SADDLE’s responsiveness to change version one 1 May 2013
Research type
Research Study
Full title
Investigating responsiveness to change for The Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE)
IRAS ID
137872
Contact name
Simon J Meggitt
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Discoid Lupus Erythematosus (DLE) is a skin condition that usually affects sun-exposed areas and typically presents with red or scaly patches, which can cause some thinning, scarring or colour change in the skin. We have developed a clinical score which is a visual assessment of DLE to help measure how bad a patient’s condition is. This assessment is called the Score of Activity and Damage in Discoid Lupus Erythematosus (SAADLE).
In order to further establish if this score is useful in clinical practice, we want to find out how it changes over time after receiving any medication given to patients as part of their standard clinical care. The aim is to see if any change in the score over time corresponds to how both the patient and the clinician feels that the DLE has changed generally over time. Patients 18 years old or over with a diagnosis of DLE confirmed by a dermatologist will be invited to participate over 18 months period.
A visual assessments of the patient’s skin will be performed by Dr Meggitt and Dr Fatah separately at the beginning of participation in the study and then again at next follow-up visit (typically a few weeks or months after receiving a prescribed treatment). The length of time between both these clinic visits will depend on the patient standard clinical care and the judgment of Dr Meggitt concerning your lupus management and will not be influenced by this study. The assessments usually take around 20 minutes.
Should the score demonstrate responsiveness to change, it would then further validate its use in the clinical setting and it would also be constructive to use it as part of a measure of disease severity and response in future studies investigating particular medical interventions in patients with DLE.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1208
Date of REC Opinion
5 Nov 2014
REC opinion
Favourable Opinion