背景:雷诺现象(RP)是SSc的主要特征,与影响生活质量的重大疾病相关发病率相关。SSc-RP的评估具有挑战性。这项范围审查的目的是评估SSc-RP临床研究中研究的结局领域和结局指标。
方法:Embase,MEDLINE,和Cochrane中央对照试验登记册用于识别随机对照试验(RCTs),准随机研究,病例对照研究,前瞻性和回顾性队列研究,案例系列,和SSc相关RP的成人参与者的横断面研究,用英语写的。至少需要25名参与者进行成像模式研究,40名参与者进行基于问卷的研究。基础实验室和遗传研究被排除。没有基于干预的限制,比较器,或学习设置。记录每个研究中的研究特征以及主要和次要目标域。
结果:58项研究(24项随机临床试验)纳入最终分析。捕获的最常见的域是攻击的严重性(n=35),攻击频率(n=28),和攻击持续时间(n=19)。数字灌注的客观评估也常用于SSc-RP的研究。
结论:用于评估SSc-RP在研究中的影响的结果领域和相关结果是广泛的,并且在研究中有所不同。这项研究的结果将告知系统性硬化症OMERACT血管疾病工作组,以建立一套涵盖RP在SSc中影响的核心疾病领域。
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.