Reliability of adverse symptom event reporting by clinicians.
Reliability of adverse symptom event reporting by clinicians.
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DOI：
10.1007/s11136-011-0031-4
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发表时间：
2012-09
影响因子：
3.5
通讯作者：
Basch, Ethan
中科院分区：
文献类型：
--
作者：
Atkinson, Thomas M.;Li, Yuelin;Coffey, Charles W.;Sit, Laura;Shaw, Mary;Lavene, Dawn;Bennett, Antonia V.;Fruscione, Mike;Rogak, Lauren;Hay, Jennifer;Goenen, Mithat;Schrag, Deborah;Basch, Ethan
不良症状事件报告作为临床试验和药物标签的一部分至关重要，以确保患者安全并为风险-受益决策提供信息。本研究的目的是评估同一患者在同一次访视中不同临床医生报告的不良事件的可靠性。对来自肺（n = 134）、前列腺（n = 113）和Ob/Gyn（n = 146）诊所的393例癌症患者（42.8%男性;年龄26-91岁，M = 62.39）样本完成了回顾性可靠性分析。这些患者分别由两名临床医生进行观察，他们独立评定了7种不良事件通用术语标准（CTCAE）症状。23%的患者参加了治疗性临床试验。评估者评估之间的平均时间为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）的组内相关系数中等。这些数值在随访访视期间保持稳定。可能影响治疗决策的两点差异最常见于便秘（18%）、呕吐（15%）和恶心（8%）症状患者。不同临床医生在报告不良症状事件时的一致性最多为中等。应考虑修改不良症状报告方法，如患者自我报告。
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.
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影响因子：
10.3
作者：
Basch, Ethan;Jia, Xiaoyu;Schrag, Deborah
通讯作者：
Schrag, Deborah
影响因子：
45.3
作者：
Kirkova, J;Davis, MP;Russell, KM
通讯作者：
Russell, KM
影响因子：
5.7
作者：
Ahmad, SR
通讯作者：
Ahmad, SR
影响因子：
1.8
作者：
MCGILL, R;TUKEY, JW;LARSEN, WA
通讯作者：
LARSEN, WA
影响因子：
45.3
作者：
Berry, Donna L.;Moinpour, Carol M.;Crawford, E. David
通讯作者：
Crawford, E. David