PRO and lupus
Research type
Research Study
Full title
A study for the early evaluation of a set of newly developed patient-reported outcomes (PRO) instruments specific to systemic lupus erythematous (SLE).
IRAS ID
212552
Contact name
Caroline Gordon
Contact email
Sponsor organisation
Sandwell and West Birmingham Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We aim to conduct a cross-sectional, non-interventional, observational study evaluating the psychometric properties of a newly developed set of lupus - specific patient-reported outcomes (PRO) questionnaires focusing mainly on symptoms, fatigue, pain, mobility issues and emotional states in lupus patients attending lupus clinic at the Sandwell and West Birmingham NHS Hospitals Trust (SWBH). This cross-sectional study is composed of a main quantitative component and a supplementary qualitative component. We aim to recruit 200 lupus patients into the study; all patients will be included into the quantitative component and only a subsample of 30 patients will contribute to the qualitative component. More specifically, we aim to generate preliminary quantitative evidence on the measurement properties of the newly developed SLE-specific questionnaires covering certain aspects of the health related quality of life such as fatigue (SLE-F), pain (SLE-P),mobility (SLE-M), symptoms (SLE-S) and emotional states (SLE-E).We also aim to provide with qualitative evidence of the understanding and comprehensiveness of the above outlined newly developed SLE-specific PRO questionnaires.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0414
Date of REC Opinion
23 Dec 2016
REC opinion
Favourable Opinion