Ann: Positive Preliminary Results from SMARTCOUGH-C-2 Study, page-108

We will have to wait for further information from Resapp to get these results in proper perspective, but on a first reading these are deeply disappointing.

1. All the results are well below the Australian results.  By a truly shocking margin.  Just to take Asthma as an example.  Australia (95% CI) 92%-99%PPA, 88%-94%NPA.  US 64%-78%PPA, 83%-88%NPA.  The others are equally awful.
2. Our primary hope – pneumonia, which was going to revolutionise medicine and save hundreds of millions of childrens' lives – is a bust.  The result is too poor to even lodge an application with the FDA.
3. As I noted above we have to wait for more detailed information from Resapp, but given that the early indications were that protocols were followed and the collected data was of high quality it is hard to see how these results would improve on a re-test.
4. The implications for the other potential applications – and here I'm thinking about sleep apnoeia – are very profound.  What is the future for this condition if we conduct a trial in the USA and we get the same kind of differential?

For what it's worth, I did point out a couple of weeks back that the algorithms were trained to match Australian adjudication standards rather than US ones.  I also flagged in the same post that it was a concern that different adjudication teams in the US were coming up with different results that were affecting ResappDx's agreement rates, which is why the decision was made to centralise adjudication for this trial.

Not a good day.