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

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...

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Bibliographic Details
Published in:Quality of life research 2020-11, Vol.29 (11), p.3009-3015
Main Authors: Liu, Lei, Suo, Tingting, Shen, Yongqing, Geng, Cuizhi, Song, Zhengchuan, Liu, Fengxia, Wang, Jianxin, Xie, Yanli, Zhang, Yanshou, Tang, Tiantian, Zhang, Lina, Wang, Weina
Format: Article
Language:English
Subjects:
Adult
Aged
Breast cancer
Chemotherapy
Drug-Related Side Effects and Adverse Reactions - diagnosis
Female
Humans
Kappa coefficient
Male
Medicine
Medicine & Public Health
Middle Aged
Patient Reported Outcome Measures
Patients
Public Health
Quality of Life
Quality of Life Research
Questionnaires
Sociology
Surveys and Questionnaires
Terminology
Young Adult
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Summary: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  
ISSN:0962-9343
1573-2649
DOI:10.1007/s11136-020-02558-7