Research methods for surgeons: an overview.

Abstract

The purpose of this paper is to outline a number of salient features in the design and conduct of clinical research in surgery. The key features emphasized are the need for clarity in the elaboration of study hypotheses, clear definition of the variables involved in the study, particularly the outcome variables, the need to confront the issue of bias and confounding, and a review of methodological issues associated with specific components in the research process. Particular attention is paid to patient selection, allocation of patients to experimental and control groups, randomization, problems of co-intervention and contamination, a brief discussion of analytic issues, and the critical importance of getting appropriate design and other methodological assistance prior to initiating a study. A short bibliography providing the reader with more in-depth discussions of the issues raised here is provided. It is the intention of this paper to introduce surgeons undertaking clinical research to these important methodological issues so that they can utilize appropriate consultative services more effectively.