Alternatives to randomized trials in clinical research

Abstract

Although prospective randomized trials are the gold standard for evidence in clinical research, they usually are too costly and complicated to warrant their routine use in addressing most questions in hand surgery. Nonrandomized study designs generally are more feasible and although they provide less evidence than the prospective randomized trial, well-planned investigations using these methodologies can be informative. The key consideration for the clinical researcher is in recognizing the limitations of each study design and asking an appropriate research question. This article reviews some study designs that can be considered alternatives to randomized trials in evaluating issues relating to treatment, prognosis, outcome, cause, and diagnosis in hand surgery.