Kiebert G, Wait S, Bernhard J, Bezjak A, Cella D, Day R, Houghton J, Moinpour C, Scott C, Stephens R
MEDTAP International, London, UK.
Qual Life Res. 2000;9(10):1073-80. doi: 10.1023/a:1016658004947.
Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed.
A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%). however, one group could not provide information for the survey, thus ten questionnaires were available for analysis.
The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies.
合作组织在健康相关生活质量（HRQL）研究的进展中发挥了重要作用。然而，该概念的定义、现有工具的选择标准以及数据收集和解释方法在文献中仍未明确界定。为了更好地了解主要癌症合作组织目前在癌症临床试验中确保最佳HRQL数据收集的政策和流程，开展了一项调查。健康经济学主题也得到了类似的探讨。
向16个主要的欧洲和北美癌症合作组织发送了书面调查问卷。11个组织回复（回复率：69%）。然而，有一个组织无法提供调查所需信息，因此可供分析的问卷有10份。
本次合作组织调查结果显示，HRQL（比健康经济学更受重视）在肿瘤学试验中被视为一项重要的结局指标，尽管通常是次要的。总体而言，合作组织在将HRQL（和健康经济学）纳入其临床试验方面政策较为灵活，实践很大程度上是根据具体情况而定，但会使用标准实践指南和内部程序来确保明确的研究方案并加强高质量研究。
