PRO development for Glucocorticoids
Research type
Research Study
Full title
Exploration of patient experience of glucocorticoids (GC) for treatment of rheumatic diseases and development of a patient reported outcome (PRO) measure \n
IRAS ID
271753
Contact name
Joanna Robson
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Glucocorticoids (GCs) are widely used in the rheumatic diseases, including rheumatoid arthritis, vasculitis, lupus, and giant cell arteritis. They are an effective therapy which can be life-saving but have significant adverse effects. The impact of such medicines 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 (PROs), which are designed to measure health status in a standard way that is reliable and valid. We aim to develop a medicine patient reported outcome measure (PRO) which will accurately and reliably measure whether the symptoms and health-related quality of life are changed by their exposure to GC. The development of a new PROM requires the use of mixed methods applied in three distinct phases: \nPhase 1 - The collection and analysis of qualitative data to inform PROM candidate questions, with additional refinement via cognitive debriefing: \nPhase 2 – item reduction and determination of underlying PRO scale structure and cross-sectional measurement properties; \nPhase 3 –longitudinal and comparative analysis/verification of the new PRO’s measurement properties. Phases 2 and 3 involve using quantitative methods within the context of a longitudinal survey. \n\nThis 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 GC use.\n\nMethods: Semi-structured Interviews 30-40 patients to explore the impact of GC on symptoms and health related quality of life to identify substantive themes of relevance to a PRO and develop draft PRO 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.\n\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0221
Date of REC Opinion
7 Jan 2020
REC opinion
Further Information Favourable Opinion