Examination of the Validity of Skin Ultrasound to Quantitate Skin Involvement for Multicenter Clinical Trials in Patients with Systemic Sclerosis (SSc): A Systematic Literature Review (SLR).

Objective: The study objective was to conduct a systematic literature review (SLR) of ultrasound of the skin in patients with systemic sclerosis (SSc) to establish the degree to which ultrasound of the skin has been validated, using the Outcome Measures in Rheumatology (OMERACT) Filter.

Methods: We conducted an SLR of publications between 1950 and 2018, using PubMed and Cochrane library, to examine ultrasound validity to quantitate SSc skin involvement. Inclusion criteria were as follows: (1) in English; (2) used the 1980 or 2013 classification criteria for SSc criteria; (3) either a randomized controlled trial, an observational study, or a case study including more than 15 patients; (4) subjects 18 years of age or older; (5) for mixed patient populations, SSc results were separable; and (6) the ultrasound machine was clearly described.