TY - JOUR
T1 - Patients' and health care professionals' perspectives on adverse drug reaction burden attributed to the use of biological DMARDs
T2 - a qualitative study
AU - Westerink, Henrike J
AU - Kosse, Leanne J
AU - Jessurun, Naomi T
AU - van Tubergen, Astrid
AU - Vonkeman, Harald E
AU - Nurmohamed, Mike T
AU - van den Bemt, Bart J F
AU - de Vries, Marieke
N1 - Publisher Copyright:
© 2022 Netherlands Pharmacovigilance Centre Lareb. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2023/5/4
Y1 - 2023/5/4
N2 - Background: Previous studies showed a discrepancy between health-care professionals’ (HCPs’) and patients’ perspective on adverse drug reaction (ADR) burden. However, it is unclear which factors make an ADR burdensome. We aimed to give insight into why ADRs are perceived as burdensome by inflammatory rheumatic disease (IRD) patients, and whether this differs from the HCPs’ perspective. Research design and methods: A qualitative study was conducted using Dutch Biologic Monitor data. Participants received bimonthly questionnaires on experienced ADRs attributed to biological DMARDs and were asked to elaborate on ADR burden using a Likert-type scale and an open-ended question for clarification. Data of 440 IRD patients were analyzed following thematic analysis. A similar analysis was done with semi-structured interviews with 13 HCPs. Results: We identified seven themes associated with ADR burden: ‘effect on medication prescription,’ ‘impact on appearance,’ ‘impact on autonomy,’ ‘impact on daily life,’ ‘psychological consequences,’ ‘distressing aspects of ADR,’ and ‘physical consequences.’ Identical themes were identified by HCPs, although they identified most subthemes in ‘psychological consequences,’ and less subthemes in ‘impact on daily life’ and ‘impact on autonomy.’ Conclusion: Patients describe perceived ADR burden in both physical and psychological themes. The HCPs’ perspective is comparable, but mostly focuses on psychological impact.
AB - Background: Previous studies showed a discrepancy between health-care professionals’ (HCPs’) and patients’ perspective on adverse drug reaction (ADR) burden. However, it is unclear which factors make an ADR burdensome. We aimed to give insight into why ADRs are perceived as burdensome by inflammatory rheumatic disease (IRD) patients, and whether this differs from the HCPs’ perspective. Research design and methods: A qualitative study was conducted using Dutch Biologic Monitor data. Participants received bimonthly questionnaires on experienced ADRs attributed to biological DMARDs and were asked to elaborate on ADR burden using a Likert-type scale and an open-ended question for clarification. Data of 440 IRD patients were analyzed following thematic analysis. A similar analysis was done with semi-structured interviews with 13 HCPs. Results: We identified seven themes associated with ADR burden: ‘effect on medication prescription,’ ‘impact on appearance,’ ‘impact on autonomy,’ ‘impact on daily life,’ ‘psychological consequences,’ ‘distressing aspects of ADR,’ and ‘physical consequences.’ Identical themes were identified by HCPs, although they identified most subthemes in ‘psychological consequences,’ and less subthemes in ‘impact on daily life’ and ‘impact on autonomy.’ Conclusion: Patients describe perceived ADR burden in both physical and psychological themes. The HCPs’ perspective is comparable, but mostly focuses on psychological impact.
U2 - 10.1080/14740338.2023.2134344
DO - 10.1080/14740338.2023.2134344
M3 - Article
C2 - 36269284
SN - 1474-0338
VL - 22
SP - 417
EP - 424
JO - Expert opinion on drug safety
JF - Expert opinion on drug safety
IS - 5
ER -