Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs.

BACKGROUND

Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, while 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.

OBJECTIVES

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 propose potential study designs at various stages of technology development.

METHODS

Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The co-chairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was co-sponsored by the American Thoracic Society and the American College of Chest Physicians.

RESULTS

Consensus was reached on 15 statements on 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.

CONCLUSIONS

This ATS/CHEST statement aims to provide a research framework that allows for greater standardization of device validations 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.