disclosure of financial conflicts of interest in continuing medical education michael d. jibson, md,...
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Disclosure of Financial Conflicts of Interest in Continuing Medical Education
Michael D. Jibson, MD, PhD and Jennifer Seibert, MDUniversity of Michigan Department of Psychiatry
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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) Disclosure Medium Disclosure High DisclosureCompany A Speaker Company B Consultant >5% Company B Consultant 25%Company B Consultant Company C Speaker >5% Company C Speaker 6%Company C Speaker Company A Speaker <5% Company A Speaker 1%
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.
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.
AbstractAbstract
IntroductionIntroduction
DiscussionDiscussion
Future DirectionsFuture Directions
MethodsMethods
ResultsResults
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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
3.0 2.53.5
Attendee Rating of Disclosures
Too MuchToo Little
Difference between Attendee and Peer Bias Scores
P=0.004 P=0.007
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Average Bias Ratings for All Speakers
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Medium
Low