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

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

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.

Aim

To define what constitutes the domain for patients’ own reports of safety by evaluating what patients consider important to measure in RCTs in relation to potential symptomatic side effects from their rheumatological drug treatment.

Contributors

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, on behalf of the OMERACT Safety Working Group

Publication

Journal: Rheumatology (Oxford)
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1093/rheumatology/keae223

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).; The Oak Foundation is a group of philanthropic organizations and, since its establishment in 1983; it has given grants to not-for-profit organizations around the world. The Oak Foundation had no role in the study design, data collection and analyses, interpretation or reporting of this work, or the decision to submit the work for publication. DBB has received PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark. The funders had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

Health Area

Disease Category: Rheumatology

Disease Name: Inflammatory arthritis

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Consumers (patients)

Study Type

- Patient perspectives

Method(s)

- Focus group(s)
- Interview

International focus groups and interviews were conducted to explore a broad range of patients’ experiences and opinions and promote discussion