Persistent Otitis Media With Effusion Research Articles

Effect of COVID-19 on the characteristics and outcome of patients who have otitis media with effusion: a case-control study

BackgroundFew studies have examined the otologic symptoms of Coronavirus disease 2019 (COVID-19). The objective of this study was to identify the effect of COVID-19 on the characteristics and outcomes of patients who have otitis media with effusion (OME).MethodsThis case-control study compared the characteristics and outcomes of OME patients who did or did not have COVID-19. A total of 65 patients with previous COVID-19 and 40 patients who did not have COVID-19 (controls) were enrolled from October 1, 2022 to January 31, 2023 at a single institution in China. Demographics, medical histories, morbidities, hearing test results, treatments, and outcomes of the two groups were compared.ResultsThe COVID-19 group had significantly better outcomes from OME than the control group, with higher rates of complete resolution (64.6% vs. 30%) and improvement (30.8% vs. 17.5%), and a lower rate of persistent OME (4.6% vs. 52.5%). Previous COVID-19 was independently associated with a more favorable OME outcome in three multivariate logistic regression models. The COVID-19 group also had a greater improvement in hearing threshold based on air-bone gap measurements.ConclusionThe outcomes of OME patients who had previous COVID-19 were generally good, in that most patients responded well to treatment and achieved complete resolution or improvement within one month.

The effect of otitis media with effusion on phonological performance of preschool children

ObjectivesPhonological development is dependent on the integrity of the auditory system. Otitis media with effusion (OME) may affect speech perception in children and therefore phonological development. The aim of this study was to investigate the impact of persistent OME on the phonological performance of preschool children.MethodsSixty children with persistent OME who were candidates for myringotomy and ventilation tube insertion were included in this prospective observational study. We assessed their phonological skills before and after surgery (3 and 6 months) by phonological production tasks that included calculation of percentage of consonants correct (PCC) and process density index (PDI).ResultsWe detected preoperative poor phonological performance in 91.7% of children. We found statistically significant differences in PCC and PDI between the three time periods. Also, there was a significant improvement after 6 months compared to 3 months.ConclusionsOME has an adverse consequence on the phonological performance of preschool children, it can affect different domains such as PCC and PDI. The findings of this study revealed that myringotomy with ventilation tube insertion for children with persistent OME could aid in the development of intact phonological skills.

Topical and oral steroids for otitis media with effusion (OME) in children.

Topical and oral steroids for otitis media with effusion (OME) in children.

Antibiotics for otitis media with effusion (OME) in children.

Antibiotics for otitis media with effusion (OME) in children.

Spontaneous resolution of ‘glue ear’ in children- An experience at a tertiary care teaching hospital of Khyber Pakhtunkhwa.

Otitis media with effusion (OME) is a common cause of treatable hearing impairment in children. As OME is a recurrent problem, a ‘wait and see’ policy is therefore worthwhile before embarking on treating it surgically. Objective: To determine the frequency of cases having spontaneous resolution of otitis media with effusion in the first 3 months after acquiring the disease. Methods: This study was conducted in ENT Department of Hayatabad Medical complex, Peshawar during the period from July 1, 2021 to Sep 3, 2022. Children aging 3-13 years diagnosed with recent onset OME were followed upto 3 months. Children were categorized into two categories; “Resolved” and “Persistent OME” on the basis of pure tone audiometry and tympanometry at the end of 3 months. Using this data, the frequency of spontaneous resolution of otitis media with effusion (glue ear) was calculated. Results: A total of 185 patients were included in the study. The male: female ratio was of 1.28: 1 with mean age of 7.71 ± 2.75years. The 6-9 years comprised 88(47.57%) & was the commonest age group involved by OME and it was in the same group where maximum percentage of spontaneous resolutions of disease occurred. Overall 148(80%) of children with glue ear achieved spontaneous resolution. Statistically this number has been highly significant (p=0.001). Conclusion: OME resolves spontaneously in a significant proportion of children in first 3 months of illness. A close follow up is recommended before embarking on surgery which is best reserved for persisting cases.

Compartive study between anterosuperior and anteroinferior insertion of tympanostomy tubes in treatment of otitis media with effusion

Background: Otitis media with effusion (OME) is the condition in which fluid was presented in the middle ear cavities with absence of signs or symptoms of acute infection. Most episodes of OME resolve within 3 months, without need for surgical intervention. The placement of tympanostomy tubes (TTs) is the treatment for persistent OME. Objective: This study is performed to compare between anterosuperior and anteroinferior insertion of tympanostomy tubes in treatment of otitis media with effusion. Methods: The study included 40 patients with bilateral OME (at least 3 months did not respond to medical treatment) , divided into two groups: Group (I) included 40 patients who had been undergone myringotomy and tympanostomy tubes insertion at antero-superior quadrant of one ear (Right ear). Group (II) included the same 40 patients who had been undergone myringotomy and tympanostomy tubes insertion at antero-inferior quadrant of other ear (left ear). All patients were exposed to complete history taking, ENT examination and audiological investigation (Tympanometry, Pure Tone Audiometry), follow up of cases by clinical and audiological investigations were performed at 1,2 and 6 months.

Predictors of Otitis Media with Effusion Recurrence Following Myringotomy.

Otitis media with effusion (OME) is the most common cause of acquired pediatric hearing loss. The treatment of persistent OME includes myringotomy with or without tube insertion, with a reported recurrence rate of 19.9-40%. This study aims to investigate the recurrence rate of OME and its predictors following myringotomy. A retrospective study that included 345 ears that underwent myringotomy for persistent OME in 179 pediatric patients during 2016-2018. Patients were followed for 36-48months post myringotomy procedure to detect the recurrence rate. The study sample was divided into two groups based on recurrence status, and the groups were compared using chi-square test and independent T-test. Significant variables (p-value ≤ 0.05) were included in the logistic regression model to determine the predictors of OME recurrence after myringotomy. OME recurrence was detected in 85 ears (24.64%). The OME recurrence rate is higher in patients who underwent myringotomy alone compared to myringotomy with tube insertion (44.1% vs. 22.8%). The insertion of a tympanostomy tube decreases the recurrence rate of OME by 59.9% (OR 0.401; 95% CI 0.162-0.933). The other socio-demographic and clinical characteristics such as age, siblings, daycare attendance, passive smoking, previous acute otitis media, atopy, and adenoidectomy did not significantly influence OME recurrence (p-value > 0.05). The recurrence rate of OME following myringotomy is high. Myringotomy with tube insertion significantly decreases the recurrence rate and the need for further surgeries compared to myringotomy alone. Adenoidectomy and the patient's age have no impact on the recurrence rate of OME.

Clinical Factors Associated With the Outcomes of Long-Term Middle Ear Ventilation Tube Insertion in Pediatric Patients.

Ventilation tube (VT) insertion is the most common treatment for otitis media with effusion (OME). However, OME recurrence and persistent tympanic membrane (TM) perforation after VT removal are encountered in a certain percentage of such children. This study was performed to determine the outcomes of children who underwent long-term VT insertion. A total of 326 ears from 192 patients were analyzed. The associations among the patient age, sex, history of OME, history of repeated acute otitis media, placement duration, whether the VT had been removed intentionally or spontaneously, and the outcome (persistent TM perforation or OME recurrence) were analyzed. The outcomes of multiple VT tube insertions were also reviewed. We also analyzed whether or not local or general anesthesia was associated with the early spontaneous extrusion of the VT. The OME recurrence and TM perforation rates were 29% (96/326 sides) and 17% (57/326 sides), respectively, for first insertions. In addition, 96 (29%) sides underwent ≥2 insertions. The shorter the duration for which the VT was retained in the middle ear, the more significant the rate of increase in OME recurrence. The OME recurrence was observed more often when VT was spontaneously removed than when intentionally removed. The rate of persistent TM perforation was significantly associated with male sex. Persistent TM perforation was not observed in patients who underwent 4 or 5 insertions. The anesthesia method did not significantly influence the timing of spontaneous extrusion of VT. The retention period of VT should be at least 2 years, and VT removal at the age of 7 might be a viable strategy. Multiple VT insertions are recommended for patients with recurrent OME. Ventilation tube under local anesthesia is an effective option for tolerable children.

Outcome of Gastroesophageal Reflux Therapy in Children with Persistent Otitis Media with Effusion.

Introduction Otitis media with effusion (OME) is considered one of the most common disorders that affect children during the first years of life. There are many risk factors of persistent middle ear effusion; one of these risk factors is gastroesophageal reflux. Association between persistent OME and gastroesophageal reflux diseases (GERDs) could be explained by respiratory tract infections, insufficient ciliary clearance, and poor drainage of the Eustachian tube. Objective To investigate whether the control of gastroesophageal reflux plays a role in the management of persistent OME and decreases tympanostomy tube insertion Method A cross-sectional study was conducted on 50 children complaining of persistent OME. Their ages ranged between 5 and 12 years old. All children were subjected to full history taking, audiological assessment and 24-hour esophageal pH monitoring. The study group was divided according to pH results into two groups: GERD positives and GERD negatives. Result The prevalence of GERD in persistent OME was 58%. There were statistically significant differences in the hearing levels and middle ear condition before and after the treatment ( p < 0.05). The percentage of improvement of children complaining of persistent OME after antireflux treatment was 52%. Conclusion Gastroesophageal reflux disease should be considered in patients with persistent OME. The administration of proton pump inhibitor (PPI) can set aside superfluous surgical treatment (such as tympanostomy).

ADENOID SIZE IN CHILDREN WITH OTITIS MEDIA WITH EFFUSION.

SUMMARYOtitis media with effusion (OME) is amongst the most common pediatric diseases and the most common cause of hearing loss in children. It is accepted that adenoid hypertrophy (AH) is related to OME incidence. Better understanding of the correlation between the relative size of AH and the incidence of persistent OME may provide evidence to support a more standardized approach to the diagnosis and treatment of OME. A retrospective study carried out between April 2016 and April 2018 collected data on 65 children aged 2-12 years, diagnosed with chronic OME and symptoms of AH, where conservative therapy failed. Pre-diagnostic data were collected from patient history, otoscopy, rhinoscopy, and oropharyngoscopy findings. Diagnostic workup included tympanometry, audiometry, and flexible nasal fiberoptic endoscopy. Adenoid grading was performed according to Cassano method after endoscopic visualization. Of the 65 patients, 37 were male and 28 were female. There was no statistically significant difference according to gender or average age. The highest incidence of persistent OME with AH was recorded in the youngest age groups (2-5 and 6-9 years). The most frequent AH grades were grade II (35.38%) and grade III (50.77%), yielding a statistically significant result. The most common presenting symptoms were hearing impairment, snoring, and nasal obstruction (100%, 64.62% and 60%, respectively). Higher AH grades are critical for persistence of OME and may cause conservative therapy failure.

Serum Interleukin-6 level a risk factor in pathogenesis of otitis media with effusion in children?

Objective: The aim of the study was to detect the serum level of cytokine interleukin-6 (IL-6) in children with persistent Otitis media with effusion (OME). Patients and methods: 50 children with OME divided into 3 groups, a group I consisted of 30 children who had persistent otitis media with effusion and did not improve by medical and surgical treatment. The age range of 5.8 ± 3. 4 years. Group (II) consisted of 20 children who had two or fewer OME episodes per year and improved by medical treatment and did not have a history of tubes insertion. The age range 6.3± 2.9 years. Group III consisted of 52 normal patients with similar age and sex as a control group. Results: There was no significant difference between group I and group II. There was a significance difference between each group and normal patients. Conclusion: The result of the present study suggesting that pro-inflammatory cytokine level Il-6 (IL-6) is significantly increased with persistent OME in children in comparison with normal patients.

The effect of ventilation tube insertion on quality of life in children with persistent otitis media with effusion.

To determine the effect of ventilation tube (VT) surgery on quality of life (QoL) in children with persistent otitis media with effusion (OME). Secondary analysis of trial data (oral steroids versus placebo for persistent OME), comparing QoL by history of VT surgery performed between 5weeks and 12months post-randomisation. Multilevel regression models were used to identify the association between VT surgery and QoL scores at 12months, controlling for pre-exposure risk factors associated with surgery, including pre-surgery hearing level. Ear, nose and throat (ENT), paediatric audiology and audiovestibular medicine (AVM) departments in Wales and England. A total of 327 children aged 2-8years with OME symptoms for at least three months and audiometry-proven bilateral hearing loss with VT surgery status. Otitis Media questionnaire (OM8-30) and Paediatric Quality of Life Inventory (PedsQL) total and subscale scores, and the Health Utilities Index Mark 3 (HUI3) at 12months post-randomisation. Participants who had VT surgery had no significant difference in OM8-30, PedsQL or HUI total scores. OM8-30 hearing difficulty (HD) subscale scores at 12months were better in those who had VT surgery (adjusted mean difference (aMD)=-0.46 (95% confidence interval: -0.69 to -0.23), P<.001), and this varied by when the surgery occurred (aMD for surgery between 5weeks and 6months=-0.4 [-0.67 to -0.13], P=.004 and between 6 and 12months=-0.54, [-0.87 to -0.22], P=.001). Ventilation tube surgery was associated with an improvement in HD-related functional health status but no change in overall QoL.

Oral steroids for hearing loss associated with otitis media with effusion in children aged 2–8 years: the OSTRICH RCT

Children with hearing loss associated with otitis media with effusion (OME) are commonly managed through surgical intervention, hearing aids or watchful waiting. A safe, inexpensive, effective medical treatment would enhance treatment options. Small, poorly conducted trials have found a short-term benefit from oral steroids. To determine the clinical effectiveness and cost-effectiveness of a 7-day course of oral steroids in improving hearing at 5 weeks in children with persistent OME symptoms and current bilateral OME and hearing loss demonstrated by audiometry. Double-blind, individually randomised, placebo-controlled trial. Ear, nose and throat outpatient or paediatric audiology and audiovestibular medicine clinics in Wales and England. Children aged 2-8 years, with symptoms of hearing loss attributable to OME for at least 3 months, a diagnosis of bilateral OME made on the day of recruitment and audiometry-confirmed hearing loss. A 7-day course of oral soluble prednisolone, as a single daily dose of 20 mg for children aged 2-5 years or 30 mg for 6- to 8-year-olds, or matched placebo. Acceptable hearing at 5 weeks from randomisation. Secondary outcomes comprised acceptable hearing at 6 and 12 months, tympanometry, otoscopic findings, health-care consultations related to OME and other resource use, proportion of children who had ventilation tube (grommet) surgery at 6 and 12 months, adverse effects, symptoms, functional health status, health-related quality of life, short- and longer-term cost-effectiveness. A total of 389 children were randomised. Satisfactory hearing at 5 weeks was achieved by 39.9% and 32.8% in the oral steroid and placebo groups, respectively (absolute difference of 7.1%, 95% confidence interval -2.8% to 16.8%; number needed to treat = 14). This difference was not statistically significant. The secondary outcomes were consistent with the picture of a small or no benefit, and we found no subgroups that achieved a meaningful benefit from oral steroids. The economic analysis showed that treatment with oral steroids was more expensive and accrued fewer quality-adjusted life-years than treatment as usual. However, the differences were small and not statistically significant, and the sensitivity analyses demonstrated large variation in the results. OME in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. Discussions about watchful waiting and other interventions will be enhanced by this evidence. The findings of this study suggest that any benefit from a short course of oral steroids for OME is likely to be small and of questionable clinical significance, and that the treatment is unlikely to be cost-effective and, therefore, their use cannot be recommended. Studies exploring optimal approaches to sharing natural history data and enhancing shared decision-making are needed for this condition. Current Controlled Trials ISRCTN49798431 and EudraCT 2012-005123-32. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 61. See the NIHR Journals Library website for further project information.

Influence of infancy care strategy on hearing in children and adolescents: A longitudinal study of children with unilateral lip and /or cleft palate

ObjectivesTo evaluate the relation between ventilation tube insertion, otitis media with effusion duration and otologic outcomes in unilateral cleft lip and/or cleft palate children from infancy to teenage age. Design and populationRetrospective longitudinal charts review of patients from the multidisciplinary cleft team of the University Hospital of Lausanne over a 30-year period. 146 charts from consecutive patients with non-syndromic unilateral cleft lip and/or cleft palate who were born between January 1986 and January 2003 were included. ResultsThe earlier in life a cleft child experience his first otitis media with effusion (OME), the worse his long-term hearing will be. Along with the age of onset of OME, we disclosed an influence of the duration of OME without ventilation tube (VT) insertion on short and long-term hearing outcomes. Different patterns were observed between cleft palate (CP) and cleft lip palate children (CLP), with a higher incidence of otitis media with effusion for the CLP group than the CP group. Direct positive relationship between VT insertion and hearing were disclosed and evaluation of long-term complications did not reveal significant relation with VT insertion. Of note, OME in CLP children led to a higher rate (but not statistically significant) of chronic ear complications than in the CP group, that may indicate more persistent OME or different adverse effect on the middle ear mucosa between CP and CLP children. ConclusionsIndividualized counseling should take into account different factors such as the type of cleft, the age of onset of OME and duration of OME, keeping in mind the adverse effect of persistent middle ear fluid. In the present report, results prone an early ventilation tube insertion to prevent short and long-term injury to the middle ear homeostasis, hearing loss and related issues.

Risk factors for persistent otitis media with effusion in children: a case-control study.

BackgroundOtitis media with effusion (OME) is defined as middle ear effusion without acute signs of infection. OME usually resolves spontaneously; however, persistent OME may require the insertion of a ventilation tube. This study investigated risk factors for persistent OME in children who undergo ventilation tube insertion.MethodsChildren who were admitted to undergo ventilation tube insertion at Jeju National University Hospital between August 2015 and July 2016 were enrolled as the case group. Healthy children without persistent OME from August 2016 to July 2017 were enrolled as the control group. Baseline characteristics and predisposing factor data were collected using an interview questionnaire. Middle ear fluids were collected from the case group.ResultsA total of 31 patients underwent ventilation tube insertion. The mean age of the case group was 4.53 years, with a male-to-female ratio of 21:10. Twenty-nine (93.5%) children attended a daycare center, and 21 (67.7%) had experience with bottle feeding. Fifteen (48.4%) children in the case group and 3 (9.7%) in the control group first attended a daycare center at <1 year of age (odds ratio=9.96; 95% confidence interval=2.44-39.70; p=0.001). No bacteria were found in middle ear fluid collected from the 31 operated children. Nasopharyngeal bacterial colonization was found in 13 (41.9%) and 17 (54.8%) children in the case and control groups, respectively.ConclusionEarlier attendance at a daycare center was the only predisposing factor for ventilation tube insertion in our study. The aseptic nature of middle ear fluids found in children with OME highlights the efficacy of antimicrobial use.

Otologic Outcomes With Two Different Surgical Protocols in Patients With a Cleft Palate: A Retrospective Study.

To compare otologic outcomes in patients with cleft palate who underwent 2 different surgical protocols. Monocentric retrospective analysis of medical reports. All consecutively treated patients affected by a cleft palate, born between January 1998 and December 2002 (group 1) and between January 2007 and December 2010 (group 2). Patients in group 1 underwent Veau-Wardill-Kilner palatoplasty at 10 months and had ventilation tubes inserted in case of otitis media with effusion (OME) during surgery. Patients in group 2 underwent Sommerlad intravelar veloplasty at 5 months. Ventilation tubes were inserted only in case of persistent OME. The need for a second set of ventilation tubes to be inserted in case of persistent OME, the presence of OME at the age of 2 years, and tympanic abnormalities at the age of 5 years were analyzed. There was no statistically significant difference either for the presence of OME at the age of 2 years (27 [45%] vs 32 [57.14%], respectively, in groups 1 and 2; P = .191) or for tympanic abnormalities at the age of 5 years (20 [33.33%] vs 15 [26.79%]; P = .433). Statistically significant difference was found for the need to insert a second set of ventilation tubes in case of persistent OME (29 [48.33%] vs 12 [21.42%], respectively; P = .02). Early Sommerlad intravelar veloplasty may reduce persistent OME and consequently the need for ventilation tubes insertion, compared to later Veau-Wardill-Kilner palatoplasty.

Resolution of Otitis Media With Effusion in Children With Cleft Palate Followed Through Five Years of Age.

To describe the temporal pattern of otitis media with effusion (OME) resolution for a cohort of nonsyndromic cleft palate children enrolled before palatoplasty and followed through 5 years of age. This is a prospective, longitudinal study of the time course for OME resolution in infants and children with palatal clefts. Cleft Palate Craniofacial Center of a tertiary care pediatric hospital. This study included 52 children with cleft palate (29 boys, 45 white, Veau 1 through 4) who had a Furlow-type palatoplasty between 10 and 24 months of age performed by one of six surgeons. Standard cleft palate management was supplemented with study visits to the research clinic pre- and postpalatoplasty and then yearly to 6 years of age for assessments of middle ear status by interval history, otoscopy, and tympanometry. The main outcome measure was age at otitis media resolution defined as the age in years at the first in a sequence of "disease-free" diagnoses not interrupted or followed by any other diagnosis. The cumulative percent OME resolution for ears/children at ages <1, 1, 2, 3, 4, 5 years was 4.1/4.4, 14.3/10.9, 31.6/21.7, 45.9/37.0, 56.1/50.0, and 70.4/60.9%. OME resolution followed a simple linear time curve with slopes of 13.5% (confidence interval [CI] = 12.2% to 14.8%, r(2) = .99) and 11.9% (CI = 10.1% to 13.6%, r(2) = .99) resolutions per year for ears and children, respectively. There is a natural, age-related pattern of resolution for persistent OME that affects most infants and young children with cleft palate that is not affected by palatoplasty.

Does the EarPopper(®) device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial.

To provide an independent evaluation of the efficacy and safety of the EarPopper(®) in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Randomised single-blinded controlled trial. The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park). Twenty-nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer-generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post-treatment audiogram. After the seven-week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P < 0.001) and 3.6 dBHL in the control group (P = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper(®) was over 90%, the only side-effect reported being discomfort in the ears immediately after use which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3% in the treatment group and 78.6% in the control group. Median follow-up time for all patients is 47.7 months. Our study shows that the EarPopper(®) is a safe, effective treatment option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion. More studies with larger sample sizes are required to support our findings.

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation.

Cleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate. To identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies. The management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP. The survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients' homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting. Clinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association. The clinician survey revealed that care was predominantly delivered via a 'hub-and-spoke' model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research. There exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered. The National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

Timing for Removal of Asymptomatic Long-Term Ventilation Tube in Children.

Otitis media with effusion (OME) is the most frequent illness in children. Surgical treatment options include ventilation tube insertion, adenoidectomy or both. Opinions regarding the risks, benefits and intubation period of ventilation tube insertion vary greatly. To determine the appropriate time for when to remove asymptomatic longterm ventilation T-tubes in children. In this prospective study, we analyzed the results of 120 pediatric patients (6-12years) (240 ears) with persistent OME; we employed the Goode T-silicone tubes. We intentionally planned to remove the tubes at different time points of the study and divided our patients randomly into four subgroups with 30 patents (60 ears in each) according to the intubation period; group I: intubation for 6months, group II: intubation for 12months, group III: intubation for 18months and group IV: intubation for 24months. The relationship between intubation period and OME recurrence, the rate of persistent tympanic membrane (TM) perforation, granulation tissue or discharge near the tympanostomy tubes, normalization of Eustachian tube function and change of hearing level was analyzed in each patient group. The χ2 analysis showed that the rate of normalization of ET function was significantly higher when tubes were removed after 12-months of intubation (P=0.002), the rate of OME recurrence was significantly higher when tubes were removed before 12-months of intubation (P=0.004), The rate of otorrhea significantly increased after 12-months of intubation, development of granulation around tubes was significantly higher after 18-months of tube insertion. The rate of appearance of permanent TM perforation significantly increased after 18-months from tube insertion (P=0.008). Adenoidectomy did not significantly influence the recurrence rate of OME or the rate of persistent TM peroration after tube removal. Our present results suggest that the appropriate intubation period for healing OME in children would be at 12-18months. Also, we can conclude that longterm ventilation tubes are recommended to avoid repeated intubation and to obtain sufficient results, although their performance is not always satisfactory; mainly because of accompanying complications.