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

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. 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. 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. 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.

Copyright © 2023. Published by Elsevier Inc.

Declaration of Competing Interest Dr Hughes reports speaking fees from Actelion Pharmaceuticals, Eli Lilly, and Pfizer, outside of the submitted work. Research funding from Janssen. Member of a Data and Safety Monitoring Board for Certa Therapeutics. Dr. Pauling reports grants and personal fees from Janssen, outside the submitted work; Dr Pauling reports personal and consultancy fees from Boehringer Ingelheim, Sojournix Pharma, Astra Zeneca, IsoMab and Permeatus, Inc. Dr Proudman reports receiving funds for the following activities: advisory board: Boehringer-Ingelheim, Janssen, Gossamer. Research Support: Janssen. Dr. Merkel reports receiving funds for the following activities: Consulting: AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, CSL Behring, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Jannsen, Kiniksa, Kyverna, Magenta, Novartis, Pfizer, Sparrow, Takeda, Talaris. Research Support: AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Sanofi. Royalties: UpToDate. Dr Herrick reports research funding from Gesynta Pharma, consultancies with Arena, Boehringer-Ingelheim, Camurus, CSL Behring, Gesynta Pharma and speaker's fees from Janssen.