An evaluation of the quality of evidence available to inform current bone conducting hearing device national policy.

OBJECTIVES: In 2016, NHS England published the commissioning policy on Bone Conducting Hearing Devices (BCHDs). This policy was informed by updated evidence on the clinical and cost-effectiveness of BCHDs as well as by the 2013 Bone Anchored Hearing Aid (BAHA) policy. Commissioning policies set the criteria for service delivery and therefore have a major impact on the care received by patients. It is important that stakeholders have a good appreciation of the available evidence informing policy, as this will promote engagement both with the policy and with future research leading on from the policy. In this article, we provide stakeholders with a transparent and pragmatic assessment of the quality of the body of evidence available to inform current BCHD national policy. METHOD: (i) A systematic review of the literature on BCHDs published since the development of the 2013 policy was performed in September 2016, adhering to PRISMA recommendations. The search terms used were as follows bone conduction; bone conducting; bone anchor; BAHA; Bone Anchored Hearing Aid; Bone Conducting Hearing Device; BCHD; Bone Conducting Hearing Implant; BCHI; Sophono; Bonebridge; Soundbite; Ponto; Hearing aid; implant; device; hearing device. Publications that could inform current BCHD policy were included. The quality of included articles was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. (ii) The quality of evidence referenced by the 2013 BAHA policy was assessed using the GRADE system. RESULTS: (i) Of the 2576 publications on BCHDs identified by the systematic search, 39 met the inclusion criteria for further analysis. Using the GRADE criteria, the quality of evidence was classified as of 'very low quality'. (ii) The 2013 BAHA policy was informed by 14 references. The GRADE system classifies the quality of evidence that informed the policy as of 'very low quality'. CONCLUSIONS: The GRADE system defines the body of evidence available to inform current national BCHD policy as of 'very low quality'. There is an urgent need for high-quality research to help make informed policy decisions about the care of patients with hearing loss. An (inter)national registry of BCHDs could address this need.

Current indications for adenoidectomy in a sample of children in the Netherlands.

OBJECTIVE: To study current indications for adenoidectomy in Dutch children. METHODS: During 6 months, ENT surgeons in 1 academic and 7 general hospitals in the Netherlands filled out a questionnaire concerning all children below 15 years of age that were selected for adenoidectomy either as a single procedure or combined with myringotomy or tympanostomy tube placement. This questionnaire collected data on patient characteristics, ENT history, and indication(s) for the procedure. RESULTS: Questionnaires were returned on 159 children. The study population was comparable to the general population of children undergoing adenoidectomy in the Dutch Health Care Services database concerning age and sex. Adenoidectomy alone was performed in 38%, adenoidectomy and myringotomy in 15%, and adenoidectomy and tympanostomy tube placement in 47%. In children selected for adenoidectomy alone, indications were recurrent upper respiratory tract infections or chronic rhinosinusitis in 60%, persistent otitis media with effusion or recurrent acute otitis media in 33%, and obstructive symptoms in 42%. In children selected for adenoidectomy and myringotomy and those selected for adenoidectomy and tympanostomy tube placement, indications were persistent otitis media with effusion or recurrent acute otitis media in 96% and 99%, recurrent upper respiratory tract infections or chronic rhinosinusitis in 88% and 59%, and obstructive symptoms in 33% and 24%, respectively. CONCLUSION: In Dutch ENT practices, almost two-thirds of adenoidectomies are combined with myringotomy or tympanostomy tube placement. The most common indication for adenoidectomy combined with myringotomy or tympanostomy tubes is middle ear disease. For adenoidectomy alone, recurrent upper respiratory tract infection is the most common indication.

[Three children with recurrent meningitis as the result of an anatomical defect]. / Drie kinderen met recidiverende meningitis als gevolg van een anatomische afwijking.

Three children, a 12-year-old girl, a 5-year-old boy and a 5-year-old girl, were referred with recurrent episodes of meningitis. After an immunological defect had been ruled out early in the diagnostic work-up, the cause appeared to be an anatomical defect. After surgical treatment, no further meningitis occurred. Recurrent meningitis in children is rare. Anatomical defects, congenital or acquired, in the otorhinolaryngological area are the main cause. Conscientious history taking, careful physical examination and imaging using high-definition cranial computed tomography are important in establishing the diagnosis. In order to minimise the risk of another episode of meningitis, the otorhinolaryngologist should be consulted immediately in the diagnostic and therapeutic process and this process should be completed as soon as possible.

Natural course of tympanic membrane pathology related to otitis media and ventilation tubes between ages 8 and 18 years.

OBJECTIVE: To present the course of tympanic membrane pathology in childhood and young adulthood after otitis media (OM) in early life. STUDY DESIGN: Prospective follow-up study. SETTING: Community study of a birth cohort. PATIENTS: Three hundred fifty-eight subjects with a positive and negative history of OM (OM+ or OM-) or ventilation tube insertion (VT+ or VT-) derived from a birth cohort that had been followed-up from preschool to adult age. METHODS: Standardized otomicroscopic examination performed at ages 8 and 18 years. MAIN OUTCOME MEASURES: Tympanic membrane abnormalities (i.e., tympanosclerosis, atrophy, atelectasis and retraction pockets of the pars tensa, and retraction of the pars flaccida). RESULTS: At the age of 8 years, tympanic membrane pathology was highly prevalent in the both OM+ subcohorts (OM+VT+, 92% and OM+VT-, 46%), whereas in the OM- ears (11%), tympanic membrane abnormalities were rare. In the subsequent 10-year period, many tympanic membrane abnormalities disappeared spontaneously, although the prevalence of tympanosclerosis remained substantial in the OM+VT+ cohort. CONCLUSION: The natural course of most tympanic membrane pathology associated with OM in early life is favorable over time, suggesting an intrinsic repair capacity of the tympanic membrane. Tympanosclerosis, the most prevalent sequelae of OM and treatment with VT, however, shows little tendency of resolution.

National differences in incidence of acute mastoiditis: relationship to prescribing patterns of antibiotics for acute otitis media?

BACKGROUND: Operating on the principle that most acute otitis media (AOM) episodes resolve without antibiotics, doctors in the Netherlands usually manage AOM in children with initial observation. Prescription of antibiotics is limited to children with a complicated course of AOM and those categorized as high risk. Consequently only 31% of patients with AOM receives antibiotics, compared with >90% in most other countries. OBJECTIVE: To substantiate the suggestion that this restrictive use of antibiotics leads to a higher incidence of acute mastoiditis. METHODS: A comparative study across several European countries, Canada, Australia and the United States was performed in the period 1991 to 1998. The incidence rate of acute mastoiditis was defined as the total number of patients age 14 years and younger discharged from all hospitals with the primary diagnosis of acute mastoiditis, during a specified period (usually 5 years), divided by the number of person years (py) in that same age range and period. The latter was calculated by totaling the midyear population estimate of children age 14 years and younger of each year. The 95% confidence intervals and incidence rate ratios were calculated to compare the observed rates. RESULTS: The incidence rate of acute mastoiditis in the Netherlands, with a low antibiotic prescription rate for AOM, was 3.8/100,000 py; in Norway and Denmark, with high prescription rates, the incidence rate was comparable at 3.5/100,000 py and 4.2/100,000 py, respectively. In all other countries with very high prescription rates, incidence rates were considerably lower, ranging from 1.2 to 2.0/100,000 py. The incidence rate in the Netherlands was about twice that in the United States (rate ratio, 0.5). CONCLUSION: The incidence rate of acute mastoiditis in the Netherlands is higher than in many countries with higher antibiotic prescription rates. Although the potential benefits of restricted use of antibiotics (i.e. cost reduction, fewer side effects from antibiotics and less antimicrobial resistance) are beyond dispute, such strategy may be associated with a somewhat higher incidence of acute mastoiditis.

Pneumococcal vaccines for preventing otitis media.

BACKGROUND: Acute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Long term effects of recurrent episodes of otitis media, rapid emergence of drug resistant bacteria associated with AOM worldwide and huge estimated direct and indirect annual costs associated with otitis media have emphasized the need for an effective vaccination program to prevent episodes of AOM. OBJECTIVES: The object of this review was to assess the effect of pneumococcal vaccination in preventing AOM in children up to 12 years of age. SEARCH STRATEGY: We searched the Cochrane Acute Respiratory Infection Group specialised register (last update, 26th April 2001), the Cochrane Library (Issue 4, 2000), MEDLINE (January 1966-August 2000) and reference list of all studies and review articles retrieved. We also contacted two vaccine manufacturers and first or corresponding authors of some included studies. SELECTION CRITERIA: Randomised controlled clinical trials of pneumococcal vaccination with prevention of AOM as outcome in children aged 12 years or younger and a follow-up of at least six months. DATA COLLECTION AND ANALYSIS: Five reviewers independently assessed trial quality and two reviewers extracted data. Two study authors were contacted. MAIN RESULTS: Eight trials on pneumococcal polysaccharide vaccine (PPV) and two trials on pneumococcal conjugate vaccine (PCV) were included. The highest efficacy of PPV was found in children aged 24 months and older: the rate ratio after adjustment for study was 0.833 [95%CI: 0.625-0.970]. The PPV has little effect on the prevention of AOM in children without documented prior episodes of AOM and only a moderate effect in the group of children with documented AOM episodes prior to vaccination. The results of the two PCV trials in healthy infants, which followed children from the age of two months until two years of age, could not be pooled because of lack of data. Both studies showed that the risk of recurrent disease decreased with 9% in the group of children receiving the PCV together with other childhood vaccinations at 2,4,6 and 14 months of age: Study Black et al 2000 : risk ratio=0.91[95%CI:0.86-0.96]; Study Eskola et al 2001: risk ratio=0.90 [95%CI:0.73-1.12]. REVIEWER'S CONCLUSIONS: Based on the currently available results of the effectiveness of pneumococcal vaccination for the prevention of AOM, a large scale use of pneumococcal vaccination for this indication is not recommended. The results of currently ongoing trials could provide more information whether pneumococcal vaccines are effective in specific high-risk (otitis-prone) populations.

Pneumococcal vaccines for preventing otitis media.

BACKGROUND: Acute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Long term effects of recurrent episodes of otitis media, rapid emergence of drug resistant bacteria associated with AOM worldwide and huge estimated direct and indirect annual costs associated with otitis media have emphasized the need for an effective vaccination program to prevent episodes of AOM. OBJECTIVES: The object of this review was to assess the effect of pneumococcal vaccination in preventing AOM in children up to 12 years of age. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 2, 2003) which contains the Cochrane Acute Respiratory Infection Group's specialised register (30th June 2003), MEDLINE (January 1966 to June 2003), EMBASE (January 1990 to June 2003) and reference lists of all studies and review articles retrieved. We also contacted two vaccine manufacturers and first or corresponding authors of some of the included studies. SELECTION CRITERIA: Randomised controlled clinical trials of pneumococcal vaccination with prevention of AOM as outcome in children aged 12 years or younger and a follow-up of at least six months after vaccination. DATA COLLECTION AND ANALYSIS: Five reviewers independently assessed trial quality and two reviewers extracted data. Two study authors were contacted. MAIN RESULTS: Eight trials on 8-to 14-valent pneumococcal polysaccharide vaccine (PPV) and four trials on 7-to 9-valent pneumococcal conjugate vaccine (PCV) were included. The highest efficacy of PPV was found in children aged 24 months and older: the rate ratio was 0.779 [95% CI: 0.625-0.970]. PPV has little effect on the prevention of AOM in children without documented prior episodes of AOM and only a moderate effect in the group of children with documented AOM episodes prior to vaccination. Pooled results of the four PCV trials in infants vaccinated as early as two months of age and toddlers attending daycare and toddlers with recurrent AOM showed only a small effect on prevention of AOM (rate ratio 0.921; 95% CI: 0.894-0.950). REVIEWER'S CONCLUSIONS: Based on the currently available results of the effectiveness of pneumococcal vaccination for the prevention of AOM, a large scale use of pneumococcal polysaccharide and conjugate vaccination for this specific indication is not yet recommended. So far, pneumococcal conjugate vaccinations are not indicated in the management of recurrent AOM in toddlers and older children. The results of currently ongoing trials of 9- and 11-valent conjugate vaccines should provide more information as to whether pneumococcal vaccines are more effective in specific high-risk populations like infants and older children with recurrent AOM or immunodeficiency.

Assessment of complications of the condition and of the treatment of otitis media with effusion.

Persistent otitis media with effusion (OME) may cause long-term changes of the tympanic membrane and middle ear, resulting in some degree of hearing loss. One of the traditional aims of treatment with ventilation tubes is to prevent these complications from developing. Ventilation tubes themselves, however, are also known to induce changes of the tympanic membrane. Several recent studies have addressed the questions: what are the effects of the disease, and what are the result of its treatment? The object of this study was to present the state of the art, by literature review, regarding structural and functional complications of OME and treatment with ventilation tubes. In both observational and experimental studies tympanosclerosis is reported to occur in 39-65% of ears treated with ventilation tubes as opposed to 0-10% of untreated ears. For segmental atrophy these percentages are 16-73 and 5-31, respectively. Regarding the prevalence of atelectasis and attic retraction, the difference between ventilated and untreated ears is less: 10-37% as opposed to 1-20% for atelectasis, and 10-52% as opposed to 29-40% for attic retraction. The average hearing loss associated with these tympanic membrane abnormalities is less than 5 dB. Although ventilation tubes have proven very effective in improving hearing in the short term, they have not proven effective in preventing long-term changes of the tympanic membrane related to OME, nor in keeping some degree of hearing loss from developing.

Tympano-ossicular allografts for cholesteatoma in children.

At the Sint Augustinus Hospital, Antwerp, Belgium, all children with cholesteatoma are operated by a canal wall up approach and immediate reconstruction with a tympano-ossicular allograft. In the majority of the cases, a second stage is performed after 1 year. This paper presents the results of a retrospective review of the charts of 103 consecutive children treated between 1979 and 1995. The mean patient age was 10 years and the mean postoperative follow-up was 4.5 years. In 28 children residual cholesteatoma was found at the second stage operation and 20 developed recurrent cholesteatoma in the course of time. So far no residual cholesteatoma surfaced after the staged procedure, but 11 children needed more than two operations to control recurrent disease. An intact, trouble-free graft was present in 79 children at the latest follow-up. The median postoperative bone-conduction thresholds were equal to the preoperative thresholds. The median postoperative air-conduction thresholds improved in 50% of the cases, remained unchanged in 25%, and deteriorated in 25% of the cases. It is concluded that the tympano-ossicular allograft technique is effective and safe and offers good anatomical and acceptable functional results.

Developmental implications of early-life otitis media.

This symposium addressed possible relationships between early-life otitis media (OM) and various components of child development. The existence and nature of such relationships are of substantial theoretical and practical consequence. Particularly at issue are policies concerning optimal frequencies of examination and screening for middle-ear disease as well as the relative appropriateness of conservative vs. aggressive regimens of management.

Current indications for (adeno)tonsillectomy in children: a survey in The Netherlands.

OBJECTIVE: Despite the fact that (adeno)tonsillectomy is one of the procedures most frequently performed on children, studies of current indications are scarce. The purpose of this study is to determine the indications for (adeno)tonsillectomy in children younger than 15 years of age according to Dutch ENT surgeons and general practitioners (GPs). METHODS: During a period of 8 months, 18 ENT surgeons in seven ENT practices and 210 referring GPs filled out standard questionnaires for 349 children listed for tonsil surgery. RESULTS: Apart from recurrent tonsillitis (ENT: 40%, GP: 35%), findings such as enlarged tonsils (ENT: 42%, GP: 24%) and tonsillar crypt debris (ENT: 29%, GP: 17%) and non-specific symptoms such as listlessness (ENT: 28%, GP: 19%) and poor appetite (ENT: 28%, GP: 16%) were considered important criteria for surgery. Symptoms of obstructive sleep apnea were present in 25% (ENT) and 6% (GP) of patients but were considered indicative for surgery in only 11% (ENT) and 4% (GP). In contrast to ENT surgeons, GPs considered otitis media and hearing loss relatively important for (adeno)tonsillectomy. CONCLUSIONS: Apart from the generally accepted indications such as recurrent tonsillitis and obstructive sleep apnea, other indications play an equally important role in the decision to perform tonsil surgery in The Netherlands.

The effects of early bilateral otitis media with effusion on educational attainment: a prospective cohort study.

The relationship between long-lasting, bilateral otitis media with effusion (OME) between the ages of 2 and 4 and educational attainment, in particular, reading and spelling ability at 7 years of age, was studied in a prospective cohort study of 946 children. After selection, three groups were distinguished: 151 children with long-lasting, bilateral OME at preschool age, 37 preschool children treated with ventilation tubes, and 82 children with no history of OME at that age. Early bilateral OME was found to affect spelling ability, but not reading ability, at 7 years. The effects of OME did not appear to increase with the number of observations of OME. Also, recurrent hearing loss did not have more detrimental effects than continuous hearing loss. Effects of treatment with ventilation tubes were not found. Only the teachers' ratings of writing ability indicated a slight advantage of treatment with ventilation tubes. In conclusion, the educational consequences of early OME appear to be very small.

[Neurological complication in 3 children with acute otitis media]. / Neurologische complicaties bij 3 kinderen met otitis media acuta.

Three boys aged 6, 7 and 4 years, had experienced fever, vomiting, headache and/or an otorrhoea for about a week. Then the clinical picture of acute otitis media exacerbated by a thrombosis of a sigmoid sinus in the 4- and 6-year-old and by brain infarcts in the 7-year-old. Treatment consisted of antibiotics and the youngest two also underwent surgery. The 6-year-old made a good recovery, the 7-year-old retained motor aphasia and hemiparalysis and the 4-year-old died. Although the incidence of acute otitis media complications has decreased since the widespread introduction of antibiotics, the complications are severe enough to warrant particular care in the treatment of these patients. The early recognition of a complicated acute otitis media and the immediate start of an appropriate therapy may lower the morbidity and mortality rates associated with this condition.

[Obstruction of the nose in newborns]. / Neusobstructie bij de pasgeborene.

Five newborns, 4 girls and 1 boy, presented with breathing and feeding difficulties caused by obstruction of the nose. The causes were choanal atresia, apertura pyriformis stenosis, teratoma, glioma and haemangioma. Following surgical treatment the children were symptom-free. Rapid diagnosis and treatment of these conditions are essential. An alternative airway should be created if a newborn suffers from breathing problems. Diagnostic work-up includes flexible laryngo-endoscopy followed by MRI- or CT-scan. Treatment is usually surgical.

[Adenotonsillectomy in children: not yet scientifically validated]. / Adenotonsillectomie bij kinderen: nog onvoldoende wetenschappelijk onderbouwd.

Tonsillectomy, in 90% of cases combined with adenoidectomy, is one of the most frequently carried out operations on children in the Netherlands: in 1998 there were 33,471 operations in children aged 0-14 years. This high frequency is in stark contrast to the scientific basis for the efficacy of this intervention. A meta-analysis carried out recently revealed just one good study. The lack of scientifically based clinical guidelines, partly explains the large international and regional differences in the number of operations carried out. In the Netherlands only 35% of the children operated on satisfy one of the criteria for which the effectiveness of (adeno)tonsillectomy has been established: frequent recurrent tonsillitis or obstructive sleep apnoea. A project has been started in the Netherlands to further study the effectiveness of this intervention, the results of which must contribute to a more thoroughly substantiated indication.

[Vaccination against acute otitis media]. / Vaccinatie tegen otitis media acuta.

Acute otitis media (AOM) is the most frequent bacterial infection in childhood. Because of the high morbidity, the costs of AOM and growing concern about increasing resistance of pneumococci, the most common bacterial cause of AOM, prevention of AOM is important. Vaccination with the recently developed pneumococcal conjugate vaccines leads to a reduction in the number of AOM cases caused by the serotypes present in the vaccine, but the reduction in overall AOM incidence is below 10%. In particular the children with recurrent episodes of AOM may benefit more from these pneumococcal conjugate vaccines.

Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial.

OBJECTIVE: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN: Open randomised controlled trial. SETTING: 11 general hospitals and two academic centres. PARTICIPANTS: 111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy. INTERVENTION: A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting. Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months). SECONDARY OUTCOME MEASURES: days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life. RESULTS: During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval -0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery. CONCLUSION: In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting. Trial registration Dutch Trial Register NTR968: ISRCTN03720485.

Otitis media across nine countries: disease burden and management.

OBJECTIVE: To assess the perceived disease burden and management of otitis media (OM) among an international cohort of experienced physicians. METHODS: A cross-sectional survey conducted in France, Germany, Spain, Poland, Argentina, Mexico, South Korea, Thailand and Saudi Arabia. Face-to-face interviews conducted with 1800 physicians (95% paediatricians, 5% family practitioners).Main outcome measures were the perceived burden on clinical practice (number of cases, complications and referrals) and first- and second-line management strategies for OM. Results are expressed as mean and range across the nine countries over three continents. RESULTS: Respondents estimated an average annual caseload of 375 (range 128-1003) children under 5 years of age with OM; 54% (range 44-71%) with an initial episode and 38% (range 27-54%) with recurrent OM (ROM). OM with complications was estimated to be approximately 20 (range 7-49) cases per year and an estimated 15% (8-41%) of children with OM was recalled as needing specialist referral. There was high awareness of Streptococcus pneumoniae and Haemophilus influenzae as causative bacterial pathogens: 77% (range 65-91%) and 74% (range 68-83%), respectively, but less recognition of non-typeable H. influenzae (NTHi); 59% (range 45-67%). Although concern over antimicrobial resistance was widespread, empirical treatment with antibiotics was the most common first-line treatment (mean 81%, range 40-96%). The burden of disease is substantial enough that many physicians would consider vaccination to prevent OM (mean score 5.1, range 4.3-6.2 on 1-7 scale). CONCLUSIONS: This large, multinational survey shows that OM remains a significant burden for clinical practice. Despite awareness of shortcomings, antimicrobial therapy remains the most frequent treatment for OM.