Singer S W, Meinert C L
Dedicated Response, Columbia, Maryland 21045, USA.
Control Clin Trials. 1995 Dec;16(6):363-76. doi: 10.1016/s0197-2456(95)00016-x.
Good form design is generally acknowledged to be a key element of clinical trials and follow-up studies. Although some data are collected directly from automated equipment, most measurements, examination findings, and interview responses require at least one manual transcription, either onto paper forms or directly into a computer. Regardless of the transcription method adopted, there is broad agreement that the quality of study data depends strongly on the format and layout of the data collection instruments. The task of form design and production is complicated by two facts: first, a series of different forms is needed even when the period of follow-up is short; and second, form design is an ongoing process that starts before the first person is enrolled and continues over the course of the trial. This paper (1) presents a concept (format independence) aimed at simplifying the design and revision of data collection forms; (2) explains how a feature (styles) present in most word processing software can be used to implement the concept; (3) discusses the advantages and disadvantages of a format-independent approach as compared to more traditional form development tools; and (4) describes the environment that prompted this approach to form development.
良好的表格设计通常被认为是临床试验和随访研究的关键要素。尽管有些数据是直接从自动化设备收集的，但大多数测量结果、检查发现和访谈回答都至少需要一次人工转录，要么转录到纸质表格上，要么直接录入计算机。无论采用何种转录方法，人们普遍认为研究数据的质量在很大程度上取决于数据收集工具的格式和布局。表格设计和制作任务因两个事实而变得复杂：其一，即使随访期很短，也需要一系列不同的表格；其二，表格设计是一个持续的过程，在第一个人入组之前就开始，并在试验过程中持续进行。本文（1）提出了一个旨在简化数据收集表格设计和修订的概念（格式独立性）；（2）解释了如何使用大多数文字处理软件中都有的一个功能（样式）来实现这一概念；（3）讨论了与更传统的表格开发工具相比，格式独立方法的优缺点；（4）描述了促使采用这种表格开发方法的环境。
