Batel-Copel L M, Kornblith A B, Batel P C, Holland J C
Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Eur J Cancer. 1997 Jan;33(1):29-32. doi: 10.1016/s0959-8049(96)00414-5.
The aim of this review is to evaluate the extent to which Quality of Life (QoL) assessment has been incorporated into clinical oncological trials in the last 15 years. All phase II and III trials published in the Journal of Clinical Oncology, Cancer, The British Journal of Cancer and the European Journal of Cancer during the years 1980, 1985, 1990 and 1995 were reviewed (n = 827). During this period, while the number of studies assessing performance status (PS) increased from 15% in 1980 to 56% in 1995, the number of trials noting a QoL assessment increased only slightly, from 0% in 1980 to 3% in 1995. Moreover, only four of the 13 studies with a QoL evaluation met our criteria for adequate QoL assessment. Thus, despite an increasing interest in QoL, it is still rarely included as an objective in clinical trials, or adequately assessed.
本综述的目的是评估在过去15年中生活质量(QoL)评估纳入临床肿瘤试验的程度。对1980年、1985年、1990年和1995年发表在《临床肿瘤学杂志》《癌症》《英国癌症杂志》和《欧洲癌症杂志》上的所有II期和III期试验进行了回顾(n = 827)。在此期间,评估体能状态(PS)的研究数量从1980年的15%增加到1995年的56%,而记录有QoL评估的试验数量仅略有增加,从1980年的0%增加到1995年的3%。此外,在13项进行了QoL评估的研究中,只有4项符合我们对充分QoL评估的标准。因此,尽管对QoL的兴趣日益增加,但它在临床试验中仍很少被作为一个目标纳入,或得到充分评估。