Research fundamentals: Selection and development of clinical outcome measures

Clinical outcomes measure patient health or well-being. The choice of an ou tcome measure for use in a clinical trial or study is complex. It is even m ore difficult when no appropriate outcome measure exists, necessitating the development of a novel one. The ideal clinical outcome should be credible, comprehensive, sensitive to change, accurate, biologically sensible, and f easible. This paper describes the attributes of clinical outcomes and illus trates how to develop novel outcomes, using as an example the authors' expe rience in developing a wound cosmesis outcome measure.