Steven C Stain, MD, Erin Schwarz, Phillip Shadduck, MD, Paresh Shah, MD, Sharona B Ross, MD, Patricia Sylla, MD, Yumi Hori, C D Smith, MD. Albany Medical College, Albany, NY; BSC Management, Los Angeles CA; Duke Regional Hospital, Durham NC; New York University, NY NY; Florida Hospital Tampa, Tampa FL, Massachusetts General Hospital, Boston MA, Mayo Clinic Jacksonville, Jacksonville FL.
Introduction
The relationship between SAGES, its member surgeons and industry has been longstanding, productive technologically, and beneficial to patient care and education. In order to both maintain this important relationship as well as to honor its responsibility to society for increasing transparency, SAGES established a Conflict of Interest Task Force (CITF) and charged it with identifying and managing potential conflicts of interest (COI) and limiting bias at the SAGES Annual Scientific Meetings. To fulfill this responsibility, the CITF developed and implemented a comprehensive process for reporting, evaluating, and managing COI in accordance with ACCME guidelines.
Methods
From 2011 to 2013, all presenters, moderators and session chairs received proactive and progressively increasing levels of education regarding the CITF rationale and processes. All presenters and faculty at the Annual Meeting (faculty, session directors, session moderators, course chairs, and program chairs) were required to disclose all relationships with commercial interests. All disclosures were reviewed and discussed by multiple layers of reviewers, including moderators, chairs, and CITF committee members. Tiered, prescribed actions were implemented in a standardized, uniform fashion (table below).
Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | |
Nothing to Disclose | Non-relevant Relationship | Relevant Relationship | Relationship with Ownership Interest | Employee of commercial interest | |
Action by SAGES | Review for Accuracy | Review by Moderator & CITF | Peer Review required prior to Presentation, with changes to Presentation as appropriate | Automatic Peer Review prior to Presentation, with changes to Presentation as appropriate | Presenter Removed from Faculty |
Resulting Actions | Print & Present Disclosures | Print & Present Disclosures | Letter to Faculty Explaining Policy; Print & Present Disclosures |
Letter to Faculty Explaining Policy; Print & Present Disclosures |
Presentation not Allowed |
All attendees at the Annual Meetings were strongly encouraged to complete anonymous surveys regarding perceived biases. The CITF database was then analyzed and compared to the reports of perceived bias to determine if the implementation of this comprehensive process had been effective.
Results
Number of faculty, presenters, moderators, and chairs | Number of faculty, presenters, moderators, and chairs | Resolved by CITF | Presentations Reviewed in Advance of Mtg | Changes made to presentation | Speaker Replaced | Reported Bias by Attendees | |
No industry relationships | Yes industry relationships | ||||||
2011 | Data not avail | Data not avail | 6 | 0 | 0 | 18/802 2.2% | |
2012 | 350 | 173 | 124 | 49 | 8 | 1 | 10/797 1.2% |
2013 | 264 | 190 | 103 | 93 | 20 | 0 | 11/717 1.5% |
In the three years prior to the implementation of this process, reporting of bias by meeting attendees was 20/427 (4.7%) in 2008, 37/596 (6.2%) in 2009, and 38/856 (4.4%) in 2010. Following implementation of this process, reports of bias were reduced to 1.2-1.5%.
Conclusion
It is possible to have a surgical meeting that includes participation of speakers that have industry relationships. Implementation of a comprehensive, standardized process for reporting, evaluating, and managing COI resulted in a reduction of perceived reports of bias from 4.4-6.2% to 1.2-1.5%, as reported by annual meeting attendees in anonymous surveys.