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Inflammatory bowel disease patients provide reliable self‐reported medical information: A multicentre prospective pharmacovigilance monitoring system
Author(s) -
Thomas Pepijn W. A.,
West Rachel L.,
Russel Maurice G. V. M.,
Jansen Jeroen M.,
Kosse Leanne J.,
Jessurun Naomi T.,
Römkens Tessa E. H.,
Hoentjen Frank
Publication year - 2021
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.5175
Subject(s) - medicine , inflammatory bowel disease , ustekinumab , infliximab , adalimumab , vedolizumab , prospective cohort study , population , pharmacovigilance , ulcerative colitis , faecal calprotectin , medical record , crohn's disease , disease , pediatrics , adverse effect , calprotectin , environmental health
Purpose To assess the agreement between patient‐reported and health care provider‐reported medical information in inflammatory bowel disease (IBD). Methods This multicentre, prospective, event monitoring study enrolled adult Crohn's disease (CD) and ulcerative colitis (UC) patients treated with a biological in four medical centers in the Netherlands. At two‐monthly intervals, patients completed questionnaires on biological use, combination therapy and indication. The patient‐reported information was compared with their electronic health records (EHRs) and analysed for percentage agreement and Cohen's kappa. A reference population from a prospective IBD registry was used to assess the representativeness of the study population. Results In total, 182 patients (female 50.5%, mean age 42.2 years, CD 76.9%) were included in the analysis. At baseline, 51.0% of the patients were prescribed an immunomodulator (43.9% thiopurines, 7.1% methotrexate), and patients were prescribed biologicals as follows: 59.3% infliximab, 30.2% adalimumab, 9.3% vedolizumab, and 1.1% ustekinumab. Agreement on patient‐reported indication and biological use was almost perfect (κ = 0.878 and κ = 1.000, respectively); substantial for combination therapy (κ = 0.672). Gender, age, type of IBD, biological use and combination therapy were comparable with the reference population. Conclusion Systematic patient‐reporting by questionnaires was reliable in retrieving indication and treatment specific information from IBD patients. These results indicate that the use of patient‐reporting outcomes in daily IBD practice can ensure reliable information collection.