Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes
Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes
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DOI：
10.1093/jnci/djp386
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发表时间：
2009-12-02
影响因子：
10.3
通讯作者：
Schrag, Deborah
中科院分区：
文献类型：
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作者：
Basch, Ethan;Jia, Xiaoyu;Schrag, Deborah
在癌症治疗试验中，不良症状数据的标准来源是临床医生使用国家癌症研究所不良事件通用术语标准 (CTCAE) 中的项目进行报告。患者自我报告已被提议作为额外的数据源，但这种转变的影响尚不清楚。接受化疗的肺癌患者及其临床医生在连续就诊时独立报告了六种 CTCAE 症状和卡诺夫斯基表现状态。为了比较患者与临床医生的报告与哨点临床事件的关系，使用时间依赖性 Cox 回归模型来测量达到特定 CTCAE 等级严重性阈值与死亡和急诊室就诊风险之间的关联。为了衡量 CTCAE 报告与日常健康状况指数的一致性，使用 EuroQoL EQ-5D 问卷和全局问题评分计算每种症状的 Kendall tau 等级相关系数。统计检验是双向的。共有 163 名患者入组，平均 12 个月（范围 = 1-28 个月），平均就诊 11 次，死亡 67 例（41%）。 CTCAE 报告由临床医生（95% 的就诊次数）和患者（80% 的就诊次数）提交。患者通常比临床医生更早、更频繁地报告症状。临床医生报告的疲劳 (P < .001)、恶心 (P = .01)、便秘 (P = .038) 和卡诺夫斯基体力状态 (P < .001) 与死亡和急诊入院之间存在统计学显着相关性，但患者对这些项目的报告则不然。与临床医生报告的症状相比，患者报告的症状与 EuroQoL EQ-5D 问卷和总体问题评分的一致性更高。纵向收集的临床医生 CTCAE 评估可以更好地预测不利的临床事件，而患者报告可以更好地反映日常健康状况。这些观点是互补的，每种观点都提供了具有临床意义的信息。将这两种类型的数据纳入治疗试验结果和药物标签似乎是有必要的。
In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood.Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided.A total of 163 patients were enrolled for an average of 12 months (range = 1-28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms.Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are complementary, each providing clinically meaningful information. Inclusion of both types of data in treatment trial results and drug labels appears to be warranted.