The 7-item Patient-Reported Infections Questionnaire (PRIQ) was found to be accurate and valid for remote monitoring of infection in the setting of inflammatory bowel diseases (IBD), according to study results published in the Journal of Crohn’s and Colitis.
Researchers developed the PRIQ instrument to remotely monitor infections among patients with IBD. The tool was intended to be user-friendly and assess bacterial, viral, and fungal infections. To evaluate whether the instrument was useful for its intended audience, 3 rounds of individual 1-on-1 interviews with 36 patients were conducted in 2018 to discuss patient thoughts about the PRIQ items. After consensus, the instrument was forward and backward translated from Dutch to English.
In the validation phase, 584 patients from a real-world, prospective, multicenter cohort study, myIBDcoach, were enrolled at 3 sites. Patient responses to the questionnaire were cross-checked for accuracy with their general practitioner and pharmacy data.
The PRIQ instrument categorized infection severity into 3 categories: mild, moderate, and severe. Mild infection was defined as requiring self-limiting or topical treatments; moderate as requiring oral antibiotics, antivirals, or antifungals; and severe requiring hospitalization or intravenous therapies.
During the 1-on-1 interviews, patients had a median age of 49.0 (IQR, 35.6-59.3) years, and 52.8% were women. Overall, patients had a good understanding of the PRIQ items, but the PRIQ was revised to define certain terms, such as antiviral and suppository.
The validation cohort comprised patients with a mean [SD] age of 48.6[14.8] years, 57.9% were women, they had a mean disease duration of 12.6[10.9] years, and 25.5% had a history of IBD surgery. Overall, 323 had Crohn disease and 261 ulcerative colitis.
In 1,626 uses, according to the PRIQ, 1,008 patients had no, 411 mild, 195 moderate, and 12 severe infections. When cross-checked with practitioners and pharmacy data, 984 patients had no, 422 mild, 207 moderate, and 13 severe infections. Overall, this indicated good agreement between PRIQ outcomes and gold standard (k, 0.92).
For only using the PRIQ to determine the presence or absence of an infection, the tool had a sensitivity of 93.9%, specificity of 98.5%, positive predictive value of 97.6%, and negative predictive value of 96.1%.
This study may have been limited by enrolling patients for the validation phase from a telemedicine platform, so these data may not be generalizable for patients unfamiliar with remote medicine.
Study authors concluded, “[T]he PRIQ is a valid and accurate remote monitoring tool for real-world assessment of patient-reported mild, moderate and severe infections in IBD patients. The PRIQ may be used for capturing of infectious side effects in post-marketing surveillance settings, in telemedicine platforms for IBD in routine care, and potentially for other IMIDs [immune mediated inflammatory diseases] in the future.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Ardabili AR, van Esser D, Wintjens D, et al. Development and validation of a remote monitoring tool for assessment of mild, moderate, and severe infections in inflammatory bowel disease. J Crohns Colitis. Published online February 16, 2023. doi:10.1093/ecco-jcc/jjad023