Clinical Trial Issues

Despite the use of stimulant medications in the treatment of hyperkinetic children over 60 years ago, and the common observation that stimulant treatment for children with ADHD is arguably the best treatment, there are relatively few studies systematically investigating efficacy in patients with ADHD. Other issues in evaluating the efficacy of treatments are a lack of understanding as to how improvement on laboratory measures reflects the real-life impact of medication.8 In fact, a study suggests that there is a minimal agreement between laboratory and natural settings, especially when investigating drug effects.75 Finally, there is evidence to suggest that the laboratory paradigms do not truly reflect the school setting in which ADHD patients are involved, which includes test-taking and note-taking.8

Among the difficulties in clinical ADHD research arethe diagnostic criteria, and concerns about the validity of existing diagnostic criteria.6 Much of the focus on adult diagnostic criteria stems from longitudinal studies of ADHD children, illustrating the perseverance of symptoms into adulthood. As an understanding of the disorder has advanced, it is clear that many of these studies excluded children that would today meet the DSM-IV criteria for ADHD, and in particular have ignored the inattentive subtype. Thus, there are really no validation studies of ADHD diagnostic criteria in adults.6 In conducting clinical trials diagnostic criteria are key for patient selection, and if the criteria are inaccurate it is difficult to assess the efficacy of novel therapeutics accurately.

The American Academy of Pediatrics (AAP) has developed a practice guideline for the diagnosis of ADHD among children from 6 to 12 years of age who are evaluated by primary care clinicians.3 The AAP has also developed a treatment guideline for school-aged children with ADHD.76 The significant components of the diagnostic guideline include: (1) the use of explicit criteria for the diagnosis, using DSM-IV criteria; (2) the importance of obtaining information about the child's symptoms in more than one setting (especially from schools); and (3) the search for coexisting conditions that may make the diagnosis more difficult or complicate treatment planning. While this guideline is intended to provide a framework for primary care clinicians, rather than the sole diagnostic criteria, it is clear that this type of approach is needed in the field. It is further evident that a similar approach is needed toward the diagnosis of adolescents and adults with ADHD, as symptoms are likely different between children, adolescents, and adults.

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