The Breathe Easy study: Mask On, Mask Off (MoMo) sub study for diagnosis of respiratory illness

Patients over 12 years of age with defined respiratory conditions (including Asthma, COPD, Pneumonia, Upper and Lower Respiratory infections), confirmed by expert review, will provide two series of (5) coughs, recorded on a smartphone: one series with a standard surgical mask on and one without a mask, for analysis. This procedure takes 30 seconds when the patient can provide a voluntary cough and up to 5 minutes if spontaneous. The procedure will be undertaken by a trained research nurse on one occasion only. The recordings will be analysed by an algorithm, housed on the smartphone that gives a point of care diagnosis. The application delivers a dichotomous result (“DISEASE PRESENT” or “DISEASE ABSENT” in a coded form). Both the App and clinical diagnostic results are blinded and are derived independently of each other. Clinical diagnosis and algorithm diagnosis (coded output) will be provided separately to an independent statistician for analysis. The specialist treating team will independently arrive at all clinical diagnoses (without knowing the App output/diagnosis). Data is collected in during one encounter, without "wash out". Participants will provide 5 coughs without a mask followed by 5 coughs with a surgical mask on in that order. Study Blinding Clinical diagnoses will be determined by the clinical team and completed prior to index test analysis. The application delivers a dichotomous result (“DISEASE PRESENT” or “DISEASE ABSENT” in a coded form. Both results are blinded to each other and are conducted independently of each other. The algorithm output will be compared to the non-standard reference clinical diagnosis by an independent statistical team.