Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

Occurrence, at least once during the natural history of the patient's disease, of one or more characteristics of aggressiveness, namely:

• Immunosuppressive/biotechnology/small molecule therapy due to failure of conventional therapy or severe disease
• Surgery due to failure of medical therapy or the onset of complications such as strictures or fistulas
• Endoscopic recurrence of disease post-surgery
• Hospitalization for severe disease or the onset of complications

Presence of one or more characteristics of frailty, namely:

• Polypharmacy (defined as the need to take at least one other medication for a condition other than inflammatory bowel disease)
• Short bowel syndrome post-surgery (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) requiring supplemental enteral/parenteral nutrition
• Osteoporosis (defined as bone mineral density - BMD - with a T-score less than -2.5) with or without pathological fractures
• One or more extraintestinal manifestations (EIMs)

Presence or absence of other comorbidities.

Presence or absence of extraintestinal manifestations.

Number of surgical interventions for luminal disease (defined as disease affecting one or more segments of the gastrointestinal tract).

Number of surgical interventions for perianal disease (defined as the presence of perianal fistulas, abscesses, ulcers, and anal strictures).

Presence of one or more of the following elements:

• Early complication (< 30 days) or late complication (> 30 days) post-surgery
• Development of short bowel syndrome (defined as a small intestine length, measured from the duodenojejunal flexure, less than 200 cm) post-surgery (if Crohn's disease)
• Need for major therapy post-surgery

Presence and typing of the neoplasm, confirmed by instrumental/radiological findings and histological verification.

Failure:

• Primary
• Secondary
• Primary failure refers to the lack of efficacy after the induction phase, while secondary failure refers to the loss of efficacy after initial benefit.

Occurrence of adverse drug reactions classified by:

• Type of adverse drug event
• Severity of the adverse event according to CTCAE 5.0

Inflammatory Bowel Disease - Questionnaire (validated questionnaire).

Assessment of the presence or absence of infections, including the type of infection/etiology if available, diagnosed through specific serology or culture tests.

Days elapsed between the date of diagnosis of neoplasia/infection and the date of death.

Introduction of a specific VAS scale for evaluating performance.