Publications by authors named "Stacey L Ishman"

172 Publications

Elevation of CD40/CD40L Inflammatory Pathway Molecules in Carotid Plaques from Moderate-and-Severe Obstructive Sleep Apnea Patients.

Diagnostics (Basel) 2021 May 22;11(6). Epub 2021 May 22.

Department of Otorhinolaryngology, Faculty of Dental Medicine, Medical University of Warsaw, 02-097 Warsaw, Poland.

A chronic inflammatory process characteristic of obstructive sleep apnea promotes vascular endothelial dysfunction and atherogenesis. This process can lead to destabilization and rupture of cardiovascular plaques, which clinically manifests as an acute coronary syndrome or stroke. The aim of this study was to investigate the inflammatory pathway leading to plaque destabilization in non-to-mild and moderate-to-severe groups of OSA patients. This prospective study involved enrollment of patients scheduled for endarterectomy. A sleep study was performed prior to surgery. Immunohistochemistry was performed on atherosclerotic plaques from carotid arteries obtained during standard open endarterectomy to determine levels of CD40, CD40L receptors, MCP-1, and MMP-9. The 46 patients included 14 controls, 13 with mild, 11 with moderate, and 8 with severe OSA. Increased expression of CD40, CD40L receptors, MCP-1, and MMP-9 were found to be proportionate with OSA severity. However, significant differences among groups were observed only for MCP-1 ( = 0.014). Increased expression of inflammatory markers (CD40, CD40L, MCP-1, MMP-9) is associated with increasing OSA severity. This suggests the CD40-CD4-L inflammatory pathway may contribute to plaque instability and rupture in OSA patients.
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http://dx.doi.org/10.3390/diagnostics11060935DOI Listing
May 2021

Persistent Obstructive Sleep Apnea Burden on Family Finances and Quality of Life.

Otolaryngol Head Neck Surg 2021 Jan 19:194599820986566. Epub 2021 Jan 19.

Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

Objective: We previously found that financial concerns negatively affect the quality of life of families of children with persistent obstructive sleep apnea (OSA) after tonsillectomy. The goal is to quantify the financial impact on families of children with persistent OSA and assess contributing factors.

Study Design: Cross-sectional survey study with comparison group.

Setting: Upper airway center at a tertiary pediatric hospital.

Methods: Participants included consecutive children with persistent OSA from September to October 2017. Healthy children seen in a general otolaryngology clinic served as controls. Families of both groups completed the Family Impact Questionnaire and the modified Comprehensive Score for Financial Toxicity (COST).

Results: Families of the 50 patients (25 study and 25 control) completed the surveys: the mean age was 6.4 years (95% CI, 5.0-7.8), and 19 (38%) were female. There were no differences in age, sex, race, or insurance status between groups ( > .05). The mean apnea-hypopnea index for the study group was 7.9 events/h (range, 5.5-10.3), and 40% (10/25) had Down syndrome. Positive airway pressure and/or oxygen were used by 72% (18/25). The Comprehensive Score for Financial Toxicity for study patients (21.9; 95% CI, 14.8-26.0) was significantly lower than for controls (30.2; 95% CI, 26.6-30.8; = .003), reflecting elevated financial toxicity. Study families reported greater financial impact on the Family Impact Questionnaire (8.4; 95% CI, 6.1-10.7) versus controls (3.6; 95% CI, 1.8-5.4; = .002); concerns regarding missed days of work and school were common (30.7%).

Conclusion: Families of children with persistent OSA reported a high financial burden related to their children's disease and were more likely to report financial toxicity than families of controls. Concern regarding missed work and school associated with appointments and treatment was a significant factor.
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http://dx.doi.org/10.1177/0194599820986566DOI Listing
January 2021

Expert Consensus Statement: Pediatric Drug-Induced Sleep Endoscopy.

Otolaryngol Head Neck Surg 2021 Jan 5:194599820985000. Epub 2021 Jan 5.

SUNY Downstate Health Sciences University, New York, New York, USA.

Objective: To develop an expert consensus statement on pediatric drug-induced sleep endoscopy (DISE) that clarifies controversies and offers opportunities for quality improvement. Pediatric DISE was defined as flexible endoscopy to examine the upper airway of a child with obstructive sleep apnea who is sedated and asleep.

Methods: Development group members with expertise in pediatric DISE followed established guidelines for developing consensus statements. A search strategist systematically reviewed the literature, and the best available evidence was used to compose consensus statements regarding DISE in children 0 to 18 years old. Topics with significant practice variation and those that would improve the quality of patient care were prioritized.

Results: The development group identified 59 candidate consensus statements, based on 50 initial proposed topics, that focused on addressing the following high-yield topics: (1) indications and utility, (2) protocol, (3) optimal sedation, (4) grading and interpretation, (5) complications and safety, and (6) outcomes for DISE-directed surgery. After 2 iterations of the Delphi survey and removal of duplicative statements, 26 statements met the criteria for consensus; 11 statements were designated as no consensus. Several areas, such as the role of DISE at the time of adenotonsillectomy, were identified as needing further research.

Conclusion: Expert consensus was achieved for 26 statements pertaining to indications, protocol, and outcomes for pediatric DISE. Clinicians can use these statements to improve quality of care, inform policy and protocols, and identify areas of uncertainty. Future research, ideally randomized controlled trials, is warranted to address additional controversies related to pediatric DISE.
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http://dx.doi.org/10.1177/0194599820985000DOI Listing
January 2021

Hypoglossal Nerve Stimulation in Veterans With Comorbid Insomnia and Sleep Apnea.

Otolaryngol Head Neck Surg 2021 06 5;164(6):1345-1353. Epub 2021 Jan 5.

Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.

Objective: Insomnia and sleep apnea frequently co-occur, with additive effects of both disorders presenting clinicians with unique treatment challenges compared to one disorder alone. The hypoglossal nerve stimulator (HNS) is a promising treatment for patients with comorbid insomnia and sleep apnea (COMISA), many of whom have positive airway pressure (PAP) intolerance. Our aim was to determine adherence to and efficacy of HNS in veterans with COMISA refractory to PAP therapy compared to those with obstructive sleep apnea alone (OSA only).

Study Design: Retrospective case series.

Setting: A single, academic Veterans Affairs medical center.

Methods: Review of clinical records, pre- and postoperative polysomnography, and clinical measures of obstructive sleep apnea (OSA), sleepiness, and insomnia was conducted in 53 consecutive cases of veterans with OSA undergoing HNS implantation. HNS adherence was obtained at postoperative visits. HNS adherence and efficacy were compared between individuals with COMISA and OSA only.

Results: COMISA was noted in 30 of 53 (56.6%) veterans studied. There was no significant difference between HNS adherence in patients with COMISA and OSA only (5.6 vs 6.4 h/night, = .17). HNS implantation improved polysomnographic and clinical measures of OSA and sleepiness in both COMISA and OSA only, and 56.5% (13/23) of patients with COMISA self-reported improvement in insomnia after surgery.

Conclusion: HNS was successful in treating a complex veteran population with COMISA refractory to PAP when examining measures of treatment adherence and efficacy. Future studies of patients with COMISA undergoing HNS will examine effective combination therapy targeting insomnia and a multidisciplinary effort to optimize treatment adherence.
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http://dx.doi.org/10.1177/0194599820982638DOI Listing
June 2021

Hypoglossal Nerve Stimulation: Outcomes in Veterans with Obstructive Sleep Apnea and Common Comorbid Post-traumatic Stress Disorder.

Laryngoscope 2021 03 9;131 Suppl 3:S1-S11. Epub 2020 Dec 9.

Department of Otolaryngology Head and Neck Surgery, University of Cincinnati Medical Center, Cincinnati, Ohio, U.S.A.

Objectives/hypothesis: Veterans have an increasing prevalence of obstructive sleep apnea (OSA) and high levels of intolerance to positive airway pressure (PAP). The hypoglossal nerve stimulator (HNS) is a promising alternative surgical treatment for OSA in these patients, many of whom suffer from mental health conditions such as post-traumatic stress disorder (PTSD) that may negatively affect their ability to use PAP. Our aims were: 1) to assess postoperative changes in OSA severity and sleepiness in a veteran only population after HNS; 2) to compare postoperative changes in OSA severity, sleepiness and HNS adherence between veterans with and without PTSD; and 3) to compare HNS adherence in our population to HNS adherence in the current literature as well as published PAP adherence data.

Study Design: Retrospective and prospective case series.

Methods: Clinical data on consecutive patients undergoing HNS in a Veterans Affairs hospital were examined for demographic data as well as medical, sleep, and mental health comorbidities. The overall cohort as well as subsets of patients with and without PTSD were examined for postoperative changes in OSA severity (apnea hypopnea index [AHI], lowest oxygen saturation (LSAT]), and sleepiness (Epworth sleepiness scale [ESS]), as well as for device adherence. PTSD and depression symptomatology were measured using the PTSD Checklist 5 (PCL-5) and Patient Health Questionnaire 9 (PHQ-9).

Results: Forty-six veterans were included. Forty-four patients were male (95.6%), 45 were white (97.8%), and the mean age was 61.3 years. Twenty-six patients met PCL-5 criteria for PTSD and 17 did not. OSA severity and sleepiness improved significantly in the overall cohort after HNS; median (IQR) AHI decreased from 39.2 (24.0, 63.0) to 7.4 (1.2, 20.8) events/hour (P < .0001), mean LSAT increased from 81% to 88% (P < .0001) and mean ESS decreased from 10.9 to 6.7 (P < .0001). These improvements were similar between patients with and without PTSD (P = .434-.918). Overall device adherence was 6.1 hours/night for the overall cohort and was not significantly different between patients with and without PTSD (P = .992).

Conclusions: HNS is an efficacious therapy in a veteran population, providing patients with significant improvements in OSA severity and sleepiness. Veterans with and without PTSD benefited similarly from HNS when comparing improvements in sleep apnea severity and sleepiness as well as device usage. Adherence was similar to previously published HNS adherence data and better than PAP adherence reported in the literature.

Level Of Evidence: 4 Laryngoscope, 131:S1-S11, 2021.
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http://dx.doi.org/10.1002/lary.29292DOI Listing
March 2021

Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome.

Laryngoscope 2020 Dec 2. Epub 2020 Dec 2.

Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, U.S.A.

Objectives/hypothesis: Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.

Study Design: Prospective longitudinal trial.

Methods: We are conducting a multicenter single-arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.

Results: The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA-18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%.

Conclusions: Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard.

Level Of Evidence: 4 Laryngoscope, 2020.
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http://dx.doi.org/10.1002/lary.29290DOI Listing
December 2020

Competency-Based Assessment Tool for Pediatric Esophagoscopy: International Modified Delphi Consensus.

Laryngoscope 2021 05 9;131(5):1168-1174. Epub 2020 Oct 9.

Department of Otolaryngology, Head and Neck Surgery, Stanford University, Lucile Salter Packard Children's Hospital, Palo Alto, California, U.S.A.

Objectives/hypothesis: Create a competency-based assessment tool for pediatric esophagoscopy with foreign body removal.

Study Design: Blinded modified Delphi consensus process.

Setting: Tertiary care center.

Methods: A list of 25 potential items was sent via the Research Electronic Data Capture database to 66 expert surgeons who perform pediatric esophagoscopy. In the first round, items were rated as "keep" or "remove" and comments were incorporated. In the second round, experts rated the importance of each item on a seven-point Likert scale. Consensus was determined with a goal of 7 to 25 final items.

Results: The response rate was 38/64 (59.4%) in the first round and returned questionnaires were 100% complete. Experts wanted to "keep" all items and 172 comments were incorporated. Twenty-four task-specific and 7 previously-validated global rating items were distributed in the second round, and the response rate was 53/64 (82.8%) with questionnaires returned 97.5% complete. Of the task-specific items, 9 reached consensus, 7 were near consensus, and 8 did not achieve consensus. For global rating items that were previously validated, 6 reached consensus and 1 was near consensus.

Conclusions: It is possible to reach consensus about the important steps involved in rigid esophagoscopy with foreign body removal using a modified Delphi consensus technique. These items can now be considered when evaluating trainees during this procedure. This tool may allow trainees to focus on important steps of the procedure and help training programs standardize how trainees are evaluated.

Level Of Evidence: 5. Laryngoscope, 131:1168-1174, 2021.
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http://dx.doi.org/10.1002/lary.29126DOI Listing
May 2021

Sleep Architecture in Children With Down Syndrome With and Without Obstructive Sleep Apnea.

Otolaryngol Head Neck Surg 2021 05 6;164(5):1108-1115. Epub 2020 Oct 6.

Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

Objective: To characterize polysomnographic sleep architecture in children with Down syndrome and compare findings in those with and without obstructive sleep apnea.

Study Design: Case series with retrospective review.

Setting: Single tertiary pediatric hospital (2005-2018).

Methods: We reviewed the electronic health records of patients undergoing polysomnography who were referred from a specialized center for children with Down syndrome (age, ≥12 months). Continuous positive airway pressure titration, oxygen titration, and split-night studies were excluded.

Results: A total of 397 children were included (52.4% male, 81.6% Caucasian). Mean age at the time of polysomnography was 4.7 years (range, 1.4-14.7); 79.4% had obstructive sleep apnea. Sleep variables were reported as mean (SD) values: sleep efficiency, 85% (11%); sleep latency, 29.8 minutes (35.6); total sleep time, 426 minutes (74.6); rapid eye movement (REM) latency, 126.8 minutes (66.3); time spent in REM sleep, 22% (7%); arousal index, 13.3 (5); and time spent supine, 44% (28%). There were no significant differences between those with obstructive sleep apnea and those without. Sleep efficiency <80% was seen in 32.5%; 34.3% had a sleep latency >30 minutes; 15.9% had total sleep time <360 minutes; and 75.6% had an arousal index >10/h. Overall, 69.2% had ≥2 metrics of poor sleep architecture. REM sleep time <20% was seen in 35.3%. REM sleep time decreased with age.

Conclusion: In children with Down syndrome, 32.5% had sleep efficiency <80%; 75.6% had an elevated arousal index; and 15.9% had total sleep time <360 minutes. More than a third of the patients had ≥3 markers of poor sleep architecture. There was no difference in children with or without obstructive sleep apnea.
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http://dx.doi.org/10.1177/0194599820960454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021597PMC
May 2021

Polysomnographic Outcomes After Observation for Mild Obstructive Sleep Apnea in Children Younger Than 3 Years.

Otolaryngol Head Neck Surg 2021 02 29;164(2):427-432. Epub 2020 Sep 29.

Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

Objective: Mild obstructive sleep apnea (OSA), particularly in young children, is often treated with observation. However, there is little evidence regarding the outcomes with this approach. Our aim was to assess the impact of observation on sleep for children aged <3 years with mild OSA.

Study Design: Case-control study.

Setting: Pediatric tertiary care center.

Methods: We reviewed cases of children (<3 years old) diagnosed with mild OSA (obstructive apnea-hypopnea index, 1-5 events/h) who were treated with observation between 2012 and 2017 and had at least 2 polysomnograms performed 3 to 12 months apart. Demographic data and comorbid diagnoses were collected.

Results: Twenty-six children met inclusion criteria; their median age was 7.2 months (95% CI, 1.2-22.8). Nine (35%) were female and 24 (92%) were White. Their median body mass index percentile was 39 (95% CI, 1-76). Comorbidities included cardiac disease (42.3%), laryngomalacia (42.3%), allergies (34.6%), reactive airway disease (23.1%), and prematurity (7.7%). The obstructive apnea-hypopnea index significantly decreased from 2.7 events/h (95% CI, 1-4.5) to 1.3 (95% CI, 0-4.5; = .013). There was no significant improvement in median saturation nadir (baseline, 86%; = .76) or median time with end-tidal carbon dioxide >50 mm Hg (baseline, 0 minutes; = .34). OSA resolved in 8 patients (31%) and worsened in 1 (3.8%). Only race was a significant predictor of resolution per regression analysis; however, only 2 non-White children were included.

Conclusion: In our cohort, resolution of mild OSA occurred in 31% of patients treated with 3 to 12 months of observation. The presence of laryngomalacia, asthma, and allergies did not affect resolution. Larger studies are needed to better identify factors (including race) associated with persistent OSA and optimal timing of intervention for these children.

Level Of Evidence: 4.
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http://dx.doi.org/10.1177/0194599820954383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7954089PMC
February 2021

Demographic and Clinical Characteristics Associated With Adherence to Guideline-Based Polysomnography in Children With Down Syndrome.

Otolaryngol Head Neck Surg 2021 04 15;164(4):877-883. Epub 2020 Sep 15.

Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.

Objectives: To compare the demographic and clinical characteristics of children with Down syndrome who did and did not receive polysomnography to evaluate for obstructive sleep apnea after publication of the American Academy of Pediatrics' guidelines recommending universal screening by age 4 years.

Study Design: Retrospective cohort study.

Setting: Single tertiary pediatric hospital.

Methods: Review was conducted of children with Down syndrome born between 2007 and 2012. Children who obtained polysomnography were compared with children who did not, regarding demographic data, socioeconomic status, and comorbidities.

Results: We included 460 children with Down syndrome; 273 (59.3%) received at least 1 polysomnogram, with a median age of 3.6 years (range, 0.1-8.9 years). There was no difference in the distribution of sex, insurance status, or socioeconomic status between children who received polysomnography and those who did not. There was a significant difference in race distribution ( = .0004) and distance from home to the medical center ( < .0001) between groups. Among multiple medical comorbidities, only children with a history of hypothyroidism ( = .003) or pulmonary aspiration ( = .01) were significantly more likely to have obtained polysomnography.

Conclusions: Overall, 60% of children with Down syndrome obtained a polysomnogram. There was no difference between groups by payer status or socioeconomic status. A significant difference in race distribution was noted. Proximity to the medical center and increased medical need appear to be associated with increased likelihood of obtaining a polysomnogram. This study illustrates the need for improvement initiatives to increase the proportion of patients receiving guideline-based screening.
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http://dx.doi.org/10.1177/0194599820954837DOI Listing
April 2021

The impact of resident involvement on tonsillectomy outcomes and surgical time.

Laryngoscope 2020 10 27;130(10):2481-2486. Epub 2019 Nov 27.

Department of Otolaryngology-Head & Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, U.S.A.

Objective: Posttonsillectomy hemorrhage can be life-threatening, so we investigated whether patients are at increased risk with an inexperienced surgeon. There is scant information on how surgical experience affects outcomes in pediatric tonsillectomy. We hypothesized that supervised residents would have longer operative times but no difference in complication rates compared to attending surgeons.

Study Design: Retrospective case series of children who underwent tonsillectomy from July 2014 to April 2017 at a tertiary pediatric medical center.

Methods: We assessed outcomes and operative times, based on the primary surgeon's level of training, for children (14 months to 22 years) who underwent tonsillectomy.

Results: A total of 7,606 children were included (mean age 7.0 ± 4.1 years, 51% female) with a mean body mass index (BMI) of 18.6 ± 5.48 kg/m ; 76% were white; and 13% were black. Residents assisted with tonsillectomy in 43% of cases. The readmission rate (5%-6%) was not different (P = 0.48) by level of experience. Similarly, return to the operating room for control of hemorrhage (3.3%-3.5%) did not differ by level of experience (P = 0.95). The median procedure time for adenotonsillectomy was shortest for attendings (9 minutes), followed by fellows (13 minutes), and residents (14 minutes, P < 0.0001). Among residents, time for adenotonsillectomy decreased significantly with each increasing year of training (P < 0.0001) from postgraduate year (PGY) 1 (17 minutes), to PGY2 (15 minutes), to PGY3 (14 minutes), and to PGY4 (12.5 minutes).

Conclusion: Attending surgeons completed tonsillectomy more quickly, and operative times decreased with increasing experience level. However, there was no difference in readmission or postoperative hemorrhage rates between residents and attending surgeons.

Level Of Evidence: 4 Laryngoscope, 130:2481-2486, 2020.
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http://dx.doi.org/10.1002/lary.28427DOI Listing
October 2020

International Pediatric Otolaryngology group (IPOG) consensus on the diagnosis and management of pediatric obstructive sleep apnea (OSA).

Int J Pediatr Otorhinolaryngol 2020 Nov 5;138:110276. Epub 2020 Aug 5.

Antwerp University of Antwerp, Department of Otolaryngology Head and Neck Surgery, University of Antwerp, Antwerp, Belgium. Electronic address:

Objective: To develop an expert-based consensus of recommendations for the diagnosis and management of pediatric obstructive sleep apnea.

Methods: A two-iterative Delphi method questionnaire was used to formulate expert recommendations by the members of the International Pediatric Otolaryngology Group (IPOG).

Results: Twenty-six members completed the survey. Consensus recommendations (>90% agreement) are formulated for 15 different items related to the clinical evaluation, diagnosis, treatment, postoperative management and follow-up of children with OSA.

Conclusion: The recommendations formulated in this IPOG consensus statement may be used along with existing clinical practice guidelines to improve the quality of care and to reduce variation in care for children with OSA.
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http://dx.doi.org/10.1016/j.ijporl.2020.110276DOI Listing
November 2020

Validation of an Objective Assessment Tool for Tonsillectomy in Otolaryngology Resident Training.

Laryngoscope 2021 02 8;131(2):E359-E366. Epub 2020 Jun 8.

Department of Otolaryngology -Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, U.S.A.

Objective: Create and validate an objective structured assessment of technical skills (OSATS) for otolaryngology residents learning how to perform a tonsillectomy.

Study Design: Multicenter prospective longitudinal validation study.

Methods: A multi-institutional study at six tertiary academic otolaryngology residency programs from July 2009 to May 2012. Using the modified Delphi technique, a panel of pediatric otolaryngologists created a tonsillectomy task-based checklist (TBC) for a tonsil OSATS using a 5-point Likert-type scale. Residents were assessed by pediatric otolaryngology staff at the time of surgery with the TBC and a global rating scale. Procedure time, patient age, number of previously performed tonsillectomies, and surgical technique were also collected.

Results: One hundred sixty-seven tonsil OSATS were completed for 38 residents, and competency was recorded for 99 (59.2%). Residents scored as competent had performed significantly more previous tonsillectomies than those deemed noncompetent, 44.4 ± 35.6 and 13.5 ± 11.6, respectively (P < .001). The mean overall score on the tonsil TBC was 4.0 ± 0.8 and 2.6 ± 1.0 for competent and noncompetent, respectively (P < .001). Higher number of tonsillectomies performed and mean tonsil TBC score significantly increased the likelihood of competency (P < .001). Each additional tonsillectomy performed increased the likelihood of achieving competency by 6.3% (P = .006, 95% confidence interval (CI): 1.330-1.110), and each 1.0 point increase in mean tonsil TBC score increased the likelihood of competency by a factor of 2.71 (P = .006, 95% CI:1.330-5.513). There is a 95% likelihood of competency at 48 tonsillectomies or a tonsil TBC score of 4.91.

Conclusion: The tonsil OSATS is a valid and feasible instrument to assess resident competency with tonsillectomy and provides timely objective feedback.

Level Of Evidence: 4. Laryngoscope, 131:E359-E366, 2021.
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http://dx.doi.org/10.1002/lary.28739DOI Listing
February 2021

The effect of in-lab polysomnography and home sleep polygraphy on sleep position.

Sleep Breath 2021 Mar 16;25(1):251-255. Epub 2020 May 16.

Division of Otolaryngology - Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

Purpose: Little is known regarding the influence of in-laboratory polysomnography (PSG) equipment on sleep position, especially on the prevalence of supine positioning, which in many cases may lead to a more severe sleep apnea diagnosis. The aim of this study was to assess the percentage of supine sleep during an in-laboratory PSG compared to that seen during a home sleep apnea test (HSAT).

Methods: This was a retrospective cohort study comparing in-laboratory PSG and HSAT using a peripheral arterial tone (PAT) technology device.

Results: Of 445 PSG and 416 HSAT studies analyzed, there was no significant difference in the proportion of supine sleep time between PSG (44%) and HSAT (45%, p = 0.53). Analysis of the differences in sleep position (supine versus non-supine), analyzed by sex, BMI (≥ 30 kg/m2 versus < 30 kg/m2), and age (≥ 60 years versus < 60 years), was significant only for women, who had more supine sleep during HSAT at 61 ± 24% than during PSG at 45 ± 26% (p < 0.001).

Conclusion: Overall there was no difference in the percentage of supine sleep when comparing in-laboratory PSG to HSAT. However, women had more supine sleep with HSAT than with PSG.
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http://dx.doi.org/10.1007/s11325-020-02099-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987683PMC
March 2021

Clinical Consensus Statement: Ankyloglossia in Children.

Otolaryngol Head Neck Surg 2020 May 14;162(5):597-611. Epub 2020 Apr 14.

American Academy of Otolaryngology-Head and Neck Surgery Foundation, Alexandria, Virginia, USA.

Objective: To identify and seek consensus on issues and controversies related to ankyloglossia and upper lip tie in children by using established methodology for American Academy of Otolaryngology-Head and Neck Surgery clinical consensus statements.

Methods: An expert panel of pediatric otolaryngologists was assembled with nominated representatives of otolaryngology organizations. The target population was children aged 0 to 18 years, including breastfeeding infants. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus, per established methodology published by the American Academy of Otolaryngology-Head and Neck Surgery.

Results: After 3 iterative Delphi method surveys of 89 total statements, 41 met the predefined criteria for consensus, 17 were near consensus, and 28 did not reach consensus. The clinical statements were grouped into several categories for the purposes of presentation and discussion: ankyloglossia (general), buccal tie, ankyloglossia and sleep apnea, ankyloglossia and breastfeeding, frenotomy indications and informed consent, frenotomy procedure, ankyloglossia in older children, and maxillary labial frenulum.

Conclusion: This expert panel reached consensus on several statements that clarify the diagnosis, management, and treatment of ankyloglossia in children 0 to 18 years of age. Lack of consensus on other statements likely reflects knowledge gaps and lack of evidence regarding the diagnosis, management, and treatment of ankyloglossia. Expert panel consensus may provide helpful information for otolaryngologists treating patients with ankyloglossia.
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http://dx.doi.org/10.1177/0194599820915457DOI Listing
May 2020

Effectiveness of pediatric drug-induced sleep endoscopy for REM-predominant obstructive sleep apnea.

Sleep Breath 2020 Dec 10;24(4):1705-1713. Epub 2020 Apr 10.

Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 2018, Cincinnati, OH, 45229-2018, USA.

Study Objectives: Because dexmedetomidine (DEX)-induced sedation mimics non-rapid eye movement (NREM) sleep, its utility in sedating children with REM-predominant disease is unclear. We sought to determine the effectiveness of pediatric drug-induced sleep endoscopy (DISE) using DEX and ketamine for children with REM-predominant OSA, specifically whether or not at least one site of obstruction could be identified.

Methods: A retrospective case series of children without tonsillar hypertrophy undergoing DISE at a tertiary pediatric hospital from 10/2013 through 9/2015 who underwent subsequent surgery to address OSA with polysomnography (PSG) before and after.

Results: We included 56 children, mean age 5.6±5.4 years, age range 0.1-17.4 years, mean BMI 20.3±7.4 kg/m2 (76±29 percentile). At least one site of obstruction was identified in all patients, regardless of REM- or NREM-predominance. The mean obstructive apnea-hypopnea index (oAHI) improved (12.6 ± 10.7 to 9.0 ± 14.0 events/h) in children with REM-predominant (P = 0.013) and NREM-predominant disease (21.3 ± 18.9 to 10.3 ± 16.2 events/h) (P = 0.008). The proportion of children with a postoperative oAHI < 5 was 53% and 55% for REM- and NREMpredominant OSA, respectively. Unlike children with NREM-predominant disease, children with REM-predominant disease had significant improvement in the mean saturation nadir (P < 0.001), total sleep time (P = 0.006), and sleep efficiency (P = 0.015).

Conclusions: For children with OSA without tonsillar hypertrophy, DISE using DEX/ketamine was useful to predict at least one site of obstruction, even for those with REM-predominant OSA. DISE-directed outcomes resulted in significant improvements in mean oAHI, total sleep time, sleep efficiency, saturation nadir, and the proportion with oAHI < 5, after surgery for some children with REM-predominant disease.
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http://dx.doi.org/10.1007/s11325-020-02056-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8007082PMC
December 2020

Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing.

BMJ Open 2020 03 15;10(3):e033889. Epub 2020 Mar 15.

Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

Introduction: Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.

Methods And Analysis: The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study's coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.

Ethics And Dissemination: The study protocol was approved by the institutional review board (IRB) at Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.

Trial Registration Number: NCT02562040; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2019-033889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073822PMC
March 2020

TLRs and RAGE are elevated in carotid plaques from patients with moderate-to-severe obstructive sleep apnea syndrome.

Sleep Breath 2020 Dec 20;24(4):1573-1580. Epub 2020 Feb 20.

Department of Otorhinolaryngology, Faculty of Dental Medicine, Medical University of Warsaw, Warsaw, Poland.

Background: There is growing evidence that obstructive sleep apnea (OSA) promotes vascular endothelial dysfunction and atherogenesis. Pathways that mediate this pathology may include Toll-like receptors (TLRs) and receptor for advanced glycation end products (RAGE) which play a significant role in proinflammatory processes. The aim of this study was to measure the expression of the above-mentioned receptors in relation to OSA severity in carotid plaques obtained during open endarterectomy.

Methods: This prospective study included patients with a sleep study prior to surgery and a plaque specimen obtained during standard open endarterectomy. Immunohistochemistry of TLR2, TLR4, TLR7, TLR9, RAGE, HMGB1, and NF-κB was performed on atherosclerotic plaques from carotid arteries of patients with and without OSA.

Results: There were 46 patients (22 women, mean age 73.2 ± 1.3 years): 14 control patients, 13 with mild, 11 with moderate, and 8 with severe OSA. The expression of all TLRs and RAGE increased proportionately with increasing OSA severity. The largest differences between patients with severe OSA and no OSA were found for TLR2 (2.88 ± 0.35 vs. 1.27 ± 0.47, p < 0.001), TLR4 (2.88 ± 0.35 vs. 1.64 ± 0.5, p < 0.001), TLR9 (2.38 ± 0.52 vs. 1.45 ± 0.52, p < 0.01), and RAGE (2.5 ± 0.53 vs. 1.82 ± 0.6, p < 0.05).

Conclusion: TLR2, TLR4, TLR9, and RAGE expression was significantly increased in carotid plaques of patients with moderate-to-severe OSA when compared with control patients with no OSA and those with mild OSA. TLR and RAGE-mediated pathways may play a significant role in OSA-dependent atherogenesis.
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http://dx.doi.org/10.1007/s11325-020-02029-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679342PMC
December 2020

Clinical Practice Guideline: Nosebleed (Epistaxis) Executive Summary.

Otolaryngol Head Neck Surg 2020 01;162(1):8-25

American Academy of Otolaryngology-Head and Neck Surgery Foundation, Alexandria, Virginia, USA.

Objective: Nosebleed, also known as epistaxis, is a common problem that occurs at some point in at least 60% of people in the United States. While the great majority of nosebleeds are limited in severity and duration, about 6% of people who experience nosebleeds will seek medical attention. For the purposes of this guideline, we define the target patient with a nosebleed as a patient with bleeding from the nostril, nasal cavity, or nasopharynx that is sufficient to warrant medical advice or care. This includes bleeding that is severe, persistent, and/or recurrent, as well as bleeding that impacts a patient's quality of life. Interventions for nosebleeds range from self-treatment and home remedies to more intensive procedural interventions in medical offices, emergency departments, hospitals, and operating rooms. Epistaxis has been estimated to account for 0.5% of all emergency department visits and up to one-third of all otolaryngology-related emergency department encounters. Inpatient hospitalization for aggressive treatment of severe nosebleeds has been reported in 0.2% of patients with nosebleeds.

Purpose: The primary purpose of this multidisciplinary guideline is to identify quality improvement opportunities in the management of nosebleeds and to create clear and actionable recommendations to implement these opportunities in clinical practice. Specific goals of this guideline are to promote best practices, reduce unjustified variations in care of patients with nosebleeds, improve health outcomes, and minimize the potential harms of nosebleeds or interventions to treat nosebleeds. The target patient for the guideline is any individual aged ≥3 years with a nosebleed or history of nosebleed who needs medical treatment or seeks medical advice. The target audience of this guideline is clinicians who evaluate and treat patients with nosebleed. This includes primary care providers such as family medicine physicians, internists, pediatricians, physician assistants, and nurse practitioners. It also includes specialists such as emergency medicine providers, otolaryngologists, interventional radiologists/neuroradiologists and neurointerventionalists, hematologists, and cardiologists. The setting for this guideline includes any site of evaluation and treatment for a patient with nosebleed, including ambulatory medical sites, the emergency department, the inpatient hospital, and even remote outpatient encounters with phone calls and telemedicine. Outcomes to be considered for patients with nosebleed include control of acute bleeding, prevention of recurrent episodes of nasal bleeding, complications of treatment modalities, and accuracy of diagnostic measures. This guideline addresses the diagnosis, treatment, and prevention of nosebleed. It will focus on nosebleeds that commonly present to clinicians with phone calls, office visits, and emergency room encounters. This guideline discusses first-line treatments such as nasal compression, application of vasoconstrictors, nasal packing, and nasal cautery. It also addresses more complex epistaxis management, which includes the use of endoscopic arterial ligation and interventional radiology procedures. Management options for 2 special groups of patients, patients with hemorrhagic telangiectasia syndrome (HHT) and patients taking medications that inhibit coagulation and/or platelet function, are included in this guideline. This guideline is intended to focus on evidence-based quality improvement opportunities judged most important by the working group. It is not intended to be a comprehensive, general guide for managing patients with nosebleed. In this context, the purpose is to define useful actions for clinicians, generalists, and specialists from a variety of disciplines to improve quality of care. Conversely, the statements in this guideline are not intended to limit or restrict care provided by clinicians based upon their experience and assessment of individual patients.

Action Statements: The guideline development group made for the following key action statements: (1) At the time of initial contact, the clinician should distinguish the nosebleed patient who requires prompt management from the patient who does not. (2) The clinician should treat active bleeding for patients in need of prompt management with firm sustained compression to the lower third of the nose, with or without the assistance of the patient or caregiver, for 5 minutes or longer. (3a) For patients in whom bleeding precludes identification of a bleeding site despite nasal compression, the clinician should treat ongoing active bleeding with nasal packing. (3b) The clinician should use resorbable packing for patients with a suspected bleeding disorder or for patients who are using anticoagulation or antiplatelet medications. (4) The clinician should educate the patient who undergoes nasal packing about the type of packing placed, timing of and plan for removal of packing (if not resorbable), postprocedure care, and any signs or symptoms that would warrant prompt reassessment. (5) The clinician should document factors that increase the frequency or severity of bleeding for any patient with a nosebleed, including personal or family history of bleeding disorders, use of anticoagulant or antiplatelet medications, or intranasal drug use. (6) The clinician should perform anterior rhinoscopy to identify a source of bleeding after removal of any blood clot (if present) for patients with nosebleeds. (7a) The clinician should perform, or should refer to a clinician who can perform, nasal endoscopy to identify the site of bleeding and guide further management in patients with recurrent nasal bleeding, despite prior treatment with packing or cautery, or with recurrent unilateral nasal bleeding. (8) The clinician should treat patients with an identified site of bleeding with an appropriate intervention, which may include 1 or more of the following: topical vasoconstrictors, nasal cautery, and moisturizing or lubricating agents. (9) When nasal cautery is chosen for treatment, the clinician should anesthetize the bleeding site and restrict application of cautery only to the active or suspected site(s) of bleeding. (10) The clinician should evaluate, or refer to a clinician who can evaluate, candidacy for surgical arterial ligation or endovascular embolization for patients with persistent or recurrent bleeding not controlled by packing or nasal cauterization. (11) In the absence of life-threatening bleeding, the clinician should initiate first-line treatments prior to transfusion, reversal of anticoagulation, or withdrawal of anticoagulation/antiplatelet medications for patients using these medications. (12) The clinician should assess, or refer to a specialist who can assess, the presence of nasal telangiectasias and/or oral mucosal telangiectasias in patients who have a history of recurrent bilateral nosebleeds or a family history of recurrent nosebleeds to diagnose hereditary hemorrhagic telangiectasia syndrome (HHT). (13) The clinician should educate patients with nosebleeds and their caregivers about preventive measures for nosebleeds, home treatment for nosebleeds, and indications to seek additional medical care. (14) The clinician or designee should document the outcome of intervention within 30 days or document transition of care in patients who had a nosebleed treated with nonresorbable packing, surgery, or arterial ligation/embolization. The policy level for the following recommendation about examination of the nasal cavity and nasopharynx using nasal endoscopy was an (7b) The clinician may perform, or may refer to a clinician who can perform, nasal endoscopy to examine the nasal cavity and nasopharynx in patients with epistaxis that is difficult to control or when there is concern for unrecognized pathology contributing to epistaxis.
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January 2020

Clinical Practice Guideline: Nosebleed (Epistaxis).

Otolaryngol Head Neck Surg 2020 01;162(1_suppl):S1-S38

American Academy of Otolaryngology-Head and Neck Surgery Foundation, Alexandria, Virginia, USA.

Objective: , also known as , is a common problem that occurs at some point in at least 60% of people in the United States. While the majority of nosebleeds are limited in severity and duration, about 6% of people who experience nosebleeds will seek medical attention. For the purposes of this guideline, we define the target patient with a nosebleed as . Interventions for nosebleeds range from self-treatment and home remedies to more intensive procedural interventions in medical offices, emergency departments, hospitals, and operating rooms. Epistaxis has been estimated to account for 0.5% of all emergency department visits and up to one-third of all otolaryngology-related emergency department encounters. Inpatient hospitalization for aggressive treatment of severe nosebleeds has been reported in 0.2% of patients with nosebleeds.

Purpose: The primary purpose of this multidisciplinary guideline is to identify quality improvement opportunities in the management of nosebleeds and to create clear and actionable recommendations to implement these opportunities in clinical practice. Specific goals of this guideline are to promote best practices, reduce unjustified variations in care of patients with nosebleeds, improve health outcomes, and minimize the potential harms of nosebleeds or interventions to treat nosebleeds. The target patient for the guideline is any individual aged ≥3 years with a nosebleed or history of nosebleed who needs medical treatment or seeks medical advice. The target audience of this guideline is clinicians who evaluate and treat patients with nosebleed. This includes primary care providers such as family medicine physicians, internists, pediatricians, physician assistants, and nurse practitioners. It also includes specialists such as emergency medicine providers, otolaryngologists, interventional radiologists/neuroradiologists and neurointerventionalists, hematologists, and cardiologists. The setting for this guideline includes any site of evaluation and treatment for a patient with nosebleed, including ambulatory medical sites, the emergency department, the inpatient hospital, and even remote outpatient encounters with phone calls and telemedicine. Outcomes to be considered for patients with nosebleed include control of acute bleeding, prevention of recurrent episodes of nasal bleeding, complications of treatment modalities, and accuracy of diagnostic measures. This guideline addresses the diagnosis, treatment, and prevention of nosebleed. It focuses on nosebleeds that commonly present to clinicians via phone calls, office visits, and emergency room encounters. This guideline discusses first-line treatments such as nasal compression, application of vasoconstrictors, nasal packing, and nasal cautery. It also addresses more complex epistaxis management, which includes the use of endoscopic arterial ligation and interventional radiology procedures. Management options for 2 special groups of patients-patients with hereditary hemorrhagic telangiectasia syndrome and patients taking medications that inhibit coagulation and/or platelet function-are included in this guideline. This guideline is intended to focus on evidence-based quality improvement opportunities judged most important by the guideline development group. It is not intended to be a comprehensive, general guide for managing patients with nosebleed. In this context, the purpose is to define useful actions for clinicians, generalists, and specialists from a variety of disciplines to improve quality of care. Conversely, the statements in this guideline are not intended to limit or restrict care provided by clinicians based on their experience and assessment of individual patients.

Action Statements: The guideline development group made for the following key action statements: (1) At the time of initial contact, the clinician should distinguish the nosebleed patient who requires prompt management from the patient who does not. (2) The clinician should treat active bleeding for patients in need of prompt management with firm sustained compression to the lower third of the nose, with or without the assistance of the patient or caregiver, for 5 minutes or longer. (3a) For patients in whom bleeding precludes identification of a bleeding site despite nasal compression, the clinician should treat ongoing active bleeding with nasal packing. (3b) The clinician should use resorbable packing for patients with a suspected bleeding disorder or for patients who are using anticoagulation or antiplatelet medications. (4) The clinician should educate the patient who undergoes nasal packing about the type of packing placed, timing of and plan for removal of packing (if not resorbable), postprocedure care, and any signs or symptoms that would warrant prompt reassessment. (5) The clinician should document factors that increase the frequency or severity of bleeding for any patient with a nosebleed, including personal or family history of bleeding disorders, use of anticoagulant or antiplatelet medications, or intranasal drug use. (6) The clinician should perform anterior rhinoscopy to identify a source of bleeding after removal of any blood clot (if present) for patients with nosebleeds. (7a) The clinician should perform, or should refer to a clinician who can perform, nasal endoscopy to identify the site of bleeding and guide further management in patients with recurrent nasal bleeding, despite prior treatment with packing or cautery, or with recurrent unilateral nasal bleeding. (8) The clinician should treat patients with an identified site of bleeding with an appropriate intervention, which may include one or more of the following: topical vasoconstrictors, nasal cautery, and moisturizing or lubricating agents. (9) When nasal cautery is chosen for treatment, the clinician should anesthetize the bleeding site and restrict application of cautery only to the active or suspected site(s) of bleeding. (10) The clinician should evaluate, or refer to a clinician who can evaluate, candidacy for surgical arterial ligation or endovascular embolization for patients with persistent or recurrent bleeding not controlled by packing or nasal cauterization. (11) In the absence of life-threatening bleeding, the clinician should initiate first-line treatments prior to transfusion, reversal of anticoagulation, or withdrawal of anticoagulation/antiplatelet medications for patients using these medications. (12) The clinician should assess, or refer to a specialist who can assess, the presence of nasal telangiectasias and/or oral mucosal telangiectasias in patients who have a history of recurrent bilateral nosebleeds or a family history of recurrent nosebleeds to diagnose hereditary hemorrhagic telangiectasia syndrome. (13) The clinician should educate patients with nosebleeds and their caregivers about preventive measures for nosebleeds, home treatment for nosebleeds, and indications to seek additional medical care. (14) The clinician or designee should document the outcome of intervention within 30 days or document transition of care in patients who had a nosebleed treated with nonresorbable packing, surgery, or arterial ligation/embolization. The policy level for the following recommendation, about examination of the nasal cavity and nasopharynx using nasal endoscopy, was an (7b) The clinician may perform, or may refer to a clinician who can perform, nasal endoscopy to examine the nasal cavity and nasopharynx in patients with epistaxis that is difficult to control or when there is concern for unrecognized pathology contributing to epistaxis.
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January 2020

Hypoglossal Nerve Stimulation in Veterans with Obstructive Sleep Apnea.

Laryngoscope 2020 09 14;130(9):2275-2280. Epub 2019 Dec 14.

Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati, Cincinnati, Ohio, U.S.A.

Objectives: The hypoglossal nerve stimulator (HNS) is an effective treatment for obstructive sleep apnea (OSA) in a relatively healthy subset of the population. Our aim was to determine the efficacy of HNS in a veteran population with a high incidence of chronic disease and mental health disorders. Our secondary aim was to compare subjective outcomes and adherence between veterans with and without mental health disorders.

Methods: We included all patients who underwent HNS at our institution to date. Veterans were divided into two groups based on whether or not they carried a diagnosis of anxiety, depression, and/or post-traumatic stress disorder. Demographics, comorbidities, previous OSA treatments, adverse events, and adherence to therapy were recorded. Baseline and treatment outcome data were collected and analyzed including polysomnographic parameters, Epworth sleepiness scale score (ESS), and body mass index.

Results: Thirty-one patients were identified: 93.5% male, median age = 63.0 years. Median apnea hypopnea index (AHI) decreased from 30.0 to 3.0 events/hour (P < .001) and median ESS dropped from 11.0 to 6.5 (P < .001). There was no difference between groups with regard to change in AHI or ESS (P = .31 and .61). Twenty-six (89.7%) patients achieved surgical success (decrease in AHI > 50% and AHI < 20 events/hour) and 21 (72.4%) had AHI < 5 events/hour. The mean device usage was 5.4 hours/night which was not significantly different between groups (P = .55).

Conclusion: Our cohort exhibited similar declines in AHI and ESS compared to published studies with adequate adherence to HNS. There were no significant differences in ESS or adherence to therapy between veterans with and without mental health disorders.

Level Of Evidence: 4 Laryngoscope, 130:2275-2280, 2020.
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September 2020

Competency-Based Assessment Tool for Pediatric Tracheotomy: International Modified Delphi Consensus.

Laryngoscope 2020 11 10;130(11):2700-2707. Epub 2019 Dec 10.

Department of Otolaryngology-Head and Neck Surgery, Oregon Health and Science University, Pediatric Otolaryngology, Doernbecher Children's Hospital, Portland, Oregon, U.S.A.

Objectives/hypothesis: Create a competency-based assessment tool for pediatric tracheotomy.

Study Design: Blinded, modified, Delphi consensus process.

Methods: Using the REDCap database, a list of 31 potential items was circulated to 65 expert surgeons who perform pediatric tracheotomy. In the first round, items were rated as "keep" or "remove," and comments were incorporated. In the second round, experts were asked to rate the importance of each item on a seven-point Likert scale. Consensus criteria were determined a priori with a goal of 7 to 25 final items.

Results: The first round achieved a response rate of 39/65 (60.0%), and returned questionnaires were 99.5% complete. All items were rated as "keep," and 137 comments were incorporated. In the second round, 30 task-specific and seven previously validated global rating items were distributed, and the response rate was 44/65 (67.7%), with returned questionnaires being 99.3% complete. Of the Task-Specific Items, 13 reached consensus, 10 were near consensus, and 7 did not achieve consensus. For the 7 previously validated global rating items, 5 reached consensus and two were near consensus.

Conclusions: It is feasible to reach consensus on the important steps involved in pediatric tracheotomy using a modified Delphi consensus process. These items can now be considered to create a competency-based assessment tool for pediatric tracheotomy. Such a tool will hopefully allow trainees to focus on the important aspects of this procedure and help teaching programs standardize how they evaluate trainees during this procedure.

Level Of Evidence: 5 Laryngoscope, 130:2700-2707, 2020.
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November 2020

The Generalizability of the Clinical Assessment Score-15 for Pediatric Sleep-Disordered Breathing.

Laryngoscope 2020 09 29;130(9):2256-2262. Epub 2019 Nov 29.

Research Division, State University of New York Downstate Medical Center, Brooklyn, New York.

Objective: The Clinical Assessment Score-15 (CAS-15) has been validated as an office-based assessment for pediatric sleep-disordered breathing in otherwise healthy children. Our objective was to determine the generalizability of the CAS-15 in a multi-institutional fashion.

Methods: Five hundred and thirty children from 13 sites with suspected sleep-disordered breathing were recruited, and the investigators completed the CAS-15. Based on decisions made in the course of clinical care, investigators recommended overnight polysomnography, observation, medical therapy, and/or surgery. Two hundred and forty-seven subjects had a follow-up CAS-15.

Results: Mean age was 5.1 (2.6) years; 54.2% were male; 39.1% were white; and 37.0% were African American. Initial mean (standard deviation [SD]) CAS-15 was 37.3 (12.7), n = 508. Spearman correlation between the initial CAS-15 and the initial apnea-hypopnea index (AHI) was 0.41 (95% confidence interval [CI], 0.29, 0.51), n = 212, P < .001. A receiver-operating characteristic curve predicting positive polysomnography (AHI > 2) had an area under the curve of 0.71 (95% CI, 0.63, 0.80). A score ≥ 32 had a sensitivity of 69.0% (95% CI, 61.7, 75.5), a specificity of 63.4% (95% CI, 47.9, 76.6), a positive predictive value of 88.7% (95% CI, 82.1, 93.1), and a negative predictive value of 32.9% (95% CI, 23.5, 44.0) in predicting positive polysomnography. Among children who underwent surgery, the mean change (SD) score was 30.5 (12.6), n = 201, t = 36.85, P < .001, effect size = 3.1.

Conclusion: This study establishes the generalizability of the CAS-15 as a useful office tool for the evaluation of pediatric sleep-disordered breathing.

Level Of Evidence: 2B Laryngoscope, 130:2256-2262, 2020.
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September 2020

Safety and cost of drug-induced sleep endoscopy outside the operating room.

Laryngoscope 2020 08 25;130(8):2076-2080. Epub 2019 Nov 25.

Division of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, U.S.A.

Introduction: Drug-induced sleep endoscopy (DISE) is used to assess site of obstruction for patients in a pharmacologically induced sleep-like state. It is traditionally performed in the operating room (OR), however, no data exists regarding the feasibility of this intervention outside the OR in children. The objective is to compare the safety of DISE performed in the MRI induction room to those performed in the OR.

Methods: Prospective case-series of patients undergoing DISE in the MRI induction room (study group) to those assessed in the OR (controls) in a single-institution pediatric tertiary care center. Consecutive patients undergoing DISE examination for persistent obstructive sleep apnea (OSA) after adenotonsillectomy from September 2016 to September 2017 were included.

Results: Overall, 118 patients (38 study patients, 80 controls) with a mean age of 10.6 years (95% confidence interval [CI], 9.3-11.9) underwent DISE; 39.8% (47/118) were female. The most frequent comorbidity was cardiac disease (22.0%, 26/118). The mean obstructive apnea-hypopnea index was 12.2 events/hour (95% CI, 8.8-15.6) for controls and 13.5 events/hour (95% CI, 8.7-18.3) for study patients (P = .76). No major complication or unplanned admissions occurred in either group. Induction time was similar (12 vs. 13 minutes, P = .7) as was total procedure time (12 vs. 14 minutes, P = .3) for procedures performed in both settings.

Conclusion: There were no significant complications for DISE performed in the OR or the MRI induction room and procedure times were similar. Further assessment of patient outcomes and resource utilization is needed.

Level Of Evidence: 4 Laryngoscope, 130: 2076-2080, 2020.
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August 2020

The Effect of Cleft Palate Repair on Polysomnography Results.

J Clin Sleep Med 2019 11;15(11):1581-1586

Cincinnati Children's Hospital Medical Center, Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati, Ohio.

Study Objectives: In view of the risk that surgical repair of cleft palate may induce or worsen obstructive sleep apnea (OSA), the goal of this study was to assess presurgical and postsurgical polysomnography (PSG) results for children who underwent primary palatoplasty.

Methods: Retrospective case-control series for children with cleft palate repair performed between January 2008 and December 2016 at a tertiary pediatric center. Children underwent PSG before and after surgery.

Results: Sixty-four children (53.1% female) with a mean age of 2.0 ± 2.8 years (range 0.6-16.4) were included in the study. Pierre-Robin sequence was the most common comorbidity (67%). Before palatal repair, the mean obstructive apnea-hypopnea index (oAHI) was 3.4 ± 3.9 (range 0-17.9) events/h; this did not significantly change, with 5.9 ± 14.5 (range 0-105.7) events/h after surgery (P = 0.30). However, 34.4% of patients had a worsening of more than 1 obstructive event/h and 18.9% had a worsening of 5 or more obstructive events/h. The presence of a concomitant syndrome (eg, Treacher Collins) was a risk factor for postoperative OSA (odds ratio 4.2, 95% confidence interval 1.1-15.8, P = .03).

Conclusions: OSA did not develop or worsen following primary palatoplasty. However, the oAHI increased by 5 or more events/h in approximately 20% of study participants. The presence of a syndrome was the only factor predictive of worsening OSA after palatoplasty. These findings suggest that palatoplasty does not worsen or cause OSA in most patients, and that nonsyndromic children are at low risk for the development or worsening of OSA.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853397PMC
November 2019

The impact of persistent pediatric obstructive sleep apnea on the Quality of Life of Patients' families.

Int J Pediatr Otorhinolaryngol 2020 Feb 12;129:109723. Epub 2019 Oct 12.

Cincinnati Children's Hospital Medical Center, Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati, OH, USA; Cincinnati Children's Hospital Medical Center, Division of Pulmonary Medicine, Cincinnati, OH, USA; University of Cincinnati College of Medicine, Department of Otolaryngology-Head and Neck Surgery, Cincinnati, OH, USA. Electronic address:

Objectives: To (1) quantify the quality of life (QOL) for families of children affected by persistent obstructive sleep apnea (OSA), and (2) assess factors contributing to the negative impact of OSA on families.

Methods: Prospective case series in a multidisciplinary upper airway center at a tertiary pediatric institution. Our study included patients with persistent OSA referred to our clinic from 2014 to 2016. Both patients and their families completed validated questionnaires assessing QOL and OSA symptoms, including the Family Impact Questionnaire (FIQ), Pediatric Sleep Questionnaire, the Pediatric Quality of Life Inventory, the OSA-18, and the Epworth Sleepiness Scale.

Results: Families of 67 patients were included. The mean patient age was 12.5 (95%CI 11.9-13.1); 23 (34.3%) were female, and the mean BMI percentile was 80.2 (95%CI 73.6-86.8). The single most common comorbidity was Down syndrome (45.6%). The mean obstructive apnea-hypopnea index was 9.7 ± 10.3 events/hour. A significant association exists between OSA severity and 18 FIQ negative subscore (P < 0.001). Financial impact was the primary negative concern for parents of patients with OSA compared to those without OSA (P = 0.03). There were no other significant differences between those with and without OSA.

Conclusions: There was a significant correlation between persistent OSA severity and the FIQ negative impact of disease score on patients' families. Concern regarding financial burden was more common for families of children with OSA than for those without OSA. This suggests that targeted interventions, particularly regarding the financial burden of persistent OSA diagnosis and management, may provide some relief to families.
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http://dx.doi.org/10.1016/j.ijporl.2019.109723DOI Listing
February 2020

Outcomes in children with down syndrome and mild obstructive sleep apnea treated non-surgically.

Laryngoscope 2020 07 11;130(7):1828-1835. Epub 2019 Oct 11.

Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati, Cincinnati, Ohio, U.S.A.

Objectives: Nasal steroids, oral anti-leukotrienes and supplemental oxygen are effective in the treatment of mild obstructive sleep apnea (OSA) in otherwise healthy children. However, their efficacy is unknown in children with Down syndrome (DS). Here we examine the effect of single medication therapy versus observation versus oxygen on polysomnographic outcomes in these children.

Methods: We reviewed children (<18 years) diagnosed with DS and mild OSA (obstructive apnea-hypopnea index [oAHI] ≥1 to <5 events/hour) treated non-surgically (with supplemental oxygen, one medication, or observation) between 2012 and 2017. Demographic data, comorbid diagnoses, and pre- and posttreatment polysomnograms were analyzed. We assessed pre- and posttreatment oAHI, oxyhemoglobin saturation nadir, percent total sleep time (%TST) in rapid eye movement (REM), and end-tidal carbon dioxide (ETCO ) >50 mmHg.

Results: Twenty-four children met inclusion criteria; 10 treated with medication, one with oxygen, and 13 with observation (baseline oAHI was 3.5, 3.3, and 2.9 events/hour, respectively). There was no significant change in oAHI, oxyhemoglobin saturation nadir, ETCO , or percent TST in REM after treatment for any treatment group (P = .21-.94). There was no association between reported symptoms and AHI severity or change in AHI. OSA resolved in one patient treated with observation and two treated with medication, but worsened in two each in the medication and observation groups. Resolution of OSA occurred in 20% treated with medication, 7.7% with observation, and 0% with oxygen (P = .82).

Conclusion: In our cohort, resolution of mild OSA was low. This suggests that consideration should be given to multimodality treatments in children with DS and mild OSA. Prospective studies will help establish effectiveness in this cohort.

Level Of Evidence: 4 Laryngoscope, 130:1828-1835, 2020.
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http://dx.doi.org/10.1002/lary.28325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996085PMC
July 2020

Evaluation of Hypoglossal Nerve Stimulation Treatment in Obstructive Sleep Apnea.

JAMA Otolaryngol Head Neck Surg 2019 Nov;145(11):1044-1052

Department of Otolaryngology-Head & Neck Surgery, University of Cincinnati, Cincinnati, Ohio.

Importance: Hypoglossal nerve stimulation is a treatment option for patients with obstructive sleep apnea unable to tolerate continuous positive airway pressure. This study evaluates demographic factors that may be associated with greater improvements in postoperative outcomes of interest.

Objective: To examine the association of hypoglossal nerve stimulation with obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life.

Design, Setting, And Participants: Patient-level data were pooled from 3 prospective cohorts and 1 retrospective observational cohort comprising 584 adults with moderate to severe obstructive sleep apnea unable to tolerate or benefit from continuous positive airway pressure. The data were gathered from the Stimulation Therapy for Apnea Reduction Trial; a postmarket approval study conducted in Germany; the multicenter, international Adherence and Outcome of Upper Airway Stimulation for OSA Registry; and a retrospective cohort study from 2 sites in the United States.

Exposure: Hypoglossal nerve stimulation.

Main Outcomes And Measures: Severity of obstructive sleep apnea was the primary outcome. The apnea-hypopnea index (AHI) (<5, normal; 5-15, mild; 15-30, moderate, and >30, severe) and Epworth Sleepiness Scale (range, 0-24; score >10 indicates pathologic sleepiness) outcomes were available at 2 to 6 months from 2 cohorts (n = 398), at 12 months from 1 cohort (n = 126), and at both times from 1 cohort (n = 60). Sleep-related quality of life and oxygen saturation nadir data were collected where available. Linear mixed-effects models were constructed to examine associations between clinical variables and reported postoperative outcomes at 6 and 12 months with study included as a random effect.

Results: Of the 584 patients included in the study, 472 were men (80.8%); mean (SD) age was 58.5 (11.0) years. Greater improvement in the postoperative AHI was associated with a higher preoperative AHI (-0.74 events/h; 95% CI, -0.82 to -0.67), older patient age (-0.10 events/h; 95% CI, -0.20 to -0.00), and lower body mass index (0.52; 95% CI, 0.22-0.83). After adjusting for these variables and considering all patients in the analysis, the AHI was statistically higher at 12 months than at 6 months (3.24 events/h; 95% CI, 1.67-4.82 events/h).

Conclusions And Relevance: Hypoglossal nerve stimulation demonstrated clinically significant improvements in obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life in this pooled cohort of patient-level results. Age, body mass index, and preoperative AHI appeared to be associated with treatment outcomes, and these variables may explain some of the difference between 2- to 6-month and 12-month outcomes.
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http://dx.doi.org/10.1001/jamaoto.2019.2723DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764149PMC
November 2019

Female Representation in Otolaryngology Leadership Roles.

Laryngoscope 2020 07 18;130(7):1664-1669. Epub 2019 Sep 18.

University of Cincinnati College of Medicine, Cincinnati, Ohio.

Objectives/hypothesis: Characterization of leadership within otolaryngology is key to evaluating trends and promoting program advancement. This study evaluates representation of women in otolaryngology holding residency and fellowship directorships, or chair positions, comparing sex differences in academic rank, years in practice, and scholarly activity.

Study Design: Cross sectional analysis.

Methods: A comprehensive list of otolaryngology residency and fellowship directors from Accreditation Council for Graduate Medical Education-accredited programs in 2017 to 2018 was compiled. Academic rank and years in practice were determined from departmental websites, with online search tools used as secondary resources. The h-index was utilized as a measure of research productivity. Regression analysis was performed to analyze these variables.

Results: Among the 306 directorships, women held 57 (18.6%) of these positions, 27 (26.5%) residency and 30 (14.7%) fellowship directorships. Of the 99 chair positions, five (5.1%) were held by women. The majority (53.6%) of male directors were full professors, whereas only 26.3% of females were full professors (P = .04). Mean years in practice for female directors (13.9 ± 6.8) was less than that of male directors (20.3 ± 9.4, P < .0001). Similarly, mean h-index for female directors (11 ± 7.2) was lower than for males (17.5 ± 12.5, P = .0001). After controlling for academic rank and years of practice in a multivariable regression, the h-index remained lower for women than for men (P = .03).

Conclusions: Women are disproportionately underrepresented in positions of residency and fellowship directorships, and chair positions, consistent with other specialties. Women in leadership had lower academic ranks, fewer years of practice, and lower h-indices than their male counterparts. This may represent a shift in academic otolaryngology as female otolaryngologists seek early involvement in leadership.

Level Of Evidence: 4 Laryngoscope, 130:1664-1669, 2020.
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http://dx.doi.org/10.1002/lary.28308DOI Listing
July 2020

Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.

J Clin Sleep Med 2019 07 15;15(7):979-983. Epub 2019 Jul 15.

Department of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.

Study Objectives: Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.

Methods: Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.

Results: A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion ( = .186), rhinitis ( = .666), or snoring ( = .177). There was no difference in the pretreatment ESS score ( = .077), body mass index ( = .173), or AHI ( = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( = .02) and percent of stage R sleep ( = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores ( = .37-.46).

Conclusions: Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.

Clinical Trial Registration: Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.
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http://dx.doi.org/10.5664/jcsm.7876DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6622504PMC
July 2019