The Breathe Easy Study. Developing diagnostic tests for respiratory disease using sound measurement and machine learning techniques.

Patients with defined respiratory conditions (including Asthma, COPD, Bronchiolitis, Croup, Interstitial Lung Disease, Pneumonia, Upper and Lower Respiratory infections, Bronchiectasis, Emphysema), confirmed by expert review, will provide one series of (5-10) coughs, recorded by a smartphone for analysis and technical development of an algorithm to produce a digital diagnostic test. This procedure takes 30 seconds when the patient can provide a voluntary cough and up to 5 minutes if spontaneous. Children (who are able to cough on demand or are doing so spontaneously) and adults will be approached. This development phase will develop tests for each of the conditions examined as well as measures of severity and complications. Once the algorithms have been developed and the diagnostic tests refined to appropriate accuracy levels [Predicted Positive and Negative Percent Agreement with expert consenus clinical adjudication to be greater than 80% using a total (n=number needed to have lower limit 95% CI above agreed regulatory body requirements] enrolled cohort with mixed respiratory diseases) further subjects will be enrolled for formal diagnostic accuracy studies with the teams determining clinical results by expert consensus adjudication panel using all available information from clinical notes, digital diagnosis and statistical analysis being blinded from each other. The enrollment and data collection (including cough recording) will be identical to the development phase however the clinical diagnostic teams adjudication will be blinded from the App algorithm developer and the algorithms will be run by a third party. Clinical diagnosis and algorithm diagnosis will be provided separately to a statistical group from Curtin University for analysis. Development of the diagnostic algorithms and the subsequent testing for accuracy is a continuum and ongoing process and is considered the same development program.