Roderick P. Venekamp

A trial of treatment for acute otorrhea in children with tympanostomy tubes.

BACKGROUND Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics. METHODS In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops (76 children) or oral amoxicillin-clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events. RESULTS Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with antibiotic-glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, -39 percentage points; 95% confidence interval [CI], -51 to -26) and 55% of those treated with initial observation (risk difference, -49 percentage points; 95% CI, -62 to -37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks. CONCLUSIONS Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1481.).

Parent-reported otorrhea in children with tympanostomy tubes: incidence and predictors.

Purpose Although common in children with tympanostomy tubes, the current incidence of tympanostomy tube otorrhea (TTO) is uncertain. TTO is generally a sign of otitis media, when middle ear fluid drains through the tube. Predictors for otitis media are therefore suggested to have predictive value for the occurrence of TTO. Objective To determine the incidence of TTO and its predictors. Methods We performed a cohort study, using a parental web-based questionnaire to retrospectively collect data on TTO episodes and its potential predictors from children younger than 10 years of age with tympanostomy tubes. Results Of the 1,184 children included in analyses (total duration of time since tube placement was 768 person years with a mean of 7.8 months per child), 616 children (52%) experienced one or more episodes of TTO. 137 children (12%) had TTO within the calendar month of tube placement. 597 (50%) children had one or more acute TTO episodes (duration <4 weeks) and 46 children (4%) one or more chronic TTO episodes (duration ≥4 weeks). 146 children (12%) experienced recurrent TTO episodes. Accounting for time since tube placement, 67% of children developed one or more TTO episodes in the year following tube placement. Young age, recurrent acute otitis media being the indication for tube placement, a recent history of recurrent upper respiratory tract infections and the presence of older siblings were independently associated with the future occurrence of TTO, and can therefore be seen as predictors for TTO. Conclusions Our survey confirms that otorrhea is a common sequela in children with tympanostomy tubes, which occurrence can be predicted by age, medical history and presence of older siblings.

Impact of early daycare on healthcare resource use related to upper respiratory tract infections during childhood: prospective WHISTLER cohort study

BackgroundDaycare attendance is an established risk factor for upper respiratory tract infections (URTI) and acute otitis media (AOM). Whether this results in higher use of healthcare resources during childhood remains unknown. We aim to assess the effect of first year daycare attendance on the timing and use of healthcare resources for URTI and AOM episodes during early childhood.MethodsIn the Wheezing-Illnesses-STudy-LEidsche-Rijn birth cohort, 2,217 children were prospectively followed up to age six years. Children were categorized according to first-year daycare attendance (yes versus no) and age at entry when applicable (age 0 to 2 months, 3 to 5 months and 6 to 12 months). Information on general practitioner (GP) diagnosed URTI and AOM, GP consultations, antibiotic prescriptions and specialist referral was collected from medical records. Daycare attendance was recorded by monthly questionnaires during the first year of life.ResultsFirst-year daycare attendees and non-attendees had similar total six-year rates of GP-diagnosed URTI and AOM episodes (59/100 child-years, 95% confidence interval 57 to 61 versus 56/100 child-years, 53 to 59). Daycare attendees had more GP-diagnosed URTI and AOM episodes before the age of one year and fewer beyond the age of four years than non-attendees (Pinteraction <0.001). Daycare attendees had higher total six-year rates for GP consultation (adjusted rate ratio 1.15, 1.00 to 1.31) and higher risk for specialist referrals (hazard ratio: 1.43, 1.01 to 2.03). The number of antibiotic prescriptions in the first six years of life was only significantly increased among children who entered daycare between six to twelve months of age (rate ratio 1.32, 1.04 to 1.67). This subgroup of child-care attendees also had the highest overall URTI and AOM incidence rates, GP consultation rates and risk for specialist referral.ConclusionsChildren who enter daycare in the first year of life, have URTI and AOM at an earlier age, leading to higher use of healthcare resources compared to non-attendees, especially when entering daycare between six to twelve months. These findings emphasize the need for improved prevention strategies in daycare facilities to lower infection rates at the early ages.

Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

Background: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis. Methods: We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7. Results: Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval −7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups. Interpretation: Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register registration no. 1295 (www.trialregister.nl/trialreg/index.asp).

Bilateral cochlear implantation in children and the impact of the inter‐implant interval

To determine the effectiveness of simultaneous versus sequential bilateral cochlear implantation on postoperative outcomes in children with bilateral deafness and to evaluate the impact of the inter‐implant interval and age at second implantation on postoperative outcomes in children who already received their first cochlear implant.

Acute otorrhea in children with tympanostomy tubes: Prevalence of bacteria and viruses in the post-pneumococcal conjugate vaccine era

Background: Acute tympanostomy-tube otorrhea is a common sequela in children with tympanostomy tubes. Acute tympanostomy-tube otorrhea is generally a symptom of an acute middle ear infection, whereby middle ear fluid drains through the tube. The widespread use of pneumococcal conjugate vaccination (PCV) has changed the bacterial prevalence in the upper respiratory tract of children, but its impact on bacterial and viral pathogens causing acute tympanostomy-tube otorrhea is yet unknown. Methods: This study was performed in the post-PCV7 era parallel to a randomized clinical trial of the clinical and cost–effectiveness of ototopical and systemic antibiotics and initial observation in 230 children aged 1 to 10 years with untreated, uncomplicated acute tympanostomy-tube otorrhea. Otorrhea and nasopharyngeal samples were collected at baseline (before treatment) and at 2 weeks (after treatment). Conventional bacterial culture was performed followed by antimicrobial-resistance assessment. Viruses were identified by polymerase chain reaction. Results: At baseline, Haemophilus influenzae (41%), Staphylococcus aureus (40%) and Pseudomonas aeruginosa (18%) were the most prevalent bacteria in otorrhea, followed by Streptococcus pneumoniae (7%) and Moraxella catarrhalis (4%). Most pneumococci were non-PCV7 serotypes. Viruses were detected in 45 otorrhea samples at baseline (21%). Most infections were polymicrobial and overall antimicrobial resistance was low. Conclusions: H. influenzae, S. aureus and P. aeruginosa are the most common microorganisms in children with untreated uncomplicated acute tympanostomy-tube otorrhea. Prevalence of S. pneumoniae has decreased since the introduction of PCV and most pneumococci are nonvaccine serotypes.

Absence of evidence for enhanced benefit of antibiotic therapy on recurrent acute rhinosinusitis episodes: a systematic review of the evidence base

Objective To systematically review the evidence base on the effectiveness of short-course antibiotic therapy in adult patients with a recurrent episode of acute rhinosinusitis as part of a disease pattern on severity and duration of symptoms and recurrences. Data Sources PubMed, EMBASE, and the Cochrane Library. Review Methods A comprehensive search was performed up to March 21, 2013. Articles reporting studies on the effects of short-course antibiotic therapy compared with placebo in patients with recurrent acute rhinosinusitis were included. For included articles, the design of reported studies was assessed for directness of evidence and risk of bias. Results In total, 3473 unique publications were retrieved, of which 30 were considered eligible based on title and abstract screening. In addition, 8 eligible articles were retrieved using cross-reference checking. Based on full-text evaluation, none of the retrieved 38 articles satisfied our predefined selection criteria. They did not compare antibiotic treatment with placebo, excluded patients with recurrent acute rhinosinusitis, or did not report findings for a subgroup of patients with recurrent acute rhinosinusitis. Conclusion and Recommendation To date, there is no evidence available on differences in effect of antibiotic therapy in primary or sporadic and recurrent episodes of acute rhinosinusitis. As such, decisions for or against initial antibiotic therapy in patients with recurring episodes of acute rhinosinusitis should be based on the same criteria used in managing primary or sporadic episodes of uncomplicated acute rhinosinusitis.

Limited Evidence Higher Efficacy of Nasal Saline Irrigation over Nasal Saline Spray in Chronic Rhinosinusitis—An Update and Reanalysis of the Evidence Base

Objective To assess the effectiveness of nasal saline irrigation in adult patients with chronic rhinosinusitis. Data Sources PubMed, EMBASE, the Cochrane Library. Review Methods A comprehensive search was performed, and 2 authors independently screened publications. The design of selected studies was assessed on directness of evidence and risk of bias. Results Of 1596 publications, 1 open-label randomized trial with high directness of evidence and moderate risk of bias was included. In this study, 127 patients were randomly allocated to isotonic nasal saline irrigation or isotonic nasal saline spray, as added to their usual medication. The mean 20-Item Sinonasal Outcome Test (SNOT-20) scores of those treated with nasal irrigation improved more than those allocated to nasal spray. While the authors consider an improvement of 16 or more to be clinically meaningful, the changes from baseline in mean SNOT-20 scores of those treated with irrigation (and the differences with those treated with nasal spray) at 2, 4, and 8 weeks were 12.2 (difference 5.5, [95% confidence interval −0.04 to 11.0]), 16.2 (difference 8.8 [3.2 to 14.4]), and 15.0 (difference 6.5 [0.4 to 12.6]), respectively. Side effects of posttreatment nasal dripping were common but minor and did not lead to discontinuation of treatment. Conclusion and Recommendation It should be explained to adult patients with chronic rhinosinusitis that there is limited information on the relative effect of nasal saline irrigation and nasal saline spray on subjective symptom improvement, since there is only 1 trial available with a moderate risk of bias showing limited benefit of irrigation over spray.

Cost-effectiveness of treatment of acute otorrhea in children with tympanostomy tubes

BACKGROUND: Acute otorrhea is a common problem in children with tympanostomy tubes. We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation. The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition. METHODS: We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments: hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension, and initial observation (no assigned medication prescription to fill). Parents kept a daily diary capturing ear-related symptoms, health care resource use, and non–health care costs for 6 months. At 2 weeks and 6 months, the study doctor visited the children at home performing otoscopy. Using a societal perspective, treatment failure (otoscopic presence of otorrhea at 2 weeks) and number of days with otorrhea as reported in the daily diary were balanced against the costs. RESULTS: Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months. At 2 weeks, mean total cost per patient was US

Limited Evidence for Effects of Intranasal Corticosteroids on Symptom Relief for Recurrent Acute Rhinosinusitis

42.43 for antibiotic-glucocorticoid eardrops, US