Terminology integration and inconsistency identification of adverse event terminology for Japanese medical devices...

For standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015. The 89 terminologies were developed independently by 13 industry associations, suggesting that there may be inconsistencies among the terms proposed. The purpose of this study was to integrate the 89 sets of terminologies and evaluate inconsistencies among them using SPARQL.

In order to evaluate the inconsistencies among the integrated terminology, the following six items were evaluated: (1) whether the two-layer structure between category term and preferred term is consistent, (2) whether synonyms of a preferred term are involved. Reversing the layer-category order of matching was also performed, (3) whether each preferred term is subordinate to only one category term, (4) whether the definitions of terms are uniquely determined, (5) whether CDRH-NCIt terms corresponding to preferred terms are uniquely determined, (6) whether a term in a medical device problem is used for patient problems.

About 60% of the total number of duplicated terms were found. This is because industry associations that created multiple terminologies adopted the same terms in terminologies of similar medical device groups. In the case that all terms with the same spelling have the same concept, efficient integration can be achieved automatically using RDF. Furthermore, we evaluated six matters of inconsistency in this study, terms that need to be reviewed accounted for about 10% or less than 10% in each item.

The RDF and SPARQL were useful tools to explore inconsistencies of hierarchies, definition statements, and synonyms when integrating terminolgy by term notation, and these had the advantage of reducing the physical and time burden.