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abstract:
Exploring differences in adverse symptom event grading thresholds between clinicians and patients in the clinical trial setting
Purpose
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).
Methods
From the medical charts of 393 patients aged 26–91 (M = 62.39;
43% male) receiving chemotherapy, we retrospectively extracted MD, RN
and patient AE ratings. Patients reported using previously developed
Common Terminology Criteria for Adverse Events (CTCAE) patient-language
adaptations called STAR (Symptom Tracking and Reporting). A GRM was
fitted to calculate the latent grading thresholds between MDs, RNs and
patients.
Results
Clinicians
have overall higher average grading thresholds than patients when
assessing diarrhea, dyspnea, nausea and vomiting. However, RNs have
lower grading thresholds than patients and MDs when assessing
constipation. The GRM shows higher variability in patients’ AE grading
thresholds than those obtained from clinicians.
Conclusions
The
present study provides evidence to support the notion that patients
report some AEs that clinicians might not consider noteworthy until they
are more severe. The availability of GRM methodology could serve to
enhance clinical understanding of the patient symptomatic experience and
facilitate discussion where AE grading discrepancies exist. Future work
should focus on capturing explicit AE grading decision criteria from
MDs, RNs, and patients.
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