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改变临床试验中给药时间和生活质量评估时间范围的影响:以一项大型止吐试验中使用欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30)为例

Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial.

作者信息

Pater J, Osoba D, Zee B, Lofters W, Gore M, Dempsey E, Palmer M, Chin C

机构信息

NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.

出版信息

Qual Life Res. 1998 Apr;7(3):273-8. doi: 10.1023/a:1024954518241.

DOI:10.1023/a:1024954518241
PMID:9584558
Abstract

Previous studies conducted by our group suggested that the ability to demonstrate an impact of emesis control on quality of life might depend upon when an quality of life instrument was administered in relation to chemotherapy and on the time frame of the questionnaire. This study was conducted to address this issue. Six hundred and fifty patients receiving moderately emetogenic chemotherapy in a randomized trial comparing a variety of anti-emetic regimens were allocated to four different modes of administration (days 4 and 8; 3 and 7 day time frames) of the QLQ-C30. Patients who completed the questionnaire at the time of maximal impact of chemotherapy (day 3) were more likely to report deterioration in quality of life. Patients who completed questionnaires at day 8 were more likely to report deterioration in quality of life if their questionnaire had a 7 day time frame rather than a 3 day time frame. Patients receiving more effective anti-emetic therapy had better quality of life. It was concluded that better anti-emetic control improves quality of life after moderately emetogenic chemotherapy. In studying quality of life in situations where the impact of treatment waxes and wanes, careful attention needs to be paid to scheduling the administration of questionnaires and to their time frame.

摘要

我们团队之前进行的研究表明,证明呕吐控制对生活质量有影响的能力可能取决于生活质量评估工具在化疗过程中的使用时间以及问卷的时间范围。本研究旨在解决这一问题。在一项比较多种止吐方案的随机试验中,650名接受中度致吐性化疗的患者被分配到QLQ-C30的四种不同给药模式(第4天和第8天;3天和7天时间范围)。在化疗影响最大时(第3天)完成问卷的患者更有可能报告生活质量恶化。如果问卷的时间范围是7天而不是3天,在第8天完成问卷的患者更有可能报告生活质量恶化。接受更有效止吐治疗的患者生活质量更好。研究得出结论,更好的止吐控制可改善中度致吐性化疗后的生活质量。在研究治疗影响有起有伏情况下的生活质量时,需要特别注意问卷的给药安排及其时间范围。

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Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial.改变临床试验中给药时间和生活质量评估时间范围的影响:以一项大型止吐试验中使用欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30)为例
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本文引用的文献

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Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.
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