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The Adverse Event Unit (AEU): A novel metric to measure the burden of treatment adverse events.
The Adverse Event Unit (AEU): A novel metric to measure the burden of treatment adverse events.
- Source :
-
PloS one [PLoS One] 2022 Feb 17; Vol. 17 (2), pp. e0262109. Date of Electronic Publication: 2022 Feb 17 (Print Publication: 2022). - Publication Year :
- 2022
-
Abstract
- Objective: To design a physician and patient derived tool, the Adverse Event Unit (AEU), akin to currency (e.g. U.S. Dollar), to improve AE burden measurement independent of any particular disease or medication class.<br />Patients/methods: A Research Electronic Data Capture (REDCap) online survey was administered to United States physicians with board certification or board eligibility in general neurology, subspecialty neurology, primary care internal medicine or family medicine, subspecialty internal medicine, general pediatrics, and subspecialty pediatrics. Physicians assigned value to 73 AE categories chosen from the Common Terminology Criteria of Adverse Events (CTCAE) relevant to neurologic disorder treatments. An online forced choice survey was administered to non-physician, potential patients, through Amazon Mechanical Turk (MTurK) to weight the severity of the same AE categories. Physician and non-physician data was combined to assign value to the AEU. Surveys completed between 1/2017 and 3/2019.<br />Results: 363 physicians rated the 73 AE categories derived from CTCAE. 660 non-physicians completed forced choice experiments comparing AEs. The AEU provides 0-10, weighted values for the AE categories studied that differ from the ordinal 1-4 CTCAE scale. For example, CTCAE severe diabetes (category 4) is assigned an AEU score of 9. Although non-physician input changed physician assigned AEU values, there was general agreement among physicians and non-physicians about severity of AEs.<br />Conclusion: The AEU has promise to be a useful, practical tool to add precision to AE burden measurement in the clinic and in comparative efficacy research with neurology patients. AEU utility will be assessed in planned comparative efficacy clinical trials.<br />Competing Interests: The authors have read the journal’s policy and have the following competing interests: MH has consulted for Alexion, Argenx, CSL Behring, and Octapharma, and EDS serves on the speaker bureau for both Alexion and CSL Behring. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
- Subjects :
- Adult
Drug-Related Side Effects and Adverse Reactions etiology
Drug-Related Side Effects and Adverse Reactions therapy
Female
Humans
Male
Middle Aged
Nervous System Diseases pathology
Surveys and Questionnaires
Adverse Drug Reaction Reporting Systems statistics & numerical data
Drug-Related Side Effects and Adverse Reactions pathology
Drugs, Investigational adverse effects
Nervous System Diseases drug therapy
Patient Reported Outcome Measures
Physicians statistics & numerical data
Subjects
Details
- Language :
- English
- ISSN :
- 1932-6203
- Volume :
- 17
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- PloS one
- Publication Type :
- Academic Journal
- Accession number :
- 35176061
- Full Text :
- https://doi.org/10.1371/journal.pone.0262109