Hakamies-Blomqvist L, Luoma M L, Sjöström J, Pluzanska A, Sjödin M, Mouridsen H, Østenstad B, Mjaaland I, Ottosson S, Bergh J, Malmström P O, Blomqvist C
Swedish School of Social Science, University of Helsinki, Helsinki, Finland.
J Adv Nurs. 2001 Sep;35(5):709-16. doi: 10.1046/j.1365-2648.2001.01903.x.
To produce an empirical estimate of the nature and magnitude of the error produced by incorrect timing quality of life (QoL) measurements in patients receiving chemotherapy.
In a multicentre trial, 283 patients were randomized to receive either docetaxel (T) or sequential methotrexate and 5-fluorouracil (MF). The QoL was assessed at baseline and before each treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The study design was retrospective. Data were analysed using t-tests.
Erroneous timing affected the QoL findings in both treatment arms. At baseline, there were statistically significant differences in the MF group on the nausea/vomiting scale, with ill-timed assessment showing more symptoms, and in the T group on the physical functioning scale with ill-timed assessments indicating better QoL. The mean scores of correct vs. incorrect timings over the first 14 cycles showed statistically significant differences on several scales. In the MF group, ill-timed assessments indicated significantly worse physical functioning and global QoL, and significantly more of the following symptoms: fatigue, nausea/vomiting, insomnia, appetite loss, and constipation. In the T group, ill-timed assessment showed better physical functioning, less dyspnoea and more insomnia than correctly timed assessments. The reasons for erroneous timing were not always detectable retrospectively. However, in some cases the MF group, being in standard treatment, seemed to have followed a clinical routine not involving the active participation of the study nurse responsible, whereas patients in the experimental T group were more consistently taken care of by the study nurses.
Incorrect timing of QoL assessments in oncological trials jeopardises both the reliability of the QoL findings within treatment and the validity of QoL outcome comparisons between treatments. This issue should be emphasized in the planning of both the study design and clinical routines.
对接受化疗患者生活质量（QoL）测量时间不正确所产生误差的性质和程度进行实证估计。
在一项多中心试验中，283名患者被随机分为接受多西他赛（T）或序贯甲氨蝶呤和5-氟尿嘧啶（MF）治疗。使用欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30）在基线和每次治疗前评估生活质量。研究设计为回顾性。使用t检验分析数据。
错误的测量时间影响了两个治疗组的生活质量结果。在基线时，MF组在恶心/呕吐量表上存在统计学显著差异，测量时间不当的评估显示症状更多，而T组在身体功能量表上，测量时间不当的评估表明生活质量更好。在前14个周期中，正确与不正确测量时间的平均得分在几个量表上显示出统计学显著差异。在MF组中，测量时间不当的评估表明身体功能和总体生活质量显著更差，以及以下症状显著更多：疲劳、恶心/呕吐、失眠、食欲减退和便秘。在T组中，测量时间不当的评估显示身体功能更好，呼吸困难更少，但失眠比测量时间正确的评估更多。错误测量时间的原因并非总是能通过回顾性检测出来。然而，在某些情况下，处于标准治疗的MF组似乎遵循了一种不涉及负责的研究护士积极参与的临床常规，而实验性T组的患者则更持续地由研究护士照顾。
肿瘤学试验中生活质量评估时间不正确会损害治疗内生活质量结果的可靠性以及治疗间生活质量结果比较的有效性。在研究设计和临床常规的规划中都应强调这个问题。
