Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY 10022, USA.
Qual Life Res. 2012 Sep;21(7):1159-64. doi: 10.1007/s11136-011-0031-4. Epub 2011 Oct 8.
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.
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.
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%).
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.
作为临床试验和药物标签的一部分，不良症状事件报告至关重要，以确保患者安全并为风险效益决策提供信息。本研究的目的是评估同一患者在同一就诊时不同临床医生报告不良事件的可靠性。
对来自肺癌（n=134）、前列腺癌（n=113）和妇产科（n=146）诊所的 393 名癌症患者（男性占 42.8%；年龄 26-91 岁，M=62.39）的样本进行了回顾性可靠性分析。每位患者均由两位临床医生进行评估，这两位医生独立评估了七种常见不良事件术语标准（CTCAE）症状。23%的患者参加了治疗性临床试验。
评估者之间的平均时间间隔为 68 分钟。便秘（0.50）、腹泻（0.58）、呼吸困难（0.69）、疲劳（0.50）、恶心（0.52）、神经病变（0.71）和呕吐（0.46）的组内相关系数为中度。这些值在随访就诊中表现出稳定性。最常出现在有症状患者中的两点差异，可能会影响治疗决策，包括便秘（18%）、呕吐（15%）和恶心（8%）。
当报告不良症状事件时，不同临床医生之间的一致性充其量是中等的。应该考虑修改不良症状报告方法，例如患者自我报告。
