Exploration of patient experience of glucocorticoids for treatment of rheumatic diseases and development of a PROM
Chief Investigator
|
Institution
|
Dates
|
Funding Stream
|
Amount
|
| Dr Jo Robson |
University Hospitals Bristol NHS Foundation Trust |
01/08/2019 - 30/09/2021
|
Above and Beyond Spring 2019
|
£19,687 |
Summary of work
Objectives
Glucocorticoids (GCs) ('steroids') are used to treat
rheumatic diseases but adverse effects are common. We aimed to
explore the impact of GC therapy on health-related quality of life
(HRQoL), to inform the development of a treatment-specific
Patient-Reported Outcome Measure (PROM) for use in clinical trials
and practice.
Methods
Semi-structured qualitative interviews were conducted with
patients from the UK, USA and Australia, treated for a rheumatic
condition with GCs in the last two years. Purposive sampling was
used to select participants with a range of demographic and disease
features. An initial conceptual framework informed interview
prompts and cues. Interviews elicited GC-related physical and
psychological symptoms and salient aspects of HRQoL in relation to
GC therapy. Interview data were analysed inductively to develop
initial individual themes and domains. Candidate questionnaire
items were developed and refined.
Main findings
Results
Sixty semi-structured qualitative interviews were conducted (UK
n=34, USA n=10, Australia n=16). Mean age 58 years; 39/60 female;
18 rheumatic diseases were represented. 126 individual themes were
identified and organised into six domains: physical symptoms;
psychological symptoms; psychological impact of steroids; impact of
steroids on participation; impact of steroids on relationships; and
benefits of steroids. Candidate questionnaire items were tested and
refined by piloting with patient research partners, iterative
rounds of cognitive interviews, and linguistic translatability
assessment, informing a draft questionnaire.
Conclusion
We describe an international qualitative study to develop
candidate items for a treatment-specific PROM for patients with
rheumatic diseases. A future survey will enable the validation of a
final version of the PROM.
Impact
This grant from Above and Beyond has created data that has
informed the development of a patient reported outcome measure to
capture the impact of steroids from the patients' perspective. This
is now being tested in other non rheumatic diseases and will be
used as an outcome measure in future randomised trials.
Project outputs
- Bridgewater S, Shepherd MA, Dawson J, Richards P, Silverthorne
C, Ndosi M, Almeida C, Black RJ, Cheah JTL, Dures E, Ghosh N, Hoon
EA, Lyne S, Navarro-Millan I, Pearce-Fisher D, Ruediger C, Tieu J,
Yip K, Mackie SL, Goodman S, Hill C, Robson JC. Measuring the
impact of steroid therapy on health-related quality of life in
patients with rheumatic diseases: international development of a
glucocorticoid treatment-specific Patient Reported Outcome Measure.
Manuscript submitted to Annals of Rheumatic Disease, October
2022.
Abstracts
- Bridgewater, S., Dawson, J., Ndosi, M., Black, R. J., Cheah, J.
T. L., Dures, E., …Robson, J. (2021). AB0834 Development of a
conceptual framework for a patient reported outcome measure to
capture patients' perceptions of glucocorticoid therapy during
treatment for rheumatic diseases.
https://doi.org/10.1136/annrheumdis-2021-eular.164. Available from
https://uwe-repository.worktribe.com/output/7433872
- Patients' perceptions of glucocorticoid therapy impact on
health-related quality of life during treatment for rheumatic
diseases: international development of a treatment-specific
patient-reported outcome measure (the Steroid PRO). Bridgewater S,
Shepherd M, Dawson J et al; Rheumatology, May 2022, 61(Suppl
1)
Conference presentations
- British Society for Rheumatology Annual Conference 2021 -
conceptual framework oral presentation: Patients' perceptions of
glucocorticoid therapy during treatment for rheumatic diseases:
development of a conceptual framework for a patient reported
outcome measure
- EULAR 2021 - conceptual framework abstract published:
Development of a conceptual framework for a patient reported
outcome measure to capture patients' perceptions of glucocorticoid
therapy during treatment for rheumatic diseases
- UK PROMS Annual Conference 2021 - conceptual framework oral
presentation: Patients' perceptions of glucocorticoid therapy
during treatment for rheumatic diseases: development of a
conceptual framework for a patient reported outcome
measure
- Royal Society of Medicine webinar 2021: Glucocorticoid impact
and development of the Steroid Patient Reported Outcome (PRO)
- ANCA Vasculitis Workshop 2022 - qualitative interviews poster
presentation: Patients' perceptions of glucocorticoid therapy:
international development of a Patient Reported Outcome (the
Steroid PRO)
- BSR 2022 poster and showcase oral presentation: Patients'
perceptions of glucocorticoid therapy impact on health-related
quality of life during treatment for rheumatic diseases
- UK PROMS Annual Conference 2022 - qualitative interviews and
large-scale survey methods abstract - poster: Experiences of
developing a treatment-specific Patient Reported Outcome
- Measure for the impact of glucocorticoid therapy using an
international online survey
- EULAR 2022 qualitative interviews abstract - poster and oral
presentation: Patient perceptions of impact of glucocorticoid
therapy in the rheumatic diseases: international development of a
treatment-specific Patient Reported Outcome Measure
Further funding applications
- Robson JC, Dures E, Ndosi M, Mackie L, Richard P, Silverthorne
C.
Development and validation of a patient reported outcome measure
for glucocorticoids: the Steroid PRO. Vifor Pharma.
October 2022-April 2022
£161,330
Approached to apply for an investigator led research grant to
develop and validate the Steroid PRO. Completed
Cross-condition Validation Of The Patient Reported Outcome
Measure For Patients Receiving Glucocorticoids (the Steroid
PRO).
1st April 2022-30th Sep 2023
£135,487.87
Approached to apply for investigator led research grant to test
the Steroid PRO in other inflammatory conditions (lung, bowel and
derm).
Other project outcomes
