From “black dot” to Web site, AAOS leads the way
Disclosing conflicts of interest has become an integral part of continuing medical education (CME) and, more generally, the practice of medicine. Recent public scrutiny of relationships between physicians and commercial entities has raised the stakes, turning “transparency” from a buzz word into a business imperative. The trend is toward increasing disclosure—not only of relationships that create conflicts of interest but also, in some instances, the amount in dollars and cents if the relationship is financial.
Understanding where this trend might be going and how to access AAOS disclosure resources is important. Disclosure enhances your ability to evaluate the Academy’s products and the scientific information presented at AAOS courses and meetings. In addition, you may find the Academy’s disclosure program useful in your own practice.
DOJ raised the stakes
The public disclosure required under the deferred and nonprosecution agreements signed by five major orthopaedic device manufacturers with the U.S. Department of Justice (DOJ) has led to more discussion about the relationships between orthopaedic surgeons and industry than ever before. Although the listings on company Web sites are required by the agreements, they reveal only a part of the story—physician names, cities, dollar amounts, and, in some cases, brief explanations of what payments were for. In certain categories, “direct payments” are separated from “in kind” payments for travel reimbursement, lodging, and meals.
A recent check of all five Web sites, however, shows that payments for intellectual property are not distinguished from consulting or other categories of payment. It should be noted that the American Academy of Orthopaedic Surgeons is listed on several sites, as a recipient of industry support for some of our programs.
The pioneering “black dot”
As early as 1985, the AAOS required presenters of scientific papers and instructional courses at the Annual Meeting to disclose whether they or their departments had received “something of value associated with product development or the content of their presentation….” Over the years, the Academy board of directors defined “something of value” in different dollar amounts ranging from a high of $500 to just $1, today’s standard.
Interestingly, the designation for a presenter who had received something of value was a black dot next to the title of the paper or the presenter’s name. The final program for the 1986 Annual Meeting says, “The Academy does not intend this identification to decrease the value of their presentations, or to imply bias. It is intended solely for the information of the listener.”
By the mid-90s, the black dot was not enough. The Accreditation Council for Continuing Medical Education (ACCME)—the body that accredits CME providers like the Academy—determined that various categories of disclosure were required. Its goal was to identify conflicts of interest and to distinguish between various types of conflicts. In complying with the ACCME Standards of Commercial Support, AAOS created the following categories:
- Research or institutional support
- Miscellaneous nonincome support (eg, equipment or services)
- Stock or stock options
- Consultant or employee
- Nothing of value received
Moreover, where conflicts exist, the names of companies must be included. “Something of value” is defined as anything of value. In addition, when faculty and authors are asked about conflicts, they must respond for themselves and any member of their family. Family is broadly defined—spouse, father, mother, son, daughter, domestic partner, children of the domestic partner, grandmother, grandfather, grandchild, brother, sister, aunt, uncle, niece, nephew, father-in-law, mother-in-law, brother-in-law, sister-in-law, daughter in-law, or son-in-law. That’s just about everybody.
The new program
Last year, the Council on Education created a computer-based disclosure program to streamline the disclosure process for faculty, editors, authors, media developers, staff, and anyone else who has any control of the educational content the Academy produces. The Board of Directors, in turn, adopted the system for capturing and sharing disclosures of all committee members.
In the 10 months since the system was implemented, more than 2,000 AAOS members have entered information on their relationships with industry, other organizations, and publishers into the database. In addition, nonmember presenters at courses and the Annual Meeting and 81 AAOS staff members have entered their disclosure information. Participants receive regular reminders (in April and October) to update their information or to confirm that what is in the system still is current.
Only AAOS members may view this information; the general public cannot.
Most entries do not include any financial details. But the Board of Directors decided that specific financial details should be available for each person working to develop AAOS guidelines, as well as for board members themselves. However, only a limited number of volunteers and staff, including the board itself, have access to this information.
The database enables AAOS committees to include disclosure information on their members in agenda books, so that any conflicts may be noted at any time during discussions. Many orthopaedic specialty societies also use the program for committee and faculty members. The information is also used in CME course planning to ensure a balanced faculty providing a range of views.
You can use the information as well. You may wish to encourage all members of your practice to enter their information, giving your practice a consistent disclosure system that is updated at least twice a year. Hospital committees might also find the AAOS database useful. A recent change in the program allows nonmembers to enter and update information, although they cannot view others’ data.
Where is all this going? I believe that pressure to disclose existing relationships will continue and may also focus on the specifics of the relationships, including the financial details. Whether within broad categories (“less than $10,000”) or as specific as down to the penny, transparency is here to stay. The AAOS disclosure program is a definitive step toward achieving it.
Mark Wieting is chief education officer for the Academy. He can be reached at email@example.com
Accessing the disclosure program
Where is the AAOS disclosure database? Who can view it? How much information is on display?
When you view a disclosure, remember that broad definition of “immediate family.” For example, I am in the system. If you were to review my information, you might be surprised to see that I have listed a conflict as a “paid consultant” with a particular company and stock holdings in that company. I don’t work for that company and have no stock in it. That disclosure involves my sister-in-law who works for the company.