Healthcare Spending and Systemic Bevacizumab for Recurrent Respiratory Papillomatosis.

OBJECTIVES: Juvenile-onset recurrent respiratory papillomatosis (JoRRP) is a rare, costly condition linked to human papillomavirus. Standard of care is serial surgical debridement. Many adjunctive therapies have been trialed, with recent success with systemic bevacizumab. This paper examines healthcare spending associated with systemic bevacizumab use for JoRRP and compares it to healthcare spending for surgical care alone to determine whether bevacizumab has a financial benefit. METHODS: Five patients treated with systemic bevacizumab for JoRRP were identified at a single institution. Spending data was derived from the electronic medical record. Sensitivity analysis was performed using variation in spending and frequency of treatments. RESULTS: Patients had an average of 4.2 treatments per year prior to bevacizumab (95% confidence interval [CI] 1.4-7.0) and 1.1 after (0.2-2.0). Patients underwent an average of 9.2 bevacizumab treatments in their first year after initiation, 4.0 in the second, and 4.5 in their third. Mean payment per debridement was $3198 ($2856-3539), with mean total surgical payment per year of $17,966 ($11,673-24,259) prior to initiating bevacizumab. Mean payment on a single bevacizumab infusion visit was $6508 ($6063-6952). Mean total surgical and bevacizumab spending per year after bevacizumab initiation were $83,951 ($12,938-154,964). CONCLUSIONS: Accounting for variations in the number of treatments per year with bevacizumab after initiation, healthcare spending after bevacizumab initiation is similar to spending on surgery alone for JoRRP in patients with severe disease.

A Mobile Application for Child-Focused Tonsillectomy Education: Development and User-Testing.

OBJECTIVE: Patient education is central to Enhanced Recovery After Surgery protocols, but child-focused materials are lacking. We developed and piloted a mobile application to support accessible, interactive patient and caregiver education about pediatric tonsillectomy. METHODS: Thirty children ages 5-12 who were preparing for tonsillectomy, their caregivers, and six attending otolaryngologists participated in a user-testing trial of a web-based prototype. The trial measured feasibility, fidelity, and patient-centered outcomes. Patients and caregivers rated usability/likeability on the mHealth App Usability Questionnaire. Otolaryngologists rated quality on the Mobile App Rating Scale. The full mobile application, "Ready for Tonsillectomy," was then developed for iOS and Android. RESULTS: Enrollment was 88.2%, retention was 90.0%, and use was 96.3%. Mean (SD) patient ratings for usability/likeability were 6.3 (1.1) out of 7; caregiver ratings were 6.5 (1.1). In common themes from open-ended feedback, patients described the application as helpful and appealing, and caregivers described it as informative, easy to understand, calming, and easy to use. Among caregivers who used the application during recovery, 92.3% reported that it helped them manage their child's pain. Providers would recommend the application to many or all of their patients (mean [SD]: 4.7 [0.5] out of 5). Mean provider ratings for domains of engagement, functionality, aesthetics, information quality, subjective quality, and app-specific value ranged from 4.1 to 4.8 out of 5. CONCLUSION: Feasibility and fidelity were high. Families and otolaryngologists endorsed the resource as an engaging, informative tool that supports positive coping. Our mobile application offers a patient-centered solution readily scalable to other surgeries. LEVEL OF EVIDENCE: NA Laryngoscope, 134:2455-2463, 2024.

Feeding after congenital heart surgery: a mixed-methods study of the caregiver experience.

OBJECTIVES: Feeding difficulties after congenital heart surgery are a common concern for caregivers of children with CHD. Insight into the intricacies of their experience is lacking. With a better understanding, healthcare providers can continue to optimize the approach and support mechanisms for these families. This study will explore the psychosocial impacts on caregivers, define barriers to care, and identify areas to improve their care. STUDY DESIGN: This mixed-methods study combined semi-structured interviews with surveys. Purposive sampling targeted caregivers of a child who underwent heart surgery and was discharged with alternative enteral feeding access. A hybrid inductive-deductive methodology was used to analyse interview transcripts. Survey scores were compared to interview content for concordance. RESULTS: Fifteen interviews were conducted with socio-demographically diverse caregivers. Feeding difficulties were often identified as their greatest challenge, with the laborious feeding schedule, sleep deprivation, and tube management being common contributors. Most caregivers described feeling overwhelmed and worried. Time-intensive feeding schedules and lack of appropriate childcare options precluded caregivers' ability to work. Barriers to care included imperfect feeding education, proximity of specialist clinics, and issues with medical supply companies. Caregiver proposals for improved care addressed easing the transition home, improving emotional support mechanisms, and intensifying feeding therapy for expedited tube removal. CONCLUSION: This study describes the psychosocial toll on the caregiver, typical barriers to care, and ideas for improved provision of care. These themes and ideas can be used to advance the family-centered approach to feeding difficulties after heart surgery.

Multisystem approach for management of OSA in Down syndrome: a case report.

Obstructive sleep apnea (OSA) is common in children with Down syndrome, with reported prevalence rates as high as 69-76%. Multiple factors predispose children with Down syndrome for OSA, including craniofacial hypoplasia (maxillary and mandibular), airway abnormalities, macroglossia, generalized hypotonia, airway hypotonia, adenotonsillar hypertrophy, and obesity. Despite the fact that the pathophysiology for OSA in children with Down syndrome is multifactorial in nature, treatment methods have focused on soft tissue in the upper airway using adenotonsillectomy and/or continuous positive airway pressure therapy. Here we present a case of a patient with Down syndrome whose severe OSA was approached in a multisystem manner, including upper airway soft tissue, orthognathic, maxillofacial, and bariatric surgery, resulting in resolution of the OSA without reliance on a continuous positive airway pressure device. CITATION: Finch CE, Raol N, Roser SM, Leu RM. Multisystem approach for management of OSA in Down syndrome: a case report. J Clin Sleep Med. 2024;20(3):471-473.

Current opinion in otolaryngology and head and neck surgery: the role of the otolaryngologist in the management of pediatric dysphagia.

PURPOSE OF REVIEW: Dysphagia affects at least 1% of the pediatric population. This prevalence further increases in patients who are born prematurely or who have underlying neuromuscular or cardiopulmonary disorders. A multidisciplinary team approach, including an Otolaryngologist, can help promote an expedited diagnosis and therapeutic regimen, ensuring that the patient receives adequate nutrition needed for growth and development. RECENT FINDINGS: The development and growth of multidisciplinary aerodigestive clinics have improved outcomes in pediatric patients with dysphagia. If a structural concern is noted on examination, there remain a multitude of medical and surgical options to help improve patient outcomes and swallow. These treatment options are usually multimodality and specific interventions may be employed to target a specific and notable abnormality. SUMMARY: Pediatric dysphagia is a complex concern. For the otolaryngologist, etiologies with surgical targets may include ankyloglossia, tonsillar hypertrophy, laryngomalacia, laryngo-esophageal cleft, vocal fold movement impairment, and cricopharyngeal achalasia. The development and formalization of a multidisciplinary approach has streamlined and broadened treatment options for these patients. An otolaryngologist is integral as part of the treatment team of these patients.

Opioid stewardship and perioperative management of pediatric tympanoplasty.

OBJECTIVE: To provide insight into the intraoperative management, admission course, pain management, and graft success of microscope- and endoscope-assisted tympanoplasty. STUDY DESIGN: Retrospective Chart Review. METHODS: This study included children 18 years and younger who underwent ambulatory tympanoplasty at a tertiary pediatric hospital between January 2018 and December 2020. Medical records were reviewed and information about intraoperative factors, surgical approach, laterality, complications, and post-operative perforation closure success rates was collected. Multivariate analysis was performed to compare and contrast the two surgical approaches. RESULTS: The review included 321 pediatric patients who underwent a tympanoplasty. Endoscopic tympanoplasty accounted for 17.4%, while microscopic tympanoplasty accounted for 82.6%. In both approaches, the rate of intraoperative complications, postoperative complications, audiological improvements, and perforation closure success rates were statistically similar. However, patients who underwent endoscopic tympanoplasty were 3.96 times less likely to require opioids in the post-anesthesia care unit (PACU) and had a shorter post-operative admission length. This pattern emerged regardless of the type of graft used. Obtaining an autograft was not associated with a higher opioid requirement in the PACU. CONCLUSION: While both approaches are viable, our findings demonstrate the reduced need for opioids with similar success rates following an endoscopic tympanoplasty. Ultimately, the trade-off for the minimally invasive endoscopic approach appears to be a less painful experience for the child while promoting clinically appropriate opioid stewardship in the perioperative setting.

Evidence-Based Medicine in Otolaryngology Part 16: Qualitative and Quantitative Methods-Contrasting and Complementary Approaches.

Qualitative methods have been increasingly applied in our literature, providing richness to data and incorporating the nuances of patient and family perspectives. These qualitative research techniques provide breadth and depth beyond what can be gleaned through quantitative methods alone. When both quantitative and qualitative approaches are coupled, their findings provide complementary information which can further substantiate study conclusions. We thus aim to provide insight into qualitative and quantitative methods in comparison and contrast to each other, as well as guidance on when each approach is most apt. In relation, we also describe mixed methods and the theory supporting their framework. In doing so, we provide the foundation for an ensuing, more detailed exposition of qualitative methods.

Quantifying the Healthcare Burden of Pediatric Feeding Disorder after Congenital Heart Surgery.

OBJECTIVE: To determine the healthcare costs and use burden of pediatric feeding disorder after congenital heart surgery. STUDY DESIGN: A retrospective, population-based cohort study using claims data (2009-2018) was performed. Participants include patients aged 0-18 years who had undergone congenital heart surgery and were included in the insurance database ≥1 year after surgery. The main exposure variable was the presence of a pediatric feeding disorder, defined as a need for a feeding tube at discharge or diagnosis of dysphagia or feeding-related difficulty within the study timeframe. Main outcomes include overall and feeding-related medical care use, defined as readmissions and outpatient use, and feeding-related cost of care within 1 year of surgery. RESULTS: A total of 10 849 pediatric patients were identified, with 3347 (30.9%) presenting with pediatric feeding disorder within 1 year of surgery. Patients with pediatric feeding disorder spent a median of 12 days (IQR, 6-33 days) in the hospital, compared with 5 days (IQR, 3-8 days) in patients without (P < .001). Rate ratios for overall readmissions, feeding-related readmissions, feeding-related outpatient use, and cost of care over the first year after surgery were significantly increased at 2.9 (95% CI, 2.5-3.4), 5.1 (95% CI, 4.6-5.7), 7.7 (95% CI, 6.5-9.1), and 2.2 (95% CI, 2.0-2.3) among patients with pediatric feeding disorder as compared with those without. CONCLUSIONS: Pediatric feeding disorder after congenital heart surgery is associated with a significant healthcare burden. Multidisciplinary care for and research on this health condition is needed to identify optimal management strategies to reduce this burden and improve outcomes.

The safety of respiratory positive pressure support immediately following pediatric tonsillectomy.

INTRODUCTION: Adenotonsillectomy is the first-line treatment for pediatric obstructive sleep apnea (OSA). The postoperative course may be complicated by hypoxia, requiring intervention. Positive pressure respiratory support (PPS) could be used to bridge the postoperative period and avoid invasive mechanical ventilation; however, the safety of PPS following tonsillectomy has not been established. Objective To review the incidence of complications and risk factors associated with PPS use immediately after tonsillectomy. METHODS: A retrospective cohort study between 2015 and 2020 of patients who underwent tonsillectomy and were admitted to the pediatric intensive care unit at a single healthcare system. RESULTS: Seven hundred eighty patients met inclusion criteria, including 101 patients treated with PPS immediately following surgery. A similar number of patients were diagnosed with severe OSA in each group prior to surgery. One patient in the PPS cohort developed pneumomediastinum and pneumothorax. Eleven patients (12%) in the PPS group and 18 patients (2%) in the non-PPS group developed life-threatening complications, defined as pneumothorax/pneumomediastinum, re-intubation, post-tonsillectomy bleeding that required surgical intervention, pulmonary edema and death, and all occurred in patients who had not used PPS at baseline. Regression analysis identified body mass index, surgical technique, and PPS use to be associated with increased odds of life-threatening complications. CONCLUSION: Our study suggests that PPS is generally safe to use. New-onset PPS is associated with increased odds of life-threatening complications, likely reflecting a severe post-surgical clinical course.

Evidence-Based Medicine in Otolaryngology Part 14: Falsehood and Bias.

OBJECTIVE: Falsehood and bias can have tangible effects, whether related to the "hoax" of Corona virus disease/COVID-19 or the impact of personal protective equipment in city-wide news. The spread of false information requires the diversion of time and resources into rebolstering the truth. Our objective is thus to elucidate types of bias that may influence our daily work, along with ways to mitigate them. DATA SOURCES: Publications are included which delineate specific aspects of bias or address how to preempt, mitigate, or correct bias, whether conscious or unconscious. REVIEW METHODS: We discuss: (1) the background and rationale for proactively considering potential sources of bias, (2) relevant definitions and concepts, (3) potential means to limit effects of inaccurate data sources, and (4) evolving frontiers in the management of bias. In doing so, we review epidemiological concepts and susceptibility to bias within study designs, including database studies, observational studies, randomized controlled trials (RCTs), systematic reviews, and meta-analyses. We additionally discuss concepts such as the difference between disinformation and misinformation, differential or nondifferential misclassification, bias toward a null result, and unconscious bias, among others. CONCLUSION: We have the means to mitigate sources of potential bias in database studies, observational studies, RCTs, and systematic reviews, beginning with education and awareness. IMPLICATIONS FOR PRACTICE: False information may spread faster than true information, so it is beneficial to understand potential sources of falsehood we face, in order to safeguard our daily impressions and decisions. Awareness of potential sources of falsehood and bias forms the foundation for accuracy in our everyday work.

Impact of OSA treatment success on changes in hypertension and obesity: A retrospective cohort study.

OBJECTIVE: Pediatric obstructive sleep apnea (OSA) has been shown to lead to the development of chronic cardiometabolic conditions, including obesity and cardiovascular disease. We sought to describe the impact of the success of continuous positive airway pressure (CPAP) and surgery, common treatment options for pediatric OSA, on cardiometabolic conditions. METHODS: A retrospective review of patients (≤18 years) diagnosed with OSA based on a polysomnogram at a tertiary care pediatric otolaryngology practice from 2015 to 2019 was conducted. Clinical data, including the systolic blood pressure (SBP) values, body mass index (BMI), overall apnea/hypopnea index (AHI) values, and CPAP compliance, were collected. Linear mixed-effects models were developed to observe the relationship between the clinical measurements of each comorbidity and OSA treatment modalities. RESULTS: 414 patients were included. BMI and SBP measures were collected for 230 and 184 patients respectively. The difference-in-difference estimate for the SBP z-score percentile after successful treatment was -5.5 ± 2.1 percentile units per 100 days. The difference-in-difference estimate for SBP z-score percentile after successful CPAP treatment was -13.2 ± 5.1 percentile units per 100 days while the estimate after successful surgical treatment was -4.6 ± 2.4 percentile units per 100 days. No significant differences were found between clinical measures for obese patients in any treatment cohort. CONCLUSIONS: Successful OSA management was shown to have a positive impact on SBP in hypertensive patients and no impact on BMI in obese patients. In hypertensive patients, CPAP success tripled improvements in SBP z-score percentile compared to surgical treatment success.

Sirolimus-induced pulmonary hemorrhage of an infant with massive cervicofacial lymphatic malformation: A case report.

Lymphatic malformations (LMs) are uncommon congenital abnormalities of the lymphatic system. As more than half of these lesions develop in the head and neck, LMs can be life-threatening if associated with airway involvement. LMs necessitate a multidisciplinary treatment approach, frequently including surgery and sclerotherapy. We present a case report of a 32-week pre-term male infant with a massive cervicofacial LM necessitating delivery via ex-utero intrapartum treatment (EXIT). The patient was treated with numerous rounds of sclerotherapy, systemic sirolimus, and surgical debulking, but ultimately died at 4 months of age due to acute pulmonary hemorrhage, which may have been related to sirolimus due to the absence of any other associable organ involvement or derangement. We document the patient's clinical course and treatment regimen, highlighting the myriad modalities employed to treat these challenging lesions, and describe a potentially lethal complication of sirolimus therapy not previously described in the treatment of pediatric LM.

Incidence and Risk Factors Associated with Respiratory Compromise in Planned PICU Admissions Following Tonsillectomy.

OBJECTIVES: Review the incidence and factors associated with respiratory compromise requiring intensive care unit level interventions in children with planned admission to the pediatric intensive care unit (PICU) following tonsillectomy or adenotonsillectomy (T/AT). STUDY DESIGN: Retrospective cohort study. METHODS: Review of all patients with PICU admissions following T/AT from 2015 to 2020 at a tertiary care pediatric hospital. Patient demographics, underlying comorbidities, operative data, and respiratory complications during PICU admission were extracted. RESULTS: Seven hundred and seventy-two patients were admitted to the PICU following T/AT, age 6.1 ± 4.6 years. All children were diagnosed with obstructive sleep apnea or sleep-disordered breathing (mean pre-operative apnea-hypopnea index 29 ± 26.5 and O2 nadir 77.1% ± 11.1). Neuromuscular disease, enteral feed dependence, and obesity were common findings (N = 240 (31%), N = 106 (14%), and N = 209 (27%) respectively). Overall, 29 patients (3.7%) developed respiratory compromise requiring PICU-level support, defined as new-onset continuous or bilevel positive airway pressure support (n = 25) or reintubation (n = 9). Three patients were diagnosed with pulmonary edema. Multivariable regression analysis demonstrated pre-operative oxygen nadir and enteral feed dependence were associated with respiratory compromise (OR = 0.97, 95% CI 0.94-0.99, P = .04; OR = 6.3, 95% CI 2.36-52.6, P = .001 respectively). CONCLUSIONS: Our study found respiratory compromise in 3.7% of patients with planned PICU admissions following T/AT. Oxygen nadir and enteral feeds were associated with higher respiratory compromise rates. Attention should be given to these factors in planning for post-operative disposition.

Measuring the Impact of a Delay in Care on Pediatric Otolaryngologic Surgery Completion.

Objective: To determine if postponement of elective pediatric otorhinolaryngology surgeries results in a change in overall healthcare utilization and if there is any commensurate impact on disease progression. Methods: We identified patients ≤18 years of age whose surgeries were postponed at the onset of the COVID-19 pandemic-related shutdown. We then tracked patients' rate of and patterns of rescheduling surgery. Surveys were also sent to caregivers to better characterize his/her decision regarding moving forward with his/her child's surgery during COVID-19. Results: A total of 1915 pediatric patients had elective surgeries canceled, of which 992 (51.8%) were rescheduled within 4 months. No difference in rates of rescheduling was identified based on race or ethnicity. Patients who were scheduled for tonsillectomies and/or adenoidectomies were 1.22 times more likely to reschedule compared to those patients with other planned procedures (CI: 1.02-1.46). A total of 95 caregivers at two hospitals completed surveys: 44 (47.4%) rescheduled their child's surgery. Most caregivers who rescheduled were concerned their child's disease could impact their future (n = 14, 32%). Conclusions: Just over half of patients who had pediatric otolaryngologic surgery canceled during a period of social distancing went on to have surgery within a 4-month timeframe. This reflects the dependence of pediatric otolaryngologic surgery on environmental exposures and may represent a potential target for prevention and management of some pediatric otolaryngology diseases.

Sustaining standardized opioid prescribing practices after pediatric tonsillectomy.

INTRODUCTION: Opioid prescribing patterns after pediatric tonsillectomy are highly variable, and opioids may not improve pain control compared to over-the-counter pain relievers. We evaluated whether a standardized, opioid-sparing analgesic protocol effectively reduced opioid prescriptions without compromising patient outcomes. METHODS: A quality improvement project was initiated in July 2019 to standardize analgesic prescribing after hospital-based tonsillectomy with/without adenoidectomy. An electronic order set provided weight-based dosing and defaulted to non-opioid prescriptions (acetaminophen and ibuprofen). Patients ages 0-6 received non-opioid analgesics alone. Patients ages 7-18 received non-opioid analgesics as first-line pain control, and providers could manually add hydrocodone-acetaminophen for breakthrough pain. Opioid prescriptions and quantities were compared for 18 months of cases pre- versus post-standardization. Postoperative returns to the system were reviewed as a balancing measure. RESULTS: From 2018 through 2020, 1817 cases were reviewed. The frequency of opioid prescriptions decreased significantly post-standardization, from 64.9% to 33.5% of cases (P < .001). Opioid prescribing for young children steadily decreased from over 50% to 2.4%. Protocol adherence improved over time; outlier prescriptions were eliminated. Opioid quantities per prescription decreased by 16.3 doses on average (P < .001), and variance decreased significantly post-standardization (P < .001). The incidence of returns to the system did not change (P = .33), including returns for pain or decreased intake (P = .28). CONCLUSION: An age-based and weight-based analgesic protocol reduced post-tonsillectomy opioid prescriptions without a commensurate increase in returns for postoperative complaints. Standardized protocols can facilitate sustained changes in prescribing patterns and limit potentially unnecessary pediatric opioid exposure.

Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea.

Importance: Patients with Down syndrome have a high incidence of persistent obstructive sleep apnea (OSA) and limited treatment options. Upper airway hypoglossal stimulation has been shown to be effective for adults with OSA but has not yet been evaluated for pediatric populations. Objective: To evaluate the safety and effectiveness of upper airway stimulation for adolescent patients with Down syndrome and severe OSA. Design, Setting, and Participants: This prospective single-group multicenter cohort study with 1-year follow-up was conducted between April 1, 2015, and July 31, 2021, among a referred sample of 42 consecutive adolescent patients with Down syndrome and persistent severe OSA after adenotonsillectomy. Intervention: Upper airway stimulation. Main Outcomes and Measures: The prespecified primary outcomes were safety and the change in apnea-hypopnea index (AHI) from baseline to 12 months postoperatively. Polysomnographic and quality of life outcomes were assessed at 1, 2, 6, and 12 months postoperatively. Results: Among the 42 patients (28 male patients [66.7%]; mean [SD] age, 15.1 [3.0] years), there was a mean (SD) decrease in AHI of 12.9 (13.2) events/h (95% CI, -17.0 to -8.7 events/h). With the use of a therapy response definition of a 50% decrease in AHI, the 12-month response rate was 65.9% (27 of 41), and 73.2% of patients (30 of 41) had a 12-month AHI of less than 10 events/h. The most common complication was temporary tongue or oral discomfort, which occurred in 5 patients (11.9%). The reoperation rate was 4.8% (n = 2). The mean (SD) improvement in the OSA-18 total score was 34.8 (20.3) (95% CI, -42.1 to -27.5), and the mean (SD) improvement in the Epworth Sleepiness Scale score was 5.1 (6.9) (95% CI, -7.4 to -2.8). The mean (SD) duration of nightly therapy was 9.0 (1.8) hours, with 40 patients (95.2%) using the device at least 4 hours a night. Conclusions and Relevance: Upper airway stimulation was able to be safely performed for 42 adolescents who had Down syndrome and persistent severe OSA after adenotonsillectomy with positive airway pressure intolerance. There was an acceptable adverse event profile with high rates of therapy response and quality of life improvement. Trial Registration: ClinicalTrials.gov Identifier: NCT02344108.

Evidence-Based Medicine in Otolaryngology, Part XIII: Health Disparities Research and Advancing Health Equity.

OBJECTIVE: To provide a contemporary resource for clinicians and researchers on health equity research and implementation strategies to mitigate or eliminate disparities in health care. DATA SOURCES: Published studies and literature on health disparities, applicable research methodologies, and social determinants of health in otolaryngology. REVIEW METHODS: Literature through October 2021 was reviewed, including consensus statements, guidelines, and scientific publications related to health care equity research. This research focus provides insights into existing disparities, why they occur, and the outcomes of interventions designed to resolve them. Progress toward equity requires intentionality in implementing quality improvement initiatives, tracking data, and fostering culturally competent care. Priority areas include improving access, removing barriers to care, and ensuring appropriate and effective treatment. Although research into health care disparities has advanced significantly in recent years, persistent knowledge gaps remain. Applying the lens of equity to data science can promote evidence-based practices and optimal strategies to reduce health inequities. CONCLUSIONS: Health disparities research has a critical role in advancing equity in otolaryngology-head and neck surgery. The phases of disparities research include detection, understanding, and reduction of disparities. A multilevel approach is necessary for understanding disparities, and health equity extensions can improve the rigor of evidence-based data synthesis. Finally, applying an equity lens is essential when designing and evaluating health care interventions, to minimize bias. IMPLICATIONS FOR PRACTICE: Understanding the data and practices related to disparities research may help promote an evidence-based approach to care of individual patients and populations, with the potential to eventually surmount the negative effects of health care disparities.

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update).

OBJECTIVE: Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term otitis media (middle ear inflammation). This guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The guideline is intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals. PURPOSE: The purpose of this clinical practice guideline update is to reassess and update recommendations in the prior guideline from 2013 and to provide clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. In planning the content of the updated guideline, the guideline update group (GUG) affirmed and included all the original key action statements (KASs), based on external review and GUG assessment of the original recommendations. The guideline update was supplemented with new research evidence and expanded profiles that addressed quality improvement and implementation issues. The group also discussed and prioritized the need for new recommendations based on gaps in the initial guideline or new evidence that would warrant and support KASs. The GUG further sought to bring greater coherence to the guideline recommendations by displaying relationships in a new flowchart to facilitate clinical decision making. Last, knowledge gaps were identified to guide future research. METHODS: In developing this update, the methods outlined in the American Academy of Otolaryngology-Head and Neck Surgery Foundation's "Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action" were followed explicitly. The GUG was convened with representation from the disciplines of otolaryngology-head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy. ACTION STATEMENTS: The GUG made strong recommendations for the following KASs: (14) clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea; (16) the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude.The GUG made recommendations for the following KASs: (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months' duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown); (2) clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties; (5) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (6) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (7) clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (8) clinicians should determine if a child with recurrent acute otitis media or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (10) the clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube; (12) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (13) clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement; (15) clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes.The GUG offered the following KASs as options: (4) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life; (9) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer; (11) clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.

Executive Summary of Clinical Practice Guideline on Tympanostomy Tubes in Children (Update).

OBJECTIVE: This executive summary of the guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The summary and guideline are intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals. PURPOSE: The purpose of this executive summary is to provide a succinct overview for clinicians of the key action statements (recommendations), summary tables, and patient decision aids from the update of the American Academy of Otolaryngology-Head and Neck Surgery Foundation's "Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)." The new guideline updates recommendations in the prior guideline from 2013 and provides clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. This summary is not intended to substitute for the full guideline, and clinicians are encouraged to read the full guideline before implementing the recommended actions. METHODS: The guideline on which this summary is based was developed using methods outlined in the American Academy of Otolaryngology-Head and Neck Surgery Foundation's "Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action," which were followed explicitly. The guideline update group represented the disciplines of otolaryngology-head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy. ACTION STATEMENTS: Strong recommendations were made for the following key action statements: (14) Clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea. (16) The surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude.Recommendations were made for the following key action statements: (1) Clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months' duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown). (2) Clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion. (3) Clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties. (5) Clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected. (6) Clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion (MEE) in either ear at the time of assessment for tube candidacy. (7) Clinicians should offer bilateral tympanostomy tube insertion in children with recurrent AOM who have unilateral or bilateral MEE at the time of assessment for tube candidacy. (8) Clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors. (10) The clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube. (12) In the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications. (13) Clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement. (15) Clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes.Options were offered from the following key action statements: (4) Clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life. (9) Clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer. (11) Clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.