Tonsillectomy is the most common childhood surgical procedure in Australia1 and the United States.2 The most common indication is sleep-disordered breathing (SDB).3 SDB symptoms affect at least 1 in 10 children.4 Concerned parents seek advice from various professionals including primary care physicians, otolaryngologists, pediatricians, sleep specialists, dentists, and orthodontists.
Adenotonsillectomy is first-line therapy for moderate to severe obstructive sleep apnea (OSA).4 Landmark studies of OSA treatment that defined the intervention group using polysomnography (eg, children with mild OSA [obstructive apneahypopnea index (OAHI) 1–5 events/h5] or children without major desaturation6) have contributed to the evidence base for treatment options in OSA, such as nasal topical corticosteroids for mild cases. However, severity of SDB based on polysomnography parameters such as OAHI does not predict the effect on quality of life, or cognitive and behavioral effects,7 nor does it predict symptomatic improvement after adenotonsillectomy.7 This may reflect the imperfection of the OAHI metric, or individual susceptibility to the effects of sleep disruption.
Approximately 90% of children having adenotonsillectomy for SDB have not had preoperative testing to determine the severity of OSA,3 and, if tested, approximately half the children waiting for adenotonsillectomy have primary snoring without OSA by polysomnography-measured criteria.6 So, given the clinical limitations and limited availability of polysomnography, otolaryngologists and other clinicians largely make treatment decisions based on history and examination. Thus, we favor prioritizing research protocols that determine the efficacy of treatment based on clinical assessment. This approach is consistent with the concept of effectiveness trials (also known as pragmatic trials) in which trials are designed to reflect what clinicians do in practice, as distinct from the usual efficacy trials that assess an intervention under controlled, idealized circumstances. Findings from pragmatic trials not relying on polysomnography will be directly translatable to the many thousands of children presenting for treatment of SDB worldwide. Polysomnography clearly has a role both clinically and in research, but in parallel we need studies addressing questions that arise in real-world practice. We suggest more trials in SDB should be designed with nonpolysomnography eligibility criteria and outcome measures, including parental satisfaction with the adequacy of treatment given that this outcome reflects the effectiveness of treatment in addressing the symptoms that drive parents to seek help for their child in the first place.
All authors have seen and approved this manuscript. The authors report no conflicts of interest.
Nixon GM, Kubba H, Perrett KP. Time to open our eyes? A challenge to the role of polysomnography for trials in pediatric sleep-disordered breathing. J Clin Sleep Med. 2018;14(3):489–490.
Australian Institute for Health and Welfare website. Procedures Data Cubes, 2014-2015. https://www.aihw.gov.au/reports-statistics/health-welfare-services/hospitals/overview. Accessed November 15, 2017.
Agency for Healthcare Research and Quality website. Healthcare Costs and Utilization Project, 2012. https://hcupnet.ahrq.gov/#setup. Accessed November 15, 2017.
Roland PS, Rosenfeld RM, Brooks LJ, et al. Clinical practice guideline: polysomnography for sleep-disordered breathing prior to tonsillectomy in children. Otolaryngol Head Neck Surg. 2011;145 1 Suppl:S1–S15. [PubMed]
Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012;130(3):576–584. [PubMed]
Kheirandish-Gozal L, Bhattacharjee R, Bandla HP, Gozal D. Antiinflammatory therapy outcomes for mild OSA in children. Chest. 2014;146(1):88–95. [PubMed Central][PubMed]
Marcus CL, Moore RH, Rosen CL, et al. A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013;368(25):2366–2376. [PubMed Central][PubMed]
Rosen CL, Wang R, Taylor HG, et al. Utility of symptoms to predict treatment outcomes in obstructive sleep apnea syndrome. Pediatrics. 2015;135(3):e662–e671. [PubMed Central][PubMed]