Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol

Authors : Joseph M Rimland, Iosief Abraha, Maria Laura Luchetta, Francesco Cozzolino, Massimiliano Orso, Antonio Cherubini, Giuseppina Dell'Aquila, Carlos Chiatti, Giuseppe Ambrosio, Alessandro Montedori

Abstract

Introduction

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.

Methods and analysis

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 and dissemination

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.

Trial registration number CRD42015029204.

Citation: Joseph M Rimland, Iosief Abraha, Maria Laura Luchetta, Francesco Cozzolino, Massimiliano Orso Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol
BMJ Open 2016;6:e011777 doi:10.1136/bmjopen-2016-011777

Received: 3 March 2016 Revised: 10 May 2016 Accepted: 11 May 2016 Published: 1 June 2016

Copyright: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Contributors

IA, JMR and MLL conceived the study. JMR, IA, MLL, FC, MO, AC, GD, CC, GA and AM were responsible for designing the protocol. MLL, JMR and IA drafted the protocol manuscript. JMR, IA, FC and MO developed the search strategy. JMR, IA, MLL, FC, MO, AC, GD, CC, GA and AM critically revised the successive versions of the manuscript and approved the final version. IA acts as guarantor.

Competing interests None declared.