In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 2 ( 2022-2-17), p. e0262109-
Abstract:
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. 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. 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. 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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0262109
DOI:
10.1371/journal.pone.0262109.g001
DOI:
10.1371/journal.pone.0262109.t001
DOI:
10.1371/journal.pone.0262109.t002
DOI:
10.1371/journal.pone.0262109.t003
DOI:
10.1371/journal.pone.0262109.t004
DOI:
10.1371/journal.pone.0262109.s001
DOI:
10.1371/journal.pone.0262109.s002
DOI:
10.1371/journal.pone.0262109.s003
DOI:
10.1371/journal.pone.0262109.s004
DOI:
10.1371/journal.pone.0262109.s005
DOI:
10.1371/journal.pone.0262109.s006
DOI:
10.1371/journal.pone.0262109.s007
DOI:
10.1371/journal.pone.0262109.s008
DOI:
10.1371/journal.pone.0262109.s009
DOI:
10.1371/journal.pone.0262109.s010
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2022
detail.hit.zdb_id:
2267670-3
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