Is Surgical Innovation Reduced with More Strict Regulations?

Abstract

Objective

With ever-increasing regulatory requirements on human subject research, we postulated that there would be a corresponding decline in the number of published reports of surgical innovation in the otolaryngology literature.

Methods

We defined innovations as new procedures, techniques, or approaches that should require IRB approval in 2007, and modifications as non-substantive changes in existing procedures or techniques that should not require IRB approval. We reviewed every abstract from 4 months of the years 1988 and 2006, from the journals Laryngoscope, Oto-HNS, and Archives. After identifying information was concealed, abstracts were reviewed and classified independently by two authors, for innovation, modification, or neither. All disagreements were judged by a third author, who reviewed the entire article. Proportions were compared using chi-square analysis.

Results

There were 367 publications reviewed from 1988, and 548 from 2006. The proportion of articles representing either innovation or modification was significantly lower in 2006 than 1988: 59/548 (10.8%) vs. 67/367 (18.3%), p<0.001. Eliminating radiology and pathology quiz cases yielded similar results: 11.1% vs. 18.9%, p<0.001. Very few articles (4 total) were classified as innovation.

Conclusions

The proportion of published studies describing surgical innovations and modifications was significantly lower in 2006 than in 1988. One cause of this decrease in innovation could be increased barriers for research approval in the current era. However, other explanations are plausible, such as increased publication of other study types, e.g., basic research. While our analysis does not prove cause and effect, it is an important finding that deserves further study.