Am J Respir Crit Care Med. 2024 Mar 15;209(6):634-646. doi: 10.1164/rccm.202401-0192ST.
Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings.
在过去的二十年中，针对肺外周的高级诊断性支气管镜技术得到了快速发展，而支持引入创新技术的证据则存在差异且不足。一个主要的差距是诊断率的报告存在差异，此外还缺乏比较研究。 为了制定一个研究框架，以标准化评估用于外周肺病变的高级诊断性支气管镜技术。具体来说，我们旨在就诊断率的稳健定义达成共识，并提出在技术发展的各个阶段进行潜在研究设计的建议。 小组成员因其多样化的专业知识而被选中。工作组会议以虚拟或混合形式进行。随后，联合主席根据修改后的 Delphi 流程制定了总结声明，并进行了投票。该声明由美国胸科学会和美国胸科医师学会共同赞助。 就诊断结果和研究设计的定义达成了 15 项共识声明。应使用严格的诊断率定义，并且应根据 STARD（诊断准确性研究报告标准）指南报告研究。临床或影像学随访可纳入参考标准定义，但不应用于根据手术遭遇计算诊断率。需要采用纳入患者报告结果的方法学稳健的比较研究来充分评估和验证针对肺外周的微创诊断技术。 这项由美国胸科学会/美国胸科医师学会发表的声明旨在提供一个研究框架，通过明确的诊断结果和稳健的研究设计，使设备验证工作更加标准化。高质量的研究，无论是由行业还是公共资助的，都可以支持随后的健康经济学分析，并指导在各种医疗保健环境中的实施决策。
