Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system

Kosse, L.; Jessurun, Naomi T; Hebing, R.; Huiskes, Victor J. B.; Spijkers, Karin; Bemt, Bart J F van den; Nurmohamed, Michael T.

doi:10.1093/rheumatology/kez412

Cited by 18 publications

(29 citation statements)

References 35 publications

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“…Furthermore, our findings of perfect agreement between self‐report and EHR indicate that patients provide reliable information on their drug use. These results were similar to those of a large rheumatology cohort study that used the same methodology for reporting treatment indication and generic biological use (κ = 0.832 and 96% agreement, respectively) 6 . In addition, all clinically relevant biological changes were reported by patients.…”

Section: Discussionsupporting

confidence: 83%

“…This prospective multicentre event monitoring study evaluated the quality of patient‐reported information on IBD subtype and IBD drug use during biological treatment, using the Dutch Biologic Monitor 6 . The study was conducted in four medical centers in the Netherlands between January 1, 2017 and December 31, 2018.…”

Section: Methodsmentioning

confidence: 99%

“…The Dutch Pharmacovigilance Centre has developed a web‐based tool ‐ Dutch Biologic Monitor 6 ‐ for patients with immunological mediated immune diseases to report ADRs related to biologic agents. We used this tool to evaluate the agreement between IBD patient‐reported and HCP‐reported subtype of IBD and IBD medication use.…”

Section: Introductionmentioning

confidence: 99%

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

Thomas

West

Rüssel

et al. 2020

Pharmacoepidemiology and Drug

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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.

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Section: Discussionsupporting

confidence: 83%

Section: Methodsmentioning

confidence: 99%

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

Thomas

West

Rüssel

et al. 2020

Pharmacoepidemiology and Drug

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“…The Dutch Biologic Monitor is a prospective cohort event monitoring model for patient-reported ADRs attributed to biologics [7]. Nine Dutch hospitals participated in the Dutch Biologic Monitor between January 1, 2017 and May 1, 2019.…”

Section: The Dutch Biologic Monitormentioning

confidence: 99%

“…It is a multicentre, web-based cohort event monitoring system that follows patients using biologics mainly for IMIDs. Participating patients complete questionnaires about ADRs they attribute to the biologic treatment, including consequences and experienced burden [7].…”

Section: Introductionmentioning

confidence: 99%

Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases

et al. 2020

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Introduction Although the burden of adverse drug reactions (ADRs) has a significant impact on patients' quality of life, thorough knowledge about patients' perspectives on the burden of ADRs attributed to biologics is lacking. Objectives This study was conducted to gain insight into the patient burden of ADRs experienced with biologic use. Methods The Dutch Biologic Monitor is a prospective, multicentre, event monitoring cohort system including information collected by web-based questionnaires from patients using biologics, mainly for immune-mediated inflammatory diseases (IMIDs). Patients were asked to complete bimonthly questionnaires on biologics used, indication for the biologic, experienced ADRs, consequences of ADRs and burden on a five-point Likert-type scale, ranging from 1 (no burden) to 5 (very high burden). We assessed potential factors associated with patient-reported burden of ADRs. Results A total of 1355 patients completed 6293 questionnaires between 1 January 2017 and 1 May 2019. Almost half of the patients (665 patients, 49%), 69% with rheumatic diseases and 31% with other diseases, collectively reported 1720 unique ADRs. Infections and musculoskeletal complaints were the most burdensome ADRs and injection-site reactions were the least burdensome. ADRs leading to healthcare professional contact were more burdensome than ADRs without healthcare professional contact. Smoking, respiratory and psychiatric comorbidities were associated with higher burden of ADRs. Crohn's disease, use of adalimumab and use of sulfasalazine as combination therapy were associated with lower burden of ADRs. Conclusions The patient perspective gives important insights into the burden of ADRs experienced with biologics. This information could be used by healthcare professionals to optimise treatment with biologics.

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Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy

et al. 2021

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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 on biological therapy. Patients completed bimonthly comprehensive webbased questionnaires regarding description of biological induced ADRs, follow-up of previous ADRs and experienced burden of the ADR using a five-point Likert scale. The relationship between patient-reported ADRs and biological therapy was assessed. HCP-reported ADRs were extracted from the electronic healthcare records. Results: In total, 182 patients (female 51%, mean age 42.2 [standard deviation 14.2] years, Crohn's disease 77%) were included and completed 728 questionnaires. At baseline, 60% of patients used infliximab, 30% adalimumab, 9% vedolizumab and 1% ustekinumab. Fifty percent of participants reported at least one ADR with a total of 239 unique ADRs. Fatigue (n = 26) and headache (n = 20) resulted in the highest burden and a correlation in time with the administration of the biological was described in 56% and 85% respectively. Out of 239 ADRs, 115 were considered biological-related. HCPs reported 119 ADRs. Agreement between patient-reported ADRs and HCP-reported ADRs was only 13%. Conclusion: IBD patients often report ADRs during biological therapy. We observed an important significant difference between the type and frequency of patient-On behalf of IBDREAM.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system

Cited by 18 publications

References 35 publications

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

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

Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases

Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy

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