%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 23
%N 12
%P e27188
%T The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study
%A Chan,Erina
%A Small,Serena S
%A Wickham,Maeve E
%A Cheng,Vicki
%A Balka,Ellen
%A Hohl,Corinne M
%+ Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, 828 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada, 1 604 875 4111 ext 55219, Serena.Small@ubc.ca
%K adverse drug events
%K health information technology
%K data standards
%D 2021
%7 10.12.2021
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: Existing systems to document adverse drug events often use free text data entry, which produces nonstandardized and unstructured data that are prone to misinterpretation. Standardized terminology may improve data quality; however, it is unclear which data standard is most appropriate for documenting adverse drug event symptoms and diagnoses. Objective: This study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. Methods: We performed a mixed methods substudy of a multicenter retrospective chart review. We reviewed the research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. A total of 2 pharmacy research assistants independently entered the symptoms and diagnoses for the adverse drug events using four standards: Medical Dictionary for Regulatory Activities (MedDRA), Systematized Nomenclature of Medicine (SNOMED) Clinical Terms, SNOMED Adverse Reaction (SNOMED ADR), and International Classification of Diseases (ICD) 11th Revision. Disagreements between research assistants regarding the case-specific utility of data standards were discussed until a consensus was reached. We used consensus ratings to determine the proportion of adverse drug events covered by a data standard and coded and analyzed field notes from the consensus sessions. Results: We reviewed 573 adverse drug events and found that MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and diagnoses. MedDRA had the highest number of matches between the research assistants, whereas ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. The research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, whereas least likely to encounter challenges with MedDRA. Conclusions: Usability, comprehensiveness, and accuracy are important features of data standards for documenting adverse drug event symptoms and diagnoses. On the basis of our results, we recommend the use of MedDRA. 
%M 34890351
%R 10.2196/27188
%U https://www.jmir.org/2021/12/e27188
%U https://doi.org/10.2196/27188
%U http://www.ncbi.nlm.nih.gov/pubmed/34890351