Letters

Annals of Internal Medicine COMMENTS

AND

RESPONSES

Potential Conflicts of Interest: Disclosures can be viewed at www .acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum ⫽L13-1150.

Management of Obstructive Sleep Apnea in Adults TO THE EDITOR: Qaseem and colleagues’ clinical practice guideline

on obstructive sleep apnea (OSA) (1) states, “no randomized trials evaluated the long-term clinical outcomes of [continuous positive airway pressure (CPAP)] use, such as death or cardiovascular illness, and evidence showing the effect of CPAP on quality of life was inconsistent and therefore inconclusive.” Nevertheless, the guideline strongly recommends CPAP as initial therapy for OSA. We agree that surgery is usually used after CPAP failure but disagree that “[c]urrent evidence evaluating surgery was limited and insufficient to show the benefits of surgery for OSA.” This statement contrasts with their recommendation of CPAP despite its similar evidence limitations. Further, the Agency for Healthcare Research and Quality’s comparative effectiveness review states that there is “insufficient trial evidence regarding the relative value of most other OSA interventions, including surgery” (italics added) (2). They specify trial evidence (not all “current evidence”) and the relative value of surgery, avoiding the implication that surgery is of no benefit. Although evidence from randomized, controlled trials (RCTs) supporting surgery alone as treatment of OSA is limited, it shows that surgery is superior to sham placebo and equivalent to CPAP (2, 3). Observational studies consistently show clinically and statistically significant treatment benefits of more invasive surgery on survival, quality of life, and symptoms (3, 4). Of note, the RCTs cited in Qaseem and colleagues’ guideline studied minimally invasive treatments, which are not meant for management of isolated OSA. This guideline draws from observational studies on surgery risks and RCTs on surgery benefits. This approach creates an inherent imbalance in considering the risks versus benefits of surgery. The authors seem not to appreciate the challenges involved in conducting RCTs of surgical interventions. Some investigators estimate that only 40% of treatment questions involving surgical procedures could have been evaluated by an RCT (5). Although conducting RCTs when appropriate and feasible is important, recognizing that trials of invasive treatments may lack placebo controls, blinding, and long-term follow-up is also critical. Recruiting for 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 equals evidence of no benefit and only harm. Robson Capasso, MD Stanford University Palo Alto, California

Eric Kezirian, MD, MPH University of Southern California Los Angeles, California

Ofer Jacobowitz, MD, PhD Mount Sinai School of Medicine New York, New York

Edward M. Weaver, MD, MPH Veterans Affairs Puget Sound Health Care System, University of Washington Seattle, Washington

Disclaimer: The opinions expressed in this letter are those of the authors and do not necessarily represent the official views of the Department of Veterans Affairs.

References 1. Qaseem A, Holty JE, Owens DK, Dallas P, Starkey M, Shekelle P; for the 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. [PMID: 24061345] 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. 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. [PMID: 12825037] 4. Weaver EM, Maynard C, Yueh B. Survival of veterans with sleep apnea: continuous positive airway pressure versus surgery. Otolaryngol Head Neck Surg. 2004;130:65965. [PMID: 15195049] 5. Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery. 1995;118:459-67. [PMID: 7652679]

IN RESPONSE: Evidence shows that CPAP improves Epworth Sleep-

iness Scale scores, decreases the Apnea–Hypopnea Index and arousal index scores, and increases oxygen saturation. Furthermore, we do not state that surgery has no benefit. Rather, we state that “[e]vidence to evaluate the relative efficacy of surgical interventions for OSA treatment was insufficient.” The Agency for Healthcare Research and Quality’s comparative effectiveness review (1) identified a single high-quality, short-term RCT of OSA surgery (2) but concluded that there was no statistically significant difference in Epworth Sleepiness Scale or Apnea–Hypopnea Index scores, minimum oxygen saturation, or quality of life. Therefore, the benefit of surgery is uncertain because no RCTs showed 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 harms that are low-frequency but severe, such that even 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 these risks exist and their magnitude. The American College of Physicians’ Clinical Guidelines Committee classifies evidence from RCTs as high quality compared with that from observational studies (3). The literature contains several noteworthy examples where observational data suggested treatment benefit but subsequent RCTs showed no benefit. For example, arthroscopic lavage of the knee for osteoarthritis pain was widely used until an RCT showed no difference between sham and actual surgery in terms of improvement in symptoms (4). The American College of Physicians’ statement about OSA surgery is a compromise with respect to the use of observational data in the absence of RCTs. As we state, “Surgical treatments are associated with risks and serious adverse effects. Current evidence evaluating surgery was limited and insufficient to show the benefits of surgery as treatment of OSA and thus should not be used as initial treatment.” Finally, although we acknowledge the difficulties in conducting RCTs for surgical compared with nonsurgical therapy for patients with OSA, we disagree that it is impossible. Such comparative effec© 2014 American College of Physicians 367

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Letters tiveness trials have been successfully completed in other populations, such as RCTs of bariatric surgery for obese patients. Paul Shekelle, MD, PhD Greater Los Angeles Veterans Affairs Health Center and RAND Corporation Los Angeles, California Jon-Erik C. Holty, MD, MS Douglas K. Owens, MD, MS Veterans Affairs Palo Alto Health Care System Palo Alto, California Amir Qaseem, MD, PhD, MHA American College of Physicians Philadelphia, Pennsylvania Potential Conflicts of Interest: Disclosures can be viewed at www .acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum ⫽M12-3188. References 1. 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. AHRQ Publication no. 11-EHC052-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2011. 2. 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. [PMID: 12825037] 3. Qaseem A, Snow V, Owens DK, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med. 2010;153:194-9. [PMID: 20679562] 4. Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347:81-8. [PMID: 12110735]

Unusual Exclusion Criteria TO THE EDITOR: I have never seen the exclusion criteria “going

abroad” and “away on business” used in a clinical trial before reading Li and colleagues’ article (1). Because I am sensitive to human rights issues in China, my innate cynicism asks whether these criteria are not euphemisms for “politically detained” or the ever-ominous “missing.” One wonders whether the concept of completely voluntary informed consent can even exist in the climate of coercion that is present in China. I do not intend to disparage our physician colleagues in China, but I do ask that the Annals be certain that the enrollment processes used in clinical trials in countries with oppressive regimes are truly voluntary. Lorraine Tosiello, MD Jersey City Medical Center Jersey City, New Jersey

Reference 1. Li MH, Chen SW, Li YD, Chen YC, Cheng YS, Hu DJ, et al. Prevalence of unruptured cerebral aneurysms in Chinese adults aged 35 to 75 years: a cross-sectional study. Ann Intern Med. 2013;159:514-21. [PMID: 24126645]

IN RESPONSE: We understand Dr. Tosiello’s concern about the ex-

clusion criteria, specifically what we called “going abroad” and “away on business.” The terminology that we used refers to the population that was not eligible when we conducted this screening survey. Local residents who were going abroad or on a long business trip were excluded due to ineligibility. “Going abroad” and “away on business” are indeed 2 detailed reasons for ineligibility and have nothing to do with participants being “politically detained.” In addition, as we mention in our article, several persons declined to participate in this study. However, all of the participants who enrolled did so voluntarily. We hope that our explanation helps to enhance readers’ understanding of the enrollment processes. Ming-Hua Li, MD, PhD Yong-Dong Li, MD, PhD Sixth People’s Hospital Shanghai, China Potential Conflicts of Interest: None disclosed. Forms can be viewed at

www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum ⫽M13-0927.

Too Lazy for Primary Care TO THE EDITOR: I read Kussmaul’s essay (1) with great interest. I

have been a primary care provider for 23 years and have worked in a hospital 1 week out of 4 for all of them. The job is impossible; the pay is ridiculous; and, by looking at the cars in the gym parking lot, I can see that the specialists aren’t working more hours. Like almost everyone else in primary care, I had family responsibilities that made another 3 to 4 years of fellowship were untenable. Internal medicine, like most of medicine, believes in the brain– uterine shunt. I graduated with honors, and my current Board scores would still make me competitive for a fellowship. Being a parent of young children—and, in our culture, especially being a mother— often determines career choice. There are exceptions, but the rule is that pregnancy and infant care do not mix well with fluoroscopy hours and 3 more years of procedural call. Not talking about it because it seems sexist is the most sexist thing of all. Lynn Bentson, MD Albany Internal Medicine Group Albany, Oregon Potential Conflicts of Interest: None disclosed. Forms can be viewed at

www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum ⫽L14-0013.

Potential Conflicts of Interest: None disclosed. Forms can be viewed at

Reference

www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum ⫽L13-1152.

1. Kussmaul WG 3rd. Too lazy for primary care? Ann Intern Med. 2013;159:711-2. [PMID: 24247676]

368 4 March 2014 Annals of Internal Medicine Volume 160 • Number 5

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