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Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd.Methods/design: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months.Discussion: It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.Trial Registration: Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines focusing on judicious use of antibiotics for childhood acute otitis media (AOM) have been introduced in many countries around the world.Objective: To systematically review the effects of these guidelines on the prescription of antibiotics and analgesics for children with AOM.Methods: Systematic searches of PubMed, Embase and Cochrane Library from inception to 6 June 2017 using broad search terms. Studies specifically aimed at evaluating the effects of introduction of national AOM practice guidelines on type of antibiotic and/or analgesic prescriptions were included, irrespective of design, setting or language. The Risk Of Bias In Non-randomized Studies of Interventions tool was used to assess risk of bias.Results: Of 411 unique records retrieved, seven studies conducted in six different countries (France, Italy, Spain, Sweden, UK and USA (twice)) compared data before and after guideline introduction. All studies had an observational design, using longitudinal data of children aged under 15 years (n=200-4.6 million) from either routine care, insurance databases or electronic surveys. Risk of bias of all studies was judged serious to critical.Of the five studies reporting on antibiotic prescription rates, three showed a decline of 5%-12% up to 3 years after guideline introduction and two found no or negligible effect. In one US study, the initial 9% decline decreased to 5% after 4-6 years. The recommended first choice antibiotic was prescribed more frequently (9%-58% increase) after guideline introduction in four out of five studies reporting on this outcome. Analgesic prescription rates for AOM were reported in one US study and increased from 14% to 24% after guideline introduction.Conclusion: Based upon what is published, the effects of introduction of national clinical practice guidelines on antibiotic and analgesic prescribing for children with AOM seem modest at the most.Registration: PROSPERO: CRD42016050976. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the predictors of general practitioner (GP) consultation and antibiotic use in those developing sore throat.Methods: We conducted a prospective population-based cohort study on 4461 participants in two rounds (2010-11) from 1897 households.Results: Participants reported 2193 sore throat illnesses, giving a community sore throat incidence of 1.57/ person-year. 13% of sore throat illnesses led to a GP consultation and 56% of these consultations led to antibiotic use. Participants most likely to have sore throats included women and children (e.g. school compared with retirement age); adjusted incidence rate ratio (aIRR) of 1.33 and 1.52, respectively. Participants with sore throat were more likely to consult their GP if they were preschool compared with retirement age [adjusted OR (aOR) 3.22], had more days of sore throat (aOR 1.11), reported more severe pain (aOR 4.24) or reported fever (aOR 3.82). Antibiotics were more often used by chronically ill individuals (aOR 1.78), those reporting severe pain (aOR 4.14), those reporting fever (aOR 2.58) or children with earache (aOR 1.85). Among those who consulted, males and adults who reported feeling anxious were more likely to use antibiotics; aOR 1.87 and 5.36, respectively.Conclusions: Only 1 in 10 people who have a sore throat see a doctor and more than half of those attending get antibiotics. Further efforts to curb antibiotic use should focus on reducing initial GP consultations through public information promoting safe self-management, targeted at groups identified above as most likely to attend with sore throats. [ABSTRACT FROM AUTHOR]

Objective: Antibiotic treatment of acute otitis media (AOM) has been suggested to increase the risk of future AOM episodes by causing unfavorable shifts in microbial flora. Because current evidence on this topic is inconclusive and long-term follow-up data are scarce, we wanted to estimate the effect of antibiotic treatment for a first AOM episode occurring during infancy on AOM recurrences and AOM-related health care utilization later in life. Methods: We obtained demographic information and risk factors from data of the Wheezing Illnesses Study Leidsche Rijn, a prospective birth cohort study in which all healthy newborns born in Leidsche Rijn (between 2001 and 2012), The Netherlands, were enrolled. These data were linked to children’s primary care electronic health records up to the age of four. Children with at least one family physician-diagnosed AOM episode before the age of two were included in analyses. The exposure of interest was the prescription of oral antibiotics (yes vs no) for a child’s first AOM episode before the age of two years. Results: 848 children were included in analyses and 512 (60%) children were prescribed antibiotics for their first AOM episode. Antibiotic treatment was not associated with an increased risk of total AOM recurrences (adjusted rate ratio: 0.94, 95% CI: 0.78–1.13), recurrent AOM (≥3 episodes in 6 months or ≥4 in one year; adjusted risk ratio: 0.79, 95% CI: 0.57–1.11), or with increased AOM-related health care utilization during children’s first four years of life. Conclusions: Oral antibiotic treatment of a first AOM episode occurring during infancy does not affect the number of AOM recurrences and AOM-related health care utilization later in life. This information can be used when weighing the pros and cons of various AOM treatment options. [ABSTRACT FROM AUTHOR]

Antibiotics are among the most important interventions in healthcare. Resistance of bacteria to antibiotics threatens the effectiveness of treatment. Systematic reviews of antibiotic treatments often do not address resistance to antibiotics even when data are available in the original studies. This omission creates a skewed view, which emphasizes short-term efficacy and ignores the long-term consequences to the patient and other people. We offer a framework for addressing antibiotic resistance in systematic reviews. We suggest that the data on background resistance in the original trials should be reported and taken into account when interpreting results. Data on emergence of resistance (whether in the body reservoirs or in the bacteria causing infection) are important outcomes. Emergence of resistance should be taken into account when interpreting the evidence on antibiotic treatment in randomized controlled trials or systematic reviews. [ABSTRACT FROM AUTHOR]

Background. Both treatment guidelines and the amount of antibiotics used for acute otitis media (AOM) vary across western countries. Parental expectations and their awareness of antimicrobial use and resistance, which may also be influenced by the guidelines, are not yet completely known. [ABSTRACT FROM PUBLISHER]

Background: Current opinions regarding the management of acute otitis media (AOM) in children vary across Western countries. With antibiotic resistance rising and more evidence regarding the limited clinical efficacy of antibiotics becoming available, interest in managing AOM other than with antibiotics is renewed. Objectives: To compare international rates of antibiotic prescription and surgery for AOM. To provide current evidence regarding the efficacy of various treatment options for AOM and their potential complications. Methods: Qualitative (narrative) review. Results: The percentage of patients given antibiotics for AOM varies from 31% in The Netherlands to more than 90% in most other Western countries. The 1998 prevalence of penicillin-resistant S. pneumoniae strains, on the other hand, ranges from 3% in The Netherlands to 53% in France. The surgical rate for tympanostomy tubes varies from 2 per 1000 children per year in the United Kingdom to 20 per 1000 in The Netherlands. The benefit of both antibiotic and surgical therapy in AOM appears to be limited, with numbers needed to treat ranging from 8 to 25 for antibiotic therapy, depending on the definition of outcome. Conclusions: International rates of antibiotic prescription and surgery for AOM vary strongly, which can be explained largely by the lack of uniform evidence-based guidelines. International debates with the aim of overcoming cultural differences regarding the management of otitis media, and of reaching agreement on guidelines on the basis of current evidence are necessary. [Copyright &y& Elsevier]

Background: Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months.Methods/design: A three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months.Discussion: The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care.Trial Registration: ISRCTN36962030 . Registered on 17 October 2018. [ABSTRACT FROM AUTHOR]

BACKGROUND. Reported trends regarding the incidence of otitis media and antibiotic prescription rates are inconsistent. OBJECTIVE. Our goal was to assess changes in incidence of consultation rates, antibiotic prescription, and referral rates for otitis media in children over the years 1995-2003. METHODS. A cohort study including all children aged 0 to 13 years within the research database of the Netherlands University Medical Center Utrecht Primary Care Network covering the period 1995-2003. Otitis media diagnoses were recorded according to the International Classification of Primary Care codes and antibiotic prescription according to the Anatomic Therapeutic Chemical Classification System codes. Otitis media incidence rates were calculated as episodes per 1000 person-years. Antibiotic prescription and referral rates were calculated per 100 otitis media episodes. RESULTS. From 1995 to 2003, the overall general practitioner consultation rates for acute otitis media and otitis media with effusion declined by 9% and 34%, respectively. In children aged 2 to 6 years and those aged 6 to 13 years, the incidence rates of acute otitis media and otitis media with effusion declined by 15% and 41% and 40% and 48%, respectively. In children <2 years of age, the incidence rates of acute otitis media and otitis media with effusion increased by 46% and 66%, respectively. Antibiotic prescription rates for acute otitis media and otitis media with effusion increased by 45% and 25%, respectively. The referral rate for acute otitis media did not change, whereas the referral rate for otitis media with effusion increased by 45%. CONCLUSIONS. Consultation rates for otitis media have changed considerably over the last decade, and so have antibiotic prescriptions and specialist referrals. The rising antibiotic prescription rate for otitis media causes concern, because this may induce increasing medical costs and antibiotic resistance. [ABSTRACT FROM AUTHOR]

The article presents a study on the effectiveness of antibiotic-glucocorticoid eardrops and oral antibiotics as a treatment for acute otorrhea in children with tympanostomy tubes. It discusses the methods used in the study, the duration of the initial otorrhea episode, complications and adverse events related to the treatments.

Abstract: Objective: To analyse which strategies are used to promote evidence based interventions in the management of children with upper respiratory tract infections (URTIs) in daily practice. To assess the effectiveness of these interventions, and when more are effective – which works best. And to analyse the costs associated with these interventions. Methods: We systematically searched Pubmed, Embase and CENTRAL bibliographies for studies on the effectiveness of strategies aimed at changing health care professionals’ behavior in the management of children with URTIs. Results: The search yielded 11,788 references, of which 18 studies were eligible, and 10 met the inclusion criteria. Most strategies were aimed at changing antibiotic prescribing behavior in children with acute otitis media. All strategies used (i.e. computer interventions, educational sessions with or without education materials, collaborative development of guidelines and a training video in combination with a risk factor checklist) were effective in changing health care professionals practice regarding children with URTIs. Multifaceted and computer strategies work best. Computer interventions reduced antibiotic prescribing by 4% and 34% and increased guideline compliance by 41%. Educational sessions combined with education materials reduced inappropriate antibiotic prescription by 2% and 17% and increased knowledge of compliance enhancing strategies by 28% and 29%. Collaborative guideline development combined with educational materials reduced inappropriate antibiotic prescription by 24% and 40%. Finally, by a combination of a training video and a risk factor checklist appropriate referrals by the GP to the otolaryngologist increased by 37%. Since the costs associated with the interventions were not explicitly mentioned in the articles, no conclusion on cost-effectiveness can be drawn. Conclusion: Multifaceted and computer strategies appear to be most effective to put evidence into practice in the area of URTIs in children. [Copyright &y& Elsevier]

Background. Limited effectiveness of current treatment strategies for recurrent acute otitis media (RAOM) and increasing antibiotic resistance have diverted attention to prevention of AOM by vaccination. Pneumococcal vaccination for AOM seems to have only modest clinical efficacy. Thus far, the effects on health-related quality of life (HRQoL) or functional health status (FHS) have not been studied. Objective. To assess the effect of vaccination on HRQoL or FHS. Methods. In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old with RAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine followed by pneumococcal polysaccharide vaccine (pneumococcal group: n = 190) or with hepatitis A or B vaccines (control group: n = 193). Parents completed validated Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS (Rand, Functional Status Questionnaire specific, and Functional Status Questionnaire generic), otitis media-specific FHS (OM-6), otitis media-specific child HRQoL (Numerical Rating Scale for Child), family functioning (Family Functioning Questionnaire), and otitis media-specific caregiver HRQoL (Numerical Rating Scale for Caregiver). Scores were compared at baseline and at 14 and 26 months' follow-up. Results. At baseline, the average AOM incidence in the pneumococcal and control group was 5.0 (SD: 2.8) and 4.9 (SD: 2.6) episodes per year, respectively, with 38.4% and 36.8% having suffered from >6 episodes per year. AOM frequency decreased 4.4 episodes per year in both groups, with a considerable and comparable improvement in HRQoL and FHS. No substantial differences in HRQoL or FHS were found between the pneumococcal and the control group at baseline or at 14 or 26 months' follow-up. Conclusion. Pneumococcal vaccination has no beneficial effect compared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM. [ABSTRACT FROM AUTHOR]