3 ms·

I wonder what factors made this decision possible? I love the idea of automated diagnosis but the performance rates are 87% true positive and 90% true negative

I wonder what factors made this decision possible? I love the idea of automated diagnosis but the performance rates are 87% true positive and 90% true negative in the article. Seems a bit low. Maybe people aren't getting diagnosed at very high rates? That would be a reasonable justification for deployment with somewhat less than perfect accuracy. Anyone have any insight?

jforman 9y ago
For new stuff, FDA performs a holistic cost/benefit analysis. In this case, they might weigh: * How many new cases are caught by expanding access to specialist tools * What fail safes exist in current course of care — how does a false negative result in a worse outcome for a patient than if they had had no diagnostic at all * etc. The summary of their decision is public record, but not the detailed analysis.
hanklazard 9y ago
It also seems like a quick way to screen for this condition, vs the level of concern that a primary care doc might need to have before referring someone to an ophthalmologist. In other words, you could screen more people, even those that are asymptomatic (but have diabetes) and potentially catch retinal disease earlier. Even without mind-blowing sensitivity / specificity, this could preserve a lot of people’s vision.
maxerickson 9y ago
The status quo is screening at the eye doctor. This enables screening at primary care visits. People mostly go to primary care more often than the eye doctor. The medical risk is that people will forgo other screening for 12 months when given a negative result. The cost of additional screening for false positives is the other big downside (this is all the machine does, recommend a specialist visit or to rescreen in a year).
- gowld 9y ago
  > People mostly go to primary care more often than the eye doctor. Really? Standard advice is 1/yr for both.
Ensorceled 9y ago
I used to work in medical startups and twice we were approved for simply being better than standard of care. If you can show a statistically better chance of a good outcome with a small chance of significantly worse outcome, the FDA will often approve.

jforman 9y ago

For new stuff, FDA performs a holistic cost/benefit analysis. In this case, they might weigh: * How many new cases are caught by expanding access to specialist tools * What fail safes exist in current course of care — how does a false negative result in a worse outcome for a patient than if they had had no diagnostic at all * etc. The summary of their decision is public record, but not the detailed analysis.

hanklazard 9y ago

It also seems like a quick way to screen for this condition, vs the level of concern that a primary care doc might need to have before referring someone to an ophthalmologist. In other words, you could screen more people, even those that are asymptomatic (but have diabetes) and potentially catch retinal disease earlier. Even without mind-blowing sensitivity / specificity, this could preserve a lot of people’s vision.

maxerickson 9y ago

The status quo is screening at the eye doctor. This enables screening at primary care visits. People mostly go to primary care more often than the eye doctor. The medical risk is that people will forgo other screening for 12 months when given a negative result. The cost of additional screening for false positives is the other big downside (this is all the machine does, recommend a specialist visit or to rescreen in a year).

gowld 9y ago
> People mostly go to primary care more often than the eye doctor. Really? Standard advice is 1/yr for both.

Ensorceled 9y ago

I used to work in medical startups and twice we were approved for simply being better than standard of care. If you can show a statistically better chance of a good outcome with a small chance of significantly worse outcome, the FDA will often approve.