Patient safety classifications, taxonomies and ontologies: A systematic review on development and evaluation methodologies

Introduction: Patient safety classifications/ontologies enable patient safety information systems to receive and analyze patient safety data to improve patient safety. Patient safety classifications/ontologies have been developed and evaluated using a variety of methods. The purpose of this review was to discuss and analyze the methodologies for developing and evaluating patient safety classifications/ontologies. Methods: Studies that developed or evaluated patient safety classifications, terminologies, taxonomies, or ontologies were searched through Google Scholar, Google search engines, National Center for Biomedical Ontology (NCBO) BioPortal, Open Biological and Biomedical Ontology (OBO) Foundry and World Health Organization (WHO) websites and Scopus, Web of Science, PubMed, and Science Direct. We updated our search on 30 February 2021 and included all studies published until the end of 2020. Studies that developed or evaluated classifications only for patient safety and provided information on how they were developed or evaluated were included. Systems with covered patient safety terms (such as ICD-10) but are not specifically developed for patient safety were excluded. The quality and the risk of bias of studies were not assessed because all methodologies and criteria were intended to be covered. In addition, we analyzed the data through descriptive narrative synthesis and compared and classified the development and evaluation methods and evaluation criteria according to available development and evaluation approaches for biomedical ontologies. Results: We identified 84 articles that met all of the inclusion criteria, resulting in 70 classifications/ontologies, nine of which were for the general medical domain. The most papers were published in 2010 and 2011, with 8 and 7 papers, respectively. The United States (50) and Australia (23) have the most studies. The most commonly used methods for developing classifications/ontologies included the use of existing systems (for expanding or mapping) (44) and qualitative analysis of event reports (39). The most common evaluation methods were coding or classifying some safety report samples (25), quantitative analysis of incidents based on the developed classification (24), and consensus among physicians (16). The most commonly applied evaluation criteria were reliability (27), content and face validity (9), comprehensiveness (6), usability (5), linguistic clarity (5), and impact (4), respectively. Conclusions: Because of the weaknesses and strengths of the development/evaluation methods, it is advised that more than one method for development or evaluation, as well as evaluation criteria, should be used. To organize the processes of developing classification/ontologies, well-established approaches such as Methontology are recommended. The most prevalent evaluation methods applied in this domain are well fitted to the biomedical ontology evaluation methods, but it is also advised to apply some evaluation approaches such as logic, rules, and Natural language processing (NLP) based in combination with other evaluation approaches. This research can assist domain researchers in developing or evaluating domain ontologies using more complete methodologies. There is also a lack of reporting consistency in the literature and same methods or criteria were reported with different terminologies.

Automated summary

This article reviews the methods for developing and evaluating patient safety classifications/ontologies. The most commonly used method for development is the use of existing systems for expansion or mapping, and the most commonly used evaluation methods involve coding or classifying safety report samples and reaching consensus among physicians. It is recommended to use multiple methods and evaluation criteria in the development and evaluation process, and well-established approaches such as Methontology are recommended for organizing the development of classifications/ontologies.