BOSTON – For those considering how to navigate their innovative health care strategy into a position that will lead to an eventual guideline recommendation, it is important to think beyond demonstration of efficacy and safety in the design of randomized trials, according to an overview of how guideline committees currently function.
“In the old days, it was only the strength of the evidence. Now, in addition to the evidence, we have three other issues we look at to form the strength of a recommendation,” John M. Inadomi, MD, AGAF, head of the division of gastroenterology, University of Washington, Seattle, said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Robert Lodge/MDedge News
Dr. John M. Inadomi
“I think the big thing is that we are trying to move away from is just-the-evidence [approach],” Dr. Inadomi explained to an audience that included physician entrepreneurs and investors with an interest in how to establish a new diagnostic tool or treatment device as a standard of care.
There is no doubt that randomized controlled trial data are critical for objectively establishing safety and efficacy, but there has been an evolutionary change. According to Dr. Inadomi, guideline committees are posing more pointed questions about the practical value of one strategy relative to others. They also have increased their scrutiny of the quality and consistency of the RCT data in relation to the specific indication being considered.
“The implication of a strong recommendation is that most people in the situation would want the recommended course of action and that only a small proportion would not,” Dr. Inadomi explained. On the basis of this criterion, an inconvenient, costly, or poorly accepted therapy may not receive a strong recommendation even if effective. Strong recommendations typically set a standard.
“For the health care provider, that means that most patients should receive that course of action,” Dr. Inadomi said. Conversely, “for a weak recommendation, it implies that the majority of people would want this, but many would not.”
