Impact of 2019 ATS/ERS Spirometry Guidelines on Clinical Trials

This technical report examines the adoption of the 2019 ATS/ERS spirometry guidelines in clinical trials, focusing on its impact on site and patient burden. The report outlines the rationale for the updated guidelines, which introduced a fourth phase for determining full inflation, and presents findings from studies comparing the number of efforts required to meet acceptability criteria under the previous 2005 guidelines versus the new standards. The analysis reveals that the average number of efforts increased from 3.4 to 4.8, with significant reductions in the percentage of sessions requiring the maximum number of efforts over time. The report also details the methodology used to assess the experience of both patients and research sites in relation to the new guidelines. Results indicate a notable decrease in patient burden as experience with the guidelines increased, highlighting the importance of site learning effects. The findings contribute to understanding the implications of guideline adoption in clinical settings.