Grommets (ventilation tubes) for recurrent acute otitis media in children.
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ABSTRACT:
SUBMITTER: Venekamp RP
PROVIDER: S-EPMC6494623 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
Publications
Grommets (ventilation tubes) for recurrent acute otitis media in children.
Venekamp Roderick P RP Mick Paul P Schilder Anne Gm AG Nunez Desmond A DA
The Cochrane database of systematic reviews 20180509
<h4>Background</h4>Acute otitis media (AOM) is one of the most common childhood illnesses. While many children experience sporadic AOM episodes, an important group suffer from recurrent AOM (rAOM), defined as three or more episodes in six months, or four or more in one year. In this subset of children AOM poses a true burden through frequent episodes of ear pain, general illness, sleepless nights and time lost from nursery or school. Grommets, also called ventilation or tympanostomy tubes, can b ...[more]
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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.).
| S-EPMC8969083 | biostudies-literature
Project description:BackgroundThe 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.
| S-EPMC5248475 | biostudies-literature
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.
| S-EPMC4112653 | biostudies-literature
Project description:Acute Otitis Media (AOM) typically affects previously healthy children and can be recurrent. This inter-society consensus aims to provide evidence-based recommendations for the antibiotic therapy of mild, severe and recurrent otitis media in previously healthy children in Italy.A systematic literature review was conducted to identify the most recent/relevant evidence. The Embase, Scopus, PubMed, and Cochrane databases were used with the terms "children," "acute otitis media", "recurrent otitis media", and "antibiotics," from 2012 to April 2024, with no language restrictions. The review focused on studies conducted in high-income countries involving antibiotic therapy in children over 3 months of age diagnosed with AOM or Recurrent AOM (RAOM). The GRADE ADOLOPMENT was used to assess the possibility of adopting or adapting recommendations from two evidence-based guidelines: 'NICE guideline Otitis media (acute): antimicrobial prescribing', updated to 2022 and SIP Intersocietal GL 2019 "Management of acute otitis media in paediatric age: diagnosis, therapy and prevention" The certainty of the evidence was assessed using the GRADE approach. Final recommendations were formulated through a Delphi consensus process with an expert panel.All major randomised trials and international guidelines promote the appropriate use of antibiotics and advocate a therapy with narrow-spectrum molecules (amoxicillin). The amoxicillin-clavulanic acid is only envisaged when there is a risk of infection by β-lactamase-producing bacteria. In healthy children, amoxicillin should be initiated as a first-line treatment only after a 48-72-h period of appropriate "watchful waiting", during which symptoms are treated while monitoring the patient clinically to see if symptoms resolve. Amoxicillin-clavulanate or second-generation cephalosporins should be reserved for non-immunized children, those with immune deficiencies or those with underlying conditions. In these cases, the use of a clavulanic acid-protected amoxicillin is preferred even though there is no specific scientific evidence to support this choice.The recommended amoxicillin dosage is 90 mg/kg/day, divided into three doses, though two doses may be considered to improve compliance. A five-day duration of therapy is advised.In conclusion the diagnosis of AOM/RAOM relies primarily on clinical assessment, which often introduces uncertainty in distinguishing between viral and bacterial infections whereby there remains significant potential to improve antibiotic utilisation. Future studies could play a key role in enhancing the management of AOM/RAOM in children, ensuring that antibiotic treatments are appropriate and effective.
| S-EPMC11844117 | biostudies-literature
Project description:ObjectivesOtitis media (OM) is one of the most frequent diseases of childhood, with a minority of children suffering from recurrent acute otitis media (rAOM) or chronic otitis media with effusion (COME), both of which are associated with significant morbidity. We investigated whether the microbiological profiling could be used to differentiate between these two conditions.MethodsChildren up to five years of age, with rAOM (n = 45) or COME (n = 129) and scheduled for tympanostomy tube insertion were enrolled in a prospective study between 2008 and 2009. Middle ear fluids (n = 119) and nasopharyngeal samples (n = 173) were collected during surgery for bacterial culture and PCR analysis to identify Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, and to detect 15 distinct respiratory viruses.ResultsThe occurrence of bacterial and viral pathogens in middle ear fluids did not significantly differ between patients suffering from rAOM and COME. In both patient cohorts, H. influenzae and rhinovirus were the predominant pathogens in the middle ear and nasopharynx. Nasopharyngeal carriage with two or three bacterial pathogens was associated with the presence of bacteria in middle ear fluid (P = 0.04). The great majority of the bacteria isolated from middle ear fluid were genetically identical to nasopharyngeal isolates from the same patient.ConclusionsBased on these results, we propose that the common perception that rAOM is associated with recurrent episodes of microbiologically mediated AOM, whereas COME is generally a sterile inflammation, should be reconsidered.
| S-EPMC7132406 | biostudies-literature
Project description: Not available
| S-EPMC6580359 | biostudies-literature
Project description:PurposeCost-utility analyses examining the value of new vaccines for pneumococcal disease will require health state utilities as inputs. Existing utilities for pneumococcal infections in young children are limited. The purpose of this study was to estimate health state utilities associated with pneumococcal infections in young children.MethodsSix health state vignettes depicting infections due to Streptococcus pneumoniae were drafted based on published literature and clinician interviews. To address methodological challenges in estimating utilities for temporary infections in children 0-5 years of age, several time trade-off approaches were explored in a pilot study (N = 28 participants). In the subsequent utility elicitation study conducted in the UK, health states were valued using the best performing method from the pilot (10-year time horizon, with infections repeated annually) with adult general population respondents imagining a child 2-5 years of age.ResultsA total of 208 participants completed interviews (51.9% female; mean [SD] age = 41.0 [14.9] years). Mean (SD) utilities were 0.902 (0.092) for pneumonia requiring hospitalization, 0.901 (0.087) for bacteremia, 0.894 (0.103) for recurrent acute otitis media (AOM), 0.882 (0.107) for recurrent AOM treated with pressure equalization tubes, 0.878 (0.109) for bacteremic pneumonia, and 0.809 (0.145) for meningitis.ConclusionLower health state utilities were associated with health states that had longer treatment periods, required more invasive treatment, and described more severe infections. Utilities from this study can be used in models examining cost-effectiveness of pneumococcal vaccines. These results have methodological implications for future research estimating utilities associated with temporary pediatric health conditions.
| S-EPMC11920316 | biostudies-literature
Project description: Not available
| S-EPMC6537667 | biostudies-literature
Project description:BackgroundLimiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.MethodsWe assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms.ResultsChildren who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001).ConclusionsAmong children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).
| S-EPMC5319589 | biostudies-literature
Project description: Not available
| S-EPMC8096893 | biostudies-literature