MYOSCOPE [v1.0]
Research type
Research Study
Full title
MYOSCOPE: Bringing a visual measure of disease activity into clinical practice to help children with dermatomyositis.
IRAS ID
333838
Contact name
Liza McCann
Contact email
Sponsor organisation
Alder Hey Children's Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, days
Research summary
This study will explore if it is helpful for children/young people with Juvenile Dermatomyositis (JDM) to see small blood vessels at the base of their fingernails as part of their clinic visit. JDM causes inflammation of muscle and skin, blood vessels and major organs. Treating quickly and ensuring treatment continues during active or grumbling disease is vital to improve long-term outcome.
Changes in blood vessels happen when JDM is active or worsening. Doctors look at nailfold vessels in clinic, but current tools only allow them to see if vessels are normal or abnormal. Patients cannot easily see this. Disease affecting blood vessels often stays after muscle weakness improves. Patients may want to stop medicines when they feel better, less weak and their disease is less visible, especially since medicines can cause sickness, weight gain and infection. The handheld CapillaryScope that we will use in this study brings imaging to patients at their usual clinic visit for the first time. Our patient/parent advisory group think this will help children understand their disease or need for medicine, aid shared decisions and improve outlook.
We will invite 40 patients from 2 hospitals (Alder Hey and Great Ormond Street) to take part in this study, running over 2 years. We will use handheld Nailfold Capillaroscopy to visualise blood vessels and document changes. This is painless. We will ask patients and parents to complete a questionnaire at their first visit and 6-monthly during follow-up, to explore if seeing blood vessels was helpful or not. They will be invited to an optional patient/family interview to further explore their feelings about this. From information that doctors will be asked to document before and after a formal nailfold capillaroscopy report, we will investigate if capillaroscopy influences treatment decisions and compare nailfold changes to other measures of disease activity.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0023
Date of REC Opinion
29 Jan 2024
REC opinion
Favourable Opinion