Sloan J A, Loprinzi C L, Kuross S A, Miser A W, O'Fallon J R, Mahoney M R, Heid I M, Bretscher M E, Vaught N L
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
J Clin Oncol. 1998 Nov;16(11):3662-73. doi: 10.1200/JCO.1998.16.11.3662.
We report on a clinical trial developed to compare four different instruments that provide overall quality-of-life (QOL) scores, ranging from a simple, one-item instrument to more detailed instruments. Two issues addressed were (1) Will QOL tools suffer from missing data when used in a community-based cooperative group setting?, and (2) Are there additional data generated by a more detailed multiitem instrument over that provided by a single-item global QOL question?
A four-arm randomized trial was designed to compare four instruments that provide overall QOL scores in patients with advanced colorectal cancer. Patients and physicians completed the single-item Spitzer Uniscale (UNISCALE) at baseline and monthly. Patients were randomly assigned to complete, in addition, either the 22-item Functional Living Index-Cancer (FLIC), the five-item Spitzer QOL index (QLI), a picture-face scale (PICT), or nothing else.
A total of 128 patients were randomized. Greater than 90% complete QOL data were obtained. There was strong correlation, concordance, and criterion-related validity among all four patient-completed tools. The UNISCALE had a greater decrease over time than did the FLIC (P=.005), which suggests a greater sensitivity; the UNISCALE was similar to the QLI and the PICT in this regard. Physicians provided lower UNISCALE scores than patients. Results supported the hypothesis that QOL is prognostic for survival.
Patients can effectively complete QOL tools in a cooperative group setting with proper education of health care providers and patients. A simple single-item tool (UNISCALE) appears to be appropriate to obtain a measure of overall QOL.
我们报告了一项临床试验，该试验旨在比较四种不同的工具，这些工具可提供总体生活质量（QOL）评分，范围从简单的单项工具到更详细的工具。探讨的两个问题是：（1）在基于社区的合作组环境中使用时，生活质量工具会受到缺失数据的影响吗？（2）与单项总体生活质量问题相比，更详细的多项目工具是否会产生额外的数据？
设计了一项四臂随机试验，以比较四种为晚期结直肠癌患者提供总体生活质量评分的工具。患者和医生在基线时及每月完成单项斯皮策简明量表（UNISCALE）。此外，患者被随机分配完成22项癌症功能生活指数（FLIC）、五项斯皮策生活质量指数（QLI）、图片面部量表（PICT），或不完成其他任何量表。
共有128名患者被随机分组。获得了超过90%的完整生活质量数据。所有四种患者完成的工具之间存在很强的相关性、一致性和与标准相关的效度。随着时间的推移，UNISCALE的下降幅度大于FLIC（P = 0.005），这表明其敏感性更高；在这方面，UNISCALE与QLI和PICT相似。医生提供的UNISCALE评分低于患者。结果支持了生活质量是生存预后指标的假设。
在对医疗保健提供者和患者进行适当教育的情况下，患者能够在合作组环境中有效地完成生活质量工具。一个简单的单项工具（UNISCALE）似乎适合用于获得总体生活质量的测量。
