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 Balloon Affirmation For” Does Not Equal “Evidence Against”
We accede the assignment complex in the American College of Physicians (ACP) guideline on adverse beddy-bye apnea (OSA), but some issues deserve consideration. 1
The ACP guideline states, “no randomized trials evaluated the abiding analytic outcomes of CPAP use, such as afterlife or cardiovascular illness, and affirmation assuming the aftereffect of CPAP on affection of activity was inconsistent and accordingly inconclusive.” Admitting these limitations, the guideline acerb recommends CPAP as antecedent OSA therapy.
We accede that anaplasty is usually acclimated afterwards CPAP failure, but disagree that, accepted affirmation evaluating anaplasty was bound and bereft to appearance the allowances of anaplasty for OSA…”.This account contrasts to that fabricated for CPAP admitting agnate affirmation limitations. Further, the Agency for Healthcare Research and Affection (AHQR) analytical analysis states there is “insufficient balloon affirmation apropos the about amount of best added OSA interventions, including surgery” [italics added for emphasis].2 This specifies balloon affirmation (not all “current evidence”) and about amount of surgery, alienated the association that anaplasty is of no benefit. While RCT affirmation is bound for anaplasty alone as analysis for OSA, it shows advanced of anaplasty to sham-placebo and adequation to CPAP.2,3 Empiric studies consistently appearance clinically and statistically cogent analysis allowances of added invasive anaplasty on adaptation ,3-4 affection of life, and symptoms.
Of note, the RCTs cited in the guideline advised minimally invasive treatments, which are not meant for abandoned OSA management.
The ACP guideline draws from empiric studies on anaplasty risks, and randomized trials on anaplasty benefits. This access creates inherent alterity in because accident against account of surgery.
The authors assume not to accede the challenges complex in administering RCTs of surgical interventions. Some appraisal that alone 40% of analysis questions involving surgical procedures could accept been evaluated by a RCT.5 While it is important to accompany RCTs area adapted and feasible, it is additionally analytical to admit that trials of invasive treatments may abridgement placebo controls, blinding, and abiding follow-up. Recruiting to such trials is additionally difficult and patients accommodating to participate may not be typical.
This guideline misleads the clairvoyant to accept that bereft RCT affirmation of account for anaplasty equates with affirmation of no account and alone 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. Administration of adverse beddy-bye apnea in adults: A analytic convenance guideline from the American College of Physicians. Ann Intern Med 2013; 159 (epublication advanced of book 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 Analysis of Adverse Beddy-bye Apnea in Adults. Allusive Capability Analysis No. 32. (Prepared by Tufts Evidence-Based Convenance Center beneath arrangement 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 balloon of temperature-controlled radiofrequency, connected absolute airway pressure, and placebo for adverse beddy-bye apnea syndrome. Otolaryngol Head Neck Surg 2003;128:848-61.
4. Weaver EM, Maynard C, Yueh B. Adaptation of veterans with beddy-bye apnea: connected absolute airway burden against surgery. Otolaryngol Head Neck Surg 2004;130:659-65.
5. Solomon MJ, McLeod RS. Should we be assuming added randomized controlled trials evaluating surgical operations? Surgery. 1995; 118:459-467.
American College of Physicians
January 6, 2014
We accede Drs. Capasso, Kezirian, Jacobowitz, and Weaver for their comments apropos the American College of Physicians’ contempo analytic guideline on administration of adverse beddy-bye apnea in adults. We would like to alpha out by emphasizing that affirmation shows that CPAP improves ESS scores, reduces AHI and activation basis scores, and increases oxygen saturation. Furthermore, we accent that we do not accompaniment that there is no account from surgery. Rather, we accompaniment that “evidence to appraise the about ability of surgical interventions for OSA analysis was insufficient.” The analytical analysis articular a distinct high-quality concise RCT of OSA anaplasty (1) but assured that there was no statistically cogent aberration in AHI, ESS, minimum oxygen saturation, or affection of life; accordingly the account of anaplasty is ambiguous back no RCTs approved benefit.
We respectfully disagree that we did not adequately appraise the allowances against the harms of surgery. We accept that assessing the accident application abstracts from empiric studies is not a disadvantage, but rather may abduction some harms that are low abundance but severe, such that alike absolute ample RCTs would not accept acceptable ability to ascertain them. Thus the use of empiric abstracts to appraise the attenuate risks of anaplasty is the fairest way of assessing whether or not these abide and their magnitude.
ACP’s Analytic Guidelines Committee classifies affirmation from RCTs as aerial affection compared to that from empiric studies (2). There are several noteworthy examples in the abstract area empiric abstracts appropriate analysis account but consecutive RCT’s approved no benefit. For instance, arthroscopic lavage of the knee for affliction in osteoarthritis was broadly acclimated until a sham-controlled RCT showed no aberration amid adulterated and absolute operation in agreement of advance in affection (3)). ACP’s account apropos OSA anaplasty is a accommodation with account to the use of empiric abstracts in the absence of RCT’s: “Surgical treatments are associated with risks and harms. Accepted affirmation evaluating anaplasty was bound and bereft to appearance allowances of anaplasty as an access to amusement OSA; therefore, anaplasty should not be acclimated as an antecedent analysis of OSA.”
Finally, alike admitting we accede the difficulties in administering RCTs for surgical analysis compared to nonsurgical analysis for OSA patients, we disagree that it an absurd task. Such allusive capability trials accept been auspiciously completed in added populations such as RCTs of bariatric anaplasty for adipose patients.
Paul Shekelle, MD, PhDGreater Los Angeles VA Health Center/RAND
Jon-Erik Holty, MD, MSVA Palo Alto Health Care System and Stanford University
Douglas K. Owens, MDVA Palo Alto Health Care System and Stanford University
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