title: Are participants in pharmacological and psychotherapy treatment trials for social anxiety disorder representative of patients in real-life settings?
abstract: BACKGROUND
  The present study sought to quantify the generalizability of clinical trial results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of social anxiety disorder (SAD) to a large representative community sample.
  
  
  METHODS
  Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, a large nationally representative sample of 34,653 adults from the US population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to all adults with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of SAD (n = 965) in the past 12 months and then to a subsample of participants seeking treatment (n = 363). Our aim was to assess how many participants with SAD would fulfill typical eligibility criteria.
  
  
  RESULTS
  We found that more than 7 of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than 6 of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least 1 criterion. In addition, more than 8 of 10 respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial. Having a current major depression explained a large proportion of ineligibility.
  
  
  CONCLUSIONS
  Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use. For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.
authors.affiliation: From the *Service de Psychiatrie, Assistance Publique-Hôpitaux de Paris, Hôpital Corentin-Celton; †Université Paris Descartes, PRES Sorbonne Paris Cité; ‡INSERM UMR 894, Centre Psychiatrie et Neurosciences; §Service Hospitalo-Universitaire, Hôpital Sainte-Anne, Paris; ∥Groupe Henri Mondor-Albert Chenevier, Pôle de Psychiatrie, Assistance Publique-Hôpitaux de Paris, Créteil; ¶Service de Pédopsychiatrie, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré; and #Laboratoire de Sciences Cognitives et Psycholinguistique, Ecole Normale Supérieure, CNRS, EHESS, Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Hoertel
authors.forename: Pierre
authors.initials: P
authors.lastname: de Maricourt
authors.forename: Julien
authors.initials: J
authors.lastname: Katz
authors.forename: Raphaël
authors.initials: R
authors.lastname: Doukhan
authors.forename: Pierre
authors.initials: P
authors.lastname: Lavaud
authors.forename: Hugo
authors.initials: H
authors.lastname: Peyre
authors.forename: Frédéric
authors.initials: F
authors.lastname: Limosin
mesh_terms: D000328:Adult; D001008:Anxiety Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006306:Health Surveys / Q000379:methods*; D006801:Humans; D008297:Male; D018579:Patient Selection; D010698:Phobic Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D011613:Psychotherapy / Q000379:methods* / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D016896:Treatment Outcome