The practical and ethical defects of surgical randomised prospective trials

Abstract

This paper presents a strong criticism of the current enthusiasm for clinical randomised prospective studies in surgery. In the process, the author probes the 'intellectualism' or lack thereof in present day surgical attitudes. The subjects are examined against a framework of ethics and inescapable dilemmas. Ways of correcting the more obvious weaknesses are suggested. The manuscript is, and is meant to be, provocative and is particularly aimed at the academic audience served by this journal.

KIE: Despite current enthusiasm for clinical randomized prospective studies in surgery, Byer, himself a surgeon, sees little merit in this method of evaluating experimental procedures. Problems in selection of patient populations, data collection and evaluation, the rigidity of protocol requirements, and the danger of obsolescence before completion of a study may expose patients to unnecessary risks and create ethical dilemmas for physicians. In his brief commentary, Baum, also a surgeon, vigorously defends randomized controlled trials and criticizes Byer's approach to scientific inquiry, which favors small study groups, case reports, and other "anecdotal" observations.