Individualized home-monitoring of disease activity in adult patients with inflammatory bowel disease can be recommended in clinical practice: A randomized-clinical trial

Table 1 Results: Baseline characteristics

Characteristics	Screening every 3M, n = 52	Screening OD, n = 50
Sex
Male	26 (50%)	24 (48%)
Female	26 (50%)	26 (52%)
Mean body mass index, SD; kg/m2	24.7 (3.7)	25.8 (5.1)
Smoking
Current	5 (9.6%)	6 (12.0%)
Former	30 (57.7%)	25 (50.0%)
Never	17 (32.7%)	19 (38.0%)
Mean age at inclusion, SD; yr	44.9 (15.2)	48.4 (16.0)
Mean age at diagnosis, SD; yr	32.0 (13.1)	37.3 (14.9)
IBD diagnosis
UC	39 (75%)	35 (70%)
CD	10 (19.2%)	13 (26.0%)
IBD-U	3 (5.8%)	2 (4.0%)
UC extent, n = 39; 35
E1, proctitis	13 (33.3%)	7 (20.0%)
E2, left side	17 (43.6%)	18 (51.4%)
E3, extensive	9 (23.1%)	10 (28.6%)
CD location, n = 10; 13
L1, small bowel	0 (0%)	1 (7.7%)
L2, colonic	3 (30.0%)	3 (23.1%)
L3, ilea-colonic	7 (70.0%)	9 (69.2%)
CD behavior, n = 10; 13
B1, inflammatory	9 (90.0%)	8 (61.5%)
B2, stricturing	0 (0%)	5 (38.5%)
B3, penetrating	1 (10.0%)	0 (0%)
Previous surgery CD, n = 10; 13	7 (70%)	5 (38%)
Median IBD duration, IQR; yr	10.5 (4.5-19.5)	8.0 (4.0-16.0)
Median short-IBD-quality of life (IQR), n = 50; 50	60.5 (54.0-65.0)	58.0 (51.0--63.0)
Median fatigue, FACIT-F (IQR), n = 48; 50	11.0 (9.0-16.0)	11 (9.0-21.0)
Median compliance, MARS (IQR), n = 41; 84	24.0 (23.0-25.0)	24.0 (24.0-25.0)
Medical treatment
None	10 (19.2%)	9 (18.0%)
5ASA	24 (46.2%)	27 (54.0%)
Corticosteroids	4 (7.7%)	4 (8.0%)
Immunomodulators	9 (17.3%)	3 (6.0%)
Biological therapy	5 (9.6%)	7 (14.0%)
Median UC disease activity, SCCAI (IQR),	0.5 (0-2.0)	1.0 (0-2.0)
n = 42; 36, Incl. 4 with IBD-U
Green < 3	36 (85.7%)	33 (91.7%)
Yellow [3-4]	6 (14.3%)	3 (8.3%)
Median CD disease activity, HBI (IQR),	1.5 (0.0–2.0)	3.0 (1.0–6.0)
n = 10; 14, Incl. 1 with IBD-U
Green < 5	9 (90.0%)	10 (71.4%)
Yellow [5-16]	1 (10.0%)	4 (28.6%)
Median fecal calprotectin (IQR; mg/kg), n = 47; 43	64.0 (20.0-382.0)	70.0 (20.0-547.0)
Green < 200	32 (61.5%)	30 (60.0%)
Yellow [200-599]	9 (17.3%)	4 (8.0%)
Red > 599	6 (11.5%)	9 (18.0%)
Missing	5 (9.6%)	7 (14.0%)
Median TIBS (IQR), n = 47; 43	4.0 (0-20.0)	4.0 (2.0-14.0)
Green [0-8]	28 (53.8%)	26 (52.0%)
Yellow [9-32]	13 (25.0%)	8 (16.0%)
Red [33-99]	6 (11.5%)	9 (18.0%)
Missing	5 (9.6%)	7 (14.0%)
Patient-reported co-morbidities
None	23 (42.2%)	18 (36.0%)
1	23 (44.2%)	24 (48.0%)
> 1	6 (11.5%)	8 (16.0%)
Education1
Short	4 (7.7%)	2 (4.0%)
Student	4 (7.7%)	2 (4.0%)
Medium	31 (59.6%)	40 (80.0%)
Higher/Academic	13 (25%)	6 (12.0%)
Occupation
Yes	42 (80.8%)	38 (76.0%)
No	10 (19.2%)	12 (24.0%)

¹Medium length education defining people with a 3-4 years education after high school, e.g., nurses, technical people and bachelors’ degrees; Higher/Academic defined as a master’s degree or higher. Data are expressed as number (%), median (IQR) or mean (SD). IBD: Inflammatory bowel disease; MARS: Medical adherence report scale; SCCAI: Simple clinical colitis activity index; HBI: Harvey-Bradshaw Index; TIBS: Total inflammation burden scoring; UC: Ulcerative colitis; CD: Crohn’s disease; IBD-U: Inflammatory bowel disease-Unclassified; SD: Standard deviation; IQR: Interquartile range; FACIT-F: Functional assessment of chronic illness therapy-fatigue; OD: On demand; 3M: Third month.

Table 2 Mean times spent in green, yellow and red zones for disease activity of fecal calprotectin, simple clinical colitis activity index, Harvey-Bradshaw index and total inflammation burden score for the two screening procedures, i.e., on demand and every third month throughout 1 year

	FC		SCCAI		HBI		TIBS		P value
	3M, n = 43	OD, n = 41	3M, n = 37	OD, n = 35	3M, n = 6	OD, n = 9	3M, n = 43	OD, n = 39
Green, mean of %	66	65	82	87	72	66	60	61	NS
Yellow, mean of %	18	19	15	10	28	34	26	22
Red, mean of %	16	16	3	3	0	0	14	16
Total of %	101	100	100	100	100	100	100	100

NS: Non-significant; SCCAI: Simple clinical colitis activity index; HBI: Harvey-Bradshaw Index; TIBS: Total inflammation burden scoring; OD: On demand; 3M: Third month; FC: Fecal calprotectin.