Methodologic requirements for assessing surgical procedures in current medical literature.

Even though, in theory, a new surgical technique should traverse all the stages established for drugs before being introduced into medical practice, it is suspected that many surgical procedures are utilized without having rigorously evaluated their efficacy and safety. With the aim of identifying the methodologic aspects currently employed for assessing new surgical procedures, a descriptive bibliographic study was carried out. Altogether, 75 journal articles published from 1996 to 1998 were reviewed. The papers must have come from studies carried out with the expressed objective of evaluating a surgical procedure and were selected through MEDLINE or directly from six prestigious medical journals (three specifically surgical and three general). Of the reviewed articles, 47% were retrospective studies, and the rest were prospective studies. More than 40% of the retrospective studies omitted some basic methodologic features, namely a description of the patients' source or a definition of the inclusion criteria. Among the 41 prospective articles, only 35 used a control group and 15 did not employ random allocation. Other basic issues, such as the sample size or inclusion of prognostic factors in the analysis, were present in fewer than 50% of the articles. It seems there is consensus about admitting that rigorous assessment of new surgical treatments should be an unavoidable condition before introducing such treatment into practice. The facts demonstrate that this principle is not being followed.