Real-world inflammatory bowel disease-modification outcomes: A narrative review

Table 3 Summary of differences between standard protocol items: Recommendations for interventional trials disease-modification endpoints and endpoints used in real-world studies

SPIRIT endpoints		Measure	Timeframe	Number of publications using SPIRIT definition	Number of publications using alternative definition	Difference from SPIRIT
Midterm	Bowel damage in patients with CD	Lemann Index	12-24 months	0	0
	IBD-related surgery	Any colectomy (UC), any CD-related surgery, endoscopic balloon dilation, perianal surgery (CD)	24-36 months	8	5	Different timeframes used
	IBD-related hospitalizations	Composite of number of hospitalizations and cumulative length of hospital stay	12-24 months	0	14	No length of stay reported
	Disease extension in UC1	Macroscopic proximal disease extension	2-5 years after diagnosis	0	0
	Extraintestinal manifestations		12-36 months	5	0
	Permanent stoma			0	0
	Short-bowel syndrome	Small-bowel length < 200 cm		0	0
Long-term	Dysplasia or cancer		5 years	0	3	No 5 year follow up
	Mortality	IBD and non IBD related	5 years	0	2	No 5 year follow up
Impact of patients’ life	Health-related quality of life	Composite of IBDQ-36 and SF-36	Every 6-12 months	0	8	Shorter forms and no composite use
	Disability	IBD Disability Index	Every 6-12 months	1	0
	Fecal incontinence2	Cleveland score or Jorge-Wexner score	Every 6-12 months	0	0

¹Excluding patients with pancolitis.

²Excluding patients with isolated liminal ileal Crohn’s disease.

SPIRIT: Standard protocol items: Recommendations for interventional trials; CD: Crohn’s disease; IBD: Inflammatory bowel disease; UC: Ulcerative colitis. IBDQ: Inflammatory Bowel Disease Questionnaire; SF-36: 36-Item Short-Form Health Survey.