FORMAT-INDEPENDENT DATA-COLLECTION FORMS

Good form design is generally acknowledged to be a key element of clin ical trials and follow-up studies. Although some data are collected di rectly from automated equipment, most measurements, examination findin gs, and interview responses require at least one manual transcription, either onto paper forms or directly into a computer. Regardless of th e transcription method adopted, there is broad agreement that the qual ity of study data depends strongly on the format and layout of the dat a collection instruments. The task of form design and production is co mplicated by two facts: first, a series of different forms is needed e ven 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 con cept (format independence) aimed at simplifying the design and revisio n of data collection forms; (2) explains how a feature (styles) presen t in most word processing software can be used to implement the concep t; (3) discusses the advantages and disadvantages of a format-independ ent approach as compared to more traditional form development tools; a nd (4) describes the environment that prompted this approach to form d evelopment.