title: Generalizability of findings from efficacy trials for chronic depression: an analysis of eligibility criteria.
abstract: OBJECTIVE
  Concerns have been raised that the rigorous eligibility criteria used to select patients for randomized controlled trials (RCTs) limit the generalizability of trial findings. The objectives of this study were to identify commonly used eligibility criteria in RCTs for chronic depression, to examine whether these criteria are met by patients with chronic depression who are in routine care, and to identify differences between patients who would and would not meet RCT criteria.
  
  
  METHODS
  Thirteen eligibility criteria were extracted from eight RCTs of combined psychotherapeutic and pharmacological interventions for patients with chronic depression. These criteria were then applied to a sample of patients with chronic depression receiving care in one of ten German hospitals (N=231). Demographic, clinical, and treatment characteristics of those who met the RCT criteria and those who did not were compared in univariate and multivariate analyses.
  
  
  RESULTS
  Only 25% of the 231 inpatients met all RCT eligibility criteria. Patients were ineligible mainly because of suicide risk, low severity of depression at admission, and concurrent psychiatric or somatic disorders. No statistically significant differences were found between those who met the criteria and those who did not in demographic characteristics, length of inpatient stay, treatment outcome, and efficacy of certain antidepressants, except that slightly more patients meeting RCT criteria received selective serotonin reuptake inhibitors.
  
  
  CONCLUSIONS
  Findings suggest that the generalizability of RCT findings to routine health care is less limited than frequently supposed.
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Alessa
authors.initials: A
authors.lastname: von Wolff
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Malte
authors.initials: M
authors.lastname: Jansen
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Lars P
authors.initials: LP
authors.lastname: Hölzel
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Annika
authors.initials: A
authors.lastname: Westphal
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Härter
authors.affiliation: Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.
authors.forename: Levente
authors.initials: L
authors.lastname: Kriston
mesh_terms: D000328:Adult; D002908:Chronic Disease; D003866:Depressive Disorder / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000592:standards*