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Clinicians versus patients subjective adverse events assessment: based on patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Quality of Life Research volume 29, pages 3009–3015 (2020)Cite this article

Abstract

Purpose

Adverse events (AEs) assessment by clinicians is a standard practice in a clinical setting. However, studies have found clinicians tend to report fewer AEs, especially subjective AEs. We aimed to explore the difference of subjective AEs assessment between clinicians and patients based on PRO-CTCAE, and to discuss the necessity of incorporating patient into the evaluation of AEs.

Methods

Between April and July 2019, two different questionnaires with the same subjective AEs were given to patients and clinicians in the Day Chemotherapy ward of Breast Center in the Fourth Hospital of HeBei Medical University. Patients completed a Simplified Chinese version of PRO-CTCAE, including six common subjective AEs of chemotherapy: nausea, vomiting, diarrhea, fatigue, pain, and constipation. Clinicians completed the common terminology criteria for adverse events (CTCAE) with the same AEs. General information of enrolled patients and results from the questionnaires were collected and analyzed.

Results

384 paired questionnaires were collected. Clinicians reported less subjective AEs than patients, and the general agreement between patients and clinicians was poor. When considering the grade difference, we utilize weighted kappa coefficient to analysis, and agreement between patients and clinicians was poor (k < 0.4) regardless of the frequency, the severity and interfering with daily life of AEs, and the most discrepancies were within one point. Patients tended to grade severer than the clinician.

Conclusions

The results of this study showed that there were differences between clinicians and patients in subjective adverse events evaluation. Patient reporting of symptoms can be used as a supplementary method to incorporate the current approach to monitor subjective AEs, to improve the timeliness and accuracy of clinical evaluation of subjective AEs.

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Acknowledgements

The study was supported by Research ability improvement project for excellent students (Grant No. YXZ2019004).

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Affiliations

  1. Community Care Teaching and Research Department, Hebei University of Chinese Medicine, Xinshi Road, Shijiazhuang, Hebei Province, China

    Lei Liu, Tingting Suo & Yongqing Shen

  2. Breast Center of the Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China

    Lei Liu, Cuizhi Geng, Zhengchuan Song, Fengxia Liu, Jianxin Wang, Yanli Xie, Yanshou Zhang, Tiantian Tang, Lina Zhang & Weina Wang

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  1. Lei Liu
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  2. Tingting Suo
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Corresponding author

Correspondence to Yongqing Shen.

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The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the independent ethics committee of the Hebei University of Chinese Medicine. All the patients provided written informed consent for this study.

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Liu, L., Suo, T., Shen, Y. et al. Clinicians versus patients subjective adverse events assessment: based on patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Qual Life Res 29, 3009–3015 (2020). https://doi.org/10.1007/s11136-020-02558-7

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Keywords

  • PRO-CTCAE
  • Breast cancer
  • Adverse events
  • Reporting