Work

Exploring differences in adverse symptom event grading thresholds between clinicians and patients in the clinical trial setting

Year: 2020

Type: article

Abstract: Symptomatic adverse event (AE) monitoring is essential in cancer clinical trials to assess patient safety, as well as inform decisions related to treatment and continued trial participation. As prior research has demonstrated that conventional concordance metrics (e.g., intraclass correlation) may not capture nuanced aspects of the association between clinician and patient-graded AEs, we aimed to characterize differences in AE grading thresholds between doctors (MDs), registered nurses (RNs), and patients using the Bayesian Graded Item Response Model (GRM).

Source: Carolina Digital Repository (University of North Carolina at Chapel Hill)

DOI: 10.17615/xevr-5q48

Authors: Ryan, Sean J., Bennett, Antonia V., Basch, Ethan, Rogak, Lauren J., Li, Yuelin, Shaw, Mary, Stark, Liora P., Atkinson, Thomas M., Heon, Narre

Institution: University of North Carolina at Chapel Hill

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W4298343781

FWCI:

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