TY - JOUR
T1 - Patients’ perspectives on a drug safety monitoring system for immune-mediated inflammatory diseases based on patient-reported outcomes
AU - Kosse, Leanne J.
AU - Weits, Gerda
AU - Vonkeman, Harald E.
AU - Tas, Sander W.
AU - Hoentjen, Frank
AU - van Doorn, Martijn B. A.
AU - Spuls, Phyllis I.
AU - D’Haens, Geert R.
AU - Nurmohamed, Michael T.
AU - van Puijenbroek, Eugène P.
AU - van den Bemt, Bart J. F.
AU - Jessurun, Naomi T.
N1 - Funding Information: HE Vonkeman reports grants and/or personal fees from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, and Sanofi-Genzyme, all outside the submitted work. SW Tas reports grants and/or personal fees from AbbVie, Arthrogen, AstraZeneca, BMS, Celgene, Galapagos, GSK, MSD, Pfizer, Roche, and Sanofi-Genzyme, all outside the submitted work. F Hoentjen has served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk, has received funding (grants/honoraria) from Dr Falk, Janssen-Cilag, Abbvie, and Takeda, and consulting fees from Celgene, and Janssen-Cilag, all outside the submitted work. MBA van Doorn reports personal fees from Leopharma, Abbvie, BMS, Celgene, Lilly, MSD, Pfizer, Sanofi-Genzyme and Janssen-Cilag, and grants and personal fees from Novartis, outside the submitted work. PI Spuls has done consultancies in the past for Sanofi 111,017 and AbbVie 041217 (unpaid), received a departmental independent research grant for TREAT NL registry from different companies for the TREAT NL registry, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and, is Chief Investigator (CI) of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children and one of the main investigators of the SECURE-AD registry, all outside the submitted work. GR D’Haens has served as advisor for Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma, Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences; Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill; Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Takeda, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor, all outside the submitted work. MT Nurmohamed has received consulting fees from AbbVie, Celgene, Celltrion, Eli Lilly, Janssen, and Sanofi, speaker’s fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Roche, and Sanofi, and research funding from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, and Sanofi, all outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2021 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - 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: 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: 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: 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.
AB - 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: 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: 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: 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.
KW - Adverse drug reactions
KW - biologics
KW - cohort event monitoring
KW - immune-mediated inflammatory diseases
KW - patient perspective
KW - patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85112258564&partnerID=8YFLogxK
U2 - https://doi.org/10.1080/14740338.2021.1963436
DO - https://doi.org/10.1080/14740338.2021.1963436
M3 - Article
C2 - 34348543
SN - 1474-0338
VL - 20
SP - 1565
EP - 1572
JO - Expert opinion on drug safety
JF - Expert opinion on drug safety
IS - 12
ER -