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.

Mapping analyses to estimate health utilities based on responses to the OM8-30 Otitis Media Questionnaire.

PURPOSE: To investigate the statistical relationship between the OM8-30 health-related quality of life measure for children with otitis media with effusion (OME) and measures of health utility (Health Utilities Index [HUI] Mark 3 and Mark 2) and to develop models to estimate HUI3 and HUI2 health utilities from OM8-30 scores. METHODS: A placebo-controlled, randomised trial (GNOME) evaluating intranasal mometasone in 217 children with OME provided concurrent responses to OM8-30 and HUI at three time points. Ordinary least squares (OLS), generalised linear models and two-step regression analyses were used to predict HUI3 and HUI2 utilities based on OM8-30 facet and domain scores. RESULTS: OLS models including all nine OM8-30 facets with or without predicted hearing level (HL) produced the best predictions of HUI3 utilities (mean absolute error: 0.134 with HL and 0.132 without; R(2): 0.63 with HL and 0.596 without). An OLS model predicting HUI3 utilities based on the two OM8-30 domain scores, reported hearing difficulties, predicted HL, age and sex also produced accurate predictions. CONCLUSION: Regression equations predicting HUI3 and HUI2 utilities based on OM8-30 facet and domain scores have been developed. These provide an empirical basis for estimating quality-adjusted life years (QALYs) for interventions in children with OME.

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial.

OBJECTIVE: To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion. DESIGN: Double blind randomised placebo controlled trial. SETTING: 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007. PARTICIPANTS: 217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types). INTERVENTION: Mometasone furoate 50 microg or placebo spray given once daily into each nostril for three months. MAIN OUTCOME MEASURES: Proportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported. CONCLUSIONS: Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.

Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial.

CONTEXT: Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched. OBJECTIVE: To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis. DESIGN, SETTING, AND PATIENTS: A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged > or =16 years) with acute nonrecurrent sinusitis (had > or =2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid. INTERVENTION: A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days. MAIN OUTCOME MEASURES: Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms. RESULTS: The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline. CONCLUSION: Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN60825437.

Consultations for middle ear disease, antibiotic prescribing and risk factors for reattendance: a case-linked cohort study.

BACKGROUND: Otitis media is the most common reason for children to receive antibiotics, but there is no evidence about the effect of prescribing on reattendance. AIM: To evaluate the changing workload of middle ear disease in general practice, and the impact on surgery reattendance of prescribing antibiotics at first attendance. DESIGN OF STUDY: A case-linked cohort analysis for antibiotic prescribing versus no prescribing at first consultation event. SETTING: Two hundred and ninety-one practices spread throughout the UK recording for the General Practice Research Database (GPRD) and incorporating individual patient data records for 2,265,574 patients. METHOD: All middle ear disease coded events that can be classed within acute otitis media (AOM) or glue ear sub-categories (and excluding chronic suppurative otitis media) were selected for analysis when the first event was from 1991-2001. The effect of antibiotic prescription on the risk of reattendance using Cox proportional hazards regression was analysed. RESULTS: Total consultations for AOM have fallen markedly over this decade, and glue ear consultations have risen but by a much smaller extent (26,000 decrease versus 4000 increase in consultations per year), which makes relabelling an unlikely explanation of the fall in AOM consultations. In the 2-10 years age range, consultations for AOM fell from 105.3 to 34.7 per 1000 per year, with glue ear consultations unaltered (15.2 to 16.7 per 1000 per year). Antibiotic prescribing for AOM has stayed remarkably constant (80-84% of consultations), but antibiotic prescribing for glue ear has risen sharply (13 to 62%). Prescribing antibiotics increased the risk of reattendance for AOM (hazard ratio [HR] = 1.09, 95% confidence interval [CI] = 1.07 to 1.10) and has reduced the risk of reattendance for glue ear (HR = 0.92, 95% CI = 0.88 to 0.96). CONCLUSION: Prescribing antibiotics for AOM probably increased reattendance, but the opposite effect has been noted for glue ear, which suggests a treatment effect of antibiotics in glue ear. Further research is needed to clarify whether this possible benefit is worth the known harms, and if so in which subgroups of children.