Indiana University SPEA Edward J. Bloustein School of Planning and Public Policy University of Pennsylvania AIR American University

Panel Paper: Some Institutional Factors Contributing to the Weak Evidence Base in Clinical Medicine

Thursday, November 12, 2015 : 2:25 PM
President's Room (Hyatt Regency Miami)

*Names in bold indicate Presenter

Jan Blustein1, Danil V. Makarov1 and Cary P. Gross2, (1)New York University, (2)Yale University
We might expect that effectiveness in medicine would be well understood, given the NIH annual budget of $30.3 billion, and the strong research infrastructure at elite medical schools.  In fact, medical care rests on a slim evidence base, and few practices have been subjected to randomized controlled trial [RCT] evaluation.   In this paper, we examine the gap between practice and evidence in the case of surgical devices.  We focus on the surgical robot, a device that allows surgeons to perform complex procedures through small operative skin incisions. In 2001, the robot was approved by US Food and Drug Administration [FDA] for surgical treatment of prostate cancer.   At the time of approval, it was known that the robot was 'safe,' but it was not known whether robotic prostatectomy offered better clinical outcomes than traditional open surgery. In two quantitative studies, we examine the role of Academic Medical Centers [AMCs] in (1) catalyzing adoption; and (2) building an evidence base on the comparative effectiveness of robotic versus conventional approaches.  We find that AMCs "led the charge" toward widespread adoption, but faculty failed to contribute anything like a methodologically robust test of comparative effectiveness.   Today the technology is essentially locked in, with more than 80% of radical prostatectomies in the US performed robotically. In our discussion, we highlight institutional factors that contribute to the paucity of research on surgical devices, and suggest changes that might improve the evidence base for these costly technologies.