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Reliability of adverse symptom event reporting by clinicians

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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.

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Notes

  1. Additional information on the PRO-CTCAE initiative can be found at https://wiki.nci.nih.gov/x/cKul

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

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Acknowledgments

This project was supported by a National Institutes of Health Research Training Grant (T32 CA009461-25); a National Institutes of Health Support Grant (P30-CA-008748). The findings in this manuscript were partially reported at the 31st Annual Meeting and Scientific Sessions of the Society of Behavioral Medicine, Seattle, WA, April 7–10, 2010.

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Authors and Affiliations

  1. Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA

    Thomas M. Atkinson, Yuelin Li & Jennifer Hay

  2. University of Kansas Medical Center, Kansas City, KS, USA

    Charles W. Coffey

  3. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    Laura Sit, Mary Shaw, Dawn Lavene, Antonia V. Bennett, Mike Fruscione, Lauren Rogak, Mithat Gönen & Ethan Basch

  4. Department of Outcomes Research, Dana-Farber Cancer Institute, Boston, MA, USA

    Deborah Schrag

Authors
  1. Thomas M. Atkinson
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  2. Yuelin Li
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  3. Charles W. Coffey
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  4. Laura Sit
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  5. Mary Shaw
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  10. Jennifer Hay
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  12. Deborah Schrag
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  13. Ethan Basch
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Correspondence to Thomas M. Atkinson.

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Atkinson, T.M., Li, Y., Coffey, C.W. et al. Reliability of adverse symptom event reporting by clinicians. Qual Life Res 21, 1159–1164 (2012). https://doi.org/10.1007/s11136-011-0031-4

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