Clinical guidelines have come under increased scrutiny over the years, thanks in part to many organizations relying on expert opinions rather than just the evidence to develop the standards, according to American College of Physicians President Dr. Robert McLean.
"Expert opinion can bring in more subjectivity," McLean said. "When you're relying on expert opinion to make recommendations and it's not evidence per se, there's a lot of room for bias and potential conflicts of interest."
ACP on Monday published details about its process for managing conflicts of interest for the first time. McLean said the methods rely on mitigating the risk of a potential conflict of interest by reducing the role of subjectivity by excluding opinions of experts and consensus panels.
The organization develops recommendations solely by examining systematic evidence-based reviews, which McLean acknowledged can be problematic when there isn't enough evidence to make a definitive conclusion.
"Some of our guidelines are a little bit frustrating at times because we're not always able to give a great, direct answer that covers every clinical scenario," McLean said. "But that's because there's not adequate evidence to give that answer—we're not willing to take a leap of faith to some extent without evidence showing doing 'A' leads to outcome 'B.' "
In a study published last December in JAMA Internal Medicine, researchers found that 91 of 160 authors of 18 clinical guidelines related to 10 medications had financial conflicts of interest and that 25 of those conflicts were not disclosed.
An August post in Health Affairs Blog contended the proliferation of clinical guidelines since the 1990s has led to more confusion among clinicians who often get contradictory recommendations.
"There is an absence of a universal methodology to create guidelines," authors of the Health Affairs Blog post wrote. "Every professional organization promulgating guidelines today generally decides freely which, if any, framework they will use to construct guidelines.
That has led to a lack of uniform medical guidelines on several issues, including when women should receive mammography screenings for breast cancer. While most groups recommend women start talking with their doctor about screening at age 40, the American Cancer Society recommends women receive screening every year beginning at age 45. The U.S. Preventive Services Task Force recommends mammography for women every two years beginning at age 50.
McLean said the ACP's focus on the evidence alone and its eligibility screening for individuals who help develop clinical guidelines makes it one of the most strict organizations for setting standards.
Anyone who may help develop ACP clinical guidelines must disclose all financial and intellectual healthcare-related interests from the last three years and update their disclosures over the course of their involvement with the clinical guidelines committee, which develops ACP's clinical policy papers.
A review panel screens all prospective participants and grades them on a three-tiered system based on whether they have high, moderate, or low levels of conflicts. High-level conflicts would include someone serving on an advisory board for a pharmaceutical company or having an active relationship with a similar company. Those people are prohibited from authoring, voting and all committee discussions related to clinical guidelines.
Moderate-level conflicts include having an intellectual interest that could spark bias or relationships with associations that could benefit from ACP clinical guidelines. These individuals can participate in guideline discussions but can't vote or author the standards.
Low-level conflicts, where there are any intellectual interests indirectly related to a clinical topic or have any inactive high-level conflicts, such as leaving a drug company advisory board, have no restrictions form participation in developing clinical guidelines.
McLean said he hoped the ACP's methods for managing conflicts in developing clinical guidelines could serve as a model for other organizations with less stringent or transparent standards.
"A little scrutiny is a good thing," McLean said.
