Mosconi P, Torri V, Cifani S, Ruggiata R, Meyerowitz B E, Apolone G, Liberati A
Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
Stat Med. 1998;17(5-7):577-85. doi: 10.1002/(sici)1097-0258(19980315/15)17:5/7<577::aid-sim805>3.0.co;2-3.
One of the main issues to be considered in conducting clinical trials concerns the presence of missing data. This aspect is particularly relevant in oncology longitudinal studies, characterized by a long follow-up, and especially in quality of life studies where there is still little knowledge about patients' characteristics that predict loss of data. Since the middle of the 1980s the GIVIO (Interdisciplinary Group for Cancer Care Evaluation) co-operative group has been involved in conducting quality of life assessment studies, also focusing on the development of some strategies aimed at the minimization of missing data. In this paper we report on the results of two trials, which are now completed, concerning the quality of life assessment in a sample of breast and colon cancer patients. In order to cope with the problem of missing data, in both the trials the strategy of follow-up mailing was adopted, which proved to be an effective way to increase the response rate by nearly 50 per cent at each time point.
开展临床试验时要考虑的主要问题之一是缺失数据的存在。这一问题在肿瘤学纵向研究中尤为重要,这类研究的特点是随访时间长,在生活质量研究中更是如此,因为对于预测数据缺失的患者特征,我们仍然知之甚少。自20世纪80年代中期以来,GIVIO(癌症护理评估跨学科小组)合作组一直参与开展生活质量评估研究,同时也专注于制定一些旨在尽量减少缺失数据的策略。在本文中,我们报告了两项现已完成的试验结果,这两项试验是关于乳腺癌和结肠癌患者样本的生活质量评估。为了解决缺失数据的问题,在这两项试验中都采用了随访邮寄策略,事实证明这是一种在每个时间点将回复率提高近50%的有效方法。