Reduction in surgical innovation, 1988 to 2006

Objective: We hypothesize that increasing regulation of human subject research has reduced the number of published reports of surgical innovation in otolaryngology. Study Design: A systematic review of a predetermined subset of otolaryngology literature. Methods: We randomly selected half of the articles published in 1988 and 2006 in three prominent journals. After identifying information was concealed, abstracts were classified independently by two authors into three groups: innovation, modification, or neither. Disagreements were resolved by a third author who read the entire article. Proportions were compared with χ² analysis. Results: The proportion of articles classified as innovation or modification decreased significantly from 67 of 367 (18.3%) in 1988 to 59 of 548 (10.8%) in 2006 (P = 0.001). The elimination of radiology and pathology quiz cases yielded similar results: 11.1 percent vs 18.9 percent, P = 0.001. Innovation or modification in animal model research also decreased (0.9% vs 3.8%, P = 0.003). Overall, only 4 articles were actually classified as true innovation. Conclusions: The frequency of true innovation was low in both years, but articles that described surgical modifications decreased significantly over this 18-year period. One reason may be increased administrative barriers for clinical research approval. Although our analysis cannot determine cause and effect, it is an important finding that deserves further study.