"I couldn't carry on taking a drug like that": A qualitative study of patient perspectives on side effects from rheumatology drugs

Dorthe B Berthelsen; Sabrina M Nielsen; Marianne U Rasmussen; Marieke Voshaar; Pamela Richards; Susan J Bartlett; Glen S Hazlewood; Beverly J Shea; Peter Tugwell; Torkell Ellingsen; Tanja S Jørgensen; Salome Kristensen; Lee S Simon; Robin Christensen; Caroline A Flurey; OMERACT Safety Working Group

doi:10.1093/rheumatology/keae223

"I couldn't carry on taking a drug like that": A qualitative study of patient perspectives on side effects from rheumatology drugs

Rheumatology (Oxford). 2024 Apr 13:keae223. doi: 10.1093/rheumatology/keae223. Online ahead of print.

Authors

Dorthe B Berthelsen^{1

2

3}, Sabrina M Nielsen^{1

2}, Marianne U Rasmussen⁴, Marieke Voshaar⁵, Pamela Richards⁶, Susan J Bartlett^{7

8

9}, Glen S Hazlewood¹⁰, Beverly J Shea¹¹, Peter Tugwell¹², Torkell Ellingsen², Tanja S Jørgensen¹³, Salome Kristensen¹⁴, Lee S Simon¹⁵, Robin Christensen^{1

2

16}, Caroline A Flurey¹⁷; OMERACT Safety Working Group

Affiliations

¹ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
² Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.
³ Department of Rehabilitation, Municipality of Guldborgsund, Nykoebing F, Denmark.
⁴ The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
⁵ Department of Pharmacy, Sint Maartenskliniek, Department of Pharmacy, Radboud UMC, Nijmegen, The Netherlands.
⁶ Department of Rheumatology, University of Bristol, Bristol, United Kingdom.
⁷ Department of Medicine, McGill University, Montreal, Canada.
⁸ Research Institute, McGill University Health Centre, Montreal, Canada.
⁹ Arthritis Research, Canada.
¹⁰ Department of Medicine, Cumming School of Medicine, University of Calgary; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary; Arthritis Research Canada.
¹¹ School of Epidemiology and Public Health, University of Ottawa, Ottawa ON, Canada.
¹² Department of Medicine, University of Ottawa, Ottawa, Canada.
¹³ Value-Based Outcomes Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
¹⁴ Department of Rheumatology, Aalborg University Hospital, and Aalborg University, Department of Clinical Medicine, Aalborg, Denmark.
¹⁵ SDG LLC Cambridge, MA 02138, USA.
¹⁶ Cochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Denmark.
¹⁷ School of Social Sciences, University of the West of England, Bristol, United Kingdom.

PMID: 38613847
DOI: 10.1093/rheumatology/keae223

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.

Keywords: Core Outcome Set; OMERACT; adverse events; harms; rheumatology; safety.