1. Disclosure of Financial Conflicts of Interest in Continuing Medical Education Michael D. Jibson, MD, PhD and Jennifer Seibert, MD University of Michigan Department of Psychiatry Introduction: Significant controversy exists as to whether current ACCME regulations regarding financial disclosure by CME speakers is adequate to ensure the objectivity of information presented, but few data are available in this area. The purpose of this study was to determine what level of information regarding speakers’ conflicts of interest is preferred by CME conference attendees, and whether the degree of disclosure assists attendees in assessing the objectivity of information presented. Methods: Three speakers at a University of Michigan CME conference were invited to provided more detailed financial disclosures than are required by the ACCME. Attendees at these conferences were randomly selected to receive one of three levels of disclosure and were surveyed regarding their opinions of the disclosure and the objectivity of the program. Attendees’ responses were compared with those of peer reviewers. Results: All speakers agreed to disclose their conflicts of interest, which ranged from 5-30% of their total income. Attendees preferred an intermediate level of disclosure. Attendees receiving medium and high levels of disclosure tended to rate objectivity closer to peer reviewers. Conclusion: Higher levels of disclosure are preferred by attendees at CME conferences and may assist attendees in assessing the objectivity of information presented at these programs. Speakers at CME conferences supported by the University of Michigan Department of Psychiatry were invited to provide more detailed financial disclosures than are required by the ACCME. Attendees at these conferences were randomly selected to receive either the minimum information required by the ACCME or one of two higher levels of disclosure. The medium level of disclosure listed companies in order of how much money had been received from each and whether it represented more or less than 5% of the speaker’s total income. The highest level of disclosure listed each company and the percent of the speaker’s income derived from that company in the last 12 months. Hypothetical examples are shown below. Low (Standard) DisclosureMedium DisclosureHigh Disclosure Company ASpeakerCompany BConsultant>5%Company BConsultant25% Company BConsultantCompany CSpeaker>5%Company CSpeaker6% Company CSpeakerCompany ASpeaker<5%Company ASpeaker1% Attendees were asked to describe their professional training (e.g., MD, PhD, etc), level of experience with the topic of the conference, their satisfaction with the disclosure they received, and their rating on the objectivity of the information presented on a 1-5 scale, with 1 being no bias and 5 being extreme bias. Peer reviewers with established expertise in the topic of the conference were asked for a similar assessment of the speakers’ objectivity. Significant concern exists about the influence of the pharmaceutical industry on the practice of medicine. Patient opinion surveys indicate that patients believe physicians should receive their education from independent sources (84%) and that ties between physicians and the pharmaceutical industry should be transparent (96%). 1 Extensive research has been undertaken to elucidate the role of pharmaceutical industry sponsorship in the objectivity of medical journal content, 2 and guidelines for interactions with industry that aim to eliminate competing interests have been implemented to preserve the integrity of medical education. 3 The Accreditation Council for Continuing Medical Education dictates the level of disclosure of financial conflicts of interest required by speakers at continuing medical education programs. 4 Significant controversy exists as to whether current ACCME regulations regarding disclosure of the involvement of CME speakers with industry are adequate to ensure the objectivity of information presented. 5,6 Few data are currently available to guide educators, institutional leaders, and professional organizations in establishing policies in this area. This study is intended to determine what level of information regarding speakers’ conflicts of interest is preferred by CME conference attendees, as well as to elucidate what level of financial disclosure is optimal to allow learners to assess the objectivity of information. It is hypothesized that higher levels of disclosure will be preferred by attendees and will assist them in more accurately assessing the objectivity of information. Despite having significant contacts with industry, all speakers in this study agreed to provide detailed disclosures. The overall level of bias in the presentations was judged by peers reviewers and attendees to be low, limiting the generalizability of these data. The possibility that speakers altered their behavior after giving detailed disclosures cannot be ruled out (and may provide an additional mechanism to improve the objectivity of CME programs). Attendees who received intermediate and high levels of disclosure rated the objectivity of CME presentations more consistently with peer reviewers. When averaged across all speakers, lower levels of financial disclosure were correlated with lower ratings of objectivity, irrespective of the rating of peer reviewers. Attendees receiving the intermediate level of disclosure expressed the most satisfaction with the information, whereas those with the low level felt they had too little and those with the high level too much. These data represent the first attempt to measure the impact of financial disclosure on the ability of CME participants to assess the objectivity of information provided and represent pilot data for further study. A larger data set will be required to confirm these preliminary findings. APA, ACCME, and an independent medical education company have expressed interest in the study and agreed to provide support for the survey during CME conferences they sponsor (APA has already done so). Comparison of presentations by speakers who are not approached for this study or who decline to provide a disclosure with those whose detailed disclosures are available will help determine if the process of disclosure contributes to more objective teaching. References 1. Eaton L. Readers want transparency in link between doctors and drug firms. BMJ. 326;1352. 2003. 2. Lexcin J. Bero L. Djulbegovic B. Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 326;1167-1176. 2003. 3. Coleman D et al. Guidelines for Interactions between Clinical Faculty and the Pharmaceutical Industry: One Medical School’s Approach. Academic Medicine, vol 81, No 2, 154-159. 4. ACCME Standards for Commercial Support : Standards to ensure the Independence of CME Activities. http://www.accme.org/index.cfm/fa/Policy.policy/Policy_id/9456ae6f-61b5- 4e80-a330-7d85d5e68421.cfm, accessed 9/21/06. http://www.accme.org/index.cfm/fa/Policy.policy/Policy_id/9456ae6f-61b5- 4e80-a330-7d85d5e68421.cfm 5. Lemmens T, Singer PA. Bioethics for clinicians: 17. Conflict of interest in research, education and patient care. Canadian Medical Association Journal. 159;960-65, 1998. 6. Steward DE. A proposal to enhance the disclosure of potential conflict of interest for continuing medical education events. Teaching and Learning in Medicine. 15;267-269, 2003. Abstract Introduction Discussion Future Directions Methods Results h Three speakers were asked for financial disclosures and all consented. Their level of involvement with industry ranged from 5-30% of their income. The survey response rate was 83.3% (135 of 162 surveys); 71.9% (97) of respondents were physicians; 86.7% (117) were prescribers (MD, DO, PA, NP). The average rating of bias by peer reviewers for the 3 speakers was 1.17 (range=1.00-1.33). All figures compare the responses of attendees who received low, medium, and high levels of disclosure 3.02.53.5 Attendee Rating of Disclosures Too MuchToo Little Difference between Attendee and Peer Bias Scores P=0.004 P=0.007 * * Average Bias Ratings for All Speakers High Medium Low