In this lecture I talked about conflicts of interest. First I define conflicts of interest and then discuss whether conflicts of interest should be view as something good or bad. I provide examples on how interests can influence scientific results in the general medical and clinical literature and in orthopedics specific. I define the seven types of Interest conform the work of Elie Akl and propose a novel approach of dealing with interests in quantitative research.
4. How do we define conflicts of interest?
“a conflict of interest exists when a past, current or
expected interest creates a significant risk of
inappropriately influencing an individual’s judgment,
decision, or action when carrying out a specific duty”
Interest refers to a benefit (e.g., money received from industry) or to
an attribute of the individual (e.g., having specific religious beliefs).
5. When do you think this definition was published?
Two weeks ago..
6. Example of an expected CoIs:
Members of a guideline panel may be influenced to vote for a
strong recommendation in favor of a specific policy, hoping the
implementation of that recommendation would create more
opportunities for them as researchers to conduct studies on the
implementation of the policy.
Akl et al. 2022 JCE
10. We interpret our findings to indicate that financial conflicts of interest are associated
with favourable recommendations of drugs and devices in clinical guidelines,
advisory committee reports, opinion pieces, and narrative reviews.
11. “Since continuing medical education providers are financially dependent on medical
education and communication companies [which are sponsored by pharmaceutical or device
industries], their obligation towards maintaining the joint provider relationship raises the
spectre of a conflict of interest that impugns the integrity of the educational content.”
12. How about CoI reporting in preprints?
A majority of studies reported COI in both versions (69%) and 5% of these had authors
reporting more COI in the peer-reviewed version.
23% reported COI only in the peer-reviewed version.
13. Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014,
and 139 (19.5%) received research payments. The mean general payment was $28 136
(SD $415 045), and the mean research payment was $37 963 (SD $175 239).
The highest median general payments were received by journal editors from
endocrinology, cardiology, and gastroenterology.
15. Fifty-seven articles were included, 30 had a financial COI, while 27 did not.
Conflicted studies were more likely to report favorable outcomes than nonconflicted studies (P = 0.020).
Articles with COIs related to consultant fees (P = 0.003), research funding (P = 0.002), and stock ownership
(P < 0.001) were more likely to report favorable outcomes.
16. Of the 5898 spine surgeons, about 91.6% reported at least one financial relationship
with industry. The median total value of payments was $994.07. Surgeons receiving over
$1,000,000 from industry during the reporting period represented 6.6% of the database
and accounted for 83.5% of the total value exchanged. Orthopedic training, academic
practice setting, [and] male gender were associated with industry payments. Years of
experience was associated with lower number of payments from industry.
17.
18.
19. 42% of the editorial board members with a potential
conflict of interest reported a financial relationship of
more than $10,000 during the prior year.
22. There is a disconnect between self-reported and industry-
reported disclosure of industry payments to physician-authors
of RCT results of about 50%.
23. So far only been talking about financial conflicts…
but more complex are the non-financial conflicts.
24. None of the authors (out of 200 articles) reported individual
intellectual COIs or personal COIs.
28. Individual financial interests with direct
financial benefit may arise from:
any payment, research funding,
consultancy, advisory board membership,
and the like from the manufacturer of a
drug or device under consideration. This
type of interests may involve the individuals
themselves, their families or a business
they own.
Akl et al. 2022 JCE
29. Examples:
Grant; salary for research; contract; fellowship; unrestricted educational funding; peer-reviewed grant
funding.
Income related to former or current employment; stipend; salary.
Honoraria, royalties, personal endowment, fees for consulting, fees for proctoring, lectures, speakers’
bureaus, expert testimony, presentations, editorial work, manuscript preparation, trial involvement.
management, educational support, production of books, article research, scientific meetings,
entertainment, gift, charitable contribution, other affiliations.
Paid travel; writing assistance; administrative support; food and beverage
Bonds, stock options, equity, ownership
Akl et al. 2022 JCE
31. Individual financial interests with benefit
through professional status may arise when:
an individual is "engaged in a specified activity
as one’s main paid occupation".
Akl et al. 2022 JCE
32. Examples:
A dietician conducts a study looking at seeking
versus not seeking advice from a dietician.
A gastroenterologist involved in recommendations
on colonoscopy screening.
A thrombologist involved in recommendations on
establishing anticoagulation clinics.
Akl et al. 2022 JCE
34. Individual intellectual interests may arise
when:
an individual participates in a study that result
in a commitment to the findings of that study.
It can also arise when an individual adopts a
position and publicly expresses it in a
statement.
Akl et al. 2022 JCE
35. Examples:
Every involvement in a study, guideline panel,
textbook, review article, editorial, presentation on
your own intellectual interest..
Akl et al. 2022 JCE
37. Individual personal interests may arise when:
when an individual has personal opinions or
conditions that relate to his/her private life,
relationships, career or public life.
Akl et al. 2022 JCE
38. Examples:
An author with strong religious beliefs towards organ donation or abortion
participates on a guideline panel on that subject.
An author with a physical disability conducting a study on the benefit of
physical rehabilitation.
An editor of a journal has a positive relationship with authors of a
submitted manuscript.
A reviewer of a submitted manuscript has a negative relationship with the
authors or is an academic competitor for the same research topic.
Akl et al. 2022 JCE
40. Institutional financial interests may arise
when:
the institution, that the individual belongs to,
has an interest with the manufacturer of a
drug or device, or holds intellectual property
rights of programs, services, or products. For
such interest to qualify as a COI the individual
should be aware of it.
Akl et al. 2022 JCE
41. Examples:
The hospital holds intellectual property of a
selfmanagement manual for patients with COPD
Conduct of research within the institution that could
affect the value of its shares.
The government has stake holding or ownership in
commercial entities or has strategic collaborations
with commercial entities.
Akl et al. 2022 JCE
43. Institutional financial interests with
benefit through increasing services
provided by the institution may arise
when:
the institution, that the individual
belongs to, delivers and financially
benefits from providing specific services.
Akl et al. 2022 JCE
44. Examples:
A hospital makes significant profit by offering
services through its anticoagulation clinic.
Akl et al. 2022 JCE
46. Institutional cultural interests may arise
when:
the institution, that the individual
belongs to, focuses or funds
research on a specific topic or has
a specific cultural identity.
Akl et al. 2022 JCE
47. Examples:
A hospital that is invested in conducting a research
on minimizing blood transfusion; a research center
focused on cognitive behavioral therapy.
Institution known for its advocacy in a certain topic
as part of its mission, objectives, etc. Example of a
catholic university advocating for its religious
beliefs.
Akl et al. 2022 JCE
49. So… what to do when you think you or your
institution have a conflict of interest?
50.
51.
52. Interest Declaration Verification Risk
assessment A COI Management
Based on interest’s
• Relevance
• Nature
• Magnitude
• Recency
Not a
COI
Publication of declared interests
Akl et al. 2022 JCE
54. Definition of reflexivity:
“Attending systematically to the context of knowledge construction, especially to
the effect of the researcher at every step of the research process.”
Introduce reflexivity in quantitative research..
55.
56. Thank you for
your attention!
Image: https://operativeneurosurgery.com/doku.php?id=conflicts_of_interest