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      Efficacy of a non-invasive middle ear aeration device in children with recurrent otitis media: A randomized controlled trial protocol

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      , ,
      Contemporary Clinical Trials Communications
      Elsevier
      Otitis media, Acute otitis media

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          Abstract

          Acute otitis media (AOM) represents a significant disease burden in the pediatric population. Besides vaccinations, there are no robust measures of reducing incidence of AOM in this age-group. This is a randomized controlled clinical trial evaluating the efficacy of a non-invasive middle ear aeration device, the EarPopper device (EP). We aim to investigate the reduction of episodes AOM in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used. The primary endpoint is incidence of AOM. The secondary endpoints are hazard ratio of time to AOM, proportion without AOM and antibiotics use, quality of life (OMO-22 Form), and adherence to treatment. Sample size is a minimum of 150 patients. The inclusion criteria is ages 4–11, with history of recurrent Acute Otitis Media (AOM).

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          Most cited references13

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          Diagnosis and management of acute otitis media.

          (2004)
          This evidence-based clinical practice guideline provides recommendations to primary care clinicians for the management of children from 2 months through 12 years of age with uncomplicated acute otitis media (AOM). The American Academy of Pediatrics and American Academy of Family Physicians convened a committee composed of primary care physicians and experts in the fields of otolaryngology, epidemiology, and infectious disease. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the evidence-based literature related to AOM. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific definition of AOM. It addresses pain management, initial observation versus antibacterial treatment, appropriate choices of antibacterials, and preventive measures. Decisions were made based on a systematic grading of the quality of evidence and strength of recommendations, as well as expert consensus when definitive data were not available. The practice guideline underwent comprehensive peer review before formal approval by the partnering organizations. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.
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            Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study.

            To determine the epidemiology of acute otitis media (AOM) and duration of middle ear effusion (MEE), we followed consecutively enrolled children from shortly after birth until 7 y of age. Because some children dropped out of the study, data were analyzed for 877 children observed for at least 1 y; 698 were observed for at least 3 y, and 498 were observed until 7 y of age. By 1 y of age, 62% of the children had greater than or equal to 1 episode of AOM and 17% had greater than or equal to 3 episodes; by 3 y of age, 83% had greater than or equal to 1 episode of AOM and 46% had greater than or equal to 3 episodes. The peak incidence occurred during the second 6-mo period of life. Significantly increased risk (by multivariate analysis) for AOM was associated with male gender, sibling history of recurrent AOM, early occurrence of AOM, and not being breast fed. MEE persisted after onset of AOM for weeks to months; prolonged duration of MEE was associated with male gender, sibling history of ear infection, and not being breast fed.
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              Quality of life for children with otitis media.

              To evaluate changes in health-related quality of life for children with otitis media. Cohort study using a 6-item quality-of-life survey (OM-6) representing the domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns. Hospital-based pediatric otolaryngology practice in a metropolitan area. One hundred eighty-six children aged 6 months to 12 years (median age, 3.4 years) with chronic otitis media with effusion or recurrent acute otitis media. The OM-6 was completed at entry by the child's caregiver and again at least 4 weeks after routine clinical care. Otoscopic findings, static admittance, tympanometric width, audiometric thresholds, and ear-related global quality of life (10-point visual scale) were recorded concurrently. Test-retest reliability, construct validity, and responsiveness to longitudinal change of the OM-6 survey score (mean value of the 6 items). Excellent test-retest reliability was obtained for the survey score (R=0.87) and individual survey items (R> or =0.71). The median survey score was 2.8 (95% confidence interval, 2.7-3.0) of a maximum 7.0, with higher values indicating poorer quality of life. Construct validity was shown by significant correlations between the survey score and global ear-related quality of life (R=-0.64), between physical suffering and physician visits in the past month (R=0.47), and between caregiver concerns and antibiotics consumed in the past month (R=0.26). The mean change in survey scores after tympanostomy tubes was 1.7, with a standardized response mean of 1.7 (95% confidence interval, 1.4-2.0), indicating large responsiveness to change. The change score was reliable (R=0.82) and correlated well with the degree of reported clinical change (R=0.66). The OM-6 is a valid, reliable, and responsive measure of quality of life for children with otitis media. The brevity and ease of administration make the OM-6 ideal for use in outcomes studies, clinical trials, and routine clinical care.
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                Author and article information

                Contributors
                Journal
                Contemp Clin Trials Commun
                Contemp Clin Trials Commun
                Contemporary Clinical Trials Communications
                Elsevier
                2451-8654
                04 October 2018
                December 2018
                04 October 2018
                : 12
                : 92-97
                Affiliations
                [1]Department of Otolaryngology – Head and Neck Surgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, USA
                Author notes
                []Corresponding author. Department of Otolaryngology – Head and Neck Surgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, 130 East 77th Street, 10th Floor New York, NY, 10075, USA. ttham@ 123456northwell.edu
                Article
                S2451-8654(18)30094-2
                10.1016/j.conctc.2018.09.008
                6180339
                a37eb386-6938-4a9b-9e1b-d897675357c0
                © 2018 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 29 June 2018
                : 18 September 2018
                : 30 September 2018
                Categories
                Article

                otitis media,acute otitis media
                otitis media, acute otitis media

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