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危机时期的检测指南制定:快速和实时指南制定的挑战和局限性。

Testing guidelines during times of crisis: challenges and limitations of developing rapid and living guidelines.

机构信息

Outcomes and Implementation Research Unit, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; School of Medicine, Case Western Reserve University, Cleveland, OH, USA.

出版信息

Clin Microbiol Infect. 2023 Apr;29(4):424-428. doi: 10.1016/j.cmi.2023.01.020. Epub 2023 Feb 2.

Abstract

BACKGROUND

The start of the COVID-19 pandemic presented a situation in which there was an urgent need for decision-making that relates to diagnosis, but the evidence was lacking, of low certainty or constantly changing. Rapid and living guideline development methods were needed and had to be applied to rigorous guideline approaches, such as the Grading of Recommendations Assessment, Development, and Evaluation approach.

OBJECTIVES

To describe the process of developing rapid diagnosis guidelines when there is limited and imperfect available data at the time of crisis.

SOURCES

Case example from four Infectious Disease Society of America COVID-19 diagnostic guidelines.

CONTENT

As the world was experiencing panic with COVID-19, there were serious doubts about the feasibility of following a rigorous process for guideline development when timeliness was of extreme value. The Infectious Disease Society of America guideline panels supported by several methodologists strongly believed that at times of crisis, it is more important than ever to follow a rigorous process. The panel adopted a rapid and living systematic review methodology and applied the Grading of Recommendations Assessment, Development and Evaluation approach to four diagnosis guidelines despite the challenges of scarce and dynamic evidence. We describe the methodological details of the rapid and living approach (data extraction, meta-analysis, Evidence to Decision framework, and recommendation development), the challenge of resources, the challenge of scarce evidence, the challenge of rapidly changing evidence, as well as 'wins' from the Infectious Disease Society of America experience.

IMPLICATIONS

Mitigation of pandemics relies on rapid and accurate diagnosis, which is challenged by many knowledge gaps. This necessitates emerging evidence is rapidly incorporated in a living fashion with several decisional and contextual factors to ensure the best public health strategies and care for patients. This process must be systematic and transparent for developing trustworthy guidelines and should be supported by all stakeholders, including researchers, editors, publishers, professional societies, and policymakers.

摘要

背景

新冠疫情大流行之际,急需针对诊断问题做出决策,但相关证据有限、质量不高或不断变化。因此需要采用快速且实时更新的指南制定方法,并将其应用于严格的指南制定方法,如推荐评估、制定和评估分级法。

目的

描述在危机时刻可用数据有限且不完美的情况下制定快速诊断指南的过程。

资料来源

美国传染病学会 4 项新冠诊断指南的案例研究。

内容

随着全球对新冠疫情感到恐慌,有人严重怀疑在时效性至关重要的情况下,能否严格遵循指南制定流程。美国传染病学会指南小组在多位方法学家的支持下坚信,在危机时刻,遵循严格流程比以往任何时候都更为重要。专家组采用快速且实时更新的系统评价方法,并在面临稀缺且动态证据的挑战下,应用推荐评估、制定和评估分级法制定了 4 项诊断指南。我们描述了快速且实时方法(数据提取、荟萃分析、证据决策框架和推荐意见制定)的方法学细节、资源挑战、证据稀缺挑战、证据快速变化的挑战,以及美国传染病学会经验中的“成功之处”。

意义

大流行的缓解依赖于快速准确的诊断,而这受到许多知识空白的挑战。这就需要以实时方式迅速纳入新兴证据,并结合多个决策和背景因素,以确保采取最佳公共卫生策略并为患者提供最佳护理。这一过程必须是系统的、透明的,以便制定值得信赖的指南,并应得到所有利益相关者的支持,包括研究人员、编辑、出版商、专业协会和政策制定者。

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