Amir Qaseem, MD, PhD, MHA; Jon-Erik C. Holty, MD, MS; Douglas K. Owens, MD, MS; Paul Dallas, MD; Melissa Starkey, PhD; Paul Shekelle, MD, PhD; and Clinical Guidelines Committee of the American College of Physicians *
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and clinical situations. Thus, they are not intended to override clinicians’ judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of the Department of Veterans Affairs.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Potential Conflicts of Interest: Dr. Shekelle: Personal fees: ECRI Institute, Veterans Affairs; Grants: Agency for Healthcare Research and Quality, Veterans Affairs, Centers for Medicare & Medicaid Services, National Institute of Nursing Research, Office of the National Coordinator for Health Information Technology. All other authors have no disclosures. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-3188. A record of conflicts of interest is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, email@example.com.
Current Author Addresses: Drs. Qaseem and Starkey: 190 N. Independence Mall West, Philadelphia, PA 19106.
Drs. Holty and Owens: Stanford University, 117 Encina Commons, Stanford, CA 94305.
Dr. Dallas: Carilion School of Medicine, 1906 Bellview Avenue, Roanoke, VA 24014.
Dr. Shekelle: West Los Angeles Veterans Affairs Medical Center, 11301 Wilshire Boulevard, Los Angeles, CA 90073.
Author Contributions: Conception and design: A. Qaseem, D.K. Owens.
Analysis and interpretation of the data: A. Qaseem, J.E.C. Holty, D.K. Owens, P. Dallas, M. Starkey, P. Shekelle.
Drafting of the article: A. Qaseem, P. Dallas, M. Starkey.
Critical revision for important intellectual content: A. Qaseem, J.E.C. Holty, D.K. Owens, P. Dallas, M. Starkey, P. Shekelle.
Final approval of the article: A. Qaseem, J.E.C. Holty, D.K. Owens, P. Dallas, P. Shekelle.
Provision of study materials or patients: A. Qaseem.
Statistical expertise: A. Qaseem.
Obtaining of funding: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem, M. Starkey.
Collection and assembly of data: A. Qaseem, J.E.C. Holty.
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of obstructive sleep apnea (OSA) in adults.
This guideline is based on published literature from 1966 to September 2010 that was identified by using MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. A supplemental MEDLINE search identified additional articles through October 2012. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included cardiovascular disease (such as heart failure, hypertension, stroke, and myocardial infarction), type 2 diabetes, death, sleep study measures (such as the Apnea–Hypopnea Index), measures of cardiovascular status (such as blood pressure), measures of diabetes status (such as hemoglobin A1c levels), and quality of life. This guideline grades the evidence and recommendations using ACP's clinical practice guidelines grading system.
ACP recommends that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight. (Grade: strong recommendation; low-quality evidence)
ACP recommends continuous positive airway pressure treatment as initial therapy for patients diagnosed with OSA. (Grade: strong recommendation; moderate-quality evidence)
ACP recommends mandibular advancement devices as an alternative therapy to continuous positive airway pressure treatment for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with continuous positive airway pressure treatment. (Grade: weak recommendation; low-quality evidence)
Table 1. Terms and Definitions Related to OSA
Table 2. The American College of Physicians’ Guideline Grading System*
Appendix Table. Evidence Summary for Interventions for OSA
Summary of the American College of Physicians guideline on management of OSA in adults.
AHI = Apnea–Hypopnea Index; CPAP = continuous positive airway pressure; MAD = mandibular advancement device; OSA = obstructive sleep apnea.
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People diagnosed with obstructive sleep apnea should lose weight and use continuous positive airway pressure as initial therapy.
Robson Capasso MD, Eric Kezirian, MD. MPH. Ofer Jacobowitz MD. PhD., Edward M. Weaver. MD. MPH
Stanford University,Stanford, CA; University of Southern California,Los Angeles, CA; Mount Sinai Medical Center, New York, NY; VA Puget Sound Health Care System University of Washington Seattle, WA
October 8, 2013
“Insufficient Trial Evidence For” Does Not Equal “Evidence Against”
We appreciate the work involved in the American College of Physicians (ACP) guideline on obstructive sleep apnea (OSA), but some issues deserve consideration. 1
The ACP guideline states, “no randomized trials evaluated the long-term clinical outcomes of CPAP use, such as death or cardiovascular illness, and evidence showing the effect of CPAP on quality of life was inconsistent and therefore inconclusive.” Despite these limitations, the guideline strongly recommends CPAP as initial OSA therapy.
We agree that surgery is usually used after CPAP failure, but disagree that, current evidence evaluating surgery was limited and insufficient to show the benefits of surgery for OSA...”.This statement contrasts to that made for CPAP despite similar evidence limitations. Further, the Agency for Healthcare Research and Quality (AHQR) systematic review states there is “insufficient trial evidence regarding the relative value of most other OSA interventions, including surgery” [italics added for emphasis].2 This specifies trial evidence (not all “current evidence”) and relative value of surgery, avoiding the implication that surgery is of no benefit. While RCT evidence is limited for surgery solely as treatment for OSA, it shows superiority of surgery to sham-placebo and equivalence to CPAP.2,3 Observational studies consistently show clinically and statistically significant treatment benefits of more invasive surgery on survival ,3-4 quality of life, and symptoms.
Of note, the RCTs cited in the guideline studied minimally invasive treatments, which are not meant for isolated OSA management.
The ACP guideline draws from observational studies on surgery risks, and randomized trials on surgery benefits. This approach creates inherent imbalance in considering risk versus benefit of surgery.
The authors seem not to appreciate the challenges involved in conducting RCTs of surgical interventions. Some estimate that only 40% of treatment questions involving surgical procedures could have been evaluated by a RCT.5 While it is important to pursue RCTs where appropriate and feasible, it is also critical to recognize that trials of invasive treatments may lack placebo controls, blinding, and long-term follow-up. Recruiting to such trials is also difficult and patients willing to participate may not be typical.
This guideline misleads the reader to believe that insufficient RCT evidence of benefit for surgery equates with evidence of no benefit and only harm.
Robson Capasso, MD
Palo Alto, CA
Eric Kezirian, MD, MPH
University of Southern California
Los Angeles, CA
Ofer Jacobowitz, MD, PhD
Mt. Sinai School of Medicine
New York, NY
Edward M. Weaver, MD, MPH
VA Puget Sound Health Care System
University of Washington
1. Qaseem A, Holty JEC, Owens DK, Dallas P, Starkey M, Shekelle P. Management of obstructive sleep apnea in adults: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2013; 159 (epublication ahead of print at www.annals.org on 24 September 2013).
2. Balk EM, Moorthy D, Obadan NO, Patel K, Ip S, Chung M, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32. (Prepared by Tufts Evidence-Based Practice Center under contract 290-2007-100551.) AHRQ Publication No. 11-EHC052-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2011.
3. Woodson BT, Steward DL, Weaver EM, Javaheri S. A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg 2003;128:848-61.
4. Weaver EM, Maynard C, Yueh B. Survival of veterans with sleep apnea: continuous positive airway pressure versus surgery. Otolaryngol Head Neck Surg 2004;130:659-65.
5. Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery. 1995; 118:459-467.
Amir Qaseem, PD, PhD, MHA, Paul Shekelle, MD, PhD, Jon-Erik Holty, MD, MS, Douglas K. Owens, MD
American College of Physicians
January 6, 2014
We thank Drs. Capasso, Kezirian, Jacobowitz, and Weaver for their comments regarding the American College of Physicians' recent clinical guideline on management of obstructive sleep apnea in adults. We would like to start out by emphasizing that evidence shows that CPAP improves ESS scores, reduces AHI and arousal index scores, and increases oxygen saturation. Furthermore, we emphasize that we do not state that there is no benefit from surgery. Rather, we state that “evidence to evaluate the relative efficacy of surgical interventions for OSA treatment was insufficient.” The systematic review identified a single high-quality short-term RCT of OSA surgery (1) but concluded that there was no statistically significant difference in AHI, ESS, minimum oxygen saturation, or quality of life; therefore the benefit of surgery is uncertain since no RCTs demonstrated benefit. We respectfully disagree that we did not fairly assess the benefits versus the harms of surgery. We believe that assessing the risk using data from observational studies is not a disadvantage, but rather may capture some harms that are low frequency but severe, such that even very large RCTs would not have sufficient power to detect them. Thus the use of observational data to assess the rare risks of surgery is the fairest way of assessing whether or not these exist and their magnitude. ACP's Clinical Guidelines Committee classifies evidence from RCTs as high quality compared to that from observational studies (2). There are several noteworthy examples in the literature where observational data suggested treatment benefit but subsequent RCT's demonstrated no benefit. For instance, arthroscopic lavage of the knee for pain in osteoarthritis was widely used until a sham-controlled RCT showed no difference between sham and actual operation in terms of improvement in symptoms (3)). ACP's statement regarding OSA surgery is a compromise with respect to the use of observational data in the absence of RCT's: "Surgical treatments are associated with risks and harms. Current evidence evaluating surgery was limited and insufficient to show benefits of surgery as an approach to treat OSA; therefore, surgery should not be used as an initial treatment of OSA."Finally, even though we acknowledge the difficulties in conducting RCTs for surgical treatment compared to nonsurgical therapy for OSA patients, we disagree that it an impossible task. Such comparative effectiveness trials have been successfully completed in other populations such as RCTs of bariatric surgery for obese patients. Paul Shekelle, MD, PhDGreater Los Angeles VA Health Center/RANDJon-Erik Holty, MD, MSVA Palo Alto Health Care System and Stanford UniversityDouglas K. Owens, MDVA Palo Alto Health Care System and Stanford University
Qaseem A, Holty JC, Owens DK, et al, and Clinical Guidelines Committee of the American College of Physicians. Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2013;159:471–483. doi: 10.7326/0003-4819-159-7-201310010-00704
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Published: Ann Intern Med. 2013;159(7):471-483.
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