Why Clinical Guidelines Are Important and How They Come Together

The 2014 release of the tinnitus clinical practice guideline by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) changed the way Minka Schofield, MD, treated patients with tinnitus.

“Before this guideline, vitamins, steroids, and melatonin were all being used in an effort to help patients with tinnitus. We’d actually done our own study that showed maybe 50% of the people who take melatonin do get better, so we were recommending melatonin as an option. Then the guideline came out and stated there’s no significant evidence for any of these interventions,” said Dr. Schofield, an otolaryngologist at The Ohio State University Wexner Medical Center. “I stopped giving melatonin once the guideline came out.”

Clinical practice guidelines are intended to influence practice. They synthesize the best available scientific evidence, making it easier for clinicians to stay up to date on the latest evidence-based practices. But some clinicians think that clinical guidelines are overly prescriptive and overlook the art of medicine.

“Some people view guidelines as threats to their autonomy and to proper patient care,” said Richard Rosenfeld, MD, MPH, Senior Advisor for Guidelines and Measures at AAO-HNS. “Many feel their experience as a clinician and their judgement are often all that’s needed, and in some cases, that may be true.”

Increasingly, though, the public (and payers) are demanding quality, evidence-based care. “If you look across the country, there are large variations in the frequency of certain procedures and treatments; it’s all over the map. Some of it is likely justified, but a lot of it probably is not,” Dr. Rosenfeld said. Clinical guidelines, he said, are an opportunity to reduce unjustified variations by identifying knowledge gaps, defining best practices, and promoting quality improvement opportunities.

[The AAO–HNS] realized we needed to start developing trustworthy guidelines that would give us credibility on the national stage, thereby allowing us to advocate properly for the interests of otolaryngologists. —Richard Rosenfeld, MD, MPH

A History of Clinical Guidelines in Otolaryngology

The development of clinical guidelines in medicine began in the 1990s, concurrent with the push toward evidence-based medicine. The National Guideline Clearinghouse, a publicly available database of clinical practice guidelines, was formed in 1998 under the Agency for Healthcare Research and Quality in the U.S. Department of Health and Human Services. But the AAO-HNS didn’t begin producing clinical guidelines until the 2000s.

The clinical indicators and procedures released by AAO-HNS in the early 2000s lacked rigor and were not considered trustworthy by the American Medical Association and the Centers for Medicare and Medicaid Services (CMS), Dr. Rosenfeld said. “We realized we needed to start developing trustworthy guidelines that would give us credibility on the national stage, thereby allowing us to advocate properly for the interests of otolaryngologists,” he said. So AAO-HNS formed the Guidelines Development Task Force in 2005, with Dr. Rosenfeld as chair.

Today, the task force is simply called the Guidelines Task Force (GTF). Since its inception, it has published 13 clinical practice guidelines, including guidelines for allergic rhinitis, Bell’s palsy, and tympanostomy tubes in children. Five more guidelines, including those for Meniere’s disease and epistaxis, are currently in development, and at least six more (including one on age-related hearing loss) are in the development queue. The American Academy of Otolaryngology–Head and Neck Surgery Foundation also recently released a clinical consensus statement on balloon dilation of the sinuses.

Consensus Statements vs. Clinical Practice Guidelines

The phrase “clinical guidelines” is often used as a catch-all to describe any official document that offers guidance on practice, but there are important differences between consensus statements and clinical practice guidelines.

“What differentiates a consensus statement from a clinical practice guideline is that a clinical practice guideline requires the evidence to be robust. If you’re actually going to come out and say, ‘This is what should be done,’ you need to have high-level evidence,” said Richard Orlandi, MD, an otolaryngologist and professor of surgery at the University of Utah who worked on the 2016 International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.

Clinical practice guidelines are also developed with input from multiple medical specialties and consumers. A committee working to develop a clinical practice guideline on rhinosinusitis, for instance, would include not only representatives of the American Rhinologic Society and the American Academy of Otolaryngology–Head and Neck Surgery, but also allergists, immunologists, infectious disease specialists, and patient advocates.

“It’s critical to have the right people there,” Dr. Rosenfeld said. “What we do is reach out to the leadership of any stakeholder group we feel is important and ask the leadership, ‘Who do you feel can advocate for you appropriately so your input is duly considered?’”

Consumer representatives typically come from advocacy groups such as the American Tinnitus Association or Consumers United for Evidence-Based Healthcare, a national coalition of health and consumer advocacy organizations.

The Effect of Guidelines on Practice and Reimbursement

Many insurers and third-party payers, including CMS, consider clinical guidelines when determining the medical necessity of a given treatment; medical care that aligns with published guidelines is likely to be covered and reimbursed.

Because clinical guidelines are based on the best available evidence, they can “temper the over-utilization of resources,” Dr. Schofield said, noting that CTs and MRIs, for instance, were often ordered simply to ensure that nothing was overlooked when working up certain problems. Guidelines that say, Imaging is not recommended unless x, y or z, can support a physician’s decision to order—or not order—the test.

Of course, some patients and scenarios don’t fit neatly into the guidelines, and physicians must consider their patients’ needs and personal experiences when assessing and treating them. Because guidelines are based on evidence, though, it’s in patients’ and physicians’ best interests to follow the guidelines more often than not.

“The reality is, if you’re deviating from the guidelines 99% of the time, you’re probably doing the wrong thing,” said David C. Brodner, MD, an otolaryngologist at The Center for Sinus, Allergy, & Sleep Wellness in Boynton Beach, Fla. “You’re not doing your patients a service by ignoring it. Why not harness the power of that information to do a better job for your patients?”

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Jennifer Fink is a freelance writer based in Wisconsin.