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评估癌症临床试验中与健康相关的生活质量:加拿大国立癌症研究所临床试验组的经验。

Evaluating health-related quality of life in cancer clinical trials: the National Cancer Institute of Canada Clinical Trials Group experience.

作者信息

Osoba David, Bezjak Andrea, Brundage Michael, Pater Joseph

机构信息

QOL Consulting, West Vancouver, BC, Canada.

出版信息

Value Health. 2007 Nov-Dec;10 Suppl 2:S138-45. doi: 10.1111/j.1524-4733.2007.00278.x.

DOI:10.1111/j.1524-4733.2007.00278.x
PMID:17995472
Abstract

INTRODUCTION

The National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986.

PURPOSE

The purpose of this review is to describe the evolution of the Committee's work and to highlight key developments such as the formulation of a policy regarding health-related quality-of-life (HRQOL) assessment, the provision of guidelines to ensure completion of HRQOL data within the protocol requirements, the rationale behind the choice of HRQOL instruments, the timing of assessments and the development of data analytic methods. These developments are illustrated with examples from CTG studies.

RECOMMENDATIONS

There is a lack of concordance between conventional toxicity data and HRQOL data and comparative studies designed to elucidate these differences are to be encouraged. Also, more studies are required to compare different analytic strategies and to determine how much missing data is acceptable, particularly in oncology studies where attrition is inevitable.

摘要

引言

加拿大国家癌症研究所(NCIC)临床试验组(CTG)生活质量(QOL)委员会于1986年成立。

目的

本综述的目的是描述该委员会工作的演变,并突出关键进展,如制定与健康相关生活质量(HRQOL)评估的政策、提供指南以确保在方案要求内完成HRQOL数据、选择HRQOL工具背后的基本原理、评估的时间安排以及数据分析方法的发展。这些进展通过CTG研究的实例进行说明。

建议

传统毒性数据与HRQOL数据之间缺乏一致性,应鼓励开展旨在阐明这些差异的比较研究。此外,需要更多研究来比较不同的分析策略,并确定可接受的缺失数据量,特别是在肿瘤学研究中,人员流失不可避免。

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