Adults and children – meaning a third US trial will be required. With new centres, new investigators, making sure everyone is trained to record coughs properly etc.
The protocol paper for the second US trial was just published. This was such a innocuous little thing it slipped by nearly completely unnoticed. But protocol papers are often published as a prelude to the study results being published.
So I would expect the second US trial results to be published shortly.
The second US trial was chasing accuracy estimates PPA and MPA estimates of 85% and 80% respectively. These were the accuracy estimates the researchers believed would establish the app as a useful tool for the aid of diagnosing respiratory disease in children.
As we know the study results failed to meet this standard for any diagnosis. But RAP thought it was worth trying to argue a case for three diagnoses. This was rejected by the FDA.
So now its down to one diagnosis - lower respiratory tract illness.
And RAP have finally twigged … doctors during a telehealth consult don’t diagnose anything. They simply triage. And so now the app (for one illness) is an aid for triaging – not diagnosing.
RAP Price at posting:
6.8¢ Sentiment: None Disclosure: Not Held
