The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study
BackgroundExisting 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 i...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2021-12-01
|
| Series: | Journal of Medical Internet Research |
| Online Access: | https://www.jmir.org/2021/12/e27188 |
| _version_ | 1797735491434446848 |
|---|---|
| author | Erina Chan Serena S Small Maeve E Wickham Vicki Cheng Ellen Balka Corinne M Hohl |
| author_facet | Erina Chan Serena S Small Maeve E Wickham Vicki Cheng Ellen Balka Corinne M Hohl |
| author_sort | Erina Chan |
| collection | DOAJ |
| description |
BackgroundExisting 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.
ObjectiveThis study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses.
MethodsWe 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.
ResultsWe 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.
ConclusionsUsability, 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. |
| first_indexed | 2024-03-12T12:59:48Z |
| format | Article |
| id | doaj.art-b53c0fe7aa724406be82b12ae21476d4 |
| institution | Directory Open Access Journal |
| issn | 1438-8871 |
| language | English |
| last_indexed | 2024-03-12T12:59:48Z |
| publishDate | 2021-12-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | Journal of Medical Internet Research |
| spelling | doaj.art-b53c0fe7aa724406be82b12ae21476d42023-08-28T19:59:48ZengJMIR PublicationsJournal of Medical Internet Research1438-88712021-12-012312e2718810.2196/27188The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods StudyErina Chanhttps://orcid.org/0000-0002-9909-5040Serena S Smallhttps://orcid.org/0000-0003-3627-9042Maeve E Wickhamhttps://orcid.org/0000-0003-0693-2223Vicki Chenghttps://orcid.org/0000-0001-5030-9135Ellen Balkahttps://orcid.org/0000-0003-2094-7907Corinne M Hohlhttps://orcid.org/0000-0002-9210-7838 BackgroundExisting 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. ObjectiveThis study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. MethodsWe 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. ResultsWe 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. ConclusionsUsability, 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.https://www.jmir.org/2021/12/e27188 |
| spellingShingle | Erina Chan Serena S Small Maeve E Wickham Vicki Cheng Ellen Balka Corinne M Hohl The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study Journal of Medical Internet Research |
| title | The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study |
| title_full | The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study |
| title_fullStr | The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study |
| title_full_unstemmed | The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study |
| title_short | The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study |
| title_sort | utility of different data standards to document adverse drug event symptoms and diagnoses mixed methods study |
| url | https://www.jmir.org/2021/12/e27188 |
| work_keys_str_mv | AT erinachan theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT serenassmall theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT maeveewickham theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT vickicheng theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT ellenbalka theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT corinnemhohl theutilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT erinachan utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT serenassmall utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT maeveewickham utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT vickicheng utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT ellenbalka utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy AT corinnemhohl utilityofdifferentdatastandardstodocumentadversedrugeventsymptomsanddiagnosesmixedmethodsstudy |