| Stricture with obstructive symptoms | 3 (5.6%) | 2 (5.6%) | 1 (8.3%) | 0 | — |
| Treatment history: disease‐related procedures | |||||
| Ileocolonic resection with ileocecal valve resection and ileocolonic anastomosis | 15 (27.8%) | 7 (19.4%) | 6 (50.0%) | 2 (33.3%) | — |
| None | 53 (100.0%) d | ||||
| Previous Billroth I gastrectomy | 1 (1.9%) | 0 | 0 | 1 (16.7%) | — |
Abbreviations: CD, Crohn's Disease; HBI, Harvey‐Bradshaw Index; MCES, Mayo Clinic Endoscopic Subscore; SCCAI, Simple Clinical Colitis Activity Index; SD, Standard Deviation; SES‐CD, Simple Endoscopic Score for Crohn's Disease; UC, Ulcerative Colitis; UCEIS, Ulcerative Colitis Endoscopic Index of Severity.
a
HBI scores range from 0 to 18, plus 1 point for each liquid stool per day.
b
Two patients in the group without comorbidities were missing endoscopic videos, however, still images were available.
c
All six participants with fistulising CD underwent baseline endoscopy and the SES‐CD was calculated, although this was not required.
d
Participants with UC were asked whether they had ever undergone IPAA surgery, colostomy, ileostomy, sub‐total colectomy or proctocolectomy.