Patient experience of SSc-DU
Research type
Research Study
Full title
Development of a conceptual framework for a novel patient-reported outcome measure for the assessment of digital ulcers in systemic sclerosis
IRAS ID
234861
Contact name
Michael Hughes
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Digital (or finger) ulcers are common in patients with systemic sclerosis (often called 'scleroderma'). Although there are a number of drug therapies to both prevent and treat digital ulcers, a number of patients suffer with recurrent digital ulcers. Digital ulcers significantly impact on hand function including occupation and are associated with great pain and disability in the disease. A key issue to develop new treatments for digital ulcers is that the agreement between rheumatologists in assessing digital ulcers is only poor to moderate at best, which has a significant impact on the design of future clinical trials of drug therapies. Furthermore, the agreement between patients with systemic sclerosis and rheumatologists is poor, which has important clinical implications. There is a strong need to understand the patient experience of digital ulcers in systemic sclerosis including pain, impact on hand function and occupation, issues to do with body appearance, and the impact on personal relationships. The present study shall explore the patient experience of digital ulcers by undertaking focus groups of patients with systemic sclerosis and applying qualitative research methods of transcriptions to identify themes and domains to describe the patient experience and impact of digital ulcers. It is expected this study shall support the development of a conceptual framework for a novel patient reported outcome measure for assessing the severity and impact of digital ulcers in systemic sclerosis.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0018
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion