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Gepubliceerd in: Quality of Life Research 7/2012

01-09-2012

Reliability of adverse symptom event reporting by clinicians

Auteurs: 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

Gepubliceerd in: Quality of Life Research | Uitgave 7/2012

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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.
Voetnoten
1
Additional information on the PRO-CTCAE initiative can be found at https://​wiki.​nci.​nih.​gov/​x/​cKul
 
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Metagegevens
Titel
Reliability of adverse symptom event reporting by clinicians
Auteurs
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
Publicatiedatum
01-09-2012
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 7/2012
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-011-0031-4

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