Stakeholders’ perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases

Published on Aug 12, 2020in Expert Opinion on Drug Safety3.383
· DOI :10.1080/14740338.2020.1803826
L. Kosse2
Estimated H-index: 2
Naomi T. Jessurun5
Estimated H-index: 5
+ 7 AuthorsMarieke de Vries19
Estimated H-index: 19
(Radboud University Nijmegen)
BACKGROUND Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the 'Dutch Biologic Monitor'. OBJECTIVE Generation of a multi-stakeholder perspective on the preferred setup, potential and added value of a PROM-based national drug safety monitoring system. METHODS Nineteen stakeholders were interviewed following a structured interview guide. Transcribed data were coded and analyzed to count frequencies and to generate recurring themes. RESULTS Stakeholders (84.2%) support the establishment of a national drug safety monitoring system, but the feasibility depends on the implementation process. The need for integration and assessment of PROMs on ADRs in clinical practice and the preference to monitor small molecules and new drugs was emphasized. Preferably, all pharmacological options per indication should be monitored. CONCLUSIONS Stakeholders recommend to establish a PROM-based national drug safety monitoring system focused on ADRs attributed to biologics, small molecules and new drugs. Moreover, PROMs on ADRs ideally need to become integrated in clinical practice to provide healthcare providers more insight in patients' perspectives.
📖 Papers frequently viewed together
18 Citations
3 Citations
21 Citations
#1L. KosseH-Index: 2
#2Naomi T. JessurunH-Index: 5
Last. Michael T. Nurmohamed (VUmc: VU University Medical Center)H-Index: 63
view all 7 authors...
OBJECTIVES: Assessment of the quality of patient-reported medical information in the Dutch Biologic Monitor and evaluation of the representativeness of the sampled participants. METHODS: Consecutive adult patients using a biologic DMARD (bDMARD) for an immune-mediated inflammatory disease were included in eight Dutch centres. For this substudy, data of 550 patients with inflammatory rheumatic diseases were used. Patient-reported bDMARD prescription, indication and combination therapy were verifi...
5 CitationsSource
#1Fabrice DenisH-Index: 20
#2Ethan Basch (UNC: University of North Carolina at Chapel Hill)H-Index: 81
Last. Christophe LetellierH-Index: 31
view all 7 authors...
135 CitationsSource
#1Ethan BaschH-Index: 81
#4Galina VelikovaH-Index: 62
There is increasing interest to integrate collection of patient-reported outcomes (PROs) in routine practice to enhance clinical care. Multiple studies show that systematic monitoring of patients using PROs improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. The general approach includes a brief electronic survey, administered via the Web or an app or an automated telephone system, with alerts...
81 CitationsSource
#1A. Costal Tirado (Cardiff University)H-Index: 1
#2Aoife M. McDermott (Cardiff University)H-Index: 13
Last. Marion McAllister (Cardiff University)H-Index: 20
view all 7 authors...
International advocacy of patient-centred healthcare delivery has led to emphasis on the (re)design and evaluation of healthcare processes and outcomes from a patient perspective. Patient-reported outcome measures (PROMs) have significant potential to inform such attempts. However there is limited understanding of the processes by which this can be achieved. This exploratory study followed attempts to utilise two different PROMs measures to support service quality improvement in clinical genetic...
17 CitationsSource
#1Florence van HunselH-Index: 15
#2Susan de Waal (UU: Utrecht University)H-Index: 1
Last. Linda HärmarkH-Index: 14
view all 3 authors...
Purpose The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. Method All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care ...
24 CitationsSource
#1Leàn Rolfes (UG: University of Groningen)H-Index: 7
#2Florence van Hunsel (UG: University of Groningen)H-Index: 15
Last. Eugène van Puijenbroek (UG: University of Groningen)H-Index: 25
view all 5 authors...
Introduction Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients.
40 CitationsSource
#1Michelle M. Holmes (University of Southampton)H-Index: 7
#2George Lewith (University of Southampton)H-Index: 72
Last. Felicity L. Bishop (University of Southampton)H-Index: 33
view all 5 authors...
Purpose Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain.
40 CitationsSource
#1Mariette Bengtsson (Malmö University)H-Index: 16
Abstract This paper describes the research process – from planning to presentation, with the emphasis on credibility throughout the whole process – when the methodology of qualitative content analysis is chosen in a qualitative study. The groundwork for the credibility initiates when the planning of the study begins. External and internal resources have to be identified, and the researcher must consider his or her experience of the phenomenon to be studied in order to minimize any bias of his/he...
1,007 CitationsSource
#1Christian U. Krägeloh (AUT: Auckland University of Technology)H-Index: 23
#2Karol J. Czuba (AUT: Auckland University of Technology)H-Index: 3
Last. Richard J. Siegert (AUT: Auckland University of Technology)H-Index: 50
view all 5 authors...
Objective:Routine evaluation of mental health services has become widespread, and the use of patient-reported outcome measures (PROMs) as clinical aids or discussion tools has been receiving increasing attention. The purpose of this scoping study was to provide a typology of the diverse ways in which studies reporting on PROM use in mental health services have utilized PROMs.Methods:Iterative scoping searches of the literature identified articles reporting on the use of PROM feedback in mental h...
73 CitationsSource
#1Leàn Rolfes (UG: University of Groningen)H-Index: 7
#2Florence van Hunsel (UG: University of Groningen)H-Index: 15
Last. Eugène van Puijenbroek (UG: University of Groningen)H-Index: 25
view all 5 authors...
PURPOSE: This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. METHODS: This retrospective study compared the reported information between 200 ADR reports of patients and HCPs. Reports were rendered anonymous and scored for the presence or absence of predefined elements of information. These elemen...
38 CitationsSource
Cited By0