Avoiding real and apparent conflicts of interest is a fundamental principle of guideline development, but what should we do when every thought leader is conflicted? An example of this conundrum in rheumatology has been the ACR’s ongoing effort to establish guidelines for the management of lupus nephritis, which has been stymied by the fact that most experts in the field have led or participated in clinical trials funded by industry. Can this dilemma be resolved?
What is a conflict of interest (COI)? In 2009, the Institute of Medicine published its seminal report, Conflict of Interest in Medical Research, Education and Practice.1 To paraphrase its definition:
A conflict occurs when a set of circumstances or relationships increases the risk that primary interests (e.g., protecting the integrity of research or the welfare of patients) will be neglected because of secondary interests (e.g., research funding, consulting fees, honoraria, favors to friends, family, students or colleagues). It is the set of circumstances, rather than any particular decision, that creates the conflict. There is no implication that any individual is improperly motivated.
A systematic literature review found favorable recommendations for drugs or devices were 26% more likely when members had financial COI, and for opinion pieces the relative risk was more than double.2 Having financial links with multiple companies doesn’t cancel the conflict of interest because multiple sources often push in the same direction.3
Self-citation and confirmation bias: Bias need not be directly motivated by financial gain. Robert DeBroff, in his essay on confirmation bias and COI, quotes the ancient Greek historian Thucydides: “for it is a habit of mankind to entrust to careless hope what they long for, and to use sovereign reason to thrust aside what they do not fancy.”4
Confirmation bias includes citing evidence that validates one’s own beliefs while ignoring or misrepresenting evidence to the contrary.4 This is the strongest argument for taking an evidence-based approach to clinical practice guidelines, but many decisions in clinical care and in research are close calls, and in rheumatology, the level of evidence supporting decision making often depends on expert opinion, previous experience or isolated case reports/case series. Clinical practice guidelines will be accepted as valid only if those participating in the work are trusted to be impartial.1
The methodology used to create clinical practice guidelines, such as employing methodological experts, systematically reviewing the literature and linking recommendations to the evidence, can help mitigate COI.