The validation cohorts were constituted of a cumulative number of 219 patients. All enrolled patients met the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for SSc [2 (link)], and they were also sub-classified as having limited cutaneous systemic sclerosis (lcSSc) or diffuse cutaneous systemic sclerosis (dcSSc) following the LeRoy et al. criteria [10 (link)]. Exclusion criteria were concomitant conditions that may potentially cause additional microvascular changes, such as diabetes, smoking and onychophagic habitus; presence of anti-phospholipid antibodies; and pregnancy. Current treatment with beta-blockers was also an exclusion criterion because it is well known that this drug may cause or exacerbate Raynaud’s phenomenon (RP).
At the time of study enrolment, 52 of the 219 patients were receiving treatment with infusions of intravenous prostanoids (45 with monthly iloprost and 7 with weekly alprostadil), and 16 were taking bosentan. It was decided for ethical reasons to continue the vasodilatory treatments for the prospectively enrolled patients in Milan. Furthermore, all of the patients were receiving stable treatment with low-dose acetylsalicylic acid and calcium channel blockers.
One hundred twenty-two patients with SSc who were referred to the rheumatic disease unit of the Gaetano Pini Institute of Milan formed the prospectively collected internal validation cohort. It was preliminarily established to consecutively include around half the patients with inactive disease (ESSG score <3 and a similar proportion of patients with active disease [ESSG score ≥3]). This cohort did not include any patient who had been recruited for the previous study [7 (link)].
Ninety-seven patients with SSc who were referred to the rheumatology unit of the 2nd University of Naples formed the external validation cohort. These patients and their NVC images were randomly selected from the database on the condition that about one-third of them should have an ESSG score ≥3.
At the time of study enrolment, 52 of the 219 patients were receiving treatment with infusions of intravenous prostanoids (45 with monthly iloprost and 7 with weekly alprostadil), and 16 were taking bosentan. It was decided for ethical reasons to continue the vasodilatory treatments for the prospectively enrolled patients in Milan. Furthermore, all of the patients were receiving stable treatment with low-dose acetylsalicylic acid and calcium channel blockers.
One hundred twenty-two patients with SSc who were referred to the rheumatic disease unit of the Gaetano Pini Institute of Milan formed the prospectively collected internal validation cohort. It was preliminarily established to consecutively include around half the patients with inactive disease (ESSG score <3 and a similar proportion of patients with active disease [ESSG score ≥3]). This cohort did not include any patient who had been recruited for the previous study [7 (link)].
Ninety-seven patients with SSc who were referred to the rheumatology unit of the 2nd University of Naples formed the external validation cohort. These patients and their NVC images were randomly selected from the database on the condition that about one-third of them should have an ESSG score ≥3.
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