Friday, February 19, 2010

The difficulty of Soft Outcomes

There is currently a movement to ban combination medications with acetaminophen as an ingredient. The reasoning behind this appears to be due to the potential for liver damage caused by excessive doses of the medication. The estimate of 458 deaths per year seems like a lot, until you realize the denominator is not specified (it won't be the entire US population but it might be 10's of millions).

The other issue, and the one that is interesting to an epidemiologist, is the soft nature of the competing risk. The alternatives to acetaminophen is either a narcotic or a non-steroidal anti-inflammatory drug like ibuprofen. Both of these drugs have downsides (addiction, gastrointestinal bleeding) as well.

But the real alternative is less pain control. And that is hard to judge because it is a soft outcome. How much suffering is worth a life? Lives are easy to count but massively reduced quality of life is much, much trickier. But I think it is important to realize that a hard to measure outcome can still have a known and measurable effect on real people.

So I guess what I want to see a clear articulation of what are the alternatives to the current approach to publishing in hot fields.

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