Quality of Life Research

, Volume 21, Issue 7, pp 1159–1164

Reliability of adverse symptom event reporting by clinicians

  • Thomas M. Atkinson
  • Yuelin Li
  • Charles W. Coffey
  • Laura Sit
  • Mary Shaw
  • Dawn Lavene
  • Antonia V. Bennett
  • Mike Fruscione
  • Lauren Rogak
  • Jennifer Hay
  • Mithat Gönen
  • Deborah Schrag
  • Ethan Basch
Article

DOI: 10.1007/s11136-011-0031-4

Cite this article as:
Atkinson, T.M., Li, Y., Coffey, C.W. et al. Qual Life Res (2012) 21: 1159. doi:10.1007/s11136-011-0031-4

Abstract

Purpose

Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk–benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit.

Methods

A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26–91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials.

Results

The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%).

Conclusion

Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered.

Keywords

Drug toxicityReproducibility of resultsRisk assessmentStatistical data interpretation

Abbreviations

CTCAE

Common Terminology Criteria for Adverse Events

ICC(s)

Intraclass correlation coefficient(s)

MedDRA

Medical dictionary of regulatory activities

MRN(s)

Medical record number(s)

NCI

National Cancer Institute

PRO(s)

Patient-reported outcome(s)

PRO-CTCAE

Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Thomas M. Atkinson
    • 1
  • Yuelin Li
    • 1
  • Charles W. Coffey
    • 2
  • Laura Sit
    • 3
  • Mary Shaw
    • 3
  • Dawn Lavene
    • 3
  • Antonia V. Bennett
    • 3
  • Mike Fruscione
    • 3
  • Lauren Rogak
    • 3
  • Jennifer Hay
    • 1
  • Mithat Gönen
    • 3
  • Deborah Schrag
    • 4
  • Ethan Basch
    • 3
  1. 1.Department of Psychiatry and Behavioral SciencesMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.University of Kansas Medical CenterKansas CityUSA
  3. 3.Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Department of Outcomes ResearchDana-Farber Cancer InstituteBostonUSA