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用于临床和研究环境中成年 COVID-19 后患者的核心结局测量工具:一项国际 Delphi 共识研究。

Core outcome measurement instruments for use in clinical and research settings for adults with post-COVID-19 condition: an international Delphi consensus study.

机构信息

MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.

Independent researcher, London, UK.

出版信息

Lancet Respir Med. 2023 Dec;11(12):1101-1114. doi: 10.1016/S2213-2600(23)00370-3. Epub 2023 Nov 2.

Abstract

Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID. The study comprised a literature review to identify measurement instruments for the core outcomes, a three-round online modified Delphi process, and an online consensus meeting to generate a core outcome measurement set (COMS). 594 individuals from 58 countries participated. The number of potential instruments for the 12 core outcomes was reduced from 319 to 19. Consensus was reached for inclusion of the modified Medical Research Council Dyspnoea Scale for respiratory outcomes. Measures for two relevant outcomes from a previously published COS for acute COVID-19 were also included: time until death, for survival, and the Recovery Scale for COVID-19, for recovery. Instruments were suggested for consideration for the remaining nine core outcomes: fatigue or exhaustion, pain, post-exertion symptoms, work or occupational and study changes, and cardiovascular, nervous system, cognitive, mental health, and physical outcomes; however, consensus was not achieved for instruments for these outcomes. The recommended COMS and instruments for consideration provide a foundation for the evaluation of post-COVID-19 condition in adults, which should help to optimise clinical care and accelerate research worldwide. Further assessment of this COMS is warranted as new data emerge on existing and novel measurement instruments.

摘要

新冠后状况(也称为长新冠)是一种新的、复杂的、尚未被充分了解的疾病。已经为成人新冠后状况制定了核心结局集(COS),现在需要就这些核心结局的最合适的测量工具达成一致意见。我们进行了一项涉及多学科专家和有长新冠经历的人的国际共识研究。该研究包括一项文献综述,以确定核心结局的测量工具,三轮在线改良 Delphi 流程,以及一次在线共识会议,以生成核心结局测量集(COMS)。来自 58 个国家的 594 人参与了研究。用于 12 个核心结局的潜在工具数量从 319 个减少到 19 个。对于呼吸结局的改良医学研究理事会呼吸困难量表的纳入达成了共识。还包括之前发表的急性 COVID-19 COS 中两个相关结局的测量方法:死亡的时间,用于生存,以及 COVID-19 恢复量表,用于恢复。对于其余九个核心结局,建议考虑使用疲劳或疲惫、疼痛、劳累后症状、工作或职业和学习变化以及心血管、神经系统、认知、心理健康和身体结局的测量工具;然而,对于这些结局的工具,尚未达成共识。建议的 COMS 和可考虑的工具为评估成人新冠后状况提供了基础,这应该有助于优化全球临床护理和加速研究。随着关于现有和新型测量工具的新数据的出现,进一步评估这个 COS 是有必要的。

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