世界卫生组织发布关于新型结核病诊断方法证据生成指南
正文 · 中文译文
世界卫生组织（WHO）今日首次发布了关于新型结核病诊断技术证据生成（GEG）的指南。该文件是WHO证据生成指南系列的第三份文件，前两份分别针对结核病治疗新方案和结核病预防性治疗。该指南为研究人员、开发者、资助方及其他利益相关方提供关于如何生成证据的指导，以最优方式为WHO关于新型结核病诊断检测、样本类型和检测策略的指南制定提供信息。 “强有力的证据是WHO高质量建议的基础。本指南为研究人员、开发者和资助方提供了清晰的路线图，以生成WHO在创新性结核病检测、样本类型和检测策略方面所需的证据，从而使更好的诊断技术更快地惠及更多需要的人群，”HIV、结核病、肝炎和性传播感染司司长Tereza Kasaeva表示。 该指南概述了为WHO建议提供最强证据基础的关键方法论路径。关键信息涵盖诊断准确性研究设计、受试者选择标准、样本量和报告等方面，以及如何生成关于对人群重要的健康结局、价值观、成本效益、公平性、可接受性和可行性的证据。 本指南还包含一个新的分析框架，该框架描绘了诊断工具在临床路径中的作用，并将该图谱与研究设计、人群、方法和结果报告的关键考量联系起来。这将使那些旨在为政策作出贡献的人员能够设计和报告研究，从而最大限度地发挥其作用。 本指南文件解决了一个关键需求。为新型结核病诊断工具生成的证据往往不充分或不完整：许多研究存在方法学局限性，排除了可能从干预措施中获益最多的弱势人群，仅侧重于检测准确性，或很少提供关于可行性、可接受性、公平性或成本等其他相关因素的信息。研究结果报告不完整或不一致，导致难以进行综合。这些挑战的原因是可以解决的，但并非所有利益攸关方都一直充分理解这些原因。 与世界卫生组织关于结核病诊断和耐药检测的目标产品概况相结合，本新指南为推进诊断创新和将科学证据转化为有效的政策与实践提供了关键基础。通过提高所生成证据的质量、相关性和完整性，本指南将有助于为世界卫生组织的建议提供有力依据，支持新诊断技术的更快采纳，并加速其在各国的推广使用。
正文 · 英文原文
The World Health Organization (WHO) has published today, for the first time, Guidance on evidence generation (GEG) for new tuberculosis diagnostics. This document is the third in WHO’s series of guidance on evidence generation documents, following the GEG for new regimens for tuberculosis treatment and on tuberculosis preventive treatment. The guidance informs researchers, developers, funders and other stakeholders about how evidence should be generated to optimally inform WHO guideline development on new TB diagnostic tests, sample types and testing strategies. “Robust evidence is the foundation of strong WHO recommendations. This guidance gives researchers, developers and funders a clear road map for generating the evidence WHO needs on innovative tuberculosis tests, sample types and testing strategies, so that better diagnostics reach more people who need them, faster,” said Tereza Kasaeva, Director, Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections. The guidance outlines key methodological approaches to provide the strongest evidence base for WHO recommendations. The key messages cover areas such as diagnostic accuracy study design, participant selection criteria, sample size and reporting, as well as how to generate evidence on people-important health outcomes, values, cost–effectiveness, equity, acceptability and feasibility. The guidance also includes a new analytical framework that maps the role of a diagnostic across the clinical pathway and links that map to key considerations for study design, population, methods and result reporting. This would enable those who aim to contribute to the policy to design and report studies in a way that maximizes their potential to do so. This guidance document addresses a critical need. Evidence generated for new TB diagnostics has often been insufficient or incomplete: many studies have had methodological limitations, excluded vulnerable populations that could benefit most from the intervention, focused solely on test accuracy, or provided little information on other relevant factors such as feasibility, acceptability, equity or cost. Study results have been reported incompletely or inconsistently, making them difficult to synthesize. The reasons for these challenges are addressable but have not always been well understood by all stakeholders. Together with WHO’s target product profiles for tuberculosis diagnosis and detection of drug resistance, this new guidance provides a critical foundation for advancing diagnostic innovation and translating scientific evidence into effective policies and practice. By strengthening the quality, relevance and completeness of evidence generated, it will help inform robust WHO recommendations, support faster adoption of new diagnostic technologies and accelerate their uptake in countries.