Digital ulceration as an outcome measure
Research type
Research Study
Full title
Digital ulceration as an outcome measure: does contextual information improve reliability between rheumatologists?
IRAS ID
130344
Contact name
Ariane Herrick
Contact email
Sponsor organisation
The University of Manchester
Research summary
Digital ulceration as an outcome measure: does contextual information improve reliability between rheumatologists?\n\nSystemic sclerosis (SSc), also known as scleroderma, is an autoimmune connective tissue disease that involves changes in the skin, blood vessels and most of the internal organs.\n\nDigital ulcers (finger and toe) which occur in around 50% of patients with SSc at some point in their disease course, are often very painful and can become infected. They can be very disabling in affecting patient’s hand function and quality of life.\n\nDigital ulcers are also often used as the primary end point in clinical trials of different treatments for SSc-related finger problems. At present, there is no one agreed definition in use by clinicians. A recent study found considerable variation in the grading of digital ulcers by rheumatologists. Furthermore, the assessment of digital ulcers within trials is based around visual appearance only. In the real life setting of everyday clinical practice, however, ulcers are assessed on visual appearance alongside a range of clinical information such as patient reports of pain and ulcer discharge. \n\nWe would like to investigate if this ’contextual’ clinical information affects the way in which clinicians/rheumatologists assess digital ulcers. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0255
Date of REC Opinion
5 Aug 2013
REC opinion
Further Information Favourable Opinion