Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: problems and solutions.

Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: problems and solutions.
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东部肿瘤合作组(ECOG)临床试验中生活质量研究的缺失数据:问题与解决方案。

DOI:
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发表时间:
1998
影响因子:
2
通讯作者:
D. Fairclough
D. Fairclough
中科院分区:
医学3区
文献类型:
--
作者:
E. Hahn;K. Webster;D. Cella;D. Fairclough

文献摘要

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将生活质量(QOL)调查纳入东部肿瘤协作组(ECOG)多中心临床试验,导致了方案设计和高质量数据收集的创新策略。一个科学咨询委员会审查方案设计组成部分、测量选择、评估时间安排和合规性问题。广泛的教育计划提供有关QOL协议的科学和临床相关性的信息,以及数据收集和管理的实用策略。前瞻性地监测和评价QOL数据收集标准的依从性。8个ECOG运行方案的初步结果发现,总体依从性约为85%(基线时为94%,治疗期间为73%)。选定的患者和机构的因素进行了评估,他们的关联与遵守。
Incorporation of quality of life (QOL) investigation into Eastern Cooperative Oncology Group (ECOG) multi-centre clinical trials has led to innovative strategies for protocol design and high quality data collection. A scientific advisory committee reviews protocol design components, measurement selection, timing of assessments and compliance issues. Extensive educational programmes provide information about the scientific and clinical relevance of QOL protocols, as well as practical strategies for data collection and management. Compliance with QOL data collection standards is prospectively monitored and evaluated. Preliminary results from eight ECOG-run protocols found overall compliance to be approximately 85 per cent (94 per cent at baseline and 73 per cent during treatment). Selected patient and institutional factors were evaluated for their association with compliance.