Development of items for ASRAP questionnaire
Research type
Research Study
Full title
Development of a novel questionnaire for assessing Raynaud’s phenomenon in systemic sclerosis
IRAS ID
251873
Contact name
John D Pauling
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 21 days
Research summary
Raynaud's phenomenon describes episodic narrowing of the blood vessels of the fingers in response to cold exposure and/or emotional stress. Attacks of RP are associated with digital colour changes, pain, numbness and loss of function. RP is a feature of systemic sclerosis (SSc) and has been highlighted as one of the commonest and most intrusive symptoms in the disease.The episodic nature of RP has made measuring RP challenging and existing patient-reported outcome (PRO) instruments haven't performed very well in RP clinical trials. We have devised a new questionnaire for assessing the severity and impact of Raynaud's phenomenon (RP) 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-RP. This step in the development of this new PRO instrument is critical to the scientific validity and success of the eventual tool.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0579
Date of REC Opinion
10 Oct 2018
REC opinion
Favourable Opinion