Tympanostomy Tubes: Are They Necessary? A Systematic Review on Implementation in Cleft Care.

OBJECTIVE: To understand the indication for and the effects of early ventilation tube insertion (VTI) on hearing and speech for patients with cleft lip and/or palate (CLP). DESIGN: We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-guided systematic review of relevant literature. SETTING: Setting varied by geographical location and level of clinical care across studies. PATIENTS, PARTICIPANTS: Patients with CLP who underwent VTI were included. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURE(S): Primary outcome measures were hearing and speech following VTI. Secondary outcome measures were tube-related and middle ear complications. Early VTI occurred before or at time of palatoplasty while late VTI occurred after palatoplasty. RESULTS: Twenty-three articles met inclusion criteria. Articles varied among study design, outcome measures, sample size, follow-up, and quality. Few studies demonstrated support for early VTI. Many studies reported no difference in hearing or speech between early and late VTI. Others reported worse outcomes, greater likelihood of complications, or needing repeat VTI following early tympanostomy placement. Several studies had significant limitations, including confounding variables, small sample size, or not reporting on our primary outcome. CONCLUSIONS: No consistency was found regarding which patients would benefit most from early VTI. Given the aforementioned variability and sub-optimal methodologies, additional studies are warranted to provide stronger evidence regarding VTI timing in cleft care.

Parental fatigue before and after ventilation tube insertion in their children.

OBJECTIVE: To determine if there is a difference in fatigue for caregivers of children with otitis media pre and post ventilation tube insertion (VTI). METHODS: Consecutive parents presenting with children at a pediatric otolaryngology practice at an academic medical center with recurrent otitis media who met criteria for VTI or who were following up within 6 weeks of VTI were surveyed with the Chalder Fatigue Scale (CFQ), a Visual Analogue Fatigue Scale (VAS-F), and demographic questions. RESULTS: No significant demographic differences were found (P < 0.05) in the preop versus postop groups. 101 parents participated, 88 mothers and 13 fathers. 59.4% were married or cohabitating, 18.8% were single, 10.9% were divorced, and 10.9% declined to answer. 45.5% were aged 18-29 years, 50.1% were 30-39 years, 2.9% were 40+ years, 1.0% declined to answer. 53.0% were college graduates. 46 (45.5%) were preop and 55 (54.5%) were postop. There were no statistical differences between these groups for age, gender, marital status, education level or number or children in the household. Mean VAS-F, with 0 being worst fatigue and 10 being normal, was 5.256 in the preop group and 6.777 in the postop group (p < 0.001). Mean CFQ, with higher numbers meaning worse fatigue, was 15.749 in the preop group and 11.804 in the postop group (p = 0.002). CONCLUSION: Parental fatigue can have significant effects on the family. Fatigue in parents whose children have otitis media has not been previously described. VTI for recurrent otitis media in children is associated with improved fatigue in their parents.

Surveillance of Otitis Media With Effusion in Thai Children With Cleft Palate: Cumulative Incidence and Outcome of the Management.

OBJECTIVE: To study the incidence and outcome of management of otitis media with effusion in Thai children with cleft palate. DESIGN: Retrospective cohort study in the tertiary care center. PATIENTS: Ninety-five children with cleft palate were referred for ear evaluation, from June 1997 to January 2015. Fifteen children (15.8%) had associated craniofacial syndromic anomalies. MAIN OUTCOME MEASURES: Cumulative incidence of otitis media with effusion, rate of ventilation tube insertion, duration of indwelling tubes, hearing outcome, and complications of ventilation tubes. RESULTS: Ear examinations were done every 8 to 12 weeks throughout the study. Cumulative incidence of otitis media with effusion was 53.7% in children within 12 months of age and 81.1% within 24 months of age. At the end of the study, all of the patients had at least 1 episode of otitis media with effusion. Eighty-eight children (92.6%) had palatoplasty, and there was no significant difference in the incidence of otitis media before and after palatoplasty. The mean hearing level at recruitment was 40.8 ±18.4 dB. Ventilation tube insertion was done in 76 patients (80%). The median time for indwelling tubes was 11.7 months. Rate of ventilation tube insertion was 0.5/year. The mean hearing level at last follow-up was 23.5 ± 14 dB. Otorrhea through tube was found in 24 cases (31.6%). CONCLUSION: Otitis media with effusion was common in Thai children with cleft palate. Surveillance of middle ear effusion and ventilation tube insertion contributed to a favorable hearing outcome.

The effect of ventilation tube insertion to the health-related quality of life in a group of children in Southeast Anatolia.

OBJECTIVE: To demonstrate the influence of ventilation tube insertion to the quality of life in a group of children in Southeast Anatolia by Otitis Media 6-item (OM6) questionnaire. DESIGN: Patients who underwent ventilation tube insertion due to otitis media with effusion (OME) at Otorhinolaryngology Department of Gaziantep University between December 2016 and April 2017 were enrolled in this prospective study. All patients were evaluated with the OM-6 survey before operation and 6 weeks after surgery. RESULTS: The mean age of 45 patients out of 50 accounted for 67.64 ± 42.89 months with 27 (60%) males and 18 (40%) females. The numbers of preoperative and postoperative overall OM6 scores represented a significant improvement with 4.34 and 2.16, respectively. Moreover, each domain of OM6 (physical suffering, hearing loss, speech impairment, emotional distress, activity limitations and caregiver concerns) showed statistically significant difference. CONCLUSION: Ventilation tube insertion procedure provided a significant improvement in a group of children in Southeast Anatolia suffering from chronic OME in terms of Quality of Life (QOL) assessed by OM6. We believe that OM6 is a useful tool for evaluating the patients' health-related quality of life and for providing additional information to the caregivers' or families' enquiries regarding the consequences of surgical intervention.

Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trial.

BACKGROUND: One third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured. METHODS: This was a phase 1B double-blinded randomized control trial conducted in Western Australia. Children between 6 months and 5 years undergoing VTI for bilateral middle ear effusion were recruited between 2012 and 2014 and followed for two years. Children's ears were randomized to receive either Dornase alfa (1 mg/mL) or 0.9 % sodium chloride (placebo) at time of surgery. Children were followed up at 2 weeks post-VTI and at 3-monthly intervals for 2 years. Outcomes assessed were: 1) safety and tolerability, 2) otorrhoea frequency, 3) blocked or extruded ventilation tube (VT) frequency, 4) time to blockage or extrusion, 5) time to infection recurrence and/or need for repeat VTI. RESULTS: Sixty children (mean age 2.3 years) were enrolled with 87 % reaching study endpoint. Treatment did not change otorrhoea frequency. Hearing improved in all children following VTI, with no indication of ototoxicity. Dornase alfa had some effect on increasing time until VT extrusion (p = 0.099); and blockage and/or extrusion (p = 0.122). Frequency of recurrence and time until recurrence were similar. Fourteen children required repeat VTI within the follow-up period. CONCLUSION: A single application of Dornase alfa into the middle ear at time of VTI was safe, non-ototoxic, and well-tolerated. TRIAL REGISTRATION: ACTRN12623000504617.

Gathering validity evidence for a 3D-printed simulator for training of myringotomy and ventilation tube insertion.

Objectives: This study aimed to gather validity evidence according to Messick's framework for a novel 3D-printed simulator for myringotomy with ventilation tube insertion for use in technical skills training of otorhinolaryngology (ORL) residents. Methods: The study included 15 junior ORL residents (trainees) and 13 experienced teaching otolaryngologists (experts). Experts and trainees first received an identically structured introduction to the procedure, simulator, and simulation setup. Five procedures performed by each participant were video-recorded and ordered randomly for blinded rating by two independent raters. The rating tools used were a global rating scale (GBRS) and a task-specific checklist. Validity evidence was collected according to Messick's framework. Differences in time consumption and performance scores were analyzed. Finally, a pass/fail standard was established using the contrasting groups' method. Results: Trainees used significantly more time per procedure (109 s, 95% CI: 99-120) than experts (82 s, 95% CI: 71-93; p < .001). Adjusted for repetition and rater leniency, experts achieved an average GBRS score of 18.8 (95% CI: 18.3-19.2) out of 20 points, whereas trainees achieved an average of 17.1 points (95% CI: 16.6-17.5; p < .001). In contrast to the task-specific checklist, the GBRS score discriminated between repetition number and participant experience. The pass/fail standard for the GBRS was established at 18.4 points. Conclusion: We established educational validity evidence for a novel 3D-printed model for simulation-based training of ventilation tube insertion and established a reliable pass/fail standard. Level of Evidence: 1b.

The association between otitis media in early childhood with later behaviour and attention problems: A longitudinal pregnancy cohort.

OBJECTIVES: The present study aims to investigate the association between an early history of recurrent otitis media (OM) with or without ventilation tube insertion (VTI) and later behavioural problems in childhood and adolescence. METHODS: Parental reports in a longitudinal pregnancy cohort were used to classify children into three groups; recurrent OM without VTI (rOM group; n = 276), recurrent OM with VTI (VTI group; n = 62), and no history of early-life recurrent OM as a reference group (n = 1485). The Child Behaviour Checklist (CBCL) was administered at ages 5, 8, 10, and 13 years and data were analysed for psychological wellbeing. Mixed-effects regression modelling was used to investigate the associations between a history of rOM and CBCL T-scores across all ages for rOM and VTI groups compared to the reference group. All analyses were controlled for a wide range of confounding variables. RESULTS: The analyses revealed a significant association between recurrent OM and behavioural problems. While there was a general decline in scores (i.e. improvement) observed over the duration of the follow-up period, children in the rOM group displayed significantly higher scores for internalising and externalising behaviours at ages five, eight and 10 years. Attention scores were significantly higher across all ages in the rOM group. A transient increase in internalising behaviour was observed in the VTI group at ages eight and 10 years. Logistic regression models showed an increased overall likelihood for the rOM group only to fall within the abnormal clinical range for internalising and externalising behaviours. CONCLUSION: Early-life recurrent OM with and without VTI was associated with increased behavioural and attention problems in early and late childhood. This suggests that recurrent OM can have a significant impact on children's behaviour and attention that can persist into early adolescence.

Balloon Dilation Eustachian Tuboplasty for Dilatory Dysfunction With and Without Effusion: A Comprehensive Outcome Analysis.

OBJECTIVE: This study aimed (1) to demonstrate the efficacy of balloon dilation Eustachian tuboplasty (BDET) for dilatory Eustachian tube dysfunction (ETD) and (2) to determine whether adjunctive ventilation tube insertion (VTI) is superior to myringotomy in relieving symptoms for patients with ETD and concurrent middle ear effusion (MEE) treated with BDET. STUDY DESIGN: A retrospective cohort study. SETTING: Tertiary care academic center. METHODS: Patients with dilatory ETD undergoing BDET with a ≥6-month follow-up period were enrolled and evaluated mainly using Eustachian tube function (ETF) tests and Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7). Participants with concurrent MEE were further classified into 2 subgroups, BDET with VTI and BDET with myringotomy. An intergroup comparison and comprehensive outcome evaluation were performed. RESULTS: In total, 35 patients with 50 symptomatic ears were enrolled. According to ETF test results, the normalized ETF rate was 94% on the last visit. The mean ETDQ-7 scores decreased significantly from 3.7 ± 1.4 to 2.0 ± 0.9 after interventions, with the most improvement in symptoms occurring for "ear fullness" and "muffled hearing." For the final visit, strong correlations among ETF tests, tympanometry, and Valsalva results were noted. The aforementioned assessment results did not significantly differ between (1) the patients with MEE and patients without MEE and (2) "BDET with VTI" subgroup and "BDET with myringotomy" subgroup. CONCLUSION: BDET was effective for dilatory ETD, even in cases with concurrent MEE. For patients with ETD and MEE, further research is required to evaluate the benefits of adjunctive myringotomy with or without VTI.

Transmyringeal ventilation tube insertion for unilateral Menière's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial.

BACKGROUND: Menière's disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, the patient is usually severely incapacitated. Currently, there is no consensus on the treatment of Menière's disease. The evidence regarding most treatment options is sparse due to a lack of randomized trials together with an often-spontaneous relief over time and a considerable placebo effect. Insertion of a transmyringeal tube is a simple and relatively safe, minimally invasive procedure and previous open-label trials have shown promising results. STUDY DESIGN: This is a prospective, sham-controlled, double-blinded, randomized, clinical trial. AIM: This trial aims to assess the effects of inserting a ventilation tube into the tympanic membrane compared with sham treatment for definite or probable unilateral Menière's disease according to the criteria formulated by the Classification Committee of the Bàràny Society. OUTCOMES: The primary outcome will be the number of spontaneous vertigo attacks lasting more than 20 min and time to treatment failure. In addition to the primary outcome, we will assess various secondary outcomes related to hearing, ear fullness, dizziness, and serious adverse events. SAMPLE SIZE: An estimated 104 participants in total or 52 participants in each group will be necessary. The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025. TRIAL STATUS: ClinicalTrials.gov : NCT04835688 . Registered on April 8, 2021. PROTOCOL VERSION: 1.8, 26-09-2022. Date of first enrollment: October 1st, 2021. End of study: anticipated January 2025.

Efficacy of Ventilation Tube Insertion with Palatal Repair for Otitis Media in Cleft Palate: Meta-Analysis and Trial Sequential Analysis.

Cleft palate is the most common congenital facial deformity and may result in multiple sequelae and disabilities. One common comorbidity is refractory otitis media with effusion (OME), as patients with cleft palate have impaired eustachian tube function with alteration of the nearby muscular structures. Ventilation tube insertion (VTI) is regarded as an effective mean to address OME in addition to palatal repair surgery. However, controversy regarding the efficacy of VTI and the timing of VTI remains. We aimed to assess the efficacy of VTI with palatal repair for cleft palate on OME development via a meta-analysis with systematic review and trial sequential analysis (TSA). Studies including patients with cleft palate who underwent palatal repair with or without VTI were considered eligible. After searching the Cochrane Library, PubMed, EMBASE, Web of Science, Scopus and China National Knowledge Infrastructure (CNKI) from inception through 5 September 2021, 9 studies involving 929 patients were included. Overall, a significantly higher OME-free rate was noted in those who underwent VTI and palatal repair than in those who underwent palatal repair alone (OR, 2.73; 95% CI, 1.37 to 5.42; p = 0.004; I2 = 84%). Subgroup analysis revealed that the OME-free rate remained higher in the concurrent VTI group (OR, 3.29; 95% CI, 1.64 to 6.59; p < 0.001; I2 = 81%). TSA indicated that all the analyses provided conclusive results by meeting the required information size and Z-value. The meta-analysis indicated that VTI is an effective procedure to prevent OME in patients with cleft palate and that VTI is beneficial when performed concurrently with palatal repair surgery.

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.

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence.

Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence. Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19-1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

Blood clots affect the response of tympanic membrane perforations to gelfoam grafting after ventilation tube insertion.

Chronic tympanic membrane (TM) perforation associated with ventilation tube (VT) insertion was commonly encountered in pediatric patients with chronic otitis media with effusion (COME) treatment and eustachian tube dysfunction. The persistent perforation require surgical closure by myringoplasty. Song JS et al. recently a paper entitled: "Evaluating short and long term outcomes following pediatric myringoplasty with gelfoam graft for tympanic membrane perforation following ventilation tube insertion." In their study, the authors performed gelfoam myringoplasty to repair the perforations following VT insertion in children and compare the successful TM closure rate among different graft materials. The authors believed that gelfoam alone was superior to hyaluronic acid (HA), tragal cartilage (TC), and gelfoam-plus-temporal fascia (TF). The sample size is unbalanced and incommensurable between gelfoam and other graft materials. In addition, a confounding factor was added in the gelfoam group, thereby affected the assessment of TM closure. Thus, the conclusion is not rigorous and scientific.

Effects of early childhood otitis media and ventilation tubes on psychosocial wellbeing - A prospective cohort study within the Danish National Birth Cohort.

BACKGROUND: Otitis Media (OM) is one of the most common infections among children in developed countries and may result in temporary conductive hearing loss (HL) if accompanied by middle ear effusion (MEE). Ventilation tube insertion (VTI) is recommended as treatment for recurrent acute OM or chronic MEE with HL. HL may lead to impaired development of psychosocial skills. However, evidence for the developmental consequences of OM and the effect of VTI is inconsistent. The objectives of this study were to investigate 1) whether OM in early childhood is associated with long-term consequences of psychosocial development and 2) if VTI prevents the possible negative consequences of OM. METHODS: This study examined prospectively collected data from 52.877 children registered in the Danish National Birth Cohort (DNBC). Information about previous OM-episodes and VTI was obtained through systematic follow-up interviews at seven years, and The Strength and Difficulties Questionnaire (SDQ) containing questions about psychological wellbeing was completed. Five groups were defined based on OM-exposure and the presence of VTI. Baseline characteristics were analysed, and comparison of mean SDQ-scores for the five exposure groups was conducted. Means were adjusted for à priori defined confounding factors. RESULTS: Data from 52,877 children in the DNBC showed an association between OM and poorer SDQ-scores. VTI was associated with an additional increase, i.e. worsening, of the SDQ-score for boys, and only a slight beneficial effect on the girls' outcome. The groups differed in their baseline characteristics in e.g. maternal education, socio-economic status, breastfeeding, and prematurity. CONCLUSION: Significant associations between parent-reported OM in early childhood and later psychosocial health difficulties were found. VTI did not resolve this association.

[Clinical analysis of tympanoplasty combined with ventilation tube insertion in otitis media].

Objective:The aim of this study is to explore the feasibility and clinical effect of tympanoplasty combined with ventilation tube insertion in otitis media.Method: Retrospective analysis of 35 patients with eustachian tube obstruction or tympanic adhesions for tympanoplasty combined with ventil ation tube insertion in otitis media in EENT Hospital of Fudan University from April 2008 to December 2010. Preoperative routine hearing tests and temporal bone CT examination. Completely remove of lesions at the same time and as much as possible to protect the integrity of the tympanic wall mucosa during operation. Reconstruction of the ossicular chain and simultaneous tympanic membrane hole and placed silicone T-type ventilation tube. All patients were tested for pure tone auditory threshold at 3 months after operation. The patients were followed up for 12 to 44 months.Result:The average hearing level of PTA (0.5,1.0,2.0 kHz) was (31.71±12.25) dBHL. 28 cases (80.0%) had improved to 40 dBHL after operation, 5 cases (14.3%) had hearing enhancement of 10-20 dBHL, and 2 patients (5.7%) had no change in hearing. The number of cases with air bone gap (ABG)(0.5, 1.0, 2.0 kHz) reduced to less than 20 dBHL was 25, 32 and 34 after operation. Ventilation tube self-prolapse in15 cases, 12 cases of artificial removal and 8 cases of inpatient. Twenty seven cases were left perforation of tympanic membrane, of which 22 cases (81.5%) were spontaneously healed and 5 cases(18.5%) were left with small perforations less than 2 mm in diameter. All of them had dry ear after operation, none of them had recurrence after operation, 33 cases (94.3%) had dry ear within 12 weeks, and only 2 cases(5.7%) had dry ear for more than 6 months.Conclusion: Tympanoplasty combined with ventilation tube insertion for the middle ear mucosal dysfunction and eustachian tube mucosal dysfunction of otitis media treatment effect is obvious. It does not extend the dry ear time and cause postoperative recurrence. This operation is feasible, reliable and effective.

A nationwide study on the impact of pneumococcal conjugate vaccination on antibiotic use and ventilation tube insertion in Denmark 2000-2014.

Introduction of Pneumococcal Conjugated Vaccines (PCV) in national immunization programs have been successful in reducing the number of invasive and lower respiratory pneumococcal infections. The impact of the vaccines on upper respiratory infections caused by pneumococci is less clear although these account for most pneumococcal infections. In this study, we used likely proxies for respiratory infections in children, such as antibiotic use and ventilation tube insertions (VTI), to estimate the impact of the vaccine on a national level. The study was designed as a population-based retrospective observational study, comparing trends in the incidence rate of antibiotic prescriptions and VTIs in the period 2000-2014, where PCV7 was introduced in 2007 and PCV13 in 2010. The introduction of PCV7 and PCV13 correlated with changes in the incidence rate from an almost steady increase in prescription of antibiotics in the pre-PCV period to a decreasing incidence for all children age 0-15years. The 2.4 DDD per person year in 2014 was at almost the same level of antibiotic use as in 2000 at 2.3 DDD per person year. Similar patterns were observed in the mostly vaccinated age groups below 5years of age. For VTI we observed a decreasing incidence rate in the years following introduction of PCV13 ending with a slightly higher incidence at 35 per 1000 person years in 2014 compared to 31 in year 2000. We conclude that the steady increase in antibiotic use and VTI in the pre-PCV period have been partially reversed to near year 2000 levels after the introduction of PCV. This indicates that implementation of pneumococcal vaccines in the Childhood Vaccination Programme has likely reduced the incidence of upper respiratory diseases due to pneumococci in Denmark.

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Abstract Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence. Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19-1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

Palatoplasty decreases the re-insertion rate of middle ear ventilation tube in cleft palate children - A population-based birth cohort study.

CONCLUSION: Palatoplasty can significantly decrease their middle ear re-intubation rate with a relatively lower hazard ratio compared to children who underwent VTI only. OBJECTIVES: In children with cleft palate, questions remain about the overall effect of ventilation tube insertion (VTI) and palatoplasty for their OME. A large-scale study might offer more evidence for the roles of palatal surgery. SUBJECTS AND METHODS: This was a retrospective birth cohort study based upon a national database. We analyzed children born between 1999-2004 and diagnosed as cleft palate and/or lips. These children, according to their surgeries, were separated into two groups: (1) VTI only, and (2) VTI and palatoplasty. Kaplan-Meier analysis and log-rank test were used to calculate their cumulative tube re-insertion rates. Their hazard ratios of tube re-insertion were also analyzed. RESULTS: In total, 1205 cleft children were collected, with 151 in the VTI only group and 1054 in the VTI + palatoplasty group. Ventilation tube re-insertion rates were significantly lower in the VTI + palatoplasty group (p = 0.002). The cumulative re-insertion rates also showed a significant difference (p = 0.001). When compared to the VTI only group, the adjusted hazard ratio was 0.528 in the VTI + palatoplasty group (p = 0.001).