Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0
Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0
复制标题
DOI：
10.1016/j.jclinepi.2013.11.013
复制
发表时间：
2014-07-01
影响因子：
7.2
通讯作者：
Tugwell, Peter
中科院分区：
文献类型：
--
作者：
Boers, Maarten;Kirwan, John R.;Tugwell, Peter
背景：缺乏标准化的结果措施限制了临床试验证据的有用性，为医疗保健决策提供信息。这可以通过商定每种健康状况的最低限度核心成果衡量标准来解决，其中包括与患者和决策者相关的衡量标准。自1992年以来，流变学结果测量（OMERACT）共识倡议已成功开发了许多流变学疾病的核心集，自2002年以来积极参与患者。其范围的扩大需要明确制定其基本的概念框架和过程。方法：文献检索和迭代共识过程（调查和小组会议）的利益相关者，包括患者，卫生专业人员，和风湿病学内外的方法学家。为了全面抽样以患者为中心和干预特定的结果，出现了一个框架，包括三个核心"领域"，即死亡，生命影响，和病理生理表现;和一个强烈建议的资源使用。通过文献回顾和共识过程，针对任何特定健康状况的核心集开发首先在每个领域内确定至少一个核心"领域"，以制定"核心领域集"。接下来，为每个核心领域确定至少一个适用的测量工具，以制定“核心成果测量集”。"每一项文书都必须证明是真实的（有效的）、有区别的和可行的。2012年，在OMERACT 11共识会议上，96%的投票参与者（n = 125）认可了该模型和process.Conclusion：OMERACT Filter 2.0明确描述了一个全面的概念框架和推荐的过程，以开发可能在其他医疗保健领域作为模板有用的流变学核心结果测量集。(C)2014作者爱思唯尔公司出版All rights reserved.
Background: Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.Methods: Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology.Results: To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n = 125) at the OMERACT 11 consensus conference endorsed this model and process.Conclusion: The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care. (C) 2014 The Authors. Published by Elsevier Inc. All rights reserved.