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Watch the baseline!

Posted Mar 09 2010 2:55am
Here is what you should watch out in the Pagoclone Phase IIb results: the baseline. I claim the baseline results will have a significant impact any outcome study. Why?

The Phase IIb is a random contol trial with participants randomly and blindly assigned to a group. One of the random group is the placebo group. They have been given an empty pill for 9 months (I believe), and can be considered the baseline. We should expect a baseline effect, i.e. the placebo effect, in the short term. The question is what happens after 9 months with the baseline. Is it back to zero or not? What are the implications?

If baseline after 9 months is zero
1) no placebo effect after 9 months and the placebo is only in the short term.

AND



2) no measurement bias in the sense that repeated measurement leads to increased fluency due to adaptation to measurement environment.


If baseline is significantly non-zero i.e. increased fluency
1) placebo effect after 9 months. (I find this unbelievable. What does this say about stuttering?)

AND / OR

2) MEASUREMENT BIAS THAT MUST AFFECT ALL OUTCOME STUDIES. We need to reduce the outcomes by this measurement bias effect.
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