Effectiveness Outcomes in Attention-Deficit/Hyperactivity Disorder
Margaret D. Weiss, Kenneth Gadow, and Michael B. Wasdell
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Attention-deficit/hyperactivity disorder (ADHD) is common, chronic, and associated with significant
functional impairment. It is highly treatable. It is therefore not only a major public health problem
but also one that provides a unique opportunity in medicine to make a significant difference. This
article will discuss the methodology needed to demonstrate empirically the impact of treatment on
actual burden of illness in practice. Where efficacy studies demonstrate whether a treatment can work,
effectiveness studies tell us whether they actually do work. Clinical trials exclude incompetent, noncompliant,
and seriously comorbid patients, so that the information obtained from these trials tells us
the most about the patients we see the least. Small differences in effect size in pivotal trials of efficacy
have become a key variable for rating treatments as first line or second line, without consideration of
effectiveness variables such as comorbidity, difficulty with appetite or sleep, patient preference, capacity
for compliance, timing of functional impairment, and substance use. These effectiveness variables
are less well studied, but critical to clinical decision making. In reality, fewer than 10% of our
patients comply with and persist with treatment. To learn more about why patients are discontinuing
treatment, we need to explore measures of effectiveness empirically. Effectiveness studies are also
important to provide regulatory bodies with the data they need to balance the risk of treatment with
the risk of failing to treat. Practical clinical trials and naturalistic follow-up studies will allow us to
evaluate the true clinical impact of short-term efficacy trials.
J Clin Psychiatry 2006;67(suppl 8):38-45
© Copyright 2006 Physicians Postgraduate Press, Inc.
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