title: Estimation of patient accrual rates in clinical trials based on routine data from hospital information systems.
abstract: BACKGROUND
  Delayed patient recruitment is a common problem in clinical trials. According to the literature, only about a third of medical research studies recruit their planned number of patients within the time originally specified.
  
  
  OBJECTIVE
  To provide a method to estimate patient accrual rates in clinical trials based on routine data from hospital information systems (HIS).
  
  
  METHODS
  Based on inclusion and exclusion criteria for each trial, a specific HIS report is generated to list potential trial subjects. Because not all information relevant for assessment of patient eligibility is available as coded HIS items, a sample of this patient list is reviewed manually by study physicians. Proportions of matching and non-matching patients are analyzed with a Chi-squared test. An estimation formula for patient accrual rate is derived from this data.
  
  
  RESULTS
  The method is demonstrated with two datasets from cardiology and oncology. HIS reports should account for previous disease episodes and eliminate duplicate persons.
  
  
  CONCLUSIONS
  HIS data in combination with manual chart review can be applied to estimate patient recruitment for clinical trials.
authors.affiliation: Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany. dugas@uni-muenster.de
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
authors.forename: Susanne
authors.initials: S
authors.lastname: Amler
authors.forename: Matthias
authors.initials: M
authors.lastname: Lange
authors.forename: Joachim
authors.initials: J
authors.lastname: Gerss
authors.forename: Bernhard
authors.initials: B
authors.lastname: Breil
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Köpcke
mesh_terms: D002986:Clinical Trials as Topic; D006751:Hospital Information Systems; D006801:Humans; D018579:Patient Selection