Community Care Teaching and Research Department, Hebei University of Chinese Medicine, Xinshi Road, Shijiazhuang, Hebei Province, China.
Breast Center of the Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China.
Qual Life Res. 2020 Nov;29(11):3009-3015. doi: 10.1007/s11136-020-02558-7. Epub 2020 Jun 20.
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.
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.
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.
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.
临床医生对不良事件（AE）的评估是临床实践中的标准做法。然而，研究发现临床医生往往报告较少的 AE，尤其是主观 AE。我们旨在基于 PRO-CTCAE 探讨临床医生和患者在主观 AE 评估方面的差异，并讨论将患者纳入 AE 评估的必要性。
2019 年 4 月至 7 月，在河北医科大学第四医院乳腺中心日间化疗病房，同时向患者和临床医生发放具有相同主观 AE 的两份问卷。患者完成了中文版简化版 PRO-CTCAE，包括化疗的六种常见主观 AE：恶心、呕吐、腹泻、疲劳、疼痛和便秘。临床医生则用相同的 AE 完成通用术语标准不良事件（CTCAE）。收集并分析入组患者的一般信息和问卷结果。
共收集到 384 对问卷。临床医生报告的主观 AE 少于患者，且患者和临床医生之间的总体一致性较差。在考虑等级差异时，我们使用加权 Kappa 系数进行分析，无论 AE 的频率、严重程度和对日常生活的干扰程度如何，患者和临床医生之间的一致性都较差（k<0.4），且最主要的差异仅在 1 级。患者倾向于比临床医生更严重地分级。
这项研究的结果表明，临床医生和患者在主观不良事件评估方面存在差异。患者对症状的报告可作为一种补充方法，纳入当前监测主观 AE 的方法，以提高主观 AE 临床评估的及时性和准确性。
