PRO development for Giant Cell Arteritis (GCA)
Research type
Research Study
Full title
PRO development for Giant Cell Arteritis (GCA). A qualitative study using interviews with patients who have Giant Cell Arteritis to develop a patient reported outcome (PRO) measure.
IRAS ID
217748
Contact name
Joanna Robson
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
1 years, 6 months, 24 days
Research summary
Giant cell arteritis (GCA) is caused by inflammation of the blood vessels of the head and neck 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 and it is vitally important to gain the patient’s perspective on changes in their health status as a part of this process. This is best achieved using patient reported outcome measures (PROMs), which are designed to measure health status in a standard way that is reliable and valid. We aim to develop a disease-specific patient reported outcome measure (PROM) which will accurately and reliably measure whether GCA patients’ symptoms and health-related quality of life are changed by new medications. The development of a new PROM requires the use of mixed methods applied in three distinct phases: Phase 1 - The collection and analysis of qualitative data to inform PROM candidate questions, with additional refinement via cognitive debriefing: Phase 2 – item reduction and determination of underlying PROM scale structure and cross-sectional measurement properties; Phase 3 –longitudinal and comparative analysis/verification of the new PROM’s measurement properties. Phases 2 and 3 involve using quantitative methods within the context of a longitudinal survey.
This study is concerned with the first qualitative study (Phase 1). Results from this study will inform and underpin the more quantitative phases 2 and 3, and highlight the impact on patients of having GCA.
Methods: Interviewing 20-30 patients to explore the impact of GCA on symptoms and health related quality of life to identify substantive themes of relevance to a PROM and develop draft PROM questions. We will then test their acceptability and whether different patients understand them in the way that is intended. Our steering committee includes patients and researchers.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0697
Date of REC Opinion
28 Dec 2016
REC opinion
Favourable Opinion