Item refinement for SSiDU questionnaire
Research type
Research Study
Full title
Evaluation and refinement of candidate items for a novel patient reported outcome instrument for assessing the severity/impact of digital ulcers in systemic sclerosis
IRAS ID
323402
Contact name
Michael Hughes
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Clinicaltrials.gov Identifier
1.0, 22MSK18-S
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Digital ulcers occurring on the fingers and toes are common in patients with systemic sclerosis (often called 'scleroderma'). These ulcers are very painful and often slow to heal and difficult to treat sometimes needing hospital admission and even amputation. Assessment of digital ulcer status (e.g. healing or worsening)) can be very challenging and is typically based upon clinician opinion based on visual inspection of the ulcer alone. We have devised a new questionnaire for assessing the severity and impact of digital ulcers in systemic sclerosis (SSc). It is hoped that the questionnaire shall be used in future clinical trials and help deliver new treatments for people affected by SSc-RP. The purpose of this "cognitive de-briefing" patient interview study is to ensure the question wording of the draft questionnaire is easily and fully understood by people with SSc-DUs. This step in the development of this new PRO instrument is critical to the scientific validity and success of the eventual tool.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0073
Date of REC Opinion
25 May 2023
REC opinion
Further Information Favourable Opinion