Taxonomy development methods regarding patient safety in health sciences – A systematic review

•A new 10-phase guide was proposed for taxonomy development, reporting, and critical quality appraisal of the development.•Testing the proposed taxonomy development guide is required.•Patient safety-related taxonomies, previously used software and statistical tests in taxonomy development are provided.•Structured taxonomy development potentially increases validity and feasibility of the taxonomies. Taxonomies are needed for automated analysis of clinical data in healthcare. Few reviews of the taxonomy development methods used in health sciences are found. This systematic review aimed to describe the scope of the available taxonomies relative to patient safety, the methods used for taxonomy development, and the strengths and limitations of the methods. The purpose of this systematic review is to guide future taxonomy development projects. The CINAHL, PubMed, Scopus, and Web of Science databases were searched for studies from January 2012 to April 25, 2023. Two authors selected the studies using inclusion and exclusion criteria and critical appraisal checklists. The data were analysed inductively, and the results were reported narratively. The studies (n = 13) across healthcare concerned mainly taxonomies of adverse events and medication safety but little for specialised fields and information technology. Critical appraisal indicated inadequate reporting of the used taxonomy development methods. Ten phases of taxonomy development were identified: (1) defining purpose and (2) the theory base for development, (3) relevant data sources’ identification, (4) main terms’ identification and definitions, (5) items’ coding and pooling, (6) reliability and validity evaluation of coding and/or codes, (7) development of a hierarchical structure, (8) testing the structure, (9) piloting the taxonomy and (10) reporting application and validation of the final taxonomy. Seventeen statistical tests and seven software systems were utilised, but automated data extraction methods were used rarely. Multimethod and multi-stakeholder approach, code- and hierarchy testing and piloting were strengths and time consumption and small samples in testing limitations. New taxonomies are needed on diverse specialities and information technology related to patient safety. Structured method is needed for taxonomy development, reporting and appraisal to strengthen taxonomies’ quality. A new guide was proposed for taxonomy development, for which testing is required. Prospero registration number