LAUSR

Immunomodulators and biologicals are cornerstones in the current management of Inflammatory Bowel Disease (IBD), but are associated with increased risk of infections. Post-marketing surveillance studies are important to assess the risk for infectious side effects in real-world populations, yet mainly focus on severe infections. Data on mild and moderate infections in IBD patients are scarce, primarily since self-limiting infections and infections treated by the general practitioner are not systematically captured in surveillance registries. Mild and moderate infections take longer to clear in immunosuppressed patients, have a large impact on (work) disability and quality of life, and potentially precede severe infections. In the current study, we aimed to develop and implement a remote monitoring tool for real-world assessment of infections in IBD patients. Through a structured iterative process with input from IBD specialists, nurse practitioners, and a comprehensive literature review, a 7-item Questionnaire comprising 15 different types of infections (covering e.g. upper/lower respiratory tract; urinary tract; eye; and skin infections) was developed to measure Patient-Reported Infections (PRIQ) with a recall period of 3 months. Infection severity was defined as either mild (self-limiting or requiring topical/local treatment), moderate (requiring oral antibiotic, antiviral or antifungal drugs) or severe (requiring hospitalization and/or IV treatment). To ascertain comprehensiveness and comprehensibility in the intended study population prior to implementation, in three rounds a total of 36 randomly selected IBD patients visiting the outpatient clinic were interviewed individually until saturation was reached. Overall, patient understanding of the PRIQ was good and cognitive interviews did not result in reduction of questionnaire-items. Analysis of feedback from interviews resulted in addition of definitions to certain response options (e.g. definition for antivirals) and minor linguistic adjustments to further improve patient understanding. A total of three patients (8.3%) raised concerns on the recall period of 3 months, which after expert consensus, did not result in alteration of the recall period. Next, the PRIQ was digitized and implemented in myIBDcoach, an established telemedicine platform for management of IBD. We developed a remote monitoring tool (PRIQ) to assess patient-reported infections in IBD and ascertained patient understanding through cognitive interviewing. A prospective multicentre study using the myIBDcoach platform is ongoing to validate the PRIQ and subsequently report the risk of mild and moderate infections across different treatment regimens in IBD patients (NCT04151420).