Format-independent data collection forms

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.