title: Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples.
abstract: The present study sought to quantify the generalizability of pharmacologic and psychotherapy clinical trial results in individuals with a DSM-IV diagnosis of posttraumatic stress disorder (PTSD) to a large representative community sample.
  
  
  
  Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of the adult US population. We applied a standard set of exclusion criteria representative of pharmacologic and psychotherapy clinical trials to all adults with a DSM-IV diagnosis of PTSD in the previous 12 months (n = 1,715) and then to a subsample of participants seeking treatment (n = 366). Our aim was to assess how many participants with PTSD would fulfill typical eligibility criteria.
  
  
  
  We found that more than 6 of 10 respondents from the overall PTSD sample and more than 7 of 10 respondents seeking treatment for PTSD would have been excluded by 1 exclusion criterion or more in a typical pharmacologic trial. In contrast, about 2 of 10 participants in the full sample and about 3 of 10 participants seeking treatment for PTSD would have been excluded in a typical psychotherapy efficacy trial.
  
  
  
  We found that psychotherapy trial results may be applied to most patients with PTSD in routine clinical practice. The designers of pharmacologic clinical trials should carefully consider the trade-offs between the application of each exclusion criterion and its impact on representativeness. Specification a priori of the goals of the study, better justification for each exclusion criterion, and estimation of the proportion of individuals ineligible for the trial would assist study design. Developing integrated forms of pharmacotherapy and psychotherapy that simultaneously target commonly overlapping psychiatric disorders may yield more informative results for mental health care providers and research funding agencies.
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, 1051 Riverside Dr, Unit 69, New York, NY 10032. corsosi@nyspi.columbia.edu.|Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.
authors.forename: Silvia
authors.initials: S
authors.lastname: Franco
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.|Assistance Publique-Hôpitaux de Paris (APHP), Corentin Celton Hospital, Department of Psychiatry, Issy-les-Moulineaux; Paris Descartes University, PRES Sorbonne Paris Cité, Paris, France.|INSERM UMR 894, Psychiatry and Neurosciences Center; Paris Descartes University, PRES Sorbonne Paris Cité, Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Hoertel
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.|Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Kibby
authors.initials: K
authors.lastname: McMahon
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.
authors.forename: Shuai
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.
authors.forename: Jorge Mario
authors.initials: JM
authors.lastname: Rodríguez-Fernández
authors.affiliation: Child and Adolescent Psychiatry Department, Robert Debré Hospital, Paris, France.
authors.forename: Hugo
authors.initials: H
authors.lastname: Peyre
authors.affiliation: Assistance Publique-Hôpitaux de Paris (APHP), Corentin Celton Hospital, Department of Psychiatry, Issy-les-Moulineaux; Paris Descartes University, PRES Sorbonne Paris Cité, Paris, France.|INSERM UMR 894, Psychiatry and Neurosciences Center; Paris Descartes University, PRES Sorbonne Paris Cité, Paris, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Limosin
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute/Columbia University, New York, USA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Blanco
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D005260:Female; D006306:Health Surveys / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011613:Psychotherapy / Q000706:statistics & numerical data*; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy / Q000628:therapy*