Dorthe Berthelsen
“I couldn't carry on taking a drug like that”: A qualitative study of patient perspectives on side effects from rheumatology drugs
Berthelsen, Dorthe; Neilsen, Sabrina; Rasmussen, Marianne; Voshaar, Marieke; Richards, Pamela; Bartlett, Susan; Hazelwood, Glen; Shea, Beverly; Tugwell, Peter; Ellingsen, Torkell; Jørgensen, Tanja; Kristensen, Salome; Simon, Lee; Christensen, Robin; Flurey, Caroline A
Authors
Sabrina Neilsen
Marianne Rasmussen
Marieke Voshaar
Pamela Richards
Susan Bartlett
Glen Hazelwood
Beverly Shea
Peter Tugwell
Torkell Ellingsen
Tanja Jørgensen
Salome Kristensen
Lee Simon
Robin Christensen
Caroline Flurey Caroline2.Flurey@uwe.ac.uk
Associate Professor in Men's Health and Long-term Conditions
Abstract
Objectives There is growing interest in collecting outcome information directly from patients in clinical trials. This study evaluates what patients with rheumatic and musculoskeletal diseases (RMDs) consider important to know about symptomatic side effects they may experience from a new prescription drug. Methods Patients with inflammatory arthritis, who had one or more prescribed drugs for their disease for at least 12 months, participated in focus groups and individual interviews. Discussions were analysed using reflexive thematic analysis. Results We conducted seven focus groups with 34 participants across three continents. We found four overarching and two underpinning themes. The ‘impact on life’ was connected to participants’ ‘daily life’, ‘family life’, ‘work life’ and ‘social life’. In ‘psychological and physical aspects’ participants described ‘limitation to physical function’, ‘emotional dysregulation’ and ‘an overall mental state’. Extra tests, hospital visits and payment for medication were considered a ‘time, energy and financial burden’ of side effects. Participants explained important measurement issues to be ‘severity’, ‘frequency’ and ‘duration’. Underpinning these issues, participants evaluated the ‘benefit–harm balance’ which includes ‘the cumulative burden’ of having several side effects and the persistence of side effects over time. Conclusions In treatment for RMDs, there seems to be an urgent need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit–harm balance. These findings contribute new evidence in support of a target domain—an outcome that represents the patient voice evaluating the symptomatic treatment-related side effects for people with RMDs enrolled in clinical trials.
Journal Article Type | Article |
---|---|
Acceptance Date | Apr 10, 2024 |
Online Publication Date | Apr 13, 2024 |
Deposit Date | May 2, 2024 |
Publicly Available Date | Apr 14, 2025 |
Journal | Rheumatology |
Print ISSN | 1462-0324 |
Electronic ISSN | 1462-0332 |
Publisher | Oxford University Press (OUP) |
Peer Reviewed | Peer Reviewed |
DOI | https://doi.org/10.1093/rheumatology/keae223 |
Public URL | https://uwe-repository.worktribe.com/output/11973963 |
Files
This file is under embargo until Apr 14, 2025 due to copyright reasons.
Contact Caroline2.Flurey@uwe.ac.uk to request a copy for personal use.
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