Scoring System for Predicting No Hearing Recovery in Unilateral Idiopathic Sudden Sensorineural Hearing Loss.

BACKGROUND: The varying degrees of hearing recovery in idiopathic sudden sensory neural hearing loss (ISSHL) patients indicate the need of model to predict no hearing recovery. We aimed to aid in the counseling of ISSHL patients about their recovery chances by developing a simple clinical scoring system to predict no hearing recovery using clinical information available at first visit. METHODS: A retrospective cohort study, using medical records was conducted from January 2017-May 2019 in Cipto Mangunkusumo General Hospital and Proklamasi Ear, Nose, Throat, Head and Neck (ENT-HN) Surgery Specialized Hospital in Jakarta, Indonesia. The outcome measure is no hearing recovery and we built the prediction score developed based on multiple logistic regression analyses and tested for discriminative ability. There were 183 adults unilateral ISSHL patients included in the study. RESULTS: The proportion of no hearing recovery was 56%. The independent predictors were older age 30-60 years and >60 years old (Odds Ratio 4.0; 95% CI 1.4-11.8; p=0.012 and OR 5.3; 95% CI 1.5-18.4; p=0.008, respectively) as compared with 18-<30 years old, later onset (onset 15-60 days and >60 days had OR 5.4; 95% CI 1.7-16.9; p=0.004 and OR 12.6; 95% CI 2.9-54.6; p=0.001, respectively, as compared with onset < 3 days), and presence of vertigo (OR 2.3; 95% CI 1.1-4.6; p=0.026). Prediction scores ranged from 3 to 12, with three categories for age, four for onset, and two for the presence of vertigo. The predictions showed adequate calibration and good discriminative ability (AUC 0.77). CONCLUSION: Using information of age, onset and presence of vertigo at first visit, ISSHL patient with increased risk of no hearing recovery can be identified with moderate accuracy. This prediction model could help clinician in predicting patients' prognosis.

Single stage maxillofacial reconstruction combined radical surgery for managing juvenile ossifying fibroma: A case report.

Ossifying fibroma (OF) in craniofacial is a rare disease, benign, locally aggressive fibro-osseous tumor. The 2017 World Health Organization classifications divided OF into two types: OF of odontogenic origin and juvenile ossifying fibroma (JOF). Determining the right surgical treatment to reduce the postoperative recurrence rate is incredibly challenging. The author reports two cases of paranasal sinuses with disease onset progressed from pre-pubertal age. The first case is an example of a recurrent case after undergoing conservative surgery, and the second is a new one. All cases underwent radical surgery with subtotal maxillectomy and reconstructive surgery in one stage. After observing all patients until one year, there was no sign of recurrence through clinical and endoscopic examination. There are two types of surgery that compare in this case report: conservative surgery and radical surgery. Conservative surgical procedures include curettage, enucleation, or peripheral osteotomies. Several studies have shown high recurrence levels in OF patients when curettage or enucleation is performed; residue caused by incomplete excision is the most common reason that is easily caused by conservative surgery. Radical surgery such as open maxillectomy is a promising approach for degrading the level of recurrence. JOF, especially trabecular juvenile ossifying fibroma, shows a high recurrence percentage comparing other types. The first-choice management for treating OF was the surgical approach. Types of surgery depend on the disease's aggressiveness and morbidity. Radical surgery was proven better at decreasing recurrence level than conservative surgery.

The Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Double-blind Randomized Clinical Trial.

BACKGROUND: Long-term sun exposure is one of the risks faced by outdoor swimmers and can cause sunburn. Using sunscreen is one way to prevent sunburn; however, physical activity can trigger sweat, friction, and water washing that can interfere with sunscreen efficacy and decrease its sun protection factor (SPF). Sunscreens are classified into inorganic and organic based on their filter. Organic sunscreen has a better bond to the skin than inorganic sunscreen, which forms a barrier above the skin layer that makes removing it easier. Organic sunscreen lasts longer than inorganic sunscreen when used in physical activities, but it has a limited spectrum, is more photolabile, and is more allergenic. OBJECTIVE: This study aims to evaluate the persistency of SPF 30 between inorganic and organic sunscreens on the back area after 1.5 hours of swimming. METHODS: This study is a randomized, split-body, double-blind clinical trial to evaluate the persistency of SPF 30 of the inorganic versus organic sunscreens in swimmers. Randomization was done to allocate the participants into treatment groups. Each participant received inorganic and organic sunscreen treatments applied to the back area. The research participants were swimmers from the Cikini swimming pool and Bina Taruna swimming pool, both in Jakarta, Indonesia. RESULTS: A total of 22 swimmers were enrolled in this study. The analysis showed no significant difference between the SPF of the two sunscreens before swimming (P=.22). After swimming, the SPF levels of both sunscreens decreased: the inorganic sunscreen decreased from a median of 27 (range 23-47) to 12.3 (range 8-19), and the organic sunscreen decreased from a median of 30 (range 24-47) to 9.9 (range 6-19), which was statistically significant (P<.001). When comparing the SPF of inorganic and organic sunscreens after swimming, there was a statistically significant difference in the decrease in SPF levels between the two groups (P=.02), which indicated a better SPF persistence for inorganic sunscreens when compared to organic sunscreens. CONCLUSIONS: There was a decrease in the SPF levels of inorganic and organic sunscreens after 1.5 hours of swimming, with better persistence in inorganic sunscreens compared to organic sunscreens. TRIAL REGISTRATION: ClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42504.

Overuse of medications in low- and middle-income countries: a scoping review.

Objective: To identify and summarize the evidence about the extent of overuse of medications in low- and middle-income countries, its drivers, consequences and potential solutions. Methods: We conducted a scoping review by searching the databases PubMed®, Embase®, APA PsycINFO® and Global Index Medicus using a combination of MeSH terms and free text words around overuse of medications and overtreatment. We included studies in any language published before 25 October 2021 that reported on the extent of overuse, its drivers, consequences and solutions. Findings: We screened 3489 unique records and included 367 studies reporting on over 5.1 million prescriptions across 80 low- and middle-income countries - with studies from 58.6% (17/29) of all low-, 62.0% (31/50) of all lower-middle- and 60.0% (33/55) of all upper-middle-income countries. Of the included studies, 307 (83.7%) reported on the extent of overuse of medications, with estimates ranging from 7.3% to 98.2% (interquartile range: 30.2-64.5). Commonly overused classes included antimicrobials, psychotropic drugs, proton pump inhibitors and antihypertensive drugs. Drivers included limited knowledge of harms of overuse, polypharmacy, poor regulation and financial influences. Consequences were patient harm and cost. Only 11.4% (42/367) of studies evaluated solutions, which included regulatory reforms, educational, deprescribing and audit-feedback initiatives. Conclusion: Growing evidence suggests overuse of medications is widespread within low- and middle-income countries, across multiple drug classes, with few data of solutions from randomized trials. Opportunities exist to build collaborations to rigorously develop and evaluate potential solutions to reduce overuse of medications.

Comparison of Sun Protection Factor (SPF) 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Protocol for a Multicenter, Randomized, Noninferiority, Split-Body, Double-Blind Clinical Trial.

BACKGROUND: Outdoor swimming athletes are often exposed to undesirable environmental conditions such as long-term sun exposure. The risk of sunburn can still occur in this population due to the loss of sunscreen and an increase in the sensitivity of the skin to ultraviolet rays, particularly ultraviolet B, in wet conditions. Some previous trials showed that organic sunscreens had a longer shelf-life than inorganic sunscreens after exercise due to their characteristics to bind better with the skin layer. Meanwhile, inorganic sunscreens tend to form layers on the skin's surface so that they can be more easily removed. To our knowledge, no studies evaluate sunscreens' resistance, either inorganic or organic, after exercising in Indonesia. OBJECTIVE: This study aims to evaluate the persistence of inorganic versus organic sunscreens used by swimmers. The primary objective is to assess whether the inorganic sunscreen is as good as the organic sunscreen in the field of the persistence of sunscreens after swimming for 1.5 hours. METHODS: This study is a randomized, split-body, double-blind, noninferiority, and multicenter clinical trial in Cikini, Jakarta, Indonesia. An estimated 22 athletes in each group, who aged 18-40 years and practice in the morning or afternoon, will be randomized using a computer-generated randomization method. We calculated the sample size using the difference in the average decrease in sun protection factor (SPF) levels that is considered significant based on the clinical judgment set by the researchers, which was 5. Neither the research subjects nor the researchers are aware of the type of sunscreen that will be applied. The hypothesis will be tested using paired-sample t test or Wilcoxon to assess the difference of SPF levels in each group between organic and inorganic sunscreens with SPSS (version 20.0; IBM Corp). RESULTS: This study has been approved by the Ethical Committee Faculty of Medicine Universitas Indonesia and is funded by the International Publication Grant from Universitas Indonesia. The enrollment process was completed in December 2020. CONCLUSIONS: This study will test all procedures in preparation for conducting the main study, including several potential obstacles and challenges from the perspective of participating physicians and eligible swimmers. The study results will be disseminated through publications in a peer-reviewed journal with Open Access format. This study will provide information about SPF 30 persistence in sunscreens and the best type of sunscreen to be used while swimming, particularly for athletes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536?term=NCT04618536. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/42504.

Factors associated with time of diagnosis and habilitation of congenital hearing loss in Indonesia: A multicenter study.

OBJECTIVES: To investigate factors associated with time of diagnosis and habilitation of congenital hearing loss in Indonesia. METHOD: A retrospective cohort study was conducted from January to December 2020 by collecting data on patients with congenital hearing loss using validated questionnaires. RESULT: Among 535 children with congenital hearing loss, 2.7% had a family history of congenital hearing loss, 11.2% and 37.4% had a maternal history of ototoxic drugs and herbal medicine use during pregnancy, respectively, and 17.8% had prenatal exposure to TORCH infection. Lower maternal education level was shown to be associated with older age at diagnosis (p = 0.045), while older maternal age (p < 0.001), non-housewife mothers (p = 0.029), and out-of-pocket payment scheme (p = 0.027) were associated with a higher rate of habilitation. CONCLUSION: The present study showed that the presence of family history, the use of certain medications during pregnancy, and prenatal TORCH infection are prevalent in children with congenital hearing loss in Indonesia. Several factors such as maternal education level, age, occupation, and habilitation payment scheme may be associated with time of diagnosis and habilitation of congenital hearing loss.

Prognostic factors and models to predict pediatric sepsis mortality: A scoping review.

Introduction: Several scoring systems are available to assess the severity of sepsis in pediatric patients in diverse settings worldwide. This study investigates the quality and applicability of predictive models for determining pediatric sepsis mortality, especially in acute care and limited-resource settings. Data sources: Mortality prediction factors and models were searched in four databases using the following criteria: developed for pediatric health care, especially in acute settings, and with mortality as an outcome. Study selection: Two or more reviewers performed the study selection to ensure no bias occurred. Any disagreements were solved by consensus or by the decision of a third reviewer. Data extraction: The authors extracted the results and mapped the selected studies qualitatively to describe the prognostic properties of the risk factors and models proposed in the study. Data synthesis: The final analysis included 28 mortality prediction models. Their characteristics, analysis, and performance measures were summarized. Performance was described in terms of calibration and discrimination, including assessing for risk of bias and applicability. A modified version of the PRISM-III score based on physiologic criteria (PRISM-III-APS) increased its predictive value to 0.85-0.95. The vasoactive-inotropic score at 12 h had a strong independent association with death. Albumin had an excellent predictive value when combined with other variables. Lactate, a biomarker widely measured in patients with sepsis, was highly associated with mortality. The bioimpedance phase angle was not considered applicable in our setting. Measurement using more straightforward methods, such as mid-upper arm circumference, was feasible in numerous health care facilities. Conclusion: Leveraging prognostic models to predict mortality among pediatric patients with sepsis remains an important and well-recognized area of study. While much validation and development work remains to be done, available prognostic models could aid clinicians at the bedside of children with sepsis. Furthermore, mortality prediction models are essential and valuable tools for assessing the quality of care provided to critically ill pediatric patients.

Evaluation of 3 and 2-point internal fixation in the management of zygomaticomaxillary complex fractures: Case report.

INTRODUCTION: The ZMC has a prominent shape compared to other parts in the midfacial region, thus small injuries will generate fractures in the ZMC. The management of ZMC fracture depends on the fracture deformity and the surgeon's considerations. Various studies have revealed the success of ZMC reconstruction with one fixation point to 4 fixation points fitting to the tetrapod shape. CASE REPORT: We report two cases of ZMC fractures which comparing the efficacy of 3- and 2-point internal fixations for improving clinical outcomes The first patient underwent ORIF which placed at 2 fixation points, the first point in the left ZF suture and the second point in the left ZMB. The second patient underwent ORIF reconstruction at 3 fixation points, the first point in the right inferior orbital rim, the second point in the right ZF suture, and the third point in the right ZMB. DISCUSSION: The most common surgical approach for ZMC fractures is through a gingivobuccal groin incision. This approach is for body exposure of the ZMB, which is the main buttress. The 3-point internal fixation improved the postoperative clinical outcome of fracture fragment stability compared to two-point fixation, but the mean malar height projection, vertical dystopia, and enophthalmos were not different between the two fixation methods. CONCLUSION: Three-point internal fixation can improve the clinical outcome of fracture fragment stability compared to 2-point fixation; however, it has a mean operative duration 22.2 minutes longer than 2-point fixation, so its application must be considered during the COVID-19 pandemic.

Prognostic Scoring System for Mortality of Hospitalized COVID-19 Patients in Resource-Limited Settings: A Multicenter Study from COVID-19 Referral Hospitals.

BACKGROUND: Many studies identified the risk factors and prognostic factors related to in-hospital COVID-19 mortality using sophisticated laboratory tests. Cost and the availability of supporting blood tests may be problematic in resource-limited settings. This multicenter cohort study was conducted to assess the factors associated with mortality of COVID-19 patients aged 18 years and older, based on history taking, physical examination, and simple blood tests to be used in resource-limited settings. METHODS: The study was conducted between July 2020 and January 2021 in five COVID-19 referral hospitals in Indonesia. Among 1048 confirmed cases of COVID-19, 160 (15%) died during hospitalization. RESULTS: Multivariate analysis showed eight predictors of in-hospital mortality, namely increased age, chronic kidney disease, chronic obstructive pulmonary disease, fatigue, dyspnea, altered mental status, neutrophil-lymphocyte ratio (NLR) ≥ 5.8, and severe-critical condition. This scoring system had an Area-under-the-curve (AUC) of 84.7%. With cut-off score of 6, the sensitivity was 76.3% and the specificity was 78.2%. CONCLUSION: The result of this practical prognostic scoring system may be a guide to decision making of physicians and help in the education of family members related to the possible outcome.

Risk factors and laboratory test results associated with severe illness and mortality in COVID-19 patients: A systematic review.

BackgroundWe aimed to systematically review all relevant studies related to the risk factors and laboratory test results associated with severe illness and mortality in COVID-19 patients.MethodsWe utilised PubMed, Scopus, ProQuest, Wiley Online Library, ScienceDirect and MedRxiv to search for studies, with additional hand-searched journals. We included systematic reviews/meta-analyses, cohort and case control studies of suspected and/or confirmed COVID-19 cases with severe illness and/or mortality as outcomes. We included laboratory test results and risk factors. We assessed risk of bias using ROBIS-I and Newcastle-Ottawa Scale assessment tool. Type of study, risk of bias, and precision of results determined evidence sufficiency.ResultsOf 26 records included, sufficient evidence suggested the association between age >60 years, hypertension, coronary heart disease, DM, serum LDH 250-500 U/L, LDH >500 U/L, and lymphopenia (lymphocyte count ≤1.0 x 109 /L) and severe illness of COVID-19. CD3+CD8+ cell count ≤ 75 cell/µl, D-dimer > 1 mg/L, AKI stage 2 and 3, proteinuria ≥1+, hematuria ≥1+, and peak serum creatinine > 13.26 µmol/L are associated with mortality.ConclusionAge >60 years, hypertension, DM, and coronary heart disease are the risk factors for severe illness of COVID-19. Laboratory test results associated with severe illness are serum LDH 250-500 U/L, LDH >500 U/L, and lymphopenia, whereas test results associated with mortality are CD3+CD8+ cell count ≤ 75 cell/µl, AKI stage 2 and 3, proteinuria ≥1+, hematuria ≥1+, D-dimer > 1 mg/L, peak serum creatinine > 13.26 µmol/L.

Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study).

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 middle ear inflammation by reducing MEE. RESULTS: We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference - 7.4 mm, 95% confidence interval (CI) - 13.4 to - 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study. CONCLUSIONS: It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this. TRIAL REGISTRATION: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Evaluation of the role of near-peer teaching in critical appraisal skills learning: a randomized crossover trial.

OBJECTIVES: The study sought to evaluate near-peer tutors' teaching of critical appraisal skills to medical students as an aspect of Evidence-based Medicine. METHODS: In a randomized crossover trial, 241 students completing a Clinical Epidemiology and Evidence-based Medicine (CE-EBM) module in the Faculty of Medicine Universitas Indonesia (FMUI) were randomly assigned to intervention or control groups. During tutorial sessions, intervention group participants were assigned to near-peer tutors, who were newly graduated doctors, and those in the control groups were assigned to staff tutors. After two tutorial sessions, intervention and control groups exchanged tutors for the next two sessions. Outcomes were measured using written knowledge and skills multiple choice questions (MCQ) test, the Evidence-based Practice Confidence Scale (EPIC) and a student attitude questionnaire, along with student evaluation of tutors to evaluate the process. RESULTS: On completion of the module, the written test scores of intervention group students were similar to those of the control group (t(239) = 1.553, p=0.122), as well as overall Evidence-based Practice Confidence Scale scores (F(2/170) = 0.179, p = 0.673) and attitude scores (t(219) =-0.676, p = 0.085). In the tutor evaluations, the students rated their near-peer tutored sessions as better than those tutored by staff in most respects. CONCLUSIONS: Near-peer tutors were as effective as and more readily accepted than staff tutors in teaching critical appraisal skills. These findings support the broader implementation of peer-teaching in other areas of medical education.

Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study).

BACKGROUND: 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. METHODS: 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 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. DISCUSSION: This 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 REGISTRATION: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Is antimicrobial administration to food animals a direct threat to human health? A rapid systematic review.

BACKGROUND: Large quantities of antimicrobials are given to food animals, particularly in feed, potentially increasing antimicrobial resistance in humans. However, the magnitude of this effect is unclear. METHODS: We searched PubMed, Embase and Web of Science for studies on interventions that limited antimicrobial use in food animals, in any setting and context, to reduce antimicrobial resistance 1) in those food animals; and 2) in humans. We validated our strategy by testing whether it identified known relevant studies. Data from included studies were extracted into pre-designed and pilot-tested forms. RESULTS: We included 104 articles containing 93 studies. Heterogeneity (different animal species, environs, antimicrobial classes, interventions, administration routes, sampling, and methods), was considerable, precluding meta-analysis. The evidence was therefore synthesised narratively. A total of 89 studies (3 directly, 86 indirectly) addressed whether limiting antimicrobial exposure in food animals led to decreased antimicrobial resistance in those animals. The evidence was adequate to conclude this, although the magnitude of the effect could not be quantified. Four studies (1 directly, 3 indirectly) examined whether withdrawal of antibiotics changed resistance of potential pathogens in retail food for human consumption, and in bacteria of humans themselves. The direct (observational) study of broiler hatchery in ovo antimicrobial injection found a credible effect in terms of size reduction and time sequences. INTERPRETATION: Limiting antimicrobial use in food animals reduces antimicrobial resistance in food animals, and probably reduces antimicrobial resistance in humans. The magnitude of the effect cannot be quantified.

Systemic corticosteroids for acute otitis media in children.

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 anti-inflammatory 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. MAIN RESULTS: We included two studies involving 252 children with AOM aged from three months to six years receiving hospital ambulatory care who were treated with intramuscular ceftriaxone, and who were then randomised to the corticosteroid group (corticosteroid and corticosteroid plus antihistamine) or the placebo group (antihistamine and double placebo). In one study, children also had a needle aspiration of middle ear fluid. Both studies were at unclear risk of bias for allocation concealment, and unclear to high risk of bias for selective reporting.One study (N = 179) included pain as an outcome, but we were unable to derive the proportion of children with persistent pain at Day 5 and Day 14. Reduction of overall or specific symptoms was presented as improvement in clinical symptoms and resolution of inflamed tympanic membranes without the need for additional antibiotic treatment: at Day 5 (94% of children in the treatment group (N = 89) versus 89% in the placebo group (N = 90); risk ratio (RR) 1.06, 95% confidence interval (CI) 0.97 to 1.16) and Day 14 (91% versus 87%; RR 1.05, 95% CI 0.95 to 1.17). Low-quality evidence meant that we are uncertain of the effectiveness of corticosteroids for this outcome.The second study (N = 73) reported a reduction of overall or specific symptoms without additional antibiotic treatment during the first two weeks as a favourable outcome. Children in the treatment group had more favourable outcomes (adjusted odds ratio 65.9, 95% CI 1.28 to 1000; P = 0.037), although the numbers were small. We were unable to pool the results with the other study because it did not report the proportion of children with this outcome by treatment group. Only one study reported adverse effects of corticosteroids (e.g. drowsiness, nappy rash), but did not quantify incidence, so we were unable to draw conclusions about adverse effects. Neither study reported a reduction in overall or specific symptom duration. AUTHORS' CONCLUSIONS: The evidence for the effect of systemic corticosteroids on AOM is of low to very low quality, meaning the effect of systemic corticosteroids on important clinical outcomes in AOM remains uncertain. Large, high-quality studies are required to resolve the question.