Department of Dermatology, Ghent University Hospital, Ghent, Belgium.
Department of Dermatology, Henry Ford Hospital, Global Vitiligo Foundation, Detroit, MI, USA.
Trials. 2022 Jul 23;23(1):591. doi: 10.1186/s13063-022-06497-1.
There is a lack of consensus related to the collection of standardized data for individuals with vitiligo enrolled in clinical trials and registries as well as those seen in clinical practice which causes difficulty in accurately interpreting, comparing, and pooling of data. Several years ago, efforts to initiate work on developing core outcome sets were performed and a consensus was reached in 2015 on the first core domain set for vitiligo clinical trials.
METHODS/DESIGN: This project aims to further develop a core outcome set for vitiligo clinical trials as well as create internationally agreed-upon core outcome sets for registries and clinical practice. These core outcome sets will include a core domain set and a core measurement instruments set and will be supplemented by contextual factors, including baseline and treatment-related characteristics. In a preparatory exercise, the 2015 core domain set will be re-evaluated and will serve as the basis for the list of outcome domains used to initiate the consensus process. This project will consist of two parts. Part 1 will focus on the selection of a core domain set, or "what to measure" and contextual factors, for each setting based on electronic surveys (e-Delphi technique) and a conclusive consensus meeting by a large group of international stakeholders. Part 2 will include selection of core measurement instruments, or "how to measure," and measurement details (e.g., scale and timing) for the core domain sets and contextual factors agreed upon in part 1. Part 2 will be based on consensus meetings with stakeholders involved in part 1 and will be guided by C3 (CHORD-COUSIN Collaboration), Harmonising Outcome Measures for Eczema (HOME), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), and Outcome Measures in Rheumatology (OMERACT) recommendations including information on measurement properties of available instruments (systematic review and expert/patient opinion). At the end of part 2, all stakeholders involved will be invited to participate in a final meeting in which the ultimate core data sets (core outcome sets and contextual factors) will be presented and the dissemination plan and implementation goals will be defined.
This project will harmonize data collection between clinical trials, registries, and clinical practices, facilitating new insights in vitiligo.
This study is registered in the Core Outcome Measures for Effectiveness Trials (COMET) database and on the C3 (CHORD-COUSIN Collaboration) website.
对于参加临床试验和注册的白癜风患者以及临床实践中所见的患者，在收集标准化数据方面缺乏共识，这导致数据的准确解释、比较和汇总变得困难。几年前，人们努力开展制定核心结局集的工作，并于 2015 年就白癜风临床试验的第一个核心领域集达成共识。
方法/设计：本项目旨在进一步制定白癜风临床试验的核心结局集，并为注册和临床实践创建国际公认的核心结局集。这些核心结局集将包括核心领域集和核心测量工具集，并辅以背景因素，包括基线和治疗相关特征。在预备性活动中，将重新评估 2015 年的核心领域集，并将其作为启动共识过程的使用结局领域列表的基础。本项目将由两部分组成。第 1 部分将侧重于根据电子调查（电子 Delphi 技术）和由众多国际利益相关者参加的总结性共识会议，为每个设置选择核心领域集或“要测量的内容”和背景因素。第 2 部分将包括为第 1 部分中商定的核心领域集和背景因素选择核心测量工具，或“如何测量”以及测量细节（例如，量表和时间）。第 2 部分将基于参与第 1 部分的利益相关者的共识会议，并将遵循 C3（CHORD-COUSIN 协作）、湿疹协调测量工具选择标准（HOME）、健康测量工具选择标准（COSMIN）和风湿病结局测量（OMERACT）建议，包括现有工具的测量特性信息（系统评价和专家/患者意见）。在第 2 部分结束时，将邀请所有参与的利益相关者参加最终会议，届时将提出最终的核心数据集（核心结局集和背景因素），并将确定传播计划和实施目标。
本项目将协调临床试验、注册和临床实践之间的数据收集，促进白癜风的新见解。
本研究在核心结局测量有效性试验（COMET）数据库和 C3（CHORD-COUSIN 协作）网站上注册。
