Research fundamentals: selection and development of clinical outcome measures

Clinical outcomes measure patient health or well-being. The choice of an outcome measure for use in a clinical trial or study is complex. It is even more 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 feasible. This paper describes the attributes of clinical outcomes and illustrates how to develop novel outcomes, using as an example the authors' experience in developing a wound cosmesis outcome measure.