Health Care Utilization and Prescribing Patterns for Adult Eustachian Tube Dysfunction.

OBJECTIVE: Eustachian tube dysfunction (ETD) prompts >2 million adult visits in the United States annually. While disease prevalence and health care utilization are established for children, practice patterns for adults remain unknown. Our objective was to determine national resource utilization for adult ETD. STUDY DESIGN: Cross-sectional study. SETTING: National database sample. SUBJECTS AND METHODS: The Truven Health MarketScan Databases (2010-2014) analytic cohort included health care encounters of patients ≥18 years of age with a diagnosis of ETD, otitis media with effusion, or tympanic membrane retraction. Visits associated with recent diagnoses of acute upper respiratory infection, head and neck cancer, or radiation therapy were excluded. Acute ETD (<3 months) and chronic ETD (≥3 months) were subgroups. Medication usage was quantified by class. RESULTS: ETD was diagnosed for 1,298,987 patients, 11% of which was chronic. Over 92% of patients were seen in outpatient clinics, most often by otolaryngology (57%) for chronic ETD and by general medicine (49%) for acute ETD. Medications were frequently utilized, as 530,146 (53.7%) patients received ≥1 prescription. Top prescriptions for chronic ETD included intranasal corticosteroids (22%), antibiotics (22%), oral corticosteroids (13%), and analgesics (6%). The overall annual cost of prescribed medications associated with visits in which either acute or chronic ETD was diagnosed exceeded $8.5 million for a mean of $80.78 per patient who filled a prescription. CONCLUSION: Adult ETD is frequently treated with several medication classes by a variety of provider types. Understanding the potential adverse effects and cost associated with these practices should be a priority.

Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.

BACKGROUND: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer. The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term. METHODS/DESIGN: A total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. DISCUSSION: An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS. ISRCTN: ISRCTN49798431 (Registered 7 December 2012).

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation.

BACKGROUND: Cleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate. OBJECTIVES: To identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies. DESIGN: The management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP. SETTING: The survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients' homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting. PARTICIPANTS: Clinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association. RESULTS: The clinician survey revealed that care was predominantly delivered via a 'hub-and-spoke' model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research. CONCLUSIONS: There exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered. FUNDING: The National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

BACKGROUND: There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. OBJECTIVES: To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. DESIGN: A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. SETTING: UK (professionals); East Midlands region of the UK (parents). PARTICIPANTS: Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). MAIN OUTCOME MEASURES: Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or discourage participation; and the importance of various outcome domains to them and for their children. For professionals: information on caseloads; approaches to clinical management; opinions on frequency and significance of the consequences of glue ear for this population; importance of different outcome measures; opinions of interventions and their role in future research; views on health research; facilitators and barriers to recruitment, and participation in research involving RCTs. RESULTS: The complexity of the experience and individual characteristics of children with Down syndrome poses challenges for the design of any future research but these challenges were not considered by professionals to raise sufficient barriers to prevent it being undertaken. Parents were generally supportive of the need for, and value of, research but identified practical and emotional issues that would need addressing. Glue ear was considered to impact more on speech, language and communication than on hearing. Outcome measures for future research would need to evaluate these elements but measures should be designed specifically for the population. Parents and professionals identified randomisation as a significant barrier to participation. The VOI analyses identified lack of data as problematic but concluded that a future trial involving surgical intervention would be feasible at costs of < £650,000. CONCLUSIONS: Future research into the benefits of interventions for glue ear in children with Down syndrome would be feasible and could be cost-effective but should be carefully designed to facilitate and maximise participation from parents and professionals responsible for recruitment. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Cost-utility analysis of topical intranasal steroids for otitis media with effusion based on evidence from the GNOME trial.

OBJECTIVES: To estimate the cost-effectiveness of topical intranasal steroids for the treatment of otitis media with effusion (OME) in primary care from the perspective of the UK National Health Service. METHODS: An economic evaluation was conducted based on evidence from the double-blind, randomized, placebo-controlled GPRF [General Practice Research Framework] Nasal Steroids for Otitis Media with Effusion (GNOME) trial. Participants comprised 217 children aged 4-11 years who had at least one episode of otitis media or related ear problem in the previous 12 months and had tympanometrically confirmed bilateral OME. Children were randomly allocated to receive either mometasone furoate 50 microg or placebo spray once daily into each nostril for 3 months. The main outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained for topical steroids compared with placebo. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative willingness to pay thresholds. RESULTS: Children receiving topical steroids accrued nonsignificantly higher costs (incremental cost/child: pound11, 95% confidence interval [CI]: - pound199 to pound222) and nonsignificantly fewer QALYs (incremental QALY gain/child: -0.0166, 95% CI: -0.0652 to 0.0320) than those receiving placebo. Topical steroids had a 24.19% probability of being cost-effective at a pound20,000 per QALY gained threshold, a 23.82% probability of being more effective and a 46.25% probability of being less costly. Sensitivity and subgroup analyses showed incremental costs and benefits to be highly sensitive to the methods used and the patient group considered, although differences between groups did not reach statistical significance in any analysis. CONCLUSIONS: Topical steroids are unlikely to be a cost-effective treatment for OME in general practice.

New vaccines against otitis media: projected benefits and cost-effectiveness.

OBJECTIVE: New vaccines that offer protection against otitis media caused by nontypeable Haemophilus influenzae and by Moraxella catarrhalis are under development. However, the potential health benefits and economic effects of such candidate vaccines have not been systematically assessed. METHODS: We created a computerized model to compare the projected benefits and costs of (1) the currently available 7-valent pneumococcal conjugate vaccine, (2) a candidate pneumococcal-nontypeable H influenzae vaccine that has been tested in Europe, (3) a hypothetical pneumococcal-nontypeable H influenzae-Moraxella vaccine, and (4) no vaccination. The clinical probabilities of acute otitis media and of otitis media with effusion were generated from multivariate analyses of data from 2 large health maintenance organizations and from the Pittsburgh Child Development/Otitis Media Study cohort. Other probabilities, costs, and quality-of-life values were derived from published and unpublished sources. The base-case analysis assumed vaccine dose costs of $65 for the 7-valent pneumococcal conjugate vaccine, $100 for the pneumococcal-nontypeable H influenzae vaccine, and $125 for the pneumococcal-nontypeable H influenzae-Moraxella vaccine. RESULTS: With no vaccination, we projected that 13.7 million episodes of acute otitis media would occur annually in US children aged 0 to 4 years, at an annual cost of $3.8 billion. The 7-valent pneumococcal conjugate vaccine was projected to prevent 878,000 acute otitis media episodes, or 6.4% of those that would occur with no vaccination; the corresponding value for the pneumococcal-nontypeable H influenzae vaccine was 3.7 million (27%) and for the pneumococcal-nontypeable H influenzae-Moraxella vaccine was 4.2 million (31%). Using the base-case vaccine costs, pneumococcal-nontypeable H influenzae vaccine use would result in net savings compared with nontypeable 7-valent pneumococcal conjugate use. Conversely, pneumococcal-nontypeable H influenzae-Moraxella vaccine use would not result in savings compared with pneumococcal-nontypeable H influenzae vaccine use, but would cost $48 000 more per quality-adjusted life-year saved. The results were sensitive to variations in assumptions on vaccine effectiveness and vaccine dose costs but not to variations in other assumptions. CONCLUSIONS: New candidate vaccines against otitis media have the potential to prevent millions of disease episodes in the United States annually. If priced comparably with other recently introduced vaccines, these new otitis vaccines could achieve cost-effectiveness comparable with or more favorable than that of the 7-valent pneumococcal conjugate vaccine.

Cost of treating otitis media in Australia.

OBJECTIVE: Otitis media (OM) is an inflammation of the middle ear. It is very common and associated with serious complications, including hearing loss. This study aimed to estimate the treatment costs of OM in Australia and the associated burden of disease (in disability-adjusted life-years). METHODS: Little Australia-wide epidemiological information is available, so international studies in the main were used to estimate the incidence and prevalence by age and gender. These were triangulated against the available Australian data. Australian health data sets and data collected from the emergency department of a tertiary pediatric hospital were used to estimate the costs of primary care, pharmaceuticals, pathology and imaging, emergency department presentations, specialists, and admitted hospital care. RESULTS: Excluding the costs of the complications and comorbidities associated with OM, treatment costs for the disease in 2008 were between AUS$100 and 400 million. Visits to general practitioners and medicines constituted a high proportion of these costs. Antibiotic prescribing rates remain high despite clear evidence for a limited benefit from antibiotics for most OM cases and concerns regarding bacterial resistance. CONCLUSION: Treatment costs of OM in Australia are high and can only be estimated within a broad range. Further research on the links between antibiotics for OM and antibiotic resistance, and on the cost-effectiveness of prevention or amelioration of OM would be useful.

Tympanostomy tubes for otitis media: quality-of-life improvement for children and parents.

We measured quality of life issues for both children and their parents on the premise that parental quality of life should be an aspect of cost-effectiveness in otitis media treatment. The patients were less than 18 years of age and had had myringotomy with tube insertion at the head and neck surgery department of a large health maintenance organization. Quality of life for patients, parents, and caregivers was evaluated by telephone survey of parents or caregivers and by retrospective chart review of the number of pre- and postoperative healthcare visits and antibiotic usage. Chart review showed a significant postoperative reduction in the number of clinic visits and in use of antibiotic drugs after insertion of tympanostomy tubes. Improved postoperative hearing was noted, and tympanostomy tube insertion was shown to be safe. The chart-review cost analysis showed that tympanostomy tube insertion is a cost-effective treatment for otitis media in children, and the telephone survey results showed that it improves quality of life for children and their parents or other caregivers.

Treating acute otitis media post-PCV-7: judicious antibiotic therapy.

Acute otitis media (AOM) is treated with antibiotics in the United States, but the changing distribution of bacterial pathogens that cause the disorder can present physicians with several challenges. Most physicians treat AOM empirically, and their treatment choice should target Streptococcus pneumonia, nontypeable Haemophilus influenzae, and Moraxella catarrhalis, as those bacteria are most often isolated in AOM. First-line treatment for new onset AOM remains amoxicillin (80-90 mg/kg/d, divided twice daily). For persistent or recurrent AOM, guidelines recommend high-dose amoxicillin-clavulanate, cefdinir, cefprozil, cefpodoxime, cefuroxime, or ceftriaxone. Improved diagnosis and optimizing the choice of therapy by considering in vitro and in vivo efficacy of the different antibiotics will improve patient outcomes. Improved patient outcomes will result in fewer AOM episodes, decreased antibiotic resistance, and reduced direct and indirect health care costs.

[Cost-efficiency analysis of treatment of otitis media with effusion in children]. / Análisis de coste-efectividad del tratamiento de la otitis media serosa infantil.

Otitis media with effusion is a common disorder in children, associated to hearing loss and recurrent acute otitis media. It has three basic treatments: Spontaneous resolution, oral antibiotics and surgery including adenoidectomy and/or grommets insertion. Through a sensibility analysis on a theoretical group of 1000 patients our aim is to study the cost-effectiveness of the different therapeutic options, evaluating direct and indirect costs, and identifying the most efficient option (cost-effective). We analysed effectiveness and variable costs of each arm of the decision tree, considering initial and rescue treatments. As expected, effectiveness grows up to the most through treatment, including adenoidectomy and grommets insertion, from 92% to 98% of children treated. Nevertheless, unitary cost of each child treated also increases, from 302 to 401 euros; that is, choosing the most cost-effective treatment enables to save approximately 100 euros per child. But, fixed costs, which are much higher (600 euros per child), will not change, limiting our management resources.

Análisis de coste-efectividad del tratamiento de la otitis media serosa infantil / Cost-effectiveness analysis of treatment of otitis media with effusion in children

La otitis media serosa (OMS) es una enfermedad muy frecuente en la infancia, estando relacionada con el desarrollo de hipoacusia y episodios de otitis media aguda de repetición. Las alternativas terapéuticas para la misma son básicamente tres: la evolución espontánea, el tratamiento con antibióticos orales, o la cirugía de adenoides y/o drenajes timpánicos. Mediante un análisis de decisión sobre un grupo teórico de 1.000 pacientes se pretende estudiar el coste-efectividad de las alternativas terapéuticas, valorando el coste directo y el coste indirecto de cada una, llegando a identificar la opción más eficiente (coste-efectiva). Se analiza la efectividad y el coste variable de cada rama del árbol de decisión, considerando el tratamiento inicial y el de rescate. La efectividad es creciente hasta la opción terapéutica más completa, que incluye adenoidectomía y drenajes timpánicos, desde el 92 por ciento hasta el 98 por ciento de los niños tratados. Sin embargo, también se incrementa el coste de cada niño que es curado con esta última opción, desde 302 euros a 401 euros; es decir, la elección del tratamiento más coste-efectivo de la OMS infantil permite un ahorro de unos 100 euros por niño tratado. No obstante, los costes fijos del proceso, que son mucho mayores (600 euros por niño), no varían, limitando nuestra capacidad de gestión (AU)

Otitis media with effusion is a common disorder in children, associated to hearing loss and recurrent acute otitis media. It has three basic treatments: Spontaneous resolution, oral antibiotics and surgery including adenoidectomy and/or grommets insertion. Through a sensibility analysis on a theoretical group of 1000 patients our aim is to study the cost-effectiveness of the different therapeutic options, evaluating direct and indirect costs, and identifying the most efficient option (cost-effective). We analysed effectiveness and variable costs of each arm of the decision tree, considering initial and rescue treatments. As expected, effectiveness grows up to the most through treatment, including adenoidectomy and grommets insertion, from 92% to 98% of children treated. Nevertheless, unitary cost of each child treated also increases, from 302 to 401 euros; that is, choosing the most cost-effective treatment enables to save approximately 100 euros per child. But, fixed costs, which are much higher (600 euros per child), will not change, limiting our management resources (AU)

Medical and surgical management of otitis media in children.

OM, though frequent and seemingly simple to evaluate and manage, remains a treatment challenge. Increasingly sophisticated clinical trials assessing OM medical treatment efficacy and outcome have demonstrated that many treatment regimens that were commonly used a decade ago are no longer recommended. Surgical therapy for OM, though remaining the same, has come under intense scrutiny from several angles but still plays a central role for this disease. Given the multiple facets of OM, its frequency, and its potential to cause short- and long-term morbidity in children, the next decade is sure to bring further treatment innovations.

Laser assisted myringotomy for otitis media with effusion in children.

Otitis media with effusion (OME) is a common childhood illness/disease and a major health care priority in the United States. This article describes a minimally invasive, office-based procedure, effectively used to treat OME.

Economic evaluation of ventilation tubes in otitis media with effusion.

OBJECTIVE: To determine the costs and effectiveness of treatment with ventilation tubes as compared with watchful waiting in children with persistent otitis media with effusion. DESIGN: Randomized controlled trial. SETTING: Institutional practice. PATIENTS: A total of 187 young children (19 months old) with persistent bilateral otitis media with effusion. INTERVENTIONS: Treatment with ventilation tubes or watchful waiting. MAIN OUTCOME MEASURES: The time without effusion, language development, and the costs from a societal perspective during 1-year follow-up. RESULTS: The mean duration of effusion was 9.2 months in the watchful waiting group and 4.7 months in the ventilation tube group. The language development was comparable in both groups (0.7 month of improvement difference [95% confidence interval, -0.3 to 1.7 months] after correction for confounding variables). Because no statistically significant differences were found in the language development between the treatment groups, we performed a cost minimization analysis. The mean costs per child during 1 year of follow-up were 454 US dollars in the ventilation tube group and 120 US dollars in the watchful waiting group. On average, an additional investment of 334 US dollars per patient was needed for ventilation tube treatment. CONCLUSION: In the absence of differences in language development and in view of higher costs, treatment with ventilation tubes is not recommended as standard treatment in all young children with persistent otitis media with effusion traced by a population-based screening program.

Management of otitis media using Agency for Health Care Policy and Research guidelines. The Agency for Health Care Policy and Research.

Increased costs of managing otitis media and its complications may result from delays in diagnosis and treatment. The Agency for Health Care Policy and Research developed guidelines to assist in the management of chronic otitis media with effusion. We examined the medical care adherence to Agency for Health Care Policy and Research guidelines in 59 consecutive patients referred because of chronic otitis media with effusion and recurrent acute otitis media. Patient history and examination data were collected prospectively. In the group with chronic otitis media with effusion, the rate of adherence to Agency for Health Care Policy and Research guidelines was 0%; in those with recurrent acute otitis media, adherence was 5%. Delayed referral occurred in 34% of patients; 25% of patients were referred early. The average duration of effusion in patients with chronic otitis media with effusion was 5.2 months; the duration of recurrent acute otitis media immediately before referral was 9.3 months. Eighteen patients (47%) in the chronic otitis media with effusion group had a history of recurrent chronic otitis media with effusion spanning an average of 22.7 months. On referral, hearing loss was discovered in 92% of all patients, and in 69% the tympanogram was flat. The complication and sequelae rate was 49.1%, and speech delay was the most frequent at 16.9%. We conclude that in our study patients there is a significant referral delay, long history of chronic otitis media with effusion in patients before referral, high rate of hearing loss, and high complication rate. Continued efforts should be directed toward improving education of all clinicians so that diagnostic tools and timely otolaryngologic referral are better used.

Otitis media health status evaluation: a pilot study for the investigation of cost-effective outcomes of recurrent acute otitis media treatment.

There are no reliable and valid instruments that measure otitis media clinical or functional health status in children ages 1 to 3 years. This study develops and tests three new instruments of clinical and functional otitis health status: the Otitis Media Clinical Severity Index (OM-CSI), the Otitis Media Functional Status Questionnaire (OM-FSQ), and the Otitis Media Diary (OMD). The OM-CSI was found to be a reliable measure of clinical acute otitis media (AOM) severity, with high internal consistency (Cronbach's alpha) scores, as well as an accurate indicator of AOM severity. The OM-FSQ and OMD were demonstrated to be reliable and valid measures of otitis-specific functional health status, with reproducible scores over time, high internal consistency alpha scores, and high correlation with measures of AOM clinical severity and other functional health status instruments. These three new instruments were also sensitive and specific indicators of AOM episodes.

Cost-effectiveness considerations in otitis media treatment.

The costs of treatment of children with otitis media with effusion comprise a substantial part of the total health care expenditure. However, there is little information about the value of therapy expressed in cost-effectiveness terms, and disagreement still exists about optimal therapy. This article considers the elements of cost-effectiveness analysis as they pertain to treatment of young children with otitis media with effusion and develops a first approximation model using data from several sources. The assumptions on which this model is based need to be validated by additional research. Otitis media with effusion treatment costs are high because of the large, and apparently increasing, number of symptomatic cases. Medical therapy, which is the primary treatment modality, consumes two thirds of the expenditures for otitis media with effusion. Surgical therapy is a cost-effective treatment for children in whom medical therapy for otitis media with effusion fails. Medical and surgical therapy are complementary, and each should be included in the analysis of cost-effectiveness.