title: Protocol for validating cardiovascular and cerebrovascular ICD-9-CM codes in healthcare administrative databases: the Umbria Data Value Project.
abstract: Administrative healthcare databases can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions and use of healthcare resources, thus providing answers to a wide spectrum of research questions. However, a crucial issue is the reliability of information gathered. Aim of this protocol is to validate International Classification of Diseases, 9th Revision-Clinical Modification (ICD-9-CM) codes for major cardiovascular diseases, including acute myocardial infarction (AMI), heart failure (HF), atrial fibrillation (AF) and stroke.
  
  
  
  Data from the centralised administrative database of the entire Umbria Region (910 000 residents, located in Central Italy) will be considered. Patients with a first hospital discharge for AMI, HF, AF or stroke, between 2012 and 2014, will be identified in the administrative database using the following groups of ICD-9-CM codes located in primary position: (1) 410.x for AMI; (2) 427.31 for AF; (3) 428 for HF; (4) 433.x1, 434 (excluding 434.x0), 436 for ischaemic stroke, 430 and 431 for haemorrhagic stroke (subarachnoid haemorrhage and intracerebral haemorrhage). A random sample of cases, and of non-cases, will be selected, and the corresponding medical charts retrieved and reviewed for validation by pairs of trained, independent reviewers. For each condition considered, case adjudication of disease will be based on symptoms, laboratory and diagnostic tests, as available in medical charts. Divergences will be resolved by consensus. Sensitivity and specificity with 95% CIs will be calculated.
  
  
  
  Research protocol has been granted approval by the Regional Ethics Committee. Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.
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: Iosief
authors.identifier: 0000-0002-5440-775X
authors.initials: I
authors.lastname: Abraha
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Orso
authors.affiliation: Division of Cardiology, Santa Maria della Misericordia Hospital, University of Perugia School of Medicine, Perugia, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Mengoni
authors.affiliation: Division of Cardiology, Santa Maria della Misericordia Hospital, University of Perugia School of Medicine, Perugia, Italy.
authors.forename: Maria Francesca
authors.initials: MF
authors.lastname: Cerasa
authors.affiliation: Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Eusebi
authors.affiliation: Division of Cardiology, Santa Maria della Misericordia Hospital, 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: D000293:Adolescent; D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000628:therapy*; D002561:Cerebrovascular Disorders / Q000628:therapy*; D059019:Clinical Coding / Q000592:standards*; D003625:Data Collection / Q000592:standards; D016208:Databases, Factual / Q000600:supply & distribution*; D003695:Delivery of Health Care / Q000458:organization & administration; D006801:Humans; D007558:Italy; D008875:Middle Aged; D012107:Research Design; D055815:Young Adult
keywords: Atrial fibrillation; Validation; administrative database