Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure
Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure
复制标题
DOI：
10.1136/bmjopen-2020-038145
复制
发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Wolkerstorfer, Albert
中科院分区：
文献类型：
--
作者：
Fransen, Frederike;Spuls, Phyllis;Wolkerstorfer, Albert
前言：虽然激光技术在过去几年里扩大了治疗各种皮肤病的手段，但研究结果的异质性阻碍了可比性和适当的证据合成。这些问题中的一部分可以通过制定一个通用的结果集来解决。使用德尔菲方法，这项研究旨在寻求关键利益相关者之间就相关的非专利结果(衡量什么)达成共识，以便在国际皮肤病激光治疗登记(LEAD)中实施。该登记集中于收集各种激光治疗皮肤病的研究数据。方法和分析通过查阅文献，以及关键利益相关群体、有需要的成年患者或激光手术后的成年患者和健康专业人员的参与，将生成一个初步的结果列表，并按领域进行分类。利用这些结果，将进行一项国际三轮德尔福研究，以评估结果在选择通用结果集方面的重要性。参与者被允许在第一轮德尔福修订的初步清单中提供新的结果。最后，将在协商一致会议上讨论结果，以商定将在牵头登记册上使用的通用结果。道德和传播不适用于道德操守批准(W19_290#18.336)。这项研究注册了Cochrane皮肤核心结果集倡议)和有效性试验倡议的核心结果衡量标准。程序将根据《赫尔辛基宣言》进行。调查结果将通过同行评议的出版物和会议发言进行传播。
Introduction While laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.Methods and analysis By reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.Ethics and dissemination An ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.