Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibio... more Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. Methods We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months–12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing...
Background Acute otitis media (AOM) is a common self-limiting infection where antibiotics confer ... more Background Acute otitis media (AOM) is a common self-limiting infection where antibiotics confer limited benefit. Other treatments, such as anti-inflammatory agents have been proposed as an alternative to antibiotics, but no high-quality clinical trials have tested this. Objective To identify current AOM management practices among Indonesian clinicians. We also required this information for our proposed corticosteroids clinical trial for AOM. Methods This cross-sectional study surveyed a convenience sample of general practitioners (GPs), pediatricians, and Ear-Nose-Throat (ENT) specialists in Jakarta, Depok, and Bekasi. We addressed their current AOM management practices and willingness to participate in a future trial on corticosteroids. Results We distributed 2,694 questionnaires through conferences, primary care/hospital visits, and by mail-list group. Of 492 questionnaires received (response rate 18%), 352 were from eligible clinicians. Most clinicians diagnosed AOM by using an ...
Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, f... more Acute 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. This 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 year...
Background Acute otitis media (AOM) is a common acute infection in children. Pain is its most pro... more Background Acute otitis media (AOM) is a common acute infection in children. Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent antiinflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics. Objectives To assess the effects of systemic corticosteroids (oral or parenteral), with or without antibiotics, for AOM in children. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) which contains the Cochrane ARI Group's Specialised Register, MEDLINE (Ovid), Embase (Elsevier), CINAHL (EBSCO), Web of Science (Thomson Reuters), and LILACS (BIREME) for published studies, and ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for completed and ongoing studies, to 20 February 2018. We checked the reference lists of all primary studies and review articles for additional references and contacted experts in the field to identify additional unpublished materials. Selection criteria We included randomised controlled trials of children with AOM that compared any systemic corticosteroid (oral or parenteral) with placebo, either with antibiotics (corticosteroid plus antibiotic versus placebo plus antibiotic) or without antibiotics (corticosteroid versus placebo). Data collection and analysis Three review authors (EDS, RR, YP) independently screened the titles and abstracts and retrieved the full texts of potentially relevant studies. We independently extracted study characteristics and outcome data from the included studies, and assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed study quality using the GRADE method.
Background: To translate and assess the validity and reliability of the Indonesian version of Tin... more 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...
Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibio... more Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. Methods We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months–12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing...
Background Acute otitis media (AOM) is a common self-limiting infection where antibiotics confer ... more Background Acute otitis media (AOM) is a common self-limiting infection where antibiotics confer limited benefit. Other treatments, such as anti-inflammatory agents have been proposed as an alternative to antibiotics, but no high-quality clinical trials have tested this. Objective To identify current AOM management practices among Indonesian clinicians. We also required this information for our proposed corticosteroids clinical trial for AOM. Methods This cross-sectional study surveyed a convenience sample of general practitioners (GPs), pediatricians, and Ear-Nose-Throat (ENT) specialists in Jakarta, Depok, and Bekasi. We addressed their current AOM management practices and willingness to participate in a future trial on corticosteroids. Results We distributed 2,694 questionnaires through conferences, primary care/hospital visits, and by mail-list group. Of 492 questionnaires received (response rate 18%), 352 were from eligible clinicians. Most clinicians diagnosed AOM by using an ...
Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, f... more Acute 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. This 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 year...
Background Acute otitis media (AOM) is a common acute infection in children. Pain is its most pro... more Background Acute otitis media (AOM) is a common acute infection in children. Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent antiinflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics. Objectives To assess the effects of systemic corticosteroids (oral or parenteral), with or without antibiotics, for AOM in children. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) which contains the Cochrane ARI Group's Specialised Register, MEDLINE (Ovid), Embase (Elsevier), CINAHL (EBSCO), Web of Science (Thomson Reuters), and LILACS (BIREME) for published studies, and ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for completed and ongoing studies, to 20 February 2018. We checked the reference lists of all primary studies and review articles for additional references and contacted experts in the field to identify additional unpublished materials. Selection criteria We included randomised controlled trials of children with AOM that compared any systemic corticosteroid (oral or parenteral) with placebo, either with antibiotics (corticosteroid plus antibiotic versus placebo plus antibiotic) or without antibiotics (corticosteroid versus placebo). Data collection and analysis Three review authors (EDS, RR, YP) independently screened the titles and abstracts and retrieved the full texts of potentially relevant studies. We independently extracted study characteristics and outcome data from the included studies, and assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed study quality using the GRADE method.
Background: To translate and assess the validity and reliability of the Indonesian version of Tin... more 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...
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