Preliminary Exploration of Main Elements for Systematic Classification Development: Case Study of Patient Safety Incidents (Preprint)

BACKGROUND Currently, there is no holistic theoretical approach available for guiding classification development. On the basis of our recent classification development research in the area of patient safety in health information technology, this focus area would benefit from a more systematic approach. Although some valuable theoretical and methodological approaches have been presented, classification development literature typically is limited to methodological development in a specific domain or is practically oriented. OBJECTIVE The main purposes of this study are to fill the methodological gap in classification development research by exploring possible elements of systematic development based on previous literature and to promote sustainable and well-grounded classification outcomes by identifying a set of recommended elements. Specifically, the aim is to answer the following question: what are the main elements for systematic classification development based on research evidence and our use case? METHODS This study applied a qualitative research approach. On the basis of previous literature, preliminary elements for classification development were specified, as follows: defining a concept model, documenting the development process, incorporating multidisciplinary expertise, validating results, and maintaining the classification. The elements were compiled as guiding principles for the research process and tested in the case of patient safety incidents (n=501). RESULTS The results illustrate classification development based on the chosen elements, with 4 examples of technology-induced errors. Examples from the use case regard usability, system downtime, clinical workflow, and medication section problems. The study results confirm and thus suggest that a more comprehensive and theory-based systematic approach promotes well-grounded classification work by enhancing transparency and possibilities for assessing the development process. CONCLUSIONS We recommend further testing the preliminary main elements presented in this study. The research presented herein could serve as a basis for future work. Our recently developed classification and the use case presented here serve as examples. Data retrieved from, for example, other type of electronic health records and use contexts could refine and validate the suggested methodological approach. CLINICALTRIAL