Exploration of the patient experience in Giant Cell Arteritis towards development of a PROM
Chief Investigator
|
Institution
|
Dates
|
Funding Stream
|
Amount
|
| Jo Robson |
University Hospitals Bristol NHS Foundation Trust |
01/01/2017 to 31/01/2018
|
Above and Beyond Autumn 2016
|
£13,978 |
Summary
Giant cell arteritis (GCA) is inflammation of the blood vessels
of the head and neck that occurs in people over 50. It can cause
permanent visual loss. Treatment is with high dose steroids, but
because of their side effects, new treatments are urgently needed.
Such medications must be evaluated. We are aiming to develop a
disease-specific patient reported outcome measure (PROM) which will
accurately and reliably measure whether GCA patients' symptoms and
quality of life are changed by new medications. This proposal is to
collect underpinning qualitative data for the future PROM grant
application. The data will also highlight the impact on
patients of having GCA to inform future research projects.
Phase one: We will interview 20-30 patients to explore the
impact of GCA on quality of life. From this, we will develop draft
PROM questions and test acceptability and whether different
patients understand them. Phase two: We will survey 250 GCA
patients, who will complete the draft PROM and other questions
about their disease and treatment. Phase three: Patients will
complete the PROM and record any health changes after 3-5 days (to
test whether questions are stable) and 6 months (to see if they
capture changes in symptoms and quality of life). Statistical
analyses will refine the structure of the questionnaire. Out
steering committee includes patients and researchers together.
This application to the Above and Beyond Fund is for the first
qualitative stage (Phase 1), we plan to apply for further funding
from Vasculitis UK, to complete the quantitative phases (2 and
3).
Main findings
Results
Thirty-six interviews were conducted to saturation with
participants with GCA from the UK (25) and Australia (11). Mean age
was 74 years, 23 (63.9%) were female, 13 (36.1%) had visual loss
and 5 (13.9%) had LVV-GCA. Thirty-nine individual themes within
five domains were identified: physical symptoms; activity of daily
living and function; participation; psychological impact; and
impact on sense of self and perception of health. Sixty-nine
candidate items were developed from individual themes; piloting and
refinement resulted in a 40-item draft questionnaire.
Conclusion
This international qualitative study underpins the development
of candidate items for a disease-specific PROM for GCA. The draft
questionnaire is now ready for psychometric testing.
Impact
This grant from the RCF provided us with underpinning
qualitative data to support the application for a larger
grant from NIHR RfPB. This has now been completed- resulting in a
validated patient reported outcome measure for use in future
clinical trials and clinical practice- the GCAPRO. It is being
translated into American English and Spanish and German with plans
for inclusion in clinical trials of biological agents in GCA
(current discussions with pharmaceutical companies).
Publications
Joanna C Robson, Celia Almeida, Jill Dawson, Alison Bromhead,
Emma Dures, Catherine Guly, Elizabeth Hoon, Sarah Mackie, Mwidimi
Ndosi, John Pauling, Catherine Hill, Patient perceptions of
health-related quality of life in giant cell arteritis:
international development of a disease-specific patient-reported
outcome measure, Rheumatology, Volume 60, Issue 10, October 2021,
Pages 4671-4680, https://doi.org/10.1093/rheumatology/keab076
Larger Grants
PB-PG-1217-20017 NIHR
Research for Patient Benefit Development and validation of a
patient reported outcome measure for Giant Cell Arteritis - GCA
PRO £149,274.00, 01/10/2019 - 30/09/2021
