How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30
How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30
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DOI：
10.1200/jco.2004.03.025
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发表时间：
2004-09-01
影响因子：
45.3
通讯作者：
Beer, TM
中科院分区：
文献类型：
--
作者：
Fromme, EK;Eilers, KM;Beer, TM
化疗临床试验中的不良事件由临床医生评估和报告，但临床医生评估症状的准确性一直受到质疑。我们使用经过验证的工具，欧洲癌症研究和治疗组织生活质量问卷C30，（QLQ-C30或QLQ）与医生在研究的不良事件日志中报告的相同症状。参加每周骨化三醇和多西他赛的II期试验的雄激素非依赖性前列腺癌患者每4周完成一次QLQ，持续28周。患者报告的症状定义为QLQ症状评分增加至少10分（0 - 100量表），持续至少4周。一个医生报告的症状被认为是存在的，如果它是以往任何时候都记录在不良事件log.ResultsForty-nine（新的或恶化）的症状被检测到的医生和QLQ，48个症状被检测到的医生单独，和55个症状被检测到的QLQ单独。他们一致认为，在254个可能的机会中，有102个没有症状。他们未校正的一致性为59.4%，但科恩的kappa，一个修正的一致性系数，为0.15，表明只有轻微的一致性。使用QLQ作为标准，整体医生的敏感性和特异性分别为47%和68%，虽然它之间的变化很大symptoms.ConclusionEven在严格控制的临床试验，医生报告既不敏感，也不具体检测常见的化疗不良反应。应开发用于收集化疗临床试验中患者报告的不良事件数据的工具。(C)2004年，美国临床肿瘤学会。
PurposeAdverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log.Patients and MethodsThirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log.ResultsForty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's kappa, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms.ConclusionEven in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed. (C) 2004 by American Society of Clinical Oncology.