Impact of ventilation tube insertion on long-term language outcomes at 6 and 10 years of age: A prospective pregnancy cohort study.

OBJECTIVE: Investigating the impact of early childhood ventilation tube insertion (VTI) on long-term language outcomes. DESIGN: Longitudinal cohort study. SETTING: A total of 2900 pregnant women participated in the Raine Study between 1989 and 1991 in Western Australia, and 2868 children have been followed up. PARTICIPANTS: Based on parental reports, 314 children had a history of recurrent otitis media but did not undergo VTI (rOM group); another 94 received VTI (VTI group); while 1735 had no history of rOM (reference group) in the first 3 years of childhood. Children with data on outcomes and confounders were included in analyses of PPVT-R at ages 6 (n = 1567) and 10 years (n = 1313) and CELF-III at 10 years (n = 1410) (approximately 5% in the VTI group and 15% in the rOM group). MAIN OUTCOME MEASURES: Peabody Picture Vocabulary Test-Revised edition and Clinical Evaluation of Language Fundamentals® Preschool-3. RESULTS: At 6 years, mean PPVT-R scores were significantly lower in the VTI group than the reference group (ß = -3.3; 95% CI [-6.5 to -0.04], p = .047). At 10 years, while the difference between the VTI and reference groups was less pronounced for PPVT-R scores, there was a small but consistent trend of lower measures, on average, across CELF-III scores (expressive: ß = -3.4 [-7.1 to 0.27], p = .069; receptive: ß = -4.1 [-7.9 to -0.34], p = .033; total: ß = -3.9 [-7.5 to -0.21], p = .038). There was no evidence to suggest that language outcomes in the rOM group differed from the reference group. CONCLUSION: Lower scores of language outcomes in school-aged children who received VTI in early childhood may suggest a long-term risk which should be considered alongside the potential benefits of VTI.

High frequency hearing 25 years after transmyringeal ventilation tube treatment.

OBJECTIVES: The main aim of the study was to compare hearing outcome between a healthy control group and patients treated with transmyringeal ventilation tubes, 25 years after primary surgery. Another aim was to analyse the relation between ventilation tube treatment in childhood and the occurrence of persistent middle ear pathology 25 years later. METHODS: In 1996, children treated with transmyringeal ventilation tubes were recruited for a prospective study on the outcome of ventilation tube treatment. In 2006, a healthy control group were recruited and examined together with the original participants (case group). All participants in the 2006 follow-up were eligible for this study. A clinical ear microscopy examination including eardrum pathology grading and high frequency audiometry (10-16 kHz) was carried out. RESULTS: A total of 52 participants were available for analysis. Hearing outcome was worse in the treatment group (n = 29) compared to the control group (n = 29), both in regard to standard frequency range hearing, (0.5-4 kHz), and high frequency hearing (HPTA3 10-16 kHz). Almost half the case group (48%) had eardrum retraction to some extent, compared to 10% in the control group. No case of cholesteatoma was found in this study and eardrum perforation was rare (<2%). CONCLUSION: In the long term, high frequency hearing (HPTA3 10-16 kHz) was more often affected in the patients with transmyringeal ventilation tube treatment during childhood compared with the healthy controls. Middle ear pathology of greater clinical significance was rare.

Clinical decision making in paediatric otitis media: A pilot quality improvement study.

OBJECTIVES: This study aimed to improve local management of paediatric otitis media using the 2022 American-Academy of Otolaryngology Head and Neck Surgery (AAO-HNS) Clinical Practice Guideline for Tympanostomy Tubes in Children. METHODS: A SQUIRE 2.0 compliant quality improvement study was carried out within the outpatient department of our otolaryngology tertiary referral centre. Local outpatient management of paediatric otitis media was compared to the AAO-HNS guidelines, specifically focussing on the decision to offer tympanostomy tubes. Following initial audit of practice, an educational session was performed within the otolaryngology department and local practice was subsequently re-evaluated. RESULTS: Overall, 88 children were included (46 pre-intervention and 42 post-intervention) with a mean age of 7.6 years (range 1-12 years). Sixty-four (72.7%) children presented with suspected otitis media with effusion. The remainder presented with recurrent or persistent acute otitis media (24/88, 27.3%). Twenty-six children were offered tympanostomy tubes (29.5%). Initial evaluation of practice identified that the decision to offer tympanostomy tubes was guideline appropriate in 76.1% of children (35/46). This significantly improved following an educational session (40/42, 95.2%, p = 0.02). The reasons for non-guideline compliance included: otitis media with effusion <3 months, no evidence of middle ear fluid and patients meeting criteria for tympanostomy tube insertion not being offered. CONCLUSIONS: A focussed educational intervention may improve local adherence to guidelines in the management of paediatric otitis media. Continued re-evaluation of local practice is essential in order to ensure children are managed in accordance with the guidelines.

Long-term follow-up after recurrent otitis media and ventilation tube insertion: Hearing outcomes and middle-ear health at six years of age.

OBJECTIVES: To investigate the long-term impact of recurrent otitis media (rOM) and ventilation tube insertion (VTI) in early childhood on hearing outcomes and middle-ear health three to five years later, in a prospective pregnancy cohort study. METHODS: Children were classified into rOM (n = 314), VTI (n = 94), and reference (n = 1735) groups, according to their otitis media (OM) history in their first three years of life. Audiometry at frequencies 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz, and tympanometry were performed when children were approximately six years of age. RESULTS: A binary logistic regression incorporating a range of potential confounding variables showed that hearing outcomes and middle-ear health status in children who had early childhood rOM with or without undergoing VTI were not significantly different to those in the reference group. The only significant difference was found in the VTI group for both tympanometry (OR = 2.190; 95% CI = 1.123, 4.270) and audiometry outcomes at 4000 Hz (OR = 3.202; 95% CI 1.341, 6.717), in the left ear only. The median score of the better ear 4FA was 20 dB in children in all groups. CONCLUSION: Children with rOM with or without undergoing VTI in the first three years of childhood had comparable hearing outcomes and middle-ear health status to those with no history of the disease, at around the age of six years. Although children who underwent VTI had an increased risk of abnormal middle-ear status and some elevation in hearing levels in their left ear only, their audiometry results were still within normal limits, indicating that the impact of VTI in early childhood is unlikely to have clinically significant adverse impact on later hearing outcomes.

Water protection in paediatric patients with ventilation tubes: Myth or reality? A systematic review.

BACKGROUND: Myringotomy with ventilation tube (VT) insertion is one the most performed procedures in children and adolescents worldwide. VTs usually remain in the eardrum between 6 and 12 months and during this period otorrhoea is the most frequent complication. For years, parents have been advised to protect the ears of children with VTs from contact with water, as water exposure in the middle ear is likely to cause acute otitis media. However, there is a growing evidence that water should not traverse VTs unless under significant pressure, so routine water precautions should not be prescribed. Despite these recommendations, many otolaryngologists and paediatricians continue to prescribe earplugs during bathing or swimming or advise against aquatic activities. There are already two reviews in the current literature on this topic: the first used strict selection criteria and included only 2 high-quality studies, while the second presented evidence up to 2005. The aim of this review is to identify, summarize and critically appraise the current evidence concerning water precautions for children with VTs. METHODS: Two independent reviewers separately searched for related scientific papers. A qualitative synthesis analysis was performed considering the selected studies regarding the effects of water exposure on paediatric subjects with VTs. RESULTS: Four randomized clinical trials (RCT) and five prospective cohort studies were included, for a total of 1299 patients aged from 3 months to 14 years. No statistically significant difference in otorrhoea incidence between water exposure with and without ear protection in children with VTs, and between water exposure and no water exposure in children with VTs, was found. Therefore avoiding water is at best inconvenient and at worst may delay learning to swim. The decision to protect the ear when exposed to water should be individualized and protection should be recommended during the first month after surgery and in cases of recurrent otorrhoea. CONCLUSION: Based on the literature available, allowing water surface activities with no ear protection seems to present a minimum risk, so it is not necessary to prohibit patients from swimming. However, some recommendations should be followed.

Water protection in paediatric patients with ventilation tubes: Myth or reality? A systematic review

BackgroundMyringotomy with ventilation tube (VT) insertion is one the most performed procedures in children and adolescents worldwide. VTs usually remain in the eardrum between 6 and 12 months and during this period otorrhoea is the most frequent complication. For years, parents have been advised to protect the ears of children with VTs from contact with water, as water exposure in the middle ear is likely to cause acute otitis media. However, there is a growing evidence that water should not traverse VTs unless under significant pressure, so routine water precautions should not be prescribed. Despite these recommendations, many otolaryngologists and paediatricians continue to prescribe earplugs during bathing or swimming or advise against aquatic activities. There are already two reviews in the current literature on this topic: the first used strict selection criteria and included only 2 high-quality studies, while the second presented evidence up to 2005. The aim of this review is to identify, summarize and critically appraise the current evidence concerning water precautions for children with VTs.MethodsTwo independent reviewers separately searched for related scientific papers. A qualitative synthesis analysis was performed considering the selected studies regarding the effects of water exposure on paediatric subjects with VTs.ResultsFour randomized clinical trials (RCT) and five prospective cohort studies were included, for a total of 1299 patients aged from 3 months to 14 years. No statistically significant difference in otorrhoea incidence between water exposure with and without ear protection in children with VTs, and between water exposure and no water exposure in children with VTs, was found. Therefore avoiding water is at best inconvenient and at worst may delay learning to swim. (AU)

AntecedentesLa miringotomía acompañada de la inserción de tubos de ventilación (TV) es uno de los procedimientos más realizados en niños y adolecentes a nivel mundial. Los TV normalmente permanecen sobre la membrana timpánica entre 6 y 12 meses, y durante este periodo una de las complicaciones más frecuentes es la presencia de otorrea. Durante muchos años, se les ha indicado a los padres la necesidad de evitar el contacto con agua de aquellos niños que tienen TV, ya que la exposición al agua puede producir otitis media aguda. Sin embargo, existe una creciente evidencia sobre la imposibilidad de que el agua pueda penetrar a través del TV a menos que exista una presión significativa y, por lo tanto, estas precauciones resultan innecesarias. A pesar de estas recomendaciones, muchos otorrinolaringólogos y pediatras siguen indicando tapones de oídos durante el baño o la natación e incluso la prohibición de deportes acuáticos. Actualmente en la literatura existen 2 revisiones sobre este tema: la primera utilizó criterios de selección estrictos e incluyó 2 estudios de alta calidad, mientras que la segunda presentó evidencia solo hasta el año 2005. El objetivo de esta revisión es identificar, resumir y evaluar críticamente la evidencia actual sobre las precauciones con el agua en los niños con TV.MétodosSe realizó un análisis de síntesis cualitativa tomando en cuenta los estudios seleccionados sobre los efectos de la exposición al agua en niños con TV.ResultadosSe incluyeron 4 ensayos clínicos aleatorizados y 5 estudios de cohortes prospectivos para un total de 1.299 pacientes con edades comprendidas entre los 3 meses y los 14 años. No se encontró una diferencia estadísticamente significativa en la incidencia de otorrea entre la exposición al agua con y sin tapones para los oídos en niños con TV, ni entre la exposición al agua y la no exposición al agua en niños con TV. (AU)

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.

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.

Water protection in paediatric patients with ventilation tubes: Myth or reality? A systematic review.

BACKGROUND: Myringotomy with ventilation tube (VT) insertion is one the most performed procedures in children and adolescents worldwide. VTs usually remain in the eardrum between 6 and 12 months and during this period otorrhoea is the most frequent complication. For years, parents have been advised to protect the ears of children with VTs from contact with water, as water exposure in the middle ear is likely to cause acute otitis media. However, there is a growing evidence that water should not traverse VTs unless under significant pressure, so routine water precautions should not be prescribed. Despite these recommendations, many otolaryngologists and paediatricians continue to prescribe earplugs during bathing or swimming or advise against aquatic activities. There are already two reviews in the current literature on this topic: the first used strict selection criteria and included only 2 high-quality studies, while the second presented evidence up to 2005. The aim of this review is to identify, summarize and critically appraise the current evidence concerning water precautions for children with VTs. METHODS: Two independent reviewers separately searched for related scientific papers. A qualitative synthesis analysis was performed considering the selected studies regarding the effects of water exposure on paediatric subjects with VTs. RESULTS: Four randomized clinical trials (RCT) and five prospective cohort studies were included, for a total of 1299 patients aged from 3 months to 14 years. No statistically significant difference in otorrhoea incidence between water exposure with and without ear protection in children with VTs, and between water exposure and no water exposure in children with VTs, was found. Therefore avoiding water is at best inconvenient and at worst may delay learning to swim. The decision to protect the ear when exposed to water should be individualized and protection should be recommended during the first month after surgery and in cases of recurrent otorrhoea. CONCLUSION: Based on the literature available, allowing water surface activities with no ear protection seems to present a minimum risk, so it is not necessary to prohibit patients from swimming. However, some recommendations should be followed.

Myringotomy and insertion of grommets as day surgery: a case study.

This evidence-based case study follows a child from a nursing assessment on the day of his elective surgery at a children's hospital for myringotomy and insertion of grommets under general anaesthesia through to his arrival at the operating room. Potential pre-operative problems are identified and two problems that arose are discussed in detail. The main care provider in this case was a student nurse referred to as 'the nurse', supported by a qualified nurse, referred to as the 'registered nurse', who performed some assessments.

Otological outcome in cleft lip and palate children with middle ear effusion.

OBJECTIVE: To evaluate the factors contributing to middle ear pathology, hearing and speech development among cleft palate children treated for middle ear effusion. METHOD: A prospective cross-sectional otoscopic and audiological analysis was conducted on 102 cleft palate children (204 ears) aged 1-18 years old who were treated for middle ear effusion at our centre. Retrospective chart review was done to determine patient characteristics and prior patient management. The aim was to assess the effect of ventilation tube insertion (VTI) on hearing, speech and chronic otitis media; comparing the timing and number of ventilation tubes per ear and determining other factors affecting the short-term and long-term outcome. RESULTS: 68 children or 130 ears (63% of all cases) were selectively treated with ventilation tube insertion. Repeat procedures (more than 2) were performed in 41 ears. Among children with VTI performed, the incidence of chronic otitis media in children after the age of 4 was 17%. Overall, abnormal tympanic membrane findings and hearing loss were detected in nearly half the cases who were previously treated with VTI. Early ventilation tube insertion at less than 1 year of age, resulted in a better middle ear and hearing outcome in children less than 4 years old (p < 0.05), however there was no significant difference in children more than 4 years old. Early surgical repair of cleft palate prior to the age of one year resulted in favourable results in both age groups (p < 0.05). There was a higher prevalence of chronic otitis media with repeated grommet insertion (3 or more) (p < 0.05). Speech and language milestones were achieved in 94% of all children above the age of four. CONCLUSION: Treatment with early ventilation tube insertion prior to the age of one year provides a hearing benefit in children less than 4 years of age, but no significant difference after 4 years of age. Factors significantly affecting the outcome after 4 years of age was the timing of palatal closure and total number of tube insertions. We recommend a conservative approach especially when considering repeated tube insertions. A long-term follow-up paired with interval hearing assessment is advocated until early adulthood.

A retrospective review of Paparella Type 1 tympanostomy tubes.

OBJECTIVE: This study aims to provide data on ear tube extrusion and complication rates for patients who have Paparella Type 1 tympanostomy tube (TT) placement. METHODS: Retrospective chart review of patients 6 months to 12 years old who underwent insertion of Paparella Type 1 TT by a single surgeon. RESULTS: Of 197 tubes evaluated, 3% were plugged between 1 and 3 months after surgery. Of the 144 tubes evaluated long-term, all tubes extruded within 4 years. There were no tympanic membrane perforations. CONCLUSIONS: This chart review showed expected rate of initial ear tube plugging. The rate of tympanic membrane perforation was lower than expected.

Changes in Otitis Media Episodes and Pressure Equalization Tube Insertions Among Young Children Following Introduction of the 13-Valent Pneumococcal Conjugate Vaccine: A Birth Cohort-based Study.

BACKGROUND: The impact of 13-valent pneumococcal conjugate vaccine (PCV13) introduction on the occurrence of first and subsequent otitis media (OM) episodes in early childhood is unclear. We compared the risk of OM episodes among children age <2 years before and after PCV13 introduction, accounting for the dependence between OM episodes. METHODS: We identified consecutive annual (July-June) cohorts of Tennessee Medicaid-enrolled children (2006-2014) from birth through age 2 years. We identified OM episodes using coded diagnoses (we classified diagnoses <21 days apart as the same episode). We modeled adjusted hazard ratios (aHRs) for OM comparing 7-valent pneumococcal conjugate vaccine (PCV7)-era (2006-2010) and PCV13-era (2011-2014) birth cohorts, accounting for risk factors and dependence between first and subsequent episodes. Secondary analyses examined pressure equalization tube (PET) insertions and compared the risk of recurrent OM (≥3 episodes in 6 months or ≥4 episodes in 12 months) between PCV7- and PCV13-era birth cohorts. RESULTS: We observed 618 968 OM episodes and 24 875 PET insertions among 368 063 children. OM and PET insertion rates increased during the PCV7 years and declined after PCV13 introduction. OM and PET insertion risks were lower in the 2013-2014 cohort compared with the 2009-2010 cohort (aHRs [95% confidence interval], 0.92 [.91-.93] and 0.76 [.72-.80], respectively). PCV13 introduction was associated with declines in the risk of first, subsequent, and recurrent OM. CONCLUSIONS: The transition from PCV7 to PCV13 was associated with a decline of OM among children aged <2 years due to a reduction in the risk of both the first and subsequent OM episodes.

Quality of life in Swedish children receiving grommets - An analysis of pre- and postoperative results based on a national quality register.

BACKGROUND: Otitis media with effusion (OME) and recurrent otitis media (rAOM) are two common diagnoses in childhood, both of which are treated with grommets, or ventilation tubes. It is known that affected children have a worse quality of life (QoL), and various questionnaires have been used to evaluate this. The national Swedish quality register for grommet insertions contains some QoL questions that have hitherto never been analysed. METHODS: Data from 2010 to 2016 was extracted from the register and analysed with regards to QoL questions, reasons for surgery, hearing levels and number of AOM episodes. RESULTS: Preoperative QoL data was available for 3835 children. Before surgery, most parents felt that the QoL of their children was negatively affected by the ear disease. Parents of children with OME were more likely to suspect that their child had a hearing loss (ORs 10.1 and 28.2 for suspecting a mild and severe hearing loss, respectively), but less likely to find that the ear disease affected the child's general wellbeing than did parents of children with rAOM (ORs 0.54 and 0.33 for somewhat and much affected, respectively). Many children underwent surgery despite not fulfilling the criteria for surgery as stipulated in the national guidelines. Those who did fulfil criteria, however, had a more severely affected QoL. A significant improvement was seen in individual QoL scores after surgery (p < 0.001). The degree of postoperative improvement in pure tone average correlated with the improvement in QoL (p < 0.001). CONCLUSION: This is the first time that the QoL aspect has been analysed in the Swedish grommet register. Though the validity of the questions has not been proven, they provide valuable information. The relevance of the surgical criteria in national guidelines is illustrated by their correlation with the QoL questions, particularly for OME, and the postoperative improvement in QoL suggests parents find that their children benefit from surgery.

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.

Grommet and adenoid pain evaluation (GRAPE) study.

In the GRAPE study an analysis is made of postoperative pain sensation in children between 6 months and 6 years after adenotomy and placement of ear grommets. Intraoperative treatment with paracetamol versus placebo shows no statistically significant difference in pain between both groups indicating that this type of surgery causes little discomfort and does not require specific intraoperative analgesic treatment.

Grommets in otitis media: a 25-year follow up.

BACKGROUND: This study is unique as it is the first study which can describe the long term sequelae of treatment of otitis media with effusion (OME) with insertion of grommets in the Primary Health Sector in Denmark. OBJECTIVES: Eardrum pathology and hearing acuity 25 years after treatment of OME by insertion of grommets, in a private ear-, nose-, and throat practice. MATERIAL AND METHODS: 262 children with OME were treated from 1975 to 1978. The patients were re-examined by otomicroscopy, tympanometry and pure tone audiometry after 7.5, 12, and 25 years. RESULTS: Hearing level, flaccida retraction and incudo pexi was equivalent. For atrophy and myringosclerosis no equivalence was shown using 95% confidence intervals. Tympanometry was fairly unchanged. CONCLUSION AND SIGNIFICANCE: The insertion of a grommet in treating OME has no influence on hearing acuity in the long term. The prevalence of myringosclerosis and atrophy was unchanged in 70-80% of the eardrums. Most important is that the small increase in myringosclerosis and atrophy does not seem to influence the hearing acuity. We show that long term sequelae from the Primary Health Sector are similar to those from the Secondary Health sector.

The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial.

BACKGROUND: The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. METHODS: The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9-36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations. DISCUSSION: This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.

Racial and Ethnic Differences in Receipt of Pressure Equalization Tubes Among US Children, 2014.

OBJECTIVE: Pressure equalization tube (PET) placement (also referred to as tympanostomy tube placement) is among the most common ambulatory surgical procedures performed on US children. More than 20 years ago, differences according to race/ethnicity in the national prevalence of having had PETs placed were documented. Whether these differences persist is unknown. METHODS: We used data from the 2014 National Health Interview Survey to examine the percentage of children 0 to 17 years of age who have ever undergone PET placement. Unadjusted logistic regression with predictive margins was used to assess the relationship between having received PETs and race/ethnicity, as well as other clinical, socioeconomic, and geographic factors. Multivariable logistic regression was used to determine whether other factors could account for any observed differences according to race/ethnicity. RESULTS: Overall, 8.9% of children 0 to 17 years of age had undergone PET surgery. By race/ethnicity, 12.6% of non-Hispanic white children received PETs, which was significantly greater than the 4.8% of non-Hispanic black, 4.4% of Hispanic, and 5.6% of non-Hispanic other/multiple race children who had this surgery (P < .001 for all comparisons). In multivariable analysis, the adjusted prevalence for non-Hispanic white children (10.8%) was greater than for non-Hispanic black (5.4%) and Hispanic (5.8%) children (P < .001 for both comparisons). CONCLUSIONS: Nearly 9% of US children have had PETs placed. Non-Hispanic white children still have a greater prevalence of PET placement compared with non-Hispanic black and Hispanic children. These differences could not be fully explained by other demographic, clinical, socioeconomic, or geographic differences between racial/ethnic groups.