title: Validity of peptic ulcer disease and upper gastrointestinal bleeding diagnoses in administrative databases: a systematic review protocol.
abstract: Administrative healthcare databases are useful to investigate the epidemiology, health outcomes, quality indicators and healthcare utilisation concerning peptic ulcers and gastrointestinal bleeding, but the databases need to be validated in order to be a reliable source for research. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases, 9th Revision and 10th version (ICD-9 and ICD-10) codes for peptic ulcer and upper gastrointestinal bleeding diagnoses.
  
  
  
  MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched, using appropriate search strategies. We will include validation studies that used administrative data to identify peptic ulcer disease and upper gastrointestinal bleeding diagnoses or studies that evaluated the validity of peptic ulcer and upper gastrointestinal bleeding codes in administrative data. The following inclusion criteria will be used: (a) the presence of a reference standard case definition for the diseases of interest; (b) the presence of at least one test measure (eg, sensitivity, etc) and (c) the use of an administrative database as a source of data. Pairs of reviewers will independently abstract data using standardised forms and will evaluate quality using the checklist of the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) 2015 statement.
  
  
  
  Ethics approval is not required given that this is a protocol for a systematic review. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide for researchers validating administrative healthcare databases to determine appropriate case definitions for peptic ulcer disease and upper gastrointestinal bleeding, as well as to perform outcome research using administrative healthcare databases of these conditions.
  
  
  
  CRD42015029216.
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Montedori
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Iosief
authors.initials: I
authors.lastname: Abraha
authors.affiliation: Scientific Directorate, Italian National Research Center on Aging, Ancona, Italy.
authors.forename: Carlos
authors.initials: C
authors.lastname: Chiatti
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cozzolino
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Orso
authors.affiliation: Department of General Medicine, Azienda USL Umbria 1, Perugia, Italy.
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Luchetta
authors.affiliation: Department of Geriatrics and Geriatric Emergency Care, Italian National Research Center on Aging, Ancona, Italy.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Rimland
authors.affiliation: Department of Cardiology, University of Perugia School of Medicine, Perugia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ambrosio
mesh_terms: D057189:Checklist; D000068598:Data Accuracy; D016208:Databases, Factual; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis*; D006801:Humans; D038801:International Classification of Diseases; D010437:Peptic Ulcer / Q000175:diagnosis*; D012015:Reference Standards; D012107:Research Design; D000078202:Systematic Reviews as Topic; D054928:Validation Studies as Topic
keywords: accuracy; administrative database; gastrointestinal haemorrhage; peptic ulcer; sensitivity; validity