Domain reporting in Systemic Sclerosis-Related Digital Ulcers: An OMERACT Scoping Review.

BACKGROUND: Digital ulcers (DUs) are a major cause of pain and disability in patients with systemic sclerosis (SSc). The aim of this scoping review was to evaluate the outcome domains used in studies of SSc-associated DUs. METHODS: Electronic databases (EMBASE, MEDLINE and the Cochrane Library) were searched for articles written (1947 onwards) in English relating to SSc-DUs. A minimum of 15 participants for studies of imaging and 25 participants for questionnaire-based studies was required for inclusion. Information on all primary and secondary domains was extracted. RESULTS: 4869 manuscripts were identified, of which 40 met the eligibility criteria and were included in the synthesis. Most studies were randomized controlled trials (n=13), or prospective (n=12)/retrospective (n=8) observational studies. Interventions included oral or intravenous drugs (n=25), topical/local treatments (n=5), and surgical interventions (n=2). Approximately half the studies assessed either the count/number of DUs (n=23) and/or improvement in DUs (n=20). Functional impact of DUs was examined in 25% (n=10) of studies. Other domains were related to complications of DUs (n=7), pain (n=6), health-related quality of life (n=4), microvascular assessment/pathophysiology (n=4), global assessment of DUs (n=2), and histopathology (n=1). CONCLUSION: This scoping review identified a broad range of disease-related domains used to study SSc-DUs. There is significant heterogeneity in these domains. These data will inform the ongoing work of the OMERACT Vascular Disease in Systemic Sclerosis Working Group to define a core set of disease broad domains to capture the burden of DUs in SSc.

Domain reporting in systemic sclerosis-related Raynaud's phenomenon: An OMERACT scoping review.

BACKGROUND: Raynaud's phenomenon (RP) is a cardinal feature of SSc and is associated with significant disease-related morbidity that impacts on quality of life. The assessment of SSc-RP is challenging. The aim of this scoping review was to evaluate the outcome domains studied and outcome measures used in clinical studies of SSc-RP. METHODS: Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were used to identify randomized control trials (RCTs), quasi-randomized studies, case-control studies, prospective and retrospective cohort studies, case series, and cross-sectional studies of adult participants with SSc-associated RP, written in English. A minimum of 25 participants for studies of imaging modalities and 40 participants for questionnaire-based studies was required for inclusion. Basic laboratory and genetic studies were excluded. No limitations were imposed based on intervention, comparator, or study setting. Study characteristics and primary and secondary target domains in each study were recorded. RESULTS: 58 studies (24 randomized clinical trials) were included in the final analysis. The commonest domains captured were severity of attacks (n=35), frequency of attacks (n=28), and duration of attacks (n=19). Objective assessments of digital perfusion were also commonly used in studies of SSc-RP. CONCLUSION: The outcome domains and the associated outcomes used to assess the impact of SSc-RP in research studies are broad and have varied across studies. The results of this study will inform the OMERACT Vascular Disease in Systemic Sclerosis Working Group to establish a core set of disease domains encompassing the impact of RP in SSc.

Developing a core set of outcome measure domains to study Raynaud's phenomenon and digital ulcers in systemic sclerosis: Report from OMERACT 2020.

Raynaud's phenomenon (RP) and digital ulcers (DUs) are important disease manifestations of systemic sclerosis (SSc) that can lead to significant pain and disability. It is essential when studying these disease features to utilize outcome measures that fully evaluate the complexities of RP and DUs . The Outcome Measures in Rheumatology (OMERACT) Vascular Disease in SSc Working Group is applying the OMERACT filter 2.1 to identify a core set of disease domains that encompass the full burden of SSc-related RP and DUs. Progress to date and future research plans were presented during a Special Interest Group held in December 2020.