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Background  Traditional concordance metrics have shortcomings based on dataset characteristics (e.g., multiple attributes rated, missing data); therefore it is necessary to explore supplemental approaches to quantifying agreement between independent assessments. The purpose of this methodological paper is to apply an Item Response Theory (IRT) -based framework to an existing dataset that included unidimensional clinician and multiple attribute patient ratings of symptomatic adverse events (AEs), and explore the utility of this method in patient-reported outcome (PRO) and health-related quality of life (HRQOL) research.    Methods  Data were derived from a National Cancer Institute-sponsored study examining the validity of a measurement system (PRO-CTCAE) for patient self-reporting of AEs in cancer patients receiving treatment ( N  = 940). AEs included 13 multiple attribute patient-reported symptoms that had corresponding unidimensional clinician AE grades. A Bayesian IRT Model was fitted to calculate the latent grading thresholds between raters. The posterior mean values of the model-fitted item responses were calculated to represent model-based AE grades obtained from patients and clinicians.    Results  Model-based AE grades showed a general pattern of clinician underestimation relative to patient-graded AEs. However, the magnitude of clinician underestimation was associated with AE severity, such that clinicians’ underestimation was more pronounced for moderate/very severe model-estimated AEs, and less so with mild AEs.    Conclusions  The Bayesian IRT approach reconciles multiple symptom attributes and elaborates on the patterns of clinician-patient non-concordance beyond that provided by traditional metrics. This IRT-based technique may be used as a supplemental tool to detect and characterize nuanced differences in patient-, clinician-, and proxy-based ratings of HRQOL and patient-centered outcomes.    Trial registration  ClinicalTrials.gov  NCT01031641 . Registered 1 December 2009.

journal of patient-reported outcomes

Application of a Bayesian graded response model to characterize areas of disagreement between clinician and patient grading of symptomatic adverse events