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.

Plain Language Summary: Tympanostomy (Ear) Tubes in Children.

This plain language summary explains tympanostomy tubes, also known as ear tubes, to patients and families. The summary applies to children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes. It is based on the "Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)," published in 2022 as a major update to the original guideline from 2013. This plain language summary is written explicitly for consumers, patients, and families as a companion publication to the full guideline, which provides greater detail for health care providers. A primary purpose is to facilitate insight and understanding that foster shared decision making regarding ear tubes. Guidelines and their recommendations may not apply to every child, but they do identify best practices and quality improvement opportunities that can help you and your child benefit most from ear tubes.

The Swedish grommet register - Hearing results and adherence to guidelines.

OBJECTIVES: The insertion of grommets is one of the most commonly performed surgical procedures in children. The underlying reason might be otitis media with effusion (OME) with concomitant hearing loss, recurrent acute otitis media (rAOM) or a combination of the two. Sweden has a national quality register for children receiving grommets with the purpose of evaluating how treatment guidelines are followed, and if surgery confers good quality health care. The purpose of this study was to investigate the circumstances during which Swedish children receive grommets and to examine how doctors follow the guidelines for grommet surgery. METHODS: Quality register data was extracted from 2010 to 2016, and information on reasons for surgery, audiometry, number of AOM episodes, type of grommet etc was analysed. RESULTS: The dominating reason for surgery was OME (71%). A large proportion (27%) of children with OME had not undergone a preoperative audiometry, despite national guidelines stating that it is hearing impairment that calls for surgery. Furthermore, among those who had done audiometry, 47% did not have a hearing impairment as measured by pure tone average. Nevertheless, a significant hearing improvement (11 dB, p < 0.001) was seen on post-operative follow-ups in those children who underwent audiometry. Forty-four percent of children operated due to rAOM had had fewer episodes of AOM than recommended as an indication for surgery, though this figure should be interpreted with caution as GP diagnosed episodes are not entered in the register. CONCLUSION: Even though grommet insertions are quick and confer a low per-operative risk, it seems many children undergo surgery without a clear indication. This puts them at an unnecessary risk of per-operative as well as long-term complications. Since the procedure is so common, it also means large sums of money are spent on operations that might not be necessary.

Appropriateness of Tympanostomy Tubes in the Boston Metropolitan Area: Are the AAO-HNSF Guidelines Being Met?

Introduction Otitis media (OM) is the most common reason children receive general anesthesia, with bilateral tympanostomy tube (TT) insertion the second most common surgery in children. Prior research suggests overuse of TT. As part of a project designed to improve appropriateness of OM referrals, we evaluated appropriateness of TT insertion in a patient cohort. Methods Patients younger than 9 years with initial otolaryngology (ORL) visits in academic and private office settings for OM from January 1, 2012, to August 31, 2013, were identified through claims database. A detailed retrospective chart review of patients undergoing TT insertion was performed to determine appropriateness of TT insertion per the 2013 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) guidelines. Results A total of 120 patients undergoing TT insertion were randomly chosen for detailed chart review; 32 patients were excluded. Sixty-six (75%) of 88 patients available for analysis met AAO-HNSF guidelines for TT. Recurrent acute OM with middle ear effusion was the most common indication (56%). Other indications included chronic OME and TT in at-risk patients with speech, learning, or behavioral delays. Of the 22 patients undergoing TT insertion not meeting AAO-HNSF guidelines, 11(50%) had abnormal exams, but were 1 to 2 infections short of meeting guidelines; 7 (33%) had normal exams but met criteria for number of infections. Discussion Contrary to prior publications, 75% of patients undergoing TT insertion had an appropriate indication per AAO-HNSF guidelines. In only 5% was TT insertion a substantial departure from guidelines. Implications for Practice The study outcomes suggest appropriate clinical decision making, improved guideline adherence, and better guideline applicability from the previously published 1994 and 2004 guidelines.

National Institute for Clinical Excellence guidelines on the surgical management of otitis media with effusion: are they being followed and have they changed practice?

OBJECTIVE: UK National Institute of Clinical Excellence (NICE) guidelines on surgical management of otitis media with effusion (OME) in children call for an initial 3 month period of observation, with ventilation tube (VT) insertion considered for children with persistent bilateral OME with a hearing level in better ear of 25-30 dB HL or worse ("core criteria"), or for children not meeting those audiologic criteria but when OME has significant impact on developmental, social or educational status (exceptional circumstances). We aimed to establish whether guidelines are followed and whether they have changed clinical practice. METHODS: Retrospective case-notes review in five different centres, analysing practice in accordance with guidelines in all children having first VT insertion before (July-December 06) and after (July-December 08) guidelines introduction. RESULTS: Records of 319 children were studied, 173 before and 146 after guidelines introduction. There were no significant differences in practice according to guidelines before and after their introduction with respect to having 2 audiograms 3 months apart (57.8 vs. 54.8%), OME persisting at least 3 months (94.8 vs. 92.5%), or fulfilment of the 25 dB audiometric criteria (68.2 vs. 61.0%). Practice in accordance with the core criteria fell significantly from 43.9 to 32.2% (Chi squared p=0.032). However, if the exceptional cases were included there was no significant difference (85.5 vs. 87.0%), as the proportion of exceptional cases rose from 48.3 to 62.2% (Chi squared p=0.021). CONCLUSION: This study shows that 87.0% of children have VTs inserted in accordance with NICE guidelines providing exceptional cases are included, but only 32.2% comply with the core criteria. A significant number have surgery due to the invoking of exceptional criteria, suggesting that clinicians are personalising the treatment to each individual child.

The simultaneous use of weighted logrank and weighted Kaplan-Meier statistics with clustered right-censored data.

Clustered right-censored data often arise from tumorigenicity experiments and clinical trials. For testing the equality of two survival functions, Jung and Jeong extended weighted logrank (WLR) tests to two independent samples of clustered right-censored data, while the weighted Kaplan-Meier (WKM) test can be derived from the work of O'Gorman and Akritas. The weight functions in both classes of tests (WLR and WKM) can be selected to be more sensitive to detect a certain alternative; however, since the exact alternative is unknown, it is difficult to specify the selected weights in advance. Since WLR is rank-based, it is not sensitive to the magnitude of the difference in survival times. Although WKM is constructed to be more sensitive to the magnitude of the difference in survival times, it is not sensitive to late hazard differences. Therefore, in order to combine the advantages of these two classes of tests, this paper developed a class of versatile tests based on simultaneously using WLR and WKM for two independent samples of clustered right-censored data. The comparative results from a simulation study are presented and the implementation of the versatile tests to two real data sets is illustrated.

Contemporary indications for ventilation tube placement.

PURPOSE OF REVIEW: To discuss the current indications for ventilation tube placement RECENT FINDINGS: In the past year, several studies have challenged the current guidelines for ventilation tube placement and antibiotic use for otitis media in children. Critics argue that some of these studies have poor scientific validity, yet these studies are being referenced, and sometimes misinterpreted, by the media. Fueled by these media reports, many concerned parents are now questioning otolaryngologists as to the efficacy and safety of ventilation tube placement. Whereas the indications for tube placement in children may be in a state of flux, the indications for tube placement in adults has (and is) fairly static. I will discuss the current published guidelines and the potential for changing trends in tube placement rates. I will also review the literature for the past year regarding postoperative management and adjuvant therapies. SUMMARY: Although there have been no radical changes in the indications for ventilation tube placement, recent studies have challenged the current clinical indicators and the ramifications of these studies may be more evident in the years to come.

Six Sigma tympanostomy tube insertion: achieving the highest safety levels during residency training.

OBJECTIVE: To evaluate a protocol designed to avoid complications during tympanostomy tube insertion by residents. DESIGN: Ten-year consecutive cases series by a single surgeon supervising residents. SETTING: Tertiary children's hospital. PATIENTS: Children 6 weeks to 21 years. INTERVENTION: Residents followed a defined protocol for tube insertion. A resident operated until the tube was placed or he/she committed one major or two minor errors. MAIN OUTCOME MEASURES: Incidence of 1) major complications: profound sensorineural hearing loss (SNHL), injury to major vascular structures, or disruption of the ossicular chain; and 2) minor complications: tube loss into the middle ear, tympanic membrane tears, or tube occlusion by blood clot. RESULTS: There were no major complications in 10,000 tube insertions. Two children had unilateral profound SNHL; both were found to have Mondini malformations. Five tubes were recovered from the middle ear. Eight tympanic membrane tears healed with gelatin patches. Three tubes were occluded by blood clots. CONCLUSION: By following a defined protocol, major complications of a common operation can be reduced to the five-sigma level and minor complications minimized.

Minimum dataset for recording myringotomy and ventilation tube insertion.

A minimum dataset for recording of findings during myringotomy and ventilation tube insertion for cases of otitis media with effusion is presented. With increasing pressures on surgeons to audit existing practices and hence improve standards of health care, it is appropriate to produce such a set of guidelines for a surgery that is frequently performed world-wide. We believe that the data presented is not too exhaustive and can be readily incorporated into the operative notes.

Recurrent otitis media: a cost-utility analysis of simulated treatment using tympanostomy tubes vs antibiotic prophylaxis.

Using a cost-utility analysis, the effectiveness of tympanostomy tubes was compared to that of antibiotic chemoprophylaxis in young patients with recurrent otitis media. The tympanostomy approach (T-tubes) consisted of placement of a polyethylene grommet in the tympanic membrane, with systemic and local antibiotics administered for one week. The chemoprophylaxis approach consisted of antibiotics in full doses for seven to ten days, followed by continuous antibiotic chemoprophylaxis for six months. Because the T-tube strategy under the model assumptions was more expensive ($396.44 vs $281.30) and yielded slightly less benefit (net utility of .9325 vs. .9476 for initial antibiotic therapy), the chemoprophylaxis option was preferred. We conclude that the initial treatment for recurrent otitis media should consist of acute antibiotics followed by chemoprophylaxis, with T-tubes reserved for treatment failure. Extreme changes in the baseline probabilities of cure or recurrence with antibiotic therapy or in the cost of antibiotic therapy or tympanostomy surgery were required to alter this conclusion. Varying therapy preference (utility) values did not materially alter the conclusions.

Factors influencing tympanostomy tube function and extrusion: a study of 1,127 ears.

Shepard, long polyethylene, and Reuter-bobbin tympanostomy tubes were studied for longevity in the inferior and anterior quadrants of 1,127 tympanic membranes. Factors that improved tube functioning time significantly for all or certain tube types included (1) general anesthesia; (2) "virgin" tympanic membranes (Shepard, Reuter-bobbin), (3) age of 9 years or younger (Reuter-bobbin), (4) normal or thin tympanic membranes (Reuter-bobbin), and (5) middle ear fluid (Reuter-bobbin for all types of fluid). Negative correlations (or those not statistically significant because of such factors as sample size) for longevity of tube functioning time included (1) effect of multiple previous intubations in the same ear, (2) age over 10 years, and (3) quadrant of insertion. No significant difference in longevity was noted between normal patients and those with a repaired or unrepaired cleft palate deformity. The data suggest that the epithelial layer of the tympanic membrane influences the longevity of the tympanostomy tube function.