To: george who wrote (1051 ) 1/11/1998 2:02:00 AM From: Jim Armstrong Read Replies (2) | Respond to of 1894
The problem as I understand it is twofold, there are not enough cytologists to handle the load, and there is an unacceptably high error rate on interpretation of the slides, both false negative and false positive. There are many cytologists working over the legal limit of slides on a given day, and some even working outside the lab environment to get the slides "done". Add to that the fact that most slides are clear, and the job is repetitive (and basically boring), and you have a situation where there is an overall high error rate on the slides. Because most of the slides are clear, there is a tendency to zone out and miss some features of importance as the day grows older. The more tired the cytologist, the greater the chance for error. And if the cytologist is one of those cheating, doing 100, 200, or maybe even 300 more slides than the legal daily limit, the chance of error is even larger. The automation is tireless. Plus, its function is only to weed out the unambiguously clear slides (and there will be a lot of them). The ThinPrep process greatly improves the clarity of the slides, improving both machine and cytologist evaluations. The effect of the automated primary screening is to enrich the slide complement that will be evaluated by the cytologists. The result is a win-win. The total number of slides to be cytologist-evaluated is smaller. That brings the number of slides that need to be evaluated by cytologists more in line with the number of cytologists available to read them (legally). In addition, there is more to find in the residual slide population, so the risk of cytologist zoning-out is reduced, improving the error rate. This is truly very important, because the error rate has been pretty high, high enough that you'd really want it done twice to improve the odds of a correct reading. So it gets down to whether the machine's concept and algorithms are demonstratably capable of screening out a relatively minority of clearly clear slides with high accuracy. That's clearly vital (in every sense), and that's what the approval of the machine for primary screening is about. If the data truly proves that the machine is highly accurate in this primary screening task (the question before the FDA), then it will save lives because it will reduce errors, both false negatives (killers), and false positives (a source of anxiety at the very least, and potentially worse). I think I could live with that. I think women could live more securely with this additional screening asset. It represents a powerful asset for relieving part of the load of an overworked cytologist population, and greatly reducing existing error rates. It's now up to the FDA to see if the primary screener accuracy case is made. JimA