OMERACT Systemic Lupus Erythematosus Delphi Survey Via REDCap
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- SLE Core Domain Set as determined by a 4-round Delphi survey
研究概览
简要总结
SLE is a chronic multi-systemic autoimmune disease with clinical manifestations characterized by recurrent flares in disease activity and damage in several organs. SLE affects primarily women during child bearing age and is negatively related to productivity, social role participation and health-related quality of life. The multi-systemic nature of SLE and its diverse clinical manifestations have led to many outcome measurements being utilized in SLE clinical trials and longitudinal studies. To standardize measurement in clinical trials and longitudinal studies, the OMERACT SLE Group developed the core domain set for SLE in 1998. A core domain set is a set of outcome measures, capturing all the facets/aspects of the disease, that standardizes measurement and research across clinical trials and longitudinal studies necessary for the advancement of the field. Since development in 1998, many new important domains for SLE have been identified, thus there is an unmet need to update the core domain set. A new OMERACT SLE Working Group has been established to update the SLE core domain set.
This is a qualitative study that aims to prioritize domains to include in the SLE core domain set. All participants will be asked to complete a four-round online survey. During rounds 1-3 participants will be asked to rate the importance of each domain to be included; round 4 will ask participants select and rank domains. Participants will also have the option of adding other items or descriptors and to provide any other feedback. Each round of the survey will take approximately 15-20 minutes to complete.
Participants will need to participate in round 1 in order to be invited to round 2, and then participate in round 2 in order to be invited to round 3, and final participate in round 3 in order to be invited to round 4.
详细描述
Objective Research question • What domains (outcome measurements) of SLE are important to the various SLE stakeholders?
Objective
• The investigators are attempting to ascertain preliminary opinions on the importance of domains measured in SLE.
Study Design Constructing e-Delphi Survey Domains REDCap will be used to assist the working group in prioritizing domains for a Core Domain Set and providing decision-making information. The investigators qualitative work and literature reviews have generated 25 domains for consideration across all Core Areas. Based on the investigator's previous qualitative work and literature review, brief definitions have been created for each domain to clarify its meaning. The domains, the core area they represent, and their definitions are included in are included in the accompanying Domain Tracking spreadsheet [Appendix A]. In addition, under Pathophysiological manifestations/abnormalities, the investigators have identified if this is a Symptom, a Sign, or a Biomarker (imaging, blood work). In total there are 25 domains being considered for inclusion in the REDCap.
The Domain Tracking spreadsheet will be reviewed for completeness by the OMERACT and used as the resource for domains to be entered into REDCap once the protocol has been completed and approved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •18 and older
- •Able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese
- •Have access to email and the internet
排除标准
- •Not able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese
- •Does not have access to email and the internet
结局指标
主要结局
SLE Core Domain Set as determined by a 4-round Delphi survey
时间窗: 6 months
A 4-round Delphi survey will be conducted to ascertain preliminary opinions on the importance of domains measured in SLE to develop a Core Domain Set. Once all 4 rounds of the Delphi are complete the feedback along with the results of all three rounds of the Delphi process will be provided to the Working Group in an anonymous format who will use the data of the voting rounds, the selection of the most important domains, and the comments to make their final evidence-based decisions on the content of Core Domain Set. The draft Core Domain Set will be presented the OMERACT Community for endorsement.
次要结局
未报告次要终点
研究者
Zahi Touma
Principal Investigator
University Health Network, Toronto