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.

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.

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.

Optimal site for throat culture: tonsillar surface versus posterior pharyngeal wall.

To determine the optimal site of throat culture for the detection of potential pathogens by comparing culture results from the tonsillar surface and the posterior pharyngeal wall in children selected for adenotonsillectomy and in children without upper respiratory disease. Cotton culture swabs were taken from the tonsillar surface and the posterior pharyngeal wall of 50 children selected for adenotonsillectomy for symptoms of recurrent tonsillitis and/or adenotonsillar hypertrophy and of 50 children without upper respiratory disease. Potential respiratory pathogens were identified. In the overall group (n = 100), positive culture results were found in 67 posterior pharyngeal wall samples and 47 tonsillar surface samples (P = 0.001). Haemophilus influenzae was the most frequently isolated micro-organism both in the posterior pharyngeal wall and the tonsillar surface samples; 55 and 35%, respectively (P = 0.001). Group A beta-haemolytic streptococci were found in the samples of the posterior pharyngeal wall and the tonsillar surface in 17 and 13%, respectively (P = 0.2). When dealing with patients with sore throat, sampling both tonsillar surfaces is enough for the detection of group A beta-haemolytic streptococci. When detection of other bacteria is also important, such as for research purposes, the posterior pharyngeal wall should be sampled as well.

Adenoidectomy and/or tonsillectomy in childhood is not associated with atopic disease later in life.

OBJECTIVE: To investigate the association between adenoidectomy and/or tonsillectomy in childhood and asthma, allergic rhinitis (AR), and eczema in adolescence. METHODS: Longitudinal birth cohort study of 1328 members born in the city of Nijmegen. Information on ear-nose-throat surgery was documented at 2, 4, and 8 years of age. In 1055 cohort members the incidence of asthma, AR, and eczema at 21 years of age was determined using the International Study of Asthma and Allergic disease in Childhood Core Questionnaire. To analyse the association between adenoidectomy and/or tonsillectomy in childhood and asthma, AR, and eczema at age 21 years, relative risks (RR) were calculated. RESULTS: Six hundred and ninety-three (66%) members completed the questionnaire at age 21 years, of whom 104 (15%) had undergone adenoidectomy and/or tonsillectomy and 262 (38%) reported atopic disease. Children who underwent adenoidectomy and/or tonsillectomy before the age of 8 years were not more likely to develop asthma, AR, or eczema at the age of 21 years than children who did not; RR 0.93 (95% confidence limits (CL) 0.52-1.64), RR 0.94 (CL 0.68-1.30), and RR 1.00 (CL 0.59-1.68), respectively. CONCLUSIONS: Our data show no association between adenoidectomy and/or tonsillectomy in childhood and the incidence of atopic disease in young adults.

Recurrent childhood upper respiratory tract infections do not reduce the risk of adult atopic disease.

BACKGROUND: Children of large families and those attending day care are at increased risk of respiratory tract infections, which in turn may protect against the development of allergic disease. Longitudinal studies investigating these associations beyond childhood are, however, scarce. OBJECTIVE: To investigate the association between childhood recurrent upper respiratory tract infections (URTI) and asthma, allergic rhinitis (AR) and eczema in adulthood. METHODS: A birth cohort of 1055 members followed prospectively from the ages of 2 to 21 years. Detailed information on URTI between the ages of 2 and 4 years was collected at 3 monthly intervals in a standardized interview. At the age of 8 years, a parental questionnaire regarding URTI between the ages of 4 and 8 years was used. The incidence of asthma and atopic disease at the age of 21 years was determined using a standardized questionnaire. RESULTS: Of the original cohort, 693 (66%) members completed the questionnaire. Children who experienced recurrent URTI before the age of 2 years, between the ages of 2-4 years and between ages of 4 and 8 years were not less likely to have asthma at 21 years of age than children who did not experience recurrent URTI, relative risk (RR) 0.97 (95% confidence interval (CI) 0.65-1.46), RR 1.45 (CI 0.95-2.21) and RR 1.51 (CI 0.97-2.36), respectively. Neither were recurrent URTI associated with a decreased risk of AR, nor eczema at the age of 21 years. CONCLUSIONS: Recurrent URTI in childhood did not reduce the risk of atopic disease in young adulthood.

[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.

The impact of recurrent acute otitis media on the quality of life of children and their caregivers.

OBJECTIVE: To assess the quality of life of 384 Dutch children aged 1-7 years with recurrent acute otitis media (AOM), and compare it with that of children from four reference populations: (i) children from a general population; (ii) children with mild-to-moderate asthma, (iii) children with mild-to-moderately severe chronic illness, and (iv) US children with persistent or recurrent otitis media. DESIGN: Survey. SETTING: A general and an academic hospital (study population of children with recurrent AOM, n = 384); general population (n = 225 and 117); primary care (children with asthma, n = 64); community care (children with chronic illness, n = 82); and a general hospital (children with persistent or recurrent otitis media, n = 169). PARTICIPANTS: A total of 384 children aged 1-7 years who had experienced at least two episodes of AOM in the preceding year and their caregivers. MAIN OUTCOME MEASURES: Generic and disease-specific quality of life as judged by the children's caregivers. Age-adjusted total and subscale scores were compared with those of the reference populations. RESULTS: For all generic questionnaires, children with recurrent AOM had poorer scores than children from the general population. Quality of life of children with four or more episodes of AOM in the preceding year was poorer than that of children with two to three episodes. Children with recurrent AOM scored lower on the health-related questionnaire than children with mild-to-moderately severe chronic illness. Quality of life of the present study population was similar to those of children with asthma and US children with chronic otitis media with effusion or recurrent AOM. CONCLUSION: Recurrent AOM has a considerable negative impact on the quality of life of children and causes concern to their caregivers. These effects are proportional to the severity of the condition. Professionals involved in the care of children with OM should be aware that OM not only affects physical functioning but also general well-being of the child and its family. These outcomes should therefore be included in the evaluation of the child with otitis media both in the clinical and research setting.

Rationale and design of the prevention of respiratory infections and management in children (PRIMAKid) study: a randomized controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections.

Health and economic burden of recurrent respiratory tract infections (RTIs) in early childhood is considerable. A systematic review of licensed influenza and pneumococcal vaccines showed substantial efficacy in children, but the health-economic impact of such vaccines among pre-school children with recurrent RTIs is unknown. We therefore, designed a double-blind randomized controlled trial to determine the effectiveness and costs of a combined influenza and pneumococcal vaccination program among a primary care based cohort of children with recurrent episodes of RTI aged between 18 and 72 months. We will enroll 690 children over three consecutive years (2003--2005) who will be randomly allocated to receive vaccinations against influenza and pneumococcal disease, influenza alone or hepatitis B in a similar schedule. Follow up by parental diaries, tympanic temperature measurements, questionnaires and interviews is planned until May 2006. Primary outcome is number of febrile RTIs. Other outcomes include duration and severity of RTI episodes, medical consumption, safety and costs.

Large international differences in (adeno)tonsillectomy rates.

This article compares recent paediatric and adolescent (adeno)tonsillectomy (T +/- Ads) rates in several countries of the European Union, the US, Canada and Australia. Trends in paediatric and adolescent surgical rates in the Netherlands and UK from 1974 to 1998 are studied as well. In 1998, the paediatric T +/- Ads rate varied from 19 per 10000 children in Canada to 118 per 10000 in Northern Ireland, while the adolescent rate varied from 19 per 10000 adolescents in Canada to 76 per 10000 in Finland. In the Netherlands, the paediatric T +/- Ads rate decreased rapidly between 1974 and 1985 and remained similar since. Ten years later, between 1985 and 1998, the adolescent T +/- Ads rate increased. In the UK, on the other hand, an increase in T +/- Ads was observed both in children and in adolescents. This study shows that paediatric and adolescent T +/- Ads rates still vary considerably between countries. There is no definitive evidence that decreasing rates of T +/- Ads in childhood are associated with tonsil-related disease, necessitating surgery, in later life.

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.

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.

[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.

[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.