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瑞士临床癌症研究组织开展的多中心试验中生活质量评估的实际问题。

Practical issues in quality of life assessment in multicentre trials conducted by the Swiss Group for Clinical Cancer Research.

作者信息

Bernhard J, Gusset H, Hürny C

机构信息

SIAK Coordinating Center, Bern, Switzerland.

出版信息

Stat Med. 1998;17(5-7):633-9. doi: 10.1002/(sici)1097-0258(19980315/15)17:5/7<633::aid-sim810>3.0.co;2-u.

Abstract

Quality of life (QOL) assessment has become an integrated part in some advanced disease trials and to a lesser extent in early disease trials conducted by the Swiss Group for Clinical Research (SAKK). In general, the concept of QOL endpoints and the additional work of collecting these data is well accepted by patients, nurses and physicians. The QOL form submission rates in recently completed trials in advanced disease have improved in response to ongoing staff training and supervision as well as direct and personal interventions in the local centres, with 82-86 per cent before treatment failure, and 59-88 per cent at failure. The main source of missing data are local administrative problems, in particular staff oversights.

摘要

生活质量(QOL)评估已成为一些晚期疾病试验中不可或缺的一部分,在瑞士临床研究组织(SAKK)开展的早期疾病试验中所占比重相对较小。总体而言,患者、护士和医生对生活质量终点的概念以及收集这些数据所需的额外工作普遍认可。在晚期疾病的近期完成试验中,由于持续的员工培训与监督以及当地中心的直接和个人干预,生活质量表格提交率有所提高,治疗失败前的提交率为82% - 86%,失败时为59% - 88%。数据缺失的主要原因是当地行政问题,尤其是工作人员的疏忽。

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