儿科肿瘤学中的生活质量评估：对III期报告的回顾性分析
Quality of life assessment in pediatric oncology: a retrospective review of phase III reports.
作者信息
Bradlyn A S, Harris C V, Spieth L E
机构信息
Department of Behavioral Medicine & Psychiatry, West Virginia University Health Sciences Center, Morgantown 26506-2854, USA.
出版信息
Soc Sci Med. 1995 Nov;41(10):1463-5. doi: 10.1016/0277-9536(95)00114-m.
BACKGROUND
although the quality of life of cancer patients has been a topic of increasing interest, the research literature to date has generally noted minimal reporting of these data in adult clinical trials.
PURPOSE
the purpose of this investigation was to examine the frequency with which these measures are reported in pediatric cancer clinical trials.
METHOD
published reports of 70 Phase III clinical trials from the Pediatric Oncology Group and Childrens Cancer Group were reviewed for presentation of quality of life and toxicity data.
RESULTS
approximately 3% of these reports included quality of life data, while toxicities were noted for over 75%
CONCLUSIONS
quality of life endpoints are not reflected in clinical trial reports. Education as to the potential usefulness of these data, as well as recognition of the barriers that exist to using such measures must be addressed.
背景
尽管癌症患者的生活质量一直是人们越来越感兴趣的话题，但迄今为止的研究文献普遍指出，成人临床试验中对这些数据的报告极少。
目的
本调查的目的是检查在儿科癌症临床试验中报告这些指标的频率。
方法
对来自儿科肿瘤学组和儿童癌症组的70项III期临床试验的已发表报告进行审查，以了解生活质量和毒性数据的呈现情况。
结果
这些报告中约3%包含生活质量数据，而超过75%的报告记录了毒性情况。
结论
生活质量终点未在临床试验报告中得到体现。必须解决关于这些数据潜在有用性的教育问题，以及认识到使用此类指标存在的障碍。
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