Patients' perspectives on a drug safety monitoring system for immune-mediated inflammatory diseases based on patient-reported outcomes.
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Biological Products
/ adverse effects
Cross-Sectional Studies
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
Humans
Immune System Diseases
/ drug therapy
Inflammation
/ drug therapy
Male
Middle Aged
Patient Reported Outcome Measures
Surveys and Questionnaires
Technology
Young Adult
Adverse drug reactions
biologics
cohort event monitoring
immune-mediated inflammatory diseases
patient perspective
patient-reported outcomes
Journal
Expert opinion on drug safety
ISSN: 1744-764X
Titre abrégé: Expert Opin Drug Saf
Pays: England
ID NLM: 101163027
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
pubmed:
6
8
2021
medline:
15
12
2021
entrez:
5
8
2021
Statut:
ppublish
Résumé
Patient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patients' real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on CEM systems. In a cross-sectional open survey following the rationale of the Technology Acceptance Model, we aimed to obtain insight in patients' perspectives on the perceived usefulness, ease of use and attitude toward using a PRO-based drug safety monitoring system for ADRs attributed to biologics. Patients considered structural reporting of ADRs in web-based questionnaires as useful and not burdensome. It was preferred to link the questionnaire frequency to regular hospital consultations or the biologic administration schedule. Various respondents were interested in sharing questionnaires with their medical specialist (49.0%) or pharmacist (34.2%), and suggested to minimize the questionnaire frequency in case of an unaltered situation or absence of ADRs. Patients' perspectives should be considered in the setup of PRO-based CEM studies, as this contributes to data quality and patient centeredness. Since incorporation of patients' perspectives in CEM studies is indispensable, a delicate balance should be found between user-friendliness and study aims.
Sections du résumé
BACKGROUND
BACKGROUND
Patient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patients' real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on CEM systems.
RESEARCH DESIGN AND METHODS
METHODS
In a cross-sectional open survey following the rationale of the Technology Acceptance Model, we aimed to obtain insight in patients' perspectives on the perceived usefulness, ease of use and attitude toward using a PRO-based drug safety monitoring system for ADRs attributed to biologics.
RESULTS
RESULTS
Patients considered structural reporting of ADRs in web-based questionnaires as useful and not burdensome. It was preferred to link the questionnaire frequency to regular hospital consultations or the biologic administration schedule. Various respondents were interested in sharing questionnaires with their medical specialist (49.0%) or pharmacist (34.2%), and suggested to minimize the questionnaire frequency in case of an unaltered situation or absence of ADRs.
CONCLUSIONS
CONCLUSIONS
Patients' perspectives should be considered in the setup of PRO-based CEM studies, as this contributes to data quality and patient centeredness. Since incorporation of patients' perspectives in CEM studies is indispensable, a delicate balance should be found between user-friendliness and study aims.
Identifiants
pubmed: 34348543
doi: 10.1080/14740338.2021.1963436
doi:
Substances chimiques
Biological Products
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM