What is the impact of over-reading quality review on spirometry in clinical trials?

Tuesday, November 1st, 2022

It has become best practice to review the quality of spirometry data, testing feedback, and overall quality of clinical trials spirometry data.

 A study by Mottram et al. identified that an average of 12.2% of test sessions had a change to the original decision by the testing site related to manoeuvre acceptability. This result was calculated from the prevalence of changes made to a spirometry test session by over-readers (OR) in three asthma clinical trials. The data was analysed to determine the number of test sessions where a manoeuvre was either accepted or rejected by the OR, and highlights the importance of quality control for spirometry data.

Read the full report from Mottram et al.

Vitalograph provides over-reading (data QA) services for all key endpoint data collected by our systems, including spirometry, DLco, respiratory muscle strength assessment, lung volumes and ECG.