Prevalence of altering selected spirometry maneuvers in asthma clinical trials

Background: It has become best practice to include a quality review of spirometry data collected in a clinical trial (CT). The Lung Health Study1 set the standard for quality review of spirometry data, testing feedback, and overall quality of CT spirometry data. There have been several studies since that have demonstrated the quality of CT spirometry data using a review process. However, there is little understanding of the prevalence of changes made by such a review process to the original decisions made by the testing site regarding maneuver acceptability. The purpose of our study was to identify the prevalence of changes made to a spirometry test session by an overreader (OR) in three asthma clinical trials. We queried the data to ascertain the number of test sessions where a maneuver was either accepted or rejected by the OR in contary with the site’s selection. Summary: Our data demonstrates an average of 12.2% test sessions had a change to the original decision by the testing site related to maneuver acceptability. This may or may not have impacted the overall outcome of the CT data but appears to support the use of an overreading quality review process. 1. Enright PL, et al Spirometry in the lung health study: 1. methods and quality control. ARRD 1991;143:121