The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study

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...

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Bibliographic Details
Published in:	Journal of medical Internet research Vol. 23; no. 12; p. e27188
Main Authors:	Chan, Erina, Small, Serena S, Wickham, Maeve E, Cheng, Vicki, Balka, Ellen, Hohl, Corinne M
Format:	Journal Article
Language:	English
Published:	Canada Gunther Eysenbach MD MPH, Associate Professor 10-12-2021 JMIR Publications
Subjects:	Adverse Assistants Canada Chart reviews Classification Clinical standards Critical incidents Data collection Data quality Departments Documentation Drug dosages Drug-Related Side Effects and Adverse Reactions - diagnosis Electronic health records Feedback Hospitals Humans Jargon Medical diagnosis Medical dictionaries Medical records Mixed methods research Multimedia Original Paper Patient safety Pharmacists Pharmacy Prescription drugs Retrospective Studies Symptoms Terminology Canada British Columbia Canada Vancouver British Columbia Canada adverse drug events data standards health information technology
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Summary:	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. This study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. 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. 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. 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1438-8871 1439-4456 1438-8871
DOI:	10.2196/27188