Validity of peptic ulcer disease and upper gastrointestinal bleeding diagnoses in administrative databases: a systematic review protocol | BMJ Open

Introduction

Non-variceal upper gastrointestinal bleeding (UGIB) is associated with significant morbidity and mortality. It has an incidence rate from 48 to 160 cases per 100 000 per year, and greater incidences in men and older people.1 ,2 Although UGIB and peptic ulcer bleeding are diminishing in the general population, hospitalisation rates from ulcer complications are growing in older populations.3 The most frequent risk factors for non-variceal UGIB comprise Helicobacter pylori infection, and the use of NSAIDs/aspirin, and other antiplatelet and anticoagulant medications. (Up to 67% of cases of UGIB are caused by peptic ulcer disease (PUD).1) Both H. pylori infection and NSAIDs are independent risk factors for PUD and UGIB.4

Health authorities generate and maintain large administrative healthcare databases that typically contain information and data regarding health resource utilisation (eg, hospitalisations, outpatient care and drug prescriptions) and vital statistics.5 For research, one of the advantages of administrative databases is that they passively collect data at a population level with longitudinal follow-up, making their results easily generalisable. In addition, they are considered to be cost-effective compared with primary data collection.6 ,7 The main disadvantage of these databases is that they are generated for administrative purposes, such as billing, and as a repository for patient hospital records, and not for research, hence, the diagnostic codes for specific disorders must be validated according to an accepted ‘gold standard’ reference diagnosis.8-14

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In the gastrointestinal field, administrative healthcare databases have been used to estimate the epidemiology of PUD15 and UGIB,16 to assess drug-related gastrointestinal outcomes,17-19 to conduct active drug surveillance20 and health service quality evaluation.21 ,22

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Current administrative databases use the International Classification of Diseases, 9th Revision (ICD-9) or 10th Revision (ICD-10) codes for PUD and UGIB. Validation of diagnostic codes is of particular interest to national healthcare authorities to perform surveillance of medical products and epidemiological studies of diseases. For example, the US Food and Drug Administration has sponsored a pilot project, Mini-Sentinel, with the aim of performing active surveillance to improve safety signals that emerge for newly released medical products. To implement this work, the programme needed to identify algorithms used to detect a number of health outcomes of interest using administrative data sources and identify the performance characteristics of these algorithms.23 The Mini-Sentinel programme produced a series of systematic reviews of validated methods and case definitions, to identify various diseases or health outcomes in administrative data, including cardiocerebrovascular diseases24-28 and other conditions.29-33 For the purpose of establishing best practices in the use of administrative data for health research and surveillance, the Canadian Rheumatology Administrative Data Network conducted a systematic review of studies reporting on the validity of diagnostic codes to identify cardiovascular diseases.34-36 Likewise, the Regional Health Authority of Umbria, is interested in the validity of administrative data diagnoses and in identifying case definitions and the algorithms developed for different diseases, including cancer (breast, lung and colorectal),9 ,11 chronic obstructive pulmonary disease13 and non-variceal UGIB, which is the focus of this article.

In the medical literature, at the present time, the validity and performance of algorithms employing diagnostic codes for PUD and UGIB have not been systematically investigated. With the current protocol, we plan to systematically evaluate validation studies of diagnostic codes corresponding to these gastrointestinal conditions in administrative databases.

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