Inflammatory bowel disease patients provide reliable self‐reported medical information: A multicentre prospective pharmacovigilance monitoring system

Published on Apr 1, 2021in Pharmacoepidemiology and Drug Safety2.918
· DOI :10.1002/PDS.5175
Pepijn W. A. Thomas1
Estimated H-index: 1
(Radboud University Nijmegen),
Rachel L. West16
Estimated H-index: 16
+ 6 AuthorsIbdream registry
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 centres 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 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.
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Cited By1
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BACKGROUND Only limited data is available on the extent and burden of adverse drug reactions (ADRs) to biological therapy in inflammatory bowel disease (IBD) patients in daily practice, especially from a patient's perspective. OBJECTIVE The aim of this study was to systematically assess patient-reported ADRs during biological therapy in IBD patients and compare these with healthcare provider (HCP)-reported ADRs. METHODS This multicentre, prospective, event monitoring study enrolled IBD patients ...