Current approaches to disease severity and therapy effectiveness assessment in patients with inflammatory bowel disease

Table 1 Endpoints for measuring disease modification and disease progression prevention according to the SPIRIT consensus[43]

Disease stage	Disease impact, measuring tools and timing
Early impact on health-related quality of patient’s life (patient-reported)	Health-related quality of life
	Tools: Questionnaires IBDQ-36 and SF-36
	Disability
	Tool: IBD disability index
	Fecal incontinence
	Tool: Jorge and Wexner (Cleveland) score
	Time point: 6-12 months
Mid-term complications	Bowel damage in CD
	Tool: Lémann index
	Time point: 12-24 months
	IBD-related surgery
	Tool for UC: Any colectomy
	Tools for CD: CD-related surgery; endoscopic balloon dilation; perianal surgery
	Time point: 24-36 months
	IBD-related hospitalizations
	Tool: Number of hospitalizations + cumulative hospital length of stay
	Time point: 12-24 months
	Disease extension in UC
	Tool: Macroscopic proximal disease extension (excluding pancolitis patients)
	Time point: 2-5 years
	Extraintestinal manifestations (all considered together)
	Time point: 12-36 months
	Permanent stoma
	Short bowel syndrome
Long-term complications	Dysplasia or cancer (all considered together)
	Time point: 5 years
	Mortality
	Tool: Both IBD-related and non-IBD-related mortality
	Time point: 5 years

IBDQ-36: The 36-item inflammatory bowel disease questionnaire; SF 36: Short form-36 health survey; IBD: Inflammatory bowel disease; CD: Crohn’s disease; UC: Ulcerative colitis.