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A New Direction for Sleep: New OSA guidelines fuel another evidence-based medicine debate
From: ENT Today, December 2010
by Mary Beth Nierengarten
Recent publication of practice parameters for surgery in adults with obstructive sleep apnea (OSA) by the American Academy of Sleep Medicine (AASM) has set off another round of debate on the need for otolaryngologists to get involved in generating their own guidelines. Although otolaryngologists have yet to agree on whether or not the time is right for guidelines on surgical treatment for sleep apnea, consensus can be claimed regarding the need perceived by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) to get on the evidence-based bandwagon.
“As a specialty, it is very important that we work on developing a way of measuring outcomes that can be applied universally so we can work toward studies that will help us determine best practices,” said John Harwick, MD, an assistant professor of otolaryngology at the University of Florida in Gainesville and a member of the AAO-HNS Sleep Disorders Committee.
Dr. Harwick’s remark points to what is perhaps the key challenge faced by otolaryngologists and other specialties in attempting to develop guidelines: the need to determine the most relevant outcomes and metrics by which to measure optimal diagnosis and treatment. Once metrics are determined, studies are needed to lay the foundation on which guidelines are developed.
Randomized, controlled clinical trials continue to be the so-called “gold standard” of evidence. But these trials require time, money and sufficient patient numbers to detect meaningful outcomes and are, therefore, often lacking. This is particularly true in surgical specialties like otolaryngology (Arch Otolaryngol Head Neck Surg. 2002;128:631-634).
Given this problem, many so-called clinical guidelines are more aptly called “consensus statements” or “practice parameters,” because they rely on other types of evidence such as expert opinion and less rigorous published data like retrospective analyses and case-control studies.
The problem that faces otolaryngologists, as it does physicians in other specialties, is how to generate appropriate and relevant guidelines, given the dearth of evidence. At stake is the reality that other specialties that cross over into areas related to otolaryngology will develop these guidelines, as highlighted this year by the AASM’s publication of the surgical management of sleep apnea (SLEEP. 2010;33(10):1408-1413).
Response to the AASM Guidelines
Last year it was hoarseness, this year sleep apnea. “Each of the guidelines that has come out has created spirited discussion,” said Pell Wardrop, MD, chair of the AAO-HNS Sleep Disorders Committee. “The hoarseness guidelines that came out in 2009 were a hot topic at the Academy last year. The biggest stir this year was the AASM sleep surgery practice parameters.”
A major criticism of the AASM practice parameters, said Dr. Wardrop, is the lack of input from otolaryngologists in the formulation of the guidelines. “Involvement of stakeholders in all relevant disciplines is a key feature in valid guideline development,” she said.
Dr. Harwick was one of two otolaryngologists who reviewed the published data used to generate the AASM practice parameters and was a co-author on a meta-analysis published as a companion piece with the parameters (SLEEP. 2010;33(10):1396-1407). He noted that both the meta-analysis and the parameters highlight the “paucity” of evidence on which the parameters were developed.
He also emphasized that he was not told that the meta-analysis he was involved in was going to be used as the basis to create the practice parameters and that his expertise was not solicited for the final analysis and publication.
It may be that this lack of expert input is at the hub of the response to the AASM guidelines; the authors of the guidelines themselves state that “the paucity and low quality of evidence concerning the surgical treatment of the upper airway for OSA [obstructive sleep apnea] in adults is conspicuous (p. 1412),” and conclude that more sound clinical research is needed in order to better understand the indication for surgical treatment of the upper airway for OSA in adults.
—John Harwick, MD
Another aspect contested by otolaryngologists: the evidence chosen by the AASM panel.
“The lack of experience among the AASM authors has raised concerns,” said Edward M. Weaver, MD, MPH, associate professor of otolaryngology and chief of sleep surgery at the University of Washington in Seattle, who also participated in a panel discussion on guidelines at the AAO-HNS meeting. He added that important studies were excluded from the review, and emphasis was directed away from clinical outcomes. “The conclusions were drawn primarily from the limited data on apnea-hypopnea index outcome, and the more important studies on clinical outcomes were not included,” he said.
Dr. Harwick also challenged the relevancy of data used to generate the parameters. “From my perspective, I don’t think the practice parameters are of great value in addressing the issues needing to be addressed in terms of looking at things associated with successful outcomes, such as improvement in the saturation index,” he said. He also emphasized the fact that the apnea-hypopnea index does not necessarily reflect important outcomes such as improvement in cardiovascular risk and patient daytime functioning.
The AASM parameters raised the question of whether otolaryngologists should develop their own guidelines on the surgical management of sleep apnea in adults.
According to Dr. Harwick, the sleep committee discussed this matter at the AAO-HNS meeting held in Boston in September and resolved to develop a realistic way to determine effective, successful outcomes and then create studies to measure that. The result is a suggested blueprint for reporting results of obstructive sleep apnea surgery trials, said Dr. Wardrop. The committee is currently reviewing the document before finalizing it.
Sleep-Disordered Breathing Guidelines
Norman Friedman, MD, director of the Children’s Sleep Medicine Laboratory at the University of Colorado Children’s Hospital in Aurora, said it is always difficult generating surgical guidelines. Dr. Friedman is currently part of an AAO-HNS-led multidisciplinary panel formed in January 2010 to create pediatric sleep-disordered breathing guidelines to be published in Otolaryngology-Head and Neck Surgery in 2011. Panel members consisting of sleep medicine physicians, pediatricians, anesthesiologists and pulmonary physicians, along with otolaryngologists, are developing the guidelines, which target children ages two to 18 years who have been given a clinical diagnosis of sleep-disordered breathing, are candidates for tonsillectomy and may benefit from a pre-operative polysonogram (PSG). External and internal review of the guidelines will be done by multiple invited representatives from a number of specialties both within and outside of AAO-HNS.
“When it comes to surgical guidelines, the difficulty is that everything is being compared to noninvasive ventilation, and all of us agree that if a person is compliant with noninvasive ventilation, noninvasive treatment will be more successful,” Dr. Friedman said. “The issue is compliance, as well as whether outcomes measured by the apnea-hypopnea index also effectively measure quality of life.”
He also emphasized the critical need for more studies and the gaps in research that need to be addressed.
Until these gaps can be closed or at least tightened, otolaryngologists don’t have much evidence to use to develop guidelines on the surgical management of sleep apnea in adults. “We are not ready to publish next week our own counter practice parameters,” said Dr. Harwick, “but we realize that we need to do that, and we need to come to a consensus on how we are going to do this.”
Dr. Weaver agreed that when sleep apnea guidelines are developed, otolaryngologists need to be involved. “We offer a unique and important perspective,” he said. “This is true for general sleep apnea guidelines and especially for sleep apnea surgery guidelines.”