Self-assessment of skin in scleroderma in relation to quality of life
Research type
Research Study
Full title
Self-assessment of skin thickness in systemic sclerosis – improving quality of life and value of telemedicine by empowering patients
IRAS ID
296947
Contact name
Christopher Denton
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Skin thickening due to fibrosis is a hallmark of systemic sclerosis (SSc) and impacts on daily function and self-image. Evaluation of skin involvement in SSc is central to clinical practice and reliable measurement of skin is key to understanding disease trajectory and response to treatment. This is generally done with the modified Rodnan Skin Score (mRSS). Also, mRSS is an important outcome measure for clinical trials, as changes in mRSS are associated with internal organ manifestations and poor prognosis. Remote consultations are now widely implemented in response to the COVID-19 pandemic, this has inevitably limited direct evaluation of skin in our patients, which may lead to suboptimal clinical monitoring and delay in treatment in case of skin progression. Importantly, as a consequence this could affect quality of life and daily functioning.
Last year, we developed the PASTUL (Patient self-Assessment of Skin Thickness in Upper Limb) questionnaire, which was evaluated on feasibility and validity in 104 SSc patients who had either a remote or face-to-face appointment at the Royal Free Hospital London during the COVID-19 pandemic. Patients reported that the self-assessment was feasible and PASTUL scores significantly correlated with mRSS and patient reported outcomes for skin-related symptoms. The PASTUL questionnaire therefore has potential for remote evaluation. However, nationwide implementation of this questionnaire in both practice and trials requires further investigation.
Our project has therefore two main goals. First, we will gain more insight into the impact of SSc skin involvement on quality of life using the PASTUL questionnaire as a patient-relevant measure of skin severity. Secondly, we aim to refine operational aspects of PASTUL and further validate potential utility for clinical trials including exploring feasibility of a simple smartphone application for future use in routine clinical care.REC name
London - Surrey Research Ethics Committee
REC reference
21/LO/0799
Date of REC Opinion
22 Dec 2021
REC opinion
Further Information Favourable Opinion