Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.
The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.
Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.
“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.
Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.
“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.
Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.
Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.
As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”
Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.
Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.
But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.