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According to the most recent National Institutes of Health Consensus Statement (1998), “attention deficit hyperactivity disorder is the most commonly diagnosed childhood behavioral disorder.” Classification of hyperactivity and defects in attention emerged in the 1960's as Minimal Brain Dysfunction and Hyperkinetic Syndrome, and has continued to evolve over time.


Figure 1 details the results of our literature searches. Overall, we identified a total of 4269 citations from searching electronic databases, reviews of reference lists, pharmaceutical manufacturer dossier submissions, peer review, and public comment. Of these, 607 were identified in the most recent update. By applying the eligibility and exclusion criteria to titles and abstracts of all identified citations, we obtained full-text copies of 1028 citations, 129 from Update 4. After re-applying the criteria for inclusion, we ultimately included 404 publications, 60 from Update 4. Dossiers were submitted by 5 pharmaceutical manufacturers for the original review: Eli Lilly (atomoxetine HCl), McNeil (methylphenidate OROS), Novartis (methylphenidate HCl, Ritalin LA®), Cephalon (modafinil), and Shire US (mixed amphetamine salts, mixed amphetamine salts XR). Additional dossiers were submitted for updates of this report as follows: Update 1, Eli Lilly (atomoxetine HCl) and McNeil (methylphenidate HCl, Concerta®); Update 2, Shire US (lisdexamfetamine dimesylate), McNeil (methylphenidate OROS), and Eli Lilly (atomoxetine HCl); Update 3, Eli Lilly (atomoxetine HCl), Shire US (lisdexamfetamine dimesylate and transdermal methylphenidate), and McNeil (methylphenidate OROS); and Update 4: Shire US, Inc (guanfacine and lisdexamfetamine), UCB, Inc, (methylphenidate CD), Shionogi Inc (clonidine), and Ortho-McNeil Janssen Scientific Affairs, LLC (methylphenidate OROS). A list of excluded studies is reported in Appendix F.


The results of this review are summarized in Table 17, below. As with other types of research, it is important to recognize the limitations of this systematic review. These can be divided into those relating to generalizability of the results and those relating to methodology within the scope of this review. The generalizability of the results is limited by the scope of the key questions and inclusion criteria, and the generalizability of the studies included. The great majority of studies included narrowly or poorly defined patient populations who met strict criteria for case definition, had few comorbidities, and used few or no concomitant medications. One concern about this group of studies is the variation in diagnostic criteria, particularly comparing studies conducted recently to those conducted in previous decades. Another concern is the handling of subtypes of ADHD in these studies. While many studies identify the proportions of patients diagnosed with various subtypes, stratification or analysis of the results based on these is lacking. Similarly, common comorbid conditions are not well addressed by the studies. In large part, the failure to address either subtypes or comorbidities may be due to small sample sizes involved in most studies, but these are serious shortcomings that should not be ignored. The failure of these studies to assess the effect of prior medication exposure or concurrent treatment with other psychoactive medications on outcomes is another serious issue, particularly when comparing older studies where very few patients had prior exposure to newer studies where large proportions did have exposure. Minorities and the most seriously ill patients were underrepresented.

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