A recent study in the New England Journal of Medicine (NEJM) found that Americans’ trust in medicine has declined significantly over the past few decades. In fact, it’s at an all-time low: just 23 percent of people in the U.S. have “great confidence” in doctors (down from 73 percent in 1966).
The NEJM authors believe that some of the frustration may relate to the very public disagreements between “experts”—specialty societies, expert panels convened by the government, and researchers who build and report the evidence—on what should be done, for whom, and when, in routine clinical practice.
This issue has come to light again recently with the release of the American Cancer Society’s (ACS) new guidelines on breast cancer screening. In this updated guideline, the ACS expresses their concerns about the intense debate that has formed around breast cancer screening recommendations.
Clinical Practice Guidelines
In an effort to guide the public through the current maze of clinical guidelines—and build greater trust in the medical community in the process—the Institute of Medicine (IOM) issued a report in 2011 called “Clinical Practice Guidelines We Can Trust.” The report made several recommendations intended to standardize clinical guidelines, of which two were key: guidelines should be based on a sound summary of the best and most current research, and the guideline developers should not be biased.
The IOM (now called the National Academy of Medicine or “NAM”) set an especially high bar with its recommendations on bias by broadening the definition of “conflict of interest” to include intellectual, professional, or values-related conflicts. This definition was expanded largely because the experts writing today’s guidelines often have something to gain if the guidelines support their particular specialty or clinical practice.
The good news: the clinical research community has made some strides meeting the standards set by the IOM in 2011. Case in point, organizations such as the ACS, the U.S. Preventive Services Task Force (USPSTF), and the American College of Physicians base their recommendations on high quality systematic evidence reviews.
The bad news: biases and conflicts of interest in the creation of guidelines remain both complicated and widespread.
What Should Be Done?
In the absence of unbiased clinical guidelines, should doctors and patients just create their own treatment plans?
Not exactly. I think the solution is actually two-pronged.
First, patients and their doctors must recognize that—-when it comes to clinical guidelines—one size does not fit all. There will always be individual characteristics or circumstances—such as comorbidities, medical history, personal preferences, and access to care—that will alter the recommendations for a specific patient. Encouraging patients to discuss those circumstances and risk factors with their doctors is the best strategy we have so far. Organizations such as the ACS and the USPSTF already incorporate shared decision making into their recommendations, and I hope others begin to do so as well.
Second, as clinicians and their patients review updated guidelines, I encourage them to follow the IOM framework by asking questions such as:
- Will the guideline developers benefit financially if their guidelines are implemented? In other words, are they advocating for a service they provide?
- Have they detailed explicitly and publicly how their guidelines were formed?
- Have they considered comments and feedback from external reviewers?
The same questions should be posed to guideline critics and naysayers as well. If they are not free of intellectual, professional, or values-related conflicts, they do not deserve the public’s trust. As such, it is imperative that both guideline developers and their critics publicly disclose their conflicts of interest in a meaningful way. They can make these disclosures through a number of channels — including in media interviews and in the medical journals that publish their work. This is a critical step towards increasing the public’s trust in medicine, and the guidelines themselves.
I am heartened by the fact that some guideline developers—such as the ACS and USPSTF—have begun to move towards achieving consensus around certain recommendations. Both the ACS and the Task Force used similar processes as outlined in the IOM report; they relied on experts who have been vetted for lack of conflicts of interest and utilized evidence from independent researchers who also did not have conflicts of interest. This may explain why these two organizations are more aligned than ever — and it is a step forward in the harmonization of their independent assessments of the evidence.
Until we see more organizations follow the guidance of the IOM framework to make clinical guidelines, the public’s trust in modern medicine will only continue to decline.