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The Special Sense Organs and Their Disorders
Published in Walter F. Stanaszek, Mary J. Stanaszek, Robert J. Holt, Steven Strauss, Understanding Medical Terms, 2020
Walter F. Stanaszek, Mary J. Stanaszek, Robert J. Holt, Steven Strauss
Material for cultures may be obtained by performing a tympanocentesis, which involves piercing the eardrum with a sterile needle and collecting fluid from the middle
Acute Otitis Media
Published in John C Watkinson, Raymond W Clarke, Christopher P Aldren, Doris-Eva Bamiou, Raymond W Clarke, Richard M Irving, Haytham Kubba, Shakeel R Saeed, Paediatrics, The Ear, Skull Base, 2018
Tympanometry may be used to establish the presence of a middle ear effusion but is not usually available. Tympanocentesis and culture of middle ear effusion have been used in a number of studies assessing diagnostic accuracy of clinical signs, and establishing the organisms prevalent in a community. It is rarely required to make the diagnosis, though may be considered in high-risk children such as the immunocompromised, an unwell neonate, those that fail to respond to conventional treatment, and children who are seriously ill or have complications of AOM. Taking a bacterial swab of persistent otorrhoea following perforation is recommended. Nasopharyngeal swabbing for bacterial culture has been assessed but the correlation with middle ear organisms has been too weak to recommend it clinically.11
Gatifloxacin
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
James Owen Robinson, Keryn Christiansen
These phase II studies were followed by two multicentre, single-blind comparative trials in children aged 6 months to 7 years. (Sher et al., 2005; Saez-Llorens et al., 2005). Gatifloxacin suspension (10 mg/kg once daily) was compared to amoxicillin/clavulanic acid (90 mg/6.4 mg in two divided doses) for 10 days in patients with recurrent AOM or non-responsive AOM as defined previously. Equivalence was demonstrated in both studies, 84.7% for gatifloxacin vs. 78.6% for amoxicillin/clavulanic acid (Sher et al., 2005), and 90.2% versus 84.3%, respectively (Saez-Llorens et al., 2005). Because tympanocentesis was not performed routinely on all patients, bacteriological cure rates were obtained on small numbers of patients but were comparable for both antibiotics. All of the studies described just above demonstrated good clinical success rates in patients likely to have higher rates of resistant organisms due to prior antibiotic selective pressure. The safety of gatifloxacin in children was of particular concern and was specifically addressed in all studies—the results of which were published separately (Pichichero et al., 2005; see section 6, Adverse reactions and toxicity). The use of the 8-methoxy-fluoroquinolones in the treatment of multidrug-resistant childhood AOM is not standard practice (Dagan et al., 2004).
Confidence intervals for assessing equivalence of two treatments with combined unilateral and bilateral data
Published in Journal of Applied Statistics, 2022
However, individuals may produce either unilateral data (e.g. data from only one organ) or bilateral data (e.g. data from two organs) in many medical comparative studies (e.g. otolaryngologic or ophthalmologic studies). For example, to evaluate the efficacy of two antibiotics (i.e. Cefaclor and Amoxicillin) for the treatment of otitis media with effusion (OME) in an otolaryngologic study, Mandel et al. [15] considered a randomized double-blinded clinical trial. In this trial, a total of 214 children (293 ears) underwent unilateral or bilateral tympanocentesis before they were randomly assigned to one of the two treatments. After a 14-day course of treatment with one of the antibiotics, the outcome of each child was recorded at the end of the treatment. In this study, only 203 evaluable children without repeat tympanocentesis, treatment change or tympanic membrane perforations have received one of the treatments. For the group with unilateral disease, two results were determined: cured and not-cured; and for the group with bilateral disease, three results, i.e. cured (both ears become OME-cured), partially cured (only one ear becomes OME-cured) and both ears are not cured were recorded. The data are reported in Table 1.
Acute otitis media pneumococcal disease burden and nasopharyngeal colonization in children due to serotypes included and not included in current and new pneumococcal conjugate vaccines
Published in Expert Review of Vaccines, 2023
Michael Pichichero, Richard Malley, Ravinder Kaur, Robert Zagursky, Porter Anderson
A systematic literature search of MEDLINE database was conducted to identify articles related to AOM and NP colonization published from January 2016 to September 2021 in the following regions and countries: South Asia: India and Bangladesh; Southeast Asia: Indonesia and Thailand; Europe: Belgium, Germany, Finland, France, Switzerland, Italy, Spain, Iceland and Sweden; Israel; and USA. We searched PubMed for articles with the following Title/Abstract terms: (Streptococcus pneumoniae) OR pneumococcal AND serotype AND (conjugate vaccine). All articles were screened in a 2-step process, (1) title/abstract and (2) full-text review. Only articles from the pre-specified countries that included serotype-specific information relating to AOM or NP colonization in children were included. Articles written in non-English languages and related to IPD were excluded. Relevant data were extracted from the included articles: 1. Region/ country; 2. Subject age; 3. Years involved in data collection; 4. Health status (AOM disease or healthy) 5. Type of sample collection (NP or spontaneous perforation of tympanic membrane (SPTM) or tympanocentesis-obtained middle ear fluid); 6. Number of subjects in the study cohort; 7. Number of pneumococcal isolates serotyped; 8. Method of serotyping (Quellung or polymerase-chain reaction); 9. Dominant serotypes; 10. Anticipated coverage of serotyped pneumococcal isolates by PCV10 manufactured by GlaxoSmithKline (PCV10GSK) and PCV13 manufactured by Pfizer and by newer PCVs: PCV10 manufactured by the Serum Institute of India (PCV10SII), PCV15 manufactured by Merck and PVC20 manufactured by Pfizer.
Testing homogeneity of difference of two proportions for stratified correlated paired binary data
Published in Journal of Applied Statistics, 2018
To demonstrate the performance of aforementioned test methods, we consider the data regarding a double-blind randomized clinical trial. This study was conducted by Mandel [9] for comparing cefaclor and amoxicillin for the treatment of acute otitis media with effusion in children with bilateral tympanocentesis. Children were randomly assigned to two groups, and children in each group receive a 14-day course with one of two antibiotics (amoxicillin or cefaclor). The number of cured ears for each child was recorded at the end of treatment period. According to the stratum determined by children's age, we summarize the observed data in Table 9.