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

  • Thomas M. AtkinsonEmail author
  • Lauren J. Rogak
  • Narre Heon
  • Sean J. Ryan
  • Mary Shaw
  • Liora P. Stark
  • Antonia V. Bennett
  • Ethan Basch
  • Yuelin Li
Original Article – Clinical Oncology

Abstract

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.

Keywords

Patient-reported outcomes Adverse events Clinical trials Clinician–patient agreement Item response theory Neoplasms 

Notes

Compliance with ethical standards

Funding

This project was supported by a National Institutes of Health Support Grant (NCI 2 P30 CA08748-48), which provides partial support for the Behavioral Research Methods Core Facility used in conducting this investigation. This study was also supported by a grant from the Society of Memorial Sloan Kettering.

Conflict of interest

The authors declare that there is no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  • Thomas M. Atkinson
    • 1
    Email author
  • Lauren J. Rogak
    • 2
  • Narre Heon
    • 2
  • Sean J. Ryan
    • 2
    • 3
  • Mary Shaw
    • 1
  • Liora P. Stark
    • 1
  • Antonia V. Bennett
    • 4
  • Ethan Basch
    • 2
    • 4
  • Yuelin Li
    • 1
  1. 1.Department of Psychiatry and Behavioral SciencesMemorial Sloan Kettering Cancer CenterNew YorkUSA
  2. 2.Department of Epidemiology and BiostatisticsMemorial Sloan Kettering Cancer CenterNew YorkUSA
  3. 3.City University of New YorkNew YorkUSA
  4. 4.University of North Carolina-Chapel HillChapel HillUSA

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