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

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.

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