Hello All.
This is starting to look like a response to journal reviewers. Rather
than make a long list of point-by-point responses, I would like to just
state some points that might generate a paradigm shift in how we think
of outcome research.
The major point I want to make is one that everyone will agree with but
no one has thought of the consequences.
This point is that humans are sentient beings who attempt to understand
and figure out which treatment condition they are in.
After they make a judgement about this, they behave consistent with the
social demands of the
research setting and other expectation biases that are consistent with
their judgments. All the research design
guides, such as Campbell and Stanley, assume that the subject is a
passive agent in the process and does
not interact with the research design. Some of the threats to internal
validity suggests something like this but they
really need a chapter called, "How Human Cognition Screws up Research".
Imagine you could create a placebo that had the same side effects as the
medication but did not have an active
agent. Both groups would have the same side effects. You then randomly
assign the meds and
placebo and the subjects and investigators are not told who got which one.
Now, I'm a subject in the placebo condition and I start experiencing dry
mouth and constipation. I infer from this that
I am getting medication. I then endorse positive change on the Beck
Depression Scale because I want to help out
the researchers or otherwise demonstrate an expectation bias. Some
proportion of the subjects in the placebo
condition behave like they were treated on the self-report measures.
This is a scenario in which the side effects are
controlled and the result is still noise. I understand that some of you
will counter that you could inform all the subjects
that they might experience side effects. This is always done on the
consent form. However, it is commonly understood
that placebos do not cause effects and subjects will reason consistent
with this. There is also a limit to which any side
effects can be emphasized because you run the risk of actually
suggesting that subjects should experience a side effect.
It is understood that all psychotherapy outcome studies cannot be
blinded. It is so widely understood that people
don't think about its consequences any longer.
If the standard for empirical validation is one blinded study showing a
treatment effect then no study of meds or
psychotherapy meets the standard.
I think this area would be fascinating to study. Survey the subjects
and ask them which condition they thought they
were in and why.
Maybe we should only analyze the data of subjects whose beliefs were
consistent with the treatment condition they
were actually assigned to. Someone should at least analyze the relevant
groups to see if there is a difference.
If the FDA mandated that the drug companies verify the blinding, the
research reps would piss their pants. They
know they are passing off a flimflam to make millions on psychotropic meds.
Mike Williams
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