BackgroundAcute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient. Accordingly, we plan a large, rigorous clinical trial to test this. Initially, we will test pre-specified methods and procedures (including the overall process, resources, management, and scientific components) in a pilot study of corticosteroids for AOM, which will inform a future, definitive trial.MethodsThis is a pilot pragmatic, randomised, open-label, single-blind, controlled study of corticosteroids as either monotherapy or an addition to antibiotics in 60 children aged 6 months to 12 years with AOM in two cities (Jakarta and Bekasi) in Indonesia. We will randomise eligible children to prednisolone or control. We will also stratify by disease severity and randomise those with mild AOM to expectant observation plus prednisolone or observation alone and those with severe AOM to prednisolone plus antibiotic or antibiotic alone. Our outcomes are to determine (1) recruitment rates, (2) the success of the study procedures, (3) the ability to measure planned outcomes of the proposed main study, (4) the compliance to study visits and study medication, and (5) verification of the sample size calculation for the main study. We will also assess middle ear effusion using tympanometry as part of a mechanistic sub-study.DiscussionThis study will test all procedures in preparation for the main study, including several potential obstacles and challenges from the perspective of participating physicians, nurses, pharmacists, and the parents of eligible children. This information will be useful for developing strategies to overcome practical and procedural issues. This study may also provide information about the effects of corticosteroids on middle ear effusion in AOM.Trial registrationStudy registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0337-x) contains supplementary material, which is available to authorized users.
This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of corticosteroids, with and without antibiotics, for AOM in children
Background: To translate and assess the validity and reliability of the Indonesian version of Tinnitus Handycap Inventory (THI) as an psychometric instrument for evaluating the quality of life in tinnitus patients. This instrument will support the clinicians to determine the appropriate tinnitus management for them.Methods: A cross-sectional psychometric validation study was performed to assess the internal consistency, reliability and validity of the Indonesian version of THI in 50 subjective tinnitus patients at ENT outpatient clinic of Cipto Mangunkusumo Hospital between May-August 2010. 25 question items of original THI were translated, back-translated and validated using the transcultural validation by WHO.Results: The validity test demonstrated a significant correlation in the emotional and the catastrophic scale whilst there was no significant correlation in the functional scale for item F2 and particularly for item F15. Nevertheless, the validity test on the functional scale showed a good result. This study also showed high internal consistency and reliability for the total scale (Cronbach-α = 0.91)Conclusion: The evaluation result indicated that the reliability of adapted Indonesian version of the THI in our study is relatively high and could be applied in clinical examination or further otolaryngology study by both specialists and general physicians.
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