AHRQ Programs

1. AHRQ Programs Do Ask, Do Tell: Best Practices in Conflict of Interest Policies for Research, Publishing, and Recommendation-Making

2. AHRQ programs • National Guideline Clearinghouse/ National Quality Measures Clearinghouse • US Preventive Services Task Force • Evidence-based Practice Center program, including Technology Assessment program

3. US Preventive Services Task Force • Convened by AHRQ • 16 member non-Federal expert body with rotating membership • Reviews systematic reviews of evidence about the benefits and harms of preventive services • Three in person meetings per year, 3-5 topics voted per meeting

4. Conflict of Interest touchpoints • Membership on the volunteer body • Review of research support • For each clinical topic, specific report on potential conflicts with regard to • Financial (also family COI) • Business, or • Intellectual interests

5. National Guideline Clearinghouse & National Quality Measures Clearinghouse • AHRQ-sponsored database-driven Web sites • Data derived from public, private sector organizations’ guidelines and measures • Data field captures COI information as reported by organization that developed guidelines or measures • Supported by an Editorial Board

6. Conflict of Interest touchpoints Editorial Board • Contractor required to identify and manage board member COI • Financial, business, professional • Guideline/measure development involvement • Family member COI • Require authors of expert commentaries to declare COI • Financial, business, professional • Family member COI

7. Evidence based Practice Center Program • Contract research • 17 North American EPCs • COI addressed with individual task orders • All key personnel • Financial and other conflicts

8. Case Study #1: Intellectual Conflict of Interest

9. Background • AHRQ commissions a report on comparative effectiveness of drugs for heart failure. • The contractor would like to include a cardiologist on the team who had written an editorial that was critical of the design of a key study for one of the drugs. • The study was sponsored by a pharmaceutical company that manufacturers the drug. • The cardiologist has no financial conflicts of interest with any pharmaceutical company.

10. Questions for the Audience • Does the cardiologist have a conflict of interest because she publicly expressed her assessment of the literature prior to the initiation of the project/contract? • Does it matter that the criticism was focused on a single drug/pharmaceutical company?

11. You be the Judge A. The cardiologist should not be considered to have a conflict of interest B. The cardiologist should be considered to have a conflict of interest, the cardiologist can still participate as a co-investigator as long as the conflict is disclosed C. The cardiologist should not participate on the project because of the conflict

12. Variations for Discussion • The editorial was commissioned as part of the pro/con debate series in the journal. The cardiologist agreed to write the editorial as a “devil’s advocate”, but prior to writing the editorial had not expressed an opinion about the study. • The editorial was not focused on a single drug/pharmaceutical company, but contained a critique of the entire class of drugs. • Not only did the cardiologist write an editorial, but she has spoken many times at professional meetings criticizing the one particular study sponsored by the pharmaceutical company.

13. Do Any of the Variations Change how you would Vote? A. The cardiologist should not be considered to have a conflict of interest B. The cardiologist should be considered to have a conflict of interest, the cardiologist can still participate as a co-investigator as long as the conflict is disclosed C. The cardiologist should not participate on the project because of the conflict

14. Case Study #2: Conflicts of Interest Caused by Professional Affiliation

15. Background • AHRQ commissions a report on the effectiveness of a particular imaging test in determining recurrence of breast cancer. • The contractor would like to include a radiologist on the team as the clinical expert. • As part of a typical clinical practice week, the radiologist might perform or provide about five of these imaging tests to breast cancer patients on average. • While there are three different manufacturers of imaging systems, all with somewhat different characteristics, this radiologist owns only one of these systems, and in fact [self-] refers patients to be studied on the equipment that he owns. • The radiologist has no financial conflicts of interest with any of the manufacturers of the imaging equipment.

16. Questions for the Audience • Does the radiologist have a conflict of interest because part of his income is derived from this imaging service? • If professional interests such as this are considered a conflict, what are the best methods for AHRQ to get input on highly technical details of medical interventions? Would including an oncologist on the team be adequate to balance the potential professional conflict? Should the team include radiologists who perform tests on equipment manufactured by other companies?

17. You be the Judge A. The radiologist should not be considered to have a conflict of interest B. The radiologist should be considered to have a conflict of interest and his professional interest should be disclosed C. The radiologist should not participate on the project because of the conflict

18. Variations for Discussion • The radiologist specializes in this particular test for breast cancer, and 90% of his practice is made up of providing this test to breast cancer patients • The radiologist does not provide this particular imaging test, but learned the principles in residency five years ago. What are the pluses and minuses of including experts with different levels of clinical experience as part of the project team?

19. Do Any of the Variations Change how you would Vote? A. The radiologist should not be considered to have a conflict of interest B. The radiologist should be considered to have a conflict of interest and his professional interest should be disclosed C. The radiologist should not participate on the project because of the conflict

20. Case Study #3: Conflicts of Interest Caused by Institutional Conflicts

21. Background • AHRQ commissions a report on drugs for asthma in children. • The contractor includes on the team a Fellow in pulmonology who is just beginning his career; he has no financial interests with any company that produces drugs for asthma. • Right after the contractor begins working on the project, other asthma researchers at the university publish the results of a large clinical study comparing the drugs (for asthma in kids) from two different pharmaceutical companies in NEJM.

22. Background cont. • The study is funded by only one pharmaceutical company, and the results of the study show a statistically significant benefit for the drug produced by the company that funded the study. • While the Fellow had no involvement in the study, the PIs of the study are very well known in the field and are faculty mentors to the Fellow. • The methodologists on the AHRQ report are in a different department and have never met the PIs of the study.

23. Questions for the Audience • Does the Fellow have a conflict of interest because of his working relationship with the PIs of the study? If this is the case, what would be the wording of the disclosure? • Do the methodologists (in the different department) also have an institutional conflict of interest?

24. You be the Judge A. The Fellow should not be considered to have a conflict of interest B. The Fellow should be considered to have a conflict of interest and disclosure is necessary C. The Fellow should not be part of the project; the team should include an expert from a different institution D. The entire institution should be considered to have a conflict of interest and the project should be assigned to a different contractor

25. Variations for Discussion • The pharmaceutical company was very pleased with the results of the study, and has pledged several million dollars to buy new state-of-the-art equipment for the pulmonology department. • One of the principle investigators in the study is the chair of the promotion and tenure committee. • The pulmonology department has 15 senior faculty and many different studies in progress funded by government and many different industry sources.

26. Do Any of the Variations Change how you would Vote? A. The Fellow should not be considered to have a conflict of interest B. The Fellow should be considered to have a conflict of interest and disclosure is necessary C. The Fellow should not be part of the project; the team should include an expert from a different institution D. The entire institution should be considered to have a conflict of interest and the project should be assigned to a different contractor