制定妇科美容干预核心结局集（COS）和核心结局测量集（COMS）：一项开发与可用性研究方案
Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.
作者信息
Doumouchtsis Stergios K, Nama Vivek, Falconi Gabriele, Rada Maria Patricia, Manonai Jittima, Iancu George, Haddad Jorge Milhem, Betschart Cornelia
机构信息
Department of Obstetrics and Gynecology, Epsom & St Helier University Hospital NHS Trust, London, United Kingdom.
Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Athens, Greece.
出版信息
JMIR Res Protoc. 2021 Nov 15;10(11):e28032. doi: 10.2196/28032.
BACKGROUND
Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions.
OBJECTIVE
This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions.
METHODS
An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing "core" outcomes.
RESULTS
Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed.
CONCLUSIONS
This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care.
TRIAL REGISTRATION
Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032.
背景
评估美容妇科干预措施的研究采用了不同的方法，并报告了多种结果。这些差异限制了研究的可比性以及基于研究的证据的价值。核心结局集（COS）和核心结局测量集（COMS）的开发将有助于解决这些问题，确保至少有对所有利益相关者（主要是要求或经历过美容妇科干预的女性）重要的结局。
目的
本方案描述了为美容妇科干预措施制定COS和COMS所使用的方法。
方法
合唱（CHORUS）项目中的一个国际指导小组，包括来自四大洲的医疗保健专业人员、研究人员以及有美容妇科干预经验的女性，将指导COS和COMS的开发。通过全面的文献综述来确定潜在的结局测量指标和结局。这些潜在的COS和COMS将被纳入一项基于网络的国际多视角德尔菲调查，德尔菲参与者将判断哪些领域将成为核心领域。在每轮德尔菲调查之前将设定共识的先验阈值。在确定“核心”结局的过程中，将在后续的利益相关者小组共识会议上对德尔菲调查结果进行定量和定性评估。
结果
将促进并审查最终形成的COS和COMS在国际范围内的传播与实施。
结论
本方案介绍了为美容妇科干预措施制定COS和COMS的步骤。将美容妇科干预措施的COS和COMS纳入未来的临床试验、系统评价和实践指南中，可能有助于提高研究价值并改善整体患者护理。
试验注册
有效性试验中的核心结局测量指标（COMET）1592；https://tinyurl.com/n8faysuh。
国际注册报告识别码（IRRID）：PRR1-10.2196/28032。
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