title: Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.
abstract: Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases.
  
  
  
  MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on 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-Analyses Protocol (PRISMA-P) 2015 statement.
  
  
  
  Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases.
  
  
  
  CRD42015029204.
authors.affiliation: 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: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Iosief
authors.initials: I
authors.lastname: Abraha
authors.affiliation: Azienda USL Umbria 1, General Medicine, Perugia, Italy.
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Luchetta
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: Geriatrics and Geriatric Emergency Care, Italian National Research Center on Aging, Ancona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Cherubini
authors.affiliation: Geriatrics and Geriatric Emergency Care, Italian National Research Center on Aging, Ancona, Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Dell'Aquila
authors.affiliation: Scientific Directorate, Italian National Research Center on Aging, Ancona, Italy.
authors.forename: Carlos
authors.initials: C
authors.lastname: Chiatti
authors.affiliation: Department of Cardiology, University of Perugia School of Medicine, Perugia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ambrosio
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Montedori
mesh_terms: D059019:Clinical Coding / Q000592:standards*; D016208:Databases, Factual; D003695:Delivery of Health Care / Q000592:standards*; D019468:Disease Management; D006801:Humans; D038801:International Classification of Diseases; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis*; D012107:Research Design; D000078202:Systematic Reviews as Topic; D054928:Validation Studies as Topic; D015201:Meta-Analysis as Topic
keywords: Administrative database; COPD algorithm; Chronic pulmonary obstructive disease; Electronic Health Record; sensitivity and specificity; systematic review