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“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

Dorthe Berthelsen

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

Profile image of Caroline Flurey

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