Upper airway surgery should not be first line treatment for obstructive sleep apnoea in adults
BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39381.509213.AE (Published 03 January 2008) Cite this as: BMJ 2008;336:44
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Dr. Elshaug concludes that “Surgery for obstructive sleep apnoea
should be done within controlled clinical trials.”
IF he means that surgery should be performed ONLY within controlled
clinical trials, then this is a sign of therapeutic nihilism. Since Dr.
Elshaug has implied such in previous publications (1,2) and in his Author
reply to Sam Robinson, I am compelled to respond to this suggestion on
several levels:
1) His statement suggests there is no evidence of the benefit with
surgical treatment for sleep apnea. To the contrary, several higher level
studies, including randomized trials, support a significant benefit of
surgery on clinically important outcomes (3-18). It is unfortunate that
Dr. Elshaug did not include these studies in his reviews nor did he
examine clinical outcomes (1,2,19). The significant subjectivity in apnea
-hypopnea definitions, the variability of technical sensitivity, and the
poor correlation with patient-oriented outcomes leaves apnea-hypopnea
index a suboptimal solo surrogate outcome measure to evaluate sleep apnea
treatment outcomes (20-22). These issues are not addressed in Dr.
Elshaug’s reviews. In separate letters to BMJ, I provided detailed
responses to some of the critiques of the clinical outcome studies
discussed in his Author reply to Sam Robinson.
2) It is therapeutic nihilism to reject any study that is not a
large, randomized, double-blinded, placebo-controlled trial. That
approach would leave us with no treatment for sleep apnea nor for many
other medical conditions. This concept was highlighted in Gordon Smith’s
tongue-in-cheek systematic review of randomized controlled trials of
parachute use, published in BMJ (23). Smith commented, “Advocates of
evidence based medicine have criticised the adoption of interventions
evaluated by using only observational data. We think that everyone might
benefit if the most radical protagonists of evidence based medicine
organised and participated in a double blind, randomised, placebo
controlled, crossover trial of the parachute.” While this report is
amusing, the suggestion to limit an important therapeutic modality for
sleep apnea, namely surgery, only to randomized trials is irresponsible.
3) It strikes me as naïve to recommend surgeons simply randomize all
surgical patients in trials. Dr. Elshaug’s suggestion (in his Author
reply to Sam Robinson) to learn better approaches from his uncontrolled
case series (1) highlights a superficial approach to the serious challenge
of obtaining rigorous evidence. There are significant feasibility
challenges to his recommendation to “randomize them.” Dr. Neville Shine
highlighted some of the challenges in his response entitled “no change; no
problem.”
4) A relative paucity of randomized, blinded, placebo-controlled
trials does NOT equate to evidence against surgery, especially when there
is a consistent finding in multiple other high level studies of treatment
benefit (albeit not cure). It should be noted that there are challenges
for CPAP evaluation as well; hence, there are no randomized, double-blind,
placebo-controlled, long-term trials of CPAP in obstructive sleep apnea
patients evaluating survival, incident cardiovascular morbidity, or motor
vehicle crashes. Even the trials on acute blood pressure changes are
mixed. Nevertheless, the smaller, less rigorous studies provide enough
evidence of benefit to proceed with therapy while more trials are underway
and the body of evidence grows.
5) Dr. Elshaug discussed opportunity cost and the directions of
resource use in his Author reply to Sam Robinson. He implies that surgery
diverts resources from non-surgical treatments, which appears to be the
root of his critical view of surgery. One could recommend he perform a
number of definitive cost-effectiveness studies assessing validated
patient-oriented effectiveness outcomes (long-term) and comprehensive cost
analyses (including indirect costs) from societal and patient perspectives
in several populations and cultures to begin to assess his concern (24).
In the meanwhile, Dr. Elshaug appears to be in a desirable situation where
multi-disciplinary care provides the opportunity for better outcomes for
patients who struggle with first-line therapies (in some cases despite
adjunctive strategies).
6) I support and encourage the research to improve CPAP outcomes with
adjunctive treatments (including adjunctive surgical treatments (3)).
Successful adjunctive treatments should be implemented. However, even
still there are patients who do not succeed with CPAP, weight loss
attempts, and/or oral appliances, and fortunately they might still achieve
benefit from surgical treatment evaluation.
Let me be clear. The thesis that surgery is typically not first-line
therapy appears sound because there is a more efficacious, low-risk
therapy available. However, when the first-line therapy is not successful
because of difficulty with adherence, the implication that surgery should
not be made available as second-line therapy is detrimental to patient and
public health.
Edward M. Weaver, MD, MPH
REFERENCES
1. Elshaug AG, Moss JR, Southcott AM, Hiller JE. An analysis of the
evidence-practice continuum: is surgery for obstructive sleep apnoea
contraindicated? J Eval Clin Pract 2007;13(1):3-9.
2. Elshaug AG, Moss JR, Southcott AM, Hiller JE. Redefining success
in airway surgery for obstructive sleep apnea: a meta analysis and
synthesis of the evidence. Sleep 2007;30(4):461-7.
3. Powell NB, Zonato AI, Weaver EM, Li K, Troell R, Riley RW, et al.
Radiofrequency treatment of turbinate hypertrophy in subjects using
continuous positive airway pressure: a randomized, double-blind, placebo-
controlled clinical pilot trial. Laryngoscope 2001;111:1783-90.
4. 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(6):848-61.
5. Lojander J, Kajaste S, Maasilta P, Partinen M. Cognitive function
and treatment of obstructive sleep apnea syndrome. J Sleep Res
1999;8(1):71-6.
6. Lojander J, Maasilta P, Partinen M, Brander PE, Salmi T, Lehtonen
H. Nasal-CPAP, surgery, and conservative management for treatment of
obstructive sleep apnea syndrome. A randomized study. Chest
1996;110(1):114-9.
7. Conradt R, Hochban W, Heitmann J, Brandenburg U, Cassel W, Penzel
T, et al. Sleep fragmentation and daytime vigilance in patients with OSA
treated by surgical maxillomandibular advancement compared to CPAP
therapy. Journal of Sleep Research 1998;7(3):217-23.
8. Prinsell JR. Maxillomandibular Advancement Surgery in a Site-
Specific Treatment Approach for Obstructive Sleep Apnea in 50 Consecutive
Patients*. Chest 1999;116(6):1519-1529.
9. Marti S, Sampol G, Munoz X, Torres F, Roca A, Lloberes P, et al.
Mortality in severe sleep apnoea/hypopnoea syndrome patients: impact of
treatment. Eur Respir J 2002;20(6):1511-8.
10. Weaver EM, Maynard C, Yueh B. Survival of veterans with sleep
apnea: continuous positive airway pressure versus surgery. Otolaryngol
Head Neck Surg 2004;130(6):659-65.
11. Keenan SP, Burt H, Ryan CF, Fleetham JA. Long-term survival of
patients with obstructive sleep apnea treated by uvulopalatopharyngoplasty
or nasal CPAP. Chest 1994;105(1):155-9.
12. Lysdahl M, Haraldsson PO. Long-term survival after
uvulopalatopharyngoplasty in nonobese heavy snorers: a 5- to 9-year follow
-up of 400 consecutive patients. Arch Otolaryngol Head Neck Surg
2000;126(9):1136-40.
13. Peker Y, Hedner J, Norum J, Kraiczi H, Carlson J. Increased
incidence of cardiovascular disease in middle-aged men with obstructive
sleep apnea: a 7-year follow-up. Am. J. Respir. Crit. Care Med.
2002;166(2):159-165.
14. Haraldsson PO, Carenfelt C, Lysdahl M, Tingvall C. Does
uvulopalatopharyngoplasty inhibit automobile accidents? Laryngoscope
1995;105(6):657-61.
15. Walker-Engstrom ML, Wilhelmsson B, Tegelberg A, Dimenas E,
Ringqvist I. Quality of life assessment of treatment with dental appliance
or UPPP in patients with mild to moderate obstructive sleep apnoea. A
prospective randomized 1-year follow-up study. J Sleep Res 2000;9(3):303-
8.
16. Li HY, Chen NH, Shu YH, Wang PC. Changes in quality of life and
respiratory disturbance after extended uvulopalatal flap surgery in
patients with obstructive sleep apnea. Arch Otolaryngol Head Neck Surg
2004;130(2):195-200.
17. Cahali MB, Formigoni GG, Gebrim EM, Miziara ID. Lateral
pharyngoplasty versus uvulopalatopharyngoplasty: a clinical,
polysomnographic and computed tomography measurement comparison. Sleep
2004;27(5):942-50.
18. Woodson BT, Robinson S, Lim HJ. Transpalatal advancement
pharyngoplasty outcomes compared with uvulopalatopharygoplasty.
Otolaryngology - Head & Neck Surgery 2005;133(2):211-7.
19. Elshaug AG, Moss JR, Hiller JE, Maddern GJ. Upper airway surgery
should not be first line treatment for obstructive sleep apnoea in adults.
Bmj 2008;336(7634):44-5.
20. Redline S, Sanders M. Hypopnea, a floating metric: implications
for prevalence, morbidity estimates, and case finding. Sleep
1997;20(12):1209-17.
21. Redline S, Kapur VK, Sanders MH, Quan SF, Gottlieb DJ, Rapoport
DM, et al. Effects of varying approaches for identifying respiratory
disturbances on sleep apnea assessment. Am J Respir Crit Care Med
2000;161(2 Pt 1):369-74.
22. Weaver EM, Woodson BT, Steward DL. Polysomnography indexes are
discordant with quality of life, symptoms, and reaction times in sleep
apnea patients. Otolaryngology - Head and Neck Surgery 2005;132(2):255-
262.
23. Smith GCS, Pell JP. Parachute use to prevent death and major
trauma related to gravitational challenge: systematic review of randomised
controlled trials. BMJ 2003;327(7429):1459-1461.
24. Drummond MF, O'Brien BJ, Stoddart GL, Torrance GW. Methods for
the Economic Evaluation of Health Care Programmes. Second ed. Oxford:
Oxford University Press, 1997.
Competing interests:
None declared
Competing interests: No competing interests
Dr. Elshaug offered comments to refute Peker’s long-term prospective
cohort study that reported a beneficial long-term clinical outcomes of
sleep surgery (1). Clarifications are in order.
Peker found that approximately half of their surgery patients were
“efficiently” treated, meaning they were in the group that experienced
dramatically fewer incident cardiovascular adverse outcomes over seven
years compared to the inefficiently-treated/untreated group.
1) “We believe [this study] supports our Change Page entirely.”
Dr. Elshaug’s suggestion that this study refutes a role for surgery
is puzzling. In fact, this study supports the thesis that surgery can
provide a long-term clinically important benefit for reducing incident
cardiovascular events compared to no treatment.
2) “Peker et al. did report equally large reductions in
cardiovascular disease (CVD) over a 7 year period in a surgically treated
cohort.”
Peker studied more than just a surgically treated cohort. He studied
a cohort of men with no cardiovascular disease at baseline, which included
men with and without sleep apnea. He followed the entire cohort,
including those with no sleep apnea, those with untreated sleep apnea,
those treated with continuous positive airway pressure (CPAP), those
treated with surgery, and those treated with an oral device.
3) “…in this study ‘approximately 50% of subjects undergoing UPPP
still had OSA at the follow-up recording’ (pg. 162) meaning they were
inefficiently/ineffectively treated with UPPP alone.”
It is true that 50% of the uvulopalatopharyngoplasty (UPPP) patients
still had obstructive sleep apnea (OSA) and were inefficiently treated.
Dr. Elshaug failed to point out that 64% of CPAP patients and 75% of oral
device patients were inefficiently treated. A pessimistic view is that no
treatment works consistently to achieve the dramatic reduction in
cardiovascular disease risk. An optimistic view is that surgery and the
other treatments offer a major health benefit in a significant proportion
of patients. NEITHER view supports Dr. Elshaug’s suggestion that other
treatments should be offered and surgery not considered.
In current practice, surgery is reserved for CPAP failures. These
failures can be left with untreated sleep apnea and, according to Peker’s
data, a 55% risk of incident cardiovascular disease in the next seven
years. Or, these failures can be offered UPPP where Peker’s data suggest
half will have their risk of incident cardiovascular disease reduced from
55% to 5% over the following seven years. It should be noted that UPPP
represents only a partial surgical treatment for sleep apnea (2,3), so
surgery to address obstruction beyond the palate and oropharynx might
further improve these outcomes.
4) “There was cross-contamination of treatment where … surgery
recipients may also have received CPAP treatment during follow-up.”
The proportion with crossover was not reported. It is not clear how
this point supports Dr. Elshaug’s thesis (which was clarified in his
Authors Reply to Sam Robinson) that surgery should not be made available
even as second-line therapy.
It is unlikely that successful UPPP patients would choose to receive
CPAP or an oral device, so the crossover effect seems unlikely. Efficient
UPPP therapy resulted in beneficial cardiovascular outcomes.
It is more likely that inefficient UPPP patients might cross over and
try another therapy. Regardless of the possible crossovers, these
inefficient UPPP patients suffered poor outcomes. Thus, the possibility
that patients might have received more than one treatment does not detract
from the conclusion that half of the surgery patients experienced a
reduced incidence of adverse cardiovascular outcomes.
5) “Given the sample sizes one needs to be observant to statistical
power.”
True. The small sample size does not provide enough statistical
power to say that UPPP is better than the other treatments. However, the
statistical power is sufficient to say the efficiently treated group (over
half of which were UPPP patients) had better outcomes than the
inefficiently/untreated treated group (less than 20% of which were UPPP
patients).
6) “UPPP recipients had milder OSA to start with.”
The baseline OSA severity was not reported for each treatment group
in this study. Peker reported that the oxygen desaturation index was 2.0
+/- 1.3 events per hour at follow up in the efficient UPPP-treated
subjects, meaning they had an excellent result.
7) “… the proportion who receive an optimal outcome from a surgical
approach is low and inconsistent and less than can be achieved by other
means, as is elegantly presented by Peker et al. and many others.”
This statement contradicts Peker’s study. Half of the surgery
patients were effectively treated, more than the other two treatments.
Peker also pointed out that even the inefficient UPPP-treated subjects
experienced improvement that occurred on an every-night basis.
In conclusion, even partial surgical therapy (UPPP addresses part of
an obstructing upper airway) improves long-term clinically important
outcomes, even though it rarely normalizes polysomnography.
Edward M. Weaver, MD, MPH
REFERENCES
1. Peker Y, Hedner J, Norum J, Kraiczi H, Carlson J. Increased
incidence of cardiovascular disease in middle-aged men with obstructive
sleep apnea: a 7-year follow-up. Am. J. Respir. Crit. Care Med.
2002;166(2):159-165.
2. Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical
modifications of the upper airway in adults with obstructive sleep apnea
syndrome. Sleep 1996;19(2):156-77.
3. Friedman M, Ibrahim H, Lee G, Joseph NJ. Combined
uvulopalatopharyngoplasty and radiofrequency tongue base reduction for
treatment of obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head
Neck Surg 2003;129(6):611-21.
4. Kezirian EJ, Weaver EM, Yueh B, Khuri SF, Daley J, Henderson WG.
Risk factors for serious complication after uvulopalatopharyngoplasty.
Arch Otolaryngol 2006;132(10):1091-1098.
5. Marti S, Sampol G, Munoz X, Torres F, Roca A, Lloberes P, et al.
Mortality in severe sleep apnoea/hypopnoea syndrome patients: impact of
treatment. Eur Respir J 2002;20(6):1511-8.
6. Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-Moron
I, Perez-Ronchel J, De la Vega-Gallardo F, et al. Mortality in obstructive
sleep apnea-hypopnea patients treated with positive airway pressure. Chest
2005;128(2):624-633.
Competing interests:
None declared
Competing interests: No competing interests
Dr. Elshaug offered comments to refute my survival study (1) in his
Author reply to Sam Robinson. Clarifications are in order.
This study compared long-term survival with two treatments for sleep
apnea: continuous positive airway pressure (CPAP) therapy or surgery in a
large cohort (N=20,826) of sleep apnea patients. Surgery patients had
better survival than all-comer CPAP patients, after adjusting for age,
gender, race, year of treatment, and comorbidity (1). We were unable to
draw conclusions about the relative benefits of surgery compared with
adherent CPAP use. We concluded that surgical treatment should be
considered in sleep apnea patients who use CPAP inadequately or not at
all.
1) “… it should be interpreted in the light of the following
observations. I note that some of these have been highlighted by the
original authors.”
We highlighted several of Dr. Elshaug’s observations and, moreover,
explained why the results remain valid.
2) “OSA severity data were unavailable. This, potentially, is a
confounder as it effects treatment choice and outcome i.e. those with mild
OSA are more likely to receive UPPP.”
Obstructive sleep apnea (OSA) severity data were not available for
the cohort. It is speculation that surgical patients more likely had mild
OSA. In fact, in a random sample of uvulopalatopharyngoplasty (UPPP)
patients drawn from a related cohort, we extracted OSA severity data from
medical records in a separate analysis of complications, and we found
surgical patients had severe OSA on average (apnea-hypopnea index >40
events/hour and lowest oxyhemoglobin saturation <78%) (2).
More importantly, it is necessary to understand how differential OSA
severity might confound the association between surgery and survival
outcome. Severe OSA appears to increase the risk of cardiovascular
disease, which is the main cause of sleep apnea-related death (3). Thus,
it is critical to adjust for comorbid cardiovascular disease (and other
comorbid conditions that contribute to death). This adjustment takes into
account the confounding effect of OSA severity on survival outcome. There
is an exception to this explanation if patients die spontaneously from OSA
primarily (no cardiovascular or respiratory element to the death), but
this is unlikely. Even sudden death associated with OSA is presumed to be
related to cardiac causes (arrhythmia or infarct) (4).
We adjusted for comorbidity in the survival analysis using a
comorbidity index (Charlson Comorbidity Index) that is a validated
predictor of mortality outcome. It incorporates 19 various comorbid
conditions, including cardiovascular diseases and others. In fact, this
adjustment is one of the strengths of this study.
Thus, the confounding effect of missing OSA severity is unclear
because the surgery patients had severe OSA and we adjusted for the
comorbid causes of death.
3) “CPAP use data were also unavailable so compliance was not
assessed.”
True. This study showed that surgery is superior to the provision of
CPAP, but we cannot (and should not) conclude that surgery is superior to
the use of CPAP. In fact, we believed that CPAP survival likely depended
on the amount of CPAP use. Later, Campos-Rodriguez demonstrated that
phenomenon in a different cohort (5).
We advocated then and continue to advocate CPAP therapy as first-line
treatment for OSA. However, OSA patients who do not use CPAP (or who use
it inadequately) should be evaluated for surgical therapy. While surgery
often does not normalize polysomnography results, it does appear to
improve the long-term clinically important outcome of survival.
4) “The CPAP group were [sic] significantly older (57 v 51 years).”
True, which is why we adjusted for age in our analysis. The surgery
benefit was observed after adjusting for this potential confounding
variable.
5) “At baseline, the CPAP group scored almost double on the
Comorbidity Index (2.0 v 1.1).”
True, which is why we adjusted for comorbidity in our analysis. The
surgery benefit was observed after adjusting for this potential
confounding variable.
6) “Residual confounding: comorbidity and mortality are so strongly
related that complete adjustment is not possible by statistical analyses.”
It is true that comorbidity and mortality are strongly associated
with an adjusted hazard ratio of 1.09 (95% confidence interval 1.08-1.10)
for each point on the Charlson Comorbidity Index in our cohort. I’m not
sure what is the basis for Dr. Elshaug’s statement that complete
adjustment is not possible. That implies a nihilistic view that
observational studies are invalid because because one can never guarantee
perfect adjustment. As noted above, the Charlson Comorbidity Index is
validated to predict mortality and is commonly used to adjust for
comorbidity in survival studies.
7) “The primary conclusions are drawn from observations of 1-year
mortality. However, the authors also looked back to 1991 (i.e. mortality
in 10 yrs v 1) and found inconsistent results that do not support their
own, or Dr Robinson’s, primary conclusion.”
False. We tested the mortality hazard for 1 - 5 years following the
initiation of therapy (CPAP or surgery) in a cohort where therapy was
started between 1997 and 2001. We also tested the mortality hazard for 1
- 11 years following the initiation of therapy in a larger cohort where
therapy was started between 1991 and 2001; however, we did not have
outpatient data on comorbidity in the earlier part of the cohort. Since
comorbidity is so critical in survival analysis, we restricted our primary
analysis to the smaller cohort reported. A secondary unadjusted analysis
of the longer cohort showed identical results. A set of tertiary analyses
attempted to adjust for the partial comorbidity data in the longer cohort,
unfortunately all of these tertiary analysis approaches resulted in a
significant proportion of patients excluded because of the missing data.
Nevertheless, in all of the tertirary analyses, surgery showed survival as
good as or better than CPAP after adjustment for confounding variables.
In another analysis of a related cohort, we found that surgery and CPAP
had superior survival to no treatment (6).
These findings are in agreement with a European cohort study (3) and
refute Dr. Elshaug’s thesis that surgery should not be offered.
In conclusion, even partial surgical therapy (UPPP addresses part of
an obstructing upper airway) results in long-term clinically important
outcomes, even though it rarely normalizes polysomnography.
Edward M. Weaver, MD, MPH
REFERENCES
(1) Weaver EM, Maynard C, Yueh B. Survival of veterans with sleep
apnea: continuous positive airway pressure versus surgery. Otolaryngol
Head Neck Surg 2004;130(6):659-65.
(2) Kezirian EJ, Weaver EM, Yueh B, Khuri SF, Daley J, Henderson WG.
Risk factors for serious complication after uvulopalatopharyngoplasty.
Arch Otolaryngol 2006;132(10):1091-1098.
(3) Marti S, Sampol G, Munoz X, Torres F, Roca A, Lloberes P, et al.
Mortality in severe sleep apnoea/hypopnoea syndrome patients: impact of
treatment. Eur Respir J 2002;20(6):1511-8.
(4) Gami AS, Howard DE, Olson EJ, Somers VK. Day-Night Pattern of
Sudden Death in Obstructive Sleep Apnea. N Engl J Med 2005;352(12):1206-
1214.
(5) Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-
Moron I, Perez-Ronchel J, De la Vega-Gallardo F, et al. Mortality in
obstructive sleep apnea-hypopnea patients treated with positive airway
pressure. Chest 2005;128(2):624-633.
(6) Weaver EM, Maynard C, Yueh B. Mortality of veterans with sleep
apnea: untreated versus treated. Sleep 2004;27:A208 (Abstract).
Competing interests:
None declared
Competing interests: No competing interests
At the risk of this turning into a personal clinical discussion, as
an Oral & Maxillofacial Surgeon, several statements mentioned in the
above discussions bear additional emphasis and/or consideration:
1) Of the three basic treatments for OSA: CPAP, oral appliances, and
surgery- none of these modalities is perfect- each has problems. The trick
is finding the therapy that the individual patient can tolerate, comply,
and live with.
2) Not all surgical procedures for treatment of OSA are the same; it
is not appropriate to group all surgical procedures for this disorder
together. Discerning who to perform what procedure on is a challenge to
any surgeon or team of surgeons. The goal should be to perform the most
efficacious, therapeutic and beneficial procedure(s) for a given patient’s
specific anatomic problem under as few anesthetic procedures as possible.
3) Published compliance data for oral appliances appears to be either
equal to or superior to CPAP.
4) As Dr. Shine so eloquently points out above, surgeons are limited
in their ability to produce Level I data (as is seen in the CPAP and oral
appliance literature). Prospective, randomized, controlled surgical trials
cannot ethically or easily be performed in humans. Do we therefore deny
surgical therapy because we lack data that we will never be able to
obtain?
5) In most cases, patients undergoing surgical treatment for OSA
undergo more than one procedure under the same anesthetic (most patients
don’t want to undergo serial procedures for this disorder); this confounds
the data related to treatment effect from any one specific procedure.
6) Dropout from treatment failure is a reality (multistep surgery
equates to a significant number of patients dropping out prior to
receiving needed therapy); As only one example, I am frustrated all too
often by patients with significant OSA who have undergone (and failed)
previous soft palate surgery who clearly would have benefitted initially
from Maxillomandibular advancement (these patients all too often drop out
because of pain, expense, and poor clinical result). In addition to the
difficulties and side-effects as stated within the article, these patients
are at risk of development of velopharyngeal incompetence as a result of
having a surgically shortened palate following upper jaw advancement
surgery. Given the known medical literature, in these patients, upper and
lower jaw advancement as an initial treatment option may well have been a
better initial treatment (most patients following initial jaw advancement
will not need subsequent soft palate surgery- saving them from the trauma
and side effects of this treatment).
Please don’t get me wrong- I am very appreciative and supportive of
my Otolaryngology colleagues (much of the surgical research being
performed for this disorder is due to their efforts), and
Maxillomandibular advancement is definitely NOT for everyone. While the
published data referred to by Dr. Robinson is impressive (soft palate
surgery certainly has its place)- but from a maxillofacial perspective
soft palate surgery may well be currently being performed far too often-
and with too many side-effects.
7) The majority of the surgical literature (and new surgical trials)
related to treatment of OSA is found within the Otolaryngology literature;
the Oral & Maxillofacial literature is not as widely read, and has
fewer trials and patient cohorts. Effect size, however, with
maxillofacial surgery- is large.
8) While controlled trials for treatment of this disorder would be of
benefit (too many new and experimental procedures are being performed
without the patients being made aware of the experimental nature of these
procedures), I agree, however, with Dr. Shine’s and Weaver’s comments.
Performance of proper prospective multidisciplinary clinical trials is
something yet to be achieved.
We have recently established the International Surgical Sleep Society
as a method for professional interaction, education, and interaction
amongst various surgical specialties as relates to surgical therapy for
this disorder. It is our hope that increased communications between the
various surgical disciplines will be of benefit ultimately to the patient
suffering from this disorder.
Competing interests:
None declared
Competing interests: No competing interests
The alleged clinical problem addressed by Elshaug on the Change page
is one that simply does not exist. Where is the evidence that surgeons are
performing surgery as first line treatment for obstructive sleep apnoea
syndrome (OSAS)? Whilst surgery for OSAS may be increasing (though I am
not convinced by his references that it universally is), one cannot infer
from this that surgeons are ignoring CPAP as the primary treatment
modality for OSAS. CPAP is widely accepted by the surgical community as
well as the medical community as being the first line of treatment for
OSAS. Any increase in surgeries performed for OSAS may be due to the
recent increase in the numbers of patients diagnosed with OSAS due to
improved availability and accessibility of diagnostic facilities and
improved recognition of this entity by primary care physicians, amongst
others. More patients with OSAS means more patients treated with CPAP, and
inevitably more CPAP failures. It well acknowledged that CPAP, whilst the
“gold standard”, is not universally acceptable to all patients and that up
to 30% of patients (even those who experience a good sympotomatic response
to treatment) will fail to tolerate CPAP in the medium to long term. A
further non-reported cohort of patients refuse CPAP treatment from the
off. These are the patients who should be considered possible surgical
candidates. For the sake of completeness however, I do have a few specific
comments:
1. The Cochrane Database is selectively quoted thus introducing a
bias into the article. The Cochrane review of Surgery in OSAS is quite
correctly alluded to and referenced. However the authors continue to
recommend lifestyle modifications which have also been subject to a
Cochrane review with no randomised trial data to support these
recommendations. Consistency is necessary
2. The argument for surgery to be only performed within the context
of a controlled clinical trial shows a significant lack of insight into
the challenges facing the clinician who interacts on a daily basis with
the individual patient. Randomized controlled trials are the accepted gold
standard and the ideal to aspire to but such trials are extremely
difficult to perform in surgery. Obviously the surgeons ability, equipoise
and willingness to participate are important. The patients’ preference may
be a significant stumbling block in recruitment and blinding patients
would prove problematic. What would the surgery be compared to? These
patients should all be CPAP failures. Is comparison to sham surgery
ethical? Should it be compared to no surgery in order to control for
regression to the mean? Or should surgical procedures be compared to each
other? If so which ones? And finally, whilst the sweeping statement that
surgery should only be performed in a controlled trial setting (a
sentiment shared by the Scottish Intercollegiate Guidelines Network)
sounds great, who will fund these studies? They require time and money. In
the meantime, patients who may benefit from surgery (and yes I believe
they do exist) may be denied potentially beneficial therapy.
3. The final sentence in the article suggests what we, as surgeons,
should discuss with our patients preoperatively. The vast majority of
surgeons (one can never say always in medicine) will discuss the risks,
complications and sequelae of each and every operation they perform with
each and every patient. The risks of not performing the operation and the
possible benefits to the patient are also discussed. This is not only the
typical surgeons routine but in most jurisdictions it represents informed
consent which is both ethically and legally necessary to proceed!
The role of the surgeon in adult OSAS remains to be fully elucidated.
Interestingly, the “gold standard” for paediatric OSAS is
adenotonsillectomy and has now become the most common indication for this
procedure. And yet the Cochrane review regarding this treatment stated
that “ this review did not find any evidence from randomised trials to
support the use of adenotonsillectomy for sleep apnoea in children”. So
we accept a lesser standard of evidence supporting surgery in our children
than in adults for the same disease process. The reality is that the
majority of surgical procedures do not have Level 1 evidence and to select
out adult OSAS surgery to be only performed in a trial setting is probably
not an achievable goal.
Competing interests:
None declared
Competing interests: No competing interests
I welcome the opportunity to debate the issues raised with Dr Elshaug
in his articles and subsequent rapid response dated 7th January. It should
be noted that the views of Dr Elshaug and co- authors are at odds with
current practice guidelines for the American Sleep Disorders Association,
which support the use of upper airway surgery for adult obstructive sleep
apnea when the devices (CPAP or MAS) are ineffective or rejected(1). I
would like to address several issues covered in his reply:
1. Compliance with devices
Until the rapid response of 7th January, Elshaug et al have not
acknowledged in the text of any their articles the central issue of the
area under the curve of efficacy x compliance, in comparing devices to
surgical treatment of sleep apnoea. I commend them for now doing so.
However, I am at a loss to explain why Dr Elshaug still interprets the
Peker article (2) as supporting his view that “the proportion who receive
an optimal outcome from a surgical approach is low and inconsistent and
less than can be achieved by other means”. Peker found that efficient
treatment from compliance of > 50% sleep time was achieved in only 36%
of CPAP patients, and 25% of MAS patients. This compares to 50% of
surgical patients (having only the simple intervention of UPP) achieving a
> 50% reduction in RDI (i.e. the same area under the curve as CPAP or
MAS, assuming full control of OSA when the device worn). I agree that
efficient treatment of OSA with any modality is likely to lead to
important health outcomes. In the Peker article, this was clearly more
frequent in the surgical group than those treated with devices due to
compliance issues. This does NOT mean that I am advocating treatment with
surgery as first line. Elshaug et al have never produced any evidence to
suggest that there is widespread surgery being performed as initial
treatment instead of trialling CPAP or MAS first (which would be in breach
of current practice guidelines (1)). Clearly, surgery has risks of post
operative complications which don't apply to noninvasive treatments.
However, the Peker article (and many others) show the dangers of leaving
patients with significant sleep apnoea untreated when the devices are
ineffective or not worn. In this situation, current guidelines dictate
that stepwise surgery be offered to the patient, after advising the
patient the likelihood of the success of each procedure and that
possibility of multiple operations to achieve an acceptable outcome.
2. The perceived need to achieve an RDI <5 with surgery
Dr Elshaug claims that more than a dozen articles cited in his Sleep
article (3) support his contention that achieving an RDI<_5 xmlns:follows="urn:x-prefix:follows" is="is" necessary="necessary" with="with" all="all" treatment="treatment" modalities.="modalities." lets="lets" look="look" at="at" the="the" landmark="landmark" paper="paper" _4="_4" he="he" quotes="quotes" as="as" prime="prime" example="example" in="in" his="his" support="support" of="of" this.="this." this="this" becker="becker" et="et" al="al" looked="looked" effect="effect" therapeutic="therapeutic" cpap="cpap" versus="versus" subtherapeutic="subtherapeutic" on="on" blood="blood" pressure="pressure" control.="control." if="if" one="one" looks="looks" true="true" for="for" whole="whole" night="effective" i.e.="i.e." area="area" under="under" efficacy="efficacy" x="x" compliance="compliance" curve="curve" calculations="calculations" are="are" follows:_="follows:_" assuming="assuming" recommended="recommended" _8="_8" hours="249.4" nightly="nightly" sleep="sleep" then="then" group="group" rdi="rdi" _3.4="_3.4" _5.5="_5.5" _="_" _62.5="_62.5" _2.5="_2.5" respiratory="respiratory" events="events" _21.9="_21.9" hour.="hour." _33.4="_33.4" _5.4="_5.4" _65="_65" _2.6="_2.6" _43.7="_43.7" p="p"/> The current most widespread outcome measure using RDI applied to
surgery is RDI <20 (+/- > 50% total RDI reduction). As surgery is
always applied 100% of sleep time, achieving an RDI <20 with surgery
is actually BETTER than the average therapeutic CPAP effect for the whole
sleep time if applied 5.5 hours a night (as in this paper). I reiterate
there is no clear evidence that mandates achieving an RDI <5 as
essential for surgery to be a useful intervention, and none of the papers
he quotes establish his case. Furthermore the changing guidelines on
measurement techniques and scoring criteria for polysomnography have made
interpreting the literature even more difficult, and reliance on a single
parameter such as the RDI more uncertain. Normative data of asymptomatic
controls in one of our local sleep laboratories using pressure transducers
to measure hypopnoeas yielded an RDI of 6.1 + 7.2 (mean + 2 SD), thus a
pathological threshold of >15 (5). Other groups have demonstrated the
need to adjust thresholds of disease upwards using the new measurement
practices, although as Dr Elshaug correctly states, the Chicago criteria
are still applied in the American Academy of Sleep Medicine guidelines.
There is much active work happening to standardize polysomnography. Until
the picture becomes clearer, it seems illogical to suggest that surgery
must achieve an RDI below that of asymptomatic controls to be efficacious!
Given that all of Dr Elshaug’s publications make the underlying assumption
that an RDI <5 be achieved to define surgical success, I find his
conclusions unconvincing.
3. Surgery analyzed
Elshaug et al correctly state that multilevel reconstructive upper
airway surgery may involve multiple steps. Superior outcomes to [not "of", as originally posted] single
level intervention (e.g. UPP alone) has been shown in a metanalysis(6). In
subsequent reports, such as that of Nuruntarat the mean RDI for all
patients fell from 47.9 + 8.4 pre-op to 18.6 + 4.1 at 3 years (N=46)
equating to a response rate of 65% maintaining a RDI<_20 long="long" term="term" _7.="_7." the="the" article="article" quoted="quoted" to="to" suggest="suggest" a="a" high="high" dropout="dropout" rate="rate" from="from" step="step" wise="wise" protocol="protocol" is="is" poorly="poorly" designed8.="designed8." definitions="definitions" of="of" phase="phase" _1="_1" and="and" _2="_2" are="are" wrong="wrong" additional="additional" categories="categories" operation="operation" created="created" for="for" synonyms.="synonyms." as="as" usual="usual" elshaug="elshaug" et="et" als="als" publications="publications" no="no" ent="ent" surgeon="surgeon" had="had" input="input" in="in" content="content" paper.="paper." personal="personal" communication="communication" _2007="_2007" with="with" surgeons="surgeons" working="working" at="at" institutions="institutions" which="which" surgery="surgery" was="was" performed="performed" reveals="reveals" extended="extended" waiting="waiting" times="times" sleep="sleep" studies="studies" after="after" also="also" lists="lists" further="further" steps="steps" stepwise="stepwise" protocol.="protocol." period="period" analysis="analysis" therefore="therefore" likely="likely" have="have" missed="missed" many="many" patients="patients" having="having" steps.="steps." analyzing="analyzing" performing="performing" does="does" not="not" help="help" demonstrate="demonstrate" effectiveness="effectiveness" or="or" otherwise="otherwise" contemporary="contemporary" upper="upper" airway="airway" so="so" conclusion="conclusion" can="can" be="be" drawn="drawn" this="this" i="i" agree="agree" that="that" resource="resource" intensive="intensive" but="but" nevertheless="nevertheless" appropriate="appropriate" correctly="correctly" selected="selected" patients.="patients." p="p"/> 4. What is the alternative to surgery?
The compliance with CPAP has not changed substantially for many
years. It is somewhat naive to pin the hopes of OSA sufferers on a single
trial of cognitive behavioural therapy(9) as being the answer to those who
cannot tolerate CPAP. Funding for upper airway surgery certainly does not
need to be reduced to initiate this strategy in any case, as the cost is
trivial compared to the investment of the patient and/or the health care
provider in CPAP equipment costs over the lifetime of the patient.
Mandibular advancement splints are variably effective, and compliance is
again variable. In short, Elshaug and colleagues offer no alternative to
the patient who cannot tolerate a device.
The real motivation for articles by this group has been revealed in
the last few paragraphs of his response. Justifying reduction in health
care costs by reducing services using flawed analysis may be good
politics. However let's not pretend that removing viable treatment options
is to the patient's benefit!
1) Practice parameters for the treatment of obstructive sleep apnea
in adults: the efficacy of surgical modifications of the upper airway.
Report of the American Sleep Disorders Association. Sleep 1996
Feb;19(2):152-5
2) Peker Y, Hedner J, Norum J, Kraiczi H, Carlson J. Increased
incidence of cardiovascular disease in middle-aged men with obstructive
sleep apnea: a 7 year follow-up. Am J Respir Crit Care Med. 2002
Jul;166(2):159-65.
3) Elshaug AG, Moss JR, Hiller JE, Maddern GJ. Upper airway surgery
should not be first line treatment for obstructive sleep apnoea in adults.
BMJ 2008;336:44-45.
4) Becker H, Jerrentrup A, Ploch T, et al. Effect of nasal continuous
positive airway pressure treatment on blood pressure in patients with
obstructive sleep apnea. Circulation 2003;107:68-73.
5) Banks S, Barnes M, Tarquino N, Pierce RJ, Lack LC, McEvoy RD.
Factors associated with maintenance of wakefulness test mean sleep latency
in patients with mild to moderate obstructive sleep apnoea and normal
subjects. J Sleep Res, 2004;13:71-782.
6) Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical
modifications of the upper airway in adults with obstructive sleep apnea
syndrome. Sleep 1996;19(2):156-77
7) Neruntarat C. Genioglossus advancement and hyoid myotomy: short-
term and long-term results. J Laryngol Otol. 2003;117(6):482-6
8) Elshaug AG, Moss JR, Southcott A, Hiller JE. An analysis of the
evidence-practice continuum: is surgery for obstructive sleep apnoea
contraindicated? J Eval Clin Pract 2007;13:3-9.
9) Richards D, Bartlett D, Wong K, Malouff J, Grunstein R. Increased
adherence to CPAP with a group cognitive behavioral treatment
intervention: a randomized trial. Sleep 2007; 30(5): 635-640
Competing interests:
None declared
Competing interests: No competing interests
I applaud Dr. Elshaug and colleagues for critically evaluating a
sample of existing evidence to strive for answers on treating the complex
condition of sleep apnea.
However, I have trouble understanding why Dr. Elshaug’s article
appears in the BMJ Change Page (1). The Change Page aims to alert
clinicians to the immediate need for a change in practice to make it
consistent with current evidence.
Dr. Elshaug’s thesis is “that upper airway surgery should not be
first line treatment for obstructive sleep apnoea in adults.” Currently,
surgery is NOT considered first line therapy for sleep apnea in adults.
Dr. Elshaug proposes the status quo, not change.
Dr. Elshaug concludes that “Surgery for obstructive sleep apnoea
should be done within controlled clinical trials. Patients should be
informed about the trial, as well as of the inconsistent results of
surgery, the associated pain, the potential side effects, and the
potential for relapse.”
As a sleep surgeon, I agree completely with Dr. Elshaug’s
conclusions. We should try to increase the evidence base around surgical
treatment (and CPAP therapy, weight loss, oral appliances, and novel new
treatments). Good surgeons always advise patients that the
polysomnography outcomes for surgery are difficult to predict, that
surgery has potential side effects, and that there is a potential for
relapse. An informed surgeon also explains to them that long-term studies
support that surgery improves survival (2), appears to reduce the risk of
cardiovascular disease in a significant proportion of patients (3),
reduces motor vehicle crash risk (4), and tends to improve reaction times
and quality of life (5). These discussions are critical in order for
patients to have realistic expectations of salvage surgery as a means to
improve, albeit rarely cure, their obstructive sleep apnea.
None of these comments dictate a change to current practice.
Edward M. Weaver, MD, MPH
REFERENCES
1. Elshaug AG, Moss JR, Hiller JE, Maddern GJ. Upper airway surgery
should not be first line treatment for obstructive sleep apnoea in adults.
Bmj 2008;336(7634):44-5.
2. Marti S, Sampol G, Munoz X, Torres F, Roca A, Lloberes P, et al.
Mortality in severe sleep apnoea/hypopnoea syndrome patients: impact of
treatment. Eur Respir J 2002;20(6):1511-8.
3. Peker Y, Carlson J, Hedner J. Increased incidence of coronary
artery disease in sleep apnoea: a long-term follow-up. Eur Respir J
2006;28(3):596-602.
4. Haraldsson PO, Carenfelt C, Lysdahl M, Tingvall C. Does
uvulopalatopharyngoplasty inhibit automobile accidents? Laryngoscope
1995;105(6):657-61.
5. 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(6):848-61.
Competing interests:
None declared
Competing interests: No competing interests
We thank Dr Robinson for his interest in our Change Page (1) and
offer the following in reply to his rapid response dated 5 January, 2008.
1. The recommendation made in our Change Page that surgery should be
restricted to controlled clinical trials echoes those made in the most
recent Cochrane review in this area (2). We support this recommendation as
we believe it will contribute to best evidence-informed practice.
2. For those interested in sourcing the original paper (3), please
note the author spelling is ‘Peker’, not ‘Pecker’ as reported by Dr
Robinson in his rapid response.
This research by Peker et al. offers an important contribution to
this area and we believe supports our Change Page entirely. Peker et al.
did report equally large reductions in cardiovascular disease (CVD) over a
7 year period in a surgically treated cohort. However, there are some
other important points from that study: 1) “When OSA was incompletely
treated, the independent risk for CVD turned out to increase up to 11-
fold, whereas efficient treatment of OSA significantly reduced this excess
risk for CVD in OSA patients” (pg.163). So, CVD reductions were evident
ONLY in those who received ‘efficient’ treatment (with surgery, CPAP or
MAS) and, 2) in this study “approximately 50% of subjects undergoing UPPP
still had OSA at the follow-up recording” (pg. 162) meaning they were
inefficiently/ineffectively treated with UPPP alone. 3) There was cross-
contamination of treatment where “during follow-up, treatment of OSA was
initiated with CPAP (n=14) AND/or UPPP (n=22) AND/or oral device (n=4)”
(pg 162) meaning surgery recipients may also have received CPAP treatment
during follow-up. 4) Given the sample sizes one needs to be observant to
statistical power and, 5) UPPP recipients had milder OSA to start with.
In summary, therefore, like Peker et al. we support any efficient or
effective surgical intervention and believe this is likely to improve
health outcomes. However, the thrust of our Change Page is that,
unfortunately, the proportion who receive an optimal outcome from a
surgical approach is low and inconsistent and less than can be achieved by
other means, as is elegantly presented by Peker et al. and many others.
3. Dr Robinson suggests “there is no clear evidence that achieving an
RDI <5 is necessary to effectively treat sleep apnoea”. In fact
evidence in this area is building. In a recent publication (4) in the
journal SLEEP, AGE, JRM, JEH and another co-author present evidence from
over one dozen published articles that support this. Further, this is a
classification endorsed by the American Academy of Sleep Medicine (AASM)
and is the primary endpoint against which CPAP is judged.
4. Similarly, the research by Weaver et al. (5) holds a notable
position in the literature but it should be interpreted in the light of
the following observations. I note that some of these have been
highlighted by the original authors.
• In the study, OSA severity data were unavailable. This,
potentially, is a confounder as it effects treatment choice and outcome
i.e. those with mild OSA are more likely to receive UPPP. CPAP use data
were also unavailable so compliance was not assessed.
• The CPAP group were significantly older (57 v 51 years)
• At baseline, the CPAP group scored almost double on the Comorbidity
Index (2.0 v 1.1)
• Residual confounding: comorbidity and mortality are so strongly related
that complete adjustment is not possible by statistical analyses
• The primary conclusions are drawn from observations of 1-year mortality.
However, the authors also looked back to 1991 (i.e. mortality in 10 yrs v
1) and found inconsistent results that do not support their own, or Dr
Robinson’s, primary conclusion
5. We take this opportunity to urge all surgeons, physicians and
researchers involved in such trials to randomize them and to observe and
address (in their data collection phase(s), not by controlling post hoc)
the many potentially confounding factors that are so commonly over-looked
and excluded in these trials. These potential confounding factors are
discussed in detail in a paper published in the Journal of Evaluation in
Clinical Practice (6).
6. We agree that ‘efficacy x compliance’ is an important
consideration, and those interested to read the cited reports in our
Change Page will gain an appreciation of this. We also direct interested
readers to a policy discussion paper (7; free access online) where several
of us include for discussion surgery for OSA as a case study. What remains
unavoidable is that surgery is resource intensive; involving multiple
visits to physicians, surgeons, overnight sleep clinics (if guidelines are
met), theatre and ward recovery resources etc. This is particularly so
given that modern reconstructive surgery most commonly involves multiple
stages/operations over a period of time – which a substantial proportion
of patients will not endure but drop out from (6).
Our collective work in this area appreciates the potential for
opportunity costs. This concept has been expressed thus by others,
“Since resources are scarce relative to needs, the use of resources
in one way prevents their use in other ways. The opportunity cost of
investing in a healthcare intervention is best measured by the health
benefits that could have been achieved had the money been spent on the
next best alternative intervention or healthcare programme” (8)
One brief example to illustrate this comes from a teaching hospital
(Sydney, Australia): RCT; n=100; comparing CPAP initiation on ‘treatment
as usual’ with ‘treatment X’. Results: 30% ‘failed’ CPAP with treatment as
usual, while only 8% ‘failed’ CPAP with ‘treatment X’. What was treatment
X? Answer: Two 1-hour Cognitive Behaviour Therapy (CBT) sessions
(including a video of real CPAP users) plus treatment as usual (mask
fitting and information) (9). Directing resources toward weight control
initiatives is another option, particularly as it focuses on a primary
risk factor for OSA and many other morbidities.
Adam Elshaug and John Moss (Professors Hiller and Maddern are
currently enjoying annual leave)
References:
(1) Elshaug AG, Moss JR, Hiller JE, Maddern GJ. Upper airway surgery
should not be first line treatment for obstructive sleep apnoea in adults.
British Medical Journal, 2008; 336(7634): 44-45.
doi:10.1136/bmj.39381.509213.AE
(2) Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for
obstructive sleep apnoea. Cochrane Database Syst Rev 2005;(4):CD001004.
(3) Peker Y, Hedner J, Norum J, Kraiczi H, Carlson J. Increased
incidence of cardiovascular disease in middle-aged men with obstructive
sleep apnea: a 7 year follow-up. Am J Respir Crit Care Med. 2002;
166(2):159-65.
(4) Elshaug AG, Moss JR, Southcott A, Hiller JE. Redefining success
in airway surgery for Obstructive Sleep Apnea: A meta analysis and
synthesis of the evidence. Sleep, 2007; 30(4): 461-467.
(5) Weaver EM, Maynard C and Yueh B. Survival of veterans with sleep
apnea: Continuous positive airway pressure versus surgery. Otolaryngol
Head Neck Surg 2004;130:659-65.
(6) Elshaug AG, Moss JR, Southcott A, Hiller JE. An analysis of the
evidence-practice continuum: Is surgery for Obstructive Sleep Apnoea
contraindicated? Journal of Evaluation in Clinical Practice, 2007; 13(1):
3-9. http://www.blackwell-synergy.com/toc/jep/13/1
(7) Elshaug AG, Hiller JE, Tunis SR, Moss JR. Challenges in
Australian policy processes for disinvestment from existing, ineffective
health care practices. Australia and New Zealand Health Policy, 2007; 4:
23 (31 October 2007). http://www.anzhealthpolicy.com/content/4/1/23
(8) Palmer S, Raftery J. Economic Notes: opportunity cost. British
Medical Journal, 1999; 318(7197): 1551-1552.
(9) Richards D, Bartlett D, Wong K, Malouff J, Grunstein R. Increased
adherence to CPAP with a group cognitive behavioral treatment
intervention: a randomized trial. Sleep 2007; 30(5): 635-640.
Competing interests:
None declared
Competing interests: No competing interests
Mr Robinson, in his response to Elshaug et al, concedes that upper
airway
surgery should not be first line treatment for obstructive sleep apnoea in
adults. However, he cites 2 references that suggest that upper airway
surgery
is as effective, or even more effective, than CPAP to prevent
cardiovascular
morbidity and death. Careful reading of the 2 articles shows that this
conclusion is unjustified.
The study of Peker et al included only 14 patients treated with CPAP,
22 with
uvulopalatopharyngoplasty (UPPP) and 4 with an oral device. Of the CPAP
patients, 64 percent did not adhere to treatment and only one subject with
an
oral appliance was considered “efficiently treated”. With such small
numbers
of subjects any statement about the relative efficacy of the therapies is
meaningless.
In the study by Weaver et al, CPAP was the therapy in 90 percent of
the
20,000 US veterans while only 10 percent were treated with UPPP. While an
attempt was made to adjust for confounding factors, they were not able to
adjust for severity of sleep apnoea or for adherence to CPAP. It is highly
likely
that CPAP was the preferred treatment on those with more severe sleep
apnoea and so the conclusion that UPPP confers a survival advantage over
CPAP seems unwarranted.
As Powell pointed out in the article cited, adherence to therapy is
an “issue
swept under the rug by sleep medicine”. In the patient who does not use
CPAP a better outcome can be expected even with a partially effective
surgical
procedure where adherence is guaranteed.
Competing interests:
None declared
Competing interests: No competing interests
Elshaug et al. reply
Reply to Messrs Weaver, Robinson and Shine
The primary theme running through the responses from Weaver (8 Jan),
Robinson (8 Jan) and Shine (9 Jan) is ¡®no problem, no change¡¯ and that
good surgeons already follow the guidelines that are presented in our
Change Page. They suggest that we have not produced evidence to the
contrary. We direct these contributors back to the cited evidence in our
Change Page, and to the general literature in this area, where evidence is
indeed presented. There are two reports (to our knowledge) that have
investigated this issue and both found a proportion of surgical recipients
by-passed sleep medicine physicians/clinics and underwent surgery both
without a formal diagnosis of OSA and without receiving a trial of CPAP.
In our own audit (1), which utilised a methodology sensitive to this
occurrence, 28 cases had to be excluded (making n=94) for this reason - a
high proportion. Marshall et al. subsequently observed the same phenomenon
(2).
Moore (11 Jan) points to the limitation within the Cochrane process
of excluding non-RCT evidence. We agree with this observation
wholeheartedly, so much so that it was the impetus behind our published
meta-analyses (3) that specifically sought to include studies that sit
lower on the hierarchy of evidence but nevertheless have much to
contribute in this area. This evidence is included in our Change Page.
Robinson, in his 8 January rapid response, suggests "The current most
widespread outcome measure using RDI applied to surgery is RDI <20 (+/
- > 50% total RDI reduction)". He goes on to state "it seems illogical
to suggest that surgery must achieve an RDI below [ ¡Ü5 ]". We ask,
what is illogical about using the criterion endorsed by the AASM (and
adopted in many parts of the world) and against which CPAP is judged?
Moreover, this is precisely the interpretive quandary presented for debate
in our recent papers in this area: that (primarily if not exclusively)
surgeons continue to apply the RDI of 20 as their primary outcome measure
which is not in keeping with 1) the more stringent AASM criteria within
which sleep medicine operates i.e AHIs of <_5 no="no" condition="condition" _5-15="_5-15" mild="mild" _15-30="_15-30" moderate="moderate" and="and"/> 30 (severe condition) and, 2) it ignores
the growing evidence base to support the validity of these (or similar)
outcome measures.
Adam Elshaug, BA, BSc(Hons), MPH, PhD
John Moss, MSocSci, BEc, MB BS, FCHSE
References:
1. Elshaug AG, Moss JR, Southcott A and Hiller JE. An analysis of the
evidence-practice continuum: Is surgery for Obstructive Sleep Apnoea
contraindicated? J Eval Clin Pract, 2007; 13(1): 3-9.
2. Marshall NS, Bartlett DJ, Matharu KS, et al. Prevalence of
treatment choices for snoring and sleep apnea in an Australian population.
J Clin Sleep Med, 2007; 3(7): 695-699.
3. Elshaug AG, Moss JR, Southcott A and Hiller JE. Redefining success
in airway surgery for Obstructive Sleep Apnea: A meta analysis and
synthesis of the evidence. Sleep, 2007; 30(4): 461-467.
Competing interests:
None declared
Competing interests: No competing interests