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. 2023 Jul 5;17(7):1079-1088.
doi: 10.1093/ecco-jcc/jjad023.

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

Ashkan Rezazadeh Ardabili  1   2 , Dirk van Esser  1 , Dion Wintjens  1 , Mia Cilissen  1 , Debbie Deben  3 , Zlatan Mujagic  1   2 , Fritzi Russ  4 , Laurents Stassen  2   5 , Adriaan A Van Bodegraven  4 , Dennis Wong  3 , Bjorn Winkens  6 , Daisy Jonkers  1   2 , Mariëlle Romberg-Camps  4 , Marie J Pierik  1   2
Affiliations

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

Ashkan Rezazadeh Ardabili et al. J Crohns Colitis. .

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.

Keywords: IBD; Remote monitoring tool; development; infections; real-world data; validation.

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Conflict of interest statement

MP reports grants and non-financial support from Falk Pharma, grants from the European commission, grants from ZONMW [Dutch national research fund], grants and non-financial support from Takeda, grants and non-financial support from Johnson and Johnson, grants and non-financial support from Abbvie, non-financial support from Ferring, non-financial support from Immunodiagnostics, non-financial support from MSD, all outside the submitted work. DJ reports grants from Top Knowledge Institute [Well on Wheat], grants from Horizon 2020 DISCOvERIE, grants from NWO-CCC Partnership programme [Carbokinetics], all outside the submitted work. AvB has served as speaker, adviser, and/or principal investigator for AbbVie, Arandal, Arena, Celgene, Ferring, Galapagos, Janssen, MSD, Pfizer, Roche, Takeda, TEVA, and received research grants from Pfizer, TEVA, Eurostars funding, ZonMW, all outside the submitted work. ZM reports grants from MLDS, Niels Stensen Fellowship, and Galapagos, and has served as speaker for Galapagos, adviser for Johnson and Johnson, all outside the submitted work. LS reports participation in another research project partly funded by an investigator-initiated grant from Takeda and has served as speaker for Takeda, both outside the submitted work.

Figures

Figure 1.
Figure 1.
Study flowchart summarising development and prospective validation of the Patient-Reported Infections Questionnaire [PRIQ].
Figure 2.
Figure 2.
Formal English translation of the original Dutch PRIQ [Patient-Reported Infections Questionnaire] version.
See this image and copyright information in PMC

References

    1. Hindryckx P, Novak G, Bonovas S, Peyrin-Biroulet L, Danese S.. Infection risk with biologic therapy in patients with inflammatory bowel disease. Clin Pharmacol Ther 2017;102:633–41. - PubMed
    1. Kucharzik T, Ellul P, Greuter T, et al. . ECCO guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease. J Crohns Colitis2021;15:879–913. - PubMed
    1. Singh JA, Cameron C, Noorbaloochi S, et al. . The risk of serious infection with biologics in treating patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet 2015;386:258–65. - PMC - PubMed
    1. Toruner M, Loftus EV Jr, Harmsen WS, et al. . Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008;134:929–36. - PubMed
    1. Lichtenstein GR, Feagan BG, Cohen RD, et al. . Serious infection and mortality in patients with Crohn’s disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol 2012;107:1409–22. - PMC - PubMed

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