Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Abstract Background Immunomodulators and biologics are cornerstones in the management of inflammatory bowel disease [IBD], but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the...

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Published in:Journal of Crohn's and colitis Vol. 17; no. 7; pp. 1079 - 1088
Main Authors: Rezazadeh Ardabili, Ashkan, van Esser, Dirk, Wintjens, Dion, Cilissen, Mia, Deben, Debbie, Mujagic, Zlatan, Russ, Fritzi, Stassen, Laurents, Van Bodegraven, Adriaan A, Wong, Dennis, Winkens, Bjorn, Jonkers, Daisy, Romberg-Camps, Mariëlle, Pierik, Marie J
Format: Journal Article
Language:English
Published: UK Oxford University Press 05-07-2023
Subjects:
Cohort Studies
Female
Humans
Inflammatory Bowel Diseases - complications
Inflammatory Bowel Diseases - diagnosis
Inflammatory Bowel Diseases - epidemiology
Male
Middle Aged
Prospective Studies
Review
Surveys and Questionnaires
infections
development
IBD
real-world data
Remote monitoring tool
validation
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Summary:Abstract Background Immunomodulators and biologics are cornerstones in the management of inflammatory bowel disease [IBD], but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the prevalence of mild and moderate infections are scarce. We developed and validated a remote monitoring tool for real-world assessment of infections in IBD patients. Methods A 7-item Patient-Reported Infections Questionnaire [PRIQ] covering 15 infection categories was developed with a 3-month recall period. Infection severity was defined as mild [self-limiting or topical treatment], moderate [oral antibiotics, antivirals, or antifungals], or severe [hospitalisation or intravenous treatment]. Comprehensiveness and comprehensibility were ascertained through cognitive interviewing of 36 IBD outpatients. After implementation in the telemedicine platform myIBDcoach, a prospective, multicentre cohort study was performed between June 2020 and June 2021 in 584 patients, to assess diagnostic accuracy. Events were cross-checked with general practitioner and pharmacy data [gold standard]. Agreement was evaluated using linear-weighted kappa with cluster-bootstrapping to account for within-patient level correlation. Results Patient understanding was good and interviews did not result in reduction of PRIQ items. During validation, 584 IBD patients {57.8% female, mean age 48.6 (standard deviaton [SD]: 14.8), disease duration 12.6 years [SD: 10.9]} completed 1386 periodic assessments, reporting 1626 events. Linear-weighted kappa for agreement between PRIQ and gold standard was 0.92 (95% confidence interval [CI] 0.89-0.94). Sensitivity and specificity for infection [yes/no] were 93.9% [95% CI 91.8-96.0] and 98.5% [95% CI 97.5-99.4], respectively. Conclusions The PRIQ is a valid and accurate remote monitoring tool to assess infections in IBD patients, providing means to personalise medicine based on adequate benefit-risk assessments.
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ISSN:1873-9946
1876-4479
DOI:10.1093/ecco-jcc/jjad023