Dataset Information

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.

ABSTRACT: 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.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.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.ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.

SUBMITTER: Demant MN

PROVIDER: S-EPMC5248475 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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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.

Demant Malene Nøhr MN Jensen Ramon Gordon RG Jakobsen Janus Christian JC Gluud Christian C Homøe Preben P

Trials 20170119 1

<h4>Background</h4>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.<h4>Methods</h4>The trial is an investigator-initiated, multicentre, random ...[more]

PMID: 28103950

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Project description:BackgroundThe surgical insertion of Ventilation Tubes (VTs) for the management of persistent bilateral Otitis Media with Effusion (OME) in children remains a contentious issue due to the varying opinions regarding the risks and benefits of this procedure. The aim of this study was to evaluate the economic impact of VTs insertion for the management of persistent bilateral OME in children, providing an additional perspective on the management of one of the commonest medical conditions of childhood.MethodsA decision-tree model was constructed to assess the cost-effectiveness of VTs strategy compared with the Hearing Aids (HAs) alone and HAs plus VTs strategies. The model used data from published sources, and assumed a 2-year time horizon and UK NHS perspective for costs. Outcomes were computed as Quality-Adjusted Life-Years (QALYs) by attaching a utility value to the total potential gains in Hearing Level in decibels (dBHL) over 12 and 24 months. Modelling uncertainty in the specification of decision-tree probabilities and QALYs was performed through Monte Carlo simulation. Expected Value of Perfect Information (EVPI) and partial EVPI (EVPPI) analyses were conducted to estimate the potential value of future research and uncertainty associated with the key parameters.ResultsThe VTs strategy was more effective and less costly when compared with the HAs plus VTs strategy, while the incremental cost-effectiveness ratio for the VTs strategy compared with the HAs strategy was £ 5,086 per QALY gained. At the willingness-to-pay threshold of £ 20,000 per QALY, the probability that the VTs strategy is likely to be more cost-effective was 0.58. The EVPI value at population level of around £ 9.5 million at the willingness-to-pay threshold of £ 20,000 indicated that future research in this area is potentially worthwhile, while the EVPPI analysis indicated considerable uncertainty surrounding the parameters used for computing the QALYs for which more precise estimates would be most valuable.ConclusionsThe VTs strategy is a cost-effective option when compared with the HAs alone and HAs plus VTs strategies, but the need for additional information from future study is evident to inform this surgical treatment choice. Future studies of surgical and non-surgical treatment of OME in childhood should evaluate the economic impact of pertinent interventions to provide greater context.

Project description:BackgroundOfficial recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.MethodsWe randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.ResultsIn our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial.ConclusionsAmong children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).

Project description:BackgroundProteins found in middle ear effusion play crucial roles in the physiological and pathological processes of otitis media with effusion (OME), influencing the etiology and clinical characteristics of this disease. The qualitative and quantitative composition of these proteins depending on the underlying pathogenesis of middle ear effusion. Understanding their physiological and pathological functions is of great importance.MethodsWe collected samples from 19 volunteers diagnosed with OME. After offline separation using high-pH reversed-phase liquid chromatography (RPLC), the pooled sample was subjected to LC-MS/MS analysis to obtain a comprehensive profile of the OME proteome. Functional analysis was performed using Gene Ontology (GO), Kyoto Encyclopedia of Genes and Genomes (KEGG), and Ingenuity Pathway Analysis (IPA) annotations. Data-independent acquisition (DIA) technology was utilized to analyze samples and fix whether the OME proteome could replicate the pathophysiological features associated with this disease. We conducted a differential proteomic analysis between patients with simple OME and patients who had received radiotherapy. The radiotherapy-reduced group was further divided into two subgroups: nasopharyngeal carcinoma (NPC) and other types of carcinoma. Parallel reaction monitoring (PRM) technology was used for validation of 36 differentially expressed proteins (DEPs).ResultsA number of 732 proteins were identified in the OME proteome database. Among them, 527 proteins were quantified using peak intensity-based semi-quantification (iBAQ), covering a wide dynamic range of approximately 8 orders of magnitude. Based on the functional analysis, we proposed a hypothetical mechanism of OME.ConclusionThis study managed to put up an inclusive analysis of the OME proteome, establishing the first human OME proteome database. We focused on differential proteomic analysis among different groups to gain a more comprehensive concept of the OME proteome and search for meaningful biomarkers.

Dataset Information

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.

Publications

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.

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