Validation of the ASRAP questionnaire
Research type
Research Study
Full title
Validation of the preliminary Assessment of Scleroderma-associated RAynaud’s Phenomenon (ASRAP) questionnaire
IRAS ID
257368
Contact name
Jane Carter
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Systemic sclerosis (SSc) is an autoimmune rheumatic disease characterised by aberrant tissue fibrosis (scar tissue formation in the skin, lungs and other organs) and vasculopathy. The vasculopathy of SSc results in symptoms of Raynaud's phenomenon (ischaemia of the fingers), the formation of telangiectasia (dilated blood vessels in the skin), digital ulcers and calcinosis cutis (small deposits of calcium crystals in the skin). Raynaud's phenomenon (RP) is a major cause of morbidity in SSc. It is not easily assessed in the clinical setting as symptoms are closely linked to cold exposure and are more prominent when outdoors. This has resulted in the adoption of diary-based approaches for assessing RP which are burdensome for patients and have not performed well in clinical trials.
The principle purpose of this study shall be to validate a new patient-reported outcome instrument for assessing the severity and impact of Raynaud's phenomenon in systemic sclerosis. This questionnaire-based study shall also allow us to explore other aspects of cutaneous vasculpathy in SSc such as calcinosis, telangiectases and digital ulceration.
Research Summary
We undertook the largest study of scleroderma associated Raynaud's phenomenon undertaken to date, enrolling over 400 patients to an international questionnaire-based cross-sectional study. This work has allowed us to score and calibrate the ASRAP questionnaire. We have confirmed good content and construct validity. We have confirmed excellent repeatability. The study data has, to date, been presented at international meetings and published in high-impact rheumatology journals. The data has been selected for oral presentations at a number of important meetings including the 2022 International Scleroderma Workshop in Boston and the 2021 American College of Rheumatology Annual Convergence Meeting. The study was selected for a pod cast highlighting influential work published in official American College of Rheumatology journals. This rich dataset will be explored further for other study objectives and result in further publications.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0155
Date of REC Opinion
10 Jan 2019
REC opinion
Favourable Opinion