title: A European inventory of data elements for patient recruitment.
abstract: BACKGROUND
  In the last few years much work has been conducted in creating systems that support clinical trials for example by utilizing electronic health record data. One of these endeavours is the Electronic Health Record for Clinical Research project (EHR4CR). An unanswered question that the project aims to answer is which data elements are most commonly required for patient recruitment.
  
  
  METHODS
  Free text eligibility criteria from 40 studies were analysed, simplified and elements were extracted. These elements where then added to an existing inventory of data elements for protocol feasibility.
  
  
  RESULTS
  We simplified and extracted data elements from 40 trials, which resulted in 1170 elements. From these we created an inventory of 150 unique data elements relevant for patient identification and recruitment with definitions and referenced codes to standard terminologies.
  
  
  CONCLUSIONS
  Our list was created with expertise from pharmaceutical companies. Comparisons with related work shows that identified concepts are similar. An evaluation of the availability of these elements in electronic health records is still ongoing. Hospitals that want to engage in re-use of electronic health record data for research purposes, for example by joining networks like EHR4CR, can now prioritize their effort based on this list.
authors.affiliation: Institute of Medical Informatics, University Münster, Albert-Schweitzer-Campus 1/A11, D-48149 Münster, Germany.
authors.forename: Justin
authors.initials: J
authors.lastname: Doods
authors.affiliation: Sanofi R&D - Feasibility Management Department - 1 rue Pierre Brossolette - 91385 CHILLY MAZARIN, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Lafitte
authors.affiliation: Sanofi R&D - Feasibility Management Department - 1 rue Pierre Brossolette - 91385 CHILLY MAZARIN, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Ulliac-Sagnes
authors.affiliation: Global Strategy and Development Advisor, Global Data Sciences and Analytics, Bayer Vital GmbH, BV-PH-MED-GDSA, 51368 Leverkusen, K 9, 413, Germany.
authors.forename: Johan
authors.initials: J
authors.lastname: Proeve
authors.affiliation: Novartis Pharma AG, CH-4002 Basel, Switzerland.
authors.forename: Florence
authors.initials: F
authors.lastname: Botteri
authors.affiliation: Real World Data Science, F.Hoffmann-La Roche Ltd, CH-4070 Basel, Switzerland.
authors.forename: Robert
authors.initials: R
authors.lastname: Walls
authors.affiliation: Projects, Clinical Platforms & Sciences - Metabolic Pathways and Cardiovascular, GlaxoSmithKline, 1-3 Iron Bridge Road, Stockley ParkUxbridge, UK UB11 1BT.
authors.forename: Andy
authors.initials: A
authors.lastname: Sykes
authors.affiliation: Institute of Medical Informatics, University Münster, Albert-Schweitzer-Campus 1/A11, D-48149 Münster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
authors.affiliation: Institute of Medical Informatics, University Münster, Albert-Schweitzer-Campus 1/A11, D-48149 Münster, Germany.
authors.forename: Fleur
authors.initials: F
authors.lastname: Fritz
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D057225:Data Mining / Q000379:methods*; D016208:Databases, Factual; D057286:Electronic Health Records / Q000145:classification* / Q000706:statistics & numerical data*; D004608:Eligibility Determination / Q000379:methods*; D005060:Europe; D018579:Patient Selection; D009626:Terminology as Topic